Hospital Medicine

Study Overview

Objective: To determine whether fractional flow reserve (FFR)–guided percutaneous coronary intervention (PCI) is noninferior to coronary-artery bypass grafting (CABG) in patients with 3-vessel coronary artery disease (CAD).

Design: Investigator-initiated, multicenter, international, randomized, controlled trial conducted at 48 sites.

Setting and participants: A total of 1500 patients with angiographically identified 3-vessel CAD not involving the left main coronary artery were randomly assigned to receive FFR-guided PCI with zotarolimus-eluting stents or CABG in a 1:1 ratio. Randomization was stratified according to trial site and diabetes status.

Main outcome measures: The primary end point was major adverse cardiac or cerebrovascular event, defined as death from any cause, myocardial infarction (MI), stroke, or repeat revascularization. The secondary end point was defined as a composite of death, MI, or stroke.

Results: At 1 year, the incidence of the composite primary end point was 10.6% for patients with FFR-guided PCI and 6.9% for patients with CABG (hazard ratio [HR], 1.5; 95% CI, 1.1-2.2; P = .35 for noninferiority), which was not consistent with noninferiority of FFR-guided PCI compared to CABG. The secondary end point occurred in 7.3% of patients in the FFR-guided PCI group compared with 5.2% in the CABG group (HR, 1.4; 95% CI, 0.9-2.1). Individual findings for the outcomes comprising the primary end point for the FFR-guided PCI group vs the CABG group were as follows: death, 1.6% vs 0.9%; MI, 5.2% vs 3.5%; stroke, 0.9% vs 1.1%; and repeat revascularization, 5.9% vs 3.9%. The CABG group had more extended hospital stays and higher incidences of major bleeding, arrhythmia, acute kidney injury, and rehospitalization within 30 days than the FFR-guided PCI group.

Conclusion: FFR-guided PCI was not found to be noninferior to CABG with respect to the incidence of a composite of death, MI, stroke, or repeat revascularization at 1 year.

Commentary

Revascularization for multivessel CAD can be performed by CABG or PCI. Previous studies have shown superior outcomes in patients with multivessel CAD who were treated with CABG compared to PCI.^1-3 The Synergy between PCI with Taxus and Cardiac Surgery (SYNTAX) trial, which compared CABG to PCI in patients with multivessel disease or unprotected left main CAD, stratified the anatomic complexity based on SYNTAX score and found that patients with higher anatomic complexity with a high SYNTAX score derive larger benefit from CABG compared to PCI.⁴ Therefore, the current guidelines favor CABG over PCI in patients with severe 3-vessel disease, except for patients with a lower SYNTAX score (<22) without diabetes.^5,6 However, except for a smaller size study,³ the previous trials that led to this recommendation used mostly first-generation drug-eluting stents and have not evaluated second-generation stents that have lower rates of in-stent restenosis and stent thrombosis. In addition, there have been significant improvements in PCI techniques since the study period, including the adoption of a radial approach and superior adjunct pharmacologic therapy. Furthermore, previous studies have not systematically investigated the use of FFR-guided PCI, which has been shown to be superior to angiography-guided PCI or medical treatment alone.^7-9

In this context, Fearon and the FAME-3 trial investigators studied the use of FFR-guided PCI with second-generation zotarolimus drug-eluting stents compared to CABG in patients with 3-vessel CAD. They randomized patients with angiographically identified 3-vessel CAD in a 1:1 ratio to receive FFR-guided PCI or CABG at 48 sites internationally. Patients with left main CAD, recent ST-elevation MI, cardiogenic shock, and left-ventricular ejection fraction <30% were excluded. The study results (composite primary end point incidence of 10.6% for patients with FFR-guided PCI vs 6.9% in the CABG group [HR, 1.5; 95% CI, 1.1-2.2; P = 0.35 for noninferiority]) showed that FFR-guided PCI did not meet the noninferiority criterion.

Although the FAME-3 study is an important study, there are a few points to consider. First, 24% of the lesions had a FFR measured at >0.80. The benefit of FFR-guided PCI lies in the number of lesions that are safely deferred compared to angiography-guided PCI. The small number of deferred lesions could have limited the benefit of FFR guidance compared with angiography. Second, this study did not include all comers who had angiographic 3-vessel disease. Patients who had FFR assessment of moderate lesions at the time of diagnostic angiogram and were found to have FFR >0.80 or were deemed single- or 2-vessel disease were likely treated with PCI. Therefore, as the authors point out, the patients included in this study may have been skewed to a higher-risk population compared to previous studies.

Third, the study may not reflect contemporary interventional practice, as the use of intravascular ultrasound was very low (12%). Intravascular ultrasound–guided PCI has been associated with increased luminal gain and improved outcomes compared to angiography-guided PCI.¹⁰ Although 20% of the patients in each arm were found to have chronic total occlusions, the completeness of revascularization has not yet been reported. It is possible that the PCI arm had fewer complete revascularizations, which has been shown in previous observational studies to be associated with worse clinical outcomes.^11,12

Although the current guidelines favor CABG over PCI in patients with multivessel disease, this recommendation is stratified by anatomic complexity.⁶ In fact, in the European guidelines, CABG and PCI are both class I recommendations for the treatment of 3-vessel disease with low SYNTAX score in patients without diabetes.⁵ Although the FAME-3 study failed to show noninferiority in the overall population, when stratified by the SYNTAX score, the major adverse cardiac event rate for the PCI group was numerically lower than that of the CABG group. The results from the FAME-3 study are overall in line with the previous studies and the current guidelines. Future studies are necessary to assess the outcomes of multivessel PCI compared to CABG using the most contemporary interventional practice and achieving complete revascularization in the PCI arm.

Applications for Clinical Practice

In patients with 3-vessel disease, FFR-guided PCI was not found to be noninferior to CABG; this finding is consistent with previous studies.

—Shubham Kanake, BS, Chirag Bavishi, MD, MPH, and Taishi Hirai, MD, University of Missouri, Columbia, MO

Disclosures: None.

Study Overview

Objective: To determine whether fractional flow reserve (FFR)–guided percutaneous coronary intervention (PCI) is noninferior to coronary-artery bypass grafting (CABG) in patients with 3-vessel coronary artery disease (CAD).

Design: Investigator-initiated, multicenter, international, randomized, controlled trial conducted at 48 sites.

Setting and participants: A total of 1500 patients with angiographically identified 3-vessel CAD not involving the left main coronary artery were randomly assigned to receive FFR-guided PCI with zotarolimus-eluting stents or CABG in a 1:1 ratio. Randomization was stratified according to trial site and diabetes status.

Main outcome measures: The primary end point was major adverse cardiac or cerebrovascular event, defined as death from any cause, myocardial infarction (MI), stroke, or repeat revascularization. The secondary end point was defined as a composite of death, MI, or stroke.

Results: At 1 year, the incidence of the composite primary end point was 10.6% for patients with FFR-guided PCI and 6.9% for patients with CABG (hazard ratio [HR], 1.5; 95% CI, 1.1-2.2; P = .35 for noninferiority), which was not consistent with noninferiority of FFR-guided PCI compared to CABG. The secondary end point occurred in 7.3% of patients in the FFR-guided PCI group compared with 5.2% in the CABG group (HR, 1.4; 95% CI, 0.9-2.1). Individual findings for the outcomes comprising the primary end point for the FFR-guided PCI group vs the CABG group were as follows: death, 1.6% vs 0.9%; MI, 5.2% vs 3.5%; stroke, 0.9% vs 1.1%; and repeat revascularization, 5.9% vs 3.9%. The CABG group had more extended hospital stays and higher incidences of major bleeding, arrhythmia, acute kidney injury, and rehospitalization within 30 days than the FFR-guided PCI group.

Conclusion: FFR-guided PCI was not found to be noninferior to CABG with respect to the incidence of a composite of death, MI, stroke, or repeat revascularization at 1 year.

Commentary

Revascularization for multivessel CAD can be performed by CABG or PCI. Previous studies have shown superior outcomes in patients with multivessel CAD who were treated with CABG compared to PCI.^1-3 The Synergy between PCI with Taxus and Cardiac Surgery (SYNTAX) trial, which compared CABG to PCI in patients with multivessel disease or unprotected left main CAD, stratified the anatomic complexity based on SYNTAX score and found that patients with higher anatomic complexity with a high SYNTAX score derive larger benefit from CABG compared to PCI.⁴ Therefore, the current guidelines favor CABG over PCI in patients with severe 3-vessel disease, except for patients with a lower SYNTAX score (<22) without diabetes.^5,6 However, except for a smaller size study,³ the previous trials that led to this recommendation used mostly first-generation drug-eluting stents and have not evaluated second-generation stents that have lower rates of in-stent restenosis and stent thrombosis. In addition, there have been significant improvements in PCI techniques since the study period, including the adoption of a radial approach and superior adjunct pharmacologic therapy. Furthermore, previous studies have not systematically investigated the use of FFR-guided PCI, which has been shown to be superior to angiography-guided PCI or medical treatment alone.^7-9

In this context, Fearon and the FAME-3 trial investigators studied the use of FFR-guided PCI with second-generation zotarolimus drug-eluting stents compared to CABG in patients with 3-vessel CAD. They randomized patients with angiographically identified 3-vessel CAD in a 1:1 ratio to receive FFR-guided PCI or CABG at 48 sites internationally. Patients with left main CAD, recent ST-elevation MI, cardiogenic shock, and left-ventricular ejection fraction <30% were excluded. The study results (composite primary end point incidence of 10.6% for patients with FFR-guided PCI vs 6.9% in the CABG group [HR, 1.5; 95% CI, 1.1-2.2; P = 0.35 for noninferiority]) showed that FFR-guided PCI did not meet the noninferiority criterion.

Although the FAME-3 study is an important study, there are a few points to consider. First, 24% of the lesions had a FFR measured at >0.80. The benefit of FFR-guided PCI lies in the number of lesions that are safely deferred compared to angiography-guided PCI. The small number of deferred lesions could have limited the benefit of FFR guidance compared with angiography. Second, this study did not include all comers who had angiographic 3-vessel disease. Patients who had FFR assessment of moderate lesions at the time of diagnostic angiogram and were found to have FFR >0.80 or were deemed single- or 2-vessel disease were likely treated with PCI. Therefore, as the authors point out, the patients included in this study may have been skewed to a higher-risk population compared to previous studies.

Third, the study may not reflect contemporary interventional practice, as the use of intravascular ultrasound was very low (12%). Intravascular ultrasound–guided PCI has been associated with increased luminal gain and improved outcomes compared to angiography-guided PCI.¹⁰ Although 20% of the patients in each arm were found to have chronic total occlusions, the completeness of revascularization has not yet been reported. It is possible that the PCI arm had fewer complete revascularizations, which has been shown in previous observational studies to be associated with worse clinical outcomes.^11,12

Although the current guidelines favor CABG over PCI in patients with multivessel disease, this recommendation is stratified by anatomic complexity.⁶ In fact, in the European guidelines, CABG and PCI are both class I recommendations for the treatment of 3-vessel disease with low SYNTAX score in patients without diabetes.⁵ Although the FAME-3 study failed to show noninferiority in the overall population, when stratified by the SYNTAX score, the major adverse cardiac event rate for the PCI group was numerically lower than that of the CABG group. The results from the FAME-3 study are overall in line with the previous studies and the current guidelines. Future studies are necessary to assess the outcomes of multivessel PCI compared to CABG using the most contemporary interventional practice and achieving complete revascularization in the PCI arm.

Applications for Clinical Practice

In patients with 3-vessel disease, FFR-guided PCI was not found to be noninferior to CABG; this finding is consistent with previous studies.

—Shubham Kanake, BS, Chirag Bavishi, MD, MPH, and Taishi Hirai, MD, University of Missouri, Columbia, MO

Disclosures: None.

Study Overview

Objective: To determine whether fractional flow reserve (FFR)–guided percutaneous coronary intervention (PCI) is noninferior to coronary-artery bypass grafting (CABG) in patients with 3-vessel coronary artery disease (CAD).

Design: Investigator-initiated, multicenter, international, randomized, controlled trial conducted at 48 sites.

Setting and participants: A total of 1500 patients with angiographically identified 3-vessel CAD not involving the left main coronary artery were randomly assigned to receive FFR-guided PCI with zotarolimus-eluting stents or CABG in a 1:1 ratio. Randomization was stratified according to trial site and diabetes status.

Main outcome measures: The primary end point was major adverse cardiac or cerebrovascular event, defined as death from any cause, myocardial infarction (MI), stroke, or repeat revascularization. The secondary end point was defined as a composite of death, MI, or stroke.

Results: At 1 year, the incidence of the composite primary end point was 10.6% for patients with FFR-guided PCI and 6.9% for patients with CABG (hazard ratio [HR], 1.5; 95% CI, 1.1-2.2; P = .35 for noninferiority), which was not consistent with noninferiority of FFR-guided PCI compared to CABG. The secondary end point occurred in 7.3% of patients in the FFR-guided PCI group compared with 5.2% in the CABG group (HR, 1.4; 95% CI, 0.9-2.1). Individual findings for the outcomes comprising the primary end point for the FFR-guided PCI group vs the CABG group were as follows: death, 1.6% vs 0.9%; MI, 5.2% vs 3.5%; stroke, 0.9% vs 1.1%; and repeat revascularization, 5.9% vs 3.9%. The CABG group had more extended hospital stays and higher incidences of major bleeding, arrhythmia, acute kidney injury, and rehospitalization within 30 days than the FFR-guided PCI group.

Conclusion: FFR-guided PCI was not found to be noninferior to CABG with respect to the incidence of a composite of death, MI, stroke, or repeat revascularization at 1 year.

Commentary

Revascularization for multivessel CAD can be performed by CABG or PCI. Previous studies have shown superior outcomes in patients with multivessel CAD who were treated with CABG compared to PCI.^1-3 The Synergy between PCI with Taxus and Cardiac Surgery (SYNTAX) trial, which compared CABG to PCI in patients with multivessel disease or unprotected left main CAD, stratified the anatomic complexity based on SYNTAX score and found that patients with higher anatomic complexity with a high SYNTAX score derive larger benefit from CABG compared to PCI.⁴ Therefore, the current guidelines favor CABG over PCI in patients with severe 3-vessel disease, except for patients with a lower SYNTAX score (<22) without diabetes.^5,6 However, except for a smaller size study,³ the previous trials that led to this recommendation used mostly first-generation drug-eluting stents and have not evaluated second-generation stents that have lower rates of in-stent restenosis and stent thrombosis. In addition, there have been significant improvements in PCI techniques since the study period, including the adoption of a radial approach and superior adjunct pharmacologic therapy. Furthermore, previous studies have not systematically investigated the use of FFR-guided PCI, which has been shown to be superior to angiography-guided PCI or medical treatment alone.^7-9

In this context, Fearon and the FAME-3 trial investigators studied the use of FFR-guided PCI with second-generation zotarolimus drug-eluting stents compared to CABG in patients with 3-vessel CAD. They randomized patients with angiographically identified 3-vessel CAD in a 1:1 ratio to receive FFR-guided PCI or CABG at 48 sites internationally. Patients with left main CAD, recent ST-elevation MI, cardiogenic shock, and left-ventricular ejection fraction <30% were excluded. The study results (composite primary end point incidence of 10.6% for patients with FFR-guided PCI vs 6.9% in the CABG group [HR, 1.5; 95% CI, 1.1-2.2; P = 0.35 for noninferiority]) showed that FFR-guided PCI did not meet the noninferiority criterion.

Although the FAME-3 study is an important study, there are a few points to consider. First, 24% of the lesions had a FFR measured at >0.80. The benefit of FFR-guided PCI lies in the number of lesions that are safely deferred compared to angiography-guided PCI. The small number of deferred lesions could have limited the benefit of FFR guidance compared with angiography. Second, this study did not include all comers who had angiographic 3-vessel disease. Patients who had FFR assessment of moderate lesions at the time of diagnostic angiogram and were found to have FFR >0.80 or were deemed single- or 2-vessel disease were likely treated with PCI. Therefore, as the authors point out, the patients included in this study may have been skewed to a higher-risk population compared to previous studies.

Third, the study may not reflect contemporary interventional practice, as the use of intravascular ultrasound was very low (12%). Intravascular ultrasound–guided PCI has been associated with increased luminal gain and improved outcomes compared to angiography-guided PCI.¹⁰ Although 20% of the patients in each arm were found to have chronic total occlusions, the completeness of revascularization has not yet been reported. It is possible that the PCI arm had fewer complete revascularizations, which has been shown in previous observational studies to be associated with worse clinical outcomes.^11,12

Although the current guidelines favor CABG over PCI in patients with multivessel disease, this recommendation is stratified by anatomic complexity.⁶ In fact, in the European guidelines, CABG and PCI are both class I recommendations for the treatment of 3-vessel disease with low SYNTAX score in patients without diabetes.⁵ Although the FAME-3 study failed to show noninferiority in the overall population, when stratified by the SYNTAX score, the major adverse cardiac event rate for the PCI group was numerically lower than that of the CABG group. The results from the FAME-3 study are overall in line with the previous studies and the current guidelines. Future studies are necessary to assess the outcomes of multivessel PCI compared to CABG using the most contemporary interventional practice and achieving complete revascularization in the PCI arm.

Applications for Clinical Practice

In patients with 3-vessel disease, FFR-guided PCI was not found to be noninferior to CABG; this finding is consistent with previous studies.

—Shubham Kanake, BS, Chirag Bavishi, MD, MPH, and Taishi Hirai, MD, University of Missouri, Columbia, MO

Disclosures: None.

Routine checks of vital signs during the night often prevent hospitalized patients from getting sufficient recuperative sleep. But patients who are judged to be clinically stable by an algorithm that uses real-time data can be safely spared these checks, according to a recent study published in JAMA Internal Medicine.

In their study, Nader Najafi, MD, MAS, from the University of California, San Francisco, and his colleagues were able to significantly reduce the number of checks at night without increasing transfers to the intensive care ward or heart-alarm triggers.

“Sleep is crucial to health,” writes Hyung J. Cho, MD, from the New York University Grossman School of Medicine, in an accompanying editorial. “Ironically, hospitals, where people go to recover from illness, are among the most difficult places to sleep.”

Number of night-time checks successfully reduced

The mean number of night-time checks was significantly lower in the algorithm group than in the standard-care group (0.97 vs. 1.41; P < .001).

The reduction in night-time checks had no effect on patient safety. There was no increase in transfers to the intensive care unit in the algorithm or standard-care groups (5% vs 5%; P = .92), and no difference between the number of heart alarms (0.2% vs. 0.9%; P = .07).

However, the reduction also had no effect on the incidence of episodes of delirium in the algorithm or standard-care groups (11% vs. 13%; P = .32).

“The reduction in vital signs checking, although statistically significant, was relatively small,” Dr. Cho explains. But the primary endpoint might have been different had the adherence to intervention been better, he notes.

In fact, the analysis confirmed that changes to routine daily practice in a hospital are not always easy to implement. In 35% of cases, the patients’ vital signs were checked at night, despite the physician’s order to the contrary.

“Busy patient-care assistants and nurses may check vital signs out of habit without noticing that the order has changed for some of the patients,” Dr. Najafi and his coauthors write. Many hospitals are used to thinking that regular measurements of the vital signs are part of good practice.
 

Include nursing staff

Future projects should use an interdisciplinary approach that includes nursing staff, Dr. Cho recommends. More user-friendly displays and optimized alerts in the electronic patient records could also encourage better implementation of the orders.

Less frequent checks of the vital signs would be welcomed by frontline staff because it would lighten their already heavy workload, he adds.

Although the study didn’t meet its primary endpoint, patients subjected to fewer night-time checks because of the algorithm were able to get a good night’s sleep. Other aspects of hospital care that are based on the patient’s stability, such as cardiac monitoring, could also potentially benefit from this type of intervention, Dr. Najafi and his colleagues suggest.

A version of this article first appeared on Medscape.com.

Routine checks of vital signs during the night often prevent hospitalized patients from getting sufficient recuperative sleep. But patients who are judged to be clinically stable by an algorithm that uses real-time data can be safely spared these checks, according to a recent study published in JAMA Internal Medicine.

In their study, Nader Najafi, MD, MAS, from the University of California, San Francisco, and his colleagues were able to significantly reduce the number of checks at night without increasing transfers to the intensive care ward or heart-alarm triggers.

“Sleep is crucial to health,” writes Hyung J. Cho, MD, from the New York University Grossman School of Medicine, in an accompanying editorial. “Ironically, hospitals, where people go to recover from illness, are among the most difficult places to sleep.”

Number of night-time checks successfully reduced

The mean number of night-time checks was significantly lower in the algorithm group than in the standard-care group (0.97 vs. 1.41; P < .001).

The reduction in night-time checks had no effect on patient safety. There was no increase in transfers to the intensive care unit in the algorithm or standard-care groups (5% vs 5%; P = .92), and no difference between the number of heart alarms (0.2% vs. 0.9%; P = .07).

However, the reduction also had no effect on the incidence of episodes of delirium in the algorithm or standard-care groups (11% vs. 13%; P = .32).

“The reduction in vital signs checking, although statistically significant, was relatively small,” Dr. Cho explains. But the primary endpoint might have been different had the adherence to intervention been better, he notes.

In fact, the analysis confirmed that changes to routine daily practice in a hospital are not always easy to implement. In 35% of cases, the patients’ vital signs were checked at night, despite the physician’s order to the contrary.

“Busy patient-care assistants and nurses may check vital signs out of habit without noticing that the order has changed for some of the patients,” Dr. Najafi and his coauthors write. Many hospitals are used to thinking that regular measurements of the vital signs are part of good practice.
 

Include nursing staff

Future projects should use an interdisciplinary approach that includes nursing staff, Dr. Cho recommends. More user-friendly displays and optimized alerts in the electronic patient records could also encourage better implementation of the orders.

Less frequent checks of the vital signs would be welcomed by frontline staff because it would lighten their already heavy workload, he adds.

Although the study didn’t meet its primary endpoint, patients subjected to fewer night-time checks because of the algorithm were able to get a good night’s sleep. Other aspects of hospital care that are based on the patient’s stability, such as cardiac monitoring, could also potentially benefit from this type of intervention, Dr. Najafi and his colleagues suggest.

A version of this article first appeared on Medscape.com.

Routine checks of vital signs during the night often prevent hospitalized patients from getting sufficient recuperative sleep. But patients who are judged to be clinically stable by an algorithm that uses real-time data can be safely spared these checks, according to a recent study published in JAMA Internal Medicine.

In their study, Nader Najafi, MD, MAS, from the University of California, San Francisco, and his colleagues were able to significantly reduce the number of checks at night without increasing transfers to the intensive care ward or heart-alarm triggers.

“Sleep is crucial to health,” writes Hyung J. Cho, MD, from the New York University Grossman School of Medicine, in an accompanying editorial. “Ironically, hospitals, where people go to recover from illness, are among the most difficult places to sleep.”

Number of night-time checks successfully reduced

The mean number of night-time checks was significantly lower in the algorithm group than in the standard-care group (0.97 vs. 1.41; P < .001).

The reduction in night-time checks had no effect on patient safety. There was no increase in transfers to the intensive care unit in the algorithm or standard-care groups (5% vs 5%; P = .92), and no difference between the number of heart alarms (0.2% vs. 0.9%; P = .07).

However, the reduction also had no effect on the incidence of episodes of delirium in the algorithm or standard-care groups (11% vs. 13%; P = .32).

“The reduction in vital signs checking, although statistically significant, was relatively small,” Dr. Cho explains. But the primary endpoint might have been different had the adherence to intervention been better, he notes.

In fact, the analysis confirmed that changes to routine daily practice in a hospital are not always easy to implement. In 35% of cases, the patients’ vital signs were checked at night, despite the physician’s order to the contrary.

“Busy patient-care assistants and nurses may check vital signs out of habit without noticing that the order has changed for some of the patients,” Dr. Najafi and his coauthors write. Many hospitals are used to thinking that regular measurements of the vital signs are part of good practice.
 

Include nursing staff

Future projects should use an interdisciplinary approach that includes nursing staff, Dr. Cho recommends. More user-friendly displays and optimized alerts in the electronic patient records could also encourage better implementation of the orders.

Less frequent checks of the vital signs would be welcomed by frontline staff because it would lighten their already heavy workload, he adds.

Although the study didn’t meet its primary endpoint, patients subjected to fewer night-time checks because of the algorithm were able to get a good night’s sleep. Other aspects of hospital care that are based on the patient’s stability, such as cardiac monitoring, could also potentially benefit from this type of intervention, Dr. Najafi and his colleagues suggest.

A version of this article first appeared on Medscape.com.

From the Department of Medicine (Drs. Meisenberg, Muganlinskaya, Sharma, Amjadi, Arnold, Barnes, Clance, Khalil, Miller, Mooradian, O’Connell, Patel, Press, Samaras, Shanmugam, Tavadze, and Thompson), Department of Pharmacy (Drs. Jiang, Jarawan, Sheth, and Trinh), Department of Nursing (Dr. Ohnmacht), and Department of Women and Children’s Services (Dr. Raji), Luminis Health, Annapolis, MD, and Lanham, MD.

Objective: The COVID-19 pandemic has been a challenge for hospital medical staffs worldwide due to high volumes of patients acutely ill with novel syndromes and prevailing uncertainty regarding optimum supportive and therapeutic interventions. Additionally, the response to this crisis was driven by a plethora of nontraditional information sources, such as email chains, websites, non–peer-reviewed preprints, and press releases. Care patterns became idiosyncratic and often incorporated unproven interventions driven by these nontraditional information sources. This report evaluates the efforts of a health system to create and empower a multidisciplinary committee to develop, implement, and monitor evidence-based, standardized protocols for patients with COVID-19.

Methods: This report describes the composition of the committee, its scope, and its important interactions with the health system pharmacy and therapeutics committee, research teams, and other work groups planning other aspects of COVID-19 management. It illustrates how the committee was used to demonstrate for trainees the process and value of critically examining evidence, even in a chaotic environment.

Results: Data show successful interventions in reducing excessive ordering of certain laboratory tests, reduction of nonrecommended therapies, and rapid uptake of evidence-based or guidelines-supported interventions.

Conclusions: A multidisciplinary committee dedicated solely to planning, implementing, and monitoring standard approaches that eventually became evidence-based decision-making led to an improved focus on treatment options and outcomes for COVID-19 patients. Data presented illustrate the attainable success that is both adaptable and suitable for similar emergencies in the future.

Keywords: COVID-19; clinical management; pharmacy and therapeutics; treatment; therapy.

The COVID-19 pandemic has spread to nearly all countries, carrying with it high morbidity, mortality, and severe impacts on both well-developed and less-well-developed health systems. Media reports of chaos within overwhelmed hospitals have been prominent.^1,2 As of January 5, 2022, SARS-CoV-2 has infected more than 295 million people globally and directly caused the death of more than 5.4 million,³ though this number is likely an undercount even in countries with well-developed mortality tracking.⁴

Throughout the COVID-19 pandemic, hospital-based medical teams have been confronted with a flood of severely ill patients with novel syndromes. Initially, there were no standards for therapy or supportive care except for treatments borrowed from similar syndromes. In the setting of high volumes, high acuity, and public dismay, it is unsurprising that the usual deliberative methods for weighing evidence and initiating interventions were often pushed aside in favor of the solace of active intervention.⁵ In this milieu of limited evidence, there was a lamentable, if understandable, tendency to seek guidance from “nontraditional” sources,⁶ including email chains from colleagues, hospital websites, non–peer-reviewed manuscripts, advanced publication by medical journals,⁷ and nonscientific media presentations. In many localities, practitioners responded in idiosyncratic ways. For example, findings of high cytokine levels in COVID-19,⁸ along with reports of in-vitro antiviral activity with drugs like hydroxychloroquine against both SARS⁹ and SARS-CoV-2,¹⁰ drove laboratory test ordering and therapeutic interventions, respectively, carving shortcuts into the traditional clinical trial–dependent standards. Clinical trial results eventually emerged.¹¹COVID-19 created a clinical dilemma for hospital medical staffs in terms of how to organize, standardize, and rapidly adapt to a flood of new information. In this report, we describe how 1 health system responded to these challenges by forming a COVID-19 Clinical Management Committee (CCMC) and empowering this interdisciplinary team to review evidence, create and adjust order sets, educate practitioners, oversee care, and collaborate across teams addressing other aspects of the COVID-19 response.

Program Overview

Health System Description

Luminis Health is a health system with 2 acute care hospitals that was formed in 2019 just before the start of the pandemic. Anne Arundel Medical Center (hospital A) is a 385-bed teaching hospital in Annapolis, MD. It has more than 23 000 discharges annually. Patients with COVID-19 were cared for by either an internal medicine teaching service or nonteaching hospitalist services on cohorted nursing units. Doctor’s Community Medical Center, in Lanham, MD (hospital B), is a 206-bed acute care hospital with more than 10 350 annual discharges. COVID-19 patients were cared for by hospitalist groups, initially in noncohorted units with transition to cohorted nursing units after a few months. The medical staffs are generally distinct, with different leadership structures, though the Luminis Health Department of Medicine has oversight responsibilities at both hospitals. More than 47 physicians attended COVID-19 patients at hospital A (with medical residents) and 30 individual physicians at hospital B, respectively, including intensivists. The nursing and pharmacy staffs are distinct, but there is a shared oversight Pharmacy and Therapeutics (P&T) Committee.

The 2 hospitals had distinct electronic medical records (EMR) until January 2021, when hospital B adopted the same EMR as hospital A (Epic).

Mission and Formation of CCMC

In order to coordinate the therapeutic approach across the health system, it was important for the CCMC to be designated by the health system P&T committee as an official subcommittee so that decisions on restrictions of medications and/or new or revised order sets could be rapidly initiated across the system without waiting for the subsequent P&T meetings. The full committee retained oversight of the CCMC. Some P&T members were also on the CCMC.

The committee reviewed new reports in medical journals and prepublication servers and consulted recommendations of professional societies, such as the National Institutes of Health (NIH) COVID-19 guidelines, Infectious Diseases Society of America, Society of Critical Care Medicine, and US Food and Drug Administration (FDA) Emergency Use Authorizations (EUA), among other sources.

Composition of the CCMC

Physician leaders from both hospitals in the following specialties were solicited for participation: critical care, epidemiology, hospital medicine (internal medicine), emergency medicine, infectious diseases, nephrology, women and children’s services, and medical informatics. Specialists in other areas, such as hematology, were invited for topic-specific discussions. Hospital pharmacists with different specialties and nursing leadership were essential contributors. The committee members were expected to use various communication channels to inform frontline clinicians of new care standards and the existence of new order sets, which were embedded in the EMR.

Clinical Research

An important connection for the CCMC was with theCOVID-19 clinical research team. Three members of the research team were also members of the CCMC. All new study proposals for therapeutics were discussed with the CCMC as they were being considered by the research team. In this way, feedback on the feasibility and acceptance of new study opportunities could be discussed with the CCMC. Occasionally, CCMC decisions impacted clinical research accrual strategies. For example, new data from randomized trials about tocilizumab^1,2 demonstrated benefits in some subsets of patients and resulted in a recommendation for use by the NIH guideline committee in these populations.¹ The CCMC quickly adopted this recommendation, which required a reprioritization of clinical research enrollment for studies testing other immune-modulating agents. This important dialogue was mediated within the CCMC.

Guideline Distribution, Reinforcement, and Platform for Feedback

New guidelines were disseminated to clinicians via daily brief patient huddles held on COVID units, with participation by nursing and pharmacy, and by weekly meetings with hospitalist leaders and frontline hospital physicians. Order sets and guidelines were maintained on the intranet. Adherence was reinforced by unit-based and central pharmacists. Order sets, including admission order sets, could be created only by designated informatics personnel, thus enforcing standardization. Feedback on the utility of the order sets was obtained during the weekly meetings or huddles, as described above. To ensure a sense of transparency, physicians who had interest in commenting on a particular therapy, or who wished to discuss a particular manuscript, news article, or website, were invited to attend CCMC meetings.

Scope of CCMC

In order to be effective and timely, we limited the scope of our work to the report to the inpatient therapeutic environment, allowing other committees to work on other aspects of the pandemic response. In addition to issuing guidance and creating order sets to direct clinical practice, the CCMC also monitored COVID-19 therapeutic shortages^15,16 and advised on prioritization of such treatments as convalescent plasma, remdesivir (prioritization and duration of therapy, 5 vs 10 days), baricitinib, and tocilizumab, depending upon the location of the patient (critical care or not). The CCMC was not involved in the management of non–COVID-19 shortages brought about by supply chain deficiencies.

Table 1 shows some aspects of the health system pandemic-response planning and the committee workforce that undertook that work. Though many items were out of scope for the CCMC, members of the CCMC did participate in the planning work of these other committees and therefore stayed connected to this complementary work.

A Teaching Opportunity About Making Thoughtful Choices

Another important feature of the CCMC was the contributions of residents from both pharmacy and internal medicine. The purpose and operations of the committee were recognized as an opportunity to involve learners in a curriculum based on Kern’s 6-step approach.¹⁷ Though the problem identification and general needs assessment were easily defined, the targeted needs assessment, extracted from individual and group interviews with learners and the committee members, pointed at the need to learn how to assess and analyze a rapidly growing body of literature on several relevant clinical aspects of SARS-CoV-2 and COVID-19. To achieve goals and objectives, residents were assigned to present current literature on a particular intervention during a committee meeting, specifically commenting on the merit or deficiencies of the study design, the strength of the data, and applicability to the local context with a recommendation. Prior to the presentations, the residents worked with faculty to identify the best studies or systematic analyses with potential to alter current practices. We thus used the CCMC process as a teaching tool about evidence-based medicine and the dilemma of clinical equipoise. This was imperative, since trainees thrust into the COVID-19 response have often keenly observed a movement away from deliberative decision-making.¹⁸ Indeed, including residents in the process of deliberative responses to COVID-19 addresses a recent call to adjust medical education during COVID-19 to “adapt curriculum to current issues in real time.”¹⁹

Interventions and Therapies Considered

Table 2 shows the topics reviewed by the CCMC. By the time of the first meeting, nonstandardization of care was already a source of concern for clinicians. Dialogue often continued outside of the formal meetings. Many topics were considered more than once as new guidance developed, changes to EUAs occurred, and new data or new publicity arose.

Methods

The Human Protections Administrator determined that this work constituted “quality improvement, and not research” and was therefore exempt from institutional review board review.

Quantitative Analysis

All admitted patients from March 10, 2020, through April 20, 2021, were considered in the quantitative aspects of this report except as noted. Patients diagnosed with COVID-19 were identified by searching our internal data base using diagnostic codes. Patient admissions with the following diagnostic codes were included (prior to April 1, 2020): J12.89, J20.8, J40, J22, J98.8, J80, each with the additional code of B97.29. After April 1, 2020, the guideline for coding COVID-19 was U07.1.

Descriptive statistics were used to measure utilization rates of certain medications and laboratory tests of interest over time. These data were adjusted for number of unique admissions. In a few cases, not all data elements were available from both hospitals due to differences in the EMR.

Case fatality rate was calculated based upon whether the patient died or was admitted to inpatient hospice as a result of COVID-19. Four patients transferred out of hospital A and 18 transferred out of hospital B were censored from case-fatality-rate determination.

Figure 1 shows the number of admissions for each acute care hospital in the health system and the combined COVID-19 case-fatality rate over time.

Results

A total of 5955 consecutive COVID-19 patients admitted from March 10, 2020, through April 30, 2021, were analyzed. Patients with International Statistical Classification of Diseases, Tenth Revision codes J12.89. J20.8, J40, J22, J98.8, J80, each with the additional code of B97.29 (or the code UO7.1 after April 1, 2020), were included in the analysis. The median age of admitted patients was 65 years (range 19-91 years). Using the NIH classification system for severity,²⁰ the distribution of severity during the first 24 hours after the time of hospital admission was as follows: asymptomatic/presymptomatic, 0.5%; mild illness, 5.3%; moderate illness, 37.1%; severe illness, 55.5%; and critical illness, 1.1%.

The impact of the CCMC can be estimated by looking at care patterns over time. Since the work of the CCMC was aimed at influencing and standardizing physician ordering and therapy choices through order set creation and other forms of oversight, we measured the use of the CCMC-approved order sets at both hospitals and the use of certain laboratory tests and therapies that the CCMC sought either to limit or increase. These counts were adjusted for number of unique COVID-19 admissions. But the limits of the case collection tool meant it also collected cases that were not eligible for some of the interventions. For example, COVID-19 admissions without hypoxemia would not have been eligible for remdesivir or glucocorticoids. When admitted, some patients were already on steroids for other medical indications and did not receive the prescribed dexamethasone dose that we measured in pharmacy databases. Similarly, a few patients were hospitalized for indications unrelated to COVID-19, such as surgery or childbirth, and were found to be SARS-CoV-2-positive on routine screening.

Figure 2 shows the utilization of CCMC-approved standard COVID-19 admission order sets as a proportion of all COVID-19 admissions over time. The trend reveals a modest increase in usage (R² = 0.34), but these data do not reflect the progressive build of content into order sets over time. One of the goals of the order sets was to standardize and reduce the ordering of certain biomarkers: C-reactive protein, serum ferritin, and D-dimer, which were ordered frequently in many early patients. Orders for these 3 laboratory tests are combined and expressed as an average number of labs per COVID-19 admission in Figure 2. A downward trend, with an R² value of 0.65, is suggestive of impact from the order sets, though other explanations are possible.

Medication guidance was also a goal of the CCMC, simultaneously discouraging poorly supported interventions and driving uptake of the recommended evidence-based interventions in appropriate patients. Figure 3 shows the utilization pattern for some drugs of interest over the course of the pandemic, specifically the proportion of patients receiving at least 1 dose of medication among all COVID-19 admissions by month. (Data for hospital B was excluded from this analysis because it did not include all admitted patients.)

Hydroxychloroquine, which enjoyed a wave of popularity early on during the pandemic, was a target of successful order stewardship through the CCMC. Use of hydroxychloroquine as a COVID-19 therapeutic option after the first 2 months of the pandemic stopped, and subsequent use at low levels likely represented continuation therapy for outpatients who took hydroxychloroquine for rheumatologic indications.

Dexamethasone, as used in the RECOVERY trial,²¹ had a swift uptake among physicians after it was incorporated into order sets and its use encouraged. Similarly, uptake was immediate for remdesivir when, in May 2020, preliminary reports showed at least some benefits, confirmed by later analysis,²² and it received an FDA EUA.

Our data also show successful stewardship of the interleukin-6 antagonist toclilizumab, which was discouraged early on by the CCMC due to lack of data or negative results. But in March 2021, with new studies releasing data^12,13 and new recommendations¹⁴ for its use in some subsets of patients with COVID-19, this drug was encouraged in appropriate subsets. A new order set with qualifying indications was prepared by the CCMC and new educational efforts made to encourage its use in appropriate patients.

Ivermectin was nonformulary at the start of the pandemic. This drug enjoyed much publicity from media sources and was promoted by certain physicians and on websites,²³ based on in-vitro activity against coronaviruses. Eventually, the World Health Organization²⁴ and the FDA²⁵ found it necessary to issue advisory statements to the public against its use outside of clinical trials. The CCMC had requests from physicians to incorporate ivermectin but declined to add it to the formulary and recommended not approving nonformulary requests due to lack of data. As a result, ivermectin was not used at either hospital.

Discussion

COVID-19 represents many challenges to health systems all over the world. For Luminis Health, the high volume of acutely ill patients with novel syndromes was a particular challenge for the hospital-based care teams. A flood of information from preprints, press releases, preliminary reports, and many other nontraditional sources made deliberative management decisions difficult for individual physicians. Much commentary has appeared around the phenomenon but with less practical advice about how to make day-to-day care decisions at a time of scientific uncertainty and intense pressure to intervene.^26,27 The CCMC was designed to overcome the information management dilemma. The need to coordinate, standardize, and oversee care was necessary given the large number of physicians who cared for COVID-19 patients on inpatient services.

It should be noted that creating order sets and issuing guidance is necessary, but not sufficient, to achieve our goals of being updated and consistent. This is especially true with large cadres of health care workers attending COVID-19 patients. Guidelines and recommendations were reinforced by unit-based oversight and stewardship from pharmacy and other leaders who constituted the CCMC.

The reduction in COVID-19 mortality over time experienced in this health care system was not unique and cannot necessarily be attributed to standardization of care. Similar improvements in mortality have been reported at many US hospitals in aggregate.²⁸ Many other factors, including changes in patient characteristics, may be responsible for reduction in mortality over time.

Throughout this report we have relied upon an implicit assumption that standardization of medical therapeutics is desirable and leads to better outcomes as compared with allowing unlimited empiricism by individual physicians, either consultants or hospitalists. Our program represents a single health system with 2 acute care hospitals located 25 miles apart and which thus were similarly impacted by the different phases of the pandemic. Generalizability to health systems either smaller or larger, or in different geographical areas, has not been established. Data limitations have already been discussed.

We did not measure user satisfaction with the program either from physicians or nurses. However, the high rate of compliance suggests general agreement with the content and process.

We cannot definitively ascribe reduction in utilization of some nonrecommended treatments and increased utilization of the recommended therapies to the work of the CCMC. Individual physicians may have made these adjustments on their own or under the influence of other sources.

Finally, it should be noted that the mission to rapidly respond to data from well-conducted trials might be thwarted by too rigid a process or a committee’s lack of a sense of urgency. Organizing a committee and then empowering it to act is no guarantee of success; commitment to the mission is.

Conclusion

COVID-19 represented a challenge to medical staffs everywhere, inundating them with high volumes of acutely ill patients presenting with unfamiliar syndromes. Initial responses were characterized by idiosyncratic management approaches based on nontraditional sources of opinion and influences.

This report describes how a complex medical system brought order and standardization through a deliberative, but urgent, multidisciplinary committee with responsibility for planning, implementing, and monitoring standard approaches that eventually became evidence based. The composition of the committee and its scope of influence, limited to inpatient management, were important elements of success, allowing for better focus on the many treatment decisions. The important connection between the management committee and the system P&T committee, the clinical research effort, and teaching programs in both medicine and pharmacy are offered as exemplars of coordination. The data presented show success in achieving standardized, guideline-directed care. The approach is adoptable and suitable for similar emergencies in the future.

Acknowledgments: The authors thank Gary Scabis, Kip Waite, John Moxley, Angela Clubb, and David Woodley for their assistance in gathering data. We express appreciation and admiration for all our colleagues at the bedside.

Corresponding author: Barry R. Meisenberg, MD, Department of Medicine, Luminis Health, 2001 Medical Pkwy, Annapolis, MD 21401; meisenberg@AAHS.org.

Financial disclosures: None.

From the Department of Medicine (Drs. Meisenberg, Muganlinskaya, Sharma, Amjadi, Arnold, Barnes, Clance, Khalil, Miller, Mooradian, O’Connell, Patel, Press, Samaras, Shanmugam, Tavadze, and Thompson), Department of Pharmacy (Drs. Jiang, Jarawan, Sheth, and Trinh), Department of Nursing (Dr. Ohnmacht), and Department of Women and Children’s Services (Dr. Raji), Luminis Health, Annapolis, MD, and Lanham, MD.

Objective: The COVID-19 pandemic has been a challenge for hospital medical staffs worldwide due to high volumes of patients acutely ill with novel syndromes and prevailing uncertainty regarding optimum supportive and therapeutic interventions. Additionally, the response to this crisis was driven by a plethora of nontraditional information sources, such as email chains, websites, non–peer-reviewed preprints, and press releases. Care patterns became idiosyncratic and often incorporated unproven interventions driven by these nontraditional information sources. This report evaluates the efforts of a health system to create and empower a multidisciplinary committee to develop, implement, and monitor evidence-based, standardized protocols for patients with COVID-19.

Methods: This report describes the composition of the committee, its scope, and its important interactions with the health system pharmacy and therapeutics committee, research teams, and other work groups planning other aspects of COVID-19 management. It illustrates how the committee was used to demonstrate for trainees the process and value of critically examining evidence, even in a chaotic environment.

Results: Data show successful interventions in reducing excessive ordering of certain laboratory tests, reduction of nonrecommended therapies, and rapid uptake of evidence-based or guidelines-supported interventions.

Conclusions: A multidisciplinary committee dedicated solely to planning, implementing, and monitoring standard approaches that eventually became evidence-based decision-making led to an improved focus on treatment options and outcomes for COVID-19 patients. Data presented illustrate the attainable success that is both adaptable and suitable for similar emergencies in the future.

Keywords: COVID-19; clinical management; pharmacy and therapeutics; treatment; therapy.

The COVID-19 pandemic has spread to nearly all countries, carrying with it high morbidity, mortality, and severe impacts on both well-developed and less-well-developed health systems. Media reports of chaos within overwhelmed hospitals have been prominent.^1,2 As of January 5, 2022, SARS-CoV-2 has infected more than 295 million people globally and directly caused the death of more than 5.4 million,³ though this number is likely an undercount even in countries with well-developed mortality tracking.⁴

Throughout the COVID-19 pandemic, hospital-based medical teams have been confronted with a flood of severely ill patients with novel syndromes. Initially, there were no standards for therapy or supportive care except for treatments borrowed from similar syndromes. In the setting of high volumes, high acuity, and public dismay, it is unsurprising that the usual deliberative methods for weighing evidence and initiating interventions were often pushed aside in favor of the solace of active intervention.⁵ In this milieu of limited evidence, there was a lamentable, if understandable, tendency to seek guidance from “nontraditional” sources,⁶ including email chains from colleagues, hospital websites, non–peer-reviewed manuscripts, advanced publication by medical journals,⁷ and nonscientific media presentations. In many localities, practitioners responded in idiosyncratic ways. For example, findings of high cytokine levels in COVID-19,⁸ along with reports of in-vitro antiviral activity with drugs like hydroxychloroquine against both SARS⁹ and SARS-CoV-2,¹⁰ drove laboratory test ordering and therapeutic interventions, respectively, carving shortcuts into the traditional clinical trial–dependent standards. Clinical trial results eventually emerged.¹¹COVID-19 created a clinical dilemma for hospital medical staffs in terms of how to organize, standardize, and rapidly adapt to a flood of new information. In this report, we describe how 1 health system responded to these challenges by forming a COVID-19 Clinical Management Committee (CCMC) and empowering this interdisciplinary team to review evidence, create and adjust order sets, educate practitioners, oversee care, and collaborate across teams addressing other aspects of the COVID-19 response.

Program Overview

Health System Description

Luminis Health is a health system with 2 acute care hospitals that was formed in 2019 just before the start of the pandemic. Anne Arundel Medical Center (hospital A) is a 385-bed teaching hospital in Annapolis, MD. It has more than 23 000 discharges annually. Patients with COVID-19 were cared for by either an internal medicine teaching service or nonteaching hospitalist services on cohorted nursing units. Doctor’s Community Medical Center, in Lanham, MD (hospital B), is a 206-bed acute care hospital with more than 10 350 annual discharges. COVID-19 patients were cared for by hospitalist groups, initially in noncohorted units with transition to cohorted nursing units after a few months. The medical staffs are generally distinct, with different leadership structures, though the Luminis Health Department of Medicine has oversight responsibilities at both hospitals. More than 47 physicians attended COVID-19 patients at hospital A (with medical residents) and 30 individual physicians at hospital B, respectively, including intensivists. The nursing and pharmacy staffs are distinct, but there is a shared oversight Pharmacy and Therapeutics (P&T) Committee.

The 2 hospitals had distinct electronic medical records (EMR) until January 2021, when hospital B adopted the same EMR as hospital A (Epic).

Mission and Formation of CCMC

In order to coordinate the therapeutic approach across the health system, it was important for the CCMC to be designated by the health system P&T committee as an official subcommittee so that decisions on restrictions of medications and/or new or revised order sets could be rapidly initiated across the system without waiting for the subsequent P&T meetings. The full committee retained oversight of the CCMC. Some P&T members were also on the CCMC.

The committee reviewed new reports in medical journals and prepublication servers and consulted recommendations of professional societies, such as the National Institutes of Health (NIH) COVID-19 guidelines, Infectious Diseases Society of America, Society of Critical Care Medicine, and US Food and Drug Administration (FDA) Emergency Use Authorizations (EUA), among other sources.

Composition of the CCMC

Physician leaders from both hospitals in the following specialties were solicited for participation: critical care, epidemiology, hospital medicine (internal medicine), emergency medicine, infectious diseases, nephrology, women and children’s services, and medical informatics. Specialists in other areas, such as hematology, were invited for topic-specific discussions. Hospital pharmacists with different specialties and nursing leadership were essential contributors. The committee members were expected to use various communication channels to inform frontline clinicians of new care standards and the existence of new order sets, which were embedded in the EMR.

Clinical Research

An important connection for the CCMC was with theCOVID-19 clinical research team. Three members of the research team were also members of the CCMC. All new study proposals for therapeutics were discussed with the CCMC as they were being considered by the research team. In this way, feedback on the feasibility and acceptance of new study opportunities could be discussed with the CCMC. Occasionally, CCMC decisions impacted clinical research accrual strategies. For example, new data from randomized trials about tocilizumab^1,2 demonstrated benefits in some subsets of patients and resulted in a recommendation for use by the NIH guideline committee in these populations.¹ The CCMC quickly adopted this recommendation, which required a reprioritization of clinical research enrollment for studies testing other immune-modulating agents. This important dialogue was mediated within the CCMC.

Guideline Distribution, Reinforcement, and Platform for Feedback

New guidelines were disseminated to clinicians via daily brief patient huddles held on COVID units, with participation by nursing and pharmacy, and by weekly meetings with hospitalist leaders and frontline hospital physicians. Order sets and guidelines were maintained on the intranet. Adherence was reinforced by unit-based and central pharmacists. Order sets, including admission order sets, could be created only by designated informatics personnel, thus enforcing standardization. Feedback on the utility of the order sets was obtained during the weekly meetings or huddles, as described above. To ensure a sense of transparency, physicians who had interest in commenting on a particular therapy, or who wished to discuss a particular manuscript, news article, or website, were invited to attend CCMC meetings.

Scope of CCMC

In order to be effective and timely, we limited the scope of our work to the report to the inpatient therapeutic environment, allowing other committees to work on other aspects of the pandemic response. In addition to issuing guidance and creating order sets to direct clinical practice, the CCMC also monitored COVID-19 therapeutic shortages^15,16 and advised on prioritization of such treatments as convalescent plasma, remdesivir (prioritization and duration of therapy, 5 vs 10 days), baricitinib, and tocilizumab, depending upon the location of the patient (critical care or not). The CCMC was not involved in the management of non–COVID-19 shortages brought about by supply chain deficiencies.

Table 1 shows some aspects of the health system pandemic-response planning and the committee workforce that undertook that work. Though many items were out of scope for the CCMC, members of the CCMC did participate in the planning work of these other committees and therefore stayed connected to this complementary work.

A Teaching Opportunity About Making Thoughtful Choices

Another important feature of the CCMC was the contributions of residents from both pharmacy and internal medicine. The purpose and operations of the committee were recognized as an opportunity to involve learners in a curriculum based on Kern’s 6-step approach.¹⁷ Though the problem identification and general needs assessment were easily defined, the targeted needs assessment, extracted from individual and group interviews with learners and the committee members, pointed at the need to learn how to assess and analyze a rapidly growing body of literature on several relevant clinical aspects of SARS-CoV-2 and COVID-19. To achieve goals and objectives, residents were assigned to present current literature on a particular intervention during a committee meeting, specifically commenting on the merit or deficiencies of the study design, the strength of the data, and applicability to the local context with a recommendation. Prior to the presentations, the residents worked with faculty to identify the best studies or systematic analyses with potential to alter current practices. We thus used the CCMC process as a teaching tool about evidence-based medicine and the dilemma of clinical equipoise. This was imperative, since trainees thrust into the COVID-19 response have often keenly observed a movement away from deliberative decision-making.¹⁸ Indeed, including residents in the process of deliberative responses to COVID-19 addresses a recent call to adjust medical education during COVID-19 to “adapt curriculum to current issues in real time.”¹⁹

Interventions and Therapies Considered

Table 2 shows the topics reviewed by the CCMC. By the time of the first meeting, nonstandardization of care was already a source of concern for clinicians. Dialogue often continued outside of the formal meetings. Many topics were considered more than once as new guidance developed, changes to EUAs occurred, and new data or new publicity arose.

Methods

The Human Protections Administrator determined that this work constituted “quality improvement, and not research” and was therefore exempt from institutional review board review.

Quantitative Analysis

All admitted patients from March 10, 2020, through April 20, 2021, were considered in the quantitative aspects of this report except as noted. Patients diagnosed with COVID-19 were identified by searching our internal data base using diagnostic codes. Patient admissions with the following diagnostic codes were included (prior to April 1, 2020): J12.89, J20.8, J40, J22, J98.8, J80, each with the additional code of B97.29. After April 1, 2020, the guideline for coding COVID-19 was U07.1.

Descriptive statistics were used to measure utilization rates of certain medications and laboratory tests of interest over time. These data were adjusted for number of unique admissions. In a few cases, not all data elements were available from both hospitals due to differences in the EMR.

Case fatality rate was calculated based upon whether the patient died or was admitted to inpatient hospice as a result of COVID-19. Four patients transferred out of hospital A and 18 transferred out of hospital B were censored from case-fatality-rate determination.

Figure 1 shows the number of admissions for each acute care hospital in the health system and the combined COVID-19 case-fatality rate over time.

Results

A total of 5955 consecutive COVID-19 patients admitted from March 10, 2020, through April 30, 2021, were analyzed. Patients with International Statistical Classification of Diseases, Tenth Revision codes J12.89. J20.8, J40, J22, J98.8, J80, each with the additional code of B97.29 (or the code UO7.1 after April 1, 2020), were included in the analysis. The median age of admitted patients was 65 years (range 19-91 years). Using the NIH classification system for severity,²⁰ the distribution of severity during the first 24 hours after the time of hospital admission was as follows: asymptomatic/presymptomatic, 0.5%; mild illness, 5.3%; moderate illness, 37.1%; severe illness, 55.5%; and critical illness, 1.1%.

The impact of the CCMC can be estimated by looking at care patterns over time. Since the work of the CCMC was aimed at influencing and standardizing physician ordering and therapy choices through order set creation and other forms of oversight, we measured the use of the CCMC-approved order sets at both hospitals and the use of certain laboratory tests and therapies that the CCMC sought either to limit or increase. These counts were adjusted for number of unique COVID-19 admissions. But the limits of the case collection tool meant it also collected cases that were not eligible for some of the interventions. For example, COVID-19 admissions without hypoxemia would not have been eligible for remdesivir or glucocorticoids. When admitted, some patients were already on steroids for other medical indications and did not receive the prescribed dexamethasone dose that we measured in pharmacy databases. Similarly, a few patients were hospitalized for indications unrelated to COVID-19, such as surgery or childbirth, and were found to be SARS-CoV-2-positive on routine screening.

Figure 2 shows the utilization of CCMC-approved standard COVID-19 admission order sets as a proportion of all COVID-19 admissions over time. The trend reveals a modest increase in usage (R² = 0.34), but these data do not reflect the progressive build of content into order sets over time. One of the goals of the order sets was to standardize and reduce the ordering of certain biomarkers: C-reactive protein, serum ferritin, and D-dimer, which were ordered frequently in many early patients. Orders for these 3 laboratory tests are combined and expressed as an average number of labs per COVID-19 admission in Figure 2. A downward trend, with an R² value of 0.65, is suggestive of impact from the order sets, though other explanations are possible.

Medication guidance was also a goal of the CCMC, simultaneously discouraging poorly supported interventions and driving uptake of the recommended evidence-based interventions in appropriate patients. Figure 3 shows the utilization pattern for some drugs of interest over the course of the pandemic, specifically the proportion of patients receiving at least 1 dose of medication among all COVID-19 admissions by month. (Data for hospital B was excluded from this analysis because it did not include all admitted patients.)

Hydroxychloroquine, which enjoyed a wave of popularity early on during the pandemic, was a target of successful order stewardship through the CCMC. Use of hydroxychloroquine as a COVID-19 therapeutic option after the first 2 months of the pandemic stopped, and subsequent use at low levels likely represented continuation therapy for outpatients who took hydroxychloroquine for rheumatologic indications.

Dexamethasone, as used in the RECOVERY trial,²¹ had a swift uptake among physicians after it was incorporated into order sets and its use encouraged. Similarly, uptake was immediate for remdesivir when, in May 2020, preliminary reports showed at least some benefits, confirmed by later analysis,²² and it received an FDA EUA.

Our data also show successful stewardship of the interleukin-6 antagonist toclilizumab, which was discouraged early on by the CCMC due to lack of data or negative results. But in March 2021, with new studies releasing data^12,13 and new recommendations¹⁴ for its use in some subsets of patients with COVID-19, this drug was encouraged in appropriate subsets. A new order set with qualifying indications was prepared by the CCMC and new educational efforts made to encourage its use in appropriate patients.

Ivermectin was nonformulary at the start of the pandemic. This drug enjoyed much publicity from media sources and was promoted by certain physicians and on websites,²³ based on in-vitro activity against coronaviruses. Eventually, the World Health Organization²⁴ and the FDA²⁵ found it necessary to issue advisory statements to the public against its use outside of clinical trials. The CCMC had requests from physicians to incorporate ivermectin but declined to add it to the formulary and recommended not approving nonformulary requests due to lack of data. As a result, ivermectin was not used at either hospital.

Discussion

COVID-19 represents many challenges to health systems all over the world. For Luminis Health, the high volume of acutely ill patients with novel syndromes was a particular challenge for the hospital-based care teams. A flood of information from preprints, press releases, preliminary reports, and many other nontraditional sources made deliberative management decisions difficult for individual physicians. Much commentary has appeared around the phenomenon but with less practical advice about how to make day-to-day care decisions at a time of scientific uncertainty and intense pressure to intervene.^26,27 The CCMC was designed to overcome the information management dilemma. The need to coordinate, standardize, and oversee care was necessary given the large number of physicians who cared for COVID-19 patients on inpatient services.

It should be noted that creating order sets and issuing guidance is necessary, but not sufficient, to achieve our goals of being updated and consistent. This is especially true with large cadres of health care workers attending COVID-19 patients. Guidelines and recommendations were reinforced by unit-based oversight and stewardship from pharmacy and other leaders who constituted the CCMC.

The reduction in COVID-19 mortality over time experienced in this health care system was not unique and cannot necessarily be attributed to standardization of care. Similar improvements in mortality have been reported at many US hospitals in aggregate.²⁸ Many other factors, including changes in patient characteristics, may be responsible for reduction in mortality over time.

Throughout this report we have relied upon an implicit assumption that standardization of medical therapeutics is desirable and leads to better outcomes as compared with allowing unlimited empiricism by individual physicians, either consultants or hospitalists. Our program represents a single health system with 2 acute care hospitals located 25 miles apart and which thus were similarly impacted by the different phases of the pandemic. Generalizability to health systems either smaller or larger, or in different geographical areas, has not been established. Data limitations have already been discussed.

We did not measure user satisfaction with the program either from physicians or nurses. However, the high rate of compliance suggests general agreement with the content and process.

We cannot definitively ascribe reduction in utilization of some nonrecommended treatments and increased utilization of the recommended therapies to the work of the CCMC. Individual physicians may have made these adjustments on their own or under the influence of other sources.

Finally, it should be noted that the mission to rapidly respond to data from well-conducted trials might be thwarted by too rigid a process or a committee’s lack of a sense of urgency. Organizing a committee and then empowering it to act is no guarantee of success; commitment to the mission is.

Conclusion

COVID-19 represented a challenge to medical staffs everywhere, inundating them with high volumes of acutely ill patients presenting with unfamiliar syndromes. Initial responses were characterized by idiosyncratic management approaches based on nontraditional sources of opinion and influences.

This report describes how a complex medical system brought order and standardization through a deliberative, but urgent, multidisciplinary committee with responsibility for planning, implementing, and monitoring standard approaches that eventually became evidence based. The composition of the committee and its scope of influence, limited to inpatient management, were important elements of success, allowing for better focus on the many treatment decisions. The important connection between the management committee and the system P&T committee, the clinical research effort, and teaching programs in both medicine and pharmacy are offered as exemplars of coordination. The data presented show success in achieving standardized, guideline-directed care. The approach is adoptable and suitable for similar emergencies in the future.

Acknowledgments: The authors thank Gary Scabis, Kip Waite, John Moxley, Angela Clubb, and David Woodley for their assistance in gathering data. We express appreciation and admiration for all our colleagues at the bedside.

Corresponding author: Barry R. Meisenberg, MD, Department of Medicine, Luminis Health, 2001 Medical Pkwy, Annapolis, MD 21401; meisenberg@AAHS.org.

Financial disclosures: None.

From the Department of Medicine (Drs. Meisenberg, Muganlinskaya, Sharma, Amjadi, Arnold, Barnes, Clance, Khalil, Miller, Mooradian, O’Connell, Patel, Press, Samaras, Shanmugam, Tavadze, and Thompson), Department of Pharmacy (Drs. Jiang, Jarawan, Sheth, and Trinh), Department of Nursing (Dr. Ohnmacht), and Department of Women and Children’s Services (Dr. Raji), Luminis Health, Annapolis, MD, and Lanham, MD.

Objective: The COVID-19 pandemic has been a challenge for hospital medical staffs worldwide due to high volumes of patients acutely ill with novel syndromes and prevailing uncertainty regarding optimum supportive and therapeutic interventions. Additionally, the response to this crisis was driven by a plethora of nontraditional information sources, such as email chains, websites, non–peer-reviewed preprints, and press releases. Care patterns became idiosyncratic and often incorporated unproven interventions driven by these nontraditional information sources. This report evaluates the efforts of a health system to create and empower a multidisciplinary committee to develop, implement, and monitor evidence-based, standardized protocols for patients with COVID-19.

Methods: This report describes the composition of the committee, its scope, and its important interactions with the health system pharmacy and therapeutics committee, research teams, and other work groups planning other aspects of COVID-19 management. It illustrates how the committee was used to demonstrate for trainees the process and value of critically examining evidence, even in a chaotic environment.

Results: Data show successful interventions in reducing excessive ordering of certain laboratory tests, reduction of nonrecommended therapies, and rapid uptake of evidence-based or guidelines-supported interventions.

Conclusions: A multidisciplinary committee dedicated solely to planning, implementing, and monitoring standard approaches that eventually became evidence-based decision-making led to an improved focus on treatment options and outcomes for COVID-19 patients. Data presented illustrate the attainable success that is both adaptable and suitable for similar emergencies in the future.

Keywords: COVID-19; clinical management; pharmacy and therapeutics; treatment; therapy.

The COVID-19 pandemic has spread to nearly all countries, carrying with it high morbidity, mortality, and severe impacts on both well-developed and less-well-developed health systems. Media reports of chaos within overwhelmed hospitals have been prominent.^1,2 As of January 5, 2022, SARS-CoV-2 has infected more than 295 million people globally and directly caused the death of more than 5.4 million,³ though this number is likely an undercount even in countries with well-developed mortality tracking.⁴

Throughout the COVID-19 pandemic, hospital-based medical teams have been confronted with a flood of severely ill patients with novel syndromes. Initially, there were no standards for therapy or supportive care except for treatments borrowed from similar syndromes. In the setting of high volumes, high acuity, and public dismay, it is unsurprising that the usual deliberative methods for weighing evidence and initiating interventions were often pushed aside in favor of the solace of active intervention.⁵ In this milieu of limited evidence, there was a lamentable, if understandable, tendency to seek guidance from “nontraditional” sources,⁶ including email chains from colleagues, hospital websites, non–peer-reviewed manuscripts, advanced publication by medical journals,⁷ and nonscientific media presentations. In many localities, practitioners responded in idiosyncratic ways. For example, findings of high cytokine levels in COVID-19,⁸ along with reports of in-vitro antiviral activity with drugs like hydroxychloroquine against both SARS⁹ and SARS-CoV-2,¹⁰ drove laboratory test ordering and therapeutic interventions, respectively, carving shortcuts into the traditional clinical trial–dependent standards. Clinical trial results eventually emerged.¹¹COVID-19 created a clinical dilemma for hospital medical staffs in terms of how to organize, standardize, and rapidly adapt to a flood of new information. In this report, we describe how 1 health system responded to these challenges by forming a COVID-19 Clinical Management Committee (CCMC) and empowering this interdisciplinary team to review evidence, create and adjust order sets, educate practitioners, oversee care, and collaborate across teams addressing other aspects of the COVID-19 response.

Program Overview

Health System Description

Luminis Health is a health system with 2 acute care hospitals that was formed in 2019 just before the start of the pandemic. Anne Arundel Medical Center (hospital A) is a 385-bed teaching hospital in Annapolis, MD. It has more than 23 000 discharges annually. Patients with COVID-19 were cared for by either an internal medicine teaching service or nonteaching hospitalist services on cohorted nursing units. Doctor’s Community Medical Center, in Lanham, MD (hospital B), is a 206-bed acute care hospital with more than 10 350 annual discharges. COVID-19 patients were cared for by hospitalist groups, initially in noncohorted units with transition to cohorted nursing units after a few months. The medical staffs are generally distinct, with different leadership structures, though the Luminis Health Department of Medicine has oversight responsibilities at both hospitals. More than 47 physicians attended COVID-19 patients at hospital A (with medical residents) and 30 individual physicians at hospital B, respectively, including intensivists. The nursing and pharmacy staffs are distinct, but there is a shared oversight Pharmacy and Therapeutics (P&T) Committee.

The 2 hospitals had distinct electronic medical records (EMR) until January 2021, when hospital B adopted the same EMR as hospital A (Epic).

Mission and Formation of CCMC

In order to coordinate the therapeutic approach across the health system, it was important for the CCMC to be designated by the health system P&T committee as an official subcommittee so that decisions on restrictions of medications and/or new or revised order sets could be rapidly initiated across the system without waiting for the subsequent P&T meetings. The full committee retained oversight of the CCMC. Some P&T members were also on the CCMC.

The committee reviewed new reports in medical journals and prepublication servers and consulted recommendations of professional societies, such as the National Institutes of Health (NIH) COVID-19 guidelines, Infectious Diseases Society of America, Society of Critical Care Medicine, and US Food and Drug Administration (FDA) Emergency Use Authorizations (EUA), among other sources.

Composition of the CCMC

Physician leaders from both hospitals in the following specialties were solicited for participation: critical care, epidemiology, hospital medicine (internal medicine), emergency medicine, infectious diseases, nephrology, women and children’s services, and medical informatics. Specialists in other areas, such as hematology, were invited for topic-specific discussions. Hospital pharmacists with different specialties and nursing leadership were essential contributors. The committee members were expected to use various communication channels to inform frontline clinicians of new care standards and the existence of new order sets, which were embedded in the EMR.

Clinical Research

An important connection for the CCMC was with theCOVID-19 clinical research team. Three members of the research team were also members of the CCMC. All new study proposals for therapeutics were discussed with the CCMC as they were being considered by the research team. In this way, feedback on the feasibility and acceptance of new study opportunities could be discussed with the CCMC. Occasionally, CCMC decisions impacted clinical research accrual strategies. For example, new data from randomized trials about tocilizumab^1,2 demonstrated benefits in some subsets of patients and resulted in a recommendation for use by the NIH guideline committee in these populations.¹ The CCMC quickly adopted this recommendation, which required a reprioritization of clinical research enrollment for studies testing other immune-modulating agents. This important dialogue was mediated within the CCMC.

Guideline Distribution, Reinforcement, and Platform for Feedback

New guidelines were disseminated to clinicians via daily brief patient huddles held on COVID units, with participation by nursing and pharmacy, and by weekly meetings with hospitalist leaders and frontline hospital physicians. Order sets and guidelines were maintained on the intranet. Adherence was reinforced by unit-based and central pharmacists. Order sets, including admission order sets, could be created only by designated informatics personnel, thus enforcing standardization. Feedback on the utility of the order sets was obtained during the weekly meetings or huddles, as described above. To ensure a sense of transparency, physicians who had interest in commenting on a particular therapy, or who wished to discuss a particular manuscript, news article, or website, were invited to attend CCMC meetings.

Scope of CCMC

In order to be effective and timely, we limited the scope of our work to the report to the inpatient therapeutic environment, allowing other committees to work on other aspects of the pandemic response. In addition to issuing guidance and creating order sets to direct clinical practice, the CCMC also monitored COVID-19 therapeutic shortages^15,16 and advised on prioritization of such treatments as convalescent plasma, remdesivir (prioritization and duration of therapy, 5 vs 10 days), baricitinib, and tocilizumab, depending upon the location of the patient (critical care or not). The CCMC was not involved in the management of non–COVID-19 shortages brought about by supply chain deficiencies.

Table 1 shows some aspects of the health system pandemic-response planning and the committee workforce that undertook that work. Though many items were out of scope for the CCMC, members of the CCMC did participate in the planning work of these other committees and therefore stayed connected to this complementary work.

A Teaching Opportunity About Making Thoughtful Choices

Another important feature of the CCMC was the contributions of residents from both pharmacy and internal medicine. The purpose and operations of the committee were recognized as an opportunity to involve learners in a curriculum based on Kern’s 6-step approach.¹⁷ Though the problem identification and general needs assessment were easily defined, the targeted needs assessment, extracted from individual and group interviews with learners and the committee members, pointed at the need to learn how to assess and analyze a rapidly growing body of literature on several relevant clinical aspects of SARS-CoV-2 and COVID-19. To achieve goals and objectives, residents were assigned to present current literature on a particular intervention during a committee meeting, specifically commenting on the merit or deficiencies of the study design, the strength of the data, and applicability to the local context with a recommendation. Prior to the presentations, the residents worked with faculty to identify the best studies or systematic analyses with potential to alter current practices. We thus used the CCMC process as a teaching tool about evidence-based medicine and the dilemma of clinical equipoise. This was imperative, since trainees thrust into the COVID-19 response have often keenly observed a movement away from deliberative decision-making.¹⁸ Indeed, including residents in the process of deliberative responses to COVID-19 addresses a recent call to adjust medical education during COVID-19 to “adapt curriculum to current issues in real time.”¹⁹

Interventions and Therapies Considered

Table 2 shows the topics reviewed by the CCMC. By the time of the first meeting, nonstandardization of care was already a source of concern for clinicians. Dialogue often continued outside of the formal meetings. Many topics were considered more than once as new guidance developed, changes to EUAs occurred, and new data or new publicity arose.

Methods

The Human Protections Administrator determined that this work constituted “quality improvement, and not research” and was therefore exempt from institutional review board review.

Quantitative Analysis

All admitted patients from March 10, 2020, through April 20, 2021, were considered in the quantitative aspects of this report except as noted. Patients diagnosed with COVID-19 were identified by searching our internal data base using diagnostic codes. Patient admissions with the following diagnostic codes were included (prior to April 1, 2020): J12.89, J20.8, J40, J22, J98.8, J80, each with the additional code of B97.29. After April 1, 2020, the guideline for coding COVID-19 was U07.1.

Descriptive statistics were used to measure utilization rates of certain medications and laboratory tests of interest over time. These data were adjusted for number of unique admissions. In a few cases, not all data elements were available from both hospitals due to differences in the EMR.

Case fatality rate was calculated based upon whether the patient died or was admitted to inpatient hospice as a result of COVID-19. Four patients transferred out of hospital A and 18 transferred out of hospital B were censored from case-fatality-rate determination.

Figure 1 shows the number of admissions for each acute care hospital in the health system and the combined COVID-19 case-fatality rate over time.

Results

A total of 5955 consecutive COVID-19 patients admitted from March 10, 2020, through April 30, 2021, were analyzed. Patients with International Statistical Classification of Diseases, Tenth Revision codes J12.89. J20.8, J40, J22, J98.8, J80, each with the additional code of B97.29 (or the code UO7.1 after April 1, 2020), were included in the analysis. The median age of admitted patients was 65 years (range 19-91 years). Using the NIH classification system for severity,²⁰ the distribution of severity during the first 24 hours after the time of hospital admission was as follows: asymptomatic/presymptomatic, 0.5%; mild illness, 5.3%; moderate illness, 37.1%; severe illness, 55.5%; and critical illness, 1.1%.

The impact of the CCMC can be estimated by looking at care patterns over time. Since the work of the CCMC was aimed at influencing and standardizing physician ordering and therapy choices through order set creation and other forms of oversight, we measured the use of the CCMC-approved order sets at both hospitals and the use of certain laboratory tests and therapies that the CCMC sought either to limit or increase. These counts were adjusted for number of unique COVID-19 admissions. But the limits of the case collection tool meant it also collected cases that were not eligible for some of the interventions. For example, COVID-19 admissions without hypoxemia would not have been eligible for remdesivir or glucocorticoids. When admitted, some patients were already on steroids for other medical indications and did not receive the prescribed dexamethasone dose that we measured in pharmacy databases. Similarly, a few patients were hospitalized for indications unrelated to COVID-19, such as surgery or childbirth, and were found to be SARS-CoV-2-positive on routine screening.

Figure 2 shows the utilization of CCMC-approved standard COVID-19 admission order sets as a proportion of all COVID-19 admissions over time. The trend reveals a modest increase in usage (R² = 0.34), but these data do not reflect the progressive build of content into order sets over time. One of the goals of the order sets was to standardize and reduce the ordering of certain biomarkers: C-reactive protein, serum ferritin, and D-dimer, which were ordered frequently in many early patients. Orders for these 3 laboratory tests are combined and expressed as an average number of labs per COVID-19 admission in Figure 2. A downward trend, with an R² value of 0.65, is suggestive of impact from the order sets, though other explanations are possible.

Medication guidance was also a goal of the CCMC, simultaneously discouraging poorly supported interventions and driving uptake of the recommended evidence-based interventions in appropriate patients. Figure 3 shows the utilization pattern for some drugs of interest over the course of the pandemic, specifically the proportion of patients receiving at least 1 dose of medication among all COVID-19 admissions by month. (Data for hospital B was excluded from this analysis because it did not include all admitted patients.)

Hydroxychloroquine, which enjoyed a wave of popularity early on during the pandemic, was a target of successful order stewardship through the CCMC. Use of hydroxychloroquine as a COVID-19 therapeutic option after the first 2 months of the pandemic stopped, and subsequent use at low levels likely represented continuation therapy for outpatients who took hydroxychloroquine for rheumatologic indications.

Dexamethasone, as used in the RECOVERY trial,²¹ had a swift uptake among physicians after it was incorporated into order sets and its use encouraged. Similarly, uptake was immediate for remdesivir when, in May 2020, preliminary reports showed at least some benefits, confirmed by later analysis,²² and it received an FDA EUA.

Our data also show successful stewardship of the interleukin-6 antagonist toclilizumab, which was discouraged early on by the CCMC due to lack of data or negative results. But in March 2021, with new studies releasing data^12,13 and new recommendations¹⁴ for its use in some subsets of patients with COVID-19, this drug was encouraged in appropriate subsets. A new order set with qualifying indications was prepared by the CCMC and new educational efforts made to encourage its use in appropriate patients.

Ivermectin was nonformulary at the start of the pandemic. This drug enjoyed much publicity from media sources and was promoted by certain physicians and on websites,²³ based on in-vitro activity against coronaviruses. Eventually, the World Health Organization²⁴ and the FDA²⁵ found it necessary to issue advisory statements to the public against its use outside of clinical trials. The CCMC had requests from physicians to incorporate ivermectin but declined to add it to the formulary and recommended not approving nonformulary requests due to lack of data. As a result, ivermectin was not used at either hospital.

Discussion

COVID-19 represents many challenges to health systems all over the world. For Luminis Health, the high volume of acutely ill patients with novel syndromes was a particular challenge for the hospital-based care teams. A flood of information from preprints, press releases, preliminary reports, and many other nontraditional sources made deliberative management decisions difficult for individual physicians. Much commentary has appeared around the phenomenon but with less practical advice about how to make day-to-day care decisions at a time of scientific uncertainty and intense pressure to intervene.^26,27 The CCMC was designed to overcome the information management dilemma. The need to coordinate, standardize, and oversee care was necessary given the large number of physicians who cared for COVID-19 patients on inpatient services.

It should be noted that creating order sets and issuing guidance is necessary, but not sufficient, to achieve our goals of being updated and consistent. This is especially true with large cadres of health care workers attending COVID-19 patients. Guidelines and recommendations were reinforced by unit-based oversight and stewardship from pharmacy and other leaders who constituted the CCMC.

The reduction in COVID-19 mortality over time experienced in this health care system was not unique and cannot necessarily be attributed to standardization of care. Similar improvements in mortality have been reported at many US hospitals in aggregate.²⁸ Many other factors, including changes in patient characteristics, may be responsible for reduction in mortality over time.

Throughout this report we have relied upon an implicit assumption that standardization of medical therapeutics is desirable and leads to better outcomes as compared with allowing unlimited empiricism by individual physicians, either consultants or hospitalists. Our program represents a single health system with 2 acute care hospitals located 25 miles apart and which thus were similarly impacted by the different phases of the pandemic. Generalizability to health systems either smaller or larger, or in different geographical areas, has not been established. Data limitations have already been discussed.

We did not measure user satisfaction with the program either from physicians or nurses. However, the high rate of compliance suggests general agreement with the content and process.

We cannot definitively ascribe reduction in utilization of some nonrecommended treatments and increased utilization of the recommended therapies to the work of the CCMC. Individual physicians may have made these adjustments on their own or under the influence of other sources.

Finally, it should be noted that the mission to rapidly respond to data from well-conducted trials might be thwarted by too rigid a process or a committee’s lack of a sense of urgency. Organizing a committee and then empowering it to act is no guarantee of success; commitment to the mission is.

Conclusion

COVID-19 represented a challenge to medical staffs everywhere, inundating them with high volumes of acutely ill patients presenting with unfamiliar syndromes. Initial responses were characterized by idiosyncratic management approaches based on nontraditional sources of opinion and influences.

This report describes how a complex medical system brought order and standardization through a deliberative, but urgent, multidisciplinary committee with responsibility for planning, implementing, and monitoring standard approaches that eventually became evidence based. The composition of the committee and its scope of influence, limited to inpatient management, were important elements of success, allowing for better focus on the many treatment decisions. The important connection between the management committee and the system P&T committee, the clinical research effort, and teaching programs in both medicine and pharmacy are offered as exemplars of coordination. The data presented show success in achieving standardized, guideline-directed care. The approach is adoptable and suitable for similar emergencies in the future.

Acknowledgments: The authors thank Gary Scabis, Kip Waite, John Moxley, Angela Clubb, and David Woodley for their assistance in gathering data. We express appreciation and admiration for all our colleagues at the bedside.

Corresponding author: Barry R. Meisenberg, MD, Department of Medicine, Luminis Health, 2001 Medical Pkwy, Annapolis, MD 21401; meisenberg@AAHS.org.

Financial disclosures: None.

Electronic consultation (e-consult) is designed to increase access to specialty care by facilitating communication between primary care and specialty clinicians without the need for outpatient face-to-face encounters.^1–4 In 2011, the US Department of Veterans Affairs (VA) implemented an e-consult program as a component of its overall strategy to increase access to specialty services, reduce costs of care, and reduce appointment travel burden on patients.

E-consult has substantially increased within the VA since its implementation.^5,6 Consistent with limited evaluations from other health care systems, evaluations of the VA e-consult program demonstrated reduced costs, reduced travel time for patients, and improved access to specialty care.^2,5–11 However, there is wide variation in e-consult use across VA specialties, facilities, and regions.^5,6,12,13 For example, hematology, preoperative evaluation, neurosurgery, endocrinology, and infectious diseases use e-consults more frequently when compared with in-person consults in the VA.⁶ Reasons for this variation or specific barriers and facilitators of using e-consults have not been described.

Prior qualitative studies report that primary care practitioners (PCPs) describe e-consults as convenient, educational, beneficial for patient care, and useful for improving patient access to specialty care.^8,14,15 One study identified limited PCP knowledge of e-consults as a barrier to use.¹⁶ Specialists have reported that e-consult improves clinical communication, but increases their workload.^1,14,17,18 These studies did not assess perspectives from both clinicians who initiate e-consults and those who respond to them. This is the first qualitative study to assess e-consult perceptions from perspectives of both PCPs and specialists among a large, national sample of VA clinicians who use e-consults. The objective of this study was to understand perspectives of e-consults between PCPs and specialists that may be relevant to increasing adoption in the VA.

Methods

The team (CL, ML, PG, 2 analysts under the guidance of GS and JS and support from RRK, and a biostatistician) conducted semistructured interviews with PCPs, specialists, and specialty division leaders who were employed by VA in 2016 and 2017. Specialties of interest were identified by the VA Office of Specialty Care and included cardiology, endocrinology, gastroenterology, and hematology.

E-Consult Procedures

Within the VA, the specific procedures used to initiate, triage and manage e-consults are coordinated at VA medical centers (VAMCs) and at the Veterans Integrated Service Network (VISN) regional level. E-consult can be requested by any clinician. Generally, e-consults are initiated by PCPs through standardized, specialty-specific templates. Recipients, typically specialists, respond by answering questions, suggesting additional testing and evaluation, or requesting an in-person visit. Communication is documented in the patient’s electronic health record (EHR). Specialists receive different levels of workload credit for responding to e-consults similar to a relative value unit reimbursement model. Training in the use of e-consults is available to practitioners but may vary at local and regional levels.

Recruitment

Our sample included PCPs, specialists, and specialty care division leaders. We first quantified e-consult rates (e-consults per 100 patient visits) between July 2016 and June 2017 at VA facilities within primary care and the 4 priority specialties and identified the 30 sites with the highest e-consult rates and 30 sites with the lowest e-consult rates. Sites with < 500 total visits, < 3 specialties, or without any e-consult visit during the study period were excluded. E-consult rates at community-based outpatient clinics were included with associated VAMCs. We then stratified PCPs by whether they were high or low users of e-consults (determined by the top and bottom users within each site) and credentials (MD vs nurse practitioner [NP] or physician assistant [PA]). Specialists were sampled based on their rate of use relative to colleagues within their site and the use rate of their division. We sampled division chiefs and individuals who had > 300 total visits and 1 e-consult during the study period. To recruit participants, the primary investigator sent an initial email and 2 reminder emails. The team followed up with respondents to schedule an interview.

Interview guides were designed to elicit rich descriptions of barriers and facilitators to e-consult use (eAppendix available at doi:10.12788/fp.0214). The team used the Practical Robust Implementation and Sustainability Model (PRISM), which considers factors along 6 domains for intervention planning, implementation, and sustainment.¹⁹ Telephone interviews lasted about 20 minutes and were conducted between September 2017 and March 2018. Interviews were recorded and transcribed verbatim.

Analysis

The team used an iterative, team-based, inductive/deductive approach to conventional content analysis.^20,21 Initial code categories were created so that we could identify e-consult best practices—facilitators of e-consult that were recommended by both PCPs and specialists. Inductive codes or labels applied to identify meaningful quotations, phrases, or key terms were used to identify emergent ideas and were added throughout coding after discussion among team members. Consensus was reached using a team-based approach.²¹ Four analysts independently coded the same 3 transcripts and met to discuss points of divergence and convergence. Analyses continued with emergent themes, categories, and conclusions. Atlas.ti. v.7 was used for coding and data management.²²

Results

We conducted 34 interviews with clinicians (Table 1) from 13 VISNs. Four best-practice themes emerged among both PCPs and specialists, including that e-consults (1) are best suited for certain clinical questions and patients; (2) require relevant background information from requesting clinicians and clear recommendations from responding clinicians; (3) are a novel opportunity to provide efficient, transparent care; and (4) may not be fully adopted due to low awareness. Supporting quotations for the following findings are provided in Table 2.

Specific Clinical Questions and Patients

PCPs described specific patients and questions for which they most frequently used e-consults, such as for medication changes (Q1), determining treatment steps (Q2,3), and or clarifying laboratory or imaging findings. PCPs frequently used e-consults for patients who did not require a physical examination or when specialists could make recommendations without seeing patients face-to-face (Q3). An important use of e-consults described by PCPs was for treating conditions they could manage within primary care if additional guidance were available (Q4). Several PCPs and specialists also noted that e-consults were particularly useful for patients who were unable to travel or did not want face-to-face appointments (Q5). Notably, PCPs and specialists mentioned situations for which e-consults were inappropriate, including when a detailed history or physical examination was needed, or if a complex condition was suspected (Q6).

Background Data and Clear Recommendations

Participants described necessary data that should be included in high-quality e-consults. Specialists voiced frustration in time-consuming chart reviews that were often necessary when these data were not provided by the requestor. In some cases, specialists were unable to access necessary EHR data, which delayed responses (Q7). PCPs noted that the most useful responses carefully considered the question, used current patient information to determine treatments, provided clear recommendations, and defined who was responsible for next steps (Q8). PCPs and specialists stated that e-consult templates that required relevant information facilitated high-quality e-consults. Neither wanted to waste the other clinician's time (Q8).

A Novel Opportunity

Many PCPs felt that e-consults improved communication (eg, efficiency, response time), established new communication between clinicians, and reduced patients’ appointment burden (Q10, Q11). Many specialists felt that e-consults improved documentation of communication between clinicians and increased transparency of clinical decisions (Q12). Additionally, many specialists mentioned that e-consults capture previously informal curbside consults, enabling them to receive workload credit (Q13).

Lack of Awareness

Some noted that the biggest barrier to e-consults was not being aware of them generally, or which specialties offer e-consults (Q14). One PCP described e-consults as the best kept secret and found value in sharing the utility of e-consults with colleagues (Q15). All participants, including those who did not frequently use e-consults, felt that e-consults improved the quality of care by providing more timely care or better answers to clinical questions (Q16). Several practitioners also felt that e-consults increased access to specialty care. For example, specialists reported that e-consults enabled them to better manage patient load by using e-consults to answer relatively simple questions, reserving face-to-face consults for more complex patients (Q17).

Discussion

The objective of this study was to identify potential best practices for e-consults that may help increase their quality and use within the VA. We built on prior studies that offered insights on PCP and specialists’ overall satisfaction with e-consult by identifying several themes relevant to the further adoption of e-consults in the VA and elsewhere without a face-to-face visit.^{8,13,14,16–18} Future work may be beneficial in identifying whether the study themes identified can explain variation in e-consult use or whether addressing these factors might lead to increased or higher quality e-consult use. We are unaware of any qualitative study of comparable scale in a different health care system. Further, this is the first study to assess perspectives on e-consults among those who initiate and respond to them within the same health care system. Perhaps the most important finding from this study is that e-consults are generally viewed favorably, which is a necessary leverage point to increase their adoption within the system.

Clinicians reported several benefits to e-consults, including timely responses to clinical questions, efficient communication, allow for documentation of specialist recommendations, and help capture workload. These benefits are consistent with prior literature that indicates both PCPs and specialists in the VA and other health care systems feel that e-consults improves communication, decreases unnecessary visits, and improves quality of care.^1,14,17,18 In particular, clinicians reported that e-consults improve their practice efficiency and efficacy. This is of critical importance given the pressures of providing timely access to primary and specialty care within the VA. Interestingly, many VA practitioners were unaware which specialties offered e-consults within their facilities, reflecting previous work showing that PCPs are often unaware of e-consult options.¹⁶ This may partially explain variation in e-consult use. Increasing awareness and educating clinicians on the benefits of e-consults may help promote use among non- and low users.

A common theme reported by both groups was the importance of providing necessary information within e-consult questions and responses. Specialists felt there was a need to ensure that PCPs provide relevant and patient-specific information that would enable them to efficiently and accurately answer questions without the need for extensive EHR review. This reflects previous work showing that specialists are often unable to respond to e-consult requests because they do not contain sufficient information.²² PCPs described a need to ensure that specialists’ responses included information that was detailed enough to make clinical decisions without the need for a reconsult. This highlights a common challenge to medical consultation, in that necessary or relevant information may not be apparent to all clinicians. To address this, there may be a role in developing enhanced, flexible templating that elicits necessary patient-specific information. Such a template may automatically pull relevant data from the EHR and prompt clinicians to provide important information. We did not assess how perspectives of templates varied, and further work could help define precisely what constitutes an effective template, including how it should capture appropriate patient data and how this impacts acceptability or use of e-consults generally. Collaboratively developed service agreements and e-consult templates could help guide PCPs and specialists to engage in efficient communication.

Another theme among both groups was that e-consult is most appropriate within specific clinical scenarios. Examples included review of laboratory results, questions about medication changes, or for patients who were reluctant to travel to appointments. Identifying and promoting specific opportunities for e-consults may help increase their use and align e-consult practices with scenarios that are likely to provide the most benefit to patients. For example, it could be helpful to understand the distance patients must travel for specialty care. Providing that information during clinical encounters could trigger clinicians to consider e-consults as an option. Future work might aim to identify clinical scenarios that clinicians feel are not well suited for e-consults and determine how to adapt them for those scenarios.

Limitations

Generalizability of these findings is limited given the qualitative study design. Participants’ descriptions of experiences with e-consults reflect the experiences of clinicians in the VA and may not reflect clinicians in other settings. We also interviewed a sample of clinicians who were already using e-consults. Important information could be learned from future work with those who have not yet adopted e-consult procedures or adopted and abandoned them.

Conclusions

E-consult is perceived as beneficial by VA PCPs and specialists. Participants suggested using e-consults for appropriate questions or patients and including necessary information and next steps in both the initial e-consult and response. Finding ways to facilitate e-consults with these suggestions in mind may increase delivery of high-quality e-consults. Future work could compare the findings of this work to similar work assessing clinicians perceptions of e-consults outside of the VA.

Electronic consultation (e-consult) is designed to increase access to specialty care by facilitating communication between primary care and specialty clinicians without the need for outpatient face-to-face encounters.^1–4 In 2011, the US Department of Veterans Affairs (VA) implemented an e-consult program as a component of its overall strategy to increase access to specialty services, reduce costs of care, and reduce appointment travel burden on patients.

E-consult has substantially increased within the VA since its implementation.^5,6 Consistent with limited evaluations from other health care systems, evaluations of the VA e-consult program demonstrated reduced costs, reduced travel time for patients, and improved access to specialty care.^2,5–11 However, there is wide variation in e-consult use across VA specialties, facilities, and regions.^5,6,12,13 For example, hematology, preoperative evaluation, neurosurgery, endocrinology, and infectious diseases use e-consults more frequently when compared with in-person consults in the VA.⁶ Reasons for this variation or specific barriers and facilitators of using e-consults have not been described.

Prior qualitative studies report that primary care practitioners (PCPs) describe e-consults as convenient, educational, beneficial for patient care, and useful for improving patient access to specialty care.^8,14,15 One study identified limited PCP knowledge of e-consults as a barrier to use.¹⁶ Specialists have reported that e-consult improves clinical communication, but increases their workload.^1,14,17,18 These studies did not assess perspectives from both clinicians who initiate e-consults and those who respond to them. This is the first qualitative study to assess e-consult perceptions from perspectives of both PCPs and specialists among a large, national sample of VA clinicians who use e-consults. The objective of this study was to understand perspectives of e-consults between PCPs and specialists that may be relevant to increasing adoption in the VA.

Methods

The team (CL, ML, PG, 2 analysts under the guidance of GS and JS and support from RRK, and a biostatistician) conducted semistructured interviews with PCPs, specialists, and specialty division leaders who were employed by VA in 2016 and 2017. Specialties of interest were identified by the VA Office of Specialty Care and included cardiology, endocrinology, gastroenterology, and hematology.

E-Consult Procedures

Within the VA, the specific procedures used to initiate, triage and manage e-consults are coordinated at VA medical centers (VAMCs) and at the Veterans Integrated Service Network (VISN) regional level. E-consult can be requested by any clinician. Generally, e-consults are initiated by PCPs through standardized, specialty-specific templates. Recipients, typically specialists, respond by answering questions, suggesting additional testing and evaluation, or requesting an in-person visit. Communication is documented in the patient’s electronic health record (EHR). Specialists receive different levels of workload credit for responding to e-consults similar to a relative value unit reimbursement model. Training in the use of e-consults is available to practitioners but may vary at local and regional levels.

Recruitment

Our sample included PCPs, specialists, and specialty care division leaders. We first quantified e-consult rates (e-consults per 100 patient visits) between July 2016 and June 2017 at VA facilities within primary care and the 4 priority specialties and identified the 30 sites with the highest e-consult rates and 30 sites with the lowest e-consult rates. Sites with < 500 total visits, < 3 specialties, or without any e-consult visit during the study period were excluded. E-consult rates at community-based outpatient clinics were included with associated VAMCs. We then stratified PCPs by whether they were high or low users of e-consults (determined by the top and bottom users within each site) and credentials (MD vs nurse practitioner [NP] or physician assistant [PA]). Specialists were sampled based on their rate of use relative to colleagues within their site and the use rate of their division. We sampled division chiefs and individuals who had > 300 total visits and 1 e-consult during the study period. To recruit participants, the primary investigator sent an initial email and 2 reminder emails. The team followed up with respondents to schedule an interview.

Interview guides were designed to elicit rich descriptions of barriers and facilitators to e-consult use (eAppendix available at doi:10.12788/fp.0214). The team used the Practical Robust Implementation and Sustainability Model (PRISM), which considers factors along 6 domains for intervention planning, implementation, and sustainment.¹⁹ Telephone interviews lasted about 20 minutes and were conducted between September 2017 and March 2018. Interviews were recorded and transcribed verbatim.

Analysis

The team used an iterative, team-based, inductive/deductive approach to conventional content analysis.^20,21 Initial code categories were created so that we could identify e-consult best practices—facilitators of e-consult that were recommended by both PCPs and specialists. Inductive codes or labels applied to identify meaningful quotations, phrases, or key terms were used to identify emergent ideas and were added throughout coding after discussion among team members. Consensus was reached using a team-based approach.²¹ Four analysts independently coded the same 3 transcripts and met to discuss points of divergence and convergence. Analyses continued with emergent themes, categories, and conclusions. Atlas.ti. v.7 was used for coding and data management.²²

Results

We conducted 34 interviews with clinicians (Table 1) from 13 VISNs. Four best-practice themes emerged among both PCPs and specialists, including that e-consults (1) are best suited for certain clinical questions and patients; (2) require relevant background information from requesting clinicians and clear recommendations from responding clinicians; (3) are a novel opportunity to provide efficient, transparent care; and (4) may not be fully adopted due to low awareness. Supporting quotations for the following findings are provided in Table 2.

Specific Clinical Questions and Patients

PCPs described specific patients and questions for which they most frequently used e-consults, such as for medication changes (Q1), determining treatment steps (Q2,3), and or clarifying laboratory or imaging findings. PCPs frequently used e-consults for patients who did not require a physical examination or when specialists could make recommendations without seeing patients face-to-face (Q3). An important use of e-consults described by PCPs was for treating conditions they could manage within primary care if additional guidance were available (Q4). Several PCPs and specialists also noted that e-consults were particularly useful for patients who were unable to travel or did not want face-to-face appointments (Q5). Notably, PCPs and specialists mentioned situations for which e-consults were inappropriate, including when a detailed history or physical examination was needed, or if a complex condition was suspected (Q6).

Background Data and Clear Recommendations

Participants described necessary data that should be included in high-quality e-consults. Specialists voiced frustration in time-consuming chart reviews that were often necessary when these data were not provided by the requestor. In some cases, specialists were unable to access necessary EHR data, which delayed responses (Q7). PCPs noted that the most useful responses carefully considered the question, used current patient information to determine treatments, provided clear recommendations, and defined who was responsible for next steps (Q8). PCPs and specialists stated that e-consult templates that required relevant information facilitated high-quality e-consults. Neither wanted to waste the other clinician's time (Q8).

A Novel Opportunity

Many PCPs felt that e-consults improved communication (eg, efficiency, response time), established new communication between clinicians, and reduced patients’ appointment burden (Q10, Q11). Many specialists felt that e-consults improved documentation of communication between clinicians and increased transparency of clinical decisions (Q12). Additionally, many specialists mentioned that e-consults capture previously informal curbside consults, enabling them to receive workload credit (Q13).

Lack of Awareness

Some noted that the biggest barrier to e-consults was not being aware of them generally, or which specialties offer e-consults (Q14). One PCP described e-consults as the best kept secret and found value in sharing the utility of e-consults with colleagues (Q15). All participants, including those who did not frequently use e-consults, felt that e-consults improved the quality of care by providing more timely care or better answers to clinical questions (Q16). Several practitioners also felt that e-consults increased access to specialty care. For example, specialists reported that e-consults enabled them to better manage patient load by using e-consults to answer relatively simple questions, reserving face-to-face consults for more complex patients (Q17).

Discussion

The objective of this study was to identify potential best practices for e-consults that may help increase their quality and use within the VA. We built on prior studies that offered insights on PCP and specialists’ overall satisfaction with e-consult by identifying several themes relevant to the further adoption of e-consults in the VA and elsewhere without a face-to-face visit.^{8,13,14,16–18} Future work may be beneficial in identifying whether the study themes identified can explain variation in e-consult use or whether addressing these factors might lead to increased or higher quality e-consult use. We are unaware of any qualitative study of comparable scale in a different health care system. Further, this is the first study to assess perspectives on e-consults among those who initiate and respond to them within the same health care system. Perhaps the most important finding from this study is that e-consults are generally viewed favorably, which is a necessary leverage point to increase their adoption within the system.

Clinicians reported several benefits to e-consults, including timely responses to clinical questions, efficient communication, allow for documentation of specialist recommendations, and help capture workload. These benefits are consistent with prior literature that indicates both PCPs and specialists in the VA and other health care systems feel that e-consults improves communication, decreases unnecessary visits, and improves quality of care.^1,14,17,18 In particular, clinicians reported that e-consults improve their practice efficiency and efficacy. This is of critical importance given the pressures of providing timely access to primary and specialty care within the VA. Interestingly, many VA practitioners were unaware which specialties offered e-consults within their facilities, reflecting previous work showing that PCPs are often unaware of e-consult options.¹⁶ This may partially explain variation in e-consult use. Increasing awareness and educating clinicians on the benefits of e-consults may help promote use among non- and low users.

A common theme reported by both groups was the importance of providing necessary information within e-consult questions and responses. Specialists felt there was a need to ensure that PCPs provide relevant and patient-specific information that would enable them to efficiently and accurately answer questions without the need for extensive EHR review. This reflects previous work showing that specialists are often unable to respond to e-consult requests because they do not contain sufficient information.²² PCPs described a need to ensure that specialists’ responses included information that was detailed enough to make clinical decisions without the need for a reconsult. This highlights a common challenge to medical consultation, in that necessary or relevant information may not be apparent to all clinicians. To address this, there may be a role in developing enhanced, flexible templating that elicits necessary patient-specific information. Such a template may automatically pull relevant data from the EHR and prompt clinicians to provide important information. We did not assess how perspectives of templates varied, and further work could help define precisely what constitutes an effective template, including how it should capture appropriate patient data and how this impacts acceptability or use of e-consults generally. Collaboratively developed service agreements and e-consult templates could help guide PCPs and specialists to engage in efficient communication.

Another theme among both groups was that e-consult is most appropriate within specific clinical scenarios. Examples included review of laboratory results, questions about medication changes, or for patients who were reluctant to travel to appointments. Identifying and promoting specific opportunities for e-consults may help increase their use and align e-consult practices with scenarios that are likely to provide the most benefit to patients. For example, it could be helpful to understand the distance patients must travel for specialty care. Providing that information during clinical encounters could trigger clinicians to consider e-consults as an option. Future work might aim to identify clinical scenarios that clinicians feel are not well suited for e-consults and determine how to adapt them for those scenarios.

Limitations

Generalizability of these findings is limited given the qualitative study design. Participants’ descriptions of experiences with e-consults reflect the experiences of clinicians in the VA and may not reflect clinicians in other settings. We also interviewed a sample of clinicians who were already using e-consults. Important information could be learned from future work with those who have not yet adopted e-consult procedures or adopted and abandoned them.

Conclusions

E-consult is perceived as beneficial by VA PCPs and specialists. Participants suggested using e-consults for appropriate questions or patients and including necessary information and next steps in both the initial e-consult and response. Finding ways to facilitate e-consults with these suggestions in mind may increase delivery of high-quality e-consults. Future work could compare the findings of this work to similar work assessing clinicians perceptions of e-consults outside of the VA.

Electronic consultation (e-consult) is designed to increase access to specialty care by facilitating communication between primary care and specialty clinicians without the need for outpatient face-to-face encounters.^1–4 In 2011, the US Department of Veterans Affairs (VA) implemented an e-consult program as a component of its overall strategy to increase access to specialty services, reduce costs of care, and reduce appointment travel burden on patients.

E-consult has substantially increased within the VA since its implementation.^5,6 Consistent with limited evaluations from other health care systems, evaluations of the VA e-consult program demonstrated reduced costs, reduced travel time for patients, and improved access to specialty care.^2,5–11 However, there is wide variation in e-consult use across VA specialties, facilities, and regions.^5,6,12,13 For example, hematology, preoperative evaluation, neurosurgery, endocrinology, and infectious diseases use e-consults more frequently when compared with in-person consults in the VA.⁶ Reasons for this variation or specific barriers and facilitators of using e-consults have not been described.

Prior qualitative studies report that primary care practitioners (PCPs) describe e-consults as convenient, educational, beneficial for patient care, and useful for improving patient access to specialty care.^8,14,15 One study identified limited PCP knowledge of e-consults as a barrier to use.¹⁶ Specialists have reported that e-consult improves clinical communication, but increases their workload.^1,14,17,18 These studies did not assess perspectives from both clinicians who initiate e-consults and those who respond to them. This is the first qualitative study to assess e-consult perceptions from perspectives of both PCPs and specialists among a large, national sample of VA clinicians who use e-consults. The objective of this study was to understand perspectives of e-consults between PCPs and specialists that may be relevant to increasing adoption in the VA.

Methods

The team (CL, ML, PG, 2 analysts under the guidance of GS and JS and support from RRK, and a biostatistician) conducted semistructured interviews with PCPs, specialists, and specialty division leaders who were employed by VA in 2016 and 2017. Specialties of interest were identified by the VA Office of Specialty Care and included cardiology, endocrinology, gastroenterology, and hematology.

E-Consult Procedures

Within the VA, the specific procedures used to initiate, triage and manage e-consults are coordinated at VA medical centers (VAMCs) and at the Veterans Integrated Service Network (VISN) regional level. E-consult can be requested by any clinician. Generally, e-consults are initiated by PCPs through standardized, specialty-specific templates. Recipients, typically specialists, respond by answering questions, suggesting additional testing and evaluation, or requesting an in-person visit. Communication is documented in the patient’s electronic health record (EHR). Specialists receive different levels of workload credit for responding to e-consults similar to a relative value unit reimbursement model. Training in the use of e-consults is available to practitioners but may vary at local and regional levels.

Recruitment

Our sample included PCPs, specialists, and specialty care division leaders. We first quantified e-consult rates (e-consults per 100 patient visits) between July 2016 and June 2017 at VA facilities within primary care and the 4 priority specialties and identified the 30 sites with the highest e-consult rates and 30 sites with the lowest e-consult rates. Sites with < 500 total visits, < 3 specialties, or without any e-consult visit during the study period were excluded. E-consult rates at community-based outpatient clinics were included with associated VAMCs. We then stratified PCPs by whether they were high or low users of e-consults (determined by the top and bottom users within each site) and credentials (MD vs nurse practitioner [NP] or physician assistant [PA]). Specialists were sampled based on their rate of use relative to colleagues within their site and the use rate of their division. We sampled division chiefs and individuals who had > 300 total visits and 1 e-consult during the study period. To recruit participants, the primary investigator sent an initial email and 2 reminder emails. The team followed up with respondents to schedule an interview.

Interview guides were designed to elicit rich descriptions of barriers and facilitators to e-consult use (eAppendix available at doi:10.12788/fp.0214). The team used the Practical Robust Implementation and Sustainability Model (PRISM), which considers factors along 6 domains for intervention planning, implementation, and sustainment.¹⁹ Telephone interviews lasted about 20 minutes and were conducted between September 2017 and March 2018. Interviews were recorded and transcribed verbatim.

Analysis

The team used an iterative, team-based, inductive/deductive approach to conventional content analysis.^20,21 Initial code categories were created so that we could identify e-consult best practices—facilitators of e-consult that were recommended by both PCPs and specialists. Inductive codes or labels applied to identify meaningful quotations, phrases, or key terms were used to identify emergent ideas and were added throughout coding after discussion among team members. Consensus was reached using a team-based approach.²¹ Four analysts independently coded the same 3 transcripts and met to discuss points of divergence and convergence. Analyses continued with emergent themes, categories, and conclusions. Atlas.ti. v.7 was used for coding and data management.²²

Results

We conducted 34 interviews with clinicians (Table 1) from 13 VISNs. Four best-practice themes emerged among both PCPs and specialists, including that e-consults (1) are best suited for certain clinical questions and patients; (2) require relevant background information from requesting clinicians and clear recommendations from responding clinicians; (3) are a novel opportunity to provide efficient, transparent care; and (4) may not be fully adopted due to low awareness. Supporting quotations for the following findings are provided in Table 2.

Specific Clinical Questions and Patients

PCPs described specific patients and questions for which they most frequently used e-consults, such as for medication changes (Q1), determining treatment steps (Q2,3), and or clarifying laboratory or imaging findings. PCPs frequently used e-consults for patients who did not require a physical examination or when specialists could make recommendations without seeing patients face-to-face (Q3). An important use of e-consults described by PCPs was for treating conditions they could manage within primary care if additional guidance were available (Q4). Several PCPs and specialists also noted that e-consults were particularly useful for patients who were unable to travel or did not want face-to-face appointments (Q5). Notably, PCPs and specialists mentioned situations for which e-consults were inappropriate, including when a detailed history or physical examination was needed, or if a complex condition was suspected (Q6).

Background Data and Clear Recommendations

Participants described necessary data that should be included in high-quality e-consults. Specialists voiced frustration in time-consuming chart reviews that were often necessary when these data were not provided by the requestor. In some cases, specialists were unable to access necessary EHR data, which delayed responses (Q7). PCPs noted that the most useful responses carefully considered the question, used current patient information to determine treatments, provided clear recommendations, and defined who was responsible for next steps (Q8). PCPs and specialists stated that e-consult templates that required relevant information facilitated high-quality e-consults. Neither wanted to waste the other clinician's time (Q8).

A Novel Opportunity

Many PCPs felt that e-consults improved communication (eg, efficiency, response time), established new communication between clinicians, and reduced patients’ appointment burden (Q10, Q11). Many specialists felt that e-consults improved documentation of communication between clinicians and increased transparency of clinical decisions (Q12). Additionally, many specialists mentioned that e-consults capture previously informal curbside consults, enabling them to receive workload credit (Q13).

Lack of Awareness

Some noted that the biggest barrier to e-consults was not being aware of them generally, or which specialties offer e-consults (Q14). One PCP described e-consults as the best kept secret and found value in sharing the utility of e-consults with colleagues (Q15). All participants, including those who did not frequently use e-consults, felt that e-consults improved the quality of care by providing more timely care or better answers to clinical questions (Q16). Several practitioners also felt that e-consults increased access to specialty care. For example, specialists reported that e-consults enabled them to better manage patient load by using e-consults to answer relatively simple questions, reserving face-to-face consults for more complex patients (Q17).

Discussion

The objective of this study was to identify potential best practices for e-consults that may help increase their quality and use within the VA. We built on prior studies that offered insights on PCP and specialists’ overall satisfaction with e-consult by identifying several themes relevant to the further adoption of e-consults in the VA and elsewhere without a face-to-face visit.^{8,13,14,16–18} Future work may be beneficial in identifying whether the study themes identified can explain variation in e-consult use or whether addressing these factors might lead to increased or higher quality e-consult use. We are unaware of any qualitative study of comparable scale in a different health care system. Further, this is the first study to assess perspectives on e-consults among those who initiate and respond to them within the same health care system. Perhaps the most important finding from this study is that e-consults are generally viewed favorably, which is a necessary leverage point to increase their adoption within the system.

Clinicians reported several benefits to e-consults, including timely responses to clinical questions, efficient communication, allow for documentation of specialist recommendations, and help capture workload. These benefits are consistent with prior literature that indicates both PCPs and specialists in the VA and other health care systems feel that e-consults improves communication, decreases unnecessary visits, and improves quality of care.^1,14,17,18 In particular, clinicians reported that e-consults improve their practice efficiency and efficacy. This is of critical importance given the pressures of providing timely access to primary and specialty care within the VA. Interestingly, many VA practitioners were unaware which specialties offered e-consults within their facilities, reflecting previous work showing that PCPs are often unaware of e-consult options.¹⁶ This may partially explain variation in e-consult use. Increasing awareness and educating clinicians on the benefits of e-consults may help promote use among non- and low users.

A common theme reported by both groups was the importance of providing necessary information within e-consult questions and responses. Specialists felt there was a need to ensure that PCPs provide relevant and patient-specific information that would enable them to efficiently and accurately answer questions without the need for extensive EHR review. This reflects previous work showing that specialists are often unable to respond to e-consult requests because they do not contain sufficient information.²² PCPs described a need to ensure that specialists’ responses included information that was detailed enough to make clinical decisions without the need for a reconsult. This highlights a common challenge to medical consultation, in that necessary or relevant information may not be apparent to all clinicians. To address this, there may be a role in developing enhanced, flexible templating that elicits necessary patient-specific information. Such a template may automatically pull relevant data from the EHR and prompt clinicians to provide important information. We did not assess how perspectives of templates varied, and further work could help define precisely what constitutes an effective template, including how it should capture appropriate patient data and how this impacts acceptability or use of e-consults generally. Collaboratively developed service agreements and e-consult templates could help guide PCPs and specialists to engage in efficient communication.

Another theme among both groups was that e-consult is most appropriate within specific clinical scenarios. Examples included review of laboratory results, questions about medication changes, or for patients who were reluctant to travel to appointments. Identifying and promoting specific opportunities for e-consults may help increase their use and align e-consult practices with scenarios that are likely to provide the most benefit to patients. For example, it could be helpful to understand the distance patients must travel for specialty care. Providing that information during clinical encounters could trigger clinicians to consider e-consults as an option. Future work might aim to identify clinical scenarios that clinicians feel are not well suited for e-consults and determine how to adapt them for those scenarios.

Limitations

Generalizability of these findings is limited given the qualitative study design. Participants’ descriptions of experiences with e-consults reflect the experiences of clinicians in the VA and may not reflect clinicians in other settings. We also interviewed a sample of clinicians who were already using e-consults. Important information could be learned from future work with those who have not yet adopted e-consult procedures or adopted and abandoned them.

Conclusions

E-consult is perceived as beneficial by VA PCPs and specialists. Participants suggested using e-consults for appropriate questions or patients and including necessary information and next steps in both the initial e-consult and response. Finding ways to facilitate e-consults with these suggestions in mind may increase delivery of high-quality e-consults. Future work could compare the findings of this work to similar work assessing clinicians perceptions of e-consults outside of the VA.

It has been 19 years since the publication of the landmark AFFIRM trial.¹ At the time of publication, a “rhythm control” strategy was the preferred therapy, with a rate control approach an accepted alternative. AFFIRM showed no mortality benefit of rhythm control over rate control, and its result dramatically shifted the paradigm of atrial fibrillation (AF) management. However, the high crossover rate between treatment arms may have biased the study toward the null hypothesis. Post hoc analyses of AFFIRM and other observational studies indicate that sinus rhythm was associated with a lower risk of death.² Since AFFIRM, technical advances and procedural experience have improved the safety and efficacy of catheter ablation (CA), and recently published randomized trials have shown improved outcomes with rhythm control. This Progress Note summarizes the recent evidence, updating hospitalists on the management of AF, including inpatient cardioversion, patient selection for CA, use of antiarrhythmic drugs (AADs), and lifestyle modifications associated with maintenance of sinus rhythm.

A PubMed search for recent publications using combined the MeSH terms “atrial fibrillation” with “catheter ablation,” “antiarrhythmic drugs,” and “lifestyle modifications.” Our review filtered for randomized trials, guidelines, and selected reviews. 

Urgent cardioversion is recommended for those with hemodynamic instability, AF associated ischemia, or acute heart failure.³ Whether to perform elective cardioversion depends on AF duration, symptoms, and the initial evaluation for structural heart disease or reversible causes of AF. Evaluation for new-onset AF includes eliciting a history of AF-associated comorbidities (hypertension, alcohol use, obstructive sleep apnea) and an echocardiogram and thyroid, renal, and liver function tests.³ Stable patients with AF precipitated by high-catecholamine states (eg, postoperative AF, sepsis, hyperthyroidism, pulmonary embolism, substance use) require management of the underlying condition before considering rhythm control. Inpatient electrical or pharmacologic cardioversion may be considered for patients with stable, new-onset AF sufficiently symptomatic to require hospitalization. Pre-procedure anticoagulation and a transesophageal echocardiogram to rule out left atrial thrombus before cardioversion is preferred for a first episode of AF suspected of lasting longer than 48 hours but requires anesthesia and considerable resources. In resource-constrained settings, patients asymptomatic once rate controlled may be safely discharged with a referral for outpatient cardioversion.

For patients with structural heart disease (left atrial dilation), previously failed cardioversion, or recurrent AF, initiating AADs (eg, ibutilide, amiodarone) before electrical cardioversion can improve the success rate of cardioversion.³ Ibutilide infusion requires cardiology consultation and postinfusion hemodynamic and QTc monitoring. Defer immediate cardioversion among stable patients unable to continue a minimum of 4 weeks of anticoagulation or with comorbidities for which risks of cardioversion outweigh benefits.

Successful maintenance of sinus rhythm is associated with reduced symptom burden and improved quality of life and is recommended for patients with persistent symptoms, failure of rate control, younger age, first episode of AF, or patient preference for rhythm control.³ Since AF progression results in irreversible cardiac remodeling, earlier rhythm control may prevent further atrial remodeling and atrial myopathy.

The EAST-AFNET 4 trial evaluated a rhythm-control strategy in patients with AF duration <12 months and who met two of the following: age > 65 years, female sex, heart failure, hypertension, diabetes, coronary artery disease, and chronic kidney disease.⁴ Maintenance of sinus rhythm was associated with a lower composite outcome of adverse cardiovascular outcomes and death from cardiovascular causes over 5 years compared to rate control (3.9/100 person-years vs 5.0/100 person-years, P = .005). Interestingly, roughly 20% of patients underwent CA and the remainder received AADs. The large proportion of patients treated with AADs raises the question of why the results differed from AFFIRM. There are four primary differences between these trials to consider. First, EAST-AFNET 4 used an early rhythm-control strategy (<12 months). Second, nearly all patients in EAST-AFNET 4 continued guideline-recommend anticoagulation compared to 70% receiving rhythm control in AFFIRM. Third, in AFFIRM, 62.8% of patients received amiodarone, which has significant long-term adverse effects compared to 11.8% by the end of EAST-AFNET 4. Finally, increased use of CA in EAST-AFNET 4 may have contributed to the success of rhythm control. In patients with cardiovascular disease or cardiovascular risk factors, a rhythm-control strategy will be best if implemented early (<12 months), before the development of long-standing persistent AF, and if clinicians adhere to anticoagulation recommendations.

Antiarrhythmic Drugs

Antiarrhythmic drug use prior to CA remains the cornerstone of a rhythm-control strategy for patients meeting EAST-AFNET 4 trial criteria or patient preference for medical management. Hospitalists’ knowledge of key differences between AADs used in EAST-AFNET 4 and AFFIRM as well as American Heart Association/American College of Cardiology/Heart Rhythm Society (AHA/ACC/HRS) guideline recommendations help avoid harmful AAD prescribing. Notably, 21.9% of patients in AFFIRM received AADs no longer recommended to maintain sinus rhythm in the AHA/ACC/HRS guidelines (quinidine, disopyramide, procainamide, moricizine).³ For patients without structural heart disease, flecainide, propafenone, sotalol, or dronedarone are preferred. Dronedarone and sotalol remain an option for those with coronary artery disease. For patients with heart failure with reduced ejection fraction (HFrEF), amiodarone and dofetilide are preferred (Table).³

Catheter Ablation

The AHA/ACC/HRS guidelines offer a Ia recommendation for CA in patients with recurrent, symptomatic AF who failed AAD therapy. Initial CA is a IIa recommendation and is increasingly common for patients with paroxysmal AF who prefer this strategy to long-term AAD use.³ Recent trials evaluated CA as a primary treatment modality in patients with heart failure and as initial management before AADs.

Initial Catheter Ablation

The CABANA trial compared CA with AADs as an initial approach for maintaining sinus rhythm.⁵ In the intention-to-treat analysis, there was no difference in all death or disabling stroke between AAD therapy and CA at 5-year follow-up. The results are limited by a 27.5% crossover rate from drug therapy to CA. The per-protocol analysis based on the treatment received favored CA for the primary composite outcome of death, disabling stroke, serious bleeding, or cardiac arrest at 12 months. The STOP-AF and EARLY-AF trials found that initial CA was more successful in maintaining freedom from atrial arrhythmias (74.6% vs 45.0%, P < .001)⁶ and fewer symptomatic atrial arrhythmias among patients with paroxysmal AF compared to AADs, without significant CA-associated adverse events.^6,7

While hospitalists should interpret the per-protocol analysis cautiously when determining the clinical benefit, these trials indicate initial CA is as safe as AADs and improves freedom from AF. Duration of AF, knowledge of periprocedural anticoagulation recommendations, and CA procedural complications are important when recommending CA (Figure). Efficacy of CA is approximately 70% in paroxysmal AF and decreases for persistent and long-standing AF.⁶ Complications of CA include venous access site hematoma, cardiac tamponade, phrenic nerve injury, pulmonary vein stenosis, atrial-esophageal fistula, left atrial flutter, and stroke due to endothelial injury and intraprocedural thrombosis.³ Therapeutic anticoagulation is required before CA and for at least 2 months post ablation regardless of the CHA₂DS₂-VASc score.³

Catheter Ablation Plus Antiarrhythmics

Ongoing AADs following CA may suppress AF triggers, especially in patients with persistent AF or high-risk for recurrence post ablation (left atrial dilation). The AMIO-CAT trial found that 4 weeks of amiodarone after ablation reduced early AF recurrence at 3 months (34% vs 53%, P = .006), arrhythmia-related hospitalizations, and need for cardioversion in patients with paroxysmal and persistent AF.⁸ However, amiodarone did not reduce recurrent atrial tachyarrhythmias at 6 months. The POWDER-AF trial evaluated AAD use for 1 year after CA in patients with drug-refractory paroxysmal AF.⁹ Continuation of class IC (eg, flecainide) and III (eg, amiodarone) AADs resulted in a near 20% absolute risk reduction in recurrent atrial arrhythmias and reduced the need for repeat CA. These trials suggest that discharging patients on adjunctive AADs decreases early recurrence of AF and arrhythmia-related hospitalizations; however, studies evaluating additional clinical outcomes are needed.

Heart Failure

The AATAC trial found CA was superior to amiodarone therapy at maintaining freedom from AF and reducing unplanned hospitalizations and mortality among patients with persistent AF and HFrEF.¹⁰ The larger CASTLE-AF trial randomized patients with an ejection fraction below 35% and NYHA class II or greater symptoms with symptomatic paroxysmal AF or persistent AF in whom AAD therapy failed to CA or medical therapy.¹¹ The CA group experienced lower cardiovascular mortality (11.2% vs 22.3%, P = .009) and fewer heart failure hospitalizations (20.7% vs 35.9%, P = .004). The subsequent AMICA trial did not find a benefit of CA in patients with HFrEF and persistent or long-standing persistent AF; however, this trial was limited to 12 months, whereas the benefit of CA in CASTLE-AF was observed after 12 months.¹² Also, AMICA enrolled patients with higher NYHA class. Therefore, hospitalists should refer AF patients with left ventricular systolic dysfunction and NYHA II or III symptoms for CA. Comparing AMICA and CASTLE-AF suggests earlier referral for CA, prior to the development of worsening heart failure symptoms, may improve outcomes.

Data for patients with heart failure with preserved EF (HFpEF) is limited. One small trial showed reduced heart failure hospitalizations in HFpEF patients treated with CA compared to AADs or beta-blockers.¹³ It is reasonable to refer HFpEF patients with persisting symptoms or reduced quality of life for CA.

The AHA Scientific Statement on Lifestyle and Risk Factor Modification for Reduction of Atrial Fibrillation delineates risk factors that increase the incidence of AF, including alcohol consumption, obstructive sleep apnea, hypertension, and obesity.¹⁴ Among regular alcohol consumers with paroxysmal or persistent AF managed with a rhythm-control strategy, cessation of alcohol has been shown to significantly lower the incidence of recurrent AF (53.0% vs 73.0%, P = .005), and lead to a longer time until recurrence of AF compared to patients regularly consuming alcohol.¹⁵ Among patients with obstructive sleep apnea, a systematic review of nonrandomized studies showed continuous positive airway pressure is associated with maintenance of sinus rhythm.¹⁴ Control of these risk factors is associated with up to approximately 40% of patients maintaining sinus rhythm without intervention, and hospitalists should encourage lifestyle modification to maximize the probability of maintaining sinus rhythm. 

Hospitalists frequently determine the best initial management strategy for patients admitted with new-onset AF, and recent literature may shift more patients towards management with rhythm control. Based on the trials reviewed in this Progress Note, hospitalists should recommend a rhythm-control strategy for patients with symptomatic, paroxysmal, or persistent AF of <12 months’ duration and refer patients with HFrEF for CA. Adherence to guideline recommendations is essential when prescribing AADs to avoid adverse drug events. It is vital to ensure patients managed with a rhythm-control strategy receive anticoagulation for 4 weeks post cardioversion or 2 months post CA with long-term anticoagulation based on CHA₂DS₂-VASc score. Finally, admissions for AF should serve as a catalyst to communicate to patients the importance of addressing obstructive sleep apnea, obesity, and alcohol use disorders. Applying these evidence-based practices will enable hospitalists to make clinical decisions that improve symptom burden and survival for patients with AF.

It has been 19 years since the publication of the landmark AFFIRM trial.¹ At the time of publication, a “rhythm control” strategy was the preferred therapy, with a rate control approach an accepted alternative. AFFIRM showed no mortality benefit of rhythm control over rate control, and its result dramatically shifted the paradigm of atrial fibrillation (AF) management. However, the high crossover rate between treatment arms may have biased the study toward the null hypothesis. Post hoc analyses of AFFIRM and other observational studies indicate that sinus rhythm was associated with a lower risk of death.² Since AFFIRM, technical advances and procedural experience have improved the safety and efficacy of catheter ablation (CA), and recently published randomized trials have shown improved outcomes with rhythm control. This Progress Note summarizes the recent evidence, updating hospitalists on the management of AF, including inpatient cardioversion, patient selection for CA, use of antiarrhythmic drugs (AADs), and lifestyle modifications associated with maintenance of sinus rhythm.

A PubMed search for recent publications using combined the MeSH terms “atrial fibrillation” with “catheter ablation,” “antiarrhythmic drugs,” and “lifestyle modifications.” Our review filtered for randomized trials, guidelines, and selected reviews. 

Urgent cardioversion is recommended for those with hemodynamic instability, AF associated ischemia, or acute heart failure.³ Whether to perform elective cardioversion depends on AF duration, symptoms, and the initial evaluation for structural heart disease or reversible causes of AF. Evaluation for new-onset AF includes eliciting a history of AF-associated comorbidities (hypertension, alcohol use, obstructive sleep apnea) and an echocardiogram and thyroid, renal, and liver function tests.³ Stable patients with AF precipitated by high-catecholamine states (eg, postoperative AF, sepsis, hyperthyroidism, pulmonary embolism, substance use) require management of the underlying condition before considering rhythm control. Inpatient electrical or pharmacologic cardioversion may be considered for patients with stable, new-onset AF sufficiently symptomatic to require hospitalization. Pre-procedure anticoagulation and a transesophageal echocardiogram to rule out left atrial thrombus before cardioversion is preferred for a first episode of AF suspected of lasting longer than 48 hours but requires anesthesia and considerable resources. In resource-constrained settings, patients asymptomatic once rate controlled may be safely discharged with a referral for outpatient cardioversion.

For patients with structural heart disease (left atrial dilation), previously failed cardioversion, or recurrent AF, initiating AADs (eg, ibutilide, amiodarone) before electrical cardioversion can improve the success rate of cardioversion.³ Ibutilide infusion requires cardiology consultation and postinfusion hemodynamic and QTc monitoring. Defer immediate cardioversion among stable patients unable to continue a minimum of 4 weeks of anticoagulation or with comorbidities for which risks of cardioversion outweigh benefits.

Successful maintenance of sinus rhythm is associated with reduced symptom burden and improved quality of life and is recommended for patients with persistent symptoms, failure of rate control, younger age, first episode of AF, or patient preference for rhythm control.³ Since AF progression results in irreversible cardiac remodeling, earlier rhythm control may prevent further atrial remodeling and atrial myopathy.

The EAST-AFNET 4 trial evaluated a rhythm-control strategy in patients with AF duration <12 months and who met two of the following: age > 65 years, female sex, heart failure, hypertension, diabetes, coronary artery disease, and chronic kidney disease.⁴ Maintenance of sinus rhythm was associated with a lower composite outcome of adverse cardiovascular outcomes and death from cardiovascular causes over 5 years compared to rate control (3.9/100 person-years vs 5.0/100 person-years, P = .005). Interestingly, roughly 20% of patients underwent CA and the remainder received AADs. The large proportion of patients treated with AADs raises the question of why the results differed from AFFIRM. There are four primary differences between these trials to consider. First, EAST-AFNET 4 used an early rhythm-control strategy (<12 months). Second, nearly all patients in EAST-AFNET 4 continued guideline-recommend anticoagulation compared to 70% receiving rhythm control in AFFIRM. Third, in AFFIRM, 62.8% of patients received amiodarone, which has significant long-term adverse effects compared to 11.8% by the end of EAST-AFNET 4. Finally, increased use of CA in EAST-AFNET 4 may have contributed to the success of rhythm control. In patients with cardiovascular disease or cardiovascular risk factors, a rhythm-control strategy will be best if implemented early (<12 months), before the development of long-standing persistent AF, and if clinicians adhere to anticoagulation recommendations.

Antiarrhythmic Drugs

Antiarrhythmic drug use prior to CA remains the cornerstone of a rhythm-control strategy for patients meeting EAST-AFNET 4 trial criteria or patient preference for medical management. Hospitalists’ knowledge of key differences between AADs used in EAST-AFNET 4 and AFFIRM as well as American Heart Association/American College of Cardiology/Heart Rhythm Society (AHA/ACC/HRS) guideline recommendations help avoid harmful AAD prescribing. Notably, 21.9% of patients in AFFIRM received AADs no longer recommended to maintain sinus rhythm in the AHA/ACC/HRS guidelines (quinidine, disopyramide, procainamide, moricizine).³ For patients without structural heart disease, flecainide, propafenone, sotalol, or dronedarone are preferred. Dronedarone and sotalol remain an option for those with coronary artery disease. For patients with heart failure with reduced ejection fraction (HFrEF), amiodarone and dofetilide are preferred (Table).³

Catheter Ablation

The AHA/ACC/HRS guidelines offer a Ia recommendation for CA in patients with recurrent, symptomatic AF who failed AAD therapy. Initial CA is a IIa recommendation and is increasingly common for patients with paroxysmal AF who prefer this strategy to long-term AAD use.³ Recent trials evaluated CA as a primary treatment modality in patients with heart failure and as initial management before AADs.

Initial Catheter Ablation

The CABANA trial compared CA with AADs as an initial approach for maintaining sinus rhythm.⁵ In the intention-to-treat analysis, there was no difference in all death or disabling stroke between AAD therapy and CA at 5-year follow-up. The results are limited by a 27.5% crossover rate from drug therapy to CA. The per-protocol analysis based on the treatment received favored CA for the primary composite outcome of death, disabling stroke, serious bleeding, or cardiac arrest at 12 months. The STOP-AF and EARLY-AF trials found that initial CA was more successful in maintaining freedom from atrial arrhythmias (74.6% vs 45.0%, P < .001)⁶ and fewer symptomatic atrial arrhythmias among patients with paroxysmal AF compared to AADs, without significant CA-associated adverse events.^6,7

While hospitalists should interpret the per-protocol analysis cautiously when determining the clinical benefit, these trials indicate initial CA is as safe as AADs and improves freedom from AF. Duration of AF, knowledge of periprocedural anticoagulation recommendations, and CA procedural complications are important when recommending CA (Figure). Efficacy of CA is approximately 70% in paroxysmal AF and decreases for persistent and long-standing AF.⁶ Complications of CA include venous access site hematoma, cardiac tamponade, phrenic nerve injury, pulmonary vein stenosis, atrial-esophageal fistula, left atrial flutter, and stroke due to endothelial injury and intraprocedural thrombosis.³ Therapeutic anticoagulation is required before CA and for at least 2 months post ablation regardless of the CHA₂DS₂-VASc score.³

Catheter Ablation Plus Antiarrhythmics

Ongoing AADs following CA may suppress AF triggers, especially in patients with persistent AF or high-risk for recurrence post ablation (left atrial dilation). The AMIO-CAT trial found that 4 weeks of amiodarone after ablation reduced early AF recurrence at 3 months (34% vs 53%, P = .006), arrhythmia-related hospitalizations, and need for cardioversion in patients with paroxysmal and persistent AF.⁸ However, amiodarone did not reduce recurrent atrial tachyarrhythmias at 6 months. The POWDER-AF trial evaluated AAD use for 1 year after CA in patients with drug-refractory paroxysmal AF.⁹ Continuation of class IC (eg, flecainide) and III (eg, amiodarone) AADs resulted in a near 20% absolute risk reduction in recurrent atrial arrhythmias and reduced the need for repeat CA. These trials suggest that discharging patients on adjunctive AADs decreases early recurrence of AF and arrhythmia-related hospitalizations; however, studies evaluating additional clinical outcomes are needed.

Heart Failure

The AATAC trial found CA was superior to amiodarone therapy at maintaining freedom from AF and reducing unplanned hospitalizations and mortality among patients with persistent AF and HFrEF.¹⁰ The larger CASTLE-AF trial randomized patients with an ejection fraction below 35% and NYHA class II or greater symptoms with symptomatic paroxysmal AF or persistent AF in whom AAD therapy failed to CA or medical therapy.¹¹ The CA group experienced lower cardiovascular mortality (11.2% vs 22.3%, P = .009) and fewer heart failure hospitalizations (20.7% vs 35.9%, P = .004). The subsequent AMICA trial did not find a benefit of CA in patients with HFrEF and persistent or long-standing persistent AF; however, this trial was limited to 12 months, whereas the benefit of CA in CASTLE-AF was observed after 12 months.¹² Also, AMICA enrolled patients with higher NYHA class. Therefore, hospitalists should refer AF patients with left ventricular systolic dysfunction and NYHA II or III symptoms for CA. Comparing AMICA and CASTLE-AF suggests earlier referral for CA, prior to the development of worsening heart failure symptoms, may improve outcomes.

Data for patients with heart failure with preserved EF (HFpEF) is limited. One small trial showed reduced heart failure hospitalizations in HFpEF patients treated with CA compared to AADs or beta-blockers.¹³ It is reasonable to refer HFpEF patients with persisting symptoms or reduced quality of life for CA.

The AHA Scientific Statement on Lifestyle and Risk Factor Modification for Reduction of Atrial Fibrillation delineates risk factors that increase the incidence of AF, including alcohol consumption, obstructive sleep apnea, hypertension, and obesity.¹⁴ Among regular alcohol consumers with paroxysmal or persistent AF managed with a rhythm-control strategy, cessation of alcohol has been shown to significantly lower the incidence of recurrent AF (53.0% vs 73.0%, P = .005), and lead to a longer time until recurrence of AF compared to patients regularly consuming alcohol.¹⁵ Among patients with obstructive sleep apnea, a systematic review of nonrandomized studies showed continuous positive airway pressure is associated with maintenance of sinus rhythm.¹⁴ Control of these risk factors is associated with up to approximately 40% of patients maintaining sinus rhythm without intervention, and hospitalists should encourage lifestyle modification to maximize the probability of maintaining sinus rhythm. 

Hospitalists frequently determine the best initial management strategy for patients admitted with new-onset AF, and recent literature may shift more patients towards management with rhythm control. Based on the trials reviewed in this Progress Note, hospitalists should recommend a rhythm-control strategy for patients with symptomatic, paroxysmal, or persistent AF of <12 months’ duration and refer patients with HFrEF for CA. Adherence to guideline recommendations is essential when prescribing AADs to avoid adverse drug events. It is vital to ensure patients managed with a rhythm-control strategy receive anticoagulation for 4 weeks post cardioversion or 2 months post CA with long-term anticoagulation based on CHA₂DS₂-VASc score. Finally, admissions for AF should serve as a catalyst to communicate to patients the importance of addressing obstructive sleep apnea, obesity, and alcohol use disorders. Applying these evidence-based practices will enable hospitalists to make clinical decisions that improve symptom burden and survival for patients with AF.

It has been 19 years since the publication of the landmark AFFIRM trial.¹ At the time of publication, a “rhythm control” strategy was the preferred therapy, with a rate control approach an accepted alternative. AFFIRM showed no mortality benefit of rhythm control over rate control, and its result dramatically shifted the paradigm of atrial fibrillation (AF) management. However, the high crossover rate between treatment arms may have biased the study toward the null hypothesis. Post hoc analyses of AFFIRM and other observational studies indicate that sinus rhythm was associated with a lower risk of death.² Since AFFIRM, technical advances and procedural experience have improved the safety and efficacy of catheter ablation (CA), and recently published randomized trials have shown improved outcomes with rhythm control. This Progress Note summarizes the recent evidence, updating hospitalists on the management of AF, including inpatient cardioversion, patient selection for CA, use of antiarrhythmic drugs (AADs), and lifestyle modifications associated with maintenance of sinus rhythm.

A PubMed search for recent publications using combined the MeSH terms “atrial fibrillation” with “catheter ablation,” “antiarrhythmic drugs,” and “lifestyle modifications.” Our review filtered for randomized trials, guidelines, and selected reviews. 

Urgent cardioversion is recommended for those with hemodynamic instability, AF associated ischemia, or acute heart failure.³ Whether to perform elective cardioversion depends on AF duration, symptoms, and the initial evaluation for structural heart disease or reversible causes of AF. Evaluation for new-onset AF includes eliciting a history of AF-associated comorbidities (hypertension, alcohol use, obstructive sleep apnea) and an echocardiogram and thyroid, renal, and liver function tests.³ Stable patients with AF precipitated by high-catecholamine states (eg, postoperative AF, sepsis, hyperthyroidism, pulmonary embolism, substance use) require management of the underlying condition before considering rhythm control. Inpatient electrical or pharmacologic cardioversion may be considered for patients with stable, new-onset AF sufficiently symptomatic to require hospitalization. Pre-procedure anticoagulation and a transesophageal echocardiogram to rule out left atrial thrombus before cardioversion is preferred for a first episode of AF suspected of lasting longer than 48 hours but requires anesthesia and considerable resources. In resource-constrained settings, patients asymptomatic once rate controlled may be safely discharged with a referral for outpatient cardioversion.

For patients with structural heart disease (left atrial dilation), previously failed cardioversion, or recurrent AF, initiating AADs (eg, ibutilide, amiodarone) before electrical cardioversion can improve the success rate of cardioversion.³ Ibutilide infusion requires cardiology consultation and postinfusion hemodynamic and QTc monitoring. Defer immediate cardioversion among stable patients unable to continue a minimum of 4 weeks of anticoagulation or with comorbidities for which risks of cardioversion outweigh benefits.

Successful maintenance of sinus rhythm is associated with reduced symptom burden and improved quality of life and is recommended for patients with persistent symptoms, failure of rate control, younger age, first episode of AF, or patient preference for rhythm control.³ Since AF progression results in irreversible cardiac remodeling, earlier rhythm control may prevent further atrial remodeling and atrial myopathy.

The EAST-AFNET 4 trial evaluated a rhythm-control strategy in patients with AF duration <12 months and who met two of the following: age > 65 years, female sex, heart failure, hypertension, diabetes, coronary artery disease, and chronic kidney disease.⁴ Maintenance of sinus rhythm was associated with a lower composite outcome of adverse cardiovascular outcomes and death from cardiovascular causes over 5 years compared to rate control (3.9/100 person-years vs 5.0/100 person-years, P = .005). Interestingly, roughly 20% of patients underwent CA and the remainder received AADs. The large proportion of patients treated with AADs raises the question of why the results differed from AFFIRM. There are four primary differences between these trials to consider. First, EAST-AFNET 4 used an early rhythm-control strategy (<12 months). Second, nearly all patients in EAST-AFNET 4 continued guideline-recommend anticoagulation compared to 70% receiving rhythm control in AFFIRM. Third, in AFFIRM, 62.8% of patients received amiodarone, which has significant long-term adverse effects compared to 11.8% by the end of EAST-AFNET 4. Finally, increased use of CA in EAST-AFNET 4 may have contributed to the success of rhythm control. In patients with cardiovascular disease or cardiovascular risk factors, a rhythm-control strategy will be best if implemented early (<12 months), before the development of long-standing persistent AF, and if clinicians adhere to anticoagulation recommendations.

Antiarrhythmic Drugs

Antiarrhythmic drug use prior to CA remains the cornerstone of a rhythm-control strategy for patients meeting EAST-AFNET 4 trial criteria or patient preference for medical management. Hospitalists’ knowledge of key differences between AADs used in EAST-AFNET 4 and AFFIRM as well as American Heart Association/American College of Cardiology/Heart Rhythm Society (AHA/ACC/HRS) guideline recommendations help avoid harmful AAD prescribing. Notably, 21.9% of patients in AFFIRM received AADs no longer recommended to maintain sinus rhythm in the AHA/ACC/HRS guidelines (quinidine, disopyramide, procainamide, moricizine).³ For patients without structural heart disease, flecainide, propafenone, sotalol, or dronedarone are preferred. Dronedarone and sotalol remain an option for those with coronary artery disease. For patients with heart failure with reduced ejection fraction (HFrEF), amiodarone and dofetilide are preferred (Table).³

Catheter Ablation

The AHA/ACC/HRS guidelines offer a Ia recommendation for CA in patients with recurrent, symptomatic AF who failed AAD therapy. Initial CA is a IIa recommendation and is increasingly common for patients with paroxysmal AF who prefer this strategy to long-term AAD use.³ Recent trials evaluated CA as a primary treatment modality in patients with heart failure and as initial management before AADs.

Initial Catheter Ablation

The CABANA trial compared CA with AADs as an initial approach for maintaining sinus rhythm.⁵ In the intention-to-treat analysis, there was no difference in all death or disabling stroke between AAD therapy and CA at 5-year follow-up. The results are limited by a 27.5% crossover rate from drug therapy to CA. The per-protocol analysis based on the treatment received favored CA for the primary composite outcome of death, disabling stroke, serious bleeding, or cardiac arrest at 12 months. The STOP-AF and EARLY-AF trials found that initial CA was more successful in maintaining freedom from atrial arrhythmias (74.6% vs 45.0%, P < .001)⁶ and fewer symptomatic atrial arrhythmias among patients with paroxysmal AF compared to AADs, without significant CA-associated adverse events.^6,7

While hospitalists should interpret the per-protocol analysis cautiously when determining the clinical benefit, these trials indicate initial CA is as safe as AADs and improves freedom from AF. Duration of AF, knowledge of periprocedural anticoagulation recommendations, and CA procedural complications are important when recommending CA (Figure). Efficacy of CA is approximately 70% in paroxysmal AF and decreases for persistent and long-standing AF.⁶ Complications of CA include venous access site hematoma, cardiac tamponade, phrenic nerve injury, pulmonary vein stenosis, atrial-esophageal fistula, left atrial flutter, and stroke due to endothelial injury and intraprocedural thrombosis.³ Therapeutic anticoagulation is required before CA and for at least 2 months post ablation regardless of the CHA₂DS₂-VASc score.³

Catheter Ablation Plus Antiarrhythmics

Ongoing AADs following CA may suppress AF triggers, especially in patients with persistent AF or high-risk for recurrence post ablation (left atrial dilation). The AMIO-CAT trial found that 4 weeks of amiodarone after ablation reduced early AF recurrence at 3 months (34% vs 53%, P = .006), arrhythmia-related hospitalizations, and need for cardioversion in patients with paroxysmal and persistent AF.⁸ However, amiodarone did not reduce recurrent atrial tachyarrhythmias at 6 months. The POWDER-AF trial evaluated AAD use for 1 year after CA in patients with drug-refractory paroxysmal AF.⁹ Continuation of class IC (eg, flecainide) and III (eg, amiodarone) AADs resulted in a near 20% absolute risk reduction in recurrent atrial arrhythmias and reduced the need for repeat CA. These trials suggest that discharging patients on adjunctive AADs decreases early recurrence of AF and arrhythmia-related hospitalizations; however, studies evaluating additional clinical outcomes are needed.

Heart Failure

The AATAC trial found CA was superior to amiodarone therapy at maintaining freedom from AF and reducing unplanned hospitalizations and mortality among patients with persistent AF and HFrEF.¹⁰ The larger CASTLE-AF trial randomized patients with an ejection fraction below 35% and NYHA class II or greater symptoms with symptomatic paroxysmal AF or persistent AF in whom AAD therapy failed to CA or medical therapy.¹¹ The CA group experienced lower cardiovascular mortality (11.2% vs 22.3%, P = .009) and fewer heart failure hospitalizations (20.7% vs 35.9%, P = .004). The subsequent AMICA trial did not find a benefit of CA in patients with HFrEF and persistent or long-standing persistent AF; however, this trial was limited to 12 months, whereas the benefit of CA in CASTLE-AF was observed after 12 months.¹² Also, AMICA enrolled patients with higher NYHA class. Therefore, hospitalists should refer AF patients with left ventricular systolic dysfunction and NYHA II or III symptoms for CA. Comparing AMICA and CASTLE-AF suggests earlier referral for CA, prior to the development of worsening heart failure symptoms, may improve outcomes.

Data for patients with heart failure with preserved EF (HFpEF) is limited. One small trial showed reduced heart failure hospitalizations in HFpEF patients treated with CA compared to AADs or beta-blockers.¹³ It is reasonable to refer HFpEF patients with persisting symptoms or reduced quality of life for CA.

The AHA Scientific Statement on Lifestyle and Risk Factor Modification for Reduction of Atrial Fibrillation delineates risk factors that increase the incidence of AF, including alcohol consumption, obstructive sleep apnea, hypertension, and obesity.¹⁴ Among regular alcohol consumers with paroxysmal or persistent AF managed with a rhythm-control strategy, cessation of alcohol has been shown to significantly lower the incidence of recurrent AF (53.0% vs 73.0%, P = .005), and lead to a longer time until recurrence of AF compared to patients regularly consuming alcohol.¹⁵ Among patients with obstructive sleep apnea, a systematic review of nonrandomized studies showed continuous positive airway pressure is associated with maintenance of sinus rhythm.¹⁴ Control of these risk factors is associated with up to approximately 40% of patients maintaining sinus rhythm without intervention, and hospitalists should encourage lifestyle modification to maximize the probability of maintaining sinus rhythm. 

Hospitalists frequently determine the best initial management strategy for patients admitted with new-onset AF, and recent literature may shift more patients towards management with rhythm control. Based on the trials reviewed in this Progress Note, hospitalists should recommend a rhythm-control strategy for patients with symptomatic, paroxysmal, or persistent AF of <12 months’ duration and refer patients with HFrEF for CA. Adherence to guideline recommendations is essential when prescribing AADs to avoid adverse drug events. It is vital to ensure patients managed with a rhythm-control strategy receive anticoagulation for 4 weeks post cardioversion or 2 months post CA with long-term anticoagulation based on CHA₂DS₂-VASc score. Finally, admissions for AF should serve as a catalyst to communicate to patients the importance of addressing obstructive sleep apnea, obesity, and alcohol use disorders. Applying these evidence-based practices will enable hospitalists to make clinical decisions that improve symptom burden and survival for patients with AF.

Rosa* was one of my first patients as an intern rotating at the county hospital. Her marriage had disintegrated years earlier. To cope with depression, she hid a daily ritual of orange juice and vodka from her children. She worked as a cashier, until nausea and fatigue overwhelmed her.

The first time I met her she sat on the gurney: petite, tanned, and pregnant. Then I saw her yellow eyes and revised: temporal wasting, jaundiced, and swollen with ascites. Rosa didn’t know that alcohol could cause liver disease. Without insurance or access to primary care, her untreated alcohol use disorder (AUD) and depression had snowballed for years. 

Midway through my intern year, I’d taken care of many people with AUD. However, I’d barely learned anything about it as a medical student, though we’d spent weeks studying esoteric diseases, that now––9 years after medical school––I still have not encountered. 

Among the 28.3 million individuals in the United States with AUD, only 1% receive medication treatment.¹ In the United States, unhealthy alcohol use accounts for more than 95,000 deaths each year.² This number likely under-captures alcohol-related mortality and is higher now given recent reports of increasing alcohol-related deaths and prevalence of unhealthy alcohol use, especially among women, younger age groups, and marginalized populations.^3-5 

Rosa had alcohol-related hepatitis, which can cause severe inflammation and liver failure and quickly lead to death. As her liver failure progressed, I asked the gastroenterologists, “What other treatments can we offer? Is she a liver transplant candidate?” “Nothing” and “No” they answered.

Later, I emailed the hepatologist and transplant surgeon begging them to reevaluate her transplantation candidacy, but they told me there was no exception to the institution’s 6-month sobriety rule.

Maintaining a 6-month sobriety period is not an evidence-based criterion for transplantation. However, 50% of transplant centers do not perform transplantation prior to 6 months of alcohol abstinence for alcohol-related hepatitis due to concern for return to drinking after transplant.⁶ This practice may promote bias in patient selection for transplantation. A recent study found that individuals with alcohol-related liver disease transplanted before 6 months of abstinence had similar rates of survival and return to drinking compared to those who abstained from alcohol for 6 months and participated in AUD treatment before transplantation.⁷

There are other liver transplant practices that result in inequities for individuals with substance use disorders (SUD). Some liver transplant centers consider being on a medication for opioid use disorder a contraindication for transplantation—even if the individual is in recovery and abstaining from substances.⁸ Others mandate that individuals with alcohol-related liver disease attend Alcoholics Anonymous (AA) meetings prior to transplant. While mutual help groups, including AA, may benefit some individuals, different approaches work for different people.⁹ Other psychosocial interventions (eg, cognitive-behavioral therapy, contingency management, and residential treatment) and medications also help individuals reduce or stop drinking. Some meet their goals without any treatment. Addiction care works best when it respects autonomy and meets individuals where they are by allowing them to decide among options.

While organ allocations are a crystalized example of inequities in addiction care, they are also ethically complex. Many individuals—with and without SUD—die on waiting lists and must meet stringent transplantation criteria. However, we can at least remove the unnecessary biases that compound inequities in care people with SUD already face.

As Rosa’s liver succumbed, her kidneys failed too, and she required dialysis. She sensed what was coming. “I want everything…for now. I need to take care of my children.” I, too, wanted Rosa to live and see her youngest start kindergarten.

A few days before her discharge, I walked to the pharmacy and bought a purple journal. In a rare moment, I found Rosa alone in her room, without her ex-husband, sister, and mother, who rarely left her bedside. Together, we called AA and explored whether she could start participating in phone meetings from the hospital. I explained that one way to document a commitment to sobriety, as the transplant center’s rules dictated, was to attend and document AA meetings in this notebook. “In 5 months, you will be a liver transplant candidate,” I remember saying, wishing it to fruition.

I became Rosa’s primary care physician and saw her in clinic. Over the next few weeks, her skin took on an ashen tone. Sleep escaped her and her thoughts and speech blurred. Her walk slowed and she needed a wheelchair. The quiet fierceness that had defined her dissipated as encephalopathy took over. But until our last visit, she brought her purple journal, tracking the AA meetings she’d attended. Dialysis became intolerable, but not before Rosa made care arrangements for her girls. When that happened, she stopped dialysis and went to Mexico, where she died in her sleep after saying good-bye to her father. 

Earlier access to healthcare and effective depression and AUD treatment could have saved Rosa’s life. While it was too late for her, as hospitalists we care for many others with substance-related complications and may miss opportunities to discuss and offer evidence-based addiction treatment. For example, we initiate the most up-to-date management for a patient’s gastrointestinal bleed but may leave the alcohol discussion for someone else. It is similar for other SUD: we treat cellulitis, epidural abscesses, bacteremia, chronic obstructive pulmonary disease, heart failure exacerbations, and other complications of SUD without addressing the root cause of the hospitalization—other than to prescribe abstinence from substance use or, at our worst, scold individuals for continuing to use.

But what can we offer? Most healthcare professionals still do not receive addiction education during training. Without tools, we enact temporizing measures, until patients return to the hospital or die.

In addition to increasing alcohol-related morbidity, there have also been increases in drug-related overdoses, fueled by COVID-19, synthetic opioids like fentanyl, and stimulants.¹⁰ In the 12-month period ending April 2021, more than 100,000 individuals died of drug-related overdoses, the highest number of deaths ever recorded in a year.¹¹ Despite this, most healthcare systems remain unequipped to provide addiction services during hospitalization due to inadequate training, stigma, and lack of systems-based care.

Hospitalists and healthcare systems cannot be bystanders amid our worsening addiction crisis. We must empower clinicians with addiction education and ensure health systems offer evidence-based SUD services.

Educational efforts can close the knowledge gaps for both medical students and hospitalists. Medical schools should include foundational curricular content in screening, assessing, diagnosing, and treating SUD in alignment with standards set by the Liaison Committee on Medical Education, which accredits US medical schools. Residency programs can offer educational conferences, cased-based discussions, and addiction medicine rotations. Hospitalists can participate in educational didactics and review evidence-based addiction guidelines.^12,13 While the focus here is on hospitalists, clinicians across practice settings and specialties will encounter patients with SUD, and all need to be well-versed in the diagnosis and treatment of addiction given the all-hands-on deck approach necessary amidst our worsening addiction crisis.

With one in nine hospitalizations involving individuals with SUD, and this number quickly rising, and with an annual cost to US hospitals of $13.2 billion, healthcare system leaders must invest in addiction care.^14,15 Hospital-based addiction services could pay for themselves and save healthcare systems money while improving the patient and clinician experience.¹⁶One way to implement hospital-based addiction care is through an addiction consult team (ACT).¹⁷ While ACT compositions vary, most are interprofessional, offer evidence-based addiction treatment, and connect patients to community care.¹⁸ Our hospital’s ACT has nurses, patient navigators, and physicians who assess, diagnose, and treat SUD, and arrange follow-up addiction care.¹⁹ In addition to caring for individual patients, our ACT has led systems change. For example, we created order sets to guide clinicians, added medications to our hospital formulary to ensure access to evidence-based addiction treatment, and partnered with community stakeholders to streamline care transitions and access to psychosocial and medication treatment. Our team also worked with hospital leadership, nursing, and a syringe service program to integrate hospital harm reduction education and supply provision. Additionally, we are building capacity among staff, trainees, and clinicians through education and systems changes.

In hospitals without an ACT, leadership can finance SUD champions and integrate them into policy-level decision-making to implement best practices in addiction care and lead hospital-wide educational efforts. This will transform hospital culture and improve care as all clinicians develop essential addiction skills.

Addiction champions and ACTs could also advocate for equitable practices for patients with SUD to reduce the stigma that both prevents patients from seeking care and results in self-discharges.²⁰ For example, with interprofessional support, we revised our in-hospital substance use policy. It previously entailed hospital security responding to substance use concerns, which unintentionally harmed patients and perpetuated stigma. Our revised policy ensures we offer medications for cravings and withdrawal, adequate pain management, and other services that address patients’ reasons for in-hospital substance use.

With the increasing prevalence of SUD among hospitalized patients, escalating substance-related deaths, rising healthcare costs, and the impact of addiction on health and well-being, addiction care, including ACTs and champions, must be adequately funded. However, sustainable financing remains a challenge.¹⁸

Caring for Rosa and others with SUD sparked my desire to learn about addiction, obtain addiction medicine board certification as a practicing hospitalist, and create an ACT that offers evidence-based addiction treatment. While much remains to be done, by collaborating with addiction champions and engaging hospital leadership, we have transformed our hospital’s approach to substance use care.

With the knowledge and resources I now have as an addiction medicine physician, I reimagine the possibilities for patients like Rosa.

Rosa died when living was possible.

*Name has been changed for patient privacy.

Rosa* was one of my first patients as an intern rotating at the county hospital. Her marriage had disintegrated years earlier. To cope with depression, she hid a daily ritual of orange juice and vodka from her children. She worked as a cashier, until nausea and fatigue overwhelmed her.

The first time I met her she sat on the gurney: petite, tanned, and pregnant. Then I saw her yellow eyes and revised: temporal wasting, jaundiced, and swollen with ascites. Rosa didn’t know that alcohol could cause liver disease. Without insurance or access to primary care, her untreated alcohol use disorder (AUD) and depression had snowballed for years. 

Midway through my intern year, I’d taken care of many people with AUD. However, I’d barely learned anything about it as a medical student, though we’d spent weeks studying esoteric diseases, that now––9 years after medical school––I still have not encountered. 

Among the 28.3 million individuals in the United States with AUD, only 1% receive medication treatment.¹ In the United States, unhealthy alcohol use accounts for more than 95,000 deaths each year.² This number likely under-captures alcohol-related mortality and is higher now given recent reports of increasing alcohol-related deaths and prevalence of unhealthy alcohol use, especially among women, younger age groups, and marginalized populations.^3-5 

Rosa had alcohol-related hepatitis, which can cause severe inflammation and liver failure and quickly lead to death. As her liver failure progressed, I asked the gastroenterologists, “What other treatments can we offer? Is she a liver transplant candidate?” “Nothing” and “No” they answered.

Later, I emailed the hepatologist and transplant surgeon begging them to reevaluate her transplantation candidacy, but they told me there was no exception to the institution’s 6-month sobriety rule.

Maintaining a 6-month sobriety period is not an evidence-based criterion for transplantation. However, 50% of transplant centers do not perform transplantation prior to 6 months of alcohol abstinence for alcohol-related hepatitis due to concern for return to drinking after transplant.⁶ This practice may promote bias in patient selection for transplantation. A recent study found that individuals with alcohol-related liver disease transplanted before 6 months of abstinence had similar rates of survival and return to drinking compared to those who abstained from alcohol for 6 months and participated in AUD treatment before transplantation.⁷

There are other liver transplant practices that result in inequities for individuals with substance use disorders (SUD). Some liver transplant centers consider being on a medication for opioid use disorder a contraindication for transplantation—even if the individual is in recovery and abstaining from substances.⁸ Others mandate that individuals with alcohol-related liver disease attend Alcoholics Anonymous (AA) meetings prior to transplant. While mutual help groups, including AA, may benefit some individuals, different approaches work for different people.⁹ Other psychosocial interventions (eg, cognitive-behavioral therapy, contingency management, and residential treatment) and medications also help individuals reduce or stop drinking. Some meet their goals without any treatment. Addiction care works best when it respects autonomy and meets individuals where they are by allowing them to decide among options.

While organ allocations are a crystalized example of inequities in addiction care, they are also ethically complex. Many individuals—with and without SUD—die on waiting lists and must meet stringent transplantation criteria. However, we can at least remove the unnecessary biases that compound inequities in care people with SUD already face.

As Rosa’s liver succumbed, her kidneys failed too, and she required dialysis. She sensed what was coming. “I want everything…for now. I need to take care of my children.” I, too, wanted Rosa to live and see her youngest start kindergarten.

A few days before her discharge, I walked to the pharmacy and bought a purple journal. In a rare moment, I found Rosa alone in her room, without her ex-husband, sister, and mother, who rarely left her bedside. Together, we called AA and explored whether she could start participating in phone meetings from the hospital. I explained that one way to document a commitment to sobriety, as the transplant center’s rules dictated, was to attend and document AA meetings in this notebook. “In 5 months, you will be a liver transplant candidate,” I remember saying, wishing it to fruition.

I became Rosa’s primary care physician and saw her in clinic. Over the next few weeks, her skin took on an ashen tone. Sleep escaped her and her thoughts and speech blurred. Her walk slowed and she needed a wheelchair. The quiet fierceness that had defined her dissipated as encephalopathy took over. But until our last visit, she brought her purple journal, tracking the AA meetings she’d attended. Dialysis became intolerable, but not before Rosa made care arrangements for her girls. When that happened, she stopped dialysis and went to Mexico, where she died in her sleep after saying good-bye to her father. 

Earlier access to healthcare and effective depression and AUD treatment could have saved Rosa’s life. While it was too late for her, as hospitalists we care for many others with substance-related complications and may miss opportunities to discuss and offer evidence-based addiction treatment. For example, we initiate the most up-to-date management for a patient’s gastrointestinal bleed but may leave the alcohol discussion for someone else. It is similar for other SUD: we treat cellulitis, epidural abscesses, bacteremia, chronic obstructive pulmonary disease, heart failure exacerbations, and other complications of SUD without addressing the root cause of the hospitalization—other than to prescribe abstinence from substance use or, at our worst, scold individuals for continuing to use.

But what can we offer? Most healthcare professionals still do not receive addiction education during training. Without tools, we enact temporizing measures, until patients return to the hospital or die.

In addition to increasing alcohol-related morbidity, there have also been increases in drug-related overdoses, fueled by COVID-19, synthetic opioids like fentanyl, and stimulants.¹⁰ In the 12-month period ending April 2021, more than 100,000 individuals died of drug-related overdoses, the highest number of deaths ever recorded in a year.¹¹ Despite this, most healthcare systems remain unequipped to provide addiction services during hospitalization due to inadequate training, stigma, and lack of systems-based care.

Hospitalists and healthcare systems cannot be bystanders amid our worsening addiction crisis. We must empower clinicians with addiction education and ensure health systems offer evidence-based SUD services.

Educational efforts can close the knowledge gaps for both medical students and hospitalists. Medical schools should include foundational curricular content in screening, assessing, diagnosing, and treating SUD in alignment with standards set by the Liaison Committee on Medical Education, which accredits US medical schools. Residency programs can offer educational conferences, cased-based discussions, and addiction medicine rotations. Hospitalists can participate in educational didactics and review evidence-based addiction guidelines.^12,13 While the focus here is on hospitalists, clinicians across practice settings and specialties will encounter patients with SUD, and all need to be well-versed in the diagnosis and treatment of addiction given the all-hands-on deck approach necessary amidst our worsening addiction crisis.

With one in nine hospitalizations involving individuals with SUD, and this number quickly rising, and with an annual cost to US hospitals of $13.2 billion, healthcare system leaders must invest in addiction care.^14,15 Hospital-based addiction services could pay for themselves and save healthcare systems money while improving the patient and clinician experience.¹⁶One way to implement hospital-based addiction care is through an addiction consult team (ACT).¹⁷ While ACT compositions vary, most are interprofessional, offer evidence-based addiction treatment, and connect patients to community care.¹⁸ Our hospital’s ACT has nurses, patient navigators, and physicians who assess, diagnose, and treat SUD, and arrange follow-up addiction care.¹⁹ In addition to caring for individual patients, our ACT has led systems change. For example, we created order sets to guide clinicians, added medications to our hospital formulary to ensure access to evidence-based addiction treatment, and partnered with community stakeholders to streamline care transitions and access to psychosocial and medication treatment. Our team also worked with hospital leadership, nursing, and a syringe service program to integrate hospital harm reduction education and supply provision. Additionally, we are building capacity among staff, trainees, and clinicians through education and systems changes.

In hospitals without an ACT, leadership can finance SUD champions and integrate them into policy-level decision-making to implement best practices in addiction care and lead hospital-wide educational efforts. This will transform hospital culture and improve care as all clinicians develop essential addiction skills.

Addiction champions and ACTs could also advocate for equitable practices for patients with SUD to reduce the stigma that both prevents patients from seeking care and results in self-discharges.²⁰ For example, with interprofessional support, we revised our in-hospital substance use policy. It previously entailed hospital security responding to substance use concerns, which unintentionally harmed patients and perpetuated stigma. Our revised policy ensures we offer medications for cravings and withdrawal, adequate pain management, and other services that address patients’ reasons for in-hospital substance use.

With the increasing prevalence of SUD among hospitalized patients, escalating substance-related deaths, rising healthcare costs, and the impact of addiction on health and well-being, addiction care, including ACTs and champions, must be adequately funded. However, sustainable financing remains a challenge.¹⁸

Caring for Rosa and others with SUD sparked my desire to learn about addiction, obtain addiction medicine board certification as a practicing hospitalist, and create an ACT that offers evidence-based addiction treatment. While much remains to be done, by collaborating with addiction champions and engaging hospital leadership, we have transformed our hospital’s approach to substance use care.

With the knowledge and resources I now have as an addiction medicine physician, I reimagine the possibilities for patients like Rosa.

Rosa died when living was possible.

*Name has been changed for patient privacy.

Rosa* was one of my first patients as an intern rotating at the county hospital. Her marriage had disintegrated years earlier. To cope with depression, she hid a daily ritual of orange juice and vodka from her children. She worked as a cashier, until nausea and fatigue overwhelmed her.

The first time I met her she sat on the gurney: petite, tanned, and pregnant. Then I saw her yellow eyes and revised: temporal wasting, jaundiced, and swollen with ascites. Rosa didn’t know that alcohol could cause liver disease. Without insurance or access to primary care, her untreated alcohol use disorder (AUD) and depression had snowballed for years. 

Midway through my intern year, I’d taken care of many people with AUD. However, I’d barely learned anything about it as a medical student, though we’d spent weeks studying esoteric diseases, that now––9 years after medical school––I still have not encountered. 

Among the 28.3 million individuals in the United States with AUD, only 1% receive medication treatment.¹ In the United States, unhealthy alcohol use accounts for more than 95,000 deaths each year.² This number likely under-captures alcohol-related mortality and is higher now given recent reports of increasing alcohol-related deaths and prevalence of unhealthy alcohol use, especially among women, younger age groups, and marginalized populations.^3-5 

Rosa had alcohol-related hepatitis, which can cause severe inflammation and liver failure and quickly lead to death. As her liver failure progressed, I asked the gastroenterologists, “What other treatments can we offer? Is she a liver transplant candidate?” “Nothing” and “No” they answered.

Later, I emailed the hepatologist and transplant surgeon begging them to reevaluate her transplantation candidacy, but they told me there was no exception to the institution’s 6-month sobriety rule.

Maintaining a 6-month sobriety period is not an evidence-based criterion for transplantation. However, 50% of transplant centers do not perform transplantation prior to 6 months of alcohol abstinence for alcohol-related hepatitis due to concern for return to drinking after transplant.⁶ This practice may promote bias in patient selection for transplantation. A recent study found that individuals with alcohol-related liver disease transplanted before 6 months of abstinence had similar rates of survival and return to drinking compared to those who abstained from alcohol for 6 months and participated in AUD treatment before transplantation.⁷

There are other liver transplant practices that result in inequities for individuals with substance use disorders (SUD). Some liver transplant centers consider being on a medication for opioid use disorder a contraindication for transplantation—even if the individual is in recovery and abstaining from substances.⁸ Others mandate that individuals with alcohol-related liver disease attend Alcoholics Anonymous (AA) meetings prior to transplant. While mutual help groups, including AA, may benefit some individuals, different approaches work for different people.⁹ Other psychosocial interventions (eg, cognitive-behavioral therapy, contingency management, and residential treatment) and medications also help individuals reduce or stop drinking. Some meet their goals without any treatment. Addiction care works best when it respects autonomy and meets individuals where they are by allowing them to decide among options.

While organ allocations are a crystalized example of inequities in addiction care, they are also ethically complex. Many individuals—with and without SUD—die on waiting lists and must meet stringent transplantation criteria. However, we can at least remove the unnecessary biases that compound inequities in care people with SUD already face.

As Rosa’s liver succumbed, her kidneys failed too, and she required dialysis. She sensed what was coming. “I want everything…for now. I need to take care of my children.” I, too, wanted Rosa to live and see her youngest start kindergarten.

A few days before her discharge, I walked to the pharmacy and bought a purple journal. In a rare moment, I found Rosa alone in her room, without her ex-husband, sister, and mother, who rarely left her bedside. Together, we called AA and explored whether she could start participating in phone meetings from the hospital. I explained that one way to document a commitment to sobriety, as the transplant center’s rules dictated, was to attend and document AA meetings in this notebook. “In 5 months, you will be a liver transplant candidate,” I remember saying, wishing it to fruition.

I became Rosa’s primary care physician and saw her in clinic. Over the next few weeks, her skin took on an ashen tone. Sleep escaped her and her thoughts and speech blurred. Her walk slowed and she needed a wheelchair. The quiet fierceness that had defined her dissipated as encephalopathy took over. But until our last visit, she brought her purple journal, tracking the AA meetings she’d attended. Dialysis became intolerable, but not before Rosa made care arrangements for her girls. When that happened, she stopped dialysis and went to Mexico, where she died in her sleep after saying good-bye to her father. 

Earlier access to healthcare and effective depression and AUD treatment could have saved Rosa’s life. While it was too late for her, as hospitalists we care for many others with substance-related complications and may miss opportunities to discuss and offer evidence-based addiction treatment. For example, we initiate the most up-to-date management for a patient’s gastrointestinal bleed but may leave the alcohol discussion for someone else. It is similar for other SUD: we treat cellulitis, epidural abscesses, bacteremia, chronic obstructive pulmonary disease, heart failure exacerbations, and other complications of SUD without addressing the root cause of the hospitalization—other than to prescribe abstinence from substance use or, at our worst, scold individuals for continuing to use.

But what can we offer? Most healthcare professionals still do not receive addiction education during training. Without tools, we enact temporizing measures, until patients return to the hospital or die.

In addition to increasing alcohol-related morbidity, there have also been increases in drug-related overdoses, fueled by COVID-19, synthetic opioids like fentanyl, and stimulants.¹⁰ In the 12-month period ending April 2021, more than 100,000 individuals died of drug-related overdoses, the highest number of deaths ever recorded in a year.¹¹ Despite this, most healthcare systems remain unequipped to provide addiction services during hospitalization due to inadequate training, stigma, and lack of systems-based care.

Hospitalists and healthcare systems cannot be bystanders amid our worsening addiction crisis. We must empower clinicians with addiction education and ensure health systems offer evidence-based SUD services.

Educational efforts can close the knowledge gaps for both medical students and hospitalists. Medical schools should include foundational curricular content in screening, assessing, diagnosing, and treating SUD in alignment with standards set by the Liaison Committee on Medical Education, which accredits US medical schools. Residency programs can offer educational conferences, cased-based discussions, and addiction medicine rotations. Hospitalists can participate in educational didactics and review evidence-based addiction guidelines.^12,13 While the focus here is on hospitalists, clinicians across practice settings and specialties will encounter patients with SUD, and all need to be well-versed in the diagnosis and treatment of addiction given the all-hands-on deck approach necessary amidst our worsening addiction crisis.

With one in nine hospitalizations involving individuals with SUD, and this number quickly rising, and with an annual cost to US hospitals of $13.2 billion, healthcare system leaders must invest in addiction care.^14,15 Hospital-based addiction services could pay for themselves and save healthcare systems money while improving the patient and clinician experience.¹⁶One way to implement hospital-based addiction care is through an addiction consult team (ACT).¹⁷ While ACT compositions vary, most are interprofessional, offer evidence-based addiction treatment, and connect patients to community care.¹⁸ Our hospital’s ACT has nurses, patient navigators, and physicians who assess, diagnose, and treat SUD, and arrange follow-up addiction care.¹⁹ In addition to caring for individual patients, our ACT has led systems change. For example, we created order sets to guide clinicians, added medications to our hospital formulary to ensure access to evidence-based addiction treatment, and partnered with community stakeholders to streamline care transitions and access to psychosocial and medication treatment. Our team also worked with hospital leadership, nursing, and a syringe service program to integrate hospital harm reduction education and supply provision. Additionally, we are building capacity among staff, trainees, and clinicians through education and systems changes.

In hospitals without an ACT, leadership can finance SUD champions and integrate them into policy-level decision-making to implement best practices in addiction care and lead hospital-wide educational efforts. This will transform hospital culture and improve care as all clinicians develop essential addiction skills.

Addiction champions and ACTs could also advocate for equitable practices for patients with SUD to reduce the stigma that both prevents patients from seeking care and results in self-discharges.²⁰ For example, with interprofessional support, we revised our in-hospital substance use policy. It previously entailed hospital security responding to substance use concerns, which unintentionally harmed patients and perpetuated stigma. Our revised policy ensures we offer medications for cravings and withdrawal, adequate pain management, and other services that address patients’ reasons for in-hospital substance use.

With the increasing prevalence of SUD among hospitalized patients, escalating substance-related deaths, rising healthcare costs, and the impact of addiction on health and well-being, addiction care, including ACTs and champions, must be adequately funded. However, sustainable financing remains a challenge.¹⁸

Caring for Rosa and others with SUD sparked my desire to learn about addiction, obtain addiction medicine board certification as a practicing hospitalist, and create an ACT that offers evidence-based addiction treatment. While much remains to be done, by collaborating with addiction champions and engaging hospital leadership, we have transformed our hospital’s approach to substance use care.

With the knowledge and resources I now have as an addiction medicine physician, I reimagine the possibilities for patients like Rosa.

Rosa died when living was possible.

*Name has been changed for patient privacy.

“...but it all started to get worse during the pandemic.”

As the patient’s^† door closed, I (JS) thought about what his father had shared: his 12-year-old son had experienced a slow decline in his mental health since March 2020. There had been a gradual loss of all the things his son needed for psychological well-being: school went virtual and extracurricular activities ceased, and with them went any sense of routine, normalcy, or authentic opportunities to socialize. His feelings of isolation and depression culminated in an attempt to end his own life. My mind shifted to other patients under our care: an 8-year-old with behavioral outbursts intensifying after school-based therapy ended, a 13-year-old who became suicidal from isolation and virtual bullying. These children’s families sought emergent care because they no longer had the resources to care for their children at home. My team left each of these rooms heartbroken, unsure of exactly what to say and aware of the limitations of our current healthcare system.

Before and during the COVID-19 pandemic, many pediatric providers have had similar experiences caring for countless patients who are “boarding”—awaiting transfer to a psychiatric facility for their primary acute psychiatric issue, initially in the emergency room, often for 5 days or more,¹ then ultimately admitted to a general medical floor if an appropriate psychiatric bed is still not available.² Unfortunately, just as parents have run out of resources to care for their children’s psychiatric needs, so too is our medical system lacking in resources to provide the acute care these children need in general hospitals. 

This mental health crisis began before the COVID-19 pandemic³ but has only worsened in the wake of its resulting social isolation. During the pandemic, suicide hotlines had a 1000% increase in call volumes.⁴ COVID-19–induced bed closures simultaneously worsened an existing critical bed shortage^5,6 and led to an increase in the average length of stay (LOS) for patients boarding in the emergency department (ED).⁷ In the state of Massachusetts, for example, psychiatric patients awaiting inpatient beds boarded for more than 10,000 hours in January 2021—more than ever before, and up approximately 4000 hours since January 2017.⁶ For pediatric patients, the average wait time is now 59 hours.⁶ In the first 6 months of the pandemic, 39% of children presenting to EDs for mental health complaints ended up boarding, which is an astounding figure and is unfortunately 7% higher than in 2019.⁸ Even these staggering numbers do not capture the full range of experiences, as many statistics do not account for time spent on inpatient units by patients who do not receive a bed placement after waiting hours to several days in the ED.

Shortages of space, as well as an underfunded and understaffed mental health workforce, lead to these prolonged, often traumatic boarding periods in hospitals designed to care for acute medical, rather than acute psychiatric, conditions. Patients awaiting psychiatric placement are waiting in settings that are chaotic, inconsistent, and lacking in privacy. A patient in the throes of psychosis or suicidality needs a therapeutic milieu, not one that interrupts their daily routine,² disconnects them from their existing support networks, and is punctuated by the incessant clangs of bedside monitors and the hubbub of code teams. These environments are not therapeutic³ for young infants with fevers, let alone for teenagers battling suicidality and eating disorders. In fact, for these reasons, we suspect that many of our patients’ inpatient ”behavioral escalations” are in fact triggered by their hospital environment, which may contribute to the 300% increase in the number of pharmacological restraints used during mental health visits in the ED over the past 10 years.⁹

None of us imagined when we chose to pursue pediatrics a that significant—and at times predominant—portion of our training would encompass caring for patients with acute mental health concerns. And although we did not anticipate this crisis, we have now been tasked with managing it. Throughout the day, when we are called to see our patients with primarily psychiatric pathology, we are often at war with ourselves. We weigh forming deeply meaningful relationships with these patients against the potential of unintentionally retraumatizing them or forming bonds that will be abruptly severed when patients are transferred to a psychiatric facility, which often occurs with barely a few hours’ notice. Moreover, many healthcare workers have training ill-suited to meet the needs of these patients. Just as emergency physicians can diagnose appendicitis but rely on surgeons to provide timely surgical treatment, general pediatricians identify psychiatric crises but rely on psychiatrists for ideal treatment plans. And almost daily, we are called to an “escalating” patient and arrive minutes into a stressful situation that others expect us to extinguish expeditiously. Along with nursing colleagues and the behavioral response team, we enact the treatment plan laid out by our psychiatry colleagues and wonder whether there is a better way. 

We propose the following changes to create a more ideal health system (Table). We acknowledge that each health system has unique resources, challenges, and patient populations. Thus, our recommendations are not comprehensive and are largely based on experiences within our own institutions and state, but they encompass many domains that impact and are affected by child and adolescent mental healthcare in the United States, ranging from program- and hospital-level innovation to community and legislative action.

Like all good health system designs, we recommend prioritizing prevention. This would entail funding programs and legislation such as H.R. 3180, the RISE from Trauma Act, and H.R. 8544, the STRONG Support for Children Act of 2020 (both currently under consideration in the US House of Representatives) that support early childhood development and prevent adverse childhood experiences and trauma, averting mental health diagnoses such as depression and attention-deficit/hyperactivity disorder before they begin.¹⁰

We recognize that schools and general pediatricians have far more exposure to children at risk for mental health crises than do subspecialists. Thus, we urge an equitable increase in access to mental healthcare in the community so that patients needing assistance are screened and diagnosed earlier in their illness, allowing for secondary prevention of worsening mental health disorders. We support increased funding for programs such as the Massachusetts Child Psychiatry Access Program, which allows primary care doctors to consult psychiatrists in real time, closing the gap between a primary care visit and specialty follow-up. Telehealth services will be key to improving access for patients themselves and to allow pediatricians to consult with mental health professionals to initiate care prior to specialist availability. We envision that strengthening school-based behavioral health resources will also help prevent ED visits. Behavioral healthcare should be integrated into schools and community centers while police presence is simultaneously reduced, as there is evidence of an increased likelihood of juvenile justice involvement for children with disabilities and mental health needs.^11,12

Ensuring access necessitates increasing the capacity of our psychiatric workforce by encouraging graduates to pursue mental health occupations with concrete financial incentives such as loan repayment and training grants. We thus support legislation such as H.R. 6597, the Mental Health Professionals Workforce Shortage Loan Repayment Act of 2018 (currently under consideration in the US House of Representatives). This may also improve recruitment and retention of individuals who are underrepresented in medicine, one step in helping ensure children have access to linguistically appropriate and culturally sensitive care. Residency programs and hospital systems should expand their training and education to identify and stabilize patients in mental health in extremis through culturally sensitive curricula focused on behavioral de-escalation techniques, trauma-informed care, and psychopharmacology. Our own residency program created a 2-week mental health rotation¹³ that includes rotating with outpatient mental health providers and our hospital’s behavioral response team, a group of trauma-informed responders for behavioral emergencies. Similar training should be available for nursing and other allied health professionals, who are often the first responders to behavioral escalations.¹³

Ideally, patients requiring higher-intensity psychiatric care would be referred to specialized pediatric behavioral health urgent care centers so their conditions can be adequately evaluated and addressed by staff trained in psychiatric management and in therapeutic environments. We believe all providers caring for children with mental health needs should be trained in basic, but core, behavioral health and de-escalation competencies, including specialized training for children with comorbid medical and neurodevelopmental diagnoses, such as autism. These centers should have specific beds for young children and those with developmental or complex care needs, and services should be available in numerous languages and levels of health literacy to allow all families to participate in their child’s care. At the same time, even nonpsychiatric EDs and inpatient units should commit resources to developing a maximally therapeutic environment, including allowing adjunctive services such as child life services, group therapy, and pet and music therapy, and create environments that support, rather than disrupt, normal routines.

Underpinning all the above innovations are changes to our healthcare payment system and provider networks, including the need for insurance coverage and payment parity for behavioral health, to ensure care is not only accessible but affordable. Additionally, for durable change, we need more than just education—we need coalition building and advocacy. Many organizations, including the American Academy of Pediatrics and the Children’s Hospital Association, have begun this work, which we must all continue.¹⁴ Bringing in diverse partners, including health systems, providers, educators, hospital administrators, payors, elected officials, and communities, will prioritize children’s needs and create a more ideal pediatric behavioral healthcare system.¹⁵

The COVID-19 pandemic has highlighted the dire need for comprehensive mental healthcare in the United States, a need that existed before the pandemic and will persist in a more fragile state long after it ends. Our hope is that the pandemic serves as the catalyst necessary to promote the magnitude of investments and stakeholder buy-in necessary to improve pediatric mental health and engender a radical redesign of our behavioral healthcare system. Our patients are counting on us to act. Together, we can build a system that ensures that the kids will be alright.

^†Patient details have been changed for patient privacy.

The authors thank Joanna Perdomo, MD, Amara Azubuike, JD, and Josh Greenberg, JD, for reading and providing feedback on earlier versions of this work.

“...but it all started to get worse during the pandemic.”

As the patient’s^† door closed, I (JS) thought about what his father had shared: his 12-year-old son had experienced a slow decline in his mental health since March 2020. There had been a gradual loss of all the things his son needed for psychological well-being: school went virtual and extracurricular activities ceased, and with them went any sense of routine, normalcy, or authentic opportunities to socialize. His feelings of isolation and depression culminated in an attempt to end his own life. My mind shifted to other patients under our care: an 8-year-old with behavioral outbursts intensifying after school-based therapy ended, a 13-year-old who became suicidal from isolation and virtual bullying. These children’s families sought emergent care because they no longer had the resources to care for their children at home. My team left each of these rooms heartbroken, unsure of exactly what to say and aware of the limitations of our current healthcare system.

Before and during the COVID-19 pandemic, many pediatric providers have had similar experiences caring for countless patients who are “boarding”—awaiting transfer to a psychiatric facility for their primary acute psychiatric issue, initially in the emergency room, often for 5 days or more,¹ then ultimately admitted to a general medical floor if an appropriate psychiatric bed is still not available.² Unfortunately, just as parents have run out of resources to care for their children’s psychiatric needs, so too is our medical system lacking in resources to provide the acute care these children need in general hospitals. 

This mental health crisis began before the COVID-19 pandemic³ but has only worsened in the wake of its resulting social isolation. During the pandemic, suicide hotlines had a 1000% increase in call volumes.⁴ COVID-19–induced bed closures simultaneously worsened an existing critical bed shortage^5,6 and led to an increase in the average length of stay (LOS) for patients boarding in the emergency department (ED).⁷ In the state of Massachusetts, for example, psychiatric patients awaiting inpatient beds boarded for more than 10,000 hours in January 2021—more than ever before, and up approximately 4000 hours since January 2017.⁶ For pediatric patients, the average wait time is now 59 hours.⁶ In the first 6 months of the pandemic, 39% of children presenting to EDs for mental health complaints ended up boarding, which is an astounding figure and is unfortunately 7% higher than in 2019.⁸ Even these staggering numbers do not capture the full range of experiences, as many statistics do not account for time spent on inpatient units by patients who do not receive a bed placement after waiting hours to several days in the ED.

Shortages of space, as well as an underfunded and understaffed mental health workforce, lead to these prolonged, often traumatic boarding periods in hospitals designed to care for acute medical, rather than acute psychiatric, conditions. Patients awaiting psychiatric placement are waiting in settings that are chaotic, inconsistent, and lacking in privacy. A patient in the throes of psychosis or suicidality needs a therapeutic milieu, not one that interrupts their daily routine,² disconnects them from their existing support networks, and is punctuated by the incessant clangs of bedside monitors and the hubbub of code teams. These environments are not therapeutic³ for young infants with fevers, let alone for teenagers battling suicidality and eating disorders. In fact, for these reasons, we suspect that many of our patients’ inpatient ”behavioral escalations” are in fact triggered by their hospital environment, which may contribute to the 300% increase in the number of pharmacological restraints used during mental health visits in the ED over the past 10 years.⁹

None of us imagined when we chose to pursue pediatrics a that significant—and at times predominant—portion of our training would encompass caring for patients with acute mental health concerns. And although we did not anticipate this crisis, we have now been tasked with managing it. Throughout the day, when we are called to see our patients with primarily psychiatric pathology, we are often at war with ourselves. We weigh forming deeply meaningful relationships with these patients against the potential of unintentionally retraumatizing them or forming bonds that will be abruptly severed when patients are transferred to a psychiatric facility, which often occurs with barely a few hours’ notice. Moreover, many healthcare workers have training ill-suited to meet the needs of these patients. Just as emergency physicians can diagnose appendicitis but rely on surgeons to provide timely surgical treatment, general pediatricians identify psychiatric crises but rely on psychiatrists for ideal treatment plans. And almost daily, we are called to an “escalating” patient and arrive minutes into a stressful situation that others expect us to extinguish expeditiously. Along with nursing colleagues and the behavioral response team, we enact the treatment plan laid out by our psychiatry colleagues and wonder whether there is a better way. 

We propose the following changes to create a more ideal health system (Table). We acknowledge that each health system has unique resources, challenges, and patient populations. Thus, our recommendations are not comprehensive and are largely based on experiences within our own institutions and state, but they encompass many domains that impact and are affected by child and adolescent mental healthcare in the United States, ranging from program- and hospital-level innovation to community and legislative action.

Like all good health system designs, we recommend prioritizing prevention. This would entail funding programs and legislation such as H.R. 3180, the RISE from Trauma Act, and H.R. 8544, the STRONG Support for Children Act of 2020 (both currently under consideration in the US House of Representatives) that support early childhood development and prevent adverse childhood experiences and trauma, averting mental health diagnoses such as depression and attention-deficit/hyperactivity disorder before they begin.¹⁰

We recognize that schools and general pediatricians have far more exposure to children at risk for mental health crises than do subspecialists. Thus, we urge an equitable increase in access to mental healthcare in the community so that patients needing assistance are screened and diagnosed earlier in their illness, allowing for secondary prevention of worsening mental health disorders. We support increased funding for programs such as the Massachusetts Child Psychiatry Access Program, which allows primary care doctors to consult psychiatrists in real time, closing the gap between a primary care visit and specialty follow-up. Telehealth services will be key to improving access for patients themselves and to allow pediatricians to consult with mental health professionals to initiate care prior to specialist availability. We envision that strengthening school-based behavioral health resources will also help prevent ED visits. Behavioral healthcare should be integrated into schools and community centers while police presence is simultaneously reduced, as there is evidence of an increased likelihood of juvenile justice involvement for children with disabilities and mental health needs.^11,12

Ensuring access necessitates increasing the capacity of our psychiatric workforce by encouraging graduates to pursue mental health occupations with concrete financial incentives such as loan repayment and training grants. We thus support legislation such as H.R. 6597, the Mental Health Professionals Workforce Shortage Loan Repayment Act of 2018 (currently under consideration in the US House of Representatives). This may also improve recruitment and retention of individuals who are underrepresented in medicine, one step in helping ensure children have access to linguistically appropriate and culturally sensitive care. Residency programs and hospital systems should expand their training and education to identify and stabilize patients in mental health in extremis through culturally sensitive curricula focused on behavioral de-escalation techniques, trauma-informed care, and psychopharmacology. Our own residency program created a 2-week mental health rotation¹³ that includes rotating with outpatient mental health providers and our hospital’s behavioral response team, a group of trauma-informed responders for behavioral emergencies. Similar training should be available for nursing and other allied health professionals, who are often the first responders to behavioral escalations.¹³

Ideally, patients requiring higher-intensity psychiatric care would be referred to specialized pediatric behavioral health urgent care centers so their conditions can be adequately evaluated and addressed by staff trained in psychiatric management and in therapeutic environments. We believe all providers caring for children with mental health needs should be trained in basic, but core, behavioral health and de-escalation competencies, including specialized training for children with comorbid medical and neurodevelopmental diagnoses, such as autism. These centers should have specific beds for young children and those with developmental or complex care needs, and services should be available in numerous languages and levels of health literacy to allow all families to participate in their child’s care. At the same time, even nonpsychiatric EDs and inpatient units should commit resources to developing a maximally therapeutic environment, including allowing adjunctive services such as child life services, group therapy, and pet and music therapy, and create environments that support, rather than disrupt, normal routines.

Underpinning all the above innovations are changes to our healthcare payment system and provider networks, including the need for insurance coverage and payment parity for behavioral health, to ensure care is not only accessible but affordable. Additionally, for durable change, we need more than just education—we need coalition building and advocacy. Many organizations, including the American Academy of Pediatrics and the Children’s Hospital Association, have begun this work, which we must all continue.¹⁴ Bringing in diverse partners, including health systems, providers, educators, hospital administrators, payors, elected officials, and communities, will prioritize children’s needs and create a more ideal pediatric behavioral healthcare system.¹⁵

The COVID-19 pandemic has highlighted the dire need for comprehensive mental healthcare in the United States, a need that existed before the pandemic and will persist in a more fragile state long after it ends. Our hope is that the pandemic serves as the catalyst necessary to promote the magnitude of investments and stakeholder buy-in necessary to improve pediatric mental health and engender a radical redesign of our behavioral healthcare system. Our patients are counting on us to act. Together, we can build a system that ensures that the kids will be alright.

^†Patient details have been changed for patient privacy.

The authors thank Joanna Perdomo, MD, Amara Azubuike, JD, and Josh Greenberg, JD, for reading and providing feedback on earlier versions of this work.

“...but it all started to get worse during the pandemic.”

As the patient’s^† door closed, I (JS) thought about what his father had shared: his 12-year-old son had experienced a slow decline in his mental health since March 2020. There had been a gradual loss of all the things his son needed for psychological well-being: school went virtual and extracurricular activities ceased, and with them went any sense of routine, normalcy, or authentic opportunities to socialize. His feelings of isolation and depression culminated in an attempt to end his own life. My mind shifted to other patients under our care: an 8-year-old with behavioral outbursts intensifying after school-based therapy ended, a 13-year-old who became suicidal from isolation and virtual bullying. These children’s families sought emergent care because they no longer had the resources to care for their children at home. My team left each of these rooms heartbroken, unsure of exactly what to say and aware of the limitations of our current healthcare system.

Before and during the COVID-19 pandemic, many pediatric providers have had similar experiences caring for countless patients who are “boarding”—awaiting transfer to a psychiatric facility for their primary acute psychiatric issue, initially in the emergency room, often for 5 days or more,¹ then ultimately admitted to a general medical floor if an appropriate psychiatric bed is still not available.² Unfortunately, just as parents have run out of resources to care for their children’s psychiatric needs, so too is our medical system lacking in resources to provide the acute care these children need in general hospitals. 

This mental health crisis began before the COVID-19 pandemic³ but has only worsened in the wake of its resulting social isolation. During the pandemic, suicide hotlines had a 1000% increase in call volumes.⁴ COVID-19–induced bed closures simultaneously worsened an existing critical bed shortage^5,6 and led to an increase in the average length of stay (LOS) for patients boarding in the emergency department (ED).⁷ In the state of Massachusetts, for example, psychiatric patients awaiting inpatient beds boarded for more than 10,000 hours in January 2021—more than ever before, and up approximately 4000 hours since January 2017.⁶ For pediatric patients, the average wait time is now 59 hours.⁶ In the first 6 months of the pandemic, 39% of children presenting to EDs for mental health complaints ended up boarding, which is an astounding figure and is unfortunately 7% higher than in 2019.⁸ Even these staggering numbers do not capture the full range of experiences, as many statistics do not account for time spent on inpatient units by patients who do not receive a bed placement after waiting hours to several days in the ED.

Shortages of space, as well as an underfunded and understaffed mental health workforce, lead to these prolonged, often traumatic boarding periods in hospitals designed to care for acute medical, rather than acute psychiatric, conditions. Patients awaiting psychiatric placement are waiting in settings that are chaotic, inconsistent, and lacking in privacy. A patient in the throes of psychosis or suicidality needs a therapeutic milieu, not one that interrupts their daily routine,² disconnects them from their existing support networks, and is punctuated by the incessant clangs of bedside monitors and the hubbub of code teams. These environments are not therapeutic³ for young infants with fevers, let alone for teenagers battling suicidality and eating disorders. In fact, for these reasons, we suspect that many of our patients’ inpatient ”behavioral escalations” are in fact triggered by their hospital environment, which may contribute to the 300% increase in the number of pharmacological restraints used during mental health visits in the ED over the past 10 years.⁹

None of us imagined when we chose to pursue pediatrics a that significant—and at times predominant—portion of our training would encompass caring for patients with acute mental health concerns. And although we did not anticipate this crisis, we have now been tasked with managing it. Throughout the day, when we are called to see our patients with primarily psychiatric pathology, we are often at war with ourselves. We weigh forming deeply meaningful relationships with these patients against the potential of unintentionally retraumatizing them or forming bonds that will be abruptly severed when patients are transferred to a psychiatric facility, which often occurs with barely a few hours’ notice. Moreover, many healthcare workers have training ill-suited to meet the needs of these patients. Just as emergency physicians can diagnose appendicitis but rely on surgeons to provide timely surgical treatment, general pediatricians identify psychiatric crises but rely on psychiatrists for ideal treatment plans. And almost daily, we are called to an “escalating” patient and arrive minutes into a stressful situation that others expect us to extinguish expeditiously. Along with nursing colleagues and the behavioral response team, we enact the treatment plan laid out by our psychiatry colleagues and wonder whether there is a better way. 

We propose the following changes to create a more ideal health system (Table). We acknowledge that each health system has unique resources, challenges, and patient populations. Thus, our recommendations are not comprehensive and are largely based on experiences within our own institutions and state, but they encompass many domains that impact and are affected by child and adolescent mental healthcare in the United States, ranging from program- and hospital-level innovation to community and legislative action.

Like all good health system designs, we recommend prioritizing prevention. This would entail funding programs and legislation such as H.R. 3180, the RISE from Trauma Act, and H.R. 8544, the STRONG Support for Children Act of 2020 (both currently under consideration in the US House of Representatives) that support early childhood development and prevent adverse childhood experiences and trauma, averting mental health diagnoses such as depression and attention-deficit/hyperactivity disorder before they begin.¹⁰

We recognize that schools and general pediatricians have far more exposure to children at risk for mental health crises than do subspecialists. Thus, we urge an equitable increase in access to mental healthcare in the community so that patients needing assistance are screened and diagnosed earlier in their illness, allowing for secondary prevention of worsening mental health disorders. We support increased funding for programs such as the Massachusetts Child Psychiatry Access Program, which allows primary care doctors to consult psychiatrists in real time, closing the gap between a primary care visit and specialty follow-up. Telehealth services will be key to improving access for patients themselves and to allow pediatricians to consult with mental health professionals to initiate care prior to specialist availability. We envision that strengthening school-based behavioral health resources will also help prevent ED visits. Behavioral healthcare should be integrated into schools and community centers while police presence is simultaneously reduced, as there is evidence of an increased likelihood of juvenile justice involvement for children with disabilities and mental health needs.^11,12

Ensuring access necessitates increasing the capacity of our psychiatric workforce by encouraging graduates to pursue mental health occupations with concrete financial incentives such as loan repayment and training grants. We thus support legislation such as H.R. 6597, the Mental Health Professionals Workforce Shortage Loan Repayment Act of 2018 (currently under consideration in the US House of Representatives). This may also improve recruitment and retention of individuals who are underrepresented in medicine, one step in helping ensure children have access to linguistically appropriate and culturally sensitive care. Residency programs and hospital systems should expand their training and education to identify and stabilize patients in mental health in extremis through culturally sensitive curricula focused on behavioral de-escalation techniques, trauma-informed care, and psychopharmacology. Our own residency program created a 2-week mental health rotation¹³ that includes rotating with outpatient mental health providers and our hospital’s behavioral response team, a group of trauma-informed responders for behavioral emergencies. Similar training should be available for nursing and other allied health professionals, who are often the first responders to behavioral escalations.¹³

Ideally, patients requiring higher-intensity psychiatric care would be referred to specialized pediatric behavioral health urgent care centers so their conditions can be adequately evaluated and addressed by staff trained in psychiatric management and in therapeutic environments. We believe all providers caring for children with mental health needs should be trained in basic, but core, behavioral health and de-escalation competencies, including specialized training for children with comorbid medical and neurodevelopmental diagnoses, such as autism. These centers should have specific beds for young children and those with developmental or complex care needs, and services should be available in numerous languages and levels of health literacy to allow all families to participate in their child’s care. At the same time, even nonpsychiatric EDs and inpatient units should commit resources to developing a maximally therapeutic environment, including allowing adjunctive services such as child life services, group therapy, and pet and music therapy, and create environments that support, rather than disrupt, normal routines.

Underpinning all the above innovations are changes to our healthcare payment system and provider networks, including the need for insurance coverage and payment parity for behavioral health, to ensure care is not only accessible but affordable. Additionally, for durable change, we need more than just education—we need coalition building and advocacy. Many organizations, including the American Academy of Pediatrics and the Children’s Hospital Association, have begun this work, which we must all continue.¹⁴ Bringing in diverse partners, including health systems, providers, educators, hospital administrators, payors, elected officials, and communities, will prioritize children’s needs and create a more ideal pediatric behavioral healthcare system.¹⁵

The COVID-19 pandemic has highlighted the dire need for comprehensive mental healthcare in the United States, a need that existed before the pandemic and will persist in a more fragile state long after it ends. Our hope is that the pandemic serves as the catalyst necessary to promote the magnitude of investments and stakeholder buy-in necessary to improve pediatric mental health and engender a radical redesign of our behavioral healthcare system. Our patients are counting on us to act. Together, we can build a system that ensures that the kids will be alright.

^†Patient details have been changed for patient privacy.

The authors thank Joanna Perdomo, MD, Amara Azubuike, JD, and Josh Greenberg, JD, for reading and providing feedback on earlier versions of this work.

Inspired by the ABIM Foundation’s Choosing Wisely^® campaign, the “Things We Do for No Reason^™ " (TWDFNR) series reviews practices that have become common parts of hospital care but may provide little value to our patients. Practices reviewed in the TWDFNR series do not represent clear-cut conclusions or clinical practice standards but are meant as a starting place for research and active discussions among hospitalists and patients. We invite you to be part of that discussion.

An infected diabetic foot ulcer requiring intravenous antibiotics prompts admission for a 58-year-old man with hypertension, insulin-dependent diabetes mellitus, gout, stage 3 chronic kidney disease (CKD), and hyperlipidemia. On admission, the hospitalist discontinued the patient’s daily 300 mg of allopurinol, which had helped prevent a flare for more than 1 year. On day 3 of hospitalization, the patient developed right knee pain, swelling, and erythema. Due to concerns for septic arthritis, he underwent lab work, imaging, and joint aspiration, which confirmed the diagnosis of an acute gout flare. The prednisone he received for his gout flare caused hyperglycemia, requiring careful insulin titration during the remainder of his hospitalization.

Gout, the most common form of inflammatory arthritis, affects 3.9% of the US population. Its incidence has doubled in the past 2 decades, partly due to an increase in risk factors for gout, including obesity, diabetes, hypertension, hyperlipidemia, and renal disease.¹ Patients with gout incur high rates of hospitalization and costs related to the disease and its comorbidities.² Volume depletion, diuretic use, fluid shifts, or discontinuation of gout medications put patients at high risk of developing acute flares during hospitalization.^2-4

Acute inflammatory response to monosodium urate crystal deposition in joints causes gout flares. Over time, uncontrolled gout leads to chronic inflammatory damage, causing permanent deformities and disability. Patients with uncontrolled gout have decreased work productivity and higher healthcare utilization and costs than patients with controlled gout.⁵

Gout treatment has two components: acute flare management and long-term therapy to lower serum uric acid levels. Patients with frequent gout attacks (≥two annually), tophi, or radiographic damage require urate-lowering therapy (ULT) to prevent further damage. Additionally, ULT is conditionally recommended for patients with their first flare and concomitant CKD stage 3 or higher, serum uric acid >9 mg/dL, or urolithiasis. First-line ULT incorporates xanthine oxidase inhibitors, such as allopurinol, due to efficacy and low cost.⁶ Using a treat-to-target approach, allopurinol is titrated to achieve uric acid levels <6 mg/dL.^6,7 Controlling gout can take many months and requires careful medication titration, lifestyle modifications, and clear communication with patients. Poor adherence to ULT treatment complicates overall gout control and partly results from patients’ and providers’ knowledge gaps about gout and gout medications.^8,9 Prior studies demonstrated that poor adherence to ULT contributes to increased gout flares and resource utilization.^6,9

In the authors’ experience, hospitalists discontinue ULT for three reasons. First, hospitalists hold ULT, particularly allopurinol, when a patient has either acute or chronic kidney injury, due to concern that decreased excretion of drug metabolites increases the risk of allopurinol hypersensitivity syndrome (AHS) and allopurinol toxicity.¹⁰ One small study reported a decrease or discontinuation of allopurinol in 21% of 73 admissions, citing concerns of using allopurinol in renal impairment.¹⁰ Oxipurinol, a renally excreted metabolite of allopurinol, accumulates at higher concentrations in individuals with kidney impairment. The belief that elevated concentrations increase the risk of adverse effects has guided past recommendations about safety and dosing of allopurinol in patients with CKD.^11,12 Due to safety concerns, older guidelines and literature¹¹ suggest not increasing allopurinol more than 300 mg daily in patients with CKD.

Second, clinicians may want to stop “nonessential” medications on admission in order to simplify a medication list. If a patient’s last gout flare occurred a long time ago, a clinician may think their gout no longer requires ULT.

Finally, ULT is discontinued during an acute gout flare because clinicians believe that continuing ULT will make flare symptoms worse. Allopurinol dissolves uric acid crystals, which can cause inflammation. The inflammation increases the risk of precipitating a gout flare when first starting allopurinol and during dose titration. Clinicians may feel that holding the medication during an acute flare avoids iatrogenesis that worsens the flare.

While physicians cite concerns of using allopurinol in renal impairment,¹⁰ there are no absolute contraindications to allopurinol in kidney impairment. Clinicians can prescribe xanthine oxidase inhibitors to patients with moderate-to-severe CKD and can titrate allopurinol to doses greater than 300 mg daily safely in these same patients.^6,7,12-14 Prior studies sparked concern that poor allopurinol metabolite excretion in CKD might contribute to AHS or toxicity. However, more recent studies show that patients with CKD can take allopurinol safely, but that they require slower up-titration to mitigate the risk of flares and AHS. Guidelines recommend a starting dose of ≤100 mg of allopurinol in patients with normal renal function, and even lower doses in patients with CKD.⁶ In studies showing safe dose titration in CKD, patients received an initial dose of allopurinol 50 mg daily, which increased by 50 mg every month.^13,14 When hospitalists abruptly stop ULT during hospitalization in patients with CKD, those patients have to restart from the initial low dose and up-titrate slowly back to the lowest dose that achieves serum uric acid <6 mg/dL.⁶

Acute kidney injury (AKI) is not an absolute contraindication to allopurinol use, and the scant amount of published literature does not support discontinuation. In this acute situation, a patient may require a dose reduction in allopurinol to avoid toxicity depending on the severity of AKI. A discussion with inpatient pharmacy can help find a safe dose based on current creatinine clearance.

Physicians anecdotally recognize ULT discontinuation as a cause of inpatient gout flares. Clinicians and patients should view ULT as essential, even in patients who remain symptom-free for years. Between acute flares, a patient enters a potentially asymptomatic phase called “intercritical gout” that varies in duration. Urate deposition causing tophi and damage still occur during this phase, so patients must continue on ULT even if they have no recent flare history.

ULT that appears on any outpatient medication list needs verification of dose and compliance before ordering. If a patient is actually taking a lower dose than listed or not taking ULT at all, starting at a higher dose puts them at risk for flare and AHS, especially in patients with renal disease. Continuing ULT during hospitalization after verifying dose and compliance can potentially prevent gout flares and their downstream effects, including increased costs and potential side effects from additional pain medications.

Patients on chronic ULT should continue it during an acute gout flare.^6,7 Literature and guidelines do not suggest that continuing ULT significantly worsens the intensity or duration of a flare. The initiation or up-titration of ULT, not the continuation of it, causes uric acid to dissolve, triggering an inflammatory response that increases the risk of gout flare. Therefore, guidelines recommend giving flare prophylaxis simultaneously for at least 3 to 6 months to prevent flares while starting and titrating ULT. Flare prophylaxis may continue longer depending on when a patient reaches a stable dose of ULT.^6,7 While patients are receiving acute flare treatment, continuing ULT will help lower their serum uric acid levels over time.

To emphasize the importance of treating gout with ULT even further, the most recent American College of Rheumatology gout management guidelines conditionally recommend starting ULT during an acute flare for increased adherence. Small studies have shown that initiation of ULT does not precipitate attacks or significantly increase duration of flare. Input from patients influenced this recommendation, as they felt highly motivated to start ULT during acute flare due to symptoms.⁶

Additionally, due to comorbidities, inpatients often cannot tolerate standard flare therapies, such as nonsteroidal anti-inflammatory drugs, corticosteroids, or oral colchicine, to treat their acute symptoms. Moreover, patients often have other analgesics, such as opiates, prescribed for pain control. During an acute flare, hospitalists will likely need to add medications to treat the acute symptoms, but ULT should be considered an essential medication and continued as well.

Allopurinol can cause mild-to-severe cutaneous adverse reactions. AHS, a rare reaction that causes significant morbidity and mortality, presents with a rash, eosinophilia, fever, hepatitis, and progressive kidney failure. Risk factors for developing AHS include kidney impairment, higher starting doses, concurrent diuretic use, and presence of the genetic marker HLA B*5801.¹² AHS usually occurs in the first 8 weeks of initiation of allopurinol, but can occur later in treatment, especially in those with risk factors—notably kidney impairment.¹² When a patient on allopurinol develops a rash, the clinician should consider stopping allopurinol if concerned about AHS or, in milder cases, decrease the dose until the rash resolves.

When you see ULT on a patient’s medication list, verify the dose with the patient and continue it (even during an acute gout flare) unless a new rash has developed, or you are concerned about a drug-drug interaction. If a patient has a significant AKI, consider discussing dose modifications with your inpatient pharmacist.

• Consider ULT an essential medication and continue it during the hospitalization of a patient with a history of gout.
• Continue ULT while treating an acute gout flare.
• Continue ULT in patients with AKI and CKD, but discuss dose modifications with a pharmacist for AKI patients.

In the clinical scenario, the hospitalist did not treat ULT as an essential medication on admission, and the patient’s gout flared, leading to increased morbidity, resource utilization, and cost of hospitalization. Stopping ULT has downstream effects after discharge, including delays in achieving prior gout control. If ULT is discontinued, outpatient clinicians must restart it at lower doses and then up-titrate slowly, increasing the risk of flares and possibly contributing to nonadherence. During hospitalization, clinicians should continue ULT.

Do you think this is a low-value practice? Is this truly a “Thing We Do for No Reason™”? Share what you do in your practice and join in the conversation online by retweeting it on Twitter (#TWDFNR) and liking it on Facebook. We invite you to propose ideas for other “Things We Do for No Reason™” topics by emailing TWDFNR@hospitalmedicine.org

Inspired by the ABIM Foundation’s Choosing Wisely^® campaign, the “Things We Do for No Reason^™ " (TWDFNR) series reviews practices that have become common parts of hospital care but may provide little value to our patients. Practices reviewed in the TWDFNR series do not represent clear-cut conclusions or clinical practice standards but are meant as a starting place for research and active discussions among hospitalists and patients. We invite you to be part of that discussion.

An infected diabetic foot ulcer requiring intravenous antibiotics prompts admission for a 58-year-old man with hypertension, insulin-dependent diabetes mellitus, gout, stage 3 chronic kidney disease (CKD), and hyperlipidemia. On admission, the hospitalist discontinued the patient’s daily 300 mg of allopurinol, which had helped prevent a flare for more than 1 year. On day 3 of hospitalization, the patient developed right knee pain, swelling, and erythema. Due to concerns for septic arthritis, he underwent lab work, imaging, and joint aspiration, which confirmed the diagnosis of an acute gout flare. The prednisone he received for his gout flare caused hyperglycemia, requiring careful insulin titration during the remainder of his hospitalization.

Gout, the most common form of inflammatory arthritis, affects 3.9% of the US population. Its incidence has doubled in the past 2 decades, partly due to an increase in risk factors for gout, including obesity, diabetes, hypertension, hyperlipidemia, and renal disease.¹ Patients with gout incur high rates of hospitalization and costs related to the disease and its comorbidities.² Volume depletion, diuretic use, fluid shifts, or discontinuation of gout medications put patients at high risk of developing acute flares during hospitalization.^2-4

Acute inflammatory response to monosodium urate crystal deposition in joints causes gout flares. Over time, uncontrolled gout leads to chronic inflammatory damage, causing permanent deformities and disability. Patients with uncontrolled gout have decreased work productivity and higher healthcare utilization and costs than patients with controlled gout.⁵

Gout treatment has two components: acute flare management and long-term therapy to lower serum uric acid levels. Patients with frequent gout attacks (≥two annually), tophi, or radiographic damage require urate-lowering therapy (ULT) to prevent further damage. Additionally, ULT is conditionally recommended for patients with their first flare and concomitant CKD stage 3 or higher, serum uric acid >9 mg/dL, or urolithiasis. First-line ULT incorporates xanthine oxidase inhibitors, such as allopurinol, due to efficacy and low cost.⁶ Using a treat-to-target approach, allopurinol is titrated to achieve uric acid levels <6 mg/dL.^6,7 Controlling gout can take many months and requires careful medication titration, lifestyle modifications, and clear communication with patients. Poor adherence to ULT treatment complicates overall gout control and partly results from patients’ and providers’ knowledge gaps about gout and gout medications.^8,9 Prior studies demonstrated that poor adherence to ULT contributes to increased gout flares and resource utilization.^6,9

In the authors’ experience, hospitalists discontinue ULT for three reasons. First, hospitalists hold ULT, particularly allopurinol, when a patient has either acute or chronic kidney injury, due to concern that decreased excretion of drug metabolites increases the risk of allopurinol hypersensitivity syndrome (AHS) and allopurinol toxicity.¹⁰ One small study reported a decrease or discontinuation of allopurinol in 21% of 73 admissions, citing concerns of using allopurinol in renal impairment.¹⁰ Oxipurinol, a renally excreted metabolite of allopurinol, accumulates at higher concentrations in individuals with kidney impairment. The belief that elevated concentrations increase the risk of adverse effects has guided past recommendations about safety and dosing of allopurinol in patients with CKD.^11,12 Due to safety concerns, older guidelines and literature¹¹ suggest not increasing allopurinol more than 300 mg daily in patients with CKD.

Second, clinicians may want to stop “nonessential” medications on admission in order to simplify a medication list. If a patient’s last gout flare occurred a long time ago, a clinician may think their gout no longer requires ULT.

Finally, ULT is discontinued during an acute gout flare because clinicians believe that continuing ULT will make flare symptoms worse. Allopurinol dissolves uric acid crystals, which can cause inflammation. The inflammation increases the risk of precipitating a gout flare when first starting allopurinol and during dose titration. Clinicians may feel that holding the medication during an acute flare avoids iatrogenesis that worsens the flare.

While physicians cite concerns of using allopurinol in renal impairment,¹⁰ there are no absolute contraindications to allopurinol in kidney impairment. Clinicians can prescribe xanthine oxidase inhibitors to patients with moderate-to-severe CKD and can titrate allopurinol to doses greater than 300 mg daily safely in these same patients.^6,7,12-14 Prior studies sparked concern that poor allopurinol metabolite excretion in CKD might contribute to AHS or toxicity. However, more recent studies show that patients with CKD can take allopurinol safely, but that they require slower up-titration to mitigate the risk of flares and AHS. Guidelines recommend a starting dose of ≤100 mg of allopurinol in patients with normal renal function, and even lower doses in patients with CKD.⁶ In studies showing safe dose titration in CKD, patients received an initial dose of allopurinol 50 mg daily, which increased by 50 mg every month.^13,14 When hospitalists abruptly stop ULT during hospitalization in patients with CKD, those patients have to restart from the initial low dose and up-titrate slowly back to the lowest dose that achieves serum uric acid <6 mg/dL.⁶

Acute kidney injury (AKI) is not an absolute contraindication to allopurinol use, and the scant amount of published literature does not support discontinuation. In this acute situation, a patient may require a dose reduction in allopurinol to avoid toxicity depending on the severity of AKI. A discussion with inpatient pharmacy can help find a safe dose based on current creatinine clearance.

Physicians anecdotally recognize ULT discontinuation as a cause of inpatient gout flares. Clinicians and patients should view ULT as essential, even in patients who remain symptom-free for years. Between acute flares, a patient enters a potentially asymptomatic phase called “intercritical gout” that varies in duration. Urate deposition causing tophi and damage still occur during this phase, so patients must continue on ULT even if they have no recent flare history.

ULT that appears on any outpatient medication list needs verification of dose and compliance before ordering. If a patient is actually taking a lower dose than listed or not taking ULT at all, starting at a higher dose puts them at risk for flare and AHS, especially in patients with renal disease. Continuing ULT during hospitalization after verifying dose and compliance can potentially prevent gout flares and their downstream effects, including increased costs and potential side effects from additional pain medications.

Patients on chronic ULT should continue it during an acute gout flare.^6,7 Literature and guidelines do not suggest that continuing ULT significantly worsens the intensity or duration of a flare. The initiation or up-titration of ULT, not the continuation of it, causes uric acid to dissolve, triggering an inflammatory response that increases the risk of gout flare. Therefore, guidelines recommend giving flare prophylaxis simultaneously for at least 3 to 6 months to prevent flares while starting and titrating ULT. Flare prophylaxis may continue longer depending on when a patient reaches a stable dose of ULT.^6,7 While patients are receiving acute flare treatment, continuing ULT will help lower their serum uric acid levels over time.

To emphasize the importance of treating gout with ULT even further, the most recent American College of Rheumatology gout management guidelines conditionally recommend starting ULT during an acute flare for increased adherence. Small studies have shown that initiation of ULT does not precipitate attacks or significantly increase duration of flare. Input from patients influenced this recommendation, as they felt highly motivated to start ULT during acute flare due to symptoms.⁶

Additionally, due to comorbidities, inpatients often cannot tolerate standard flare therapies, such as nonsteroidal anti-inflammatory drugs, corticosteroids, or oral colchicine, to treat their acute symptoms. Moreover, patients often have other analgesics, such as opiates, prescribed for pain control. During an acute flare, hospitalists will likely need to add medications to treat the acute symptoms, but ULT should be considered an essential medication and continued as well.

Allopurinol can cause mild-to-severe cutaneous adverse reactions. AHS, a rare reaction that causes significant morbidity and mortality, presents with a rash, eosinophilia, fever, hepatitis, and progressive kidney failure. Risk factors for developing AHS include kidney impairment, higher starting doses, concurrent diuretic use, and presence of the genetic marker HLA B*5801.¹² AHS usually occurs in the first 8 weeks of initiation of allopurinol, but can occur later in treatment, especially in those with risk factors—notably kidney impairment.¹² When a patient on allopurinol develops a rash, the clinician should consider stopping allopurinol if concerned about AHS or, in milder cases, decrease the dose until the rash resolves.

When you see ULT on a patient’s medication list, verify the dose with the patient and continue it (even during an acute gout flare) unless a new rash has developed, or you are concerned about a drug-drug interaction. If a patient has a significant AKI, consider discussing dose modifications with your inpatient pharmacist.

• Consider ULT an essential medication and continue it during the hospitalization of a patient with a history of gout.
• Continue ULT while treating an acute gout flare.
• Continue ULT in patients with AKI and CKD, but discuss dose modifications with a pharmacist for AKI patients.

In the clinical scenario, the hospitalist did not treat ULT as an essential medication on admission, and the patient’s gout flared, leading to increased morbidity, resource utilization, and cost of hospitalization. Stopping ULT has downstream effects after discharge, including delays in achieving prior gout control. If ULT is discontinued, outpatient clinicians must restart it at lower doses and then up-titrate slowly, increasing the risk of flares and possibly contributing to nonadherence. During hospitalization, clinicians should continue ULT.

Do you think this is a low-value practice? Is this truly a “Thing We Do for No Reason™”? Share what you do in your practice and join in the conversation online by retweeting it on Twitter (#TWDFNR) and liking it on Facebook. We invite you to propose ideas for other “Things We Do for No Reason™” topics by emailing TWDFNR@hospitalmedicine.org

Inspired by the ABIM Foundation’s Choosing Wisely^® campaign, the “Things We Do for No Reason^™ " (TWDFNR) series reviews practices that have become common parts of hospital care but may provide little value to our patients. Practices reviewed in the TWDFNR series do not represent clear-cut conclusions or clinical practice standards but are meant as a starting place for research and active discussions among hospitalists and patients. We invite you to be part of that discussion.

An infected diabetic foot ulcer requiring intravenous antibiotics prompts admission for a 58-year-old man with hypertension, insulin-dependent diabetes mellitus, gout, stage 3 chronic kidney disease (CKD), and hyperlipidemia. On admission, the hospitalist discontinued the patient’s daily 300 mg of allopurinol, which had helped prevent a flare for more than 1 year. On day 3 of hospitalization, the patient developed right knee pain, swelling, and erythema. Due to concerns for septic arthritis, he underwent lab work, imaging, and joint aspiration, which confirmed the diagnosis of an acute gout flare. The prednisone he received for his gout flare caused hyperglycemia, requiring careful insulin titration during the remainder of his hospitalization.

Gout, the most common form of inflammatory arthritis, affects 3.9% of the US population. Its incidence has doubled in the past 2 decades, partly due to an increase in risk factors for gout, including obesity, diabetes, hypertension, hyperlipidemia, and renal disease.¹ Patients with gout incur high rates of hospitalization and costs related to the disease and its comorbidities.² Volume depletion, diuretic use, fluid shifts, or discontinuation of gout medications put patients at high risk of developing acute flares during hospitalization.^2-4

Acute inflammatory response to monosodium urate crystal deposition in joints causes gout flares. Over time, uncontrolled gout leads to chronic inflammatory damage, causing permanent deformities and disability. Patients with uncontrolled gout have decreased work productivity and higher healthcare utilization and costs than patients with controlled gout.⁵

Gout treatment has two components: acute flare management and long-term therapy to lower serum uric acid levels. Patients with frequent gout attacks (≥two annually), tophi, or radiographic damage require urate-lowering therapy (ULT) to prevent further damage. Additionally, ULT is conditionally recommended for patients with their first flare and concomitant CKD stage 3 or higher, serum uric acid >9 mg/dL, or urolithiasis. First-line ULT incorporates xanthine oxidase inhibitors, such as allopurinol, due to efficacy and low cost.⁶ Using a treat-to-target approach, allopurinol is titrated to achieve uric acid levels <6 mg/dL.^6,7 Controlling gout can take many months and requires careful medication titration, lifestyle modifications, and clear communication with patients. Poor adherence to ULT treatment complicates overall gout control and partly results from patients’ and providers’ knowledge gaps about gout and gout medications.^8,9 Prior studies demonstrated that poor adherence to ULT contributes to increased gout flares and resource utilization.^6,9

In the authors’ experience, hospitalists discontinue ULT for three reasons. First, hospitalists hold ULT, particularly allopurinol, when a patient has either acute or chronic kidney injury, due to concern that decreased excretion of drug metabolites increases the risk of allopurinol hypersensitivity syndrome (AHS) and allopurinol toxicity.¹⁰ One small study reported a decrease or discontinuation of allopurinol in 21% of 73 admissions, citing concerns of using allopurinol in renal impairment.¹⁰ Oxipurinol, a renally excreted metabolite of allopurinol, accumulates at higher concentrations in individuals with kidney impairment. The belief that elevated concentrations increase the risk of adverse effects has guided past recommendations about safety and dosing of allopurinol in patients with CKD.^11,12 Due to safety concerns, older guidelines and literature¹¹ suggest not increasing allopurinol more than 300 mg daily in patients with CKD.

Second, clinicians may want to stop “nonessential” medications on admission in order to simplify a medication list. If a patient’s last gout flare occurred a long time ago, a clinician may think their gout no longer requires ULT.

Finally, ULT is discontinued during an acute gout flare because clinicians believe that continuing ULT will make flare symptoms worse. Allopurinol dissolves uric acid crystals, which can cause inflammation. The inflammation increases the risk of precipitating a gout flare when first starting allopurinol and during dose titration. Clinicians may feel that holding the medication during an acute flare avoids iatrogenesis that worsens the flare.

While physicians cite concerns of using allopurinol in renal impairment,¹⁰ there are no absolute contraindications to allopurinol in kidney impairment. Clinicians can prescribe xanthine oxidase inhibitors to patients with moderate-to-severe CKD and can titrate allopurinol to doses greater than 300 mg daily safely in these same patients.^6,7,12-14 Prior studies sparked concern that poor allopurinol metabolite excretion in CKD might contribute to AHS or toxicity. However, more recent studies show that patients with CKD can take allopurinol safely, but that they require slower up-titration to mitigate the risk of flares and AHS. Guidelines recommend a starting dose of ≤100 mg of allopurinol in patients with normal renal function, and even lower doses in patients with CKD.⁶ In studies showing safe dose titration in CKD, patients received an initial dose of allopurinol 50 mg daily, which increased by 50 mg every month.^13,14 When hospitalists abruptly stop ULT during hospitalization in patients with CKD, those patients have to restart from the initial low dose and up-titrate slowly back to the lowest dose that achieves serum uric acid <6 mg/dL.⁶

Acute kidney injury (AKI) is not an absolute contraindication to allopurinol use, and the scant amount of published literature does not support discontinuation. In this acute situation, a patient may require a dose reduction in allopurinol to avoid toxicity depending on the severity of AKI. A discussion with inpatient pharmacy can help find a safe dose based on current creatinine clearance.

Physicians anecdotally recognize ULT discontinuation as a cause of inpatient gout flares. Clinicians and patients should view ULT as essential, even in patients who remain symptom-free for years. Between acute flares, a patient enters a potentially asymptomatic phase called “intercritical gout” that varies in duration. Urate deposition causing tophi and damage still occur during this phase, so patients must continue on ULT even if they have no recent flare history.

ULT that appears on any outpatient medication list needs verification of dose and compliance before ordering. If a patient is actually taking a lower dose than listed or not taking ULT at all, starting at a higher dose puts them at risk for flare and AHS, especially in patients with renal disease. Continuing ULT during hospitalization after verifying dose and compliance can potentially prevent gout flares and their downstream effects, including increased costs and potential side effects from additional pain medications.

Patients on chronic ULT should continue it during an acute gout flare.^6,7 Literature and guidelines do not suggest that continuing ULT significantly worsens the intensity or duration of a flare. The initiation or up-titration of ULT, not the continuation of it, causes uric acid to dissolve, triggering an inflammatory response that increases the risk of gout flare. Therefore, guidelines recommend giving flare prophylaxis simultaneously for at least 3 to 6 months to prevent flares while starting and titrating ULT. Flare prophylaxis may continue longer depending on when a patient reaches a stable dose of ULT.^6,7 While patients are receiving acute flare treatment, continuing ULT will help lower their serum uric acid levels over time.

To emphasize the importance of treating gout with ULT even further, the most recent American College of Rheumatology gout management guidelines conditionally recommend starting ULT during an acute flare for increased adherence. Small studies have shown that initiation of ULT does not precipitate attacks or significantly increase duration of flare. Input from patients influenced this recommendation, as they felt highly motivated to start ULT during acute flare due to symptoms.⁶

Additionally, due to comorbidities, inpatients often cannot tolerate standard flare therapies, such as nonsteroidal anti-inflammatory drugs, corticosteroids, or oral colchicine, to treat their acute symptoms. Moreover, patients often have other analgesics, such as opiates, prescribed for pain control. During an acute flare, hospitalists will likely need to add medications to treat the acute symptoms, but ULT should be considered an essential medication and continued as well.

Allopurinol can cause mild-to-severe cutaneous adverse reactions. AHS, a rare reaction that causes significant morbidity and mortality, presents with a rash, eosinophilia, fever, hepatitis, and progressive kidney failure. Risk factors for developing AHS include kidney impairment, higher starting doses, concurrent diuretic use, and presence of the genetic marker HLA B*5801.¹² AHS usually occurs in the first 8 weeks of initiation of allopurinol, but can occur later in treatment, especially in those with risk factors—notably kidney impairment.¹² When a patient on allopurinol develops a rash, the clinician should consider stopping allopurinol if concerned about AHS or, in milder cases, decrease the dose until the rash resolves.

When you see ULT on a patient’s medication list, verify the dose with the patient and continue it (even during an acute gout flare) unless a new rash has developed, or you are concerned about a drug-drug interaction. If a patient has a significant AKI, consider discussing dose modifications with your inpatient pharmacist.

• Consider ULT an essential medication and continue it during the hospitalization of a patient with a history of gout.
• Continue ULT while treating an acute gout flare.
• Continue ULT in patients with AKI and CKD, but discuss dose modifications with a pharmacist for AKI patients.

In the clinical scenario, the hospitalist did not treat ULT as an essential medication on admission, and the patient’s gout flared, leading to increased morbidity, resource utilization, and cost of hospitalization. Stopping ULT has downstream effects after discharge, including delays in achieving prior gout control. If ULT is discontinued, outpatient clinicians must restart it at lower doses and then up-titrate slowly, increasing the risk of flares and possibly contributing to nonadherence. During hospitalization, clinicians should continue ULT.

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Alcohol is the most common substance implicated in hospitalizations for substance use disorders,¹ and as a result, hospitalists commonly diagnose and manage alcohol withdrawal syndrome (AWS) in the inpatient medical setting. The 2020 guidelines of the American Society of Addiction Medicine (ASAM) provide updated recommendations for the diagnosis, monitoring, and treatment of patients hospitalized with AWS, which we have condensed to emphasize key changes from the last update² and clarify ongoing areas of uncertainty. 

Diagnosis

Recommendation 1. All inpatients who have used alcohol recently or regularly should be risk-stratified for AWS, regardless of whether or not they have suggestive symptoms (recommendations I.3, I.4, I.5, II.10). The Alcohol Use Disorders Identification Test-(Piccinelli) Consumption (AUDIT-PC) identifies patients at risk for AWS, and the Prediction of Alcohol Withdrawal Severity Scale (PAWSS) identifies those at risk for severe or complicated AWS, which includes seizures and alcohol withdrawal delirium (formerly delirium tremens). The guideline emphasizes use of these tools rather than simply initiating Clinical Institute Withdrawal Assessment for Alcohol, revised (CIWA-Ar) monitoring on all such patients to diagnose AWS, as CIWA-Ar was developed for monitoring response to treatment, not diagnosis (recommendation I.6). 

Treating Mild/Moderate or Uncomplicated AWS

Recommendation 2. Because of their proven track record of reducing the incidence of seizure and alcohol withdrawal delirium, benzodiazepines remain the recommended first-line therapy (recommendations V.13, V.16). Symptom-triggered administration of benzodiazepines (via CIWA-Ar) is recommended over fixed-dose administration because the former is associated with shorter length of stay and lower cumulative benzodiazepine administration^3,4 (recommendation V.23). Patients with mild AWS who are at low risk for severe or complicated withdrawal should be monitored for up to 36 hours for the development of worsening symptoms (recommendation V.1). For patients with high CIWA-Ar scores or who are at increased risk for severe or complicated AWS, frequent administration of moderate to high doses of a long-acting benzodiazepine early in AWS treatment (a practice called frontloading) is recommended to quickly control symptoms and prevent clinical worsening. This approach has been shown to reduce the incidence of seizures and alcohol withdrawal delirium (recommendations V.14, V.19, V.24).

Carbamazepine or gabapentin may be used in mild or moderate AWS if benzodiazepines are contraindicated; however, neither agent is recommended as first-line therapy because a clear reduction in seizure and withdrawal delirium has not been established (recommendation V.16). Alpha-2 agonists (eg, clonidine, dexmedetomidine) may be used to treat persistent autonomic hyperactivity or anxiety when these are not adequately controlled by benzodiazepines alone (recommendation V.36).

Treating Severe or Complicated AWS

Recommendation 3. The guideline defines severe AWS as withdrawal with severe signs and symptoms, and complicated AWS as withdrawal accompanied by seizures or delirium (Appendix Table⁵). The development of complications warrants prompt treatment. Patients who experience seizure should receive a fast-acting benzodiazepine (eg, intravenous [IV] diazepam or lorazepam) (recommendation VI.4). Patients with withdrawal delirium should receive a benzodiazepine (preferably parenterally) dosed to achieve light sedation. Clinicians should be prepared for the possibility that large doses may be required and to monitor patients for oversedation and respiratory depression (recommendations VI.13, VI.17). Antipsychotics may be used as adjuncts when withdrawal delirium or other symptoms, such as hallucinosis, are not adequately controlled by benzodiazepines alone, but should not be used as monotherapy (recommendation VI.20). The guideline emphasizes that alpha-2 agonists should not be used to treat withdrawal delirium (recommendation VI.21), but they may be used as adjuncts for resistant alcohol withdrawal in the intensive care unit (ICU) (recommendations VI.27, VI.29). Phenobarbital is an acceptable alternative to benzodiazepines for severe withdrawal (recommendation V.17); however, the guideline recommends that clinicians should be experienced in its use.

Treating Wernicke Encephalopathy

Recommendation 4. Thiamine should be administered to prevent Wernicke encephalopathy (WE), with parenteral formulations recommended in patients with malnutrition, severe/complicated withdrawal, or requiring ICU-level care (recommendations V.7, V.8). In particular, all patients admitted to an ICU for AWS should receive thiamine, as diagnosis of WE is often difficult in this population. Although there is no consensus on the required dose of thiamine to treat WE, 100 mg IV or intramuscularly (IM) daily for 3 to 5 days is commonly administered (recommendation V.7). Because of a lack of evidence of harm, thiamine may be given before, after, or concurrently with glucose or dextrose (recommendation V.7). The guideline does not make a specific recommendation regarding how to risk-stratify patients for WE.

Treating Underlying Alcohol Use Disorder 

Recommendation 5. Hospitalization for AWS is an important opportunity to engage patients in treatment for alcohol use disorder (AUD), including pharmacotherapy and connection with outpatient providers (recommendation V.12). The guideline emphasizes that treatment for AUD should be initiated concomitantly with AWS management whenever possible but does not make recommendations regarding specific pharmacotherapies.

This guideline was authored by a committee of emergency medicine physicians, psychiatrists, and internists using the Department of Veterans Affairs/Department of Defense guidelines and the RAND/UCLA appropriateness method to combine the scientific literature with expert opinion. The result is a series of recommendations for physicians, physician assistants, nurse practitioners, and pharmacists that are not rated by strength; an assessment of the quality of the supporting evidence is available in an appendix. Four of the nine guideline committee members reported significant financial relationships with industry and other entities relevant to these guidelines.

Despite concern about oversedation from phenobarbital raised in small case series,⁶ observational studies comparing phenobarbital with benzodiazepines suggest phenobarbital has similar efficacy for treating AWS and that oversedation is rare.^7-9 Large randomized controlled trials in this area are lacking; however, at least one small randomized controlled trial¹⁰ among patients with AWS presenting to emergency departments supports the safety and efficacy of phenobarbital when used in combination with benzodiazepines. Given the growing body of evidence supporting the safety of phenobarbital, we believe a stronger recommendation for use in patients presenting with alcohol withdrawal delirium or treatment-resistant alcohol withdrawal is warranted. The guidelines also suggest that only “experienced clinicians” use phenobarbital for AWS, which may suppress appropriate use. Nationally, phenobarbital use for AWS remains low.¹¹Finally, although the guideline recommends initiation of treatment for AUD, specific recommendations for pharmacotherapy are not provided. Three medications currently have approval from the US Food and Drug Administration for treatment of AUD: acamprosate, naltrexone, and disulfiram. Large randomized controlled trials support the safety and efficacy of acamprosate and naltrexone, with or without counselling, in the treatment of AUD,¹² and disulfiram may be appropriate for selected highly motivated patients. We believe more specific recommendations to assist in choosing among these options would be useful.

More data are needed on the safety and efficacy of phenobarbital in patients with AWS, as well as comparative effectiveness against benzodiazepines. Recruitment is ongoing for a single clinical trial comparing the effect of phenobarbital and lorazepam on length of stay among patients in the ICU with AWS (NCT04156464); to date, no randomized trials of phenobarbital have been conducted in medical inpatients with AWS. In addition, gaps in the literature exist regarding benzodiazepine selection, and head-to-head comparisons of symptom-triggered usage of different benzodiazepines are lacking.

Alcohol is the most common substance implicated in hospitalizations for substance use disorders,¹ and as a result, hospitalists commonly diagnose and manage alcohol withdrawal syndrome (AWS) in the inpatient medical setting. The 2020 guidelines of the American Society of Addiction Medicine (ASAM) provide updated recommendations for the diagnosis, monitoring, and treatment of patients hospitalized with AWS, which we have condensed to emphasize key changes from the last update² and clarify ongoing areas of uncertainty. 

Diagnosis

Recommendation 1. All inpatients who have used alcohol recently or regularly should be risk-stratified for AWS, regardless of whether or not they have suggestive symptoms (recommendations I.3, I.4, I.5, II.10). The Alcohol Use Disorders Identification Test-(Piccinelli) Consumption (AUDIT-PC) identifies patients at risk for AWS, and the Prediction of Alcohol Withdrawal Severity Scale (PAWSS) identifies those at risk for severe or complicated AWS, which includes seizures and alcohol withdrawal delirium (formerly delirium tremens). The guideline emphasizes use of these tools rather than simply initiating Clinical Institute Withdrawal Assessment for Alcohol, revised (CIWA-Ar) monitoring on all such patients to diagnose AWS, as CIWA-Ar was developed for monitoring response to treatment, not diagnosis (recommendation I.6). 

Treating Mild/Moderate or Uncomplicated AWS

Recommendation 2. Because of their proven track record of reducing the incidence of seizure and alcohol withdrawal delirium, benzodiazepines remain the recommended first-line therapy (recommendations V.13, V.16). Symptom-triggered administration of benzodiazepines (via CIWA-Ar) is recommended over fixed-dose administration because the former is associated with shorter length of stay and lower cumulative benzodiazepine administration^3,4 (recommendation V.23). Patients with mild AWS who are at low risk for severe or complicated withdrawal should be monitored for up to 36 hours for the development of worsening symptoms (recommendation V.1). For patients with high CIWA-Ar scores or who are at increased risk for severe or complicated AWS, frequent administration of moderate to high doses of a long-acting benzodiazepine early in AWS treatment (a practice called frontloading) is recommended to quickly control symptoms and prevent clinical worsening. This approach has been shown to reduce the incidence of seizures and alcohol withdrawal delirium (recommendations V.14, V.19, V.24).

Carbamazepine or gabapentin may be used in mild or moderate AWS if benzodiazepines are contraindicated; however, neither agent is recommended as first-line therapy because a clear reduction in seizure and withdrawal delirium has not been established (recommendation V.16). Alpha-2 agonists (eg, clonidine, dexmedetomidine) may be used to treat persistent autonomic hyperactivity or anxiety when these are not adequately controlled by benzodiazepines alone (recommendation V.36).

Treating Severe or Complicated AWS

Recommendation 3. The guideline defines severe AWS as withdrawal with severe signs and symptoms, and complicated AWS as withdrawal accompanied by seizures or delirium (Appendix Table⁵). The development of complications warrants prompt treatment. Patients who experience seizure should receive a fast-acting benzodiazepine (eg, intravenous [IV] diazepam or lorazepam) (recommendation VI.4). Patients with withdrawal delirium should receive a benzodiazepine (preferably parenterally) dosed to achieve light sedation. Clinicians should be prepared for the possibility that large doses may be required and to monitor patients for oversedation and respiratory depression (recommendations VI.13, VI.17). Antipsychotics may be used as adjuncts when withdrawal delirium or other symptoms, such as hallucinosis, are not adequately controlled by benzodiazepines alone, but should not be used as monotherapy (recommendation VI.20). The guideline emphasizes that alpha-2 agonists should not be used to treat withdrawal delirium (recommendation VI.21), but they may be used as adjuncts for resistant alcohol withdrawal in the intensive care unit (ICU) (recommendations VI.27, VI.29). Phenobarbital is an acceptable alternative to benzodiazepines for severe withdrawal (recommendation V.17); however, the guideline recommends that clinicians should be experienced in its use.

Treating Wernicke Encephalopathy

Recommendation 4. Thiamine should be administered to prevent Wernicke encephalopathy (WE), with parenteral formulations recommended in patients with malnutrition, severe/complicated withdrawal, or requiring ICU-level care (recommendations V.7, V.8). In particular, all patients admitted to an ICU for AWS should receive thiamine, as diagnosis of WE is often difficult in this population. Although there is no consensus on the required dose of thiamine to treat WE, 100 mg IV or intramuscularly (IM) daily for 3 to 5 days is commonly administered (recommendation V.7). Because of a lack of evidence of harm, thiamine may be given before, after, or concurrently with glucose or dextrose (recommendation V.7). The guideline does not make a specific recommendation regarding how to risk-stratify patients for WE.

Treating Underlying Alcohol Use Disorder 

Recommendation 5. Hospitalization for AWS is an important opportunity to engage patients in treatment for alcohol use disorder (AUD), including pharmacotherapy and connection with outpatient providers (recommendation V.12). The guideline emphasizes that treatment for AUD should be initiated concomitantly with AWS management whenever possible but does not make recommendations regarding specific pharmacotherapies.

This guideline was authored by a committee of emergency medicine physicians, psychiatrists, and internists using the Department of Veterans Affairs/Department of Defense guidelines and the RAND/UCLA appropriateness method to combine the scientific literature with expert opinion. The result is a series of recommendations for physicians, physician assistants, nurse practitioners, and pharmacists that are not rated by strength; an assessment of the quality of the supporting evidence is available in an appendix. Four of the nine guideline committee members reported significant financial relationships with industry and other entities relevant to these guidelines.

Despite concern about oversedation from phenobarbital raised in small case series,⁶ observational studies comparing phenobarbital with benzodiazepines suggest phenobarbital has similar efficacy for treating AWS and that oversedation is rare.^7-9 Large randomized controlled trials in this area are lacking; however, at least one small randomized controlled trial¹⁰ among patients with AWS presenting to emergency departments supports the safety and efficacy of phenobarbital when used in combination with benzodiazepines. Given the growing body of evidence supporting the safety of phenobarbital, we believe a stronger recommendation for use in patients presenting with alcohol withdrawal delirium or treatment-resistant alcohol withdrawal is warranted. The guidelines also suggest that only “experienced clinicians” use phenobarbital for AWS, which may suppress appropriate use. Nationally, phenobarbital use for AWS remains low.¹¹Finally, although the guideline recommends initiation of treatment for AUD, specific recommendations for pharmacotherapy are not provided. Three medications currently have approval from the US Food and Drug Administration for treatment of AUD: acamprosate, naltrexone, and disulfiram. Large randomized controlled trials support the safety and efficacy of acamprosate and naltrexone, with or without counselling, in the treatment of AUD,¹² and disulfiram may be appropriate for selected highly motivated patients. We believe more specific recommendations to assist in choosing among these options would be useful.

More data are needed on the safety and efficacy of phenobarbital in patients with AWS, as well as comparative effectiveness against benzodiazepines. Recruitment is ongoing for a single clinical trial comparing the effect of phenobarbital and lorazepam on length of stay among patients in the ICU with AWS (NCT04156464); to date, no randomized trials of phenobarbital have been conducted in medical inpatients with AWS. In addition, gaps in the literature exist regarding benzodiazepine selection, and head-to-head comparisons of symptom-triggered usage of different benzodiazepines are lacking.

Alcohol is the most common substance implicated in hospitalizations for substance use disorders,¹ and as a result, hospitalists commonly diagnose and manage alcohol withdrawal syndrome (AWS) in the inpatient medical setting. The 2020 guidelines of the American Society of Addiction Medicine (ASAM) provide updated recommendations for the diagnosis, monitoring, and treatment of patients hospitalized with AWS, which we have condensed to emphasize key changes from the last update² and clarify ongoing areas of uncertainty. 

Diagnosis

Recommendation 1. All inpatients who have used alcohol recently or regularly should be risk-stratified for AWS, regardless of whether or not they have suggestive symptoms (recommendations I.3, I.4, I.5, II.10). The Alcohol Use Disorders Identification Test-(Piccinelli) Consumption (AUDIT-PC) identifies patients at risk for AWS, and the Prediction of Alcohol Withdrawal Severity Scale (PAWSS) identifies those at risk for severe or complicated AWS, which includes seizures and alcohol withdrawal delirium (formerly delirium tremens). The guideline emphasizes use of these tools rather than simply initiating Clinical Institute Withdrawal Assessment for Alcohol, revised (CIWA-Ar) monitoring on all such patients to diagnose AWS, as CIWA-Ar was developed for monitoring response to treatment, not diagnosis (recommendation I.6). 

Treating Mild/Moderate or Uncomplicated AWS

Recommendation 2. Because of their proven track record of reducing the incidence of seizure and alcohol withdrawal delirium, benzodiazepines remain the recommended first-line therapy (recommendations V.13, V.16). Symptom-triggered administration of benzodiazepines (via CIWA-Ar) is recommended over fixed-dose administration because the former is associated with shorter length of stay and lower cumulative benzodiazepine administration^3,4 (recommendation V.23). Patients with mild AWS who are at low risk for severe or complicated withdrawal should be monitored for up to 36 hours for the development of worsening symptoms (recommendation V.1). For patients with high CIWA-Ar scores or who are at increased risk for severe or complicated AWS, frequent administration of moderate to high doses of a long-acting benzodiazepine early in AWS treatment (a practice called frontloading) is recommended to quickly control symptoms and prevent clinical worsening. This approach has been shown to reduce the incidence of seizures and alcohol withdrawal delirium (recommendations V.14, V.19, V.24).

Carbamazepine or gabapentin may be used in mild or moderate AWS if benzodiazepines are contraindicated; however, neither agent is recommended as first-line therapy because a clear reduction in seizure and withdrawal delirium has not been established (recommendation V.16). Alpha-2 agonists (eg, clonidine, dexmedetomidine) may be used to treat persistent autonomic hyperactivity or anxiety when these are not adequately controlled by benzodiazepines alone (recommendation V.36).

Treating Severe or Complicated AWS

Recommendation 3. The guideline defines severe AWS as withdrawal with severe signs and symptoms, and complicated AWS as withdrawal accompanied by seizures or delirium (Appendix Table⁵). The development of complications warrants prompt treatment. Patients who experience seizure should receive a fast-acting benzodiazepine (eg, intravenous [IV] diazepam or lorazepam) (recommendation VI.4). Patients with withdrawal delirium should receive a benzodiazepine (preferably parenterally) dosed to achieve light sedation. Clinicians should be prepared for the possibility that large doses may be required and to monitor patients for oversedation and respiratory depression (recommendations VI.13, VI.17). Antipsychotics may be used as adjuncts when withdrawal delirium or other symptoms, such as hallucinosis, are not adequately controlled by benzodiazepines alone, but should not be used as monotherapy (recommendation VI.20). The guideline emphasizes that alpha-2 agonists should not be used to treat withdrawal delirium (recommendation VI.21), but they may be used as adjuncts for resistant alcohol withdrawal in the intensive care unit (ICU) (recommendations VI.27, VI.29). Phenobarbital is an acceptable alternative to benzodiazepines for severe withdrawal (recommendation V.17); however, the guideline recommends that clinicians should be experienced in its use.

Treating Wernicke Encephalopathy

Recommendation 4. Thiamine should be administered to prevent Wernicke encephalopathy (WE), with parenteral formulations recommended in patients with malnutrition, severe/complicated withdrawal, or requiring ICU-level care (recommendations V.7, V.8). In particular, all patients admitted to an ICU for AWS should receive thiamine, as diagnosis of WE is often difficult in this population. Although there is no consensus on the required dose of thiamine to treat WE, 100 mg IV or intramuscularly (IM) daily for 3 to 5 days is commonly administered (recommendation V.7). Because of a lack of evidence of harm, thiamine may be given before, after, or concurrently with glucose or dextrose (recommendation V.7). The guideline does not make a specific recommendation regarding how to risk-stratify patients for WE.

Treating Underlying Alcohol Use Disorder 

Recommendation 5. Hospitalization for AWS is an important opportunity to engage patients in treatment for alcohol use disorder (AUD), including pharmacotherapy and connection with outpatient providers (recommendation V.12). The guideline emphasizes that treatment for AUD should be initiated concomitantly with AWS management whenever possible but does not make recommendations regarding specific pharmacotherapies.

This guideline was authored by a committee of emergency medicine physicians, psychiatrists, and internists using the Department of Veterans Affairs/Department of Defense guidelines and the RAND/UCLA appropriateness method to combine the scientific literature with expert opinion. The result is a series of recommendations for physicians, physician assistants, nurse practitioners, and pharmacists that are not rated by strength; an assessment of the quality of the supporting evidence is available in an appendix. Four of the nine guideline committee members reported significant financial relationships with industry and other entities relevant to these guidelines.

Despite concern about oversedation from phenobarbital raised in small case series,⁶ observational studies comparing phenobarbital with benzodiazepines suggest phenobarbital has similar efficacy for treating AWS and that oversedation is rare.^7-9 Large randomized controlled trials in this area are lacking; however, at least one small randomized controlled trial¹⁰ among patients with AWS presenting to emergency departments supports the safety and efficacy of phenobarbital when used in combination with benzodiazepines. Given the growing body of evidence supporting the safety of phenobarbital, we believe a stronger recommendation for use in patients presenting with alcohol withdrawal delirium or treatment-resistant alcohol withdrawal is warranted. The guidelines also suggest that only “experienced clinicians” use phenobarbital for AWS, which may suppress appropriate use. Nationally, phenobarbital use for AWS remains low.¹¹Finally, although the guideline recommends initiation of treatment for AUD, specific recommendations for pharmacotherapy are not provided. Three medications currently have approval from the US Food and Drug Administration for treatment of AUD: acamprosate, naltrexone, and disulfiram. Large randomized controlled trials support the safety and efficacy of acamprosate and naltrexone, with or without counselling, in the treatment of AUD,¹² and disulfiram may be appropriate for selected highly motivated patients. We believe more specific recommendations to assist in choosing among these options would be useful.

More data are needed on the safety and efficacy of phenobarbital in patients with AWS, as well as comparative effectiveness against benzodiazepines. Recruitment is ongoing for a single clinical trial comparing the effect of phenobarbital and lorazepam on length of stay among patients in the ICU with AWS (NCT04156464); to date, no randomized trials of phenobarbital have been conducted in medical inpatients with AWS. In addition, gaps in the literature exist regarding benzodiazepine selection, and head-to-head comparisons of symptom-triggered usage of different benzodiazepines are lacking.

Narrative competence is the ability to acquire, interpret, and act on the stories of others.¹ Developing this skill through guided medical storytelling can improve health care practitioners’ (HCPs) sense of empathy and satisfaction with their work.² Narrative medicine experiences for medical students can foster a deeper understanding of their patients beyond illness-associated identities.³

Within narrative medicine, the “life story” is a specific technique that allows patients to share experiences through open-ended interviews that are entered into the health record.^4,5 By sharing life stories, patients control a narrative encompassing more than their illness and can reinforce a sense of purpose in their lives.⁶ The US Department of Veterans Affairs (VA) My Life My Story (MLMS) program gives veterans the opportunity to share their narrative with staff and volunteer interviewers. MLMS is well received by veterans, has durable positive effects for HCPs who read the stories, and has been used as a tool to teach patient-centered care to medical trainees.^7-9

We created a narrative medicine curriculum at the San Francisco VA Medical Center (SFVAMC) in which medical students interviewed veterans for the MLMS program. Medical students initially collected life stories through in-person conversation. During the COVID-19 pandemic, physical distancing regulations limited direct patient interaction for students and prompted a switch to phone and video interviews. This shift paralleled the widespread adoption of telehealth, which will persist beyond the pandemic and require teachers and learners to develop competency in forming personal connections with patients through videoconferencing.^10,11

There are no published studies describing how to guide medical students (or other historians) in generating life stories without in-person patient contact. This article details the design of a medical student curriculum incorporating MLMS and the transition to remote interaction between instructors, students, and veterans during the early COVID-19 pandemic.

MLMS Program Origins

The MLMS project began at the William S. Middleton Memorial Veterans Hospital in Madison, Wisconsin, in 2013 with staff and volunteer interviewers and has expanded to more than 60 VA facilities.⁷ In January 2020, we initiated a narrative medicine curriculum incorporating MLMS at the SFVAMC as a required component of a third-year internal medicine clerkship for medical students at the University of California San Francisco (UCSF). Fifty-four medical students in 10 cohorts participated in the curriculum in 2020. The primary program objectives were for medical students to develop skills for eliciting and recording a life story and to appreciate the impact of this activity on a veteran’s experience of receiving health care. Secondary objectives were for students to understand the mission of the VA health care system and veteran demographics.

The first cohort of 6 UCSF medical students participated in MLMS during their 8-week VA clerkship. Students attended a 1-hour small group session to introduce the program and build narrative medicine skills. Preparation for this session involved listening to 2 podcast episodes introducing the VA health care system and MLMS.^12,13 The session began with a short interactive discussion of veteran demographics with an emphasis on addressing assumptions students might have about the veteran population. Students were taught strategies for engaging in open-ended conversations without emphasizing illness. Each student practiced collecting a life story with a simulated patient portrayed by an instructor and received feedback from classmates and instructors.

Over the following weeks, students selected a hospitalized veteran, typically a patient they were caring for, introduced MLMS, and obtained verbal consent to participate. They conducted a 60- to 90-minute interview, wrote and organized the life story, read it to the veteran, and solicited edits. Once a final version was generated, the student provided the veteran with printed copies and offered to place the story in the Computerized Patient Record System (CPRS).

Near the end of their rotation, students attended a 1-hour small group session in which they shared reflections on the experience of collecting a life story, the impact of veterans’ life experiences on their health and illness, and moments when students confronted their own stereotypes and implicit biases. Students then reviewed narrative medicine skills that are generalizable to all patient interactions.

COVID-19-Related Adaptation

In March 2020, shortly after the second student cohort began, medical students were removed from the clinical setting in response to the COVID-19 pandemic. The 8-week clerkship was converted to a 3-week remote learning rotation. The MLMS experience was preserved by converting small group sessions to videoconferences and expanding the pool of eligible patients to include veterans who students had met on prior rotations, current inpatients, and outpatients from VA primary care clinics. Students contacted veterans after an instructor had introduced MLMS to the veteran and confirmed that the veteran was interested in participating.

Students in the second and third cohorts completed a telephone-based iteration of MLMS in which interviews and life story reviews were conducted over the telephone and printed copies mailed to the veteran. For the fourth, fifth, and sixth cohorts, MLMS was transitioned to a video-based program with inpatients. Instructors collaborated with a volunteer group supplying tablet devices to inpatients to make video calls to their families during the pandemic.¹⁴ Clerkship students coordinated with that volunteer group to interview veterans and review their stories through the tablet devices.

From July to December 2020 medical students returned to 4-week on-site clinical rotations at the SFVAMC. The program returned to the original format for cohorts 7 to 10, with students attending in-person small group sessions and conducting in-person interviews with inpatients.

Curriculum Evaluation

Students completed surveys in the week after the curriculum concluded. Survey completion was voluntary, anonymous, and had no bearing on their evaluation or grade (pass/fail only). Likert scale questions (1, strongly disagree; 5, strongly agree) were used to assess the program (eAppendix 1). One-way analysis of variance testing was used to compare means stratified by method of interview (in person, telephone, or video). Surveys also included free-response questions asking students to highlight aspects of the program they valued or would change; responses were summarized by theme. This program evaluation was deemed exempt from review by the UCSF Human Research Protection Program Institutional Review Board.

Sixty-two veteran stories were collected by 54 participating students (one student was unable to complete an interview, while several students completed multiple interviews). Fifty-four (87%) veterans requested their stories be entered into the medical record.

All 54 students completed the survey. Students reported that the MLMS curriculum helped them develop new skills for eliciting and recording a life story (mean [SD] 4.5 [0.7]). Most students strongly agreed that MLMS helped them understand how sharing a life story can impact a veteran’s experience of receiving health care, with a mean (SD) score of 4.8 (0.4). After completing MLMS, students also reported a better understanding of the mission of the VA and veteran demographics with a mean (SD) score of 4.4 (0.7) and 4.3 (0.7), respectively. Stratification of survey responses by method of interview (in person, telephone, or video) revealed no statistically significant differences in evaluations (Table 1).

Discussion

Previous research has demonstrated that a narrative medicine curriculum can help medicine clerkship students develop narrative competence through patient storytelling with a focus on a patient’s illness narrative.¹⁵ The VA MLMS program extends the patient narrative beyond health care–related experiences and encompasses their broader life story. This article adds to the MLMS and narrative medicine literature by demonstrating that the efficacy of teaching patient-centered care to medical trainees through direct interviews can be maintained in remote formats.⁹ The article also provides guidance for MLMS programs that wish to conduct remote veteran interviews.

The widespread adoption of telemedicine will require trainees to develop communication skills to establish therapeutic relationships with patients both face-to-face and through videoconferencing. In order to promote this important skill across varying levels of physical distancing, narrative medicine programs should be adaptable to a virtual learning environment. As we redesigned MLMS for the remote setting, we learned several key lessons that can guide similar curricular and programmatic innovations at other institutions. For example, videoconferencing created stronger connections between the students and veterans than telephone calls. However, tablet-based video interviews also introduced many technological challenges and required on-site personnel (nurses and volunteers) to connect students, veterans, and technology. Solutions for technology and communication challenges related to the basic personnel and infrastructure needed to start and maintain a remote MLMS program are outlined in Table 2.

Limitations

Limitations of this study include the participation of trainees from a single institution and a lack of assessment of the impact of MLMS on veterans. Future research could assess whether life story skills and practices are maintained after the medicine clerkship. In addition, future studies could examine veterans’ perspectives through interviews with qualitative analysis to learn how MLMS affected their experience of receiving health care.

Conclusions

This is the first report of a remote-capable life story curriculum for medical students. Shifting to a virtual MLMS curriculum requires protocols and people to link interviewers, veterans, and technology. Training for in-person interactions while being prepared for remote interviewing is essential to ensure that the MLMS experience remains available to interviewers and veterans who otherwise may never have the chance to connect. The restrictions and isolation of the COVID-19 pandemic will fade, but using MLMS to virtually connect patients, providers, and students will remain an important capability and opportunity as health care shifts to more virtual interaction.

Acknowledgments

The authors thank Emma Levine, MD, for her assistance coordinating video interviews; Thor Ringler, MS, MFA, for his assistance with manuscript review; and the veterans of the San Francisco VA Health Care System for sharing their stories.

Narrative competence is the ability to acquire, interpret, and act on the stories of others.¹ Developing this skill through guided medical storytelling can improve health care practitioners’ (HCPs) sense of empathy and satisfaction with their work.² Narrative medicine experiences for medical students can foster a deeper understanding of their patients beyond illness-associated identities.³

Within narrative medicine, the “life story” is a specific technique that allows patients to share experiences through open-ended interviews that are entered into the health record.^4,5 By sharing life stories, patients control a narrative encompassing more than their illness and can reinforce a sense of purpose in their lives.⁶ The US Department of Veterans Affairs (VA) My Life My Story (MLMS) program gives veterans the opportunity to share their narrative with staff and volunteer interviewers. MLMS is well received by veterans, has durable positive effects for HCPs who read the stories, and has been used as a tool to teach patient-centered care to medical trainees.^7-9

We created a narrative medicine curriculum at the San Francisco VA Medical Center (SFVAMC) in which medical students interviewed veterans for the MLMS program. Medical students initially collected life stories through in-person conversation. During the COVID-19 pandemic, physical distancing regulations limited direct patient interaction for students and prompted a switch to phone and video interviews. This shift paralleled the widespread adoption of telehealth, which will persist beyond the pandemic and require teachers and learners to develop competency in forming personal connections with patients through videoconferencing.^10,11

There are no published studies describing how to guide medical students (or other historians) in generating life stories without in-person patient contact. This article details the design of a medical student curriculum incorporating MLMS and the transition to remote interaction between instructors, students, and veterans during the early COVID-19 pandemic.

MLMS Program Origins

The MLMS project began at the William S. Middleton Memorial Veterans Hospital in Madison, Wisconsin, in 2013 with staff and volunteer interviewers and has expanded to more than 60 VA facilities.⁷ In January 2020, we initiated a narrative medicine curriculum incorporating MLMS at the SFVAMC as a required component of a third-year internal medicine clerkship for medical students at the University of California San Francisco (UCSF). Fifty-four medical students in 10 cohorts participated in the curriculum in 2020. The primary program objectives were for medical students to develop skills for eliciting and recording a life story and to appreciate the impact of this activity on a veteran’s experience of receiving health care. Secondary objectives were for students to understand the mission of the VA health care system and veteran demographics.

The first cohort of 6 UCSF medical students participated in MLMS during their 8-week VA clerkship. Students attended a 1-hour small group session to introduce the program and build narrative medicine skills. Preparation for this session involved listening to 2 podcast episodes introducing the VA health care system and MLMS.^12,13 The session began with a short interactive discussion of veteran demographics with an emphasis on addressing assumptions students might have about the veteran population. Students were taught strategies for engaging in open-ended conversations without emphasizing illness. Each student practiced collecting a life story with a simulated patient portrayed by an instructor and received feedback from classmates and instructors.

Over the following weeks, students selected a hospitalized veteran, typically a patient they were caring for, introduced MLMS, and obtained verbal consent to participate. They conducted a 60- to 90-minute interview, wrote and organized the life story, read it to the veteran, and solicited edits. Once a final version was generated, the student provided the veteran with printed copies and offered to place the story in the Computerized Patient Record System (CPRS).

Near the end of their rotation, students attended a 1-hour small group session in which they shared reflections on the experience of collecting a life story, the impact of veterans’ life experiences on their health and illness, and moments when students confronted their own stereotypes and implicit biases. Students then reviewed narrative medicine skills that are generalizable to all patient interactions.

COVID-19-Related Adaptation

In March 2020, shortly after the second student cohort began, medical students were removed from the clinical setting in response to the COVID-19 pandemic. The 8-week clerkship was converted to a 3-week remote learning rotation. The MLMS experience was preserved by converting small group sessions to videoconferences and expanding the pool of eligible patients to include veterans who students had met on prior rotations, current inpatients, and outpatients from VA primary care clinics. Students contacted veterans after an instructor had introduced MLMS to the veteran and confirmed that the veteran was interested in participating.

Students in the second and third cohorts completed a telephone-based iteration of MLMS in which interviews and life story reviews were conducted over the telephone and printed copies mailed to the veteran. For the fourth, fifth, and sixth cohorts, MLMS was transitioned to a video-based program with inpatients. Instructors collaborated with a volunteer group supplying tablet devices to inpatients to make video calls to their families during the pandemic.¹⁴ Clerkship students coordinated with that volunteer group to interview veterans and review their stories through the tablet devices.

From July to December 2020 medical students returned to 4-week on-site clinical rotations at the SFVAMC. The program returned to the original format for cohorts 7 to 10, with students attending in-person small group sessions and conducting in-person interviews with inpatients.

Curriculum Evaluation

Students completed surveys in the week after the curriculum concluded. Survey completion was voluntary, anonymous, and had no bearing on their evaluation or grade (pass/fail only). Likert scale questions (1, strongly disagree; 5, strongly agree) were used to assess the program (eAppendix 1). One-way analysis of variance testing was used to compare means stratified by method of interview (in person, telephone, or video). Surveys also included free-response questions asking students to highlight aspects of the program they valued or would change; responses were summarized by theme. This program evaluation was deemed exempt from review by the UCSF Human Research Protection Program Institutional Review Board.

Sixty-two veteran stories were collected by 54 participating students (one student was unable to complete an interview, while several students completed multiple interviews). Fifty-four (87%) veterans requested their stories be entered into the medical record.

All 54 students completed the survey. Students reported that the MLMS curriculum helped them develop new skills for eliciting and recording a life story (mean [SD] 4.5 [0.7]). Most students strongly agreed that MLMS helped them understand how sharing a life story can impact a veteran’s experience of receiving health care, with a mean (SD) score of 4.8 (0.4). After completing MLMS, students also reported a better understanding of the mission of the VA and veteran demographics with a mean (SD) score of 4.4 (0.7) and 4.3 (0.7), respectively. Stratification of survey responses by method of interview (in person, telephone, or video) revealed no statistically significant differences in evaluations (Table 1).

Discussion

Previous research has demonstrated that a narrative medicine curriculum can help medicine clerkship students develop narrative competence through patient storytelling with a focus on a patient’s illness narrative.¹⁵ The VA MLMS program extends the patient narrative beyond health care–related experiences and encompasses their broader life story. This article adds to the MLMS and narrative medicine literature by demonstrating that the efficacy of teaching patient-centered care to medical trainees through direct interviews can be maintained in remote formats.⁹ The article also provides guidance for MLMS programs that wish to conduct remote veteran interviews.

The widespread adoption of telemedicine will require trainees to develop communication skills to establish therapeutic relationships with patients both face-to-face and through videoconferencing. In order to promote this important skill across varying levels of physical distancing, narrative medicine programs should be adaptable to a virtual learning environment. As we redesigned MLMS for the remote setting, we learned several key lessons that can guide similar curricular and programmatic innovations at other institutions. For example, videoconferencing created stronger connections between the students and veterans than telephone calls. However, tablet-based video interviews also introduced many technological challenges and required on-site personnel (nurses and volunteers) to connect students, veterans, and technology. Solutions for technology and communication challenges related to the basic personnel and infrastructure needed to start and maintain a remote MLMS program are outlined in Table 2.

Limitations

Limitations of this study include the participation of trainees from a single institution and a lack of assessment of the impact of MLMS on veterans. Future research could assess whether life story skills and practices are maintained after the medicine clerkship. In addition, future studies could examine veterans’ perspectives through interviews with qualitative analysis to learn how MLMS affected their experience of receiving health care.

Conclusions

This is the first report of a remote-capable life story curriculum for medical students. Shifting to a virtual MLMS curriculum requires protocols and people to link interviewers, veterans, and technology. Training for in-person interactions while being prepared for remote interviewing is essential to ensure that the MLMS experience remains available to interviewers and veterans who otherwise may never have the chance to connect. The restrictions and isolation of the COVID-19 pandemic will fade, but using MLMS to virtually connect patients, providers, and students will remain an important capability and opportunity as health care shifts to more virtual interaction.

Acknowledgments

The authors thank Emma Levine, MD, for her assistance coordinating video interviews; Thor Ringler, MS, MFA, for his assistance with manuscript review; and the veterans of the San Francisco VA Health Care System for sharing their stories.

Narrative competence is the ability to acquire, interpret, and act on the stories of others.¹ Developing this skill through guided medical storytelling can improve health care practitioners’ (HCPs) sense of empathy and satisfaction with their work.² Narrative medicine experiences for medical students can foster a deeper understanding of their patients beyond illness-associated identities.³

Within narrative medicine, the “life story” is a specific technique that allows patients to share experiences through open-ended interviews that are entered into the health record.^4,5 By sharing life stories, patients control a narrative encompassing more than their illness and can reinforce a sense of purpose in their lives.⁶ The US Department of Veterans Affairs (VA) My Life My Story (MLMS) program gives veterans the opportunity to share their narrative with staff and volunteer interviewers. MLMS is well received by veterans, has durable positive effects for HCPs who read the stories, and has been used as a tool to teach patient-centered care to medical trainees.^7-9

We created a narrative medicine curriculum at the San Francisco VA Medical Center (SFVAMC) in which medical students interviewed veterans for the MLMS program. Medical students initially collected life stories through in-person conversation. During the COVID-19 pandemic, physical distancing regulations limited direct patient interaction for students and prompted a switch to phone and video interviews. This shift paralleled the widespread adoption of telehealth, which will persist beyond the pandemic and require teachers and learners to develop competency in forming personal connections with patients through videoconferencing.^10,11

There are no published studies describing how to guide medical students (or other historians) in generating life stories without in-person patient contact. This article details the design of a medical student curriculum incorporating MLMS and the transition to remote interaction between instructors, students, and veterans during the early COVID-19 pandemic.

MLMS Program Origins

The MLMS project began at the William S. Middleton Memorial Veterans Hospital in Madison, Wisconsin, in 2013 with staff and volunteer interviewers and has expanded to more than 60 VA facilities.⁷ In January 2020, we initiated a narrative medicine curriculum incorporating MLMS at the SFVAMC as a required component of a third-year internal medicine clerkship for medical students at the University of California San Francisco (UCSF). Fifty-four medical students in 10 cohorts participated in the curriculum in 2020. The primary program objectives were for medical students to develop skills for eliciting and recording a life story and to appreciate the impact of this activity on a veteran’s experience of receiving health care. Secondary objectives were for students to understand the mission of the VA health care system and veteran demographics.

The first cohort of 6 UCSF medical students participated in MLMS during their 8-week VA clerkship. Students attended a 1-hour small group session to introduce the program and build narrative medicine skills. Preparation for this session involved listening to 2 podcast episodes introducing the VA health care system and MLMS.^12,13 The session began with a short interactive discussion of veteran demographics with an emphasis on addressing assumptions students might have about the veteran population. Students were taught strategies for engaging in open-ended conversations without emphasizing illness. Each student practiced collecting a life story with a simulated patient portrayed by an instructor and received feedback from classmates and instructors.

Over the following weeks, students selected a hospitalized veteran, typically a patient they were caring for, introduced MLMS, and obtained verbal consent to participate. They conducted a 60- to 90-minute interview, wrote and organized the life story, read it to the veteran, and solicited edits. Once a final version was generated, the student provided the veteran with printed copies and offered to place the story in the Computerized Patient Record System (CPRS).

Near the end of their rotation, students attended a 1-hour small group session in which they shared reflections on the experience of collecting a life story, the impact of veterans’ life experiences on their health and illness, and moments when students confronted their own stereotypes and implicit biases. Students then reviewed narrative medicine skills that are generalizable to all patient interactions.

COVID-19-Related Adaptation

In March 2020, shortly after the second student cohort began, medical students were removed from the clinical setting in response to the COVID-19 pandemic. The 8-week clerkship was converted to a 3-week remote learning rotation. The MLMS experience was preserved by converting small group sessions to videoconferences and expanding the pool of eligible patients to include veterans who students had met on prior rotations, current inpatients, and outpatients from VA primary care clinics. Students contacted veterans after an instructor had introduced MLMS to the veteran and confirmed that the veteran was interested in participating.

Students in the second and third cohorts completed a telephone-based iteration of MLMS in which interviews and life story reviews were conducted over the telephone and printed copies mailed to the veteran. For the fourth, fifth, and sixth cohorts, MLMS was transitioned to a video-based program with inpatients. Instructors collaborated with a volunteer group supplying tablet devices to inpatients to make video calls to their families during the pandemic.¹⁴ Clerkship students coordinated with that volunteer group to interview veterans and review their stories through the tablet devices.

From July to December 2020 medical students returned to 4-week on-site clinical rotations at the SFVAMC. The program returned to the original format for cohorts 7 to 10, with students attending in-person small group sessions and conducting in-person interviews with inpatients.

Curriculum Evaluation

Students completed surveys in the week after the curriculum concluded. Survey completion was voluntary, anonymous, and had no bearing on their evaluation or grade (pass/fail only). Likert scale questions (1, strongly disagree; 5, strongly agree) were used to assess the program (eAppendix 1). One-way analysis of variance testing was used to compare means stratified by method of interview (in person, telephone, or video). Surveys also included free-response questions asking students to highlight aspects of the program they valued or would change; responses were summarized by theme. This program evaluation was deemed exempt from review by the UCSF Human Research Protection Program Institutional Review Board.

Sixty-two veteran stories were collected by 54 participating students (one student was unable to complete an interview, while several students completed multiple interviews). Fifty-four (87%) veterans requested their stories be entered into the medical record.

All 54 students completed the survey. Students reported that the MLMS curriculum helped them develop new skills for eliciting and recording a life story (mean [SD] 4.5 [0.7]). Most students strongly agreed that MLMS helped them understand how sharing a life story can impact a veteran’s experience of receiving health care, with a mean (SD) score of 4.8 (0.4). After completing MLMS, students also reported a better understanding of the mission of the VA and veteran demographics with a mean (SD) score of 4.4 (0.7) and 4.3 (0.7), respectively. Stratification of survey responses by method of interview (in person, telephone, or video) revealed no statistically significant differences in evaluations (Table 1).

Discussion

Previous research has demonstrated that a narrative medicine curriculum can help medicine clerkship students develop narrative competence through patient storytelling with a focus on a patient’s illness narrative.¹⁵ The VA MLMS program extends the patient narrative beyond health care–related experiences and encompasses their broader life story. This article adds to the MLMS and narrative medicine literature by demonstrating that the efficacy of teaching patient-centered care to medical trainees through direct interviews can be maintained in remote formats.⁹ The article also provides guidance for MLMS programs that wish to conduct remote veteran interviews.

The widespread adoption of telemedicine will require trainees to develop communication skills to establish therapeutic relationships with patients both face-to-face and through videoconferencing. In order to promote this important skill across varying levels of physical distancing, narrative medicine programs should be adaptable to a virtual learning environment. As we redesigned MLMS for the remote setting, we learned several key lessons that can guide similar curricular and programmatic innovations at other institutions. For example, videoconferencing created stronger connections between the students and veterans than telephone calls. However, tablet-based video interviews also introduced many technological challenges and required on-site personnel (nurses and volunteers) to connect students, veterans, and technology. Solutions for technology and communication challenges related to the basic personnel and infrastructure needed to start and maintain a remote MLMS program are outlined in Table 2.

Limitations

Limitations of this study include the participation of trainees from a single institution and a lack of assessment of the impact of MLMS on veterans. Future research could assess whether life story skills and practices are maintained after the medicine clerkship. In addition, future studies could examine veterans’ perspectives through interviews with qualitative analysis to learn how MLMS affected their experience of receiving health care.

Conclusions

This is the first report of a remote-capable life story curriculum for medical students. Shifting to a virtual MLMS curriculum requires protocols and people to link interviewers, veterans, and technology. Training for in-person interactions while being prepared for remote interviewing is essential to ensure that the MLMS experience remains available to interviewers and veterans who otherwise may never have the chance to connect. The restrictions and isolation of the COVID-19 pandemic will fade, but using MLMS to virtually connect patients, providers, and students will remain an important capability and opportunity as health care shifts to more virtual interaction.

Acknowledgments

The authors thank Emma Levine, MD, for her assistance coordinating video interviews; Thor Ringler, MS, MFA, for his assistance with manuscript review; and the veterans of the San Francisco VA Health Care System for sharing their stories.