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Implementation of a Process for Initiating Naltrexone in Patients Hospitalized for Alcohol Detoxification or Withdrawal
Alcohol use disorders (AUDs) are common, with an estimated lifetime prevalence of 17.8% for alcohol dependence.1 Alcohol misuse is costly, accounting for $24.6 billion in annual healthcare expenditures, including $5.1 billion for alcohol-related hospitalizations.2 A number of trials have demonstrated that naltrexone can help patients with AUDs maintain abstinence or diminish heavy drinking.3-10 A recent meta-analysis of pharmacotherapy trials for patients with AUDs reported that for patients using 50 mg of naltrexone daily, the number needed to treat was 12 to prevent a return to heavy drinking and 20 to prevent a return to any drinking.11 Despite good evidence for its effectiveness, naltrexone is not prescribed to the majority of patients with AUDs. In a study of veterans with AUDs cared for in the Veterans Affairs health system, only 1.9% of patients were prescribed naltrexone over the 6-month study period.12 A 2003 survey of 2 professional organizations for addiction treatment specialists reported that a mean of 13% of providers prescribed naltrexone to their patients.13
When naltrexone is prescribed, it is most frequently in the outpatient setting.3-10 Data for initiation of naltrexone in the inpatient setting are more limited. Wei et al.14 reported on the implementation of a discharge protocol, including counseling about naltrexone, for hospitalized patients with AUDs at an urban academic medical center. They reported a significant increase in the prescription of naltrexone to eligible patients by the time of discharge that was associated with a significant decrease in 30-day readmissions. Initiation of naltrexone in the inpatient versus the outpatient setting has some potential advantages. First, patients hospitalized for alcohol withdrawal have AUDs, obviating the need for screening. Second, the outpatient trials of naltrexone typically required 3 days of sobriety before initiation, which is generally achieved during hospitalization for detoxification or withdrawal.
Previous work at our institution centered on standardizing the process of evaluating patients needing alcohol detoxification at the time of referral for admission.15 The use of a standardized protocol reduced the number of inpatient admissions for alcohol-related diagnoses but had no effect on the 30-day readmission rate (28%) for those patients who were hospitalized. Our hospitalist group had no standardized process for discharging hospitalized patients with AUDs, and the discharge process rarely included counseling on medications for maintenance of sobriety. In this manuscript, we describe the implementation and impact of a process for counseling patients hospitalized for alcohol detoxification or withdrawal about naltrexone for maintenance of sobriety by the time of hospital discharge.
METHODS
Study Setting
The University of North Carolina (UNC) Hospitals is an 803-bed tertiary academic center. UNC Hospital Medicine is staffed by 29 physicians and 3 advanced practice providers (APPs). During the study period, there were 3 hospital medicine services at UNC Hospitals with a combined average daily census of approximately 40 patients, and each service was staffed by one attending physician every day of the week and one APP Monday through Friday.
Study Design
We used a pre-post study design, in which we implemented a new process for standardizing the discharge of hospitalized patients with AUDs, including a process for counseling about naltrexone by the time of discharge. We sought and received institutional review board (IRB) approval for this study (UNC IRB 15-1441).
Interventions
We formed an improvement team that included 3 physicians and an APP in hospital medicine, a general internist and a psychiatrist, both with expertise in the use of medications for maintenance of sobriety, the director of UNC’s Alcohol and Substance Abuse Program, and 2 case managers. The team developed a number of interventions, including group education, a process for patient identification, and algorithms for counseling about, prescribing, and documenting the discussion of naltrexone.
Group Education
We presented evidence about medications for the maintenance of sobriety at a regularly scheduled hospitalist meeting. An hour-long session on motivational interviewing techniques was also presented at a separate meeting. All created algorithms were circulated to the group electronically and posted at workstations in the hospitalist work area. As data were generated postimplementation, control charts of process measures were created, posted in the hospitalist work area, and presented at subsequent group meetings.
Identification of Patients
We focused our interventions on patients admitted for alcohol detoxification or withdrawal (including withdrawal seizures). We asked our group to preferentially admit these patients to 1 of our 3 hospitalists services, on which the service APP (K.S.) was also an improvement team member.
Creation of Algorithms and Scripts for Counseling
We created a simple algorithm for evaluating patients for naltrexone. We recommended that all patients admitted for alcohol detoxification or withdrawal be counseled about naltrexone for the maintenance of sobriety before discharge. The contraindications to naltrexone we included were (1) concurrent opioid use, (2) documented cirrhosis, and/or (3) liver function tests greater than 3 times the upper limit of normal by the time of hospital discharge.
We also created a suggested script for motivational interviewing (supplemental Appendix 1). This was presented at a group meeting and circulated via e-mail. The actual counseling technique and process was left up to individual providers. In practice, counseling took place in the course of daily rounds, generally the day before or day of hospital discharge.
Prescription of Medication
For interested patients without contraindications, we recommended a prescription of naltrexone at 50 mg daily for 3 months. For patients prescribed naltrexone without medical insurance (n = 17), we utilized our existing pharmacy assistance program, whereby discharging patients can obtain an initial 14-day supply after applying to the program and then can fill subsequent prescriptions if they meet program financial requirements.
Follow-up Appointments
For patients with established outpatient providers, we asked patients to schedule follow-up appointments within a month of discharge. Patients prescribed naltrexone without primary providers (n = 16) were eligible for an existing program, the UNC Transitions Program, whereby patients identified as having moderate-to-high risk of hospital readmission can receive a follow-up appointment at UNC Internal Medicine or UNC Family Medicine within 2 weeks of discharge.
Creation of “Smart Phrases”
To aid in documentation, we created “smart phrases” (easily accessed, previously created phrases that can be adopted by all users) within the hospital electronic health record. We created one smart phrase for documentation of counseling about naltrexone, which included dropdown menus for contraindications and the patient’s preference and one for discharge instructions for patients started on naltrexone (supplemental Appendix 2).
Implementation
After the presentation of suggested interventions in July 2015 and the subsequent dissemination of educational materials, we implemented our new process on August 1, 2015.
Data Collection
Patients were identified for inclusion in the study analysis by querying UNC Hospitals’ billing database for the inpatient diagnosis codes (diagnosis-related groupings) 896 and 897, “alcohol/drug abuse or dependence without rehabilitation therapy,” with and without major comorbidity or complication, respectively, and with hospital medicine as the discharging service. All encounters were then manually reviewed by 2 investigators (J.S. and C.M.). Encounters were included if the history and physical indicated that the primary reason for admission was alcohol detoxification or withdrawal. Encounters with other primary reasons for admission (eg, pancreatitis, gastrointestinal bleeding) were excluded. For patients with multiple encounters, only the first eligible encounter in the pre- and/or postimplementation period was included. Comorbidities for identified patients were assessed via the search of study encounters for the International Classification of Diseases, 9th Revision-Clinical Modification codes for hypertension, anxiety, depression, cirrhosis, diabetes, and congestive heart failure.
Process, Outcomes, and Balancing Measures
The study process measures included the percentage of patients hospitalized for alcohol detoxification or withdrawal with documentation of counseling about naltrexone by the time of discharge, before and after process intervention. Documentation was defined as the description of counseling about naltrexone in the discharge summary or progress notes of identified encounters. We also measured the percentage of patients started on naltrexone before and after intervention. Lastly, we measured the percentage of patients prescribed naltrexone who filled at least 1 prescription for the medication, assessed by calls to the pharmacy where the medication was prescribed. Prescriptions that could not be confirmed (ie, paper rather than electronic prescriptions) were counted as not filled.
For outcome measures, we recorded the percentages of study patients who returned to the emergency department (ED) and were readmitted to UNC Hospitals (inpatient or observation) for any reason within 30 days of discharge. These outcomes were determined by a manual chart review.
In order to ensure the new process was not associated with delays in patient discharge, we measured the mean length of stay in days for study patient encounters before and after intervention as a balancing measure.
Statistical Analysis
Demographic and clinical characteristics for included patients were compared for the 16 months preimplementation (April 1, 2014 through July 31, 2015) and the 19 months postimplementation (August 1, 2015 through February 28, 2017). Descriptive statistics were calculated by using the Student t test for continuous variables and the χ2 test for dichotomous variables. We used multivariate logistic regression to evaluate the associations between the intervention arms (pre- vs postintervention) and study outcomes, adjusting for age, gender, race, insurance type, and medical comorbidities. We chose these variables for inclusion based on their association with study outcomes at the P ≤ .20 level in bivariate analyses. P < .05 was considered statistically significant. All analyses were performed by using Stata version 13.1 (StataCorp LLC, College Station, TX).
For 2 process measures, the percentages of patients counseled about and started on naltrexone, we plotted consecutive samples of 10 patients before and after intervention on a control chart, using preintervention data to calculate means and control limits.
Subgroup Analysis
We used multivariate logistic regression to evaluate the associations between counseling versus no counseling and prescription of naltrexone versus no prescription for study outcomes in the postintervention subgroup, adjusting for age, gender, race, insurance type, and medical comorbidities.
RESULTS
Patients
We identified 188 preimplementation encounters and excluded 12 patients (6.4%) for primary admission reasons other than alcohol withdrawal or detoxification and 48 (25.5%) repeat hospitalizations, leaving 128 unique patient encounters. We identified 166 postimplementation encounters and excluded 25 (15.1%) hospitalizations for admission reason and 27 repeat hospitalizations (16.3%), leaving 114 unique patient encounters (flow diagram in supplemental Appendix 3). The most common admission reason for the exclusion of encounters was withdrawal from a substance other than alcohol (supplemental Appendix 4). The percentages of encounters excluded in preimplementation and postimplementation periods were similar at 31.9% and 31.4%, respectively.
The majority of patients were male and white, and almost half were uninsured (Table 1). There were no demographic differences between patients in the pre- versus postimplementation groups. For studied comorbidities, postintervention patients were more likely to have hypertension, anxiety, and depression.
Process Measures
Among those counseled about naltrexone before discharge, 34 of 74 patients (45.9%) had no contraindications to naltrexone and were interested in taking the medication. Among the 40 patients who were counseled about but not prescribed naltrexone, 19 (47.5%) declined, 9 (22.5%) had liver function tests elevated more than 3 times the upper limit of the reference range, 9 (22.5%) had concurrent opiate use, and 3 (7.5%) had multiple contraindications.
Among the 34 patients who were prescribed naltrexone, 25 (73.5%) filled at least 1 prescription as confirmed by phone call to the relevant pharmacy.
Outcome Measures
Subgroup Analysis
Balancing Measure
The mean length of stay for all patient encounters was 3.3 days. There were no differences in length of stay comparing pre- with postintervention patient encounters (Table 1) or those postintervention patients counseled versus not counseled (Table 2).
DISCUSSION
Our study demonstrates that counseling about medications for the maintenance of sobriety can be implemented as part of the routine care of hospitalized patients with AUDs. In our experience, about half of the patients counseled had no contraindications to naltrexone and were willing to take it at discharge. Almost three-fourths of those who were prescribed naltrexone filled the prescription at least once. The counseling process was not associated with increased length of stay. In the adjusted analysis, postintervention patients had significantly lower odds of 30-day ED returns. Additionally, in subgroup analysis, postintervention patients counseled about naltrexone had significantly lower rates of subsequent healthcare utilization compared with those not counseled, with absolute differences of 26% for ED revisits and 22% for rehospitalizations within 30 days.
The failure to demonstrate a difference in adjusted rehospitalization rates in the postintervention versus the preintervention group has several possible explanations. First, we had incomplete fidelity to our interventions, documenting counseling about naltrexone before discharge in over 60% of postintervention patients, raising the possibility that better fidelity may have resulted in improved outcomes. Related to this, only 28% of postintervention patients were prescribed naltrexone, which may be an inadequate sample size to demonstrate positive effects from the medication. Another possible explanation is that the postintervention group had higher rates of some of the comorbidities we assessed, namely, anxiety, depression, and hypertension, which could have negatively impacted the effectiveness of the interventions to prevent rehospitalization; however, after adjusting for comorbidities, the odds of rehospitalization were still not significantly different. It is interesting that the odds of postintervention ED revisits (but not rehospitalizations) were lower in the adjusted analysis. It may be that patients who revisit the ED and are not rehospitalized are different in important ways from those who are readmitted. Alternately, the larger number of ED revisits overall (about twice the rate of rehospitalization) may have made it easier to identify positive effects from the intervention for this outcome than rehospitalization (ie, the study may have been underpowered to detect a relatively small reduction in rehospitalization). It is also possible, however, that the interventions were simply insufficient to prevent rehospitalization.
The subgroup analysis, however, did find significant differences in both outcome measures for postintervention patients counseled versus not counseled about naltrexone before discharge. There are several possible explanations for these results. First, there may have been unmeasured differences in those counseled versus not counseled that explain the reductions observed in subsequent healthcare utilization. For example, the counseled patients could have been more motivated to change and, thus, more readily approached by providers for counseling. The lack of any demographic differences between the 2 groups and the relative simplicity of the counseling part of the intervention occurring as part of daily rounds argue against this hypothesis, but there are many potential unmeasured confounders (eg, homelessness, ability to afford medications), and this possibility remains. A second possible explanation is that patients counseled about naltrexone could have been more likely than those not counseled to seek subsequent care at other institutions. A third possibility is that that the counseling about (and prescribing when appropriate) naltrexone itself led to the observed decreases in subsequent ED visits and hospitalizations. This hypothesis would have been more supported had we been able to demonstrate a statistically significant reduction in healthcare utilization in those prescribed versus not prescribed naltrexone. But there were nonsignificant trends in the reduction of ED revisits and rehospitalizations among those prescribed the medication, suggesting we may have been able to demonstrate statistically significant reductions with a larger sample size.
Comparing our results with existing literature is challenging. The majority of randomized trials of naltrexone for AUDs were conducted in the outpatient setting.3-10 Most of these trials utilized some type of psychosocial intervention in addition to naltrexone.3-5,8-10 The 1 prior naltrexone study we identified conducted in the inpatient setting by Wei et al.14 is the most similar to our study. The authors reported the effects of a new process for assessing hospitalized patients with AUDs, including the use of a discharge planning tool for all patients admitted with alcohol dependence. The discharge tool included prompts for naltrexone in appropriate patients. The measured outcomes included the percentage of eligible patients prescribed naltrexone at discharge and the percentages of ED revisits and rehospitalizations within 30 days. Postintervention, 64% of eligible patients were prescribed naltrexone compared with 0% before, very similar to our results. There were significant decreases among all discharged patients with alcohol dependence for 30-day ED revisits (18.8% pre- vs 6.1% postimplementation) and rehospitalizations (23.4% vs 8.2%). The study differed from ours in a number of important respects, including a location in a large urban setting and implementation on a teaching service rather than an attending-only hospitalist service. Additionally, the authors studied 1 month of process implementation and compared it to another month 1 year before the new process, with an overall smaller sample size of 64 patients before and 49 patients after implementation. Potential reasons why Wei et al.14 were able to document lower rehospitalization rates postintervention when we did not include the differences in patient population (eg, high homeless rate, lower percentage of female patients in Wei study) and secular trends unrelated to interventions in either study.
Limitations of our study include the nonrandomized and uncontrolled design, which introduces the possibility of unmeasured confounding factors leading to the decrease we observed in healthcare utilization. Additionally, the single-center design precludes our ability to assess for healthcare utilization outcomes in other nearby facilities. We had incomplete implementation of our new process, counseling just over 60% of patients. As our primary outcomes relied on documentation in the medical record, both undersampling (not documenting some interventions) and reporting bias (being more likely to record positive sessions from intervention) are possible. Lastly, despite a moderate total sample size of almost 250 patients, the relatively small numbers of patients who were actually prescribed naltrexone in our study lessens our ability to show direct impact.
In conclusion, our study demonstrates a practical process for counseling about and prescribing naltrexone to patients hospitalized for alcohol detoxification or withdrawal. We demonstrate that many of these patients will be interested in starting naltrexone at discharge and will reliably fill the prescriptions if written. Counseling was associated with a significant reduction in subsequent healthcare utilization. These results have a wide potential impact given the ubiquitous nature of AUDs among hospitalized patients in community and academic settings.
Disclosure
The authors have no conflicts of interest relevant to this article to disclose. There were no sources of funding for this work.
1. Hasin DS, Stinson FS, Ogburn E, Grant BF. Prevalence, correlates, disability, and comorbidity of DSM-IV alcohol abuse and dependence in the United States: results from the National Epidemiologic Survey on Alcohol and Related Conditions. Arch Gen Psychiatry. 2007;64(7):830-842. PubMed
2. Bouchery EE, Harwood HJ, Sacks JJ, Simon CJ, Brewer RD. Economic costs of excessive alcohol consumption in the U.S., 2006. Am J Prev Med. 2011;41(5):516-524. PubMed
3. Anton RF, Moak DH, Waid LR, Latham PK, Malcolm RJ, Dias JK. Naltrexone and cognitive behavioral therapy for the treatment of outpatient alcoholics: results of a placebo-controlled trial. Am J Psychiatry. 1999;156(11):1758-1764. PubMed
4. Anton RF, Moak DH, Latham P, et al. Naltrexone combined with either cognitive behavioral or motivational enhancement therapy for alcohol dependence. J Clin Psychopharmacol. 2005;25(4):349-357. PubMed
5. Guardia J, Caso C, Arias F, et al. A double-blind, placebo-controlled study of naltrexone in the treatment of alcohol-dependence disorder: results from a multicenter clinical trial. Alcohol Clin Exp Res. 2002;26(9):1381-1387. PubMed
6. Kiefer F, Jahn H, Tarnaske T, et al. Comparing and combining naltrexone and acamprosate in relapse prevention of alcoholism: a double-blind, placebo-controlled study. Arch Gen Psychiatry. 2003;60(1):92-99. PubMed
7. Latt NC, Jurd S, Houseman J, Wutzke SE. Naltrexone in alcohol dependence: a randomised controlled trial of effectiveness in a standard clinical setting. Med J Aust. 2002;176(11):530-534. PubMed
8. Morris PL, Hopwood M, Whelan G, Gardiner J, Drummond E. Naltrexone for alcohol dependence: a randomized controlled trial. Addiction. 2001;96(11):1565-1573. PubMed
9. O’Malley SS, Jaffe AJ, Chang G, Schottenfeld RS, Meyer RE, Rounsaville B. Naltrexone and coping skills therapy for alcohol dependence. A controlled study. Arch Gen Psychiatry. 1992;49(11):881-887. PubMed
10. O’Malley SS, Robin RW, Levenson AL, et al. Naltrexone alone and with sertraline for the treatment of alcohol dependence in Alaska natives and non-natives residing in rural settings: a randomized controlled trial. Alcohol Clin Exp Res. 2008;32(7):1271-1283. PubMed
11. Jonas DE, Amick HR, Feltner C, et al. Pharmacotherapy for adults with alcohol use disorders in outpatient settings: a systematic review and meta-analysis. JAMA 2014;311(18):1889-1900. PubMed
12. Petrakis IL, Leslie D, Rosenheck R. Use of naltrexone in the treatment of alcoholism nationally in the Department of Veterans Affairs. Alcohol Clin Exp Res. 2003;27(11):1780-1784. PubMed
13. Mark TL, Kranzler HR, Song X. Understanding US addiction physicians’ low rate of naltrexone prescription. Drug Alcohol Depend. 2003;71(3):219-228. PubMed
14. Wei J, Defries T, Lozada M, Young N, Huen W, Tulsky J. An inpatient treatment and discharge planning protocol for alcohol dependence: efficacy in reducing 30-day readmissions and emergency department visits. J Gen Intern Med. 2015;30(3):365-370. PubMed
15. Stephens JR, Liles EA, Dancel R, Gilchrist M, Kirsch J, DeWalt DA. Who needs inpatient detox? Development and implementation of a hospitalist protocol for the evaluation of patients for alcohol detoxification. J Gen Intern Med. 2014;29(4):587-593. PubMed
16. Provost LP, Murray SK. The Health Care Data Guide: Learning from Data for Improvement. San Francisco: Jossey-Bass; 2011.
Alcohol use disorders (AUDs) are common, with an estimated lifetime prevalence of 17.8% for alcohol dependence.1 Alcohol misuse is costly, accounting for $24.6 billion in annual healthcare expenditures, including $5.1 billion for alcohol-related hospitalizations.2 A number of trials have demonstrated that naltrexone can help patients with AUDs maintain abstinence or diminish heavy drinking.3-10 A recent meta-analysis of pharmacotherapy trials for patients with AUDs reported that for patients using 50 mg of naltrexone daily, the number needed to treat was 12 to prevent a return to heavy drinking and 20 to prevent a return to any drinking.11 Despite good evidence for its effectiveness, naltrexone is not prescribed to the majority of patients with AUDs. In a study of veterans with AUDs cared for in the Veterans Affairs health system, only 1.9% of patients were prescribed naltrexone over the 6-month study period.12 A 2003 survey of 2 professional organizations for addiction treatment specialists reported that a mean of 13% of providers prescribed naltrexone to their patients.13
When naltrexone is prescribed, it is most frequently in the outpatient setting.3-10 Data for initiation of naltrexone in the inpatient setting are more limited. Wei et al.14 reported on the implementation of a discharge protocol, including counseling about naltrexone, for hospitalized patients with AUDs at an urban academic medical center. They reported a significant increase in the prescription of naltrexone to eligible patients by the time of discharge that was associated with a significant decrease in 30-day readmissions. Initiation of naltrexone in the inpatient versus the outpatient setting has some potential advantages. First, patients hospitalized for alcohol withdrawal have AUDs, obviating the need for screening. Second, the outpatient trials of naltrexone typically required 3 days of sobriety before initiation, which is generally achieved during hospitalization for detoxification or withdrawal.
Previous work at our institution centered on standardizing the process of evaluating patients needing alcohol detoxification at the time of referral for admission.15 The use of a standardized protocol reduced the number of inpatient admissions for alcohol-related diagnoses but had no effect on the 30-day readmission rate (28%) for those patients who were hospitalized. Our hospitalist group had no standardized process for discharging hospitalized patients with AUDs, and the discharge process rarely included counseling on medications for maintenance of sobriety. In this manuscript, we describe the implementation and impact of a process for counseling patients hospitalized for alcohol detoxification or withdrawal about naltrexone for maintenance of sobriety by the time of hospital discharge.
METHODS
Study Setting
The University of North Carolina (UNC) Hospitals is an 803-bed tertiary academic center. UNC Hospital Medicine is staffed by 29 physicians and 3 advanced practice providers (APPs). During the study period, there were 3 hospital medicine services at UNC Hospitals with a combined average daily census of approximately 40 patients, and each service was staffed by one attending physician every day of the week and one APP Monday through Friday.
Study Design
We used a pre-post study design, in which we implemented a new process for standardizing the discharge of hospitalized patients with AUDs, including a process for counseling about naltrexone by the time of discharge. We sought and received institutional review board (IRB) approval for this study (UNC IRB 15-1441).
Interventions
We formed an improvement team that included 3 physicians and an APP in hospital medicine, a general internist and a psychiatrist, both with expertise in the use of medications for maintenance of sobriety, the director of UNC’s Alcohol and Substance Abuse Program, and 2 case managers. The team developed a number of interventions, including group education, a process for patient identification, and algorithms for counseling about, prescribing, and documenting the discussion of naltrexone.
Group Education
We presented evidence about medications for the maintenance of sobriety at a regularly scheduled hospitalist meeting. An hour-long session on motivational interviewing techniques was also presented at a separate meeting. All created algorithms were circulated to the group electronically and posted at workstations in the hospitalist work area. As data were generated postimplementation, control charts of process measures were created, posted in the hospitalist work area, and presented at subsequent group meetings.
Identification of Patients
We focused our interventions on patients admitted for alcohol detoxification or withdrawal (including withdrawal seizures). We asked our group to preferentially admit these patients to 1 of our 3 hospitalists services, on which the service APP (K.S.) was also an improvement team member.
Creation of Algorithms and Scripts for Counseling
We created a simple algorithm for evaluating patients for naltrexone. We recommended that all patients admitted for alcohol detoxification or withdrawal be counseled about naltrexone for the maintenance of sobriety before discharge. The contraindications to naltrexone we included were (1) concurrent opioid use, (2) documented cirrhosis, and/or (3) liver function tests greater than 3 times the upper limit of normal by the time of hospital discharge.
We also created a suggested script for motivational interviewing (supplemental Appendix 1). This was presented at a group meeting and circulated via e-mail. The actual counseling technique and process was left up to individual providers. In practice, counseling took place in the course of daily rounds, generally the day before or day of hospital discharge.
Prescription of Medication
For interested patients without contraindications, we recommended a prescription of naltrexone at 50 mg daily for 3 months. For patients prescribed naltrexone without medical insurance (n = 17), we utilized our existing pharmacy assistance program, whereby discharging patients can obtain an initial 14-day supply after applying to the program and then can fill subsequent prescriptions if they meet program financial requirements.
Follow-up Appointments
For patients with established outpatient providers, we asked patients to schedule follow-up appointments within a month of discharge. Patients prescribed naltrexone without primary providers (n = 16) were eligible for an existing program, the UNC Transitions Program, whereby patients identified as having moderate-to-high risk of hospital readmission can receive a follow-up appointment at UNC Internal Medicine or UNC Family Medicine within 2 weeks of discharge.
Creation of “Smart Phrases”
To aid in documentation, we created “smart phrases” (easily accessed, previously created phrases that can be adopted by all users) within the hospital electronic health record. We created one smart phrase for documentation of counseling about naltrexone, which included dropdown menus for contraindications and the patient’s preference and one for discharge instructions for patients started on naltrexone (supplemental Appendix 2).
Implementation
After the presentation of suggested interventions in July 2015 and the subsequent dissemination of educational materials, we implemented our new process on August 1, 2015.
Data Collection
Patients were identified for inclusion in the study analysis by querying UNC Hospitals’ billing database for the inpatient diagnosis codes (diagnosis-related groupings) 896 and 897, “alcohol/drug abuse or dependence without rehabilitation therapy,” with and without major comorbidity or complication, respectively, and with hospital medicine as the discharging service. All encounters were then manually reviewed by 2 investigators (J.S. and C.M.). Encounters were included if the history and physical indicated that the primary reason for admission was alcohol detoxification or withdrawal. Encounters with other primary reasons for admission (eg, pancreatitis, gastrointestinal bleeding) were excluded. For patients with multiple encounters, only the first eligible encounter in the pre- and/or postimplementation period was included. Comorbidities for identified patients were assessed via the search of study encounters for the International Classification of Diseases, 9th Revision-Clinical Modification codes for hypertension, anxiety, depression, cirrhosis, diabetes, and congestive heart failure.
Process, Outcomes, and Balancing Measures
The study process measures included the percentage of patients hospitalized for alcohol detoxification or withdrawal with documentation of counseling about naltrexone by the time of discharge, before and after process intervention. Documentation was defined as the description of counseling about naltrexone in the discharge summary or progress notes of identified encounters. We also measured the percentage of patients started on naltrexone before and after intervention. Lastly, we measured the percentage of patients prescribed naltrexone who filled at least 1 prescription for the medication, assessed by calls to the pharmacy where the medication was prescribed. Prescriptions that could not be confirmed (ie, paper rather than electronic prescriptions) were counted as not filled.
For outcome measures, we recorded the percentages of study patients who returned to the emergency department (ED) and were readmitted to UNC Hospitals (inpatient or observation) for any reason within 30 days of discharge. These outcomes were determined by a manual chart review.
In order to ensure the new process was not associated with delays in patient discharge, we measured the mean length of stay in days for study patient encounters before and after intervention as a balancing measure.
Statistical Analysis
Demographic and clinical characteristics for included patients were compared for the 16 months preimplementation (April 1, 2014 through July 31, 2015) and the 19 months postimplementation (August 1, 2015 through February 28, 2017). Descriptive statistics were calculated by using the Student t test for continuous variables and the χ2 test for dichotomous variables. We used multivariate logistic regression to evaluate the associations between the intervention arms (pre- vs postintervention) and study outcomes, adjusting for age, gender, race, insurance type, and medical comorbidities. We chose these variables for inclusion based on their association with study outcomes at the P ≤ .20 level in bivariate analyses. P < .05 was considered statistically significant. All analyses were performed by using Stata version 13.1 (StataCorp LLC, College Station, TX).
For 2 process measures, the percentages of patients counseled about and started on naltrexone, we plotted consecutive samples of 10 patients before and after intervention on a control chart, using preintervention data to calculate means and control limits.
Subgroup Analysis
We used multivariate logistic regression to evaluate the associations between counseling versus no counseling and prescription of naltrexone versus no prescription for study outcomes in the postintervention subgroup, adjusting for age, gender, race, insurance type, and medical comorbidities.
RESULTS
Patients
We identified 188 preimplementation encounters and excluded 12 patients (6.4%) for primary admission reasons other than alcohol withdrawal or detoxification and 48 (25.5%) repeat hospitalizations, leaving 128 unique patient encounters. We identified 166 postimplementation encounters and excluded 25 (15.1%) hospitalizations for admission reason and 27 repeat hospitalizations (16.3%), leaving 114 unique patient encounters (flow diagram in supplemental Appendix 3). The most common admission reason for the exclusion of encounters was withdrawal from a substance other than alcohol (supplemental Appendix 4). The percentages of encounters excluded in preimplementation and postimplementation periods were similar at 31.9% and 31.4%, respectively.
The majority of patients were male and white, and almost half were uninsured (Table 1). There were no demographic differences between patients in the pre- versus postimplementation groups. For studied comorbidities, postintervention patients were more likely to have hypertension, anxiety, and depression.
Process Measures
Among those counseled about naltrexone before discharge, 34 of 74 patients (45.9%) had no contraindications to naltrexone and were interested in taking the medication. Among the 40 patients who were counseled about but not prescribed naltrexone, 19 (47.5%) declined, 9 (22.5%) had liver function tests elevated more than 3 times the upper limit of the reference range, 9 (22.5%) had concurrent opiate use, and 3 (7.5%) had multiple contraindications.
Among the 34 patients who were prescribed naltrexone, 25 (73.5%) filled at least 1 prescription as confirmed by phone call to the relevant pharmacy.
Outcome Measures
Subgroup Analysis
Balancing Measure
The mean length of stay for all patient encounters was 3.3 days. There were no differences in length of stay comparing pre- with postintervention patient encounters (Table 1) or those postintervention patients counseled versus not counseled (Table 2).
DISCUSSION
Our study demonstrates that counseling about medications for the maintenance of sobriety can be implemented as part of the routine care of hospitalized patients with AUDs. In our experience, about half of the patients counseled had no contraindications to naltrexone and were willing to take it at discharge. Almost three-fourths of those who were prescribed naltrexone filled the prescription at least once. The counseling process was not associated with increased length of stay. In the adjusted analysis, postintervention patients had significantly lower odds of 30-day ED returns. Additionally, in subgroup analysis, postintervention patients counseled about naltrexone had significantly lower rates of subsequent healthcare utilization compared with those not counseled, with absolute differences of 26% for ED revisits and 22% for rehospitalizations within 30 days.
The failure to demonstrate a difference in adjusted rehospitalization rates in the postintervention versus the preintervention group has several possible explanations. First, we had incomplete fidelity to our interventions, documenting counseling about naltrexone before discharge in over 60% of postintervention patients, raising the possibility that better fidelity may have resulted in improved outcomes. Related to this, only 28% of postintervention patients were prescribed naltrexone, which may be an inadequate sample size to demonstrate positive effects from the medication. Another possible explanation is that the postintervention group had higher rates of some of the comorbidities we assessed, namely, anxiety, depression, and hypertension, which could have negatively impacted the effectiveness of the interventions to prevent rehospitalization; however, after adjusting for comorbidities, the odds of rehospitalization were still not significantly different. It is interesting that the odds of postintervention ED revisits (but not rehospitalizations) were lower in the adjusted analysis. It may be that patients who revisit the ED and are not rehospitalized are different in important ways from those who are readmitted. Alternately, the larger number of ED revisits overall (about twice the rate of rehospitalization) may have made it easier to identify positive effects from the intervention for this outcome than rehospitalization (ie, the study may have been underpowered to detect a relatively small reduction in rehospitalization). It is also possible, however, that the interventions were simply insufficient to prevent rehospitalization.
The subgroup analysis, however, did find significant differences in both outcome measures for postintervention patients counseled versus not counseled about naltrexone before discharge. There are several possible explanations for these results. First, there may have been unmeasured differences in those counseled versus not counseled that explain the reductions observed in subsequent healthcare utilization. For example, the counseled patients could have been more motivated to change and, thus, more readily approached by providers for counseling. The lack of any demographic differences between the 2 groups and the relative simplicity of the counseling part of the intervention occurring as part of daily rounds argue against this hypothesis, but there are many potential unmeasured confounders (eg, homelessness, ability to afford medications), and this possibility remains. A second possible explanation is that patients counseled about naltrexone could have been more likely than those not counseled to seek subsequent care at other institutions. A third possibility is that that the counseling about (and prescribing when appropriate) naltrexone itself led to the observed decreases in subsequent ED visits and hospitalizations. This hypothesis would have been more supported had we been able to demonstrate a statistically significant reduction in healthcare utilization in those prescribed versus not prescribed naltrexone. But there were nonsignificant trends in the reduction of ED revisits and rehospitalizations among those prescribed the medication, suggesting we may have been able to demonstrate statistically significant reductions with a larger sample size.
Comparing our results with existing literature is challenging. The majority of randomized trials of naltrexone for AUDs were conducted in the outpatient setting.3-10 Most of these trials utilized some type of psychosocial intervention in addition to naltrexone.3-5,8-10 The 1 prior naltrexone study we identified conducted in the inpatient setting by Wei et al.14 is the most similar to our study. The authors reported the effects of a new process for assessing hospitalized patients with AUDs, including the use of a discharge planning tool for all patients admitted with alcohol dependence. The discharge tool included prompts for naltrexone in appropriate patients. The measured outcomes included the percentage of eligible patients prescribed naltrexone at discharge and the percentages of ED revisits and rehospitalizations within 30 days. Postintervention, 64% of eligible patients were prescribed naltrexone compared with 0% before, very similar to our results. There were significant decreases among all discharged patients with alcohol dependence for 30-day ED revisits (18.8% pre- vs 6.1% postimplementation) and rehospitalizations (23.4% vs 8.2%). The study differed from ours in a number of important respects, including a location in a large urban setting and implementation on a teaching service rather than an attending-only hospitalist service. Additionally, the authors studied 1 month of process implementation and compared it to another month 1 year before the new process, with an overall smaller sample size of 64 patients before and 49 patients after implementation. Potential reasons why Wei et al.14 were able to document lower rehospitalization rates postintervention when we did not include the differences in patient population (eg, high homeless rate, lower percentage of female patients in Wei study) and secular trends unrelated to interventions in either study.
Limitations of our study include the nonrandomized and uncontrolled design, which introduces the possibility of unmeasured confounding factors leading to the decrease we observed in healthcare utilization. Additionally, the single-center design precludes our ability to assess for healthcare utilization outcomes in other nearby facilities. We had incomplete implementation of our new process, counseling just over 60% of patients. As our primary outcomes relied on documentation in the medical record, both undersampling (not documenting some interventions) and reporting bias (being more likely to record positive sessions from intervention) are possible. Lastly, despite a moderate total sample size of almost 250 patients, the relatively small numbers of patients who were actually prescribed naltrexone in our study lessens our ability to show direct impact.
In conclusion, our study demonstrates a practical process for counseling about and prescribing naltrexone to patients hospitalized for alcohol detoxification or withdrawal. We demonstrate that many of these patients will be interested in starting naltrexone at discharge and will reliably fill the prescriptions if written. Counseling was associated with a significant reduction in subsequent healthcare utilization. These results have a wide potential impact given the ubiquitous nature of AUDs among hospitalized patients in community and academic settings.
Disclosure
The authors have no conflicts of interest relevant to this article to disclose. There were no sources of funding for this work.
Alcohol use disorders (AUDs) are common, with an estimated lifetime prevalence of 17.8% for alcohol dependence.1 Alcohol misuse is costly, accounting for $24.6 billion in annual healthcare expenditures, including $5.1 billion for alcohol-related hospitalizations.2 A number of trials have demonstrated that naltrexone can help patients with AUDs maintain abstinence or diminish heavy drinking.3-10 A recent meta-analysis of pharmacotherapy trials for patients with AUDs reported that for patients using 50 mg of naltrexone daily, the number needed to treat was 12 to prevent a return to heavy drinking and 20 to prevent a return to any drinking.11 Despite good evidence for its effectiveness, naltrexone is not prescribed to the majority of patients with AUDs. In a study of veterans with AUDs cared for in the Veterans Affairs health system, only 1.9% of patients were prescribed naltrexone over the 6-month study period.12 A 2003 survey of 2 professional organizations for addiction treatment specialists reported that a mean of 13% of providers prescribed naltrexone to their patients.13
When naltrexone is prescribed, it is most frequently in the outpatient setting.3-10 Data for initiation of naltrexone in the inpatient setting are more limited. Wei et al.14 reported on the implementation of a discharge protocol, including counseling about naltrexone, for hospitalized patients with AUDs at an urban academic medical center. They reported a significant increase in the prescription of naltrexone to eligible patients by the time of discharge that was associated with a significant decrease in 30-day readmissions. Initiation of naltrexone in the inpatient versus the outpatient setting has some potential advantages. First, patients hospitalized for alcohol withdrawal have AUDs, obviating the need for screening. Second, the outpatient trials of naltrexone typically required 3 days of sobriety before initiation, which is generally achieved during hospitalization for detoxification or withdrawal.
Previous work at our institution centered on standardizing the process of evaluating patients needing alcohol detoxification at the time of referral for admission.15 The use of a standardized protocol reduced the number of inpatient admissions for alcohol-related diagnoses but had no effect on the 30-day readmission rate (28%) for those patients who were hospitalized. Our hospitalist group had no standardized process for discharging hospitalized patients with AUDs, and the discharge process rarely included counseling on medications for maintenance of sobriety. In this manuscript, we describe the implementation and impact of a process for counseling patients hospitalized for alcohol detoxification or withdrawal about naltrexone for maintenance of sobriety by the time of hospital discharge.
METHODS
Study Setting
The University of North Carolina (UNC) Hospitals is an 803-bed tertiary academic center. UNC Hospital Medicine is staffed by 29 physicians and 3 advanced practice providers (APPs). During the study period, there were 3 hospital medicine services at UNC Hospitals with a combined average daily census of approximately 40 patients, and each service was staffed by one attending physician every day of the week and one APP Monday through Friday.
Study Design
We used a pre-post study design, in which we implemented a new process for standardizing the discharge of hospitalized patients with AUDs, including a process for counseling about naltrexone by the time of discharge. We sought and received institutional review board (IRB) approval for this study (UNC IRB 15-1441).
Interventions
We formed an improvement team that included 3 physicians and an APP in hospital medicine, a general internist and a psychiatrist, both with expertise in the use of medications for maintenance of sobriety, the director of UNC’s Alcohol and Substance Abuse Program, and 2 case managers. The team developed a number of interventions, including group education, a process for patient identification, and algorithms for counseling about, prescribing, and documenting the discussion of naltrexone.
Group Education
We presented evidence about medications for the maintenance of sobriety at a regularly scheduled hospitalist meeting. An hour-long session on motivational interviewing techniques was also presented at a separate meeting. All created algorithms were circulated to the group electronically and posted at workstations in the hospitalist work area. As data were generated postimplementation, control charts of process measures were created, posted in the hospitalist work area, and presented at subsequent group meetings.
Identification of Patients
We focused our interventions on patients admitted for alcohol detoxification or withdrawal (including withdrawal seizures). We asked our group to preferentially admit these patients to 1 of our 3 hospitalists services, on which the service APP (K.S.) was also an improvement team member.
Creation of Algorithms and Scripts for Counseling
We created a simple algorithm for evaluating patients for naltrexone. We recommended that all patients admitted for alcohol detoxification or withdrawal be counseled about naltrexone for the maintenance of sobriety before discharge. The contraindications to naltrexone we included were (1) concurrent opioid use, (2) documented cirrhosis, and/or (3) liver function tests greater than 3 times the upper limit of normal by the time of hospital discharge.
We also created a suggested script for motivational interviewing (supplemental Appendix 1). This was presented at a group meeting and circulated via e-mail. The actual counseling technique and process was left up to individual providers. In practice, counseling took place in the course of daily rounds, generally the day before or day of hospital discharge.
Prescription of Medication
For interested patients without contraindications, we recommended a prescription of naltrexone at 50 mg daily for 3 months. For patients prescribed naltrexone without medical insurance (n = 17), we utilized our existing pharmacy assistance program, whereby discharging patients can obtain an initial 14-day supply after applying to the program and then can fill subsequent prescriptions if they meet program financial requirements.
Follow-up Appointments
For patients with established outpatient providers, we asked patients to schedule follow-up appointments within a month of discharge. Patients prescribed naltrexone without primary providers (n = 16) were eligible for an existing program, the UNC Transitions Program, whereby patients identified as having moderate-to-high risk of hospital readmission can receive a follow-up appointment at UNC Internal Medicine or UNC Family Medicine within 2 weeks of discharge.
Creation of “Smart Phrases”
To aid in documentation, we created “smart phrases” (easily accessed, previously created phrases that can be adopted by all users) within the hospital electronic health record. We created one smart phrase for documentation of counseling about naltrexone, which included dropdown menus for contraindications and the patient’s preference and one for discharge instructions for patients started on naltrexone (supplemental Appendix 2).
Implementation
After the presentation of suggested interventions in July 2015 and the subsequent dissemination of educational materials, we implemented our new process on August 1, 2015.
Data Collection
Patients were identified for inclusion in the study analysis by querying UNC Hospitals’ billing database for the inpatient diagnosis codes (diagnosis-related groupings) 896 and 897, “alcohol/drug abuse or dependence without rehabilitation therapy,” with and without major comorbidity or complication, respectively, and with hospital medicine as the discharging service. All encounters were then manually reviewed by 2 investigators (J.S. and C.M.). Encounters were included if the history and physical indicated that the primary reason for admission was alcohol detoxification or withdrawal. Encounters with other primary reasons for admission (eg, pancreatitis, gastrointestinal bleeding) were excluded. For patients with multiple encounters, only the first eligible encounter in the pre- and/or postimplementation period was included. Comorbidities for identified patients were assessed via the search of study encounters for the International Classification of Diseases, 9th Revision-Clinical Modification codes for hypertension, anxiety, depression, cirrhosis, diabetes, and congestive heart failure.
Process, Outcomes, and Balancing Measures
The study process measures included the percentage of patients hospitalized for alcohol detoxification or withdrawal with documentation of counseling about naltrexone by the time of discharge, before and after process intervention. Documentation was defined as the description of counseling about naltrexone in the discharge summary or progress notes of identified encounters. We also measured the percentage of patients started on naltrexone before and after intervention. Lastly, we measured the percentage of patients prescribed naltrexone who filled at least 1 prescription for the medication, assessed by calls to the pharmacy where the medication was prescribed. Prescriptions that could not be confirmed (ie, paper rather than electronic prescriptions) were counted as not filled.
For outcome measures, we recorded the percentages of study patients who returned to the emergency department (ED) and were readmitted to UNC Hospitals (inpatient or observation) for any reason within 30 days of discharge. These outcomes were determined by a manual chart review.
In order to ensure the new process was not associated with delays in patient discharge, we measured the mean length of stay in days for study patient encounters before and after intervention as a balancing measure.
Statistical Analysis
Demographic and clinical characteristics for included patients were compared for the 16 months preimplementation (April 1, 2014 through July 31, 2015) and the 19 months postimplementation (August 1, 2015 through February 28, 2017). Descriptive statistics were calculated by using the Student t test for continuous variables and the χ2 test for dichotomous variables. We used multivariate logistic regression to evaluate the associations between the intervention arms (pre- vs postintervention) and study outcomes, adjusting for age, gender, race, insurance type, and medical comorbidities. We chose these variables for inclusion based on their association with study outcomes at the P ≤ .20 level in bivariate analyses. P < .05 was considered statistically significant. All analyses were performed by using Stata version 13.1 (StataCorp LLC, College Station, TX).
For 2 process measures, the percentages of patients counseled about and started on naltrexone, we plotted consecutive samples of 10 patients before and after intervention on a control chart, using preintervention data to calculate means and control limits.
Subgroup Analysis
We used multivariate logistic regression to evaluate the associations between counseling versus no counseling and prescription of naltrexone versus no prescription for study outcomes in the postintervention subgroup, adjusting for age, gender, race, insurance type, and medical comorbidities.
RESULTS
Patients
We identified 188 preimplementation encounters and excluded 12 patients (6.4%) for primary admission reasons other than alcohol withdrawal or detoxification and 48 (25.5%) repeat hospitalizations, leaving 128 unique patient encounters. We identified 166 postimplementation encounters and excluded 25 (15.1%) hospitalizations for admission reason and 27 repeat hospitalizations (16.3%), leaving 114 unique patient encounters (flow diagram in supplemental Appendix 3). The most common admission reason for the exclusion of encounters was withdrawal from a substance other than alcohol (supplemental Appendix 4). The percentages of encounters excluded in preimplementation and postimplementation periods were similar at 31.9% and 31.4%, respectively.
The majority of patients were male and white, and almost half were uninsured (Table 1). There were no demographic differences between patients in the pre- versus postimplementation groups. For studied comorbidities, postintervention patients were more likely to have hypertension, anxiety, and depression.
Process Measures
Among those counseled about naltrexone before discharge, 34 of 74 patients (45.9%) had no contraindications to naltrexone and were interested in taking the medication. Among the 40 patients who were counseled about but not prescribed naltrexone, 19 (47.5%) declined, 9 (22.5%) had liver function tests elevated more than 3 times the upper limit of the reference range, 9 (22.5%) had concurrent opiate use, and 3 (7.5%) had multiple contraindications.
Among the 34 patients who were prescribed naltrexone, 25 (73.5%) filled at least 1 prescription as confirmed by phone call to the relevant pharmacy.
Outcome Measures
Subgroup Analysis
Balancing Measure
The mean length of stay for all patient encounters was 3.3 days. There were no differences in length of stay comparing pre- with postintervention patient encounters (Table 1) or those postintervention patients counseled versus not counseled (Table 2).
DISCUSSION
Our study demonstrates that counseling about medications for the maintenance of sobriety can be implemented as part of the routine care of hospitalized patients with AUDs. In our experience, about half of the patients counseled had no contraindications to naltrexone and were willing to take it at discharge. Almost three-fourths of those who were prescribed naltrexone filled the prescription at least once. The counseling process was not associated with increased length of stay. In the adjusted analysis, postintervention patients had significantly lower odds of 30-day ED returns. Additionally, in subgroup analysis, postintervention patients counseled about naltrexone had significantly lower rates of subsequent healthcare utilization compared with those not counseled, with absolute differences of 26% for ED revisits and 22% for rehospitalizations within 30 days.
The failure to demonstrate a difference in adjusted rehospitalization rates in the postintervention versus the preintervention group has several possible explanations. First, we had incomplete fidelity to our interventions, documenting counseling about naltrexone before discharge in over 60% of postintervention patients, raising the possibility that better fidelity may have resulted in improved outcomes. Related to this, only 28% of postintervention patients were prescribed naltrexone, which may be an inadequate sample size to demonstrate positive effects from the medication. Another possible explanation is that the postintervention group had higher rates of some of the comorbidities we assessed, namely, anxiety, depression, and hypertension, which could have negatively impacted the effectiveness of the interventions to prevent rehospitalization; however, after adjusting for comorbidities, the odds of rehospitalization were still not significantly different. It is interesting that the odds of postintervention ED revisits (but not rehospitalizations) were lower in the adjusted analysis. It may be that patients who revisit the ED and are not rehospitalized are different in important ways from those who are readmitted. Alternately, the larger number of ED revisits overall (about twice the rate of rehospitalization) may have made it easier to identify positive effects from the intervention for this outcome than rehospitalization (ie, the study may have been underpowered to detect a relatively small reduction in rehospitalization). It is also possible, however, that the interventions were simply insufficient to prevent rehospitalization.
The subgroup analysis, however, did find significant differences in both outcome measures for postintervention patients counseled versus not counseled about naltrexone before discharge. There are several possible explanations for these results. First, there may have been unmeasured differences in those counseled versus not counseled that explain the reductions observed in subsequent healthcare utilization. For example, the counseled patients could have been more motivated to change and, thus, more readily approached by providers for counseling. The lack of any demographic differences between the 2 groups and the relative simplicity of the counseling part of the intervention occurring as part of daily rounds argue against this hypothesis, but there are many potential unmeasured confounders (eg, homelessness, ability to afford medications), and this possibility remains. A second possible explanation is that patients counseled about naltrexone could have been more likely than those not counseled to seek subsequent care at other institutions. A third possibility is that that the counseling about (and prescribing when appropriate) naltrexone itself led to the observed decreases in subsequent ED visits and hospitalizations. This hypothesis would have been more supported had we been able to demonstrate a statistically significant reduction in healthcare utilization in those prescribed versus not prescribed naltrexone. But there were nonsignificant trends in the reduction of ED revisits and rehospitalizations among those prescribed the medication, suggesting we may have been able to demonstrate statistically significant reductions with a larger sample size.
Comparing our results with existing literature is challenging. The majority of randomized trials of naltrexone for AUDs were conducted in the outpatient setting.3-10 Most of these trials utilized some type of psychosocial intervention in addition to naltrexone.3-5,8-10 The 1 prior naltrexone study we identified conducted in the inpatient setting by Wei et al.14 is the most similar to our study. The authors reported the effects of a new process for assessing hospitalized patients with AUDs, including the use of a discharge planning tool for all patients admitted with alcohol dependence. The discharge tool included prompts for naltrexone in appropriate patients. The measured outcomes included the percentage of eligible patients prescribed naltrexone at discharge and the percentages of ED revisits and rehospitalizations within 30 days. Postintervention, 64% of eligible patients were prescribed naltrexone compared with 0% before, very similar to our results. There were significant decreases among all discharged patients with alcohol dependence for 30-day ED revisits (18.8% pre- vs 6.1% postimplementation) and rehospitalizations (23.4% vs 8.2%). The study differed from ours in a number of important respects, including a location in a large urban setting and implementation on a teaching service rather than an attending-only hospitalist service. Additionally, the authors studied 1 month of process implementation and compared it to another month 1 year before the new process, with an overall smaller sample size of 64 patients before and 49 patients after implementation. Potential reasons why Wei et al.14 were able to document lower rehospitalization rates postintervention when we did not include the differences in patient population (eg, high homeless rate, lower percentage of female patients in Wei study) and secular trends unrelated to interventions in either study.
Limitations of our study include the nonrandomized and uncontrolled design, which introduces the possibility of unmeasured confounding factors leading to the decrease we observed in healthcare utilization. Additionally, the single-center design precludes our ability to assess for healthcare utilization outcomes in other nearby facilities. We had incomplete implementation of our new process, counseling just over 60% of patients. As our primary outcomes relied on documentation in the medical record, both undersampling (not documenting some interventions) and reporting bias (being more likely to record positive sessions from intervention) are possible. Lastly, despite a moderate total sample size of almost 250 patients, the relatively small numbers of patients who were actually prescribed naltrexone in our study lessens our ability to show direct impact.
In conclusion, our study demonstrates a practical process for counseling about and prescribing naltrexone to patients hospitalized for alcohol detoxification or withdrawal. We demonstrate that many of these patients will be interested in starting naltrexone at discharge and will reliably fill the prescriptions if written. Counseling was associated with a significant reduction in subsequent healthcare utilization. These results have a wide potential impact given the ubiquitous nature of AUDs among hospitalized patients in community and academic settings.
Disclosure
The authors have no conflicts of interest relevant to this article to disclose. There were no sources of funding for this work.
1. Hasin DS, Stinson FS, Ogburn E, Grant BF. Prevalence, correlates, disability, and comorbidity of DSM-IV alcohol abuse and dependence in the United States: results from the National Epidemiologic Survey on Alcohol and Related Conditions. Arch Gen Psychiatry. 2007;64(7):830-842. PubMed
2. Bouchery EE, Harwood HJ, Sacks JJ, Simon CJ, Brewer RD. Economic costs of excessive alcohol consumption in the U.S., 2006. Am J Prev Med. 2011;41(5):516-524. PubMed
3. Anton RF, Moak DH, Waid LR, Latham PK, Malcolm RJ, Dias JK. Naltrexone and cognitive behavioral therapy for the treatment of outpatient alcoholics: results of a placebo-controlled trial. Am J Psychiatry. 1999;156(11):1758-1764. PubMed
4. Anton RF, Moak DH, Latham P, et al. Naltrexone combined with either cognitive behavioral or motivational enhancement therapy for alcohol dependence. J Clin Psychopharmacol. 2005;25(4):349-357. PubMed
5. Guardia J, Caso C, Arias F, et al. A double-blind, placebo-controlled study of naltrexone in the treatment of alcohol-dependence disorder: results from a multicenter clinical trial. Alcohol Clin Exp Res. 2002;26(9):1381-1387. PubMed
6. Kiefer F, Jahn H, Tarnaske T, et al. Comparing and combining naltrexone and acamprosate in relapse prevention of alcoholism: a double-blind, placebo-controlled study. Arch Gen Psychiatry. 2003;60(1):92-99. PubMed
7. Latt NC, Jurd S, Houseman J, Wutzke SE. Naltrexone in alcohol dependence: a randomised controlled trial of effectiveness in a standard clinical setting. Med J Aust. 2002;176(11):530-534. PubMed
8. Morris PL, Hopwood M, Whelan G, Gardiner J, Drummond E. Naltrexone for alcohol dependence: a randomized controlled trial. Addiction. 2001;96(11):1565-1573. PubMed
9. O’Malley SS, Jaffe AJ, Chang G, Schottenfeld RS, Meyer RE, Rounsaville B. Naltrexone and coping skills therapy for alcohol dependence. A controlled study. Arch Gen Psychiatry. 1992;49(11):881-887. PubMed
10. O’Malley SS, Robin RW, Levenson AL, et al. Naltrexone alone and with sertraline for the treatment of alcohol dependence in Alaska natives and non-natives residing in rural settings: a randomized controlled trial. Alcohol Clin Exp Res. 2008;32(7):1271-1283. PubMed
11. Jonas DE, Amick HR, Feltner C, et al. Pharmacotherapy for adults with alcohol use disorders in outpatient settings: a systematic review and meta-analysis. JAMA 2014;311(18):1889-1900. PubMed
12. Petrakis IL, Leslie D, Rosenheck R. Use of naltrexone in the treatment of alcoholism nationally in the Department of Veterans Affairs. Alcohol Clin Exp Res. 2003;27(11):1780-1784. PubMed
13. Mark TL, Kranzler HR, Song X. Understanding US addiction physicians’ low rate of naltrexone prescription. Drug Alcohol Depend. 2003;71(3):219-228. PubMed
14. Wei J, Defries T, Lozada M, Young N, Huen W, Tulsky J. An inpatient treatment and discharge planning protocol for alcohol dependence: efficacy in reducing 30-day readmissions and emergency department visits. J Gen Intern Med. 2015;30(3):365-370. PubMed
15. Stephens JR, Liles EA, Dancel R, Gilchrist M, Kirsch J, DeWalt DA. Who needs inpatient detox? Development and implementation of a hospitalist protocol for the evaluation of patients for alcohol detoxification. J Gen Intern Med. 2014;29(4):587-593. PubMed
16. Provost LP, Murray SK. The Health Care Data Guide: Learning from Data for Improvement. San Francisco: Jossey-Bass; 2011.
1. Hasin DS, Stinson FS, Ogburn E, Grant BF. Prevalence, correlates, disability, and comorbidity of DSM-IV alcohol abuse and dependence in the United States: results from the National Epidemiologic Survey on Alcohol and Related Conditions. Arch Gen Psychiatry. 2007;64(7):830-842. PubMed
2. Bouchery EE, Harwood HJ, Sacks JJ, Simon CJ, Brewer RD. Economic costs of excessive alcohol consumption in the U.S., 2006. Am J Prev Med. 2011;41(5):516-524. PubMed
3. Anton RF, Moak DH, Waid LR, Latham PK, Malcolm RJ, Dias JK. Naltrexone and cognitive behavioral therapy for the treatment of outpatient alcoholics: results of a placebo-controlled trial. Am J Psychiatry. 1999;156(11):1758-1764. PubMed
4. Anton RF, Moak DH, Latham P, et al. Naltrexone combined with either cognitive behavioral or motivational enhancement therapy for alcohol dependence. J Clin Psychopharmacol. 2005;25(4):349-357. PubMed
5. Guardia J, Caso C, Arias F, et al. A double-blind, placebo-controlled study of naltrexone in the treatment of alcohol-dependence disorder: results from a multicenter clinical trial. Alcohol Clin Exp Res. 2002;26(9):1381-1387. PubMed
6. Kiefer F, Jahn H, Tarnaske T, et al. Comparing and combining naltrexone and acamprosate in relapse prevention of alcoholism: a double-blind, placebo-controlled study. Arch Gen Psychiatry. 2003;60(1):92-99. PubMed
7. Latt NC, Jurd S, Houseman J, Wutzke SE. Naltrexone in alcohol dependence: a randomised controlled trial of effectiveness in a standard clinical setting. Med J Aust. 2002;176(11):530-534. PubMed
8. Morris PL, Hopwood M, Whelan G, Gardiner J, Drummond E. Naltrexone for alcohol dependence: a randomized controlled trial. Addiction. 2001;96(11):1565-1573. PubMed
9. O’Malley SS, Jaffe AJ, Chang G, Schottenfeld RS, Meyer RE, Rounsaville B. Naltrexone and coping skills therapy for alcohol dependence. A controlled study. Arch Gen Psychiatry. 1992;49(11):881-887. PubMed
10. O’Malley SS, Robin RW, Levenson AL, et al. Naltrexone alone and with sertraline for the treatment of alcohol dependence in Alaska natives and non-natives residing in rural settings: a randomized controlled trial. Alcohol Clin Exp Res. 2008;32(7):1271-1283. PubMed
11. Jonas DE, Amick HR, Feltner C, et al. Pharmacotherapy for adults with alcohol use disorders in outpatient settings: a systematic review and meta-analysis. JAMA 2014;311(18):1889-1900. PubMed
12. Petrakis IL, Leslie D, Rosenheck R. Use of naltrexone in the treatment of alcoholism nationally in the Department of Veterans Affairs. Alcohol Clin Exp Res. 2003;27(11):1780-1784. PubMed
13. Mark TL, Kranzler HR, Song X. Understanding US addiction physicians’ low rate of naltrexone prescription. Drug Alcohol Depend. 2003;71(3):219-228. PubMed
14. Wei J, Defries T, Lozada M, Young N, Huen W, Tulsky J. An inpatient treatment and discharge planning protocol for alcohol dependence: efficacy in reducing 30-day readmissions and emergency department visits. J Gen Intern Med. 2015;30(3):365-370. PubMed
15. Stephens JR, Liles EA, Dancel R, Gilchrist M, Kirsch J, DeWalt DA. Who needs inpatient detox? Development and implementation of a hospitalist protocol for the evaluation of patients for alcohol detoxification. J Gen Intern Med. 2014;29(4):587-593. PubMed
16. Provost LP, Murray SK. The Health Care Data Guide: Learning from Data for Improvement. San Francisco: Jossey-Bass; 2011.
© 2018 Society of Hospital Medicine
Periprocedural Bridging Anticoagulation
The “Things We Do for No Reason” (TWDFNR) series reviews practices that have become common parts of hospital care but that may provide little value to our patients. Practices reviewed in the TWDFNR series do not represent “black and white” 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. https://www.choosingwisely.org/
Oral anticoagulation (OAC) is commonly prescribed to patients with atrial fibrillation, venous thromboembolism (VTE), and mechanical heart valves (MHVs) for primary and secondary thromboembolism prevention. When patients require surgery or an invasive procedure, “bridging” anticoagulants (eg, enoxaparin) are commonly administered during the period of OAC interruption to reduce thromboembolic risk. This practice stems from small observational studies and expert opinion, which influenced several clinical guidelines despite the lack of high-quality evidence. Although prospective randomized trials of periprocedural bridging in patients with VTE and MHVs are lacking, available evidence is consistent with findings from the BRIDGE trial, which guides the following general recommendations: (1) avoid unnecessary periprocedural interruptions of OAC, especially for low bleeding risk procedures; (2) avoid the administration of periprocedural bridging anticoagulation in patients with low to moderate thromboembolic risk; (3) in patients with high thromboembolic risk, individually assess the patient-specific and procedure-specific bleeding risks versus thromboembolic risks.
A 75-year-old man with a history of hypertension, diabetes mellitus, and atrial fibrillation is admitted for surgical repair of a comminuted intertrochanteric left hip fracture. He suffered a mechanical ground-level fall without loss of consciousness. At baseline, he denies any chest pain, dyspnea on exertion, or recent change in his exercise tolerance. A physical examination is notable for stable vital signs, irregular cardiac rhythm, and a shortened and externally rotated left lower extremity with exquisite tenderness to palpation and range of motion. The patient is taking warfarin for stroke prophylaxis based on a CHA2DS2VaSc score of 4 points. The international normalized ratio (INR) is 1.9 upon admission, and surgery is planned within 48 hours, once the patient is “medically cleared.” Will this patient benefit from periprocedural bridging anticoagulation?
WHY YOU MIGHT THINK PERIPROCEDURAL “BRIDGING” ANTICOAGULATION IS HELPFUL
OAC is commonly prescribed to patients with atrial fibrillation, venous thromboembolism (VTE), and mechanical heart valves (MHVs) for the primary or secondary prevention of thromboembolic events, with more than 35 million prescriptions written annually in the United States alone.1 Many of these patients will require a temporary interruption of their OAC for surgery or an invasive procedure.2 As a result, patients may be treated with short-acting, or “bridging,” anticoagulants, such as low-molecular-weight heparin (LMWH), to minimize the duration of anticoagulation interruption and theoretically reduce their thromboembolic risk. The rationale for bridging stemmed from small observational studies and expert opinion that perceived the estimated thromboembolic risk to be higher than the estimated bleeding risk.3-5 One such example estimated that the VTE risk increased 100-fold postoperatively, whereas heparin administration only doubled the bleeding risk.3 Furthermore, clinical practice guidelines published from the American Heart Association, American College of Cardiology, European Heart Rhythm Society, and American College of Chest Physicians recommend when and how to initiate bridging anticoagulation. Clinicians have widely adopted these recommendations despite an acknowledged paucity of high-quality supporting evidence.6,7
WHY PERIPROCEDURAL “BRIDGING” ANTICOAGULATION IS MORE HARMFUL THAN HELPFUL
Periprocedural Anticoagulation Interruption is Often Not Indicated
Patients undergoing a surgical or invasive procedure may require an interruption of OAC to minimize the periprocedural bleeding risk. The decision to interrupt OAC should generally be based on the procedure-specific bleeding risk. Procedures with low bleeding risk such as cataract surgery, dermatologic biopsy (including Mohs), arthrocentesis, diagnostic gastrointestinal endoscopy, and cardiac pacemaker implantation can be performed safely without OAC interruption.5,7 Despite evidence supporting the safety of periprocedural OAC continuation, unnecessary OAC interruptions remain commonplace and are associated with increased adverse outcomes.8 The BRUISE CONTROL trial compared uninterrupted OAC to interrupted OAC with periprocedural bridging for cardiac pacemaker or defibrillator implantation in a moderate to high thromboembolic risk population. The uninterrupted OAC group experienced significantly fewer pocket hematomas, hematoma evacuations, and prolonged hospitalizations (relative risk [RR] 0.19-0.24; P < .05) without significantly increased thromboembolic events, highlighting the potential benefits of this approach.9
Nevertheless, many surgical and invasive procedures do warrant OAC interruption due to the inherent bleeding risk of the procedure or other logistical considerations. Procedures associated with an increased bleeding risk include urologic surgery (except laser lithotripsy), surgery on highly vascular organs (eg, kidney, liver, spleen), bowel resection, cardiac surgery, and intracranial or spinal surgery.7 Alternatively, some procedures with acceptably low bleeding risk (eg, colonoscopy) are routinely performed during an OAC interruption due to the fact that a high bleeding risk intervention may be necessary during the procedure (eg, polypectomy). This approach may be preferable when a significant amount of preparation is required (eg, bowel preparation) and may be a more efficient use of healthcare resources by avoiding repeat procedures.
Bridging Anticoagulation Does Not Significantly Reduce Thromboembolic Events
BRIDGE was a randomized, double-blind, placebo-controlled trial among patients with atrial fibrillation (n = 1884) requiring OAC interruption for mostly low-risk, ambulatory surgeries or invasive procedures (eg, gastrointestinal endoscopy, cardiac catheterization). Notably, thromboembolism events were rare, and there was no significant difference in thromboembolism events between patients randomized to placebo or bridging with LMWH (0.4% vs 0.3%, respectively; P = .73).14 However, the proportion of patients enrolled with the highest thromboembolic risk (ie, CHADS2 score 5-6 or prior transient ischemic attack and/or stroke) was low, potentially indicating an underestimated benefit in these patients. Major bleeding was significantly reduced in patients forgoing bridging anticoagulation (1.3% vs 3.2%; RR 0.41; 95% confidence interval, 0.20-0.78; P = .005), although bleeding occurred more frequently than thromboembolism in both groups.
Even though randomized trials assessing the safety and efficacy of bridging for VTE or MHVs have not been completed, evidence is not entirely lacking.16,17 A rigorous observational study limited to a VTE cohort (deep vein thrombosis of upper or lower extremity and/or pulmonary embolism) analyzed the effects of bridging in patients with a surgical or invasive procedure-related OAC interruption. Patients were stratified according to the American College of Chest Physicians perioperative guideline risk-stratification schema, and most VTE events (≥93%) occurred more than 12 months prior to OAC interruption.7 Importantly, the study found a nonsignificant difference in thromboembolism events between patients who were bridged and those who were not (0.0% vs 0.2%, respectively; P = .56), a very low overall thromboembolism event rate (0.2%), and a lack of correlation between events and risk-stratification category.17 In other words, all thromboembolic events occurred in the low- and moderate-risk groups, which include patients who do not warrant bridging under current guidelines. Clinically relevant bleeding occurred in 17 (0.9%) of 1812 patients studied. Notably, 15 (2.7%) of 555 patients receiving bridging suffered clinically relevant bleeding as compared with 2 (0.2%) of 1257 patients forgoing bridging anticoagulation.
The Bleeding Risk of Bridging Anticoagulation Often Outweighs the Potential Benefits
The early observational studies on LMWH bridging demonstrated that thromboembolic events are infrequent (0.4%-0.9%), whereas major bleeding events occur up to 7 times more often (0.7%-6.7%).10-12 The BRIDGE trial demonstrated comparably low thromboembolic events (0.3%). In the patients treated with bridging LMWH, major bleeding (3.2%) occurred 10 times more frequently than thromboembolism.14 Likewise, in a VTE cohort study, Clark et al.17 demonstrated “a 17-fold higher risk of bleeding without a significant difference in the rate of recurrent VTE” in patients bridged with heparin as compared with those who were not. Considering that recurrent VTE and major bleeding events have similar case-fatality rates,18 these increases in major bleeding events without reductions in thromboembolic events unmistakably tip the risk–benefit balance sharply towards an increased risk of harm.
When is bridging anticoagulation potentially helpful?
WHAT SHOULD YOU DO INSTEAD?
First, determine whether periprocedural OAC interruption is necessary for patients on chronic OAC due to atrial fibrillation, VTE, or MHVs. Avoid unwarranted OAC interruption by discussing the need for OAC interruptions with the surgeon or proceduralist, especially if the surgery is associated with a low bleeding risk and the patient has a high thromboembolic risk. When a periprocedural OAC interruption is justified, bridging should be avoided in the majority of patients, especially those with low to moderate thromboembolic risk or increased bleeding risk according to current risk-stratification schema.7,15,19
Periprocedural management of direct oral anticoagulants (DOACs) is different than that of warfarin. The duration of DOAC interruption is determined by the procedural bleeding risk, drug half-life, and a patient’s creatinine clearance. Although the pharmacokinetics of DOACs generally allow for brief interruptions (eg, 24-48 hours), longer interruptions (eg, 96-120 hours) are warranted prior to high bleeding risk procedures, when drug half-life is prolonged (ie, dabigatran), and in patients with renal impairment. Parenteral bridging anticoagulation is not recommended during brief DOAC interruptions, and substituting a DOAC in place of LMWH for bridging is not advised. The 2017 American College of Cardiology Expert Consensus Decision Pathway provides periprocedural OAC interruption guidance for atrial fibrillation, with many principles applicable to other OAC indications.15We developed an institutional guideline that provides clinicians a structured approach to bridging OAC that steers them away from inappropriate bridging and helps them make decisions when evidence is lacking. Shared decision-making represents another effective method for well-informed patients and clinicians to arrive at a mutually agreed upon bridging decision.
RECOMMENDATIONS
- Avoid unnecessary periprocedural interruptions of OAC, especially for procedures with a low bleeding risk.
- Avoid the administration of bridging anticoagulation in patients with low to moderate thromboembolic risk during periprocedural OAC interruptions.
- In patients with a high thromboembolic risk, an individualized assessment of the patient-specific and procedure-specific bleeding risks versus the thromboembolic risks is necessary when considering bridging anticoagulation administration.
CONCLUSION
Returning to the opening case, the patient requires an anticoagulation interruption and INR correction prior to surgery. Because the CHA2DS2VaSc score of 4 does not categorize him as a high thromboembolic risk, bridging anticoagulation should be avoided. In the majority of patients on OAC, bridging anticoagulation does not reduce thromboembolic events and is associated with increased major bleeding. Unnecessary anticoagulation interruptions should be avoided for procedures associated with low bleeding risk. Bridging should not be administered to the majority of patients requiring a periprocedural anticoagulation interruption.
Do
Disclosure: The authors report no conflicts of interest relevant to this article to disclose.
1. Kirley K, Qato DM, Kornfield R, Stafford RS, Alexander GC. National trends in oral anticoagulant use in the United States, 2007 to 2011. Circ Cardiovasc Qual Outcomes. 2012;5(5):615-621. PubMed
2. Steinberg BA, Peterson ED, Kim S, et al. Use and outcomes associated with bridging during anticoagulation interruptions in patients with atrial fibrillation: findings from the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF). Circulation. 2015;131(5):488-494. PubMed
3. Kearon C, Hirsh J. Management of anticoagulation before and after elective surgery. N Engl J Med. 1997;336(21):1506-1511. PubMed
4. Eckman MH. “Bridging on the river Kwai”: the perioperative management of anticoagulation therapy. Med Decis Making. 2005;25(4):370-373. PubMed
5. Dunn AS, Turpie AG. Perioperative management of patients receiving oral anticoagulants: a systematic review. Arch Intern Med. 2003;163(8):901-908. PubMed
6. January CT, Wann LS, Alpert JS, et al. 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on practice guidelines and the Heart Rhythm Society. Circulation. 2014;130(23):2071-2104. PubMed
7. Douketis JD, Spyropoulos AC, Spencer FA, et al. Perioperative management of antithrombotic therapy: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012;141(2 Suppl):e326S-e350S. PubMed
8. Gerson LB, Gage BF, Owens DK, Triadafilopoulos G. Effect and outcomes of the ASGE guidelines on the periendoscopic management of patients who take anticoagulants. Am J Gastroenterol. 2000;95(7):1717-1724. PubMed
9. Birnie DH, Healey JS, Wells GA, et al. Pacemaker or defibrillator surgery without interruption of anticoagulation. N Engl J Med. 2013;368(22):2084-2093. PubMed
10. Douketis JD, Johnson JA, Turpie AG. Low-molecular-weight heparin as bridging anticoagulation during interruption of warfarin: assessment of a standardized periprocedural anticoagulation regimen. Arch Intern Med. 2004;164(12):1319-1326. PubMed
11. Spyropoulos AC, Turpie AG, Dunn AS, et al. Clinical outcomes with unfractionated heparin or low-molecular-weight heparin as bridging therapy in patients on long-term oral anticoagulants: the REGIMEN registry. J Thromb Haemost. 2006;4(6):1246-1252. PubMed
12. Kovacs MJ, Kearon C, Rodger M, et al. Single-arm study of bridging therapy with low-molecular-weight heparin for patients at risk of arterial embolism who require temporary interruption of warfarin. Circulation. 2004;110(12):1658-1663. PubMed
13. Siegal D, Yudin J, Kaatz S, Douketis JD, Lim W, Spyropoulos AC. Periprocedural heparin bridging in patients receiving vitamin K antagonists: systematic review and meta-analysis of bleeding and thromboembolic rates. Circulation. 2012;126(13):1630-1639. PubMed
14. Douketis JD, Spyropoulos AC, Kaatz S, et al. Perioperative Bridging Anticoagulation in Patients with Atrial Fibrillation. N Engl J Med. 2015;373(9):823-833. PubMed
15. Doherty JU, Gluckman TJ, Hucker WJ, et al. 2017 ACC Expert Consensus Decision Pathway for Periprocedural Management of Anticoagulation in Patients With Nonvalvular Atrial Fibrillation: A Report of the American College of Cardiology Clinical Expert Consensus Document Task Force. J Am Coll Cardiol. 2017;69(7):871-898. PubMed
16. Daniels PR, McBane RD, Litin SC, et al. Peri-procedural anticoagulation management of mechanical prosthetic heart valve patients. Thromb Res. 2009;124(3):300-305. PubMed
17. Clark NP, Witt DM, Davies LE, et al. Bleeding, Recurrent Venous Thromboembolism, and Mortality Risks During Warfarin Interruption for Invasive Procedures. JAMA Intern Med. 2015;175(7):1163-1168. PubMed
18. Carrier M, Le Gal G, Wells PS, Rodger MA. Systematic review: case-fatality rates of recurrent venous thromboembolism and major bleeding events among patients treated for venous thromboembolism. Ann Intern Med. 2010;152(9):578-589. PubMed
19. Nishimura RA, Otto CM, Bonow RO, et al. 2017 AHA/ACC Focused Update of the 2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2017;135(25):e1159-e1195. PubMed
The “Things We Do for No Reason” (TWDFNR) series reviews practices that have become common parts of hospital care but that may provide little value to our patients. Practices reviewed in the TWDFNR series do not represent “black and white” 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. https://www.choosingwisely.org/
Oral anticoagulation (OAC) is commonly prescribed to patients with atrial fibrillation, venous thromboembolism (VTE), and mechanical heart valves (MHVs) for primary and secondary thromboembolism prevention. When patients require surgery or an invasive procedure, “bridging” anticoagulants (eg, enoxaparin) are commonly administered during the period of OAC interruption to reduce thromboembolic risk. This practice stems from small observational studies and expert opinion, which influenced several clinical guidelines despite the lack of high-quality evidence. Although prospective randomized trials of periprocedural bridging in patients with VTE and MHVs are lacking, available evidence is consistent with findings from the BRIDGE trial, which guides the following general recommendations: (1) avoid unnecessary periprocedural interruptions of OAC, especially for low bleeding risk procedures; (2) avoid the administration of periprocedural bridging anticoagulation in patients with low to moderate thromboembolic risk; (3) in patients with high thromboembolic risk, individually assess the patient-specific and procedure-specific bleeding risks versus thromboembolic risks.
A 75-year-old man with a history of hypertension, diabetes mellitus, and atrial fibrillation is admitted for surgical repair of a comminuted intertrochanteric left hip fracture. He suffered a mechanical ground-level fall without loss of consciousness. At baseline, he denies any chest pain, dyspnea on exertion, or recent change in his exercise tolerance. A physical examination is notable for stable vital signs, irregular cardiac rhythm, and a shortened and externally rotated left lower extremity with exquisite tenderness to palpation and range of motion. The patient is taking warfarin for stroke prophylaxis based on a CHA2DS2VaSc score of 4 points. The international normalized ratio (INR) is 1.9 upon admission, and surgery is planned within 48 hours, once the patient is “medically cleared.” Will this patient benefit from periprocedural bridging anticoagulation?
WHY YOU MIGHT THINK PERIPROCEDURAL “BRIDGING” ANTICOAGULATION IS HELPFUL
OAC is commonly prescribed to patients with atrial fibrillation, venous thromboembolism (VTE), and mechanical heart valves (MHVs) for the primary or secondary prevention of thromboembolic events, with more than 35 million prescriptions written annually in the United States alone.1 Many of these patients will require a temporary interruption of their OAC for surgery or an invasive procedure.2 As a result, patients may be treated with short-acting, or “bridging,” anticoagulants, such as low-molecular-weight heparin (LMWH), to minimize the duration of anticoagulation interruption and theoretically reduce their thromboembolic risk. The rationale for bridging stemmed from small observational studies and expert opinion that perceived the estimated thromboembolic risk to be higher than the estimated bleeding risk.3-5 One such example estimated that the VTE risk increased 100-fold postoperatively, whereas heparin administration only doubled the bleeding risk.3 Furthermore, clinical practice guidelines published from the American Heart Association, American College of Cardiology, European Heart Rhythm Society, and American College of Chest Physicians recommend when and how to initiate bridging anticoagulation. Clinicians have widely adopted these recommendations despite an acknowledged paucity of high-quality supporting evidence.6,7
WHY PERIPROCEDURAL “BRIDGING” ANTICOAGULATION IS MORE HARMFUL THAN HELPFUL
Periprocedural Anticoagulation Interruption is Often Not Indicated
Patients undergoing a surgical or invasive procedure may require an interruption of OAC to minimize the periprocedural bleeding risk. The decision to interrupt OAC should generally be based on the procedure-specific bleeding risk. Procedures with low bleeding risk such as cataract surgery, dermatologic biopsy (including Mohs), arthrocentesis, diagnostic gastrointestinal endoscopy, and cardiac pacemaker implantation can be performed safely without OAC interruption.5,7 Despite evidence supporting the safety of periprocedural OAC continuation, unnecessary OAC interruptions remain commonplace and are associated with increased adverse outcomes.8 The BRUISE CONTROL trial compared uninterrupted OAC to interrupted OAC with periprocedural bridging for cardiac pacemaker or defibrillator implantation in a moderate to high thromboembolic risk population. The uninterrupted OAC group experienced significantly fewer pocket hematomas, hematoma evacuations, and prolonged hospitalizations (relative risk [RR] 0.19-0.24; P < .05) without significantly increased thromboembolic events, highlighting the potential benefits of this approach.9
Nevertheless, many surgical and invasive procedures do warrant OAC interruption due to the inherent bleeding risk of the procedure or other logistical considerations. Procedures associated with an increased bleeding risk include urologic surgery (except laser lithotripsy), surgery on highly vascular organs (eg, kidney, liver, spleen), bowel resection, cardiac surgery, and intracranial or spinal surgery.7 Alternatively, some procedures with acceptably low bleeding risk (eg, colonoscopy) are routinely performed during an OAC interruption due to the fact that a high bleeding risk intervention may be necessary during the procedure (eg, polypectomy). This approach may be preferable when a significant amount of preparation is required (eg, bowel preparation) and may be a more efficient use of healthcare resources by avoiding repeat procedures.
Bridging Anticoagulation Does Not Significantly Reduce Thromboembolic Events
BRIDGE was a randomized, double-blind, placebo-controlled trial among patients with atrial fibrillation (n = 1884) requiring OAC interruption for mostly low-risk, ambulatory surgeries or invasive procedures (eg, gastrointestinal endoscopy, cardiac catheterization). Notably, thromboembolism events were rare, and there was no significant difference in thromboembolism events between patients randomized to placebo or bridging with LMWH (0.4% vs 0.3%, respectively; P = .73).14 However, the proportion of patients enrolled with the highest thromboembolic risk (ie, CHADS2 score 5-6 or prior transient ischemic attack and/or stroke) was low, potentially indicating an underestimated benefit in these patients. Major bleeding was significantly reduced in patients forgoing bridging anticoagulation (1.3% vs 3.2%; RR 0.41; 95% confidence interval, 0.20-0.78; P = .005), although bleeding occurred more frequently than thromboembolism in both groups.
Even though randomized trials assessing the safety and efficacy of bridging for VTE or MHVs have not been completed, evidence is not entirely lacking.16,17 A rigorous observational study limited to a VTE cohort (deep vein thrombosis of upper or lower extremity and/or pulmonary embolism) analyzed the effects of bridging in patients with a surgical or invasive procedure-related OAC interruption. Patients were stratified according to the American College of Chest Physicians perioperative guideline risk-stratification schema, and most VTE events (≥93%) occurred more than 12 months prior to OAC interruption.7 Importantly, the study found a nonsignificant difference in thromboembolism events between patients who were bridged and those who were not (0.0% vs 0.2%, respectively; P = .56), a very low overall thromboembolism event rate (0.2%), and a lack of correlation between events and risk-stratification category.17 In other words, all thromboembolic events occurred in the low- and moderate-risk groups, which include patients who do not warrant bridging under current guidelines. Clinically relevant bleeding occurred in 17 (0.9%) of 1812 patients studied. Notably, 15 (2.7%) of 555 patients receiving bridging suffered clinically relevant bleeding as compared with 2 (0.2%) of 1257 patients forgoing bridging anticoagulation.
The Bleeding Risk of Bridging Anticoagulation Often Outweighs the Potential Benefits
The early observational studies on LMWH bridging demonstrated that thromboembolic events are infrequent (0.4%-0.9%), whereas major bleeding events occur up to 7 times more often (0.7%-6.7%).10-12 The BRIDGE trial demonstrated comparably low thromboembolic events (0.3%). In the patients treated with bridging LMWH, major bleeding (3.2%) occurred 10 times more frequently than thromboembolism.14 Likewise, in a VTE cohort study, Clark et al.17 demonstrated “a 17-fold higher risk of bleeding without a significant difference in the rate of recurrent VTE” in patients bridged with heparin as compared with those who were not. Considering that recurrent VTE and major bleeding events have similar case-fatality rates,18 these increases in major bleeding events without reductions in thromboembolic events unmistakably tip the risk–benefit balance sharply towards an increased risk of harm.
When is bridging anticoagulation potentially helpful?
WHAT SHOULD YOU DO INSTEAD?
First, determine whether periprocedural OAC interruption is necessary for patients on chronic OAC due to atrial fibrillation, VTE, or MHVs. Avoid unwarranted OAC interruption by discussing the need for OAC interruptions with the surgeon or proceduralist, especially if the surgery is associated with a low bleeding risk and the patient has a high thromboembolic risk. When a periprocedural OAC interruption is justified, bridging should be avoided in the majority of patients, especially those with low to moderate thromboembolic risk or increased bleeding risk according to current risk-stratification schema.7,15,19
Periprocedural management of direct oral anticoagulants (DOACs) is different than that of warfarin. The duration of DOAC interruption is determined by the procedural bleeding risk, drug half-life, and a patient’s creatinine clearance. Although the pharmacokinetics of DOACs generally allow for brief interruptions (eg, 24-48 hours), longer interruptions (eg, 96-120 hours) are warranted prior to high bleeding risk procedures, when drug half-life is prolonged (ie, dabigatran), and in patients with renal impairment. Parenteral bridging anticoagulation is not recommended during brief DOAC interruptions, and substituting a DOAC in place of LMWH for bridging is not advised. The 2017 American College of Cardiology Expert Consensus Decision Pathway provides periprocedural OAC interruption guidance for atrial fibrillation, with many principles applicable to other OAC indications.15We developed an institutional guideline that provides clinicians a structured approach to bridging OAC that steers them away from inappropriate bridging and helps them make decisions when evidence is lacking. Shared decision-making represents another effective method for well-informed patients and clinicians to arrive at a mutually agreed upon bridging decision.
RECOMMENDATIONS
- Avoid unnecessary periprocedural interruptions of OAC, especially for procedures with a low bleeding risk.
- Avoid the administration of bridging anticoagulation in patients with low to moderate thromboembolic risk during periprocedural OAC interruptions.
- In patients with a high thromboembolic risk, an individualized assessment of the patient-specific and procedure-specific bleeding risks versus the thromboembolic risks is necessary when considering bridging anticoagulation administration.
CONCLUSION
Returning to the opening case, the patient requires an anticoagulation interruption and INR correction prior to surgery. Because the CHA2DS2VaSc score of 4 does not categorize him as a high thromboembolic risk, bridging anticoagulation should be avoided. In the majority of patients on OAC, bridging anticoagulation does not reduce thromboembolic events and is associated with increased major bleeding. Unnecessary anticoagulation interruptions should be avoided for procedures associated with low bleeding risk. Bridging should not be administered to the majority of patients requiring a periprocedural anticoagulation interruption.
Do
Disclosure: The authors report no conflicts of interest relevant to this article to disclose.
The “Things We Do for No Reason” (TWDFNR) series reviews practices that have become common parts of hospital care but that may provide little value to our patients. Practices reviewed in the TWDFNR series do not represent “black and white” 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. https://www.choosingwisely.org/
Oral anticoagulation (OAC) is commonly prescribed to patients with atrial fibrillation, venous thromboembolism (VTE), and mechanical heart valves (MHVs) for primary and secondary thromboembolism prevention. When patients require surgery or an invasive procedure, “bridging” anticoagulants (eg, enoxaparin) are commonly administered during the period of OAC interruption to reduce thromboembolic risk. This practice stems from small observational studies and expert opinion, which influenced several clinical guidelines despite the lack of high-quality evidence. Although prospective randomized trials of periprocedural bridging in patients with VTE and MHVs are lacking, available evidence is consistent with findings from the BRIDGE trial, which guides the following general recommendations: (1) avoid unnecessary periprocedural interruptions of OAC, especially for low bleeding risk procedures; (2) avoid the administration of periprocedural bridging anticoagulation in patients with low to moderate thromboembolic risk; (3) in patients with high thromboembolic risk, individually assess the patient-specific and procedure-specific bleeding risks versus thromboembolic risks.
A 75-year-old man with a history of hypertension, diabetes mellitus, and atrial fibrillation is admitted for surgical repair of a comminuted intertrochanteric left hip fracture. He suffered a mechanical ground-level fall without loss of consciousness. At baseline, he denies any chest pain, dyspnea on exertion, or recent change in his exercise tolerance. A physical examination is notable for stable vital signs, irregular cardiac rhythm, and a shortened and externally rotated left lower extremity with exquisite tenderness to palpation and range of motion. The patient is taking warfarin for stroke prophylaxis based on a CHA2DS2VaSc score of 4 points. The international normalized ratio (INR) is 1.9 upon admission, and surgery is planned within 48 hours, once the patient is “medically cleared.” Will this patient benefit from periprocedural bridging anticoagulation?
WHY YOU MIGHT THINK PERIPROCEDURAL “BRIDGING” ANTICOAGULATION IS HELPFUL
OAC is commonly prescribed to patients with atrial fibrillation, venous thromboembolism (VTE), and mechanical heart valves (MHVs) for the primary or secondary prevention of thromboembolic events, with more than 35 million prescriptions written annually in the United States alone.1 Many of these patients will require a temporary interruption of their OAC for surgery or an invasive procedure.2 As a result, patients may be treated with short-acting, or “bridging,” anticoagulants, such as low-molecular-weight heparin (LMWH), to minimize the duration of anticoagulation interruption and theoretically reduce their thromboembolic risk. The rationale for bridging stemmed from small observational studies and expert opinion that perceived the estimated thromboembolic risk to be higher than the estimated bleeding risk.3-5 One such example estimated that the VTE risk increased 100-fold postoperatively, whereas heparin administration only doubled the bleeding risk.3 Furthermore, clinical practice guidelines published from the American Heart Association, American College of Cardiology, European Heart Rhythm Society, and American College of Chest Physicians recommend when and how to initiate bridging anticoagulation. Clinicians have widely adopted these recommendations despite an acknowledged paucity of high-quality supporting evidence.6,7
WHY PERIPROCEDURAL “BRIDGING” ANTICOAGULATION IS MORE HARMFUL THAN HELPFUL
Periprocedural Anticoagulation Interruption is Often Not Indicated
Patients undergoing a surgical or invasive procedure may require an interruption of OAC to minimize the periprocedural bleeding risk. The decision to interrupt OAC should generally be based on the procedure-specific bleeding risk. Procedures with low bleeding risk such as cataract surgery, dermatologic biopsy (including Mohs), arthrocentesis, diagnostic gastrointestinal endoscopy, and cardiac pacemaker implantation can be performed safely without OAC interruption.5,7 Despite evidence supporting the safety of periprocedural OAC continuation, unnecessary OAC interruptions remain commonplace and are associated with increased adverse outcomes.8 The BRUISE CONTROL trial compared uninterrupted OAC to interrupted OAC with periprocedural bridging for cardiac pacemaker or defibrillator implantation in a moderate to high thromboembolic risk population. The uninterrupted OAC group experienced significantly fewer pocket hematomas, hematoma evacuations, and prolonged hospitalizations (relative risk [RR] 0.19-0.24; P < .05) without significantly increased thromboembolic events, highlighting the potential benefits of this approach.9
Nevertheless, many surgical and invasive procedures do warrant OAC interruption due to the inherent bleeding risk of the procedure or other logistical considerations. Procedures associated with an increased bleeding risk include urologic surgery (except laser lithotripsy), surgery on highly vascular organs (eg, kidney, liver, spleen), bowel resection, cardiac surgery, and intracranial or spinal surgery.7 Alternatively, some procedures with acceptably low bleeding risk (eg, colonoscopy) are routinely performed during an OAC interruption due to the fact that a high bleeding risk intervention may be necessary during the procedure (eg, polypectomy). This approach may be preferable when a significant amount of preparation is required (eg, bowel preparation) and may be a more efficient use of healthcare resources by avoiding repeat procedures.
Bridging Anticoagulation Does Not Significantly Reduce Thromboembolic Events
BRIDGE was a randomized, double-blind, placebo-controlled trial among patients with atrial fibrillation (n = 1884) requiring OAC interruption for mostly low-risk, ambulatory surgeries or invasive procedures (eg, gastrointestinal endoscopy, cardiac catheterization). Notably, thromboembolism events were rare, and there was no significant difference in thromboembolism events between patients randomized to placebo or bridging with LMWH (0.4% vs 0.3%, respectively; P = .73).14 However, the proportion of patients enrolled with the highest thromboembolic risk (ie, CHADS2 score 5-6 or prior transient ischemic attack and/or stroke) was low, potentially indicating an underestimated benefit in these patients. Major bleeding was significantly reduced in patients forgoing bridging anticoagulation (1.3% vs 3.2%; RR 0.41; 95% confidence interval, 0.20-0.78; P = .005), although bleeding occurred more frequently than thromboembolism in both groups.
Even though randomized trials assessing the safety and efficacy of bridging for VTE or MHVs have not been completed, evidence is not entirely lacking.16,17 A rigorous observational study limited to a VTE cohort (deep vein thrombosis of upper or lower extremity and/or pulmonary embolism) analyzed the effects of bridging in patients with a surgical or invasive procedure-related OAC interruption. Patients were stratified according to the American College of Chest Physicians perioperative guideline risk-stratification schema, and most VTE events (≥93%) occurred more than 12 months prior to OAC interruption.7 Importantly, the study found a nonsignificant difference in thromboembolism events between patients who were bridged and those who were not (0.0% vs 0.2%, respectively; P = .56), a very low overall thromboembolism event rate (0.2%), and a lack of correlation between events and risk-stratification category.17 In other words, all thromboembolic events occurred in the low- and moderate-risk groups, which include patients who do not warrant bridging under current guidelines. Clinically relevant bleeding occurred in 17 (0.9%) of 1812 patients studied. Notably, 15 (2.7%) of 555 patients receiving bridging suffered clinically relevant bleeding as compared with 2 (0.2%) of 1257 patients forgoing bridging anticoagulation.
The Bleeding Risk of Bridging Anticoagulation Often Outweighs the Potential Benefits
The early observational studies on LMWH bridging demonstrated that thromboembolic events are infrequent (0.4%-0.9%), whereas major bleeding events occur up to 7 times more often (0.7%-6.7%).10-12 The BRIDGE trial demonstrated comparably low thromboembolic events (0.3%). In the patients treated with bridging LMWH, major bleeding (3.2%) occurred 10 times more frequently than thromboembolism.14 Likewise, in a VTE cohort study, Clark et al.17 demonstrated “a 17-fold higher risk of bleeding without a significant difference in the rate of recurrent VTE” in patients bridged with heparin as compared with those who were not. Considering that recurrent VTE and major bleeding events have similar case-fatality rates,18 these increases in major bleeding events without reductions in thromboembolic events unmistakably tip the risk–benefit balance sharply towards an increased risk of harm.
When is bridging anticoagulation potentially helpful?
WHAT SHOULD YOU DO INSTEAD?
First, determine whether periprocedural OAC interruption is necessary for patients on chronic OAC due to atrial fibrillation, VTE, or MHVs. Avoid unwarranted OAC interruption by discussing the need for OAC interruptions with the surgeon or proceduralist, especially if the surgery is associated with a low bleeding risk and the patient has a high thromboembolic risk. When a periprocedural OAC interruption is justified, bridging should be avoided in the majority of patients, especially those with low to moderate thromboembolic risk or increased bleeding risk according to current risk-stratification schema.7,15,19
Periprocedural management of direct oral anticoagulants (DOACs) is different than that of warfarin. The duration of DOAC interruption is determined by the procedural bleeding risk, drug half-life, and a patient’s creatinine clearance. Although the pharmacokinetics of DOACs generally allow for brief interruptions (eg, 24-48 hours), longer interruptions (eg, 96-120 hours) are warranted prior to high bleeding risk procedures, when drug half-life is prolonged (ie, dabigatran), and in patients with renal impairment. Parenteral bridging anticoagulation is not recommended during brief DOAC interruptions, and substituting a DOAC in place of LMWH for bridging is not advised. The 2017 American College of Cardiology Expert Consensus Decision Pathway provides periprocedural OAC interruption guidance for atrial fibrillation, with many principles applicable to other OAC indications.15We developed an institutional guideline that provides clinicians a structured approach to bridging OAC that steers them away from inappropriate bridging and helps them make decisions when evidence is lacking. Shared decision-making represents another effective method for well-informed patients and clinicians to arrive at a mutually agreed upon bridging decision.
RECOMMENDATIONS
- Avoid unnecessary periprocedural interruptions of OAC, especially for procedures with a low bleeding risk.
- Avoid the administration of bridging anticoagulation in patients with low to moderate thromboembolic risk during periprocedural OAC interruptions.
- In patients with a high thromboembolic risk, an individualized assessment of the patient-specific and procedure-specific bleeding risks versus the thromboembolic risks is necessary when considering bridging anticoagulation administration.
CONCLUSION
Returning to the opening case, the patient requires an anticoagulation interruption and INR correction prior to surgery. Because the CHA2DS2VaSc score of 4 does not categorize him as a high thromboembolic risk, bridging anticoagulation should be avoided. In the majority of patients on OAC, bridging anticoagulation does not reduce thromboembolic events and is associated with increased major bleeding. Unnecessary anticoagulation interruptions should be avoided for procedures associated with low bleeding risk. Bridging should not be administered to the majority of patients requiring a periprocedural anticoagulation interruption.
Do
Disclosure: The authors report no conflicts of interest relevant to this article to disclose.
1. Kirley K, Qato DM, Kornfield R, Stafford RS, Alexander GC. National trends in oral anticoagulant use in the United States, 2007 to 2011. Circ Cardiovasc Qual Outcomes. 2012;5(5):615-621. PubMed
2. Steinberg BA, Peterson ED, Kim S, et al. Use and outcomes associated with bridging during anticoagulation interruptions in patients with atrial fibrillation: findings from the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF). Circulation. 2015;131(5):488-494. PubMed
3. Kearon C, Hirsh J. Management of anticoagulation before and after elective surgery. N Engl J Med. 1997;336(21):1506-1511. PubMed
4. Eckman MH. “Bridging on the river Kwai”: the perioperative management of anticoagulation therapy. Med Decis Making. 2005;25(4):370-373. PubMed
5. Dunn AS, Turpie AG. Perioperative management of patients receiving oral anticoagulants: a systematic review. Arch Intern Med. 2003;163(8):901-908. PubMed
6. January CT, Wann LS, Alpert JS, et al. 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on practice guidelines and the Heart Rhythm Society. Circulation. 2014;130(23):2071-2104. PubMed
7. Douketis JD, Spyropoulos AC, Spencer FA, et al. Perioperative management of antithrombotic therapy: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012;141(2 Suppl):e326S-e350S. PubMed
8. Gerson LB, Gage BF, Owens DK, Triadafilopoulos G. Effect and outcomes of the ASGE guidelines on the periendoscopic management of patients who take anticoagulants. Am J Gastroenterol. 2000;95(7):1717-1724. PubMed
9. Birnie DH, Healey JS, Wells GA, et al. Pacemaker or defibrillator surgery without interruption of anticoagulation. N Engl J Med. 2013;368(22):2084-2093. PubMed
10. Douketis JD, Johnson JA, Turpie AG. Low-molecular-weight heparin as bridging anticoagulation during interruption of warfarin: assessment of a standardized periprocedural anticoagulation regimen. Arch Intern Med. 2004;164(12):1319-1326. PubMed
11. Spyropoulos AC, Turpie AG, Dunn AS, et al. Clinical outcomes with unfractionated heparin or low-molecular-weight heparin as bridging therapy in patients on long-term oral anticoagulants: the REGIMEN registry. J Thromb Haemost. 2006;4(6):1246-1252. PubMed
12. Kovacs MJ, Kearon C, Rodger M, et al. Single-arm study of bridging therapy with low-molecular-weight heparin for patients at risk of arterial embolism who require temporary interruption of warfarin. Circulation. 2004;110(12):1658-1663. PubMed
13. Siegal D, Yudin J, Kaatz S, Douketis JD, Lim W, Spyropoulos AC. Periprocedural heparin bridging in patients receiving vitamin K antagonists: systematic review and meta-analysis of bleeding and thromboembolic rates. Circulation. 2012;126(13):1630-1639. PubMed
14. Douketis JD, Spyropoulos AC, Kaatz S, et al. Perioperative Bridging Anticoagulation in Patients with Atrial Fibrillation. N Engl J Med. 2015;373(9):823-833. PubMed
15. Doherty JU, Gluckman TJ, Hucker WJ, et al. 2017 ACC Expert Consensus Decision Pathway for Periprocedural Management of Anticoagulation in Patients With Nonvalvular Atrial Fibrillation: A Report of the American College of Cardiology Clinical Expert Consensus Document Task Force. J Am Coll Cardiol. 2017;69(7):871-898. PubMed
16. Daniels PR, McBane RD, Litin SC, et al. Peri-procedural anticoagulation management of mechanical prosthetic heart valve patients. Thromb Res. 2009;124(3):300-305. PubMed
17. Clark NP, Witt DM, Davies LE, et al. Bleeding, Recurrent Venous Thromboembolism, and Mortality Risks During Warfarin Interruption for Invasive Procedures. JAMA Intern Med. 2015;175(7):1163-1168. PubMed
18. Carrier M, Le Gal G, Wells PS, Rodger MA. Systematic review: case-fatality rates of recurrent venous thromboembolism and major bleeding events among patients treated for venous thromboembolism. Ann Intern Med. 2010;152(9):578-589. PubMed
19. Nishimura RA, Otto CM, Bonow RO, et al. 2017 AHA/ACC Focused Update of the 2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2017;135(25):e1159-e1195. PubMed
1. Kirley K, Qato DM, Kornfield R, Stafford RS, Alexander GC. National trends in oral anticoagulant use in the United States, 2007 to 2011. Circ Cardiovasc Qual Outcomes. 2012;5(5):615-621. PubMed
2. Steinberg BA, Peterson ED, Kim S, et al. Use and outcomes associated with bridging during anticoagulation interruptions in patients with atrial fibrillation: findings from the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF). Circulation. 2015;131(5):488-494. PubMed
3. Kearon C, Hirsh J. Management of anticoagulation before and after elective surgery. N Engl J Med. 1997;336(21):1506-1511. PubMed
4. Eckman MH. “Bridging on the river Kwai”: the perioperative management of anticoagulation therapy. Med Decis Making. 2005;25(4):370-373. PubMed
5. Dunn AS, Turpie AG. Perioperative management of patients receiving oral anticoagulants: a systematic review. Arch Intern Med. 2003;163(8):901-908. PubMed
6. January CT, Wann LS, Alpert JS, et al. 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on practice guidelines and the Heart Rhythm Society. Circulation. 2014;130(23):2071-2104. PubMed
7. Douketis JD, Spyropoulos AC, Spencer FA, et al. Perioperative management of antithrombotic therapy: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012;141(2 Suppl):e326S-e350S. PubMed
8. Gerson LB, Gage BF, Owens DK, Triadafilopoulos G. Effect and outcomes of the ASGE guidelines on the periendoscopic management of patients who take anticoagulants. Am J Gastroenterol. 2000;95(7):1717-1724. PubMed
9. Birnie DH, Healey JS, Wells GA, et al. Pacemaker or defibrillator surgery without interruption of anticoagulation. N Engl J Med. 2013;368(22):2084-2093. PubMed
10. Douketis JD, Johnson JA, Turpie AG. Low-molecular-weight heparin as bridging anticoagulation during interruption of warfarin: assessment of a standardized periprocedural anticoagulation regimen. Arch Intern Med. 2004;164(12):1319-1326. PubMed
11. Spyropoulos AC, Turpie AG, Dunn AS, et al. Clinical outcomes with unfractionated heparin or low-molecular-weight heparin as bridging therapy in patients on long-term oral anticoagulants: the REGIMEN registry. J Thromb Haemost. 2006;4(6):1246-1252. PubMed
12. Kovacs MJ, Kearon C, Rodger M, et al. Single-arm study of bridging therapy with low-molecular-weight heparin for patients at risk of arterial embolism who require temporary interruption of warfarin. Circulation. 2004;110(12):1658-1663. PubMed
13. Siegal D, Yudin J, Kaatz S, Douketis JD, Lim W, Spyropoulos AC. Periprocedural heparin bridging in patients receiving vitamin K antagonists: systematic review and meta-analysis of bleeding and thromboembolic rates. Circulation. 2012;126(13):1630-1639. PubMed
14. Douketis JD, Spyropoulos AC, Kaatz S, et al. Perioperative Bridging Anticoagulation in Patients with Atrial Fibrillation. N Engl J Med. 2015;373(9):823-833. PubMed
15. Doherty JU, Gluckman TJ, Hucker WJ, et al. 2017 ACC Expert Consensus Decision Pathway for Periprocedural Management of Anticoagulation in Patients With Nonvalvular Atrial Fibrillation: A Report of the American College of Cardiology Clinical Expert Consensus Document Task Force. J Am Coll Cardiol. 2017;69(7):871-898. PubMed
16. Daniels PR, McBane RD, Litin SC, et al. Peri-procedural anticoagulation management of mechanical prosthetic heart valve patients. Thromb Res. 2009;124(3):300-305. PubMed
17. Clark NP, Witt DM, Davies LE, et al. Bleeding, Recurrent Venous Thromboembolism, and Mortality Risks During Warfarin Interruption for Invasive Procedures. JAMA Intern Med. 2015;175(7):1163-1168. PubMed
18. Carrier M, Le Gal G, Wells PS, Rodger MA. Systematic review: case-fatality rates of recurrent venous thromboembolism and major bleeding events among patients treated for venous thromboembolism. Ann Intern Med. 2010;152(9):578-589. PubMed
19. Nishimura RA, Otto CM, Bonow RO, et al. 2017 AHA/ACC Focused Update of the 2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2017;135(25):e1159-e1195. PubMed
© 2018 Society of Hospital Medicine
The Authors Reply, “The Weekend Effect in Hospitalized Patients”
We would like to thank Drs. Flansbaum and Sheehy for their interest in our article.1 We appreciate their mentioning the highly publicized disputes and additional manuscripts2,3 that were published after our literature review, which was conducted in 2013
Despite the uncertainty surrounding the exact composition and contributions of various elements to the weekend effect, it does appear to be a real phenomenon, as noted by the editorialists.4 We hope that our manuscript encourages future investigators to help elucidate the nature of the input contributing to the weekend effect.
1. Pauls LA, Johnson-Paben R, McGready J, Murphy JD, Pronovost PJ, Wu CL. The weekend effect in hospitalized patients: A meta-analysis. J Hosp Med. 2017;12(9):760-766. PubMed
2. Freemantle N, Ray D, McNulty D, et al. Increased mortality associated with weekend hospital admission: a case for expanded seven day service? BMJ. 2015;351:h4596. PubMed
3. Walker AS, Mason A, Phoung Quan TP, et al. Mortality risks associated with emergency admissions during weekends and public holidays: An analysis of electronic health records. Lancet. 2017;390(10089):62-72. PubMed
4. Quinn KL, Bell CM. Does the week-end justify the means? J Hosp Med. 2017;12(9):779-780. PubMed
We would like to thank Drs. Flansbaum and Sheehy for their interest in our article.1 We appreciate their mentioning the highly publicized disputes and additional manuscripts2,3 that were published after our literature review, which was conducted in 2013
Despite the uncertainty surrounding the exact composition and contributions of various elements to the weekend effect, it does appear to be a real phenomenon, as noted by the editorialists.4 We hope that our manuscript encourages future investigators to help elucidate the nature of the input contributing to the weekend effect.
We would like to thank Drs. Flansbaum and Sheehy for their interest in our article.1 We appreciate their mentioning the highly publicized disputes and additional manuscripts2,3 that were published after our literature review, which was conducted in 2013
Despite the uncertainty surrounding the exact composition and contributions of various elements to the weekend effect, it does appear to be a real phenomenon, as noted by the editorialists.4 We hope that our manuscript encourages future investigators to help elucidate the nature of the input contributing to the weekend effect.
1. Pauls LA, Johnson-Paben R, McGready J, Murphy JD, Pronovost PJ, Wu CL. The weekend effect in hospitalized patients: A meta-analysis. J Hosp Med. 2017;12(9):760-766. PubMed
2. Freemantle N, Ray D, McNulty D, et al. Increased mortality associated with weekend hospital admission: a case for expanded seven day service? BMJ. 2015;351:h4596. PubMed
3. Walker AS, Mason A, Phoung Quan TP, et al. Mortality risks associated with emergency admissions during weekends and public holidays: An analysis of electronic health records. Lancet. 2017;390(10089):62-72. PubMed
4. Quinn KL, Bell CM. Does the week-end justify the means? J Hosp Med. 2017;12(9):779-780. PubMed
1. Pauls LA, Johnson-Paben R, McGready J, Murphy JD, Pronovost PJ, Wu CL. The weekend effect in hospitalized patients: A meta-analysis. J Hosp Med. 2017;12(9):760-766. PubMed
2. Freemantle N, Ray D, McNulty D, et al. Increased mortality associated with weekend hospital admission: a case for expanded seven day service? BMJ. 2015;351:h4596. PubMed
3. Walker AS, Mason A, Phoung Quan TP, et al. Mortality risks associated with emergency admissions during weekends and public holidays: An analysis of electronic health records. Lancet. 2017;390(10089):62-72. PubMed
4. Quinn KL, Bell CM. Does the week-end justify the means? J Hosp Med. 2017;12(9):779-780. PubMed
© 2018 Society of Hospital Medicine
What Is Career Success for Academic Hospitalists? A Qualitative Analysis of Early-Career Faculty Perspectives
Academic hospital medicine is a young specialty, with most faculty at the rank of instructor or assistant professor.1 Traditional markers of academic success for clinical and translational investigators emphasize progressive, externally funded grants, achievements in basic science research, and prolific publication in the peer-reviewed literature.2 Promotion is often used as a proxy measure for academic success.
Conceptual models of career success derived from nonhealthcare industries and for physician-scientists include both extrinsic and intrinsic domains.3,4 Extrinsic domains of career success include financial rewards (compensation) and progression in hierarchical status (advancement).3,4 Intrinsic domains of career success include pleasure derived from daily work (job satisfaction) and satisfaction derived from aspects of the career over time (career satisfaction).3,4
Research is limited regarding hospitalist faculty beliefs about career success. A better understanding of hospitalist perspectives can inform program development to support junior faculty in academic hospital medicine. In this phenomenological, qualitative study, we explore the global concept of career success as perceived by early-career clinician-educator hospitalists.
METHODS
Study Design, Setting, and Participants
We conducted interviews with hospitalists from 3 academic medical centers between May 2016 and October 2016. Purposeful sampling was used.5 Leaders within each hospital medicine group identified early-career faculty with approximately 2 to 5 years in academic medicine with a rank of instructor or assistant professor at each institution likely to self-identify as clinician-educators for targeted solicitation to enroll. Additional subjects were recruited until thematic saturation had been achieved on the personal definition of career success. Participants received disclosure and consent documents prior to enrollment. No compensation was provided to participants. This study was approved by the Colorado Multiple Institutional Review Board.
Interview Guide Development and Content
The semistructured interview format was developed and validated through an iterative process. Proposed questions were developed by study investigators on the basis of review of the literature on career success in nonhealthcare industries and academic hospitalist promotion. The questions were assessed for content validity through a review of interview domains by an academic hospitalist program director (R. P.). Cognitive interviewing with 3 representative academic hospitalists who were not part of the study cohort was done as an additional face-validation step of the question probe structure. As a result of the cognitive interviews, 1 question was eliminated, and a framework for clarifications and answer probes was derived prior to the enrollment of the first study subject. No changes were made to the interview format during the study period.
Data Collection
The principal investigator (E.C.) performed all interviews by using the interview tool consisting of 7 demographic questions and 11 open-ended questions and exploring aspects of the concept of career success. The initial open-ended question, “How would you personally define career success as an academic hospitalist at this stage in your career?” represented the primary question of interest. Follow-up questions were used to better understand responses to the primary question. All interviews were audio recorded, deidentified, and transcribed by the principal investigator. Transcripts were randomly audited by a second investigator (E.Y.) for accuracy and completeness.
Sample Size Determination
Interviews were continued to thematic saturation. After the first 3 interviews were transcribed, 2 members of the research team (E.C. and P.K.) reviewed the transcripts and developed a preliminary thematic codebook for the primary question. Subsequent interviews were reviewed and analyzed against these themes. Interviews were continued to thematic saturation, which was defined as more than 3 sequential interviews with no new identified themes.6
Data Analysis
By using qualitative data analysis software (ATLAS.ti version 7; ATLAS.ti Scientific Software Development GmbH, Berlin, Germany), transcriptions were analyzed with a team-based, mixed inductive-deductive approach. An inductive approach was utilized to allow basic theme codes to emerge from the raw text, and thus remaining open to unanticipated themes. Investigators assessed each distinct quote for new themes, confirmatory themes, and challenges to previously developed concepts. Basic themes were then discussed among research team members to determine prominent themes, with basic theme codes added, removed, or combined at this stage of the analysis. Responses to each follow-up question were subsequently assessed for new themes, confirmatory themes, or challenges to previously developed concepts related to the personal definition of career success. A deductive approach was then used to map our inductively generated themes back to the organizing themes of the existing conceptual framework.
RESULTS
Thematic Mapping to Organizing Themes of the Conceptual Model (Table)
The single most dominant theme, “excitement about daily work” was connected to an intrinsic sense of job satisfaction. Career satisfaction emerged from interviews more frequently than extrinsic organizing themes, such as advancement or compensation. Advancement through promotion was infrequently referenced as part of success, and tenure was never raised despite being available for clinician-educators at 2 of the 3 institutions. Compensation was not referenced in any interviewee’s initial definition of career success, although in 1 interview, it came up in response to a follow-up question. The Figure visually represents the relative weighting (shown by the sizes of the boxes) of organizing themes to the early-career hospitalists’ self-concepts of career success. Relationships among organizing themes as they emerged from interviews are represented by arrows.
Intrinsic—Job Satisfaction
With regard to job satisfaction, early-career faculty often invoked words such as “excitement,” “enjoyment,” and “passionate” to describe an overall theme of “excitement about daily work.” A positive affective state created by the nature of daily work was described as integral to the personal sense of career success. It was also strongly associated with perception of sustainability in a hospitalist career.
“I think [career success] would be job satisfaction. …So, for me, that would be happiness with my job. I like coming to work. I like doing what I do and at the end of the day going home and saying that was a good day. I like to think that would be success at work…is how I would define it.”
This theme was also related to a negative aspect often referred to as burnout, which many identified as antithetical to career success. More often, they described success as a heightened state of enthusiasm for the daily work experience.
“I am staying engaged and excited. So, I am not just taking care of patients; I am not just teaching. Having enough excitement from my work to come home and talk about it at dinner. To enjoy my days off but at the same time being excited to get back to work.”
This description of passion toward the work of being a hospitalist was often linked to a sense of deeper purpose found through the delivery of clinical care and education of learners.
“I really feel that we have the opportunity to very meaningfully and powerfully impact people’s lives, and that to me is meaningful. …That’s value. ...That’s coming home at the end of the day and thinking that you have had a positive impact.”
The interviews reflected that core to meaningful work was a sense of personal efficacy as a clinician, which was reflected in the themes of clinical proficiency and practicing high-quality care.
“I think developing clinical expertise, both through experience and studying. Getting to the point to where you can take really excellent care of your patient through expertise would be a sense of success that a lot of academic hospitalists would strive for.”
Intrinsic—Career Satisfaction
Within career satisfaction, participants described that “being respected and recognized” and “dissemination of work” were important contributors to career success. Reputation was frequently referenced as a measure of career success. Reputation was defined by some in a local context of having the respect of learners, peers, and others as a national renown. As a prerequisite for developing a reputation beyond the local academic environment, dissemination of work was often referenced as an important component of satisfaction in the career. This dissemination extended beyond peer-reviewed publications and included other forms of scholarship, presentations at conferences, and sharing clinical innovations between hospitals.
“For me personally, I have less of an emphasis on research and some of the more, I don’t want to say ‘academic’ because I think education is academic, but maybe some of the more scholarly practice of medicine, doing research and the writing of papers and things like that, although I certainly view some of that as a part of career success.”
Within career satisfaction, participants also described a diverse set of themes, including progressive improvement in skills, developing a self-perception of excellence in 1 or more arenas of academic medicine, leadership, work–life integration, innovation, and relationships. The concept of developing a niche, or becoming an expert in a particular domain of hospital medicine, was frequently referenced.
“I think part of [success] is ‘Have they identified a niche?’ Because I think if you want to be in an academic center, as much as I value teaching and taking care of patients, I think 1 of the advantages is the opportunity to potentially identify an area of expertise.”
Participants frequently alluded to the idea that the most important aspects of career satisfaction are not static phenomena but rather values that could evolve over the course of a career. For instance, in the early-career, making a difference with individual learners or patients could have greater valence, but as the career progressed, finding a niche, disseminating work, and building a national reputation would gain importance to a personal sense of career satisfaction.
Extrinsic—Advancement
Promotion was typically referenced when discussing career success, but it was not uniformly valued by early career hospitalists. Some expressed significant ambivalence about its effect on their personal sense of career success. Academic hospitalists identified a number of organizations with definitions of success that influence them. Definitions of success for the university were more relevant to interviewees compared to those of the hospital or professional societies. Interviewees were able to describe a variety of criteria by which their universities define or recognize career success. These commonly included promotion, publications and/or scholarship, and research. The list of factors perceived as success by the hospital were often distinct from those of the university and included cost-effective care, patient safety, and clinical leadership roles.
Participants described a sense of internal conflict when external-stakeholder definitions of success diverged from internal motivators. This was particularly true when this divergence led academic hospitalists to engage in activities for advancement that they did not find personally fulfilling. Academic hospitalists recognized that advancement was central to the concept of career success for organizations even if this was not identified as being core to their personal definitions of success.
“I think that for me, the idea of being promoted and being a leader in the field is less important to me than...for the organization.”
Hospitalists expressed that objective markers, such as promotion and publications, were perceived as more important at higher levels of the academic organization, whereas more subjective aspects of success, aligned with intrinsic personal definitions, were more valued within the hospital medicine group.
Extrinsic—Compensation
Compensation was notable for its absence in participants’ discussion of career success. When asked about their definitions of career success, academic hospitalists did not spontaneously raise the topic of compensation. The only mention of compensation was in response to a question about how personal and external definitions of career success differ.
Unexpected Findings
While it was almost universally recognized by participants as important, ambivalence toward the “academic value of clinical work,” “scholarship,” and especially “promotion” represented an unexpected thematic family.
“I can’t quite get excited about a title attached to my name or the number of times my name pops up when I enter it into PubMed. My personal definition is more…where do I have something that I am interested [in] that someone else values. And that value is not shown as an associate professorship or an assistant professorship next to my name. …When you push me on it, you could call me clinical instructor forever, and I don’t think I would care too much.”
The interaction between work and personal activities as representing complementary aspects of a global sense of success was also unexpected and ran contrary to a simplistic conception of work and life in conflict. Academic hospitalists referenced that the ability to participate in aspects of life external to the workplace was important to their sense of career success. Participants frequently used phrases such as “work–life balance” to encompass a larger sense that work and nonwork life needed to merge to form a holistic sense of having a positive impact.
“Personal success is becoming what I have termed a ‘man of worth.’ I think [that is] someone who feels as though they make a positive impact in the world. Through both my career, but I guess the things that I do that are external to my career. Those would be defined by being a good husband, a good son, a philanthropist out in the community…sometimes, these are not things that can necessarily go on a [curriculum vitae].”
Conflict Among Organizing Themes
At times, academic hospitalists described a tension between day-to-day job satisfaction and what would be necessary to accomplish longer-term career success in the other organizing themes. This was reflected by a sense of trade-off. For instance, activities that lead to some aspects of career satisfaction or advancement would take time away from the direct exposure to learners and clinical care that currently drive job satisfaction.
“If the institution wanted me to be more productive from a research standpoint or…advocate that I receive funding so I could buy down clinical time and interactions I have with my students and my patients, then I can see my satisfaction going down.”
Many described a sense of engaging in activities they did not find personally fulfilling because of a sense of expectation that those activities were considered successful by others. Some described a state in which the drive toward advancement as an extrinsic incentive could come at the expense of the intrinsic rewards of being an academic hospitalist.
DISCUSSION
Career success has been defined as “the positive psychological or work-related outcomes or achievements one accumulates as a result of work experiences.”4,7,8 Academic career success for hospitalist faculty isn’t as well defined and has not been examined from the perspectives of early-career clinician-educator hospitalist faculty themselves.
The themes that emerged in this study describe a definition of success anchored in the daily work of striving to become an exceptional clinician and teacher. The major themes included (1) having excitement about daily work, (2) having meaningful impact, (3) development of a niche (4) a sense of respect within the sphere of academic medicine, and (5) disseminating work.
Success was very much internally defined as having a positive, meaningful impact on patients, learners, and the systems in which they practice. The faculty had a conception of what promotion committees value and often internalized aspects of this, such as developing a national reputation and giving talks at national meetings. Participants typically self-identified as clinician-educators, and yet dissemination of work remained an important component of personal success. While promotion was clearly identified as a marker of success, academic hospitalists often rejected the supposition of promotion itself as a professional goal. They expressed hope, and some skepticism, that external recognition of career success would follow the pursuit of internally meaningful goals.
While promotion and peer-reviewed publications represent easily measured markers often used as proxies for individual career and programmatic success, our research demonstrates that there is a deep well of externally imperceptible influences on an individual’s sense of success as an academic hospitalist. In our analysis, intrinsic elements of career success received far greater weight with early-career academic hospitalists. Our findings are supported by a prior survey of academic physicians that similarly found that faculty with >50% of their time devoted to clinical care placed greater career value in patient care, relationships with patients, and recognition by patients and residents compared to national reputation.9 Similar to our own findings, highly clinical faculty in that study were also less likely to value promotion and tenure as indicators of career success.9
The main focus of our questions was how early-career faculty define success at this point in their careers. When asked to extrapolate to a future state of career success, the concept of progression was repeatedly raised. This included successive promotions to higher academic ranks, increasing responsibility, titles, leadership, and achieving competitive roles or awards. It also included a progressively increasing impact of scholarship, growing national reputation, and becoming part of a network of accomplished academic hospitalists across the country. Looking forward, our early-career hospitalists felt that long-term career success would represent accomplishing these things and still being able to be focused on being excellent clinicians to patients, having a work–life balance, and keeping joy and excitement in daily activities.
Our work has limitations, including a focus on early-career clinician-educator hospitalists. The perception of career success may evolve over time, and future work to examine perceptions in more advanced academic hospitalists would be of interest. Our work used purposeful sampling to capture individuals who were likely to self-identify as academic clinician-educators, and results may not generalize to hospitalist physician-scientists or hospitalists in community practices.
Our analysis suggests that external organizations influence internal perceptions of career success. However, success is ultimately defined by the individual and not the institution. Efforts to measure and improve academic hospitalists’ attainment of career success should attend to intrinsic aspects of satisfaction in addition to objective measures, such as publications and promotion. This may provide a mechanism to address burnout and improve retention. As important as commonality in themes is the variation in self-definitions of career success among individuals. This suggests the value of inquiry by academic leadership in exploring and understanding what success is from the individual faculty perspective. This may enhance the alignment among personal definitions, organizational values, and, ultimately, sustainable, successful careers.
Disclosure: The authors have nothing to disclose.
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4. Judge TA, Cable DM, Boudreau JW, Bretz RD. An empirical investigation of the predictors of executive career success (CAHRS Working Paper #94-08). Ithaca, NY: Cornell University, School of Industrial and Labor Relations, Center for Advanced Human Resource Studies. 1994. http://digitalcommons.ilr.cornell.edu/cahrswp/233. Accessed November 27, 2017.
5. Palinkas LA, Horwitz SM, Green CA, Wisdom JP, Duan N, Hoagwood K. Purposeful sampling for qualitative data collection and analysis in mixed method implementation research. Adm Policy Ment Health. 2015;42(5):533-544. PubMed
6. Francis JJ, Johnston M, Robertson C, et al. What is an adequate sample size? Operationalising data saturation for theory-based interview studies. Psychol Health. 2010;25(10):1229-1245. PubMed
7. Abele AE, Spurk, D. The longitudinal impact of self-efficacy and career goals on objective and subjective career success. J Vocat Behav. 2009;74(1):53-62.
8. Seibert SE, Kraimer ML. The five-factor model of personality and career success. J Vocat Behav. 2011;58(1):1-21.
9. Buckley, LM, Sanders K, Shih M, Hampton CL. Attitudes of Clinical Faculty About Career Progress, Career Success, and Commitment to Academic Medicine: Results of a Survey. Arch Intern Med. 2000;160(17):2625-2629. PubMed
Academic hospital medicine is a young specialty, with most faculty at the rank of instructor or assistant professor.1 Traditional markers of academic success for clinical and translational investigators emphasize progressive, externally funded grants, achievements in basic science research, and prolific publication in the peer-reviewed literature.2 Promotion is often used as a proxy measure for academic success.
Conceptual models of career success derived from nonhealthcare industries and for physician-scientists include both extrinsic and intrinsic domains.3,4 Extrinsic domains of career success include financial rewards (compensation) and progression in hierarchical status (advancement).3,4 Intrinsic domains of career success include pleasure derived from daily work (job satisfaction) and satisfaction derived from aspects of the career over time (career satisfaction).3,4
Research is limited regarding hospitalist faculty beliefs about career success. A better understanding of hospitalist perspectives can inform program development to support junior faculty in academic hospital medicine. In this phenomenological, qualitative study, we explore the global concept of career success as perceived by early-career clinician-educator hospitalists.
METHODS
Study Design, Setting, and Participants
We conducted interviews with hospitalists from 3 academic medical centers between May 2016 and October 2016. Purposeful sampling was used.5 Leaders within each hospital medicine group identified early-career faculty with approximately 2 to 5 years in academic medicine with a rank of instructor or assistant professor at each institution likely to self-identify as clinician-educators for targeted solicitation to enroll. Additional subjects were recruited until thematic saturation had been achieved on the personal definition of career success. Participants received disclosure and consent documents prior to enrollment. No compensation was provided to participants. This study was approved by the Colorado Multiple Institutional Review Board.
Interview Guide Development and Content
The semistructured interview format was developed and validated through an iterative process. Proposed questions were developed by study investigators on the basis of review of the literature on career success in nonhealthcare industries and academic hospitalist promotion. The questions were assessed for content validity through a review of interview domains by an academic hospitalist program director (R. P.). Cognitive interviewing with 3 representative academic hospitalists who were not part of the study cohort was done as an additional face-validation step of the question probe structure. As a result of the cognitive interviews, 1 question was eliminated, and a framework for clarifications and answer probes was derived prior to the enrollment of the first study subject. No changes were made to the interview format during the study period.
Data Collection
The principal investigator (E.C.) performed all interviews by using the interview tool consisting of 7 demographic questions and 11 open-ended questions and exploring aspects of the concept of career success. The initial open-ended question, “How would you personally define career success as an academic hospitalist at this stage in your career?” represented the primary question of interest. Follow-up questions were used to better understand responses to the primary question. All interviews were audio recorded, deidentified, and transcribed by the principal investigator. Transcripts were randomly audited by a second investigator (E.Y.) for accuracy and completeness.
Sample Size Determination
Interviews were continued to thematic saturation. After the first 3 interviews were transcribed, 2 members of the research team (E.C. and P.K.) reviewed the transcripts and developed a preliminary thematic codebook for the primary question. Subsequent interviews were reviewed and analyzed against these themes. Interviews were continued to thematic saturation, which was defined as more than 3 sequential interviews with no new identified themes.6
Data Analysis
By using qualitative data analysis software (ATLAS.ti version 7; ATLAS.ti Scientific Software Development GmbH, Berlin, Germany), transcriptions were analyzed with a team-based, mixed inductive-deductive approach. An inductive approach was utilized to allow basic theme codes to emerge from the raw text, and thus remaining open to unanticipated themes. Investigators assessed each distinct quote for new themes, confirmatory themes, and challenges to previously developed concepts. Basic themes were then discussed among research team members to determine prominent themes, with basic theme codes added, removed, or combined at this stage of the analysis. Responses to each follow-up question were subsequently assessed for new themes, confirmatory themes, or challenges to previously developed concepts related to the personal definition of career success. A deductive approach was then used to map our inductively generated themes back to the organizing themes of the existing conceptual framework.
RESULTS
Thematic Mapping to Organizing Themes of the Conceptual Model (Table)
The single most dominant theme, “excitement about daily work” was connected to an intrinsic sense of job satisfaction. Career satisfaction emerged from interviews more frequently than extrinsic organizing themes, such as advancement or compensation. Advancement through promotion was infrequently referenced as part of success, and tenure was never raised despite being available for clinician-educators at 2 of the 3 institutions. Compensation was not referenced in any interviewee’s initial definition of career success, although in 1 interview, it came up in response to a follow-up question. The Figure visually represents the relative weighting (shown by the sizes of the boxes) of organizing themes to the early-career hospitalists’ self-concepts of career success. Relationships among organizing themes as they emerged from interviews are represented by arrows.
Intrinsic—Job Satisfaction
With regard to job satisfaction, early-career faculty often invoked words such as “excitement,” “enjoyment,” and “passionate” to describe an overall theme of “excitement about daily work.” A positive affective state created by the nature of daily work was described as integral to the personal sense of career success. It was also strongly associated with perception of sustainability in a hospitalist career.
“I think [career success] would be job satisfaction. …So, for me, that would be happiness with my job. I like coming to work. I like doing what I do and at the end of the day going home and saying that was a good day. I like to think that would be success at work…is how I would define it.”
This theme was also related to a negative aspect often referred to as burnout, which many identified as antithetical to career success. More often, they described success as a heightened state of enthusiasm for the daily work experience.
“I am staying engaged and excited. So, I am not just taking care of patients; I am not just teaching. Having enough excitement from my work to come home and talk about it at dinner. To enjoy my days off but at the same time being excited to get back to work.”
This description of passion toward the work of being a hospitalist was often linked to a sense of deeper purpose found through the delivery of clinical care and education of learners.
“I really feel that we have the opportunity to very meaningfully and powerfully impact people’s lives, and that to me is meaningful. …That’s value. ...That’s coming home at the end of the day and thinking that you have had a positive impact.”
The interviews reflected that core to meaningful work was a sense of personal efficacy as a clinician, which was reflected in the themes of clinical proficiency and practicing high-quality care.
“I think developing clinical expertise, both through experience and studying. Getting to the point to where you can take really excellent care of your patient through expertise would be a sense of success that a lot of academic hospitalists would strive for.”
Intrinsic—Career Satisfaction
Within career satisfaction, participants described that “being respected and recognized” and “dissemination of work” were important contributors to career success. Reputation was frequently referenced as a measure of career success. Reputation was defined by some in a local context of having the respect of learners, peers, and others as a national renown. As a prerequisite for developing a reputation beyond the local academic environment, dissemination of work was often referenced as an important component of satisfaction in the career. This dissemination extended beyond peer-reviewed publications and included other forms of scholarship, presentations at conferences, and sharing clinical innovations between hospitals.
“For me personally, I have less of an emphasis on research and some of the more, I don’t want to say ‘academic’ because I think education is academic, but maybe some of the more scholarly practice of medicine, doing research and the writing of papers and things like that, although I certainly view some of that as a part of career success.”
Within career satisfaction, participants also described a diverse set of themes, including progressive improvement in skills, developing a self-perception of excellence in 1 or more arenas of academic medicine, leadership, work–life integration, innovation, and relationships. The concept of developing a niche, or becoming an expert in a particular domain of hospital medicine, was frequently referenced.
“I think part of [success] is ‘Have they identified a niche?’ Because I think if you want to be in an academic center, as much as I value teaching and taking care of patients, I think 1 of the advantages is the opportunity to potentially identify an area of expertise.”
Participants frequently alluded to the idea that the most important aspects of career satisfaction are not static phenomena but rather values that could evolve over the course of a career. For instance, in the early-career, making a difference with individual learners or patients could have greater valence, but as the career progressed, finding a niche, disseminating work, and building a national reputation would gain importance to a personal sense of career satisfaction.
Extrinsic—Advancement
Promotion was typically referenced when discussing career success, but it was not uniformly valued by early career hospitalists. Some expressed significant ambivalence about its effect on their personal sense of career success. Academic hospitalists identified a number of organizations with definitions of success that influence them. Definitions of success for the university were more relevant to interviewees compared to those of the hospital or professional societies. Interviewees were able to describe a variety of criteria by which their universities define or recognize career success. These commonly included promotion, publications and/or scholarship, and research. The list of factors perceived as success by the hospital were often distinct from those of the university and included cost-effective care, patient safety, and clinical leadership roles.
Participants described a sense of internal conflict when external-stakeholder definitions of success diverged from internal motivators. This was particularly true when this divergence led academic hospitalists to engage in activities for advancement that they did not find personally fulfilling. Academic hospitalists recognized that advancement was central to the concept of career success for organizations even if this was not identified as being core to their personal definitions of success.
“I think that for me, the idea of being promoted and being a leader in the field is less important to me than...for the organization.”
Hospitalists expressed that objective markers, such as promotion and publications, were perceived as more important at higher levels of the academic organization, whereas more subjective aspects of success, aligned with intrinsic personal definitions, were more valued within the hospital medicine group.
Extrinsic—Compensation
Compensation was notable for its absence in participants’ discussion of career success. When asked about their definitions of career success, academic hospitalists did not spontaneously raise the topic of compensation. The only mention of compensation was in response to a question about how personal and external definitions of career success differ.
Unexpected Findings
While it was almost universally recognized by participants as important, ambivalence toward the “academic value of clinical work,” “scholarship,” and especially “promotion” represented an unexpected thematic family.
“I can’t quite get excited about a title attached to my name or the number of times my name pops up when I enter it into PubMed. My personal definition is more…where do I have something that I am interested [in] that someone else values. And that value is not shown as an associate professorship or an assistant professorship next to my name. …When you push me on it, you could call me clinical instructor forever, and I don’t think I would care too much.”
The interaction between work and personal activities as representing complementary aspects of a global sense of success was also unexpected and ran contrary to a simplistic conception of work and life in conflict. Academic hospitalists referenced that the ability to participate in aspects of life external to the workplace was important to their sense of career success. Participants frequently used phrases such as “work–life balance” to encompass a larger sense that work and nonwork life needed to merge to form a holistic sense of having a positive impact.
“Personal success is becoming what I have termed a ‘man of worth.’ I think [that is] someone who feels as though they make a positive impact in the world. Through both my career, but I guess the things that I do that are external to my career. Those would be defined by being a good husband, a good son, a philanthropist out in the community…sometimes, these are not things that can necessarily go on a [curriculum vitae].”
Conflict Among Organizing Themes
At times, academic hospitalists described a tension between day-to-day job satisfaction and what would be necessary to accomplish longer-term career success in the other organizing themes. This was reflected by a sense of trade-off. For instance, activities that lead to some aspects of career satisfaction or advancement would take time away from the direct exposure to learners and clinical care that currently drive job satisfaction.
“If the institution wanted me to be more productive from a research standpoint or…advocate that I receive funding so I could buy down clinical time and interactions I have with my students and my patients, then I can see my satisfaction going down.”
Many described a sense of engaging in activities they did not find personally fulfilling because of a sense of expectation that those activities were considered successful by others. Some described a state in which the drive toward advancement as an extrinsic incentive could come at the expense of the intrinsic rewards of being an academic hospitalist.
DISCUSSION
Career success has been defined as “the positive psychological or work-related outcomes or achievements one accumulates as a result of work experiences.”4,7,8 Academic career success for hospitalist faculty isn’t as well defined and has not been examined from the perspectives of early-career clinician-educator hospitalist faculty themselves.
The themes that emerged in this study describe a definition of success anchored in the daily work of striving to become an exceptional clinician and teacher. The major themes included (1) having excitement about daily work, (2) having meaningful impact, (3) development of a niche (4) a sense of respect within the sphere of academic medicine, and (5) disseminating work.
Success was very much internally defined as having a positive, meaningful impact on patients, learners, and the systems in which they practice. The faculty had a conception of what promotion committees value and often internalized aspects of this, such as developing a national reputation and giving talks at national meetings. Participants typically self-identified as clinician-educators, and yet dissemination of work remained an important component of personal success. While promotion was clearly identified as a marker of success, academic hospitalists often rejected the supposition of promotion itself as a professional goal. They expressed hope, and some skepticism, that external recognition of career success would follow the pursuit of internally meaningful goals.
While promotion and peer-reviewed publications represent easily measured markers often used as proxies for individual career and programmatic success, our research demonstrates that there is a deep well of externally imperceptible influences on an individual’s sense of success as an academic hospitalist. In our analysis, intrinsic elements of career success received far greater weight with early-career academic hospitalists. Our findings are supported by a prior survey of academic physicians that similarly found that faculty with >50% of their time devoted to clinical care placed greater career value in patient care, relationships with patients, and recognition by patients and residents compared to national reputation.9 Similar to our own findings, highly clinical faculty in that study were also less likely to value promotion and tenure as indicators of career success.9
The main focus of our questions was how early-career faculty define success at this point in their careers. When asked to extrapolate to a future state of career success, the concept of progression was repeatedly raised. This included successive promotions to higher academic ranks, increasing responsibility, titles, leadership, and achieving competitive roles or awards. It also included a progressively increasing impact of scholarship, growing national reputation, and becoming part of a network of accomplished academic hospitalists across the country. Looking forward, our early-career hospitalists felt that long-term career success would represent accomplishing these things and still being able to be focused on being excellent clinicians to patients, having a work–life balance, and keeping joy and excitement in daily activities.
Our work has limitations, including a focus on early-career clinician-educator hospitalists. The perception of career success may evolve over time, and future work to examine perceptions in more advanced academic hospitalists would be of interest. Our work used purposeful sampling to capture individuals who were likely to self-identify as academic clinician-educators, and results may not generalize to hospitalist physician-scientists or hospitalists in community practices.
Our analysis suggests that external organizations influence internal perceptions of career success. However, success is ultimately defined by the individual and not the institution. Efforts to measure and improve academic hospitalists’ attainment of career success should attend to intrinsic aspects of satisfaction in addition to objective measures, such as publications and promotion. This may provide a mechanism to address burnout and improve retention. As important as commonality in themes is the variation in self-definitions of career success among individuals. This suggests the value of inquiry by academic leadership in exploring and understanding what success is from the individual faculty perspective. This may enhance the alignment among personal definitions, organizational values, and, ultimately, sustainable, successful careers.
Disclosure: The authors have nothing to disclose.
Academic hospital medicine is a young specialty, with most faculty at the rank of instructor or assistant professor.1 Traditional markers of academic success for clinical and translational investigators emphasize progressive, externally funded grants, achievements in basic science research, and prolific publication in the peer-reviewed literature.2 Promotion is often used as a proxy measure for academic success.
Conceptual models of career success derived from nonhealthcare industries and for physician-scientists include both extrinsic and intrinsic domains.3,4 Extrinsic domains of career success include financial rewards (compensation) and progression in hierarchical status (advancement).3,4 Intrinsic domains of career success include pleasure derived from daily work (job satisfaction) and satisfaction derived from aspects of the career over time (career satisfaction).3,4
Research is limited regarding hospitalist faculty beliefs about career success. A better understanding of hospitalist perspectives can inform program development to support junior faculty in academic hospital medicine. In this phenomenological, qualitative study, we explore the global concept of career success as perceived by early-career clinician-educator hospitalists.
METHODS
Study Design, Setting, and Participants
We conducted interviews with hospitalists from 3 academic medical centers between May 2016 and October 2016. Purposeful sampling was used.5 Leaders within each hospital medicine group identified early-career faculty with approximately 2 to 5 years in academic medicine with a rank of instructor or assistant professor at each institution likely to self-identify as clinician-educators for targeted solicitation to enroll. Additional subjects were recruited until thematic saturation had been achieved on the personal definition of career success. Participants received disclosure and consent documents prior to enrollment. No compensation was provided to participants. This study was approved by the Colorado Multiple Institutional Review Board.
Interview Guide Development and Content
The semistructured interview format was developed and validated through an iterative process. Proposed questions were developed by study investigators on the basis of review of the literature on career success in nonhealthcare industries and academic hospitalist promotion. The questions were assessed for content validity through a review of interview domains by an academic hospitalist program director (R. P.). Cognitive interviewing with 3 representative academic hospitalists who were not part of the study cohort was done as an additional face-validation step of the question probe structure. As a result of the cognitive interviews, 1 question was eliminated, and a framework for clarifications and answer probes was derived prior to the enrollment of the first study subject. No changes were made to the interview format during the study period.
Data Collection
The principal investigator (E.C.) performed all interviews by using the interview tool consisting of 7 demographic questions and 11 open-ended questions and exploring aspects of the concept of career success. The initial open-ended question, “How would you personally define career success as an academic hospitalist at this stage in your career?” represented the primary question of interest. Follow-up questions were used to better understand responses to the primary question. All interviews were audio recorded, deidentified, and transcribed by the principal investigator. Transcripts were randomly audited by a second investigator (E.Y.) for accuracy and completeness.
Sample Size Determination
Interviews were continued to thematic saturation. After the first 3 interviews were transcribed, 2 members of the research team (E.C. and P.K.) reviewed the transcripts and developed a preliminary thematic codebook for the primary question. Subsequent interviews were reviewed and analyzed against these themes. Interviews were continued to thematic saturation, which was defined as more than 3 sequential interviews with no new identified themes.6
Data Analysis
By using qualitative data analysis software (ATLAS.ti version 7; ATLAS.ti Scientific Software Development GmbH, Berlin, Germany), transcriptions were analyzed with a team-based, mixed inductive-deductive approach. An inductive approach was utilized to allow basic theme codes to emerge from the raw text, and thus remaining open to unanticipated themes. Investigators assessed each distinct quote for new themes, confirmatory themes, and challenges to previously developed concepts. Basic themes were then discussed among research team members to determine prominent themes, with basic theme codes added, removed, or combined at this stage of the analysis. Responses to each follow-up question were subsequently assessed for new themes, confirmatory themes, or challenges to previously developed concepts related to the personal definition of career success. A deductive approach was then used to map our inductively generated themes back to the organizing themes of the existing conceptual framework.
RESULTS
Thematic Mapping to Organizing Themes of the Conceptual Model (Table)
The single most dominant theme, “excitement about daily work” was connected to an intrinsic sense of job satisfaction. Career satisfaction emerged from interviews more frequently than extrinsic organizing themes, such as advancement or compensation. Advancement through promotion was infrequently referenced as part of success, and tenure was never raised despite being available for clinician-educators at 2 of the 3 institutions. Compensation was not referenced in any interviewee’s initial definition of career success, although in 1 interview, it came up in response to a follow-up question. The Figure visually represents the relative weighting (shown by the sizes of the boxes) of organizing themes to the early-career hospitalists’ self-concepts of career success. Relationships among organizing themes as they emerged from interviews are represented by arrows.
Intrinsic—Job Satisfaction
With regard to job satisfaction, early-career faculty often invoked words such as “excitement,” “enjoyment,” and “passionate” to describe an overall theme of “excitement about daily work.” A positive affective state created by the nature of daily work was described as integral to the personal sense of career success. It was also strongly associated with perception of sustainability in a hospitalist career.
“I think [career success] would be job satisfaction. …So, for me, that would be happiness with my job. I like coming to work. I like doing what I do and at the end of the day going home and saying that was a good day. I like to think that would be success at work…is how I would define it.”
This theme was also related to a negative aspect often referred to as burnout, which many identified as antithetical to career success. More often, they described success as a heightened state of enthusiasm for the daily work experience.
“I am staying engaged and excited. So, I am not just taking care of patients; I am not just teaching. Having enough excitement from my work to come home and talk about it at dinner. To enjoy my days off but at the same time being excited to get back to work.”
This description of passion toward the work of being a hospitalist was often linked to a sense of deeper purpose found through the delivery of clinical care and education of learners.
“I really feel that we have the opportunity to very meaningfully and powerfully impact people’s lives, and that to me is meaningful. …That’s value. ...That’s coming home at the end of the day and thinking that you have had a positive impact.”
The interviews reflected that core to meaningful work was a sense of personal efficacy as a clinician, which was reflected in the themes of clinical proficiency and practicing high-quality care.
“I think developing clinical expertise, both through experience and studying. Getting to the point to where you can take really excellent care of your patient through expertise would be a sense of success that a lot of academic hospitalists would strive for.”
Intrinsic—Career Satisfaction
Within career satisfaction, participants described that “being respected and recognized” and “dissemination of work” were important contributors to career success. Reputation was frequently referenced as a measure of career success. Reputation was defined by some in a local context of having the respect of learners, peers, and others as a national renown. As a prerequisite for developing a reputation beyond the local academic environment, dissemination of work was often referenced as an important component of satisfaction in the career. This dissemination extended beyond peer-reviewed publications and included other forms of scholarship, presentations at conferences, and sharing clinical innovations between hospitals.
“For me personally, I have less of an emphasis on research and some of the more, I don’t want to say ‘academic’ because I think education is academic, but maybe some of the more scholarly practice of medicine, doing research and the writing of papers and things like that, although I certainly view some of that as a part of career success.”
Within career satisfaction, participants also described a diverse set of themes, including progressive improvement in skills, developing a self-perception of excellence in 1 or more arenas of academic medicine, leadership, work–life integration, innovation, and relationships. The concept of developing a niche, or becoming an expert in a particular domain of hospital medicine, was frequently referenced.
“I think part of [success] is ‘Have they identified a niche?’ Because I think if you want to be in an academic center, as much as I value teaching and taking care of patients, I think 1 of the advantages is the opportunity to potentially identify an area of expertise.”
Participants frequently alluded to the idea that the most important aspects of career satisfaction are not static phenomena but rather values that could evolve over the course of a career. For instance, in the early-career, making a difference with individual learners or patients could have greater valence, but as the career progressed, finding a niche, disseminating work, and building a national reputation would gain importance to a personal sense of career satisfaction.
Extrinsic—Advancement
Promotion was typically referenced when discussing career success, but it was not uniformly valued by early career hospitalists. Some expressed significant ambivalence about its effect on their personal sense of career success. Academic hospitalists identified a number of organizations with definitions of success that influence them. Definitions of success for the university were more relevant to interviewees compared to those of the hospital or professional societies. Interviewees were able to describe a variety of criteria by which their universities define or recognize career success. These commonly included promotion, publications and/or scholarship, and research. The list of factors perceived as success by the hospital were often distinct from those of the university and included cost-effective care, patient safety, and clinical leadership roles.
Participants described a sense of internal conflict when external-stakeholder definitions of success diverged from internal motivators. This was particularly true when this divergence led academic hospitalists to engage in activities for advancement that they did not find personally fulfilling. Academic hospitalists recognized that advancement was central to the concept of career success for organizations even if this was not identified as being core to their personal definitions of success.
“I think that for me, the idea of being promoted and being a leader in the field is less important to me than...for the organization.”
Hospitalists expressed that objective markers, such as promotion and publications, were perceived as more important at higher levels of the academic organization, whereas more subjective aspects of success, aligned with intrinsic personal definitions, were more valued within the hospital medicine group.
Extrinsic—Compensation
Compensation was notable for its absence in participants’ discussion of career success. When asked about their definitions of career success, academic hospitalists did not spontaneously raise the topic of compensation. The only mention of compensation was in response to a question about how personal and external definitions of career success differ.
Unexpected Findings
While it was almost universally recognized by participants as important, ambivalence toward the “academic value of clinical work,” “scholarship,” and especially “promotion” represented an unexpected thematic family.
“I can’t quite get excited about a title attached to my name or the number of times my name pops up when I enter it into PubMed. My personal definition is more…where do I have something that I am interested [in] that someone else values. And that value is not shown as an associate professorship or an assistant professorship next to my name. …When you push me on it, you could call me clinical instructor forever, and I don’t think I would care too much.”
The interaction between work and personal activities as representing complementary aspects of a global sense of success was also unexpected and ran contrary to a simplistic conception of work and life in conflict. Academic hospitalists referenced that the ability to participate in aspects of life external to the workplace was important to their sense of career success. Participants frequently used phrases such as “work–life balance” to encompass a larger sense that work and nonwork life needed to merge to form a holistic sense of having a positive impact.
“Personal success is becoming what I have termed a ‘man of worth.’ I think [that is] someone who feels as though they make a positive impact in the world. Through both my career, but I guess the things that I do that are external to my career. Those would be defined by being a good husband, a good son, a philanthropist out in the community…sometimes, these are not things that can necessarily go on a [curriculum vitae].”
Conflict Among Organizing Themes
At times, academic hospitalists described a tension between day-to-day job satisfaction and what would be necessary to accomplish longer-term career success in the other organizing themes. This was reflected by a sense of trade-off. For instance, activities that lead to some aspects of career satisfaction or advancement would take time away from the direct exposure to learners and clinical care that currently drive job satisfaction.
“If the institution wanted me to be more productive from a research standpoint or…advocate that I receive funding so I could buy down clinical time and interactions I have with my students and my patients, then I can see my satisfaction going down.”
Many described a sense of engaging in activities they did not find personally fulfilling because of a sense of expectation that those activities were considered successful by others. Some described a state in which the drive toward advancement as an extrinsic incentive could come at the expense of the intrinsic rewards of being an academic hospitalist.
DISCUSSION
Career success has been defined as “the positive psychological or work-related outcomes or achievements one accumulates as a result of work experiences.”4,7,8 Academic career success for hospitalist faculty isn’t as well defined and has not been examined from the perspectives of early-career clinician-educator hospitalist faculty themselves.
The themes that emerged in this study describe a definition of success anchored in the daily work of striving to become an exceptional clinician and teacher. The major themes included (1) having excitement about daily work, (2) having meaningful impact, (3) development of a niche (4) a sense of respect within the sphere of academic medicine, and (5) disseminating work.
Success was very much internally defined as having a positive, meaningful impact on patients, learners, and the systems in which they practice. The faculty had a conception of what promotion committees value and often internalized aspects of this, such as developing a national reputation and giving talks at national meetings. Participants typically self-identified as clinician-educators, and yet dissemination of work remained an important component of personal success. While promotion was clearly identified as a marker of success, academic hospitalists often rejected the supposition of promotion itself as a professional goal. They expressed hope, and some skepticism, that external recognition of career success would follow the pursuit of internally meaningful goals.
While promotion and peer-reviewed publications represent easily measured markers often used as proxies for individual career and programmatic success, our research demonstrates that there is a deep well of externally imperceptible influences on an individual’s sense of success as an academic hospitalist. In our analysis, intrinsic elements of career success received far greater weight with early-career academic hospitalists. Our findings are supported by a prior survey of academic physicians that similarly found that faculty with >50% of their time devoted to clinical care placed greater career value in patient care, relationships with patients, and recognition by patients and residents compared to national reputation.9 Similar to our own findings, highly clinical faculty in that study were also less likely to value promotion and tenure as indicators of career success.9
The main focus of our questions was how early-career faculty define success at this point in their careers. When asked to extrapolate to a future state of career success, the concept of progression was repeatedly raised. This included successive promotions to higher academic ranks, increasing responsibility, titles, leadership, and achieving competitive roles or awards. It also included a progressively increasing impact of scholarship, growing national reputation, and becoming part of a network of accomplished academic hospitalists across the country. Looking forward, our early-career hospitalists felt that long-term career success would represent accomplishing these things and still being able to be focused on being excellent clinicians to patients, having a work–life balance, and keeping joy and excitement in daily activities.
Our work has limitations, including a focus on early-career clinician-educator hospitalists. The perception of career success may evolve over time, and future work to examine perceptions in more advanced academic hospitalists would be of interest. Our work used purposeful sampling to capture individuals who were likely to self-identify as academic clinician-educators, and results may not generalize to hospitalist physician-scientists or hospitalists in community practices.
Our analysis suggests that external organizations influence internal perceptions of career success. However, success is ultimately defined by the individual and not the institution. Efforts to measure and improve academic hospitalists’ attainment of career success should attend to intrinsic aspects of satisfaction in addition to objective measures, such as publications and promotion. This may provide a mechanism to address burnout and improve retention. As important as commonality in themes is the variation in self-definitions of career success among individuals. This suggests the value of inquiry by academic leadership in exploring and understanding what success is from the individual faculty perspective. This may enhance the alignment among personal definitions, organizational values, and, ultimately, sustainable, successful careers.
Disclosure: The authors have nothing to disclose.
1. Harrison R, Hunter AJ, Sharpe B, Auerbach AD. Survey of US Academic Hospitalist Leaders About Mentorship and Academic Activities in Hospitalist Groups. J Hosp Med. 2011;6(1):5-9. PubMed
2. Buddeberg-Fischer B, Stamm M, Buddeberg C, Klaghofer R. Career-Success Scale. A New Instrument to Assess Young Physicians Academic Career Steps. BMC Health Serv Res. 2008;8:120. PubMed
3. Rubio DM, Primack BA, Switzer GE, Bryce CL, Selzer DL, Kapoor WN. A Comprehensive Career-Success Model for Physician-Scientists. Acad Med. 2011;86(12):1571-1576. PubMed
4. Judge TA, Cable DM, Boudreau JW, Bretz RD. An empirical investigation of the predictors of executive career success (CAHRS Working Paper #94-08). Ithaca, NY: Cornell University, School of Industrial and Labor Relations, Center for Advanced Human Resource Studies. 1994. http://digitalcommons.ilr.cornell.edu/cahrswp/233. Accessed November 27, 2017.
5. Palinkas LA, Horwitz SM, Green CA, Wisdom JP, Duan N, Hoagwood K. Purposeful sampling for qualitative data collection and analysis in mixed method implementation research. Adm Policy Ment Health. 2015;42(5):533-544. PubMed
6. Francis JJ, Johnston M, Robertson C, et al. What is an adequate sample size? Operationalising data saturation for theory-based interview studies. Psychol Health. 2010;25(10):1229-1245. PubMed
7. Abele AE, Spurk, D. The longitudinal impact of self-efficacy and career goals on objective and subjective career success. J Vocat Behav. 2009;74(1):53-62.
8. Seibert SE, Kraimer ML. The five-factor model of personality and career success. J Vocat Behav. 2011;58(1):1-21.
9. Buckley, LM, Sanders K, Shih M, Hampton CL. Attitudes of Clinical Faculty About Career Progress, Career Success, and Commitment to Academic Medicine: Results of a Survey. Arch Intern Med. 2000;160(17):2625-2629. PubMed
1. Harrison R, Hunter AJ, Sharpe B, Auerbach AD. Survey of US Academic Hospitalist Leaders About Mentorship and Academic Activities in Hospitalist Groups. J Hosp Med. 2011;6(1):5-9. PubMed
2. Buddeberg-Fischer B, Stamm M, Buddeberg C, Klaghofer R. Career-Success Scale. A New Instrument to Assess Young Physicians Academic Career Steps. BMC Health Serv Res. 2008;8:120. PubMed
3. Rubio DM, Primack BA, Switzer GE, Bryce CL, Selzer DL, Kapoor WN. A Comprehensive Career-Success Model for Physician-Scientists. Acad Med. 2011;86(12):1571-1576. PubMed
4. Judge TA, Cable DM, Boudreau JW, Bretz RD. An empirical investigation of the predictors of executive career success (CAHRS Working Paper #94-08). Ithaca, NY: Cornell University, School of Industrial and Labor Relations, Center for Advanced Human Resource Studies. 1994. http://digitalcommons.ilr.cornell.edu/cahrswp/233. Accessed November 27, 2017.
5. Palinkas LA, Horwitz SM, Green CA, Wisdom JP, Duan N, Hoagwood K. Purposeful sampling for qualitative data collection and analysis in mixed method implementation research. Adm Policy Ment Health. 2015;42(5):533-544. PubMed
6. Francis JJ, Johnston M, Robertson C, et al. What is an adequate sample size? Operationalising data saturation for theory-based interview studies. Psychol Health. 2010;25(10):1229-1245. PubMed
7. Abele AE, Spurk, D. The longitudinal impact of self-efficacy and career goals on objective and subjective career success. J Vocat Behav. 2009;74(1):53-62.
8. Seibert SE, Kraimer ML. The five-factor model of personality and career success. J Vocat Behav. 2011;58(1):1-21.
9. Buckley, LM, Sanders K, Shih M, Hampton CL. Attitudes of Clinical Faculty About Career Progress, Career Success, and Commitment to Academic Medicine: Results of a Survey. Arch Intern Med. 2000;160(17):2625-2629. PubMed
©2018 Society of Hospital Medicine
A Prescription for Note Bloat: An Effective Progress Note Template
The widespread adoption of electronic health records (EHRs) has led to significant progress in the modernization of healthcare delivery. Ease of access has improved clinical efficiency, and digital data have allowed for point-of-care decision support tools ranging from predicting the 30-day risk of readmission to providing up-to-date guidelines for the care of various diseases.1,2 Documentation tools such as copy-forward and autopopulation increase the speed of documentation, and typed notes improve legibility and ease of note transmission.3,4
However, all of these benefits come with a potential for harm, particularly with respect to accurate and concise documentation. Many experts have described the perpetuation of false information leading to errors, copying-forward of inconsistent and outdated information, and the phenomenon of “note bloat” — physician notes that contain multiple pages of nonessential information, often leaving key aspects buried or lost.5-7 Providers seem to recognize the hazards of copy-and-paste functionality yet persist in utilizing it. In 1 survey, more than 70% of attendings and residents felt that copy and paste led to inaccurate and outdated information, yet 80% stated they would still use it.8
There is little evidence to guide institutions on ways to improve EHR documentation practices. Recent studies have shown that operative note templates improved documentation and decreased the number of missing components.9,10 In the nonoperative setting, 1 small pilot study of pediatric interns demonstrated that a bundled intervention composed of a note template and classroom teaching resulted in improvement in overall note quality and a decrease in “note clutter.”11 In a larger study of pediatric residents, a standardized and simplified note template resulted in a shorter note, although notes were completed later in the day.12 The present study seeks to build upon these efforts by investigating the effect of didactic teaching and an electronic progress note template on note quality, length, and timeliness across 4 academic internal medicine residency programs.
METHODS
Study Design
This prospective quality improvement study took place across 4 academic institutions: University of California Los Angeles (UCLA), University of California San Francisco (UCSF), University of California San Diego (UCSD), and University of Iowa, all of which use Epic EHR (Epic Corp., Madison, WI). The intervention combined brief educational conferences directed at housestaff and attendings with the implementation of an electronic progress note template. Guided by resident input, a note-writing task force at UCSF and UCLA developed a set of best practice guidelines and an aligned note template for progress notes (supplementary Appendix 1). UCSD and the University of Iowa adopted them at their respective institutions. The template’s design minimized autopopulation while encouraging providers to enter relevant data via free text fields (eg, physical exam), prompts (eg, “I have reviewed all the labs from today. Pertinent labs include…”), and drop-down menus (eg, deep vein thrombosis [DVT] prophylaxis: enoxaparin, heparin subcutaneously, etc; supplementary Appendix 2). Additionally, an inpatient checklist was included at the end of the note to serve as a reminder for key inpatient concerns and quality measures, such as Foley catheter days, discharge planning, and code status. Lectures that focused on issues with documentation in the EHR, the best practice guidelines, and a review of the note template with instructions on how to access it were presented to the housestaff. Each institution tailored the lecture to suit their culture. Housestaff were encouraged but not required to use the note template.
Selection and Grading of Progress Notes
Progress notes were eligible for the study if they were written by an intern on an internal medicine teaching service, from a patient with a hospitalization length of at least 3 days with a progress note selected from hospital day 2 or 3, and written while the patient was on the general medicine wards. The preintervention notes were authored from September 2013 to December 2013 and the postintervention notes from April 2014 to June 2014. One note was selected per patient and no more than 3 notes were selected per intern. Each institution selected the first 50 notes chronologically that met these criteria for both the preintervention and the postintervention periods, for a total of 400 notes. The note-grading tool consisted of the following 3 sections to analyze note quality: (1) a general impression of the note (eg, below average, average, above average); (2) the validated Physician Documentation Quality Instrument, 9-item version (PDQI-9) that evaluates notes on 9 domains (up to date, accurate, thorough, useful, organized, comprehensible, succinct, synthesized, internally consistent) on a Likert scale from 1 (not at all) to 5 (extremely); and (3) a note competency questionnaire based on the Accreditation Council for Graduate Medical Education competency note checklist that asked yes or no questions about best practice elements (eg, is there a relevant and focused physical exam).12
Graders were internal medicine teaching faculty involved in the study and were assigned to review notes from their respective sites by directly utilizing the EHR. Although this introduces potential for bias, it was felt that many of the grading elements required the grader to know details of the patient that would not be captured if the note was removed from the context of the EHR. Additionally, graders documented note length (number of lines of text), the time signed by the housestaff, and whether the template was used. Three different graders independently evaluated each note and submitted ratings by using Research Electronic Data Capture.13
Statistical Analysis
Means for each item on the grading tool were computed across raters for each progress note. These were summarized by institution as well as by pre- and postintervention. Cumulative logit mixed effects models were used to compare item responses between study conditions. The number of lines per note before and after the note template intervention was compared by using a mixed effects negative binomial regression model. The timestamp on each note, representing the time of day the note was signed, was compared pre- and postintervention by using a linear mixed effects model. All models included random note and rater effects, and fixed institution and intervention period effects, as well as their interaction. Inter-rater reliability of the grading tool was assessed by calculating the intraclass correlation coefficient (ICC) using the estimated variance components. Data obtained from the PDQI-9 portion were analyzed by individual components as well as by sum score combining each component. The sum score was used to generate odds ratios to assess the likelihood that postintervention notes that used the template compared to those that did not would increase PDQI-9 sum scores. Both cumulative and site-specific data were analyzed. P values < .05 were considered statistically significant. All analyses were performed using SAS version 9.4 (SAS Institute Inc, Cary, NC).
RESULTS
The mean general impression score significantly improved from 2.0 to 2.3 (on a 1-3 scale in which 2 is average) after the intervention (P < .001). Additionally, note quality significantly improved across each domain of the PDQI-9 (P < .001 for all domains, Table 1). The ICC was 0.245 for the general impression score and 0.143 for the PDQI-9 sum score.
Three of 4 institutions documented the number of lines per note and the time the note was signed by the intern. Mean number of lines per note decreased by 25% (361 lines preintervention, 265 lines postintervention, P < .001). Mean time signed was approximately 1 hour and 15 minutes earlier in the day (3:27
Site-specific data revealed variation between sites. Template use was 92% at UCSF, 90% at UCLA, 79% at Iowa, and 21% at UCSD. The mean general impression score significantly improved at UCSF, UCLA, and UCSD, but not at Iowa. The PDQI-9 score improved across all domains at UCSF and UCLA, 2 domains at UCSD, and 0 domains at Iowa. Documentation of pertinent labs and studies significantly improved at UCSF, UCLA, and Iowa, but not UCSD. Note length decreased at UCSF and UCLA, but not at UCSD. Notes were signed earlier at UCLA and UCSD, but not at UCSF.
When comparing postintervention notes based on template use, notes that used the template were significantly more likely to receive a higher mean impression score (odds ratio [OR] 11.95, P < .001), higher PDQI-9 sum score (OR 3.05, P < .001), be approximately 25% shorter (326 lines vs 239 lines, P < .001), and be completed approximately 1 hour and 20 minutes earlier (3:07
DISCUSSION
A bundled intervention consisting of educational lectures and a best practice progress note template significantly improved the quality, decreased the length, and resulted in earlier completion of inpatient progress notes. These findings are consistent with a prior study that demonstrated that a bundled note template intervention improved total note score and reduced note clutter.11 We saw a broad improvement in progress notes across all 9 domains of the PDQI-9, which corresponded with an improved general impression score. We also found statistically significant improvements in 7 of the 13 categories of the competency questionnaire.
Arguably the greatest impact of the intervention was shortening the documentation of labs and studies. Autopopulation can lead to the appearance of a comprehensive note; however, key data are often lost in a sea of numbers and imaging reports.6,14 Using simple prompts followed by free text such as, “I have reviewed all the labs from today. Pertinent labs include…” reduced autopopulation and reminded housestaff to identify only the key information that affected patient care for that day, resulting in a more streamlined, clear, and high-yield note.
The time spent documenting care is an important consideration for physician workflow and for uptake of any note intervention.14-18 One study from 2016 revealed that internal medicine housestaff spend more than half of an average shift using the computer, with 52% of that time spent on documentation.17 Although functions such as autopopulation and copy-forward were created as efficiency tools, we hypothesize that they may actually prolong note writing time by leading to disorganized, distended notes that are difficult to use the following day. There was concern that limiting these “efficiency functions” might discourage housestaff from using the progress note template. It was encouraging to find that postintervention notes were signed 1.3 hours earlier in the day. This study did not measure the impact of shorter notes and earlier completion time, but in theory, this could allow interns to spend more time in direct patient care and to be at lower risk of duty hour violations.19 Furthermore, while the clinical impact of this is unknown, it is possible that timely note completion may improve patient care by making notes available earlier for consultants and other members of the care team.
We found that adding an “inpatient checklist” to the progress note template facilitated a review of key inpatient concerns and quality measures. Although we did not specifically compare before-and-after documentation of all of the components of the checklist, there appeared to be improvement in the domains measured. Notably, there was a 31% increase (P < .001) in the percentage of notes documenting the “discharge plan, goals of hospitalization, or estimated length of stay.” In the surgical literature, studies have demonstrated that incorporating checklists improves patient safety, the delivery of care, and potentially shortens the length of stay.20-22 Future studies should explore the impact of adding a checklist to the daily progress note, as there may be potential to improve both process and outcome measures.
Institution-specific data provided insightful results. UCSD encountered low template use among their interns; however, they still had evidence of improvement in note quality, though not at the same level of UCLA and UCSF. Some barriers to uptake identified were as follows: (1) interns were accustomed to import labs and studies into their note to use as their rounding report, and (2) the intervention took place late in the year when interns had developed a functional writing system that they were reluctant to change. The University of Iowa did not show significant improvement in their note quality despite a relatively high template uptake. Both of these outcomes raise the possibility that in addition to the template, there were other factors at play. Perhaps because UCSF and UCLA created the best practice guidelines and template, it was a better fit for their culture and they had more institutional buy-in. Or because the educational lectures were similar, but not standardized across institutions, some lectures may have been more effective than others. However, when evaluating the postintervention notes at UCSD and Iowa, templated notes were found to be much more likely to score higher on the PDQI-9 than nontemplated notes, which serves as evidence of the efficacy of the note template.
Some of the strengths of this study include the relatively large sample size spanning 4 institutions and the use of 3 different assessment tools for grading progress note quality (general impression score, PDQI-9, and competency note questionnaire). An additional strength is our unique finding suggesting that note writing may be more efficient by removing, rather than adding, “efficiency functions.” There were several limitations of this study. Pre- and postintervention notes were examined at different points in the same academic year, thus certain domains may have improved as interns progressed in clinical skill and comfort with documentation, independent of our intervention.21 However, our analysis of postintervention notes across the same time period revealed that use of the template was strongly associated with higher quality, shorter notes and earlier completion time arguing that the effect seen was not merely intern experience. The poor interrater reliability is also a limitation. Although the PDQI-9 was previously validated, future use of the grading tool may require more rater training for calibration or more objective wording.23 The study was not blinded, and thus, bias may have falsely elevated postintervention scores; however, we attempted to minimize bias by incorporating a more objective yes/no competency questionnaire and by having each note scored by 3 graders. Other studies have attempted to address this form of bias by printing out notes and blinding the graders. This design, however, isolates the note from all other data in the medical record, making it difficult to assess domains such as accuracy and completeness. Our inclusion of objective outcomes such as note length and time of note completion help to mitigate some of the bias.
Future research can expand on the results of this study by introducing similar progress note interventions at other institutions and/or in nonacademic environments to validate the results and expand generalizability. Longer term follow-up would be useful to determine if these effects are transient or long lasting. Similarly, it would be interesting to determine if such results are sustained even after new interns start suggesting that institutional culture can be changed. Investigators could focus on similar projects to improve other notes that are particularly at a high risk for propagating false information, such as the History and Physical or Discharge Summary. Future research should also focus on outcomes data, including whether a more efficient note can allow housestaff to spend more time with patients, decrease patient length of stay, reduce clinical errors, and improve educational time for trainees. Lastly, we should determine if interventions such as this can mitigate the widespread frustrations with electronic documentation that are associated with physician and provider burnout.15,24 One would hope that the technology could be harnessed to improve provider productivity and be effectively integrated into comprehensive patient care.
Our research makes progress toward recommendations made by the American College of Physicians “to improve accuracy of information recorded and the value of information,” and develop automated tools that “enhance documentation quality without facilitating improper behaviors.”19 Institutions should consider developing internal best practices for clinical documentation and building structured note templates.19 Our research would suggest that, combined with a small educational intervention, such templates can make progress notes more accurate and succinct, make note writing more efficient, and be harnessed to improve quality metrics.
ACKNOWLEDGMENTS
The authors thank Michael Pfeffer, MD, and Sitaram Vangala, MS, for their contributions to and support of this research study and manuscript.
Disclosure: The authors declare no conflicts of interest.
1. Herzig SJ, Guess JR, Feinbloom DB, et al. Improving appropriateness of acid-suppressive medication use via computerized clinical decision support. J Hosp Med. 2015;10(1):41-45. PubMed
2. Nguyen OK, Makam AN, Clark C, et al. Predicting all-cause readmissions using electronic health record data from the entire hospitalization: Model development and comparison. J Hosp Med. 2016;11(7):473-480. PubMed
3. Donati A, Gabbanelli V, Pantanetti S, et al. The impact of a clinical information system in an intensive care unit. J Clin Monit Comput. 2008;22(1):31-36. PubMed
4. Schiff GD, Bates DW. Can electronic clinical documentation help prevent diagnostic errors? N Engl J Med. 2010;362(12):1066-1069. PubMed
5. Hartzband P, Groopman J. Off the record--avoiding the pitfalls of going electronic. N Engl J Med. 2008;358(16):1656-1658. PubMed
6. Hirschtick RE. A piece of my mind. Copy-and-paste. JAMA. 2006;295(20):2335-2336. PubMed
7. Hirschtick RE. A piece of my mind. John Lennon’s elbow. JAMA. 2012;308(5):463-464. PubMed
8. O’Donnell HC, Kaushal R, Barrón Y, Callahan MA, Adelman RD, Siegler EL. Physicians’ attitudes towards copy and pasting in electronic note writing. J Gen Intern Med. 2009;24(1):63-68. PubMed
9. Mahapatra P, Ieong E. Improving Documentation and Communication Using Operative Note Proformas. BMJ Qual Improv Rep. 2016;5(1):u209122.w3712. PubMed
10. Thomson DR, Baldwin MJ, Bellini MI, Silva MA. Improving the quality of operative notes for laparoscopic cholecystectomy: Assessing the impact of a standardized operation note proforma. Int J Surg. 2016;27:17-20. PubMed
11. Dean SM, Eickhoff JC, Bakel LA. The effectiveness of a bundled intervention to improve resident progress notes in an electronic health record. J Hosp Med. 2015;10(2):104-107. PubMed
12. Aylor M, Campbell EM, Winter C, Phillipi CA. Resident Notes in an Electronic Health Record: A Mixed-Methods Study Using a Standardized Intervention With Qualitative Analysis. Clin Pediatr (Phila). 2016;6(3):257-262.
13. Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009;42(2):377-381. PubMed
14. Chi J, Kugler J, Chu IM, et al. Medical students and the electronic health record: ‘an epic use of time’. Am J Med. 2014;127(9):891-895. PubMed
15. Martin SA, Sinsky CA. The map is not the territory: medical records and 21st century practice. Lancet. 2016;388(10055):2053-2056. PubMed
16. Oxentenko AS, Manohar CU, McCoy CP, et al. Internal medicine residents’ computer use in the inpatient setting. J Grad Med Educ. 2012;4(4):529-532. PubMed
17. Mamykina L, Vawdrey DK, Hripcsak G. How Do Residents Spend Their Shift Time? A Time and Motion Study With a Particular Focus on the Use of Computers. Acad Med. 2016;91(6):827-832. PubMed
18. Chen L, Guo U, Illipparambil LC, et al. Racing Against the Clock: Internal Medicine Residents’ Time Spent On Electronic Health Records. J Grad Med Educ. 2016;8(1):39-44. PubMed
19. Kuhn T, Basch P, Barr M, Yackel T, Physicians MICotACo. Clinical documentation in the 21st century: executive summary of a policy position paper from the American College of Physicians. Ann Intern Med. 2015;162(4):301-303. PubMed
20. Treadwell JR, Lucas S, Tsou AY. Surgical checklists: a systematic review of impacts and implementation. BMJ Qual Saf. 2014;23(4):299-318. PubMed
21. Ko HC, Turner TJ, Finnigan MA. Systematic review of safety checklists for use by medical care teams in acute hospital settings--limited evidence of effectiveness. BMC Health Serv Res. 2011;11:211. PubMed
22. Diaz-Montes TP, Cobb L, Ibeanu OA, Njoku P, Gerardi MA. Introduction of checklists at daily progress notes improves patient care among the gynecological oncology service. J Patient Saf. 2012;8(4):189-193. PubMed
23. Stetson PD, Bakken S, Wrenn JO, Siegler EL. Assessing Electronic Note Quality Using the Physician Documentation Quality Instrument (PDQI-9). Appl Clin Inform. 2012;3(2):164-174. PubMed
24. Friedberg MW, Chen PG, Van Busum KR, et al. Factors affecting physician professional satisfaction and their implications for patient care, health systems, and health policy. Santa Monica, CA: RAND Corporation; 2013. PubMed
The widespread adoption of electronic health records (EHRs) has led to significant progress in the modernization of healthcare delivery. Ease of access has improved clinical efficiency, and digital data have allowed for point-of-care decision support tools ranging from predicting the 30-day risk of readmission to providing up-to-date guidelines for the care of various diseases.1,2 Documentation tools such as copy-forward and autopopulation increase the speed of documentation, and typed notes improve legibility and ease of note transmission.3,4
However, all of these benefits come with a potential for harm, particularly with respect to accurate and concise documentation. Many experts have described the perpetuation of false information leading to errors, copying-forward of inconsistent and outdated information, and the phenomenon of “note bloat” — physician notes that contain multiple pages of nonessential information, often leaving key aspects buried or lost.5-7 Providers seem to recognize the hazards of copy-and-paste functionality yet persist in utilizing it. In 1 survey, more than 70% of attendings and residents felt that copy and paste led to inaccurate and outdated information, yet 80% stated they would still use it.8
There is little evidence to guide institutions on ways to improve EHR documentation practices. Recent studies have shown that operative note templates improved documentation and decreased the number of missing components.9,10 In the nonoperative setting, 1 small pilot study of pediatric interns demonstrated that a bundled intervention composed of a note template and classroom teaching resulted in improvement in overall note quality and a decrease in “note clutter.”11 In a larger study of pediatric residents, a standardized and simplified note template resulted in a shorter note, although notes were completed later in the day.12 The present study seeks to build upon these efforts by investigating the effect of didactic teaching and an electronic progress note template on note quality, length, and timeliness across 4 academic internal medicine residency programs.
METHODS
Study Design
This prospective quality improvement study took place across 4 academic institutions: University of California Los Angeles (UCLA), University of California San Francisco (UCSF), University of California San Diego (UCSD), and University of Iowa, all of which use Epic EHR (Epic Corp., Madison, WI). The intervention combined brief educational conferences directed at housestaff and attendings with the implementation of an electronic progress note template. Guided by resident input, a note-writing task force at UCSF and UCLA developed a set of best practice guidelines and an aligned note template for progress notes (supplementary Appendix 1). UCSD and the University of Iowa adopted them at their respective institutions. The template’s design minimized autopopulation while encouraging providers to enter relevant data via free text fields (eg, physical exam), prompts (eg, “I have reviewed all the labs from today. Pertinent labs include…”), and drop-down menus (eg, deep vein thrombosis [DVT] prophylaxis: enoxaparin, heparin subcutaneously, etc; supplementary Appendix 2). Additionally, an inpatient checklist was included at the end of the note to serve as a reminder for key inpatient concerns and quality measures, such as Foley catheter days, discharge planning, and code status. Lectures that focused on issues with documentation in the EHR, the best practice guidelines, and a review of the note template with instructions on how to access it were presented to the housestaff. Each institution tailored the lecture to suit their culture. Housestaff were encouraged but not required to use the note template.
Selection and Grading of Progress Notes
Progress notes were eligible for the study if they were written by an intern on an internal medicine teaching service, from a patient with a hospitalization length of at least 3 days with a progress note selected from hospital day 2 or 3, and written while the patient was on the general medicine wards. The preintervention notes were authored from September 2013 to December 2013 and the postintervention notes from April 2014 to June 2014. One note was selected per patient and no more than 3 notes were selected per intern. Each institution selected the first 50 notes chronologically that met these criteria for both the preintervention and the postintervention periods, for a total of 400 notes. The note-grading tool consisted of the following 3 sections to analyze note quality: (1) a general impression of the note (eg, below average, average, above average); (2) the validated Physician Documentation Quality Instrument, 9-item version (PDQI-9) that evaluates notes on 9 domains (up to date, accurate, thorough, useful, organized, comprehensible, succinct, synthesized, internally consistent) on a Likert scale from 1 (not at all) to 5 (extremely); and (3) a note competency questionnaire based on the Accreditation Council for Graduate Medical Education competency note checklist that asked yes or no questions about best practice elements (eg, is there a relevant and focused physical exam).12
Graders were internal medicine teaching faculty involved in the study and were assigned to review notes from their respective sites by directly utilizing the EHR. Although this introduces potential for bias, it was felt that many of the grading elements required the grader to know details of the patient that would not be captured if the note was removed from the context of the EHR. Additionally, graders documented note length (number of lines of text), the time signed by the housestaff, and whether the template was used. Three different graders independently evaluated each note and submitted ratings by using Research Electronic Data Capture.13
Statistical Analysis
Means for each item on the grading tool were computed across raters for each progress note. These were summarized by institution as well as by pre- and postintervention. Cumulative logit mixed effects models were used to compare item responses between study conditions. The number of lines per note before and after the note template intervention was compared by using a mixed effects negative binomial regression model. The timestamp on each note, representing the time of day the note was signed, was compared pre- and postintervention by using a linear mixed effects model. All models included random note and rater effects, and fixed institution and intervention period effects, as well as their interaction. Inter-rater reliability of the grading tool was assessed by calculating the intraclass correlation coefficient (ICC) using the estimated variance components. Data obtained from the PDQI-9 portion were analyzed by individual components as well as by sum score combining each component. The sum score was used to generate odds ratios to assess the likelihood that postintervention notes that used the template compared to those that did not would increase PDQI-9 sum scores. Both cumulative and site-specific data were analyzed. P values < .05 were considered statistically significant. All analyses were performed using SAS version 9.4 (SAS Institute Inc, Cary, NC).
RESULTS
The mean general impression score significantly improved from 2.0 to 2.3 (on a 1-3 scale in which 2 is average) after the intervention (P < .001). Additionally, note quality significantly improved across each domain of the PDQI-9 (P < .001 for all domains, Table 1). The ICC was 0.245 for the general impression score and 0.143 for the PDQI-9 sum score.
Three of 4 institutions documented the number of lines per note and the time the note was signed by the intern. Mean number of lines per note decreased by 25% (361 lines preintervention, 265 lines postintervention, P < .001). Mean time signed was approximately 1 hour and 15 minutes earlier in the day (3:27
Site-specific data revealed variation between sites. Template use was 92% at UCSF, 90% at UCLA, 79% at Iowa, and 21% at UCSD. The mean general impression score significantly improved at UCSF, UCLA, and UCSD, but not at Iowa. The PDQI-9 score improved across all domains at UCSF and UCLA, 2 domains at UCSD, and 0 domains at Iowa. Documentation of pertinent labs and studies significantly improved at UCSF, UCLA, and Iowa, but not UCSD. Note length decreased at UCSF and UCLA, but not at UCSD. Notes were signed earlier at UCLA and UCSD, but not at UCSF.
When comparing postintervention notes based on template use, notes that used the template were significantly more likely to receive a higher mean impression score (odds ratio [OR] 11.95, P < .001), higher PDQI-9 sum score (OR 3.05, P < .001), be approximately 25% shorter (326 lines vs 239 lines, P < .001), and be completed approximately 1 hour and 20 minutes earlier (3:07
DISCUSSION
A bundled intervention consisting of educational lectures and a best practice progress note template significantly improved the quality, decreased the length, and resulted in earlier completion of inpatient progress notes. These findings are consistent with a prior study that demonstrated that a bundled note template intervention improved total note score and reduced note clutter.11 We saw a broad improvement in progress notes across all 9 domains of the PDQI-9, which corresponded with an improved general impression score. We also found statistically significant improvements in 7 of the 13 categories of the competency questionnaire.
Arguably the greatest impact of the intervention was shortening the documentation of labs and studies. Autopopulation can lead to the appearance of a comprehensive note; however, key data are often lost in a sea of numbers and imaging reports.6,14 Using simple prompts followed by free text such as, “I have reviewed all the labs from today. Pertinent labs include…” reduced autopopulation and reminded housestaff to identify only the key information that affected patient care for that day, resulting in a more streamlined, clear, and high-yield note.
The time spent documenting care is an important consideration for physician workflow and for uptake of any note intervention.14-18 One study from 2016 revealed that internal medicine housestaff spend more than half of an average shift using the computer, with 52% of that time spent on documentation.17 Although functions such as autopopulation and copy-forward were created as efficiency tools, we hypothesize that they may actually prolong note writing time by leading to disorganized, distended notes that are difficult to use the following day. There was concern that limiting these “efficiency functions” might discourage housestaff from using the progress note template. It was encouraging to find that postintervention notes were signed 1.3 hours earlier in the day. This study did not measure the impact of shorter notes and earlier completion time, but in theory, this could allow interns to spend more time in direct patient care and to be at lower risk of duty hour violations.19 Furthermore, while the clinical impact of this is unknown, it is possible that timely note completion may improve patient care by making notes available earlier for consultants and other members of the care team.
We found that adding an “inpatient checklist” to the progress note template facilitated a review of key inpatient concerns and quality measures. Although we did not specifically compare before-and-after documentation of all of the components of the checklist, there appeared to be improvement in the domains measured. Notably, there was a 31% increase (P < .001) in the percentage of notes documenting the “discharge plan, goals of hospitalization, or estimated length of stay.” In the surgical literature, studies have demonstrated that incorporating checklists improves patient safety, the delivery of care, and potentially shortens the length of stay.20-22 Future studies should explore the impact of adding a checklist to the daily progress note, as there may be potential to improve both process and outcome measures.
Institution-specific data provided insightful results. UCSD encountered low template use among their interns; however, they still had evidence of improvement in note quality, though not at the same level of UCLA and UCSF. Some barriers to uptake identified were as follows: (1) interns were accustomed to import labs and studies into their note to use as their rounding report, and (2) the intervention took place late in the year when interns had developed a functional writing system that they were reluctant to change. The University of Iowa did not show significant improvement in their note quality despite a relatively high template uptake. Both of these outcomes raise the possibility that in addition to the template, there were other factors at play. Perhaps because UCSF and UCLA created the best practice guidelines and template, it was a better fit for their culture and they had more institutional buy-in. Or because the educational lectures were similar, but not standardized across institutions, some lectures may have been more effective than others. However, when evaluating the postintervention notes at UCSD and Iowa, templated notes were found to be much more likely to score higher on the PDQI-9 than nontemplated notes, which serves as evidence of the efficacy of the note template.
Some of the strengths of this study include the relatively large sample size spanning 4 institutions and the use of 3 different assessment tools for grading progress note quality (general impression score, PDQI-9, and competency note questionnaire). An additional strength is our unique finding suggesting that note writing may be more efficient by removing, rather than adding, “efficiency functions.” There were several limitations of this study. Pre- and postintervention notes were examined at different points in the same academic year, thus certain domains may have improved as interns progressed in clinical skill and comfort with documentation, independent of our intervention.21 However, our analysis of postintervention notes across the same time period revealed that use of the template was strongly associated with higher quality, shorter notes and earlier completion time arguing that the effect seen was not merely intern experience. The poor interrater reliability is also a limitation. Although the PDQI-9 was previously validated, future use of the grading tool may require more rater training for calibration or more objective wording.23 The study was not blinded, and thus, bias may have falsely elevated postintervention scores; however, we attempted to minimize bias by incorporating a more objective yes/no competency questionnaire and by having each note scored by 3 graders. Other studies have attempted to address this form of bias by printing out notes and blinding the graders. This design, however, isolates the note from all other data in the medical record, making it difficult to assess domains such as accuracy and completeness. Our inclusion of objective outcomes such as note length and time of note completion help to mitigate some of the bias.
Future research can expand on the results of this study by introducing similar progress note interventions at other institutions and/or in nonacademic environments to validate the results and expand generalizability. Longer term follow-up would be useful to determine if these effects are transient or long lasting. Similarly, it would be interesting to determine if such results are sustained even after new interns start suggesting that institutional culture can be changed. Investigators could focus on similar projects to improve other notes that are particularly at a high risk for propagating false information, such as the History and Physical or Discharge Summary. Future research should also focus on outcomes data, including whether a more efficient note can allow housestaff to spend more time with patients, decrease patient length of stay, reduce clinical errors, and improve educational time for trainees. Lastly, we should determine if interventions such as this can mitigate the widespread frustrations with electronic documentation that are associated with physician and provider burnout.15,24 One would hope that the technology could be harnessed to improve provider productivity and be effectively integrated into comprehensive patient care.
Our research makes progress toward recommendations made by the American College of Physicians “to improve accuracy of information recorded and the value of information,” and develop automated tools that “enhance documentation quality without facilitating improper behaviors.”19 Institutions should consider developing internal best practices for clinical documentation and building structured note templates.19 Our research would suggest that, combined with a small educational intervention, such templates can make progress notes more accurate and succinct, make note writing more efficient, and be harnessed to improve quality metrics.
ACKNOWLEDGMENTS
The authors thank Michael Pfeffer, MD, and Sitaram Vangala, MS, for their contributions to and support of this research study and manuscript.
Disclosure: The authors declare no conflicts of interest.
The widespread adoption of electronic health records (EHRs) has led to significant progress in the modernization of healthcare delivery. Ease of access has improved clinical efficiency, and digital data have allowed for point-of-care decision support tools ranging from predicting the 30-day risk of readmission to providing up-to-date guidelines for the care of various diseases.1,2 Documentation tools such as copy-forward and autopopulation increase the speed of documentation, and typed notes improve legibility and ease of note transmission.3,4
However, all of these benefits come with a potential for harm, particularly with respect to accurate and concise documentation. Many experts have described the perpetuation of false information leading to errors, copying-forward of inconsistent and outdated information, and the phenomenon of “note bloat” — physician notes that contain multiple pages of nonessential information, often leaving key aspects buried or lost.5-7 Providers seem to recognize the hazards of copy-and-paste functionality yet persist in utilizing it. In 1 survey, more than 70% of attendings and residents felt that copy and paste led to inaccurate and outdated information, yet 80% stated they would still use it.8
There is little evidence to guide institutions on ways to improve EHR documentation practices. Recent studies have shown that operative note templates improved documentation and decreased the number of missing components.9,10 In the nonoperative setting, 1 small pilot study of pediatric interns demonstrated that a bundled intervention composed of a note template and classroom teaching resulted in improvement in overall note quality and a decrease in “note clutter.”11 In a larger study of pediatric residents, a standardized and simplified note template resulted in a shorter note, although notes were completed later in the day.12 The present study seeks to build upon these efforts by investigating the effect of didactic teaching and an electronic progress note template on note quality, length, and timeliness across 4 academic internal medicine residency programs.
METHODS
Study Design
This prospective quality improvement study took place across 4 academic institutions: University of California Los Angeles (UCLA), University of California San Francisco (UCSF), University of California San Diego (UCSD), and University of Iowa, all of which use Epic EHR (Epic Corp., Madison, WI). The intervention combined brief educational conferences directed at housestaff and attendings with the implementation of an electronic progress note template. Guided by resident input, a note-writing task force at UCSF and UCLA developed a set of best practice guidelines and an aligned note template for progress notes (supplementary Appendix 1). UCSD and the University of Iowa adopted them at their respective institutions. The template’s design minimized autopopulation while encouraging providers to enter relevant data via free text fields (eg, physical exam), prompts (eg, “I have reviewed all the labs from today. Pertinent labs include…”), and drop-down menus (eg, deep vein thrombosis [DVT] prophylaxis: enoxaparin, heparin subcutaneously, etc; supplementary Appendix 2). Additionally, an inpatient checklist was included at the end of the note to serve as a reminder for key inpatient concerns and quality measures, such as Foley catheter days, discharge planning, and code status. Lectures that focused on issues with documentation in the EHR, the best practice guidelines, and a review of the note template with instructions on how to access it were presented to the housestaff. Each institution tailored the lecture to suit their culture. Housestaff were encouraged but not required to use the note template.
Selection and Grading of Progress Notes
Progress notes were eligible for the study if they were written by an intern on an internal medicine teaching service, from a patient with a hospitalization length of at least 3 days with a progress note selected from hospital day 2 or 3, and written while the patient was on the general medicine wards. The preintervention notes were authored from September 2013 to December 2013 and the postintervention notes from April 2014 to June 2014. One note was selected per patient and no more than 3 notes were selected per intern. Each institution selected the first 50 notes chronologically that met these criteria for both the preintervention and the postintervention periods, for a total of 400 notes. The note-grading tool consisted of the following 3 sections to analyze note quality: (1) a general impression of the note (eg, below average, average, above average); (2) the validated Physician Documentation Quality Instrument, 9-item version (PDQI-9) that evaluates notes on 9 domains (up to date, accurate, thorough, useful, organized, comprehensible, succinct, synthesized, internally consistent) on a Likert scale from 1 (not at all) to 5 (extremely); and (3) a note competency questionnaire based on the Accreditation Council for Graduate Medical Education competency note checklist that asked yes or no questions about best practice elements (eg, is there a relevant and focused physical exam).12
Graders were internal medicine teaching faculty involved in the study and were assigned to review notes from their respective sites by directly utilizing the EHR. Although this introduces potential for bias, it was felt that many of the grading elements required the grader to know details of the patient that would not be captured if the note was removed from the context of the EHR. Additionally, graders documented note length (number of lines of text), the time signed by the housestaff, and whether the template was used. Three different graders independently evaluated each note and submitted ratings by using Research Electronic Data Capture.13
Statistical Analysis
Means for each item on the grading tool were computed across raters for each progress note. These were summarized by institution as well as by pre- and postintervention. Cumulative logit mixed effects models were used to compare item responses between study conditions. The number of lines per note before and after the note template intervention was compared by using a mixed effects negative binomial regression model. The timestamp on each note, representing the time of day the note was signed, was compared pre- and postintervention by using a linear mixed effects model. All models included random note and rater effects, and fixed institution and intervention period effects, as well as their interaction. Inter-rater reliability of the grading tool was assessed by calculating the intraclass correlation coefficient (ICC) using the estimated variance components. Data obtained from the PDQI-9 portion were analyzed by individual components as well as by sum score combining each component. The sum score was used to generate odds ratios to assess the likelihood that postintervention notes that used the template compared to those that did not would increase PDQI-9 sum scores. Both cumulative and site-specific data were analyzed. P values < .05 were considered statistically significant. All analyses were performed using SAS version 9.4 (SAS Institute Inc, Cary, NC).
RESULTS
The mean general impression score significantly improved from 2.0 to 2.3 (on a 1-3 scale in which 2 is average) after the intervention (P < .001). Additionally, note quality significantly improved across each domain of the PDQI-9 (P < .001 for all domains, Table 1). The ICC was 0.245 for the general impression score and 0.143 for the PDQI-9 sum score.
Three of 4 institutions documented the number of lines per note and the time the note was signed by the intern. Mean number of lines per note decreased by 25% (361 lines preintervention, 265 lines postintervention, P < .001). Mean time signed was approximately 1 hour and 15 minutes earlier in the day (3:27
Site-specific data revealed variation between sites. Template use was 92% at UCSF, 90% at UCLA, 79% at Iowa, and 21% at UCSD. The mean general impression score significantly improved at UCSF, UCLA, and UCSD, but not at Iowa. The PDQI-9 score improved across all domains at UCSF and UCLA, 2 domains at UCSD, and 0 domains at Iowa. Documentation of pertinent labs and studies significantly improved at UCSF, UCLA, and Iowa, but not UCSD. Note length decreased at UCSF and UCLA, but not at UCSD. Notes were signed earlier at UCLA and UCSD, but not at UCSF.
When comparing postintervention notes based on template use, notes that used the template were significantly more likely to receive a higher mean impression score (odds ratio [OR] 11.95, P < .001), higher PDQI-9 sum score (OR 3.05, P < .001), be approximately 25% shorter (326 lines vs 239 lines, P < .001), and be completed approximately 1 hour and 20 minutes earlier (3:07
DISCUSSION
A bundled intervention consisting of educational lectures and a best practice progress note template significantly improved the quality, decreased the length, and resulted in earlier completion of inpatient progress notes. These findings are consistent with a prior study that demonstrated that a bundled note template intervention improved total note score and reduced note clutter.11 We saw a broad improvement in progress notes across all 9 domains of the PDQI-9, which corresponded with an improved general impression score. We also found statistically significant improvements in 7 of the 13 categories of the competency questionnaire.
Arguably the greatest impact of the intervention was shortening the documentation of labs and studies. Autopopulation can lead to the appearance of a comprehensive note; however, key data are often lost in a sea of numbers and imaging reports.6,14 Using simple prompts followed by free text such as, “I have reviewed all the labs from today. Pertinent labs include…” reduced autopopulation and reminded housestaff to identify only the key information that affected patient care for that day, resulting in a more streamlined, clear, and high-yield note.
The time spent documenting care is an important consideration for physician workflow and for uptake of any note intervention.14-18 One study from 2016 revealed that internal medicine housestaff spend more than half of an average shift using the computer, with 52% of that time spent on documentation.17 Although functions such as autopopulation and copy-forward were created as efficiency tools, we hypothesize that they may actually prolong note writing time by leading to disorganized, distended notes that are difficult to use the following day. There was concern that limiting these “efficiency functions” might discourage housestaff from using the progress note template. It was encouraging to find that postintervention notes were signed 1.3 hours earlier in the day. This study did not measure the impact of shorter notes and earlier completion time, but in theory, this could allow interns to spend more time in direct patient care and to be at lower risk of duty hour violations.19 Furthermore, while the clinical impact of this is unknown, it is possible that timely note completion may improve patient care by making notes available earlier for consultants and other members of the care team.
We found that adding an “inpatient checklist” to the progress note template facilitated a review of key inpatient concerns and quality measures. Although we did not specifically compare before-and-after documentation of all of the components of the checklist, there appeared to be improvement in the domains measured. Notably, there was a 31% increase (P < .001) in the percentage of notes documenting the “discharge plan, goals of hospitalization, or estimated length of stay.” In the surgical literature, studies have demonstrated that incorporating checklists improves patient safety, the delivery of care, and potentially shortens the length of stay.20-22 Future studies should explore the impact of adding a checklist to the daily progress note, as there may be potential to improve both process and outcome measures.
Institution-specific data provided insightful results. UCSD encountered low template use among their interns; however, they still had evidence of improvement in note quality, though not at the same level of UCLA and UCSF. Some barriers to uptake identified were as follows: (1) interns were accustomed to import labs and studies into their note to use as their rounding report, and (2) the intervention took place late in the year when interns had developed a functional writing system that they were reluctant to change. The University of Iowa did not show significant improvement in their note quality despite a relatively high template uptake. Both of these outcomes raise the possibility that in addition to the template, there were other factors at play. Perhaps because UCSF and UCLA created the best practice guidelines and template, it was a better fit for their culture and they had more institutional buy-in. Or because the educational lectures were similar, but not standardized across institutions, some lectures may have been more effective than others. However, when evaluating the postintervention notes at UCSD and Iowa, templated notes were found to be much more likely to score higher on the PDQI-9 than nontemplated notes, which serves as evidence of the efficacy of the note template.
Some of the strengths of this study include the relatively large sample size spanning 4 institutions and the use of 3 different assessment tools for grading progress note quality (general impression score, PDQI-9, and competency note questionnaire). An additional strength is our unique finding suggesting that note writing may be more efficient by removing, rather than adding, “efficiency functions.” There were several limitations of this study. Pre- and postintervention notes were examined at different points in the same academic year, thus certain domains may have improved as interns progressed in clinical skill and comfort with documentation, independent of our intervention.21 However, our analysis of postintervention notes across the same time period revealed that use of the template was strongly associated with higher quality, shorter notes and earlier completion time arguing that the effect seen was not merely intern experience. The poor interrater reliability is also a limitation. Although the PDQI-9 was previously validated, future use of the grading tool may require more rater training for calibration or more objective wording.23 The study was not blinded, and thus, bias may have falsely elevated postintervention scores; however, we attempted to minimize bias by incorporating a more objective yes/no competency questionnaire and by having each note scored by 3 graders. Other studies have attempted to address this form of bias by printing out notes and blinding the graders. This design, however, isolates the note from all other data in the medical record, making it difficult to assess domains such as accuracy and completeness. Our inclusion of objective outcomes such as note length and time of note completion help to mitigate some of the bias.
Future research can expand on the results of this study by introducing similar progress note interventions at other institutions and/or in nonacademic environments to validate the results and expand generalizability. Longer term follow-up would be useful to determine if these effects are transient or long lasting. Similarly, it would be interesting to determine if such results are sustained even after new interns start suggesting that institutional culture can be changed. Investigators could focus on similar projects to improve other notes that are particularly at a high risk for propagating false information, such as the History and Physical or Discharge Summary. Future research should also focus on outcomes data, including whether a more efficient note can allow housestaff to spend more time with patients, decrease patient length of stay, reduce clinical errors, and improve educational time for trainees. Lastly, we should determine if interventions such as this can mitigate the widespread frustrations with electronic documentation that are associated with physician and provider burnout.15,24 One would hope that the technology could be harnessed to improve provider productivity and be effectively integrated into comprehensive patient care.
Our research makes progress toward recommendations made by the American College of Physicians “to improve accuracy of information recorded and the value of information,” and develop automated tools that “enhance documentation quality without facilitating improper behaviors.”19 Institutions should consider developing internal best practices for clinical documentation and building structured note templates.19 Our research would suggest that, combined with a small educational intervention, such templates can make progress notes more accurate and succinct, make note writing more efficient, and be harnessed to improve quality metrics.
ACKNOWLEDGMENTS
The authors thank Michael Pfeffer, MD, and Sitaram Vangala, MS, for their contributions to and support of this research study and manuscript.
Disclosure: The authors declare no conflicts of interest.
1. Herzig SJ, Guess JR, Feinbloom DB, et al. Improving appropriateness of acid-suppressive medication use via computerized clinical decision support. J Hosp Med. 2015;10(1):41-45. PubMed
2. Nguyen OK, Makam AN, Clark C, et al. Predicting all-cause readmissions using electronic health record data from the entire hospitalization: Model development and comparison. J Hosp Med. 2016;11(7):473-480. PubMed
3. Donati A, Gabbanelli V, Pantanetti S, et al. The impact of a clinical information system in an intensive care unit. J Clin Monit Comput. 2008;22(1):31-36. PubMed
4. Schiff GD, Bates DW. Can electronic clinical documentation help prevent diagnostic errors? N Engl J Med. 2010;362(12):1066-1069. PubMed
5. Hartzband P, Groopman J. Off the record--avoiding the pitfalls of going electronic. N Engl J Med. 2008;358(16):1656-1658. PubMed
6. Hirschtick RE. A piece of my mind. Copy-and-paste. JAMA. 2006;295(20):2335-2336. PubMed
7. Hirschtick RE. A piece of my mind. John Lennon’s elbow. JAMA. 2012;308(5):463-464. PubMed
8. O’Donnell HC, Kaushal R, Barrón Y, Callahan MA, Adelman RD, Siegler EL. Physicians’ attitudes towards copy and pasting in electronic note writing. J Gen Intern Med. 2009;24(1):63-68. PubMed
9. Mahapatra P, Ieong E. Improving Documentation and Communication Using Operative Note Proformas. BMJ Qual Improv Rep. 2016;5(1):u209122.w3712. PubMed
10. Thomson DR, Baldwin MJ, Bellini MI, Silva MA. Improving the quality of operative notes for laparoscopic cholecystectomy: Assessing the impact of a standardized operation note proforma. Int J Surg. 2016;27:17-20. PubMed
11. Dean SM, Eickhoff JC, Bakel LA. The effectiveness of a bundled intervention to improve resident progress notes in an electronic health record. J Hosp Med. 2015;10(2):104-107. PubMed
12. Aylor M, Campbell EM, Winter C, Phillipi CA. Resident Notes in an Electronic Health Record: A Mixed-Methods Study Using a Standardized Intervention With Qualitative Analysis. Clin Pediatr (Phila). 2016;6(3):257-262.
13. Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009;42(2):377-381. PubMed
14. Chi J, Kugler J, Chu IM, et al. Medical students and the electronic health record: ‘an epic use of time’. Am J Med. 2014;127(9):891-895. PubMed
15. Martin SA, Sinsky CA. The map is not the territory: medical records and 21st century practice. Lancet. 2016;388(10055):2053-2056. PubMed
16. Oxentenko AS, Manohar CU, McCoy CP, et al. Internal medicine residents’ computer use in the inpatient setting. J Grad Med Educ. 2012;4(4):529-532. PubMed
17. Mamykina L, Vawdrey DK, Hripcsak G. How Do Residents Spend Their Shift Time? A Time and Motion Study With a Particular Focus on the Use of Computers. Acad Med. 2016;91(6):827-832. PubMed
18. Chen L, Guo U, Illipparambil LC, et al. Racing Against the Clock: Internal Medicine Residents’ Time Spent On Electronic Health Records. J Grad Med Educ. 2016;8(1):39-44. PubMed
19. Kuhn T, Basch P, Barr M, Yackel T, Physicians MICotACo. Clinical documentation in the 21st century: executive summary of a policy position paper from the American College of Physicians. Ann Intern Med. 2015;162(4):301-303. PubMed
20. Treadwell JR, Lucas S, Tsou AY. Surgical checklists: a systematic review of impacts and implementation. BMJ Qual Saf. 2014;23(4):299-318. PubMed
21. Ko HC, Turner TJ, Finnigan MA. Systematic review of safety checklists for use by medical care teams in acute hospital settings--limited evidence of effectiveness. BMC Health Serv Res. 2011;11:211. PubMed
22. Diaz-Montes TP, Cobb L, Ibeanu OA, Njoku P, Gerardi MA. Introduction of checklists at daily progress notes improves patient care among the gynecological oncology service. J Patient Saf. 2012;8(4):189-193. PubMed
23. Stetson PD, Bakken S, Wrenn JO, Siegler EL. Assessing Electronic Note Quality Using the Physician Documentation Quality Instrument (PDQI-9). Appl Clin Inform. 2012;3(2):164-174. PubMed
24. Friedberg MW, Chen PG, Van Busum KR, et al. Factors affecting physician professional satisfaction and their implications for patient care, health systems, and health policy. Santa Monica, CA: RAND Corporation; 2013. PubMed
1. Herzig SJ, Guess JR, Feinbloom DB, et al. Improving appropriateness of acid-suppressive medication use via computerized clinical decision support. J Hosp Med. 2015;10(1):41-45. PubMed
2. Nguyen OK, Makam AN, Clark C, et al. Predicting all-cause readmissions using electronic health record data from the entire hospitalization: Model development and comparison. J Hosp Med. 2016;11(7):473-480. PubMed
3. Donati A, Gabbanelli V, Pantanetti S, et al. The impact of a clinical information system in an intensive care unit. J Clin Monit Comput. 2008;22(1):31-36. PubMed
4. Schiff GD, Bates DW. Can electronic clinical documentation help prevent diagnostic errors? N Engl J Med. 2010;362(12):1066-1069. PubMed
5. Hartzband P, Groopman J. Off the record--avoiding the pitfalls of going electronic. N Engl J Med. 2008;358(16):1656-1658. PubMed
6. Hirschtick RE. A piece of my mind. Copy-and-paste. JAMA. 2006;295(20):2335-2336. PubMed
7. Hirschtick RE. A piece of my mind. John Lennon’s elbow. JAMA. 2012;308(5):463-464. PubMed
8. O’Donnell HC, Kaushal R, Barrón Y, Callahan MA, Adelman RD, Siegler EL. Physicians’ attitudes towards copy and pasting in electronic note writing. J Gen Intern Med. 2009;24(1):63-68. PubMed
9. Mahapatra P, Ieong E. Improving Documentation and Communication Using Operative Note Proformas. BMJ Qual Improv Rep. 2016;5(1):u209122.w3712. PubMed
10. Thomson DR, Baldwin MJ, Bellini MI, Silva MA. Improving the quality of operative notes for laparoscopic cholecystectomy: Assessing the impact of a standardized operation note proforma. Int J Surg. 2016;27:17-20. PubMed
11. Dean SM, Eickhoff JC, Bakel LA. The effectiveness of a bundled intervention to improve resident progress notes in an electronic health record. J Hosp Med. 2015;10(2):104-107. PubMed
12. Aylor M, Campbell EM, Winter C, Phillipi CA. Resident Notes in an Electronic Health Record: A Mixed-Methods Study Using a Standardized Intervention With Qualitative Analysis. Clin Pediatr (Phila). 2016;6(3):257-262.
13. Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009;42(2):377-381. PubMed
14. Chi J, Kugler J, Chu IM, et al. Medical students and the electronic health record: ‘an epic use of time’. Am J Med. 2014;127(9):891-895. PubMed
15. Martin SA, Sinsky CA. The map is not the territory: medical records and 21st century practice. Lancet. 2016;388(10055):2053-2056. PubMed
16. Oxentenko AS, Manohar CU, McCoy CP, et al. Internal medicine residents’ computer use in the inpatient setting. J Grad Med Educ. 2012;4(4):529-532. PubMed
17. Mamykina L, Vawdrey DK, Hripcsak G. How Do Residents Spend Their Shift Time? A Time and Motion Study With a Particular Focus on the Use of Computers. Acad Med. 2016;91(6):827-832. PubMed
18. Chen L, Guo U, Illipparambil LC, et al. Racing Against the Clock: Internal Medicine Residents’ Time Spent On Electronic Health Records. J Grad Med Educ. 2016;8(1):39-44. PubMed
19. Kuhn T, Basch P, Barr M, Yackel T, Physicians MICotACo. Clinical documentation in the 21st century: executive summary of a policy position paper from the American College of Physicians. Ann Intern Med. 2015;162(4):301-303. PubMed
20. Treadwell JR, Lucas S, Tsou AY. Surgical checklists: a systematic review of impacts and implementation. BMJ Qual Saf. 2014;23(4):299-318. PubMed
21. Ko HC, Turner TJ, Finnigan MA. Systematic review of safety checklists for use by medical care teams in acute hospital settings--limited evidence of effectiveness. BMC Health Serv Res. 2011;11:211. PubMed
22. Diaz-Montes TP, Cobb L, Ibeanu OA, Njoku P, Gerardi MA. Introduction of checklists at daily progress notes improves patient care among the gynecological oncology service. J Patient Saf. 2012;8(4):189-193. PubMed
23. Stetson PD, Bakken S, Wrenn JO, Siegler EL. Assessing Electronic Note Quality Using the Physician Documentation Quality Instrument (PDQI-9). Appl Clin Inform. 2012;3(2):164-174. PubMed
24. Friedberg MW, Chen PG, Van Busum KR, et al. Factors affecting physician professional satisfaction and their implications for patient care, health systems, and health policy. Santa Monica, CA: RAND Corporation; 2013. PubMed
© 2018 Society of Hospital Medicine
Brief preoperative score predicts postoperative complications in the elderly
Background: Elective operations have become increasingly more common in the elderly. This population is at a higher risk for postsurgical complications. Previous research into preoperative risk assessment relied on geriatricians, of whom there is a national shortage.
Study design: Prospective cohort study.
Setting: Preoperative surgery clinics at the University of Michigan Health System.
Synopsis: A total of 736 elderly patients had a preoperative Vulnerable Elders Surgical Pathways and Outcomes Assessment (VESPA) administered by a surgical physician assistant in clinic. VESPA assessed activities of daily living, history of falling or gait impairment, and depressive symptoms. Patients underwent a Mini-Cog examination and a Timed Up and Go assessment. Patients were asked whether they expected they could manage themselves alone after discharge. One in seven patients reported difficulty with one or more of the activities of daily living and one in three stated they would be unable to manage postoperative self-care alone. Overall, 25.3% of patients had geriatric or surgical complications. The VESPA score predicted postoperative complications (area under the curve, 0.76). More specifically, preexisting difficulties with activities of daily living, anticipated self-care difficulty, a Charlson Comorbidity score of 2 or greater, male sex, or higher surgical relative value units were all independently associated with postoperative complications.
Bottom line: Elderly patients at an increased risk of postoperative complications can be identified by nonphysician staff using the VESPA preoperative assessment.
Citation: Min L et al. Estimating risk of postsurgical general and geriatric complications using the VESPA preoperative tool. JAMA Surg. 2017 Aug 2. doi: 10.1001/jamasurg.2017.2635.
Dr. Hoegh is a hospitalist at the University of Colorado School of Medicine.
Background: Elective operations have become increasingly more common in the elderly. This population is at a higher risk for postsurgical complications. Previous research into preoperative risk assessment relied on geriatricians, of whom there is a national shortage.
Study design: Prospective cohort study.
Setting: Preoperative surgery clinics at the University of Michigan Health System.
Synopsis: A total of 736 elderly patients had a preoperative Vulnerable Elders Surgical Pathways and Outcomes Assessment (VESPA) administered by a surgical physician assistant in clinic. VESPA assessed activities of daily living, history of falling or gait impairment, and depressive symptoms. Patients underwent a Mini-Cog examination and a Timed Up and Go assessment. Patients were asked whether they expected they could manage themselves alone after discharge. One in seven patients reported difficulty with one or more of the activities of daily living and one in three stated they would be unable to manage postoperative self-care alone. Overall, 25.3% of patients had geriatric or surgical complications. The VESPA score predicted postoperative complications (area under the curve, 0.76). More specifically, preexisting difficulties with activities of daily living, anticipated self-care difficulty, a Charlson Comorbidity score of 2 or greater, male sex, or higher surgical relative value units were all independently associated with postoperative complications.
Bottom line: Elderly patients at an increased risk of postoperative complications can be identified by nonphysician staff using the VESPA preoperative assessment.
Citation: Min L et al. Estimating risk of postsurgical general and geriatric complications using the VESPA preoperative tool. JAMA Surg. 2017 Aug 2. doi: 10.1001/jamasurg.2017.2635.
Dr. Hoegh is a hospitalist at the University of Colorado School of Medicine.
Background: Elective operations have become increasingly more common in the elderly. This population is at a higher risk for postsurgical complications. Previous research into preoperative risk assessment relied on geriatricians, of whom there is a national shortage.
Study design: Prospective cohort study.
Setting: Preoperative surgery clinics at the University of Michigan Health System.
Synopsis: A total of 736 elderly patients had a preoperative Vulnerable Elders Surgical Pathways and Outcomes Assessment (VESPA) administered by a surgical physician assistant in clinic. VESPA assessed activities of daily living, history of falling or gait impairment, and depressive symptoms. Patients underwent a Mini-Cog examination and a Timed Up and Go assessment. Patients were asked whether they expected they could manage themselves alone after discharge. One in seven patients reported difficulty with one or more of the activities of daily living and one in three stated they would be unable to manage postoperative self-care alone. Overall, 25.3% of patients had geriatric or surgical complications. The VESPA score predicted postoperative complications (area under the curve, 0.76). More specifically, preexisting difficulties with activities of daily living, anticipated self-care difficulty, a Charlson Comorbidity score of 2 or greater, male sex, or higher surgical relative value units were all independently associated with postoperative complications.
Bottom line: Elderly patients at an increased risk of postoperative complications can be identified by nonphysician staff using the VESPA preoperative assessment.
Citation: Min L et al. Estimating risk of postsurgical general and geriatric complications using the VESPA preoperative tool. JAMA Surg. 2017 Aug 2. doi: 10.1001/jamasurg.2017.2635.
Dr. Hoegh is a hospitalist at the University of Colorado School of Medicine.
FDA grants ‘Breakthrough Therapy Designation’ for upadacitinib for atopic dermatitis
The Food and Drug Administration has granted “Breakthrough Therapy Designation” for the investigational, once-daily oral Janus kinase 1 (JAK1)-selective inhibitor upadacitinib (ABT-494) in adult patients with moderate to severe atopic dermatitis who are candidates for systemic therapy.
The Breakthrough Therapy Designation is based on positive phase 2b results announced in Sept. 2017. The study found that patients treated with upadacitinib achieved statistically significant improvements in the primary endpoint (greater mean percentage change from baseline in Eczema Area and Severity Index score) and in all skin- and itch-specific secondary endpoints across all doses (30 mg, 15mg, or 7.5 mg once-daily) at week 16, compared with placebo (P less than .05). Reduction in itch was observed within the first week and improvement in skin within the first 2 weeks (P less than .001 across all doses). Of patients receiving the 30 mg once-daily dose of upadacitinib, 50% had clear or almost clear skin, according to a press release. There were 42 patients in each of the three treatment groups and 41 patients in the placebo group in this randomized, double-blind, parallel-group study sponsored by AbbVie, which discovered and developed upadacitinib.
The phase 3 clinical program is expected to begin in the first half of 2018, according to AbbVie. Any additional information on the clinical trials for upadacitinib is available at clinicaltrials.gov.
SOURCE: Prnewswire.com.
The Food and Drug Administration has granted “Breakthrough Therapy Designation” for the investigational, once-daily oral Janus kinase 1 (JAK1)-selective inhibitor upadacitinib (ABT-494) in adult patients with moderate to severe atopic dermatitis who are candidates for systemic therapy.
The Breakthrough Therapy Designation is based on positive phase 2b results announced in Sept. 2017. The study found that patients treated with upadacitinib achieved statistically significant improvements in the primary endpoint (greater mean percentage change from baseline in Eczema Area and Severity Index score) and in all skin- and itch-specific secondary endpoints across all doses (30 mg, 15mg, or 7.5 mg once-daily) at week 16, compared with placebo (P less than .05). Reduction in itch was observed within the first week and improvement in skin within the first 2 weeks (P less than .001 across all doses). Of patients receiving the 30 mg once-daily dose of upadacitinib, 50% had clear or almost clear skin, according to a press release. There were 42 patients in each of the three treatment groups and 41 patients in the placebo group in this randomized, double-blind, parallel-group study sponsored by AbbVie, which discovered and developed upadacitinib.
The phase 3 clinical program is expected to begin in the first half of 2018, according to AbbVie. Any additional information on the clinical trials for upadacitinib is available at clinicaltrials.gov.
SOURCE: Prnewswire.com.
The Food and Drug Administration has granted “Breakthrough Therapy Designation” for the investigational, once-daily oral Janus kinase 1 (JAK1)-selective inhibitor upadacitinib (ABT-494) in adult patients with moderate to severe atopic dermatitis who are candidates for systemic therapy.
The Breakthrough Therapy Designation is based on positive phase 2b results announced in Sept. 2017. The study found that patients treated with upadacitinib achieved statistically significant improvements in the primary endpoint (greater mean percentage change from baseline in Eczema Area and Severity Index score) and in all skin- and itch-specific secondary endpoints across all doses (30 mg, 15mg, or 7.5 mg once-daily) at week 16, compared with placebo (P less than .05). Reduction in itch was observed within the first week and improvement in skin within the first 2 weeks (P less than .001 across all doses). Of patients receiving the 30 mg once-daily dose of upadacitinib, 50% had clear or almost clear skin, according to a press release. There were 42 patients in each of the three treatment groups and 41 patients in the placebo group in this randomized, double-blind, parallel-group study sponsored by AbbVie, which discovered and developed upadacitinib.
The phase 3 clinical program is expected to begin in the first half of 2018, according to AbbVie. Any additional information on the clinical trials for upadacitinib is available at clinicaltrials.gov.
SOURCE: Prnewswire.com.
Our fascination with medication compliance
As a forensic psychiatrist, I follow news relating to mental illness and crime. Like many of the judges and lawyers with whom I work, the media appear to have an obsession with medication compliance in those with mental illness. Being “off medications” has become a threatening term suggestive of unbridled impulsivity and violence – a term that can explain any behavior, implying that without medication, humans are routinely capable of all things without warning.
The year 2018 already has provided two stark examples of this phenomenon. During the first week of the year, two articles with the following headlines were published: “ ‘He was off his meds’: Son charged in mother’s murder”1 and “A man lost his life in the subway after telling a teen off of his medication to ‘get away.’ ”2 Those two articles describe awful events that, as the headlines suggest, are best explained by a lack of compliance with a psychotropic medication regimen.
“A man lost his life in the subway after telling a teen off of his medication to ‘get away’ ” reports on a 65-year-old man who was pushed onto New York’s subway tracks after interacting with an 18-year-old who “did not take medication that day for his mental illness.” This article provides some limited details on the state of mind of the defendant, indicating that he had been “talking to himself.” However, to reinforce the message, the article informs the reader that he had been prescribed three psychotropics – insinuating a multiplier effect for the role of noncompliance. Furthermore, the article implies that missing a single day of psychotropics is an explanation for the incident.
The media routinely use this bias in favor of the medication explanation in its analysis – or lack thereof – of violent behavior in people with mental illness. Recent stories include a man killing his nephew3 and a man killing his girlfriend4, and both were incidents apparently best explained by medication noncompliance. Another story reports of police officers who were charged with assault after an altercation with a patient with mental illness led to the patient’s death. In the latter case, the article suggests that the simple fact that the victim had been acting erratically warrants the comment that he was “likely was off his medications.”
My work in the jail system also has been tainted by this overreliance on the unquestioned dogma of medication compliance. Discussions pertaining to punishment and privileges of inmates with mental illness often would lead to the question: “Is he taking his meds?” I have witnessed countless times when crucial decisions about placement in solitary confinement were predicated on questions of medication compliance. My answer was always the same: “Why does it matter? If the inmate is following the rules and behaving respectfully, how does taking a pill provide more important information?”
What was once thought to be a predictor of relapse risk, despite limited evidence, has become the outcome itself. As a society, we have falsely equated mental illness with violence; we have furthermore falsely equated remission and safety with medication compliance. The consequences of those beliefs are severe as we have limited attention, and our focus on medications blinds us to much clearer risk factors. 5
The court system is equally riveted with this question. Judges and lawyers associate medication compliance with legal competency, safety in probation or parole, and general well-being. I have witnessed agitated patients being reprimanded for their lack of medication adherence, leaving me to remind lawyers that the patient has been compliant. Conversely, patients are congratulated for their medication adherence when appearing well, until I remind the lawyers that the patient missed his last two visits for long-acting injectables.
As our field is reconciling new evidence questioning the long-term role of antipsychotics in schizophrenia, I am questioning whether society has accepted their value as a foregone conclusion. Lex Wunderink, MD, PhD, and his associates challenged accepted dogma when conducting a long-term, randomized trial of antipsychotics, in which patients on a dose reduction and discontinuation arm did better at 7 years than the patients on the continuation arm.6 The then National Institute of Mental Health director, Thomas Insel, MD, wrote in his blog that for some schizophrenia patients, “remaining on medication long term might impede a full return to wellness.”7
A Cochrane review of the literature found that, over time, antipsychotics had a diminishing effect on relapse prevention. After 2 years, the effect approached zero.8 In 2016, Nancy L. Sohler, PhD, and her colleagues looked at the literature on antipsychotic use in longer trials. The data were of poor quality and inconclusive.9 However, stories in the popular press suggest that the best explanation for violent behavior in the mentally ill population is medication noncompliance.
Inextricably bound up with this dogma regarding noncompliance is the incorporation of the pharmaceutical industry into mainstream psychiatry. The promise of psychopharmacology to treat mental illness was adopted in a wholesale manner for financial and practical reasons as well as a desperate optimism to relieve seemingly intractable problems. Sadly, the failure of psychopharmacology to produce on said promises has not produced a backlash. Instead, there is a doubling down on this belief, which can be seen, for example, in the creation of Abilify MyCite – with its promise to keep clinicians informed about their patients’ medication compliance.10 The alternative to this prescribing culture would be an attentive reckoning of the ongoing limitations inherent in the treatment of those with mental illness. If noncompliance cannot explain violence in people with mental illness, we are left with the same complex and subtle issues surrounding violence that frustrate easy journalistic explanations, and relatively cheap and easy interventions for the care of this population. It feels better and is more cost effective to blame the patients for not fitting our biological models by being drug nonresponders or noncompliant.
Blaming pills is facile. It is tangible and easier to measure than looking into someone’s mind. Psychiatrists have promoted this idea by teaching the public about chemical imbalances and by focusing on medication management. However, when the consequences are as severe as placing people in solitary confinement or explaining murder, the evidence needs to be equally solid as the severity of the punishment. This must start with psychiatrists reeducating the public on the role, the power, and the limitations of psychotropics.
Dr. Badre is a forensic psychiatrist in San Diego and an expert in correctional mental health. He holds teaching positions at the University of California, San Diego, and the University of San Diego. He teaches medical education, psychopharmacology, ethics in psychiatry, and correctional care. Dr. Badre mentors residents on projects, including reduction in the use of solitary confinement of patients with mental illness and examination of the mentally ill offender. Dr. Badre can be reached at Badremd.com.
References
1. Worcester Patch. Jan. 2, 2018.
2. Rare News. Jan. 4, 2018.
3. WTSP.com. Dec. 31, 2017.
4. Wavy.com, Dec. 20, 2017.
5. U.S. Attorney General. 2016. U.S. Department of Justice Report and Recommendations Concerning the Use of Restrictive Housing.
6. JAMA Psychiatry. 2013 Sep;70(9):913-20.
7. Blogpost, by Thomas Insel, MD. Aug. 28, 2013.
8. Cochrane Database Syst Rev. 2012 May 16. doi: 10.1002/14651858.CD008016.pub2.
9. Am J Orthopsychiatry. 2016;86(5):477-85.
10. New York Times. Nov. 13, 2017.
As a forensic psychiatrist, I follow news relating to mental illness and crime. Like many of the judges and lawyers with whom I work, the media appear to have an obsession with medication compliance in those with mental illness. Being “off medications” has become a threatening term suggestive of unbridled impulsivity and violence – a term that can explain any behavior, implying that without medication, humans are routinely capable of all things without warning.
The year 2018 already has provided two stark examples of this phenomenon. During the first week of the year, two articles with the following headlines were published: “ ‘He was off his meds’: Son charged in mother’s murder”1 and “A man lost his life in the subway after telling a teen off of his medication to ‘get away.’ ”2 Those two articles describe awful events that, as the headlines suggest, are best explained by a lack of compliance with a psychotropic medication regimen.
“A man lost his life in the subway after telling a teen off of his medication to ‘get away’ ” reports on a 65-year-old man who was pushed onto New York’s subway tracks after interacting with an 18-year-old who “did not take medication that day for his mental illness.” This article provides some limited details on the state of mind of the defendant, indicating that he had been “talking to himself.” However, to reinforce the message, the article informs the reader that he had been prescribed three psychotropics – insinuating a multiplier effect for the role of noncompliance. Furthermore, the article implies that missing a single day of psychotropics is an explanation for the incident.
The media routinely use this bias in favor of the medication explanation in its analysis – or lack thereof – of violent behavior in people with mental illness. Recent stories include a man killing his nephew3 and a man killing his girlfriend4, and both were incidents apparently best explained by medication noncompliance. Another story reports of police officers who were charged with assault after an altercation with a patient with mental illness led to the patient’s death. In the latter case, the article suggests that the simple fact that the victim had been acting erratically warrants the comment that he was “likely was off his medications.”
My work in the jail system also has been tainted by this overreliance on the unquestioned dogma of medication compliance. Discussions pertaining to punishment and privileges of inmates with mental illness often would lead to the question: “Is he taking his meds?” I have witnessed countless times when crucial decisions about placement in solitary confinement were predicated on questions of medication compliance. My answer was always the same: “Why does it matter? If the inmate is following the rules and behaving respectfully, how does taking a pill provide more important information?”
What was once thought to be a predictor of relapse risk, despite limited evidence, has become the outcome itself. As a society, we have falsely equated mental illness with violence; we have furthermore falsely equated remission and safety with medication compliance. The consequences of those beliefs are severe as we have limited attention, and our focus on medications blinds us to much clearer risk factors. 5
The court system is equally riveted with this question. Judges and lawyers associate medication compliance with legal competency, safety in probation or parole, and general well-being. I have witnessed agitated patients being reprimanded for their lack of medication adherence, leaving me to remind lawyers that the patient has been compliant. Conversely, patients are congratulated for their medication adherence when appearing well, until I remind the lawyers that the patient missed his last two visits for long-acting injectables.
As our field is reconciling new evidence questioning the long-term role of antipsychotics in schizophrenia, I am questioning whether society has accepted their value as a foregone conclusion. Lex Wunderink, MD, PhD, and his associates challenged accepted dogma when conducting a long-term, randomized trial of antipsychotics, in which patients on a dose reduction and discontinuation arm did better at 7 years than the patients on the continuation arm.6 The then National Institute of Mental Health director, Thomas Insel, MD, wrote in his blog that for some schizophrenia patients, “remaining on medication long term might impede a full return to wellness.”7
A Cochrane review of the literature found that, over time, antipsychotics had a diminishing effect on relapse prevention. After 2 years, the effect approached zero.8 In 2016, Nancy L. Sohler, PhD, and her colleagues looked at the literature on antipsychotic use in longer trials. The data were of poor quality and inconclusive.9 However, stories in the popular press suggest that the best explanation for violent behavior in the mentally ill population is medication noncompliance.
Inextricably bound up with this dogma regarding noncompliance is the incorporation of the pharmaceutical industry into mainstream psychiatry. The promise of psychopharmacology to treat mental illness was adopted in a wholesale manner for financial and practical reasons as well as a desperate optimism to relieve seemingly intractable problems. Sadly, the failure of psychopharmacology to produce on said promises has not produced a backlash. Instead, there is a doubling down on this belief, which can be seen, for example, in the creation of Abilify MyCite – with its promise to keep clinicians informed about their patients’ medication compliance.10 The alternative to this prescribing culture would be an attentive reckoning of the ongoing limitations inherent in the treatment of those with mental illness. If noncompliance cannot explain violence in people with mental illness, we are left with the same complex and subtle issues surrounding violence that frustrate easy journalistic explanations, and relatively cheap and easy interventions for the care of this population. It feels better and is more cost effective to blame the patients for not fitting our biological models by being drug nonresponders or noncompliant.
Blaming pills is facile. It is tangible and easier to measure than looking into someone’s mind. Psychiatrists have promoted this idea by teaching the public about chemical imbalances and by focusing on medication management. However, when the consequences are as severe as placing people in solitary confinement or explaining murder, the evidence needs to be equally solid as the severity of the punishment. This must start with psychiatrists reeducating the public on the role, the power, and the limitations of psychotropics.
Dr. Badre is a forensic psychiatrist in San Diego and an expert in correctional mental health. He holds teaching positions at the University of California, San Diego, and the University of San Diego. He teaches medical education, psychopharmacology, ethics in psychiatry, and correctional care. Dr. Badre mentors residents on projects, including reduction in the use of solitary confinement of patients with mental illness and examination of the mentally ill offender. Dr. Badre can be reached at Badremd.com.
References
1. Worcester Patch. Jan. 2, 2018.
2. Rare News. Jan. 4, 2018.
3. WTSP.com. Dec. 31, 2017.
4. Wavy.com, Dec. 20, 2017.
5. U.S. Attorney General. 2016. U.S. Department of Justice Report and Recommendations Concerning the Use of Restrictive Housing.
6. JAMA Psychiatry. 2013 Sep;70(9):913-20.
7. Blogpost, by Thomas Insel, MD. Aug. 28, 2013.
8. Cochrane Database Syst Rev. 2012 May 16. doi: 10.1002/14651858.CD008016.pub2.
9. Am J Orthopsychiatry. 2016;86(5):477-85.
10. New York Times. Nov. 13, 2017.
As a forensic psychiatrist, I follow news relating to mental illness and crime. Like many of the judges and lawyers with whom I work, the media appear to have an obsession with medication compliance in those with mental illness. Being “off medications” has become a threatening term suggestive of unbridled impulsivity and violence – a term that can explain any behavior, implying that without medication, humans are routinely capable of all things without warning.
The year 2018 already has provided two stark examples of this phenomenon. During the first week of the year, two articles with the following headlines were published: “ ‘He was off his meds’: Son charged in mother’s murder”1 and “A man lost his life in the subway after telling a teen off of his medication to ‘get away.’ ”2 Those two articles describe awful events that, as the headlines suggest, are best explained by a lack of compliance with a psychotropic medication regimen.
“A man lost his life in the subway after telling a teen off of his medication to ‘get away’ ” reports on a 65-year-old man who was pushed onto New York’s subway tracks after interacting with an 18-year-old who “did not take medication that day for his mental illness.” This article provides some limited details on the state of mind of the defendant, indicating that he had been “talking to himself.” However, to reinforce the message, the article informs the reader that he had been prescribed three psychotropics – insinuating a multiplier effect for the role of noncompliance. Furthermore, the article implies that missing a single day of psychotropics is an explanation for the incident.
The media routinely use this bias in favor of the medication explanation in its analysis – or lack thereof – of violent behavior in people with mental illness. Recent stories include a man killing his nephew3 and a man killing his girlfriend4, and both were incidents apparently best explained by medication noncompliance. Another story reports of police officers who were charged with assault after an altercation with a patient with mental illness led to the patient’s death. In the latter case, the article suggests that the simple fact that the victim had been acting erratically warrants the comment that he was “likely was off his medications.”
My work in the jail system also has been tainted by this overreliance on the unquestioned dogma of medication compliance. Discussions pertaining to punishment and privileges of inmates with mental illness often would lead to the question: “Is he taking his meds?” I have witnessed countless times when crucial decisions about placement in solitary confinement were predicated on questions of medication compliance. My answer was always the same: “Why does it matter? If the inmate is following the rules and behaving respectfully, how does taking a pill provide more important information?”
What was once thought to be a predictor of relapse risk, despite limited evidence, has become the outcome itself. As a society, we have falsely equated mental illness with violence; we have furthermore falsely equated remission and safety with medication compliance. The consequences of those beliefs are severe as we have limited attention, and our focus on medications blinds us to much clearer risk factors. 5
The court system is equally riveted with this question. Judges and lawyers associate medication compliance with legal competency, safety in probation or parole, and general well-being. I have witnessed agitated patients being reprimanded for their lack of medication adherence, leaving me to remind lawyers that the patient has been compliant. Conversely, patients are congratulated for their medication adherence when appearing well, until I remind the lawyers that the patient missed his last two visits for long-acting injectables.
As our field is reconciling new evidence questioning the long-term role of antipsychotics in schizophrenia, I am questioning whether society has accepted their value as a foregone conclusion. Lex Wunderink, MD, PhD, and his associates challenged accepted dogma when conducting a long-term, randomized trial of antipsychotics, in which patients on a dose reduction and discontinuation arm did better at 7 years than the patients on the continuation arm.6 The then National Institute of Mental Health director, Thomas Insel, MD, wrote in his blog that for some schizophrenia patients, “remaining on medication long term might impede a full return to wellness.”7
A Cochrane review of the literature found that, over time, antipsychotics had a diminishing effect on relapse prevention. After 2 years, the effect approached zero.8 In 2016, Nancy L. Sohler, PhD, and her colleagues looked at the literature on antipsychotic use in longer trials. The data were of poor quality and inconclusive.9 However, stories in the popular press suggest that the best explanation for violent behavior in the mentally ill population is medication noncompliance.
Inextricably bound up with this dogma regarding noncompliance is the incorporation of the pharmaceutical industry into mainstream psychiatry. The promise of psychopharmacology to treat mental illness was adopted in a wholesale manner for financial and practical reasons as well as a desperate optimism to relieve seemingly intractable problems. Sadly, the failure of psychopharmacology to produce on said promises has not produced a backlash. Instead, there is a doubling down on this belief, which can be seen, for example, in the creation of Abilify MyCite – with its promise to keep clinicians informed about their patients’ medication compliance.10 The alternative to this prescribing culture would be an attentive reckoning of the ongoing limitations inherent in the treatment of those with mental illness. If noncompliance cannot explain violence in people with mental illness, we are left with the same complex and subtle issues surrounding violence that frustrate easy journalistic explanations, and relatively cheap and easy interventions for the care of this population. It feels better and is more cost effective to blame the patients for not fitting our biological models by being drug nonresponders or noncompliant.
Blaming pills is facile. It is tangible and easier to measure than looking into someone’s mind. Psychiatrists have promoted this idea by teaching the public about chemical imbalances and by focusing on medication management. However, when the consequences are as severe as placing people in solitary confinement or explaining murder, the evidence needs to be equally solid as the severity of the punishment. This must start with psychiatrists reeducating the public on the role, the power, and the limitations of psychotropics.
Dr. Badre is a forensic psychiatrist in San Diego and an expert in correctional mental health. He holds teaching positions at the University of California, San Diego, and the University of San Diego. He teaches medical education, psychopharmacology, ethics in psychiatry, and correctional care. Dr. Badre mentors residents on projects, including reduction in the use of solitary confinement of patients with mental illness and examination of the mentally ill offender. Dr. Badre can be reached at Badremd.com.
References
1. Worcester Patch. Jan. 2, 2018.
2. Rare News. Jan. 4, 2018.
3. WTSP.com. Dec. 31, 2017.
4. Wavy.com, Dec. 20, 2017.
5. U.S. Attorney General. 2016. U.S. Department of Justice Report and Recommendations Concerning the Use of Restrictive Housing.
6. JAMA Psychiatry. 2013 Sep;70(9):913-20.
7. Blogpost, by Thomas Insel, MD. Aug. 28, 2013.
8. Cochrane Database Syst Rev. 2012 May 16. doi: 10.1002/14651858.CD008016.pub2.
9. Am J Orthopsychiatry. 2016;86(5):477-85.
10. New York Times. Nov. 13, 2017.
Putting a number on biologic DMARD costs
Annual medical costs for patients with rheumatoid arthritis were almost three times higher for those who used biologic disease-modifying antirheumatic drugs (bDMARDs), compared with those who used any treatment regimen, according to meta-analysis of 12 studies conducted since bDMARDs were introduced in 1999.
RA patients who used bDMARDs had an average direct cost of $36,053 per year, which was 2.9 times higher than the $12,509 in annual direct medical costs for all RA patients on any treatment regimen. Proportionately, the difference was even greater for RA-specific care, with the annual cost of bDMARD care ($20,262) 5.4 times higher than that of all treatment regimens ($3,723), reported Andrew Hresko and his associates at Brigham and Women’s Hospital, Boston.
Funding for the study was supported through a grant from the National Institutes of Health. Mr. Hresko was supported by a fellowship from Tufts University. One of his associates receives research support from grants to his hospital from Amgen, Pfizer, Eli Lilly, AstraZeneca, Genentech, Bristol Myers Squibb, and Corrona. The third investigator is now an employee of Amgen but was not during the study.
SOURCE: Hresko A et al. Arthritis Care Res. 2018 Jan 5. doi: 10.1002/acr.23512.
Annual medical costs for patients with rheumatoid arthritis were almost three times higher for those who used biologic disease-modifying antirheumatic drugs (bDMARDs), compared with those who used any treatment regimen, according to meta-analysis of 12 studies conducted since bDMARDs were introduced in 1999.
RA patients who used bDMARDs had an average direct cost of $36,053 per year, which was 2.9 times higher than the $12,509 in annual direct medical costs for all RA patients on any treatment regimen. Proportionately, the difference was even greater for RA-specific care, with the annual cost of bDMARD care ($20,262) 5.4 times higher than that of all treatment regimens ($3,723), reported Andrew Hresko and his associates at Brigham and Women’s Hospital, Boston.
Funding for the study was supported through a grant from the National Institutes of Health. Mr. Hresko was supported by a fellowship from Tufts University. One of his associates receives research support from grants to his hospital from Amgen, Pfizer, Eli Lilly, AstraZeneca, Genentech, Bristol Myers Squibb, and Corrona. The third investigator is now an employee of Amgen but was not during the study.
SOURCE: Hresko A et al. Arthritis Care Res. 2018 Jan 5. doi: 10.1002/acr.23512.
Annual medical costs for patients with rheumatoid arthritis were almost three times higher for those who used biologic disease-modifying antirheumatic drugs (bDMARDs), compared with those who used any treatment regimen, according to meta-analysis of 12 studies conducted since bDMARDs were introduced in 1999.
RA patients who used bDMARDs had an average direct cost of $36,053 per year, which was 2.9 times higher than the $12,509 in annual direct medical costs for all RA patients on any treatment regimen. Proportionately, the difference was even greater for RA-specific care, with the annual cost of bDMARD care ($20,262) 5.4 times higher than that of all treatment regimens ($3,723), reported Andrew Hresko and his associates at Brigham and Women’s Hospital, Boston.
Funding for the study was supported through a grant from the National Institutes of Health. Mr. Hresko was supported by a fellowship from Tufts University. One of his associates receives research support from grants to his hospital from Amgen, Pfizer, Eli Lilly, AstraZeneca, Genentech, Bristol Myers Squibb, and Corrona. The third investigator is now an employee of Amgen but was not during the study.
SOURCE: Hresko A et al. Arthritis Care Res. 2018 Jan 5. doi: 10.1002/acr.23512.
FROM ARTHRITIS CARE & RESEARCH
Finance Committee votes on Azar HHS nomination
With a Senate Finance Committee vote of 15 to 12, Alex Azar’s nomination for secretary of Health & Human Services has been sent to the full Senate for consideration.
Finance Committee Chairman Orrin Hatch (R-Utah) said at a Jan. 17 hearing that “by any objective account, Mr. Azar is very well qualified for this important position. He has close to two decades of experience, the right expertise, and sound judgment.”
Most recently, Mr. Azar served as president of Eli Lilly’s U.S. operations from 2012 to 2017 after joining the company in 2007. His drug industry ties have raised concerns that the agency’s regulatory actions would be favorable to pharmaceutical manufacturers at the expense of patients. However, at his confirmation hearing, Mr. Azar noted that he would be willing to investigate government drug price negotiations for Medicare Part B drugs.
The top Democrat on the Finance Committee, Sen. Ron Wyden (D-Ore.) voted against Mr. Azar’s nomination, noting that President Trump “famously said, his words, in the 2016 campaign, ‘price-hiking drug companies were getting away with murder.’ The President has now nominated a drug company executive with a documented history of raising drug prices.”
Sen. Wyden noted that prices of many commonly prescribed drugs “more than doubled under [Mr. Azar’s] watch” while no drugs saw a decline in pricing.
With a Senate Finance Committee vote of 15 to 12, Alex Azar’s nomination for secretary of Health & Human Services has been sent to the full Senate for consideration.
Finance Committee Chairman Orrin Hatch (R-Utah) said at a Jan. 17 hearing that “by any objective account, Mr. Azar is very well qualified for this important position. He has close to two decades of experience, the right expertise, and sound judgment.”
Most recently, Mr. Azar served as president of Eli Lilly’s U.S. operations from 2012 to 2017 after joining the company in 2007. His drug industry ties have raised concerns that the agency’s regulatory actions would be favorable to pharmaceutical manufacturers at the expense of patients. However, at his confirmation hearing, Mr. Azar noted that he would be willing to investigate government drug price negotiations for Medicare Part B drugs.
The top Democrat on the Finance Committee, Sen. Ron Wyden (D-Ore.) voted against Mr. Azar’s nomination, noting that President Trump “famously said, his words, in the 2016 campaign, ‘price-hiking drug companies were getting away with murder.’ The President has now nominated a drug company executive with a documented history of raising drug prices.”
Sen. Wyden noted that prices of many commonly prescribed drugs “more than doubled under [Mr. Azar’s] watch” while no drugs saw a decline in pricing.
With a Senate Finance Committee vote of 15 to 12, Alex Azar’s nomination for secretary of Health & Human Services has been sent to the full Senate for consideration.
Finance Committee Chairman Orrin Hatch (R-Utah) said at a Jan. 17 hearing that “by any objective account, Mr. Azar is very well qualified for this important position. He has close to two decades of experience, the right expertise, and sound judgment.”
Most recently, Mr. Azar served as president of Eli Lilly’s U.S. operations from 2012 to 2017 after joining the company in 2007. His drug industry ties have raised concerns that the agency’s regulatory actions would be favorable to pharmaceutical manufacturers at the expense of patients. However, at his confirmation hearing, Mr. Azar noted that he would be willing to investigate government drug price negotiations for Medicare Part B drugs.
The top Democrat on the Finance Committee, Sen. Ron Wyden (D-Ore.) voted against Mr. Azar’s nomination, noting that President Trump “famously said, his words, in the 2016 campaign, ‘price-hiking drug companies were getting away with murder.’ The President has now nominated a drug company executive with a documented history of raising drug prices.”
Sen. Wyden noted that prices of many commonly prescribed drugs “more than doubled under [Mr. Azar’s] watch” while no drugs saw a decline in pricing.
REPORTING FROM A SENATE FINANCE COMMITTEE HEARING