Health Policy

From the Mobile Integrated Health and Emergency Medicine Department, South Shore Health, Weymouth, MA.

Objective: To develop a process through which Mobile Integrated Health (MIH) can treat patients with chronic obstructive pulmonary disease (COPD) at high risk for readmission in an outpatient setting. In turn, South Shore Hospital (SSH) looks to leverage MIH to improve hospital flow, decrease costs, and improve patient quality of life.

Methods: With the recent approval of hospital-based MIH programs in Massachusetts, SSH used MIH to target specific patient demographics in an at-home setting. Here, we describe the planning and implementation of this program for patients with COPD. Key components to success include collaboration among providers, early follow-up visits, patient education, and in-depth medical reconciliations. Analysis includes a retrospective examination of a structured COPD outpatient pathway.

Results: A total of 214 patients with COPD were treated with MIH from March 2, 2020, to August 1, 2021. Eighty-seven emergent visits were conducted, and more than 650 total visits were made. A more intensive outpatient pathway was implemented for patients deemed to be at the highest risk for readmission by pulmonary specialists.

Conclusion: This process can serve as a template for future institutions to treat patients with COPD using MIH or similar hospital-at-home services.

Keywords: Mobile Integrated Health; MIH; COPD; population health.

It is estimated that chronic obstructive pulmonary disease (COPD) affects more than 16 million Americans¹ and accounts for more than 700 000 hospitalizations each year in the US.² Thirty-day COPD readmission rates hover around 22.6%,³ and readmission within 90 days of initial discharge can jump to between 31% and 35%.⁴ This is the highest of any patient demographic, and more than half of these readmissions are due to COPD. To counter this, government and state entities have made nationwide efforts to encourage health systems to focus on preventing readmissions. In October 2014, the US added COPD to the active list of diseases in Medicare’s Hospital Readmissions Reduction Program (HRRP), later adding COPD to various risk-based bundle programs that hospitals may choose to opt into. These programs are designed to reduce all-cause readmissions after an acute exacerbation of COPD, as the HRRP penalizes hospitals for all-cause 30-day readmissions.³ However, what is most troubling is that, despite these efforts, readmission rates have not dropped in the past decade.⁵ COPD remains the third leading cause of death in America and still poses a significant burden both clinically and economically to hospitals across the country.³

A solution that is gaining traction is to encourage outpatient care initiatives and discharge pathways. Early follow-up is proven to decrease chances of readmission, and studies have shown that more than half of readmitted patients did not follow up with a primary care physician (PCP) within 30 days of their initial discharge.⁶ Additionally, large meta-analyses show hospital-at-home–type programs can lead to reductions in mortality, decrease costs, decrease readmissions, and increase patient satisfaction.^7-9 Therefore, for more challenging patient populations with regard to readmissions and mortality, Mobile Integrated Health (MIH) may be the solution that we are looking for.

This article presents a viable process to treat patients with COPD in an outpatient setting with MIH Services. It includes an examination of what makes MIH successful as well as a closer look at a structured COPD outpatient pathway.

Methods

South Shore Hospital (SSH) is an independent, not-for-profit hospital located in Weymouth, Massachusetts. It is host to 400 beds, 100 000 annual visits to the emergency department (ED), and its own emergency medical services program. In March 2020, SSH became the first Massachusetts hospital-based program to acquire an MIH license. MIH paramedics receive 300 hours of specialized training, including time in clinical clerkships shadowing pulmonary specialists, cardiology/congestive heart failure (CHF) providers, addiction medicine specialists, home care and care progression colleagues, and wound center providers. Specialist providers become more comfortable with paramedic capabilities as a result of these clerkships, improving interactions and relationships going forward. At the time of writing, SSH MIH is staffed by 12 paramedics, 4 of whom are full time; 2 medical directors; 2 internal coordinators; and 1 registered nurse (RN). A minimum of 2 paramedics are on call each day, each with twice-daily intravenous (IV) capabilities. The first shift slot is 16 hours, from 7:00 AM to 11:00 PM. The second slot is 12 hours, from 8:00 AM to 8:00 PM. Each paramedic cares for 4 to 6 patients per day.

The goal of developing MIH is to improve upon the current standard of care. For hospitals without MIH capabilities, there are limited options to treat acute exacerbations of chronic obstructive pulmonary disease (AECOPD) patients postdischarge. It is common for the only outpatient referral to be a lone PCP visit, and many patients who need more extensive treatment options don’t have access to a timely PCP follow-up or resources for alternative care. This is part of why there has been little improvement in the 21st century with regard to reducing COPD hospitalizations. As it stands, approximately 10% to 55% of all AECOPD readmissions are preventable, and more than one-fifth of patients with COPD are rehospitalized within 30 days of discharge.³ In response, MIH has been designed to provide robust care options postdischarge in the patient home, with the eventual goal of reducing preventable hospitalizations and readmissions for all patients with COPD.

Patient selection

Patients with COPD are admitted to the MIH program in 1 of 3 ways: (1) directly from the ED; (2) at discharge from inpatient care; or (3) from a SSH affiliate referral.

With option 1, the ED physician assesses patient need for MIH services and places a referral to MIH in the electronic medical record (EMR). The ED provider also specifies whether follow-up is “urgent” and sets an alternative level of priority if not. With option 2, the inpatient provider and case manager follow a similar process, first determining whether a patient is stable enough to go home with outpatient services and then if MIH would be beneficial to the patient. If the patient is discharged home, a follow-up visit by an MIH paramedic is scheduled within 48 hours. With option 3, the patient is referred to MIH by an affiliate of SSH. This can be through the patient’s PCP, their visiting nurse association (VNA) service provider, or through any SSH urgent care center. In all 3 referral processes, the patient has the option to consent into the program or refuse services. Once referred, MIH coordinators review patients on a case-by-case basis. Patients with a history of prior admissions are given preference, with the goal being to keep the frailer, older, and comorbid patients at home. Other considerations include recent admission(s), length of stay, and overall stability. Social factors considered by the team include whether the patient lives alone and has alternative home services and the patient’s total distance from the hospital. Patients with a history of violence, mental health concerns, or substance abuse go through a more extensive screening process to ensure paramedic safety.

Given their patient profile and high hospital usage rates, MIH is sometimes requested for patients with end-stage COPD. Many of these patients benefit from MIH goals-of-care conversations to ensure they understand all their options and choose an approach that fits their preferences. In these cases, MIH has been instrumental in assisting patients and families with completing Medical Orders for Life-Sustaining Treatment and health care proxy forms and transitioning patients to palliative care, hospice, advanced-illness care management programs, or other long-term care options to prevent the need for rehospitalization. The MIH team focuses heavily on providing quality end-of-life care for patients and aligning care models with patient and family goals, often finding that having these sensitive conversations in the comfort of home enables transparency and comfort not otherwise experienced by hospitalized patients.

Initial patient follow-up

For patients with COPD enrolled in the MIH program, their first patient visit is scheduled within 48 hours of discharge from the ED or inpatient hospital. In many cases, this visit can be conducted within 24 hours of returning home. Once at the patient’s home, the paramedic begins with general introductions, vital signs, and a basic physical examination. The remainder of the visit focuses on patient education and symptom recognition. The paramedic reviews the COPD action plan (Figure 1), including how to recognize the onset of a “COPD flare-up” and the appropriate response. Patients are provided with a paper copy of the action plan for future reference.

The next point of educational emphasis is the patient’s individual medication regimen. This involves differentiating between control (daily) and rescue medications, how to use oxygen tanks, and how to safely wean off of oxygen. Specific attention is given to how to use a metered-dose inhaler, as studies have found that more than half of all patients use their inhaler devices incorrectly.¹⁰

Paramedics also complete a home safety evaluation of the patient’s residence, which involves checking for tripping hazards, lighting, handrails, slippery surfaces, and general access to patient medication. If an issue cannot be resolved by the paramedic on site and is considered a safety hazard, it is reported back to the hospital team for assistance.

Finally, patients are educated on the capabilities of MIH as a program and what to expect when they reach out over the phone. Patients are given a phone number to call for both “urgent” and “nonemergent” situations. In both cases, they will be greeted by one of the MIH coordinators or nurses who assist with triaging patient symptoms, scheduling a visit, or providing other guidance. It is a point of emphasis that the patient can use MIH for more than just COPD and should call in the event of any illness or discomfort (eg, dehydration, fever) in an effort to prevent unnecessary ED visits.

Medication reconciliation

Patients with COPD often have complex medication regimens. To help alleviate any confusion, medication reconciliations are done in conjunction with every COPD patient’s initial visit. During this process, the paramedic first takes an inventory of all medications in the patient home. Common reasons for nonadherence include confusing packaging, inability to reach the pharmacy, or medication not being covered by insurance. The paramedic reconciles the updated medication regimen against the medications that are physically in the home. Once the initial review is complete, the paramedic teleconferences with a registered hospitalist pharmacist (RHP) for a more in-depth review. Over video chat, the RHP reviews each medication individually to make sure the patient understands how many times per day they take each medication, whether it is a control or rescue medication, and what times of the day to take them. The RHP will then clarify any other medication questions the patient has, assure all recent medications have been picked up from the pharmacy, and determine any barriers, such as cost or transportation.

Follow-ups and PCP involvement

At each in-person visit, paramedics coordinate with an advanced practice clinician (APC) through telehealth communication. On these video calls with a provider, the paramedic relays relevant information pertaining to patient history, vital signs, and current status. Any concerning findings, symptoms of COPD flare-ups, or recent changes in status will be discussed. The APC then speaks directly to the patient to gather additional details about their condition and any recent hospitalizations, with their primary role being to make clinical decisions on further treatment. For the COPD population, this often includes orders for the MIH paramedic to administer IV medication (ie, IV methylprednisolone or other corticosteroids), antibiotics, home nebulizers, and at-home oxygen.

Second and third follow-up paramedic visits are often less intensive. Although these visits often still involve telehealth calls to the APC, the overall focus shifts toward medication adherence, ED avoidance, and readmission avoidance. On these visits, the paramedic also checks vitals, conducts a physical examination, and completes follow-up testing or orders per the APC.

PCP involvement is critical to streamlining and transitioning patient care. Patients who are admitted to MIH without insurance or a PCP are assisted in the process of finding one. PCPs automatically receive a patient enrollment letter when their patient is seen by an MIH paramedic. Following each individual visit, paramedic and APC notes are sent to the PCP through the EMR or via fax, at which time the PCP may be consulted on patient history and/or future care decisions. After the transition back to care by their PCP, patients are still encouraged to utilize MIH if acute changes arise. If a patient is readmitted back to the hospital, MIH is automatically notified, and coordinators will assess whether there is continued need for outpatient services or areas for potential improvement.

 

 

Emergent MIH visits

While MIH visits with patients with COPD are often scheduled, MIH can also be leveraged in urgent situations to prevent the need for a patient to come to the ED or hospital. Patients with COPD are told to call MIH if they have worsening symptoms or have exhausted all methods of self-treatment without an improvement in status. In this case, a paramedic is notified and sent to the patient’s home at the earliest time possible. The paramedic then completes an assessment of the patient’s status and relays information to the MIH APC or medical director. From there, treatment decisions, such as starting the patient on an IV, using nebulizers, or doing an electrocardiogram for diagnostic purposes, are guided by the provider team with the ultimate goal of caring for the patient in the home. For our population, providing urgent care in the home has proven to be an effective way to avoid unnecessary readmissions while still ensuring high-quality patient care.

Outpatient pathway

In May 2021, select patients with COPD were given the option to participate in a more intensive MIH outpatient pathway. Pilot patients were chosen by 2 pulmonary specialists, with a focus on enrolling patients with COPD at the highest risk for readmission. Patients who opted in were followed by MIH for a total of 30 days.

The first visit was made as usual within 48 hours of discharge. Patients received education, medication reconciliation, vitals examination, home safety evaluation, and a facilitated telehealth evaluation with the APC. What differentiates the pathway from standard MIH services is that after the first visit, the follow-ups are prescheduled and more numerous. This is outlined best in Figure 2, which serves as a guideline for coordinators and paramedics in the cadence and focus of visits for each patient on the pathway. The initial 2 weeks are designed to check in on the patient in person and ensure active recovery. The latter 2 weeks are designed to ensure that the patient follows up with their care team and understands their medications and action plan going forward. Pathway patients were also monitored using a remote patient monitoring (RPM) kit. On the initial visit, paramedics set up the RPM equipment and provided a demonstration on how to use each device. Patients were issued a Bluetooth-enabled scale, blood pressure cuff, video-enabled tablet, and wearable device. The wearable device continuously recorded respiration rate, heart rate, and oxygen saturation and had fall-detection enabled. Over the course of a month, an experienced MIH nurse monitored the vitals transmitted by the wearable device and checked patient weight and blood pressure 1 to 2 times per day, utilizing these data to proactively outreach to patients if abnormalities occurred. Prior to the start of the program, the MIH nurse contacted each patient to introduce herself and notify them that they would receive a call if any vitals were unusual.

Results

MIH treated 214 patients with COPD from March 2, 2020, to August 2, 2021. In total, paramedics made more than 650 visits. Eighty-seven of these were documented as urgent visits with AECOPD, shortness of breath, cough, or wheezing as the primary concern.

In the calendar year of 2019, our institution admitted 804 patients with a primary diagnosis of COPD. In 2020, the first year with MIH, total COPD admissions decreased to 473; however, the effect of the COVID-19 pandemic cannot be discounted. At of the time of writing—219 days into 2021—253 patients with COPD have been admitted thus far (Table 1).

 

 

Pathway results

Sixteen patients were referred to the MIH COPD Discharge Pathway Pilot during May 2021. Ten patients went on to complete the entire 30-day pathway. Six did not finish the program. Three of these 6 patients were referred by a pulmonary specialist for enrollment but not ultimately referred to the pilot program by case management and therefore not enrolled. The other 3 of the 6 patients who did not complete the pilot program were enrolled but discontinued owing to noncompliance.

Of the 10 patients who completed the pathway, 3 patients were male, and 7 were female. Ages ranged from 55 to 84 years. On average, the RHP found 3.6 medication reconciliation errors per patient. One patient was readmitted within 30 days (only 3 days after the initial discharge), and 5 were readmitted within 90 days.

A retrospective analysis was conducted on patients with COPD who were not provided with MIH services and were admitted to our hospital between September 1, 2020, and March 1, 2021, for comparison. Age, sex, and other related conditions are shown in Table 2. Medication reconciliation error data were not tracked for this demographic, as they did not have an in-home medication reconciliation completed.

Discussion

MIH has treated 214 patients with COPD from March 2, 2020, to August 2, 2021, a 17-month period. In that same timeframe, the hospital experienced a 42% decrease in COPD admissions. Although this effect is not the sole product of MIH (specifically, COVID-19 caused a drop in all-cause hospital admissions), we believe MIH did play a small role in this reduction. Eighty-seven emergent visits were conducted for patients with a primary complaint of AECOPD, shortness of breath, cough, or wheezing. On these visits, MIH provided urgent treatment to prevent the patient returning to the ED and potentially leading to readmission.

The program’s impact extends beyond the numbers. With more than 200 patients with COPD treated at home, we improved hospital flow, shortened patients’ overall length of stay, and increased capacity in the ED and inpatient units. In addition, MIH has been able to fill in care gaps present in the current health care system by providing acute care in the home to patients who otherwise have access-to-care and transportation issues.

 

 

What made the program successful

With the COPD population prone to having complex medication regimens, medication reconciliations were critical to improving patient outcomes. During the documented medication reconciliations for pathway patients, 8 of 10 patients had medication errors identified. Some of the more common errors included incorrect inhaler usage, patient medication not arriving to the pharmacy for a week or more after discharge, prescribed medication dosages that were too high or too low, and a lack of transportation to pick up the patient’s prescription. Even more problematic is that 7 of these 8 patients required multiple interventions to correct their regimen. What was cited as most beneficial by both the paramedic and the RHP was taking time to walk through each medication individually and ensuring that the patient could recite back how often and when they should be using it. What also proved to be helpful was spending extra time on the inhalers and nebulizers. Multiple patients did not know how to use them properly and/or cited a history of struggling with them.

The MIH COPD pathway patients showed encouraging preliminary results. In the initial 30-day window, only 1 of 10 (10%) patients was readmitted, which is lower than the 37.7% rate for comparable patients who did not have MIH services. This could imply that patients with COPD respond positively to active and consistent management with predetermined points of contact. Ninety-day readmission rates jumped to 5 of 10, with 4 of these patients being readmitted multiple times. Approximately half of these readmissions were COPD related. It is important to remember that the patients being targeted by the pathway are deemed to be at very high risk of readmission. As such, one could expect that even with a successful reduction in rates, pathway patient readmission rates may be slightly elevated compared with national COPD averages.

Given the more personalized and at-home care, patients also expressed higher levels of care satisfaction. Most patients want to avoid the hospital at all costs, and MIH provides a safe and effective alternative. Patients with COPD have also relayed that the education they receive on their medication, disease, and how to use MIH has been useful. This is reflected in the volume of urgent calls that MIH receives. A patient calling MIH in place of 911 shows not only that the patient has a level of trust in the MIH team, but also that they have learned how to recognize symptoms earlier to prevent major flare-ups.

This study had several limitations. On the pilot pathway, 3 patients were removed from MIH services because of repeated noncompliance. These instances primarily involved aggression toward the paramedics, both verbal and physical, as well as refusal to allow the MIH paramedics into the home. Going forward, it will be valuable to have a screening process for pathway patients to determine likelihood of compliance. This could include speaking to the patient’s PCP or other in-hospital providers before accepting them into the program.

Remote patient monitoring also presented its challenges. Despite extensive equipment demonstrations, some patients struggled to grasp the technology. Some of the biggest problems cited were confusion operating the tablet, inability to charge the devices, and issues with connectivity. In the future, it may be useful to simplify the devices even more. Further work should also be done to evaluate the efficacy of remote patient technology in this specific setting, as studies have shown varied results with regard to RPM success. In 1 meta-analysis of 91 different published studies that took place between 2015 and 2020, approximately half of the RPM studies resulted in no change in hospital readmissions, length of stay, or ED presentations, while the other half saw improvement in these categories.¹¹ We suspect that the greatest benefits of our work came from the patient education, trust built over time, in-home urgent evaluations, and 1-on-1 time with the paramedic.

With many people forgoing care during the pandemic, COVID-19 has also caused a downward trend in overall and non-COVID-19 admissions. In a review of more than 500 000 ED visits in Massachusetts between March 11, 2020, and September 8, 2021, there was a 32% decrease in admissions when compared with those same weeks in 2019.¹⁰ There was an even greater drop-off when it came to COPD and other respiratory-related admissions. In evaluating the impact SSH MIH has made, it is important to recognize that the pandemic contributed to reducing total COPD admissions. Adding merit to the success of MIH in contributing to the reduction in admissions is the continued downward trend in total COPD admissions year-to-date in 2021. Despite total hospital usage rates increasing at our institution over the course of this year, the overall COPD usage rates have remained lower than before.

Another limitation is that in the selection of patients, both for general MIH care and for the COPD pathway, there was room for bias. The pilot pathway was offered specifically to patients at the highest risk for readmission; however, patients were referred at the discretion of our pulmonologist care team and not selected by any standardized rubric. Additionally, MIH only operates on a 16-hour schedule. This means that patients admitted to the ED or inpatient at night may sometimes be missed and not referred to MIH for care.

The biggest caveat to the pathway results is, of course, the small sample size. With only 10 patients completing the pilot, it is impossible to come to any concrete conclusions. Such an intensive pathway requires dedicating large amounts of time and resources, which is why the pilot was small. However, considering the preliminary results, the outline given could provide a starting point for future work to evaluate a similar COPD pathway on a larger scale.

Future considerations

Risk stratification of patients is critical to achieving even further reductions in readmissions and mortality. Hospitals can get the most value from MIH by focusing on patients with COPD at the highest risk for return, and it would be valuable to explicitly define who fits into this criterion. Utilizing a tool similar to the LACE index for readmission but tailoring it to patients with COPD when admitting patients into the program would be a logical next step.

Reducing the points of patient contact could also prove valuable. Over the course of a patient’s time with MIH, they interact with an RHP, APC, paramedic, RN, and discharging hospitalist. Additionally, we found many patients had VNA services, home health aides, care managers, and/or social workers involved in their care. Some patients found this to be stressful and overwhelming, especially regarding the number of outreach calls soon after discharge.

It would also be useful to look at the impact of MIH on total COPD admissions independent of the artificial variation created by COVID-19. This may require waiting until there are higher levels of vaccination and/or finding ways to control for the potential variation. In doing so, one could look at the direct effect MIH has on COPD readmissions when compared with a control group without MIH services, which could then serve as a comparison point to the results of this study. As it stands, given the relative novelty of MIH, there are primarily only broad reviews of MIH’s effectiveness and/or impact on patient populations that have been published. Of these, only a few directly mentioned MIH in relation to COPD, and none have comparable designs that look at overall COPD hospitalization reductions post-MIH implementation. There is also little to no literature looking at the utilization of MIH in a more intensive COPD outpatient pathway.

Finally, MIH has proven to be a useful tool for our institution in many areas outside of COPD management. Specifically, MIH has been utilized as a mobile influenza and COVID-19 vaccination unit and in-home testing service and now operates both a hospital-at-home and skilled nursing facility-at-home program. Analysis of the overall needs of the system and where this valuable MIH resource would have the biggest impact will be key in future growth opportunities.

Conclusion

MIH has been an invaluable tool for our hospital, especially in light of the recent shift toward more in-home and virtual care. MIH cared for 214 patients with COPD with more than 650 visits between March 2020 and August 2021. Eighty-seven emergent COPD visits were conducted, and COPD admissions were reduced dramatically from 2019 to 2020. MIH services have improved hospital flow, allowed for earlier discharge from the ED and inpatient care, and helped improve all-cause COPD readmission rates. The importance of postdischarge care and follow-up visits for patients with COPD, especially those at higher risk for readmission, cannot be understated. We hope our experience working to improve COPD patient outcomes serves as valuable a reference point for future MIH programs.

Corresponding author: Kelly Lannutti, DO, Mobile Integrated Health and Emergency Medicine Department, South Shore Health, 55 Fogg Rd, South Weymouth, MA 02190; klannutti@southshorehealth.org.

Financial disclosures: None.

From the Mobile Integrated Health and Emergency Medicine Department, South Shore Health, Weymouth, MA.

Objective: To develop a process through which Mobile Integrated Health (MIH) can treat patients with chronic obstructive pulmonary disease (COPD) at high risk for readmission in an outpatient setting. In turn, South Shore Hospital (SSH) looks to leverage MIH to improve hospital flow, decrease costs, and improve patient quality of life.

Methods: With the recent approval of hospital-based MIH programs in Massachusetts, SSH used MIH to target specific patient demographics in an at-home setting. Here, we describe the planning and implementation of this program for patients with COPD. Key components to success include collaboration among providers, early follow-up visits, patient education, and in-depth medical reconciliations. Analysis includes a retrospective examination of a structured COPD outpatient pathway.

Results: A total of 214 patients with COPD were treated with MIH from March 2, 2020, to August 1, 2021. Eighty-seven emergent visits were conducted, and more than 650 total visits were made. A more intensive outpatient pathway was implemented for patients deemed to be at the highest risk for readmission by pulmonary specialists.

Conclusion: This process can serve as a template for future institutions to treat patients with COPD using MIH or similar hospital-at-home services.

Keywords: Mobile Integrated Health; MIH; COPD; population health.

It is estimated that chronic obstructive pulmonary disease (COPD) affects more than 16 million Americans¹ and accounts for more than 700 000 hospitalizations each year in the US.² Thirty-day COPD readmission rates hover around 22.6%,³ and readmission within 90 days of initial discharge can jump to between 31% and 35%.⁴ This is the highest of any patient demographic, and more than half of these readmissions are due to COPD. To counter this, government and state entities have made nationwide efforts to encourage health systems to focus on preventing readmissions. In October 2014, the US added COPD to the active list of diseases in Medicare’s Hospital Readmissions Reduction Program (HRRP), later adding COPD to various risk-based bundle programs that hospitals may choose to opt into. These programs are designed to reduce all-cause readmissions after an acute exacerbation of COPD, as the HRRP penalizes hospitals for all-cause 30-day readmissions.³ However, what is most troubling is that, despite these efforts, readmission rates have not dropped in the past decade.⁵ COPD remains the third leading cause of death in America and still poses a significant burden both clinically and economically to hospitals across the country.³

A solution that is gaining traction is to encourage outpatient care initiatives and discharge pathways. Early follow-up is proven to decrease chances of readmission, and studies have shown that more than half of readmitted patients did not follow up with a primary care physician (PCP) within 30 days of their initial discharge.⁶ Additionally, large meta-analyses show hospital-at-home–type programs can lead to reductions in mortality, decrease costs, decrease readmissions, and increase patient satisfaction.^7-9 Therefore, for more challenging patient populations with regard to readmissions and mortality, Mobile Integrated Health (MIH) may be the solution that we are looking for.

This article presents a viable process to treat patients with COPD in an outpatient setting with MIH Services. It includes an examination of what makes MIH successful as well as a closer look at a structured COPD outpatient pathway.

Methods

South Shore Hospital (SSH) is an independent, not-for-profit hospital located in Weymouth, Massachusetts. It is host to 400 beds, 100 000 annual visits to the emergency department (ED), and its own emergency medical services program. In March 2020, SSH became the first Massachusetts hospital-based program to acquire an MIH license. MIH paramedics receive 300 hours of specialized training, including time in clinical clerkships shadowing pulmonary specialists, cardiology/congestive heart failure (CHF) providers, addiction medicine specialists, home care and care progression colleagues, and wound center providers. Specialist providers become more comfortable with paramedic capabilities as a result of these clerkships, improving interactions and relationships going forward. At the time of writing, SSH MIH is staffed by 12 paramedics, 4 of whom are full time; 2 medical directors; 2 internal coordinators; and 1 registered nurse (RN). A minimum of 2 paramedics are on call each day, each with twice-daily intravenous (IV) capabilities. The first shift slot is 16 hours, from 7:00 AM to 11:00 PM. The second slot is 12 hours, from 8:00 AM to 8:00 PM. Each paramedic cares for 4 to 6 patients per day.

The goal of developing MIH is to improve upon the current standard of care. For hospitals without MIH capabilities, there are limited options to treat acute exacerbations of chronic obstructive pulmonary disease (AECOPD) patients postdischarge. It is common for the only outpatient referral to be a lone PCP visit, and many patients who need more extensive treatment options don’t have access to a timely PCP follow-up or resources for alternative care. This is part of why there has been little improvement in the 21st century with regard to reducing COPD hospitalizations. As it stands, approximately 10% to 55% of all AECOPD readmissions are preventable, and more than one-fifth of patients with COPD are rehospitalized within 30 days of discharge.³ In response, MIH has been designed to provide robust care options postdischarge in the patient home, with the eventual goal of reducing preventable hospitalizations and readmissions for all patients with COPD.

Patient selection

Patients with COPD are admitted to the MIH program in 1 of 3 ways: (1) directly from the ED; (2) at discharge from inpatient care; or (3) from a SSH affiliate referral.

With option 1, the ED physician assesses patient need for MIH services and places a referral to MIH in the electronic medical record (EMR). The ED provider also specifies whether follow-up is “urgent” and sets an alternative level of priority if not. With option 2, the inpatient provider and case manager follow a similar process, first determining whether a patient is stable enough to go home with outpatient services and then if MIH would be beneficial to the patient. If the patient is discharged home, a follow-up visit by an MIH paramedic is scheduled within 48 hours. With option 3, the patient is referred to MIH by an affiliate of SSH. This can be through the patient’s PCP, their visiting nurse association (VNA) service provider, or through any SSH urgent care center. In all 3 referral processes, the patient has the option to consent into the program or refuse services. Once referred, MIH coordinators review patients on a case-by-case basis. Patients with a history of prior admissions are given preference, with the goal being to keep the frailer, older, and comorbid patients at home. Other considerations include recent admission(s), length of stay, and overall stability. Social factors considered by the team include whether the patient lives alone and has alternative home services and the patient’s total distance from the hospital. Patients with a history of violence, mental health concerns, or substance abuse go through a more extensive screening process to ensure paramedic safety.

Given their patient profile and high hospital usage rates, MIH is sometimes requested for patients with end-stage COPD. Many of these patients benefit from MIH goals-of-care conversations to ensure they understand all their options and choose an approach that fits their preferences. In these cases, MIH has been instrumental in assisting patients and families with completing Medical Orders for Life-Sustaining Treatment and health care proxy forms and transitioning patients to palliative care, hospice, advanced-illness care management programs, or other long-term care options to prevent the need for rehospitalization. The MIH team focuses heavily on providing quality end-of-life care for patients and aligning care models with patient and family goals, often finding that having these sensitive conversations in the comfort of home enables transparency and comfort not otherwise experienced by hospitalized patients.

Initial patient follow-up

For patients with COPD enrolled in the MIH program, their first patient visit is scheduled within 48 hours of discharge from the ED or inpatient hospital. In many cases, this visit can be conducted within 24 hours of returning home. Once at the patient’s home, the paramedic begins with general introductions, vital signs, and a basic physical examination. The remainder of the visit focuses on patient education and symptom recognition. The paramedic reviews the COPD action plan (Figure 1), including how to recognize the onset of a “COPD flare-up” and the appropriate response. Patients are provided with a paper copy of the action plan for future reference.

The next point of educational emphasis is the patient’s individual medication regimen. This involves differentiating between control (daily) and rescue medications, how to use oxygen tanks, and how to safely wean off of oxygen. Specific attention is given to how to use a metered-dose inhaler, as studies have found that more than half of all patients use their inhaler devices incorrectly.¹⁰

Paramedics also complete a home safety evaluation of the patient’s residence, which involves checking for tripping hazards, lighting, handrails, slippery surfaces, and general access to patient medication. If an issue cannot be resolved by the paramedic on site and is considered a safety hazard, it is reported back to the hospital team for assistance.

Finally, patients are educated on the capabilities of MIH as a program and what to expect when they reach out over the phone. Patients are given a phone number to call for both “urgent” and “nonemergent” situations. In both cases, they will be greeted by one of the MIH coordinators or nurses who assist with triaging patient symptoms, scheduling a visit, or providing other guidance. It is a point of emphasis that the patient can use MIH for more than just COPD and should call in the event of any illness or discomfort (eg, dehydration, fever) in an effort to prevent unnecessary ED visits.

Medication reconciliation

Patients with COPD often have complex medication regimens. To help alleviate any confusion, medication reconciliations are done in conjunction with every COPD patient’s initial visit. During this process, the paramedic first takes an inventory of all medications in the patient home. Common reasons for nonadherence include confusing packaging, inability to reach the pharmacy, or medication not being covered by insurance. The paramedic reconciles the updated medication regimen against the medications that are physically in the home. Once the initial review is complete, the paramedic teleconferences with a registered hospitalist pharmacist (RHP) for a more in-depth review. Over video chat, the RHP reviews each medication individually to make sure the patient understands how many times per day they take each medication, whether it is a control or rescue medication, and what times of the day to take them. The RHP will then clarify any other medication questions the patient has, assure all recent medications have been picked up from the pharmacy, and determine any barriers, such as cost or transportation.

Follow-ups and PCP involvement

At each in-person visit, paramedics coordinate with an advanced practice clinician (APC) through telehealth communication. On these video calls with a provider, the paramedic relays relevant information pertaining to patient history, vital signs, and current status. Any concerning findings, symptoms of COPD flare-ups, or recent changes in status will be discussed. The APC then speaks directly to the patient to gather additional details about their condition and any recent hospitalizations, with their primary role being to make clinical decisions on further treatment. For the COPD population, this often includes orders for the MIH paramedic to administer IV medication (ie, IV methylprednisolone or other corticosteroids), antibiotics, home nebulizers, and at-home oxygen.

Second and third follow-up paramedic visits are often less intensive. Although these visits often still involve telehealth calls to the APC, the overall focus shifts toward medication adherence, ED avoidance, and readmission avoidance. On these visits, the paramedic also checks vitals, conducts a physical examination, and completes follow-up testing or orders per the APC.

PCP involvement is critical to streamlining and transitioning patient care. Patients who are admitted to MIH without insurance or a PCP are assisted in the process of finding one. PCPs automatically receive a patient enrollment letter when their patient is seen by an MIH paramedic. Following each individual visit, paramedic and APC notes are sent to the PCP through the EMR or via fax, at which time the PCP may be consulted on patient history and/or future care decisions. After the transition back to care by their PCP, patients are still encouraged to utilize MIH if acute changes arise. If a patient is readmitted back to the hospital, MIH is automatically notified, and coordinators will assess whether there is continued need for outpatient services or areas for potential improvement.

 

 

Emergent MIH visits

While MIH visits with patients with COPD are often scheduled, MIH can also be leveraged in urgent situations to prevent the need for a patient to come to the ED or hospital. Patients with COPD are told to call MIH if they have worsening symptoms or have exhausted all methods of self-treatment without an improvement in status. In this case, a paramedic is notified and sent to the patient’s home at the earliest time possible. The paramedic then completes an assessment of the patient’s status and relays information to the MIH APC or medical director. From there, treatment decisions, such as starting the patient on an IV, using nebulizers, or doing an electrocardiogram for diagnostic purposes, are guided by the provider team with the ultimate goal of caring for the patient in the home. For our population, providing urgent care in the home has proven to be an effective way to avoid unnecessary readmissions while still ensuring high-quality patient care.

Outpatient pathway

In May 2021, select patients with COPD were given the option to participate in a more intensive MIH outpatient pathway. Pilot patients were chosen by 2 pulmonary specialists, with a focus on enrolling patients with COPD at the highest risk for readmission. Patients who opted in were followed by MIH for a total of 30 days.

The first visit was made as usual within 48 hours of discharge. Patients received education, medication reconciliation, vitals examination, home safety evaluation, and a facilitated telehealth evaluation with the APC. What differentiates the pathway from standard MIH services is that after the first visit, the follow-ups are prescheduled and more numerous. This is outlined best in Figure 2, which serves as a guideline for coordinators and paramedics in the cadence and focus of visits for each patient on the pathway. The initial 2 weeks are designed to check in on the patient in person and ensure active recovery. The latter 2 weeks are designed to ensure that the patient follows up with their care team and understands their medications and action plan going forward. Pathway patients were also monitored using a remote patient monitoring (RPM) kit. On the initial visit, paramedics set up the RPM equipment and provided a demonstration on how to use each device. Patients were issued a Bluetooth-enabled scale, blood pressure cuff, video-enabled tablet, and wearable device. The wearable device continuously recorded respiration rate, heart rate, and oxygen saturation and had fall-detection enabled. Over the course of a month, an experienced MIH nurse monitored the vitals transmitted by the wearable device and checked patient weight and blood pressure 1 to 2 times per day, utilizing these data to proactively outreach to patients if abnormalities occurred. Prior to the start of the program, the MIH nurse contacted each patient to introduce herself and notify them that they would receive a call if any vitals were unusual.

Results

MIH treated 214 patients with COPD from March 2, 2020, to August 2, 2021. In total, paramedics made more than 650 visits. Eighty-seven of these were documented as urgent visits with AECOPD, shortness of breath, cough, or wheezing as the primary concern.

In the calendar year of 2019, our institution admitted 804 patients with a primary diagnosis of COPD. In 2020, the first year with MIH, total COPD admissions decreased to 473; however, the effect of the COVID-19 pandemic cannot be discounted. At of the time of writing—219 days into 2021—253 patients with COPD have been admitted thus far (Table 1).

 

 

Pathway results

Sixteen patients were referred to the MIH COPD Discharge Pathway Pilot during May 2021. Ten patients went on to complete the entire 30-day pathway. Six did not finish the program. Three of these 6 patients were referred by a pulmonary specialist for enrollment but not ultimately referred to the pilot program by case management and therefore not enrolled. The other 3 of the 6 patients who did not complete the pilot program were enrolled but discontinued owing to noncompliance.

Of the 10 patients who completed the pathway, 3 patients were male, and 7 were female. Ages ranged from 55 to 84 years. On average, the RHP found 3.6 medication reconciliation errors per patient. One patient was readmitted within 30 days (only 3 days after the initial discharge), and 5 were readmitted within 90 days.

A retrospective analysis was conducted on patients with COPD who were not provided with MIH services and were admitted to our hospital between September 1, 2020, and March 1, 2021, for comparison. Age, sex, and other related conditions are shown in Table 2. Medication reconciliation error data were not tracked for this demographic, as they did not have an in-home medication reconciliation completed.

Discussion

MIH has treated 214 patients with COPD from March 2, 2020, to August 2, 2021, a 17-month period. In that same timeframe, the hospital experienced a 42% decrease in COPD admissions. Although this effect is not the sole product of MIH (specifically, COVID-19 caused a drop in all-cause hospital admissions), we believe MIH did play a small role in this reduction. Eighty-seven emergent visits were conducted for patients with a primary complaint of AECOPD, shortness of breath, cough, or wheezing. On these visits, MIH provided urgent treatment to prevent the patient returning to the ED and potentially leading to readmission.

The program’s impact extends beyond the numbers. With more than 200 patients with COPD treated at home, we improved hospital flow, shortened patients’ overall length of stay, and increased capacity in the ED and inpatient units. In addition, MIH has been able to fill in care gaps present in the current health care system by providing acute care in the home to patients who otherwise have access-to-care and transportation issues.

 

 

What made the program successful

With the COPD population prone to having complex medication regimens, medication reconciliations were critical to improving patient outcomes. During the documented medication reconciliations for pathway patients, 8 of 10 patients had medication errors identified. Some of the more common errors included incorrect inhaler usage, patient medication not arriving to the pharmacy for a week or more after discharge, prescribed medication dosages that were too high or too low, and a lack of transportation to pick up the patient’s prescription. Even more problematic is that 7 of these 8 patients required multiple interventions to correct their regimen. What was cited as most beneficial by both the paramedic and the RHP was taking time to walk through each medication individually and ensuring that the patient could recite back how often and when they should be using it. What also proved to be helpful was spending extra time on the inhalers and nebulizers. Multiple patients did not know how to use them properly and/or cited a history of struggling with them.

The MIH COPD pathway patients showed encouraging preliminary results. In the initial 30-day window, only 1 of 10 (10%) patients was readmitted, which is lower than the 37.7% rate for comparable patients who did not have MIH services. This could imply that patients with COPD respond positively to active and consistent management with predetermined points of contact. Ninety-day readmission rates jumped to 5 of 10, with 4 of these patients being readmitted multiple times. Approximately half of these readmissions were COPD related. It is important to remember that the patients being targeted by the pathway are deemed to be at very high risk of readmission. As such, one could expect that even with a successful reduction in rates, pathway patient readmission rates may be slightly elevated compared with national COPD averages.

Given the more personalized and at-home care, patients also expressed higher levels of care satisfaction. Most patients want to avoid the hospital at all costs, and MIH provides a safe and effective alternative. Patients with COPD have also relayed that the education they receive on their medication, disease, and how to use MIH has been useful. This is reflected in the volume of urgent calls that MIH receives. A patient calling MIH in place of 911 shows not only that the patient has a level of trust in the MIH team, but also that they have learned how to recognize symptoms earlier to prevent major flare-ups.

This study had several limitations. On the pilot pathway, 3 patients were removed from MIH services because of repeated noncompliance. These instances primarily involved aggression toward the paramedics, both verbal and physical, as well as refusal to allow the MIH paramedics into the home. Going forward, it will be valuable to have a screening process for pathway patients to determine likelihood of compliance. This could include speaking to the patient’s PCP or other in-hospital providers before accepting them into the program.

Remote patient monitoring also presented its challenges. Despite extensive equipment demonstrations, some patients struggled to grasp the technology. Some of the biggest problems cited were confusion operating the tablet, inability to charge the devices, and issues with connectivity. In the future, it may be useful to simplify the devices even more. Further work should also be done to evaluate the efficacy of remote patient technology in this specific setting, as studies have shown varied results with regard to RPM success. In 1 meta-analysis of 91 different published studies that took place between 2015 and 2020, approximately half of the RPM studies resulted in no change in hospital readmissions, length of stay, or ED presentations, while the other half saw improvement in these categories.¹¹ We suspect that the greatest benefits of our work came from the patient education, trust built over time, in-home urgent evaluations, and 1-on-1 time with the paramedic.

With many people forgoing care during the pandemic, COVID-19 has also caused a downward trend in overall and non-COVID-19 admissions. In a review of more than 500 000 ED visits in Massachusetts between March 11, 2020, and September 8, 2021, there was a 32% decrease in admissions when compared with those same weeks in 2019.¹⁰ There was an even greater drop-off when it came to COPD and other respiratory-related admissions. In evaluating the impact SSH MIH has made, it is important to recognize that the pandemic contributed to reducing total COPD admissions. Adding merit to the success of MIH in contributing to the reduction in admissions is the continued downward trend in total COPD admissions year-to-date in 2021. Despite total hospital usage rates increasing at our institution over the course of this year, the overall COPD usage rates have remained lower than before.

Another limitation is that in the selection of patients, both for general MIH care and for the COPD pathway, there was room for bias. The pilot pathway was offered specifically to patients at the highest risk for readmission; however, patients were referred at the discretion of our pulmonologist care team and not selected by any standardized rubric. Additionally, MIH only operates on a 16-hour schedule. This means that patients admitted to the ED or inpatient at night may sometimes be missed and not referred to MIH for care.

The biggest caveat to the pathway results is, of course, the small sample size. With only 10 patients completing the pilot, it is impossible to come to any concrete conclusions. Such an intensive pathway requires dedicating large amounts of time and resources, which is why the pilot was small. However, considering the preliminary results, the outline given could provide a starting point for future work to evaluate a similar COPD pathway on a larger scale.

Future considerations

Risk stratification of patients is critical to achieving even further reductions in readmissions and mortality. Hospitals can get the most value from MIH by focusing on patients with COPD at the highest risk for return, and it would be valuable to explicitly define who fits into this criterion. Utilizing a tool similar to the LACE index for readmission but tailoring it to patients with COPD when admitting patients into the program would be a logical next step.

Reducing the points of patient contact could also prove valuable. Over the course of a patient’s time with MIH, they interact with an RHP, APC, paramedic, RN, and discharging hospitalist. Additionally, we found many patients had VNA services, home health aides, care managers, and/or social workers involved in their care. Some patients found this to be stressful and overwhelming, especially regarding the number of outreach calls soon after discharge.

It would also be useful to look at the impact of MIH on total COPD admissions independent of the artificial variation created by COVID-19. This may require waiting until there are higher levels of vaccination and/or finding ways to control for the potential variation. In doing so, one could look at the direct effect MIH has on COPD readmissions when compared with a control group without MIH services, which could then serve as a comparison point to the results of this study. As it stands, given the relative novelty of MIH, there are primarily only broad reviews of MIH’s effectiveness and/or impact on patient populations that have been published. Of these, only a few directly mentioned MIH in relation to COPD, and none have comparable designs that look at overall COPD hospitalization reductions post-MIH implementation. There is also little to no literature looking at the utilization of MIH in a more intensive COPD outpatient pathway.

Finally, MIH has proven to be a useful tool for our institution in many areas outside of COPD management. Specifically, MIH has been utilized as a mobile influenza and COVID-19 vaccination unit and in-home testing service and now operates both a hospital-at-home and skilled nursing facility-at-home program. Analysis of the overall needs of the system and where this valuable MIH resource would have the biggest impact will be key in future growth opportunities.

Conclusion

MIH has been an invaluable tool for our hospital, especially in light of the recent shift toward more in-home and virtual care. MIH cared for 214 patients with COPD with more than 650 visits between March 2020 and August 2021. Eighty-seven emergent COPD visits were conducted, and COPD admissions were reduced dramatically from 2019 to 2020. MIH services have improved hospital flow, allowed for earlier discharge from the ED and inpatient care, and helped improve all-cause COPD readmission rates. The importance of postdischarge care and follow-up visits for patients with COPD, especially those at higher risk for readmission, cannot be understated. We hope our experience working to improve COPD patient outcomes serves as valuable a reference point for future MIH programs.

Corresponding author: Kelly Lannutti, DO, Mobile Integrated Health and Emergency Medicine Department, South Shore Health, 55 Fogg Rd, South Weymouth, MA 02190; klannutti@southshorehealth.org.

Financial disclosures: None.

From the Mobile Integrated Health and Emergency Medicine Department, South Shore Health, Weymouth, MA.

Objective: To develop a process through which Mobile Integrated Health (MIH) can treat patients with chronic obstructive pulmonary disease (COPD) at high risk for readmission in an outpatient setting. In turn, South Shore Hospital (SSH) looks to leverage MIH to improve hospital flow, decrease costs, and improve patient quality of life.

Methods: With the recent approval of hospital-based MIH programs in Massachusetts, SSH used MIH to target specific patient demographics in an at-home setting. Here, we describe the planning and implementation of this program for patients with COPD. Key components to success include collaboration among providers, early follow-up visits, patient education, and in-depth medical reconciliations. Analysis includes a retrospective examination of a structured COPD outpatient pathway.

Results: A total of 214 patients with COPD were treated with MIH from March 2, 2020, to August 1, 2021. Eighty-seven emergent visits were conducted, and more than 650 total visits were made. A more intensive outpatient pathway was implemented for patients deemed to be at the highest risk for readmission by pulmonary specialists.

Conclusion: This process can serve as a template for future institutions to treat patients with COPD using MIH or similar hospital-at-home services.

Keywords: Mobile Integrated Health; MIH; COPD; population health.

It is estimated that chronic obstructive pulmonary disease (COPD) affects more than 16 million Americans¹ and accounts for more than 700 000 hospitalizations each year in the US.² Thirty-day COPD readmission rates hover around 22.6%,³ and readmission within 90 days of initial discharge can jump to between 31% and 35%.⁴ This is the highest of any patient demographic, and more than half of these readmissions are due to COPD. To counter this, government and state entities have made nationwide efforts to encourage health systems to focus on preventing readmissions. In October 2014, the US added COPD to the active list of diseases in Medicare’s Hospital Readmissions Reduction Program (HRRP), later adding COPD to various risk-based bundle programs that hospitals may choose to opt into. These programs are designed to reduce all-cause readmissions after an acute exacerbation of COPD, as the HRRP penalizes hospitals for all-cause 30-day readmissions.³ However, what is most troubling is that, despite these efforts, readmission rates have not dropped in the past decade.⁵ COPD remains the third leading cause of death in America and still poses a significant burden both clinically and economically to hospitals across the country.³

A solution that is gaining traction is to encourage outpatient care initiatives and discharge pathways. Early follow-up is proven to decrease chances of readmission, and studies have shown that more than half of readmitted patients did not follow up with a primary care physician (PCP) within 30 days of their initial discharge.⁶ Additionally, large meta-analyses show hospital-at-home–type programs can lead to reductions in mortality, decrease costs, decrease readmissions, and increase patient satisfaction.^7-9 Therefore, for more challenging patient populations with regard to readmissions and mortality, Mobile Integrated Health (MIH) may be the solution that we are looking for.

This article presents a viable process to treat patients with COPD in an outpatient setting with MIH Services. It includes an examination of what makes MIH successful as well as a closer look at a structured COPD outpatient pathway.

Methods

South Shore Hospital (SSH) is an independent, not-for-profit hospital located in Weymouth, Massachusetts. It is host to 400 beds, 100 000 annual visits to the emergency department (ED), and its own emergency medical services program. In March 2020, SSH became the first Massachusetts hospital-based program to acquire an MIH license. MIH paramedics receive 300 hours of specialized training, including time in clinical clerkships shadowing pulmonary specialists, cardiology/congestive heart failure (CHF) providers, addiction medicine specialists, home care and care progression colleagues, and wound center providers. Specialist providers become more comfortable with paramedic capabilities as a result of these clerkships, improving interactions and relationships going forward. At the time of writing, SSH MIH is staffed by 12 paramedics, 4 of whom are full time; 2 medical directors; 2 internal coordinators; and 1 registered nurse (RN). A minimum of 2 paramedics are on call each day, each with twice-daily intravenous (IV) capabilities. The first shift slot is 16 hours, from 7:00 AM to 11:00 PM. The second slot is 12 hours, from 8:00 AM to 8:00 PM. Each paramedic cares for 4 to 6 patients per day.

The goal of developing MIH is to improve upon the current standard of care. For hospitals without MIH capabilities, there are limited options to treat acute exacerbations of chronic obstructive pulmonary disease (AECOPD) patients postdischarge. It is common for the only outpatient referral to be a lone PCP visit, and many patients who need more extensive treatment options don’t have access to a timely PCP follow-up or resources for alternative care. This is part of why there has been little improvement in the 21st century with regard to reducing COPD hospitalizations. As it stands, approximately 10% to 55% of all AECOPD readmissions are preventable, and more than one-fifth of patients with COPD are rehospitalized within 30 days of discharge.³ In response, MIH has been designed to provide robust care options postdischarge in the patient home, with the eventual goal of reducing preventable hospitalizations and readmissions for all patients with COPD.

Patient selection

Patients with COPD are admitted to the MIH program in 1 of 3 ways: (1) directly from the ED; (2) at discharge from inpatient care; or (3) from a SSH affiliate referral.

With option 1, the ED physician assesses patient need for MIH services and places a referral to MIH in the electronic medical record (EMR). The ED provider also specifies whether follow-up is “urgent” and sets an alternative level of priority if not. With option 2, the inpatient provider and case manager follow a similar process, first determining whether a patient is stable enough to go home with outpatient services and then if MIH would be beneficial to the patient. If the patient is discharged home, a follow-up visit by an MIH paramedic is scheduled within 48 hours. With option 3, the patient is referred to MIH by an affiliate of SSH. This can be through the patient’s PCP, their visiting nurse association (VNA) service provider, or through any SSH urgent care center. In all 3 referral processes, the patient has the option to consent into the program or refuse services. Once referred, MIH coordinators review patients on a case-by-case basis. Patients with a history of prior admissions are given preference, with the goal being to keep the frailer, older, and comorbid patients at home. Other considerations include recent admission(s), length of stay, and overall stability. Social factors considered by the team include whether the patient lives alone and has alternative home services and the patient’s total distance from the hospital. Patients with a history of violence, mental health concerns, or substance abuse go through a more extensive screening process to ensure paramedic safety.

Given their patient profile and high hospital usage rates, MIH is sometimes requested for patients with end-stage COPD. Many of these patients benefit from MIH goals-of-care conversations to ensure they understand all their options and choose an approach that fits their preferences. In these cases, MIH has been instrumental in assisting patients and families with completing Medical Orders for Life-Sustaining Treatment and health care proxy forms and transitioning patients to palliative care, hospice, advanced-illness care management programs, or other long-term care options to prevent the need for rehospitalization. The MIH team focuses heavily on providing quality end-of-life care for patients and aligning care models with patient and family goals, often finding that having these sensitive conversations in the comfort of home enables transparency and comfort not otherwise experienced by hospitalized patients.

Initial patient follow-up

For patients with COPD enrolled in the MIH program, their first patient visit is scheduled within 48 hours of discharge from the ED or inpatient hospital. In many cases, this visit can be conducted within 24 hours of returning home. Once at the patient’s home, the paramedic begins with general introductions, vital signs, and a basic physical examination. The remainder of the visit focuses on patient education and symptom recognition. The paramedic reviews the COPD action plan (Figure 1), including how to recognize the onset of a “COPD flare-up” and the appropriate response. Patients are provided with a paper copy of the action plan for future reference.

The next point of educational emphasis is the patient’s individual medication regimen. This involves differentiating between control (daily) and rescue medications, how to use oxygen tanks, and how to safely wean off of oxygen. Specific attention is given to how to use a metered-dose inhaler, as studies have found that more than half of all patients use their inhaler devices incorrectly.¹⁰

Paramedics also complete a home safety evaluation of the patient’s residence, which involves checking for tripping hazards, lighting, handrails, slippery surfaces, and general access to patient medication. If an issue cannot be resolved by the paramedic on site and is considered a safety hazard, it is reported back to the hospital team for assistance.

Finally, patients are educated on the capabilities of MIH as a program and what to expect when they reach out over the phone. Patients are given a phone number to call for both “urgent” and “nonemergent” situations. In both cases, they will be greeted by one of the MIH coordinators or nurses who assist with triaging patient symptoms, scheduling a visit, or providing other guidance. It is a point of emphasis that the patient can use MIH for more than just COPD and should call in the event of any illness or discomfort (eg, dehydration, fever) in an effort to prevent unnecessary ED visits.

Medication reconciliation

Patients with COPD often have complex medication regimens. To help alleviate any confusion, medication reconciliations are done in conjunction with every COPD patient’s initial visit. During this process, the paramedic first takes an inventory of all medications in the patient home. Common reasons for nonadherence include confusing packaging, inability to reach the pharmacy, or medication not being covered by insurance. The paramedic reconciles the updated medication regimen against the medications that are physically in the home. Once the initial review is complete, the paramedic teleconferences with a registered hospitalist pharmacist (RHP) for a more in-depth review. Over video chat, the RHP reviews each medication individually to make sure the patient understands how many times per day they take each medication, whether it is a control or rescue medication, and what times of the day to take them. The RHP will then clarify any other medication questions the patient has, assure all recent medications have been picked up from the pharmacy, and determine any barriers, such as cost or transportation.

Follow-ups and PCP involvement

At each in-person visit, paramedics coordinate with an advanced practice clinician (APC) through telehealth communication. On these video calls with a provider, the paramedic relays relevant information pertaining to patient history, vital signs, and current status. Any concerning findings, symptoms of COPD flare-ups, or recent changes in status will be discussed. The APC then speaks directly to the patient to gather additional details about their condition and any recent hospitalizations, with their primary role being to make clinical decisions on further treatment. For the COPD population, this often includes orders for the MIH paramedic to administer IV medication (ie, IV methylprednisolone or other corticosteroids), antibiotics, home nebulizers, and at-home oxygen.

Second and third follow-up paramedic visits are often less intensive. Although these visits often still involve telehealth calls to the APC, the overall focus shifts toward medication adherence, ED avoidance, and readmission avoidance. On these visits, the paramedic also checks vitals, conducts a physical examination, and completes follow-up testing or orders per the APC.

PCP involvement is critical to streamlining and transitioning patient care. Patients who are admitted to MIH without insurance or a PCP are assisted in the process of finding one. PCPs automatically receive a patient enrollment letter when their patient is seen by an MIH paramedic. Following each individual visit, paramedic and APC notes are sent to the PCP through the EMR or via fax, at which time the PCP may be consulted on patient history and/or future care decisions. After the transition back to care by their PCP, patients are still encouraged to utilize MIH if acute changes arise. If a patient is readmitted back to the hospital, MIH is automatically notified, and coordinators will assess whether there is continued need for outpatient services or areas for potential improvement.

 

 

Emergent MIH visits

While MIH visits with patients with COPD are often scheduled, MIH can also be leveraged in urgent situations to prevent the need for a patient to come to the ED or hospital. Patients with COPD are told to call MIH if they have worsening symptoms or have exhausted all methods of self-treatment without an improvement in status. In this case, a paramedic is notified and sent to the patient’s home at the earliest time possible. The paramedic then completes an assessment of the patient’s status and relays information to the MIH APC or medical director. From there, treatment decisions, such as starting the patient on an IV, using nebulizers, or doing an electrocardiogram for diagnostic purposes, are guided by the provider team with the ultimate goal of caring for the patient in the home. For our population, providing urgent care in the home has proven to be an effective way to avoid unnecessary readmissions while still ensuring high-quality patient care.

Outpatient pathway

In May 2021, select patients with COPD were given the option to participate in a more intensive MIH outpatient pathway. Pilot patients were chosen by 2 pulmonary specialists, with a focus on enrolling patients with COPD at the highest risk for readmission. Patients who opted in were followed by MIH for a total of 30 days.

The first visit was made as usual within 48 hours of discharge. Patients received education, medication reconciliation, vitals examination, home safety evaluation, and a facilitated telehealth evaluation with the APC. What differentiates the pathway from standard MIH services is that after the first visit, the follow-ups are prescheduled and more numerous. This is outlined best in Figure 2, which serves as a guideline for coordinators and paramedics in the cadence and focus of visits for each patient on the pathway. The initial 2 weeks are designed to check in on the patient in person and ensure active recovery. The latter 2 weeks are designed to ensure that the patient follows up with their care team and understands their medications and action plan going forward. Pathway patients were also monitored using a remote patient monitoring (RPM) kit. On the initial visit, paramedics set up the RPM equipment and provided a demonstration on how to use each device. Patients were issued a Bluetooth-enabled scale, blood pressure cuff, video-enabled tablet, and wearable device. The wearable device continuously recorded respiration rate, heart rate, and oxygen saturation and had fall-detection enabled. Over the course of a month, an experienced MIH nurse monitored the vitals transmitted by the wearable device and checked patient weight and blood pressure 1 to 2 times per day, utilizing these data to proactively outreach to patients if abnormalities occurred. Prior to the start of the program, the MIH nurse contacted each patient to introduce herself and notify them that they would receive a call if any vitals were unusual.

Results

MIH treated 214 patients with COPD from March 2, 2020, to August 2, 2021. In total, paramedics made more than 650 visits. Eighty-seven of these were documented as urgent visits with AECOPD, shortness of breath, cough, or wheezing as the primary concern.

In the calendar year of 2019, our institution admitted 804 patients with a primary diagnosis of COPD. In 2020, the first year with MIH, total COPD admissions decreased to 473; however, the effect of the COVID-19 pandemic cannot be discounted. At of the time of writing—219 days into 2021—253 patients with COPD have been admitted thus far (Table 1).

 

 

Pathway results

Sixteen patients were referred to the MIH COPD Discharge Pathway Pilot during May 2021. Ten patients went on to complete the entire 30-day pathway. Six did not finish the program. Three of these 6 patients were referred by a pulmonary specialist for enrollment but not ultimately referred to the pilot program by case management and therefore not enrolled. The other 3 of the 6 patients who did not complete the pilot program were enrolled but discontinued owing to noncompliance.

Of the 10 patients who completed the pathway, 3 patients were male, and 7 were female. Ages ranged from 55 to 84 years. On average, the RHP found 3.6 medication reconciliation errors per patient. One patient was readmitted within 30 days (only 3 days after the initial discharge), and 5 were readmitted within 90 days.

A retrospective analysis was conducted on patients with COPD who were not provided with MIH services and were admitted to our hospital between September 1, 2020, and March 1, 2021, for comparison. Age, sex, and other related conditions are shown in Table 2. Medication reconciliation error data were not tracked for this demographic, as they did not have an in-home medication reconciliation completed.

Discussion

MIH has treated 214 patients with COPD from March 2, 2020, to August 2, 2021, a 17-month period. In that same timeframe, the hospital experienced a 42% decrease in COPD admissions. Although this effect is not the sole product of MIH (specifically, COVID-19 caused a drop in all-cause hospital admissions), we believe MIH did play a small role in this reduction. Eighty-seven emergent visits were conducted for patients with a primary complaint of AECOPD, shortness of breath, cough, or wheezing. On these visits, MIH provided urgent treatment to prevent the patient returning to the ED and potentially leading to readmission.

The program’s impact extends beyond the numbers. With more than 200 patients with COPD treated at home, we improved hospital flow, shortened patients’ overall length of stay, and increased capacity in the ED and inpatient units. In addition, MIH has been able to fill in care gaps present in the current health care system by providing acute care in the home to patients who otherwise have access-to-care and transportation issues.

 

 

What made the program successful

With the COPD population prone to having complex medication regimens, medication reconciliations were critical to improving patient outcomes. During the documented medication reconciliations for pathway patients, 8 of 10 patients had medication errors identified. Some of the more common errors included incorrect inhaler usage, patient medication not arriving to the pharmacy for a week or more after discharge, prescribed medication dosages that were too high or too low, and a lack of transportation to pick up the patient’s prescription. Even more problematic is that 7 of these 8 patients required multiple interventions to correct their regimen. What was cited as most beneficial by both the paramedic and the RHP was taking time to walk through each medication individually and ensuring that the patient could recite back how often and when they should be using it. What also proved to be helpful was spending extra time on the inhalers and nebulizers. Multiple patients did not know how to use them properly and/or cited a history of struggling with them.

The MIH COPD pathway patients showed encouraging preliminary results. In the initial 30-day window, only 1 of 10 (10%) patients was readmitted, which is lower than the 37.7% rate for comparable patients who did not have MIH services. This could imply that patients with COPD respond positively to active and consistent management with predetermined points of contact. Ninety-day readmission rates jumped to 5 of 10, with 4 of these patients being readmitted multiple times. Approximately half of these readmissions were COPD related. It is important to remember that the patients being targeted by the pathway are deemed to be at very high risk of readmission. As such, one could expect that even with a successful reduction in rates, pathway patient readmission rates may be slightly elevated compared with national COPD averages.

Given the more personalized and at-home care, patients also expressed higher levels of care satisfaction. Most patients want to avoid the hospital at all costs, and MIH provides a safe and effective alternative. Patients with COPD have also relayed that the education they receive on their medication, disease, and how to use MIH has been useful. This is reflected in the volume of urgent calls that MIH receives. A patient calling MIH in place of 911 shows not only that the patient has a level of trust in the MIH team, but also that they have learned how to recognize symptoms earlier to prevent major flare-ups.

This study had several limitations. On the pilot pathway, 3 patients were removed from MIH services because of repeated noncompliance. These instances primarily involved aggression toward the paramedics, both verbal and physical, as well as refusal to allow the MIH paramedics into the home. Going forward, it will be valuable to have a screening process for pathway patients to determine likelihood of compliance. This could include speaking to the patient’s PCP or other in-hospital providers before accepting them into the program.

Remote patient monitoring also presented its challenges. Despite extensive equipment demonstrations, some patients struggled to grasp the technology. Some of the biggest problems cited were confusion operating the tablet, inability to charge the devices, and issues with connectivity. In the future, it may be useful to simplify the devices even more. Further work should also be done to evaluate the efficacy of remote patient technology in this specific setting, as studies have shown varied results with regard to RPM success. In 1 meta-analysis of 91 different published studies that took place between 2015 and 2020, approximately half of the RPM studies resulted in no change in hospital readmissions, length of stay, or ED presentations, while the other half saw improvement in these categories.¹¹ We suspect that the greatest benefits of our work came from the patient education, trust built over time, in-home urgent evaluations, and 1-on-1 time with the paramedic.

With many people forgoing care during the pandemic, COVID-19 has also caused a downward trend in overall and non-COVID-19 admissions. In a review of more than 500 000 ED visits in Massachusetts between March 11, 2020, and September 8, 2021, there was a 32% decrease in admissions when compared with those same weeks in 2019.¹⁰ There was an even greater drop-off when it came to COPD and other respiratory-related admissions. In evaluating the impact SSH MIH has made, it is important to recognize that the pandemic contributed to reducing total COPD admissions. Adding merit to the success of MIH in contributing to the reduction in admissions is the continued downward trend in total COPD admissions year-to-date in 2021. Despite total hospital usage rates increasing at our institution over the course of this year, the overall COPD usage rates have remained lower than before.

Another limitation is that in the selection of patients, both for general MIH care and for the COPD pathway, there was room for bias. The pilot pathway was offered specifically to patients at the highest risk for readmission; however, patients were referred at the discretion of our pulmonologist care team and not selected by any standardized rubric. Additionally, MIH only operates on a 16-hour schedule. This means that patients admitted to the ED or inpatient at night may sometimes be missed and not referred to MIH for care.

The biggest caveat to the pathway results is, of course, the small sample size. With only 10 patients completing the pilot, it is impossible to come to any concrete conclusions. Such an intensive pathway requires dedicating large amounts of time and resources, which is why the pilot was small. However, considering the preliminary results, the outline given could provide a starting point for future work to evaluate a similar COPD pathway on a larger scale.

Future considerations

Risk stratification of patients is critical to achieving even further reductions in readmissions and mortality. Hospitals can get the most value from MIH by focusing on patients with COPD at the highest risk for return, and it would be valuable to explicitly define who fits into this criterion. Utilizing a tool similar to the LACE index for readmission but tailoring it to patients with COPD when admitting patients into the program would be a logical next step.

Reducing the points of patient contact could also prove valuable. Over the course of a patient’s time with MIH, they interact with an RHP, APC, paramedic, RN, and discharging hospitalist. Additionally, we found many patients had VNA services, home health aides, care managers, and/or social workers involved in their care. Some patients found this to be stressful and overwhelming, especially regarding the number of outreach calls soon after discharge.

It would also be useful to look at the impact of MIH on total COPD admissions independent of the artificial variation created by COVID-19. This may require waiting until there are higher levels of vaccination and/or finding ways to control for the potential variation. In doing so, one could look at the direct effect MIH has on COPD readmissions when compared with a control group without MIH services, which could then serve as a comparison point to the results of this study. As it stands, given the relative novelty of MIH, there are primarily only broad reviews of MIH’s effectiveness and/or impact on patient populations that have been published. Of these, only a few directly mentioned MIH in relation to COPD, and none have comparable designs that look at overall COPD hospitalization reductions post-MIH implementation. There is also little to no literature looking at the utilization of MIH in a more intensive COPD outpatient pathway.

Finally, MIH has proven to be a useful tool for our institution in many areas outside of COPD management. Specifically, MIH has been utilized as a mobile influenza and COVID-19 vaccination unit and in-home testing service and now operates both a hospital-at-home and skilled nursing facility-at-home program. Analysis of the overall needs of the system and where this valuable MIH resource would have the biggest impact will be key in future growth opportunities.

Conclusion

MIH has been an invaluable tool for our hospital, especially in light of the recent shift toward more in-home and virtual care. MIH cared for 214 patients with COPD with more than 650 visits between March 2020 and August 2021. Eighty-seven emergent COPD visits were conducted, and COPD admissions were reduced dramatically from 2019 to 2020. MIH services have improved hospital flow, allowed for earlier discharge from the ED and inpatient care, and helped improve all-cause COPD readmission rates. The importance of postdischarge care and follow-up visits for patients with COPD, especially those at higher risk for readmission, cannot be understated. We hope our experience working to improve COPD patient outcomes serves as valuable a reference point for future MIH programs.

Corresponding author: Kelly Lannutti, DO, Mobile Integrated Health and Emergency Medicine Department, South Shore Health, 55 Fogg Rd, South Weymouth, MA 02190; klannutti@southshorehealth.org.

Financial disclosures: None.

From Sheffield Teaching Hospitals, Sheffield, UK, S5 7AU.

Objective: Constipation is widely prevalent in older adults and may result in complications such as urinary retention, delirium, and bowel obstruction. Previous studies have indicated that while the nursing staff do well in completing stool charts, doctors monitor them infrequently. This project aimed to improve the documentation of bowel movement by doctors on ward rounds to 85%, by the end of a 3-month period.

Methods: Baseline, postintervention, and sustainability data were collected from inpatient notes on weekdays on a geriatric ward in Northern General Hospital, Sheffield, UK. Posters and stickers of the poo emoji were placed on walls and in inpatient notes, respectively, as a reminder.

Results: Data on bowel activity documentation were collected from 28 patients. The baseline data showed that bowel activity was monitored daily on the ward 60.49% of the time. However, following the interventions, there was a significant increase in documentation, to 86.78%. The sustainability study showed that bowel activity was documented on the ward 56.56% of the time.

Conclusion: This study shows how a strong initial effect on behavioral change can be accomplished through simple interventions such as stickers and posters. As most wards currently still use paper notes, this is a generalizable model that other wards can trial. However, this study also shows the difficulty in maintaining behavioral change over extended periods of time.

Keywords: bowel movement; documentation; obstruction; constipation; geriatrics; incontinence; junior doctor; quality improvement.

Constipation is widely prevalent in the elderly, encountered frequently in both community and hospital medicine.¹ Its estimated prevalence in adults over 84 years old is 34% for women and 25% for men, rising to up to 80% for long-term care residents.²

Chronic constipation is generally characterized by unsatisfactory defecation due to infrequent bowel emptying or difficulty with stool passage, which may lead to incomplete evacuation.^2-4 Constipation in the elderly, in addition to causing abdominal pain, nausea, and reduced appetite, may result in complications such as fecal incontinence (and overflow diarrhea), urinary retention, delirium, and bowel obstruction, which may in result in life-threatening perforation.^5,6 For inpatients on geriatric wards, these consequences may increase morbidity and mortality, while prolonging hospital stays, thereby also increasing exposure to hospital-acquired infections.⁷ Furthermore, constipation is also associated with impaired health-related quality of life.⁸

Management includes treating the cause, stopping contributing medications, early mobilization, diet modification, and, if all else fails, prescription laxatives. Therefore, early identification and appropriate treatment of constipation is beneficial in inpatient care, as well as when planning safe and patient-centered discharges.

Given the risks and complications of constipation in the elderly, we, a group of Foundation Year 2 (FY2) doctors in the UK Foundation Programme, decided to explore how doctors can help to recognize this condition early. Regular bowel movement documentation in patient notes on ward rounds is crucial, as it has been shown to reduce constipation-associated complications.⁵ However, complications from constipation can take significant amounts of time to develop and, therefore, documenting bowel movements on a daily basis is not necessary.

Based on these observations along with targets set out in previous studies,⁷ our aim was to improve documentation of bowel movement on ward rounds to 85% by March 2020.

Methods

Before the data collection process, a fishbone diagram was designed to identify the potential causes of poor documentation of bowel movement on geriatric wards. There were several aspects that were reviewed, including, for example, patients, health care professionals, organizational policies, procedures, and equipment. It was then decided to focus on raising awareness of the documentation of bowel movement by doctors specifically.

Retrospective data were collected from the inpatient paper notes of 28 patients on Brearley 6, a geriatric ward at the Northern General Hospital within Sheffield Teaching Hospitals (STH), on weekdays over a 3-week period. The baseline data collected included the bed number of the patient, whether or not bowel movement on initial ward round was documented, and whether it was the junior, registrar, or consultant leading the ward round. End-of-life and discharged patients were excluded (Table).

The interventions consisted of posters and stickers. Posters were displayed on Brearley 6, including the doctors’ office, nurses’ station, and around the bays where notes were kept, in order to emphasize their importance. The stickers of the poo emoji were also printed and placed at the front of each set of inpatient paper notes as a reminder for the doctor documenting on the ward round. The interventions were also introduced in the morning board meeting to ensure all staff on Brearley 6 were aware of them.

Data were collected on weekdays over a 3-week period starting 2 weeks after the interventions were put in place (Table). In order to assess that the intervention had been sustained, data were again collected 1 month later over a 2-week period (Table). Microsoft Excel (Microsoft Corporation, Redmond, Washington, USA) was used to analyze all data, and control charts were used to assess variability in the data.

Results

The baseline data showed that bowel movement was documented 60.49% of the time by doctors on the initial ward round before intervention, as illustrated in Figure 1. There was no evidence of an out-of-control process in this baseline data set.

The comparison between the preintervention and postintervention data is illustrated in Figure 1. The postintervention data, which were taken 2 weeks after intervention, showed a significant increase in the documentation of bowel movements, to 86.78%. The figure displays a number of features consistent with an out-of-control process: beyond limits (≥ 1 points beyond control limits), Zone A rule (2 out of 3 consecutive points beyond 2 standard deviations from the mean), Zone B rule (4 out of 5 consecutive points beyond 1 standard deviation from the mean), and Zone C rule (≥ 8 consecutive points on 1 side of the mean). These findings demonstrate a special cause variation in the documentation of bowel movements.

Figure 2 shows the sustainability of the intervention, which averaged 56.56% postintervention nearly 2 months later. The data returned to preintervention variability levels.

Discussion

Our project explored an important issue that was frequently encountered by department clinicians. Our team of FY2 doctors, in general, had little experience with quality improvement. We have developed our understanding and experience through planning, making, and measuring improvement.

It was challenging deciding on how to deal with the problem. A number of ways were considered to improve the paper rounding chart, but the nursing team had already planned to make changes to it. Bowel activity is mainly documented by nursing staff, but there was no specific protocol for recognizing constipation and when to inform the medical team. We decided to focus on doctors’ documentation in patient notes during the ward round, as this is where the decision regarding management of bowels is made, including interventions that could only be done by doctors, such as prescribing laxatives.

Strom et al⁹ have described a number of successful quality improvement interventions, and we decided to follow the authors’ guidance to implement a reminder system strategy using both posters and stickers to prompt doctors to document bowel activity. Both of these were simple, and the text on the poster was concise. The only cost incurred on the project was from printing the stickers; this totalled £2.99 (US $4.13). Individual stickers for each ward round entry were considered but not used, as it would create an additional task for doctors.

The data initially indicated that the interventions had their desired effect. However, this positive change was unsustainable, most likely suggesting that the novelty of the stickers and posters wore off at some point, leading to junior doctors no longer noticing them. Further Plan-Do-Study-Act cycles should examine the reasons why the change is difficult to sustain and implement new policies that aim to overcome them.

There were a number of limitations to this study. A patient could be discharged before data collection, which was done twice weekly. This could have resulted in missed data during the collection period. In addition, the accuracy of the documentation is dependent on nursing staff correctly recording—as well as the doctors correctly viewing—all sources of information on bowel activity. Observer bias is possible, too, as a steering group member was involved in data collection. Their awareness of the project could cause a positive skew in the data. And, unfortunately, the project came to an abrupt end because of COVID-19 cases on the ward.

We examined the daily documentation of bowel activity, which may not be necessary considering that internationally recognized constipation classifications, such as the Rome III criteria, define constipation as fewer than 3 bowel movements per week.¹⁰ However, the data collection sheet did not include patient identifiers, so it was impossible to determine whether bowel activity had been documented 3 or more times per week for each patient. This is important because a clinician may only decide to act if there is no bowel movement activity for 3 or more days.

Because our data were collected on a single geriatric ward, which had an emphasis on Parkinson’s disease, it is unclear whether our findings are generalizable to other clinical areas in STH. However, constipation is common in the elderly, so it is likely to be relevant to other wards, as more than a third of STH hospital beds are occupied by patients aged 75 years and older.¹¹

Conclusion

Overall, our study highlights the fact that monitoring bowel activity is important on a geriatric ward. Recognizing constipation early prevents complications and delays to discharge. As mentioned earlier, our aim was achieved initially but not sustained. Therefore, future development should focus on sustainability. For example, laxative-focused ward rounds have shown to be effective at recognizing and preventing constipation by intervening early.¹² Future cycles that we considered included using an electronic reminder on the hospital IT system, as the trust is aiming to introduce electronic documentation. Focus could also be placed on improving documentation in bowel charts by ward staff. This could be achieved by organizing regular educational sessions on the complications of constipation and when to inform the medical team regarding concerns.

Acknowledgments: The authors thank Dr. Jamie Kapur, Sheffield Teaching Hospitals, for his guidance and supervision, as well as our collaborators: Rachel Hallam, Claire Walker, Monisha Chakravorty, and Hamza Khan.

Corresponding author: Alexander P. Noar, BMBCh, BA, 10 Stanhope Gardens, London, N6 5TS; alecnoar@live.co.uk.

Financial disclosures: None.

From Sheffield Teaching Hospitals, Sheffield, UK, S5 7AU.

Objective: Constipation is widely prevalent in older adults and may result in complications such as urinary retention, delirium, and bowel obstruction. Previous studies have indicated that while the nursing staff do well in completing stool charts, doctors monitor them infrequently. This project aimed to improve the documentation of bowel movement by doctors on ward rounds to 85%, by the end of a 3-month period.

Methods: Baseline, postintervention, and sustainability data were collected from inpatient notes on weekdays on a geriatric ward in Northern General Hospital, Sheffield, UK. Posters and stickers of the poo emoji were placed on walls and in inpatient notes, respectively, as a reminder.

Results: Data on bowel activity documentation were collected from 28 patients. The baseline data showed that bowel activity was monitored daily on the ward 60.49% of the time. However, following the interventions, there was a significant increase in documentation, to 86.78%. The sustainability study showed that bowel activity was documented on the ward 56.56% of the time.

Conclusion: This study shows how a strong initial effect on behavioral change can be accomplished through simple interventions such as stickers and posters. As most wards currently still use paper notes, this is a generalizable model that other wards can trial. However, this study also shows the difficulty in maintaining behavioral change over extended periods of time.

Keywords: bowel movement; documentation; obstruction; constipation; geriatrics; incontinence; junior doctor; quality improvement.

Constipation is widely prevalent in the elderly, encountered frequently in both community and hospital medicine.¹ Its estimated prevalence in adults over 84 years old is 34% for women and 25% for men, rising to up to 80% for long-term care residents.²

Chronic constipation is generally characterized by unsatisfactory defecation due to infrequent bowel emptying or difficulty with stool passage, which may lead to incomplete evacuation.^2-4 Constipation in the elderly, in addition to causing abdominal pain, nausea, and reduced appetite, may result in complications such as fecal incontinence (and overflow diarrhea), urinary retention, delirium, and bowel obstruction, which may in result in life-threatening perforation.^5,6 For inpatients on geriatric wards, these consequences may increase morbidity and mortality, while prolonging hospital stays, thereby also increasing exposure to hospital-acquired infections.⁷ Furthermore, constipation is also associated with impaired health-related quality of life.⁸

Management includes treating the cause, stopping contributing medications, early mobilization, diet modification, and, if all else fails, prescription laxatives. Therefore, early identification and appropriate treatment of constipation is beneficial in inpatient care, as well as when planning safe and patient-centered discharges.

Given the risks and complications of constipation in the elderly, we, a group of Foundation Year 2 (FY2) doctors in the UK Foundation Programme, decided to explore how doctors can help to recognize this condition early. Regular bowel movement documentation in patient notes on ward rounds is crucial, as it has been shown to reduce constipation-associated complications.⁵ However, complications from constipation can take significant amounts of time to develop and, therefore, documenting bowel movements on a daily basis is not necessary.

Based on these observations along with targets set out in previous studies,⁷ our aim was to improve documentation of bowel movement on ward rounds to 85% by March 2020.

Methods

Before the data collection process, a fishbone diagram was designed to identify the potential causes of poor documentation of bowel movement on geriatric wards. There were several aspects that were reviewed, including, for example, patients, health care professionals, organizational policies, procedures, and equipment. It was then decided to focus on raising awareness of the documentation of bowel movement by doctors specifically.

Retrospective data were collected from the inpatient paper notes of 28 patients on Brearley 6, a geriatric ward at the Northern General Hospital within Sheffield Teaching Hospitals (STH), on weekdays over a 3-week period. The baseline data collected included the bed number of the patient, whether or not bowel movement on initial ward round was documented, and whether it was the junior, registrar, or consultant leading the ward round. End-of-life and discharged patients were excluded (Table).

The interventions consisted of posters and stickers. Posters were displayed on Brearley 6, including the doctors’ office, nurses’ station, and around the bays where notes were kept, in order to emphasize their importance. The stickers of the poo emoji were also printed and placed at the front of each set of inpatient paper notes as a reminder for the doctor documenting on the ward round. The interventions were also introduced in the morning board meeting to ensure all staff on Brearley 6 were aware of them.

Data were collected on weekdays over a 3-week period starting 2 weeks after the interventions were put in place (Table). In order to assess that the intervention had been sustained, data were again collected 1 month later over a 2-week period (Table). Microsoft Excel (Microsoft Corporation, Redmond, Washington, USA) was used to analyze all data, and control charts were used to assess variability in the data.

Results

The baseline data showed that bowel movement was documented 60.49% of the time by doctors on the initial ward round before intervention, as illustrated in Figure 1. There was no evidence of an out-of-control process in this baseline data set.

The comparison between the preintervention and postintervention data is illustrated in Figure 1. The postintervention data, which were taken 2 weeks after intervention, showed a significant increase in the documentation of bowel movements, to 86.78%. The figure displays a number of features consistent with an out-of-control process: beyond limits (≥ 1 points beyond control limits), Zone A rule (2 out of 3 consecutive points beyond 2 standard deviations from the mean), Zone B rule (4 out of 5 consecutive points beyond 1 standard deviation from the mean), and Zone C rule (≥ 8 consecutive points on 1 side of the mean). These findings demonstrate a special cause variation in the documentation of bowel movements.

Figure 2 shows the sustainability of the intervention, which averaged 56.56% postintervention nearly 2 months later. The data returned to preintervention variability levels.

Discussion

Our project explored an important issue that was frequently encountered by department clinicians. Our team of FY2 doctors, in general, had little experience with quality improvement. We have developed our understanding and experience through planning, making, and measuring improvement.

It was challenging deciding on how to deal with the problem. A number of ways were considered to improve the paper rounding chart, but the nursing team had already planned to make changes to it. Bowel activity is mainly documented by nursing staff, but there was no specific protocol for recognizing constipation and when to inform the medical team. We decided to focus on doctors’ documentation in patient notes during the ward round, as this is where the decision regarding management of bowels is made, including interventions that could only be done by doctors, such as prescribing laxatives.

Strom et al⁹ have described a number of successful quality improvement interventions, and we decided to follow the authors’ guidance to implement a reminder system strategy using both posters and stickers to prompt doctors to document bowel activity. Both of these were simple, and the text on the poster was concise. The only cost incurred on the project was from printing the stickers; this totalled £2.99 (US $4.13). Individual stickers for each ward round entry were considered but not used, as it would create an additional task for doctors.

The data initially indicated that the interventions had their desired effect. However, this positive change was unsustainable, most likely suggesting that the novelty of the stickers and posters wore off at some point, leading to junior doctors no longer noticing them. Further Plan-Do-Study-Act cycles should examine the reasons why the change is difficult to sustain and implement new policies that aim to overcome them.

There were a number of limitations to this study. A patient could be discharged before data collection, which was done twice weekly. This could have resulted in missed data during the collection period. In addition, the accuracy of the documentation is dependent on nursing staff correctly recording—as well as the doctors correctly viewing—all sources of information on bowel activity. Observer bias is possible, too, as a steering group member was involved in data collection. Their awareness of the project could cause a positive skew in the data. And, unfortunately, the project came to an abrupt end because of COVID-19 cases on the ward.

We examined the daily documentation of bowel activity, which may not be necessary considering that internationally recognized constipation classifications, such as the Rome III criteria, define constipation as fewer than 3 bowel movements per week.¹⁰ However, the data collection sheet did not include patient identifiers, so it was impossible to determine whether bowel activity had been documented 3 or more times per week for each patient. This is important because a clinician may only decide to act if there is no bowel movement activity for 3 or more days.

Because our data were collected on a single geriatric ward, which had an emphasis on Parkinson’s disease, it is unclear whether our findings are generalizable to other clinical areas in STH. However, constipation is common in the elderly, so it is likely to be relevant to other wards, as more than a third of STH hospital beds are occupied by patients aged 75 years and older.¹¹

Conclusion

Overall, our study highlights the fact that monitoring bowel activity is important on a geriatric ward. Recognizing constipation early prevents complications and delays to discharge. As mentioned earlier, our aim was achieved initially but not sustained. Therefore, future development should focus on sustainability. For example, laxative-focused ward rounds have shown to be effective at recognizing and preventing constipation by intervening early.¹² Future cycles that we considered included using an electronic reminder on the hospital IT system, as the trust is aiming to introduce electronic documentation. Focus could also be placed on improving documentation in bowel charts by ward staff. This could be achieved by organizing regular educational sessions on the complications of constipation and when to inform the medical team regarding concerns.

Acknowledgments: The authors thank Dr. Jamie Kapur, Sheffield Teaching Hospitals, for his guidance and supervision, as well as our collaborators: Rachel Hallam, Claire Walker, Monisha Chakravorty, and Hamza Khan.

Corresponding author: Alexander P. Noar, BMBCh, BA, 10 Stanhope Gardens, London, N6 5TS; alecnoar@live.co.uk.

Financial disclosures: None.

From Sheffield Teaching Hospitals, Sheffield, UK, S5 7AU.

Objective: Constipation is widely prevalent in older adults and may result in complications such as urinary retention, delirium, and bowel obstruction. Previous studies have indicated that while the nursing staff do well in completing stool charts, doctors monitor them infrequently. This project aimed to improve the documentation of bowel movement by doctors on ward rounds to 85%, by the end of a 3-month period.

Methods: Baseline, postintervention, and sustainability data were collected from inpatient notes on weekdays on a geriatric ward in Northern General Hospital, Sheffield, UK. Posters and stickers of the poo emoji were placed on walls and in inpatient notes, respectively, as a reminder.

Results: Data on bowel activity documentation were collected from 28 patients. The baseline data showed that bowel activity was monitored daily on the ward 60.49% of the time. However, following the interventions, there was a significant increase in documentation, to 86.78%. The sustainability study showed that bowel activity was documented on the ward 56.56% of the time.

Conclusion: This study shows how a strong initial effect on behavioral change can be accomplished through simple interventions such as stickers and posters. As most wards currently still use paper notes, this is a generalizable model that other wards can trial. However, this study also shows the difficulty in maintaining behavioral change over extended periods of time.

Keywords: bowel movement; documentation; obstruction; constipation; geriatrics; incontinence; junior doctor; quality improvement.

Constipation is widely prevalent in the elderly, encountered frequently in both community and hospital medicine.¹ Its estimated prevalence in adults over 84 years old is 34% for women and 25% for men, rising to up to 80% for long-term care residents.²

Chronic constipation is generally characterized by unsatisfactory defecation due to infrequent bowel emptying or difficulty with stool passage, which may lead to incomplete evacuation.^2-4 Constipation in the elderly, in addition to causing abdominal pain, nausea, and reduced appetite, may result in complications such as fecal incontinence (and overflow diarrhea), urinary retention, delirium, and bowel obstruction, which may in result in life-threatening perforation.^5,6 For inpatients on geriatric wards, these consequences may increase morbidity and mortality, while prolonging hospital stays, thereby also increasing exposure to hospital-acquired infections.⁷ Furthermore, constipation is also associated with impaired health-related quality of life.⁸

Management includes treating the cause, stopping contributing medications, early mobilization, diet modification, and, if all else fails, prescription laxatives. Therefore, early identification and appropriate treatment of constipation is beneficial in inpatient care, as well as when planning safe and patient-centered discharges.

Given the risks and complications of constipation in the elderly, we, a group of Foundation Year 2 (FY2) doctors in the UK Foundation Programme, decided to explore how doctors can help to recognize this condition early. Regular bowel movement documentation in patient notes on ward rounds is crucial, as it has been shown to reduce constipation-associated complications.⁵ However, complications from constipation can take significant amounts of time to develop and, therefore, documenting bowel movements on a daily basis is not necessary.

Based on these observations along with targets set out in previous studies,⁷ our aim was to improve documentation of bowel movement on ward rounds to 85% by March 2020.

Methods

Before the data collection process, a fishbone diagram was designed to identify the potential causes of poor documentation of bowel movement on geriatric wards. There were several aspects that were reviewed, including, for example, patients, health care professionals, organizational policies, procedures, and equipment. It was then decided to focus on raising awareness of the documentation of bowel movement by doctors specifically.

Retrospective data were collected from the inpatient paper notes of 28 patients on Brearley 6, a geriatric ward at the Northern General Hospital within Sheffield Teaching Hospitals (STH), on weekdays over a 3-week period. The baseline data collected included the bed number of the patient, whether or not bowel movement on initial ward round was documented, and whether it was the junior, registrar, or consultant leading the ward round. End-of-life and discharged patients were excluded (Table).

The interventions consisted of posters and stickers. Posters were displayed on Brearley 6, including the doctors’ office, nurses’ station, and around the bays where notes were kept, in order to emphasize their importance. The stickers of the poo emoji were also printed and placed at the front of each set of inpatient paper notes as a reminder for the doctor documenting on the ward round. The interventions were also introduced in the morning board meeting to ensure all staff on Brearley 6 were aware of them.

Data were collected on weekdays over a 3-week period starting 2 weeks after the interventions were put in place (Table). In order to assess that the intervention had been sustained, data were again collected 1 month later over a 2-week period (Table). Microsoft Excel (Microsoft Corporation, Redmond, Washington, USA) was used to analyze all data, and control charts were used to assess variability in the data.

Results

The baseline data showed that bowel movement was documented 60.49% of the time by doctors on the initial ward round before intervention, as illustrated in Figure 1. There was no evidence of an out-of-control process in this baseline data set.

The comparison between the preintervention and postintervention data is illustrated in Figure 1. The postintervention data, which were taken 2 weeks after intervention, showed a significant increase in the documentation of bowel movements, to 86.78%. The figure displays a number of features consistent with an out-of-control process: beyond limits (≥ 1 points beyond control limits), Zone A rule (2 out of 3 consecutive points beyond 2 standard deviations from the mean), Zone B rule (4 out of 5 consecutive points beyond 1 standard deviation from the mean), and Zone C rule (≥ 8 consecutive points on 1 side of the mean). These findings demonstrate a special cause variation in the documentation of bowel movements.

Figure 2 shows the sustainability of the intervention, which averaged 56.56% postintervention nearly 2 months later. The data returned to preintervention variability levels.

Discussion

Our project explored an important issue that was frequently encountered by department clinicians. Our team of FY2 doctors, in general, had little experience with quality improvement. We have developed our understanding and experience through planning, making, and measuring improvement.

It was challenging deciding on how to deal with the problem. A number of ways were considered to improve the paper rounding chart, but the nursing team had already planned to make changes to it. Bowel activity is mainly documented by nursing staff, but there was no specific protocol for recognizing constipation and when to inform the medical team. We decided to focus on doctors’ documentation in patient notes during the ward round, as this is where the decision regarding management of bowels is made, including interventions that could only be done by doctors, such as prescribing laxatives.

Strom et al⁹ have described a number of successful quality improvement interventions, and we decided to follow the authors’ guidance to implement a reminder system strategy using both posters and stickers to prompt doctors to document bowel activity. Both of these were simple, and the text on the poster was concise. The only cost incurred on the project was from printing the stickers; this totalled £2.99 (US $4.13). Individual stickers for each ward round entry were considered but not used, as it would create an additional task for doctors.

The data initially indicated that the interventions had their desired effect. However, this positive change was unsustainable, most likely suggesting that the novelty of the stickers and posters wore off at some point, leading to junior doctors no longer noticing them. Further Plan-Do-Study-Act cycles should examine the reasons why the change is difficult to sustain and implement new policies that aim to overcome them.

There were a number of limitations to this study. A patient could be discharged before data collection, which was done twice weekly. This could have resulted in missed data during the collection period. In addition, the accuracy of the documentation is dependent on nursing staff correctly recording—as well as the doctors correctly viewing—all sources of information on bowel activity. Observer bias is possible, too, as a steering group member was involved in data collection. Their awareness of the project could cause a positive skew in the data. And, unfortunately, the project came to an abrupt end because of COVID-19 cases on the ward.

We examined the daily documentation of bowel activity, which may not be necessary considering that internationally recognized constipation classifications, such as the Rome III criteria, define constipation as fewer than 3 bowel movements per week.¹⁰ However, the data collection sheet did not include patient identifiers, so it was impossible to determine whether bowel activity had been documented 3 or more times per week for each patient. This is important because a clinician may only decide to act if there is no bowel movement activity for 3 or more days.

Because our data were collected on a single geriatric ward, which had an emphasis on Parkinson’s disease, it is unclear whether our findings are generalizable to other clinical areas in STH. However, constipation is common in the elderly, so it is likely to be relevant to other wards, as more than a third of STH hospital beds are occupied by patients aged 75 years and older.¹¹

Conclusion

Overall, our study highlights the fact that monitoring bowel activity is important on a geriatric ward. Recognizing constipation early prevents complications and delays to discharge. As mentioned earlier, our aim was achieved initially but not sustained. Therefore, future development should focus on sustainability. For example, laxative-focused ward rounds have shown to be effective at recognizing and preventing constipation by intervening early.¹² Future cycles that we considered included using an electronic reminder on the hospital IT system, as the trust is aiming to introduce electronic documentation. Focus could also be placed on improving documentation in bowel charts by ward staff. This could be achieved by organizing regular educational sessions on the complications of constipation and when to inform the medical team regarding concerns.

Acknowledgments: The authors thank Dr. Jamie Kapur, Sheffield Teaching Hospitals, for his guidance and supervision, as well as our collaborators: Rachel Hallam, Claire Walker, Monisha Chakravorty, and Hamza Khan.

Corresponding author: Alexander P. Noar, BMBCh, BA, 10 Stanhope Gardens, London, N6 5TS; alecnoar@live.co.uk.

Financial disclosures: None.

From Health Center, New York University Abu Dhabi, Abu Dhabi, United Arab Emirates (Dr. Virji and Aisha Al Hamiz), Public Health, Abu Dhabi Public Health Center, Abu Dhabi, United Arab Emirates (Drs. Al Hajeri, Al Shehhi, Al Memari, and Ahlam Al Maskari), College of Medicine and Health Sciences, Khalifa University, Abu Dhabi, United Arab Emirates, Department of Medicine, Sheikh Shakhbout Medical City, Abu Dhabi, United Arab Emirates (Dr. Alhajri), Public Health Research Center, New York University Abu Dhabi, Abu Dhabi, United Arab Emirates, Oxford University Hospitals NHS Foundation Trust, Oxford, England, and the MRC Epidemiology Unit, University of Cambridge, Cambridge, England (Dr. Ali).

Objective: The pandemic has forced closures of primary schools, resulting in loss of learning time on a global scale. In addition to face coverings, social distancing, and hand hygiene, an efficient testing method is important to mitigate the spread of COVID-19 in schools. We evaluated the feasibility of a saliva-based SARS-CoV-2 polymerase chain reaction testing program among 18 primary schools in the Emirate of Abu Dhabi, United Arab Emirates. Qualitative results show that children 4 to 5 years old had difficulty producing an adequate saliva specimen compared to those 6 to 12 years old.

Methods: A short training video on saliva collection beforehand helps demystify the process for students and parents alike. Informed consent was challenging yet should be done beforehand by school health nurses or other medical professionals to reassure parents and maximize participation.

Results: Telephone interviews with school administrators resulted in an 83% response rate. Overall, 93% of school administrators had a positive experience with saliva testing and felt the program improved the safety of their schools. The ongoing use of saliva testing for SARS-CoV-2 was supported by 73% of respondents.

Conclusion: On-campus saliva testing is a feasible option for primary schools to screen for COVID-19 in their student population to help keep their campuses safe and open for learning.

Keywords: COVID-19; saliva testing; mitigation; primary school.

The COVID-19 pandemic is a leading cause of morbidity and mortality worldwide and continues to exhaust health care resources on a large scale.¹ Efficient testing is critical to identify cases early and to help mitigate the deleterious effects of the pandemic.² Saliva polymerase chain reaction (PCR) nucleic acid amplification testing (NAAT) is more comfortable than nasopharyngeal (NP) NAAT and has been validated as a test for SARS-CoV-2.¹ Although children are less susceptible to severe disease, primary schools are considered a vector for transmission and community spread.³ Efficient and scalable methods of routine testing are needed globally to help keep schools open. Saliva testing has proven a useful resource for this population.^4,5

Abu Dhabi is the largest Emirate in the United Arab Emirates (UAE), with an estimated population of 2.5 million.⁶ The first case of COVID-19 was discovered in the UAE on January 29, 2020.⁷ The UAE has been recognized worldwide for its robust pandemic response. Along with the coordinated and swift application of public health measures, the country has one of the highest COVID-19 testing rates per capita and one of the highest vaccination rates worldwide.^8,9 The Abu Dhabi Public Health Center (ADPHC) works alongside the Ministry of Education (MOE) to establish testing, quarantine, and general safety guidelines for primary schools. In December 2020, the ADPHC partnered with a local, accredited diagnostic laboratory to test the feasibility of a saliva-based screening program for COVID-19 directly on school campuses for 18 primary schools in the Emirate.

Saliva-based PCR testing for COVID-19 was approved for use in schools in the UAE on January 24, 2021.¹⁰ As part of a greater mitigation strategy to reduce both school-based transmission and, hence, community spread, the ADPHC focused its on-site testing program on children aged 4 to 12 years. The program required collaboration among medical professionals, school administrators and teachers, students, and parents. Our study evaluates the feasibility of implementing a saliva-based COVID-19 screening program directly on primary school campuses involving children as young as 4 years of age.

Methods

The ADPHC, in collaboration with G42 Biogenix Labs, conducted a saliva SARS-CoV-2 NAAT testing program in 18 primary schools in the Emirate. Schools were selected based on outbreak prevalence at the time and focused on “hot spot” areas. The school on-site saliva testing program included children aged 4 to 12 years old in a “bubble” attendance model during the school day. This model involved children being assigned to groups or “pods.” This allowed us to limit a potential outbreak to a single pod, as opposed to risk exposing the entire school, should a single student test positive. The well-established SalivaDirect protocol developed at Yale University was used for testing and included an RNA extraction-free, RT-qPCR method for SARS-CoV-2 detection.¹¹

We conducted a qualitative study involving telephone interviews of school administrators to evaluate their experience with the ADPHC testing program at their schools. In addition, we interviewed the G42 Biogenix Lab providers to understand the logistics that supported on-campus collection of saliva specimens for this age group. We also gathered the attitudes of school children before and after testing. This study was reviewed and approved by the Abu Dhabi Health Research and Technology Committee and the Institutional Review Board (IRB), New York University Abu Dhabi (NYUAD).

Sample and recruitment

The original sample collection of saliva specimens was performed by the ADPHC in collaboration with G42 Biogenix Lab providers on school campuses between December 6 and December 10, 2020. During this time, schools operated in a hybrid teaching model, where learning took place both online and in person. Infection control measures were deployed based on ADPHC standards and guidelines. Nurses utilized appropriate patient protective equipment, frequent hand hygiene, and social distancing during the collection process. Inclusion criteria included asymptomatic students aged 4 to 12 years attending in-person classes on campus. Students with respiratory symptoms who were asked to stay home or those not attending in-person classes were excluded.

 

 

Data collection

Data with regard to school children’s attitudes before and after testing were compiled through an online survey sent randomly to participants postintervention. Data from school administrators were collected through video and telephone interviews between April 14 and April 29, 2021. We first interviewed G42 Biogenix Lab providers to obtain previously acquired qualitative and quantitative data, which were collected during the intervention itself. After obtaining this information, we designed a questionnaire and proceeded with a structured interview process for school officials.

We interviewed school principals and administrators to collect their overall experiences with the saliva testing program. Before starting each interview, we established the interviewees preferred language, either English or Arabic. We then introduced the meeting attendees and provided study details, aims, and objectives, and described collaborating entities. We obtained verbal informed consent from a script approved by the NYUAD IRB and then proceeded with the interview, which included 4 questions. The first 3 questions were answered on a 5-point Likert scale model that consisted of 5 answer options: 5 being completely agree, 4 agree, 3 somewhat agree, 2 somewhat disagree, and 1 completely disagree. The fourth question invited open-ended feedback and comments on the following statements:

1. I believe the COVID-19 saliva testing program improved the safety for my school campus.
2. Our community had an overall positive experience with the COVID saliva testing.
3. We would like to continue a saliva-based COVID testing program on our school campus.
4. Please provide any additional comments you feel important about the program.

During the interview, we transcribed the answers as the interviewee was answering. We then translated those in Arabic into English and collected the data in 1 Excel spreadsheet. School interviewees and school names were de-identified in the collection and storage process.

Results

A total of 2011 saliva samples were collected from 18 different primary school campuses. Samples were sent the same day to G42 Biogenix Labs in Abu Dhabi for COVID PCR testing. A team consisting of 5 doctors providing general oversight, along with 2 to 6 nurses per site, were able to manage the collection process for all 18 school campuses. Samples were collected between 8 am and 2 pm and required variation among sites depending on factors such as staff availability and class schedules. Additional scheduling challenges included compliance with public safety mandates involving the maintenance of defined “safety bubbles” that forbid certain personnel from moving between floors, and the avoidance of mixing students from different classes.

Sample stations were set up in either the school auditorium or gymnasium to ensure appropriate crowd control and ventilation. Teachers and other school staff, including public safety, were able to manage lines and the shuttling of students back and forth from classes to testing stations, which allowed medical staff to focus on sample collection.

Informed consent was obtained by prior electronic communication to parents from school staff, asking them to agree to allow their child to participate in the testing program. Informed consent was identified as a challenge: Getting parents to understand that saliva testing was more comfortable than NP testing, and that the results were only being used to help keep the school safe, took time. School staff are used to obtaining consent from parents for field trips, but this was clearly more challenging for them.

The saliva collection process per child took more time than expected. Children fasted for 45 minutes before saliva collection. We used an active drool technique, which required children to pool saliva in their mouth then express it into a collection tube. Adults can generally do this on command, but we found it took 10 to 12 minutes per child. Saliva production was cued by asking the children to think about food, and by showing them pictures and TV commercials depicting food. Children 4 to 5 years old had more difficulty with the process despite active cueing, while those 6 to 12 years old had an easier time with the process. We collected data on a cohort of 80 children regarding their attitudes pre (Figure 1) and post collection (Figure 2). Children felt happier, less nervous, and less scared after collection than before collection. This trend reassured us that future collections would be easier for students.

A total of 15 of 18 school principals completed the telephone interview, yielding a response rate of 83%. Overall, 93% of the school principals agreed or completely agreed that the COVID-19 saliva testing program improved school safety; 93% agreed or completely agreed that they had an overall positive experience with the program; and 73% supported the ongoing use of saliva testing in their schools (Table 1). Administrators’ open-ended comments on their experience were positive overall (Table 2).

Discussion

By March 2020, many kindergarten to grade 12 public and private schools suspended in-person classes due to the pandemic and turned to online learning platforms. The negative impact of school closures on academic achievement is projected to be significant.^7,12,13 Ensuring schools can stay open and run operations safely will require routine SARS-CoV-2 testing. Our study investigated the feasibility of routine saliva testing on children aged 4 to 12 years on their school campuses. The ADPHC school on-site saliva testing program involved bringing lab providers onto 18 primary school campuses and required cooperation among parents, students, school administrators, and health care professionals.

Children younger than 6 years had difficulty producing an adequate saliva specimen, whereas those 6 to 12 years did so with relative ease when cued by thoughts or pictures of food while waiting in line for collection. Schools considering on-site testing programs should consider the age range of 6 to 12 years as a viable age range for saliva screening. Children should fast for a minimum of 45 minutes prior to saliva collection and should be cued by thoughts of food, food pictures, or food commercials. Setting up a sampling station close to the cafeteria where students can smell meal preparation may also help.^14,15 Sampling before breakfast or lunch, when children are potentially at their hungriest, should also be considered.

The greatest challenge was obtaining informed consent from parents who were not yet familiar with the reliability of saliva testing as a tool for SARS-CoV-2 screening or with the saliva collection process as a whole. Informed consent was initially done electronically, lacking direct human interaction to answer parents’ questions. Parents who refused had a follow-up call from the school nurse to further explain the logistics and rationale for saliva screening. Having medical professionals directly answer parents’ questions was helpful. Parents were reassured that the process was painless, confidential, and only to be used for school safety purposes. Despite school administrators being experienced in obtaining consent from parents for field trips, obtaining informed consent for a medical testing procedure is more complicated, and parents aren’t accustomed to providing such consent in a school environment. Schools considering on-site testing should ensure that their school nurse or other health care providers are on the front line obtaining informed consent and allaying parents’ fears.

School staff were able to effectively provide crowd control for testing, and children felt at ease being in a familiar environment. Teachers and public safety officers are well-equipped at managing the shuttling of students to class, to lunch, to physical education, and, finally, to dismissal. They were equally equipped at handling the logistics of students to and from testing, including minimizing crowds and helping students feel at ease during the process. This effective collaboration allowed the lab personnel to focus on sample collection and storage, while school staff managed all other aspects of the children’s safety and care.

Conclusion

Overall, school administrators had a positive experience with the testing program, felt the program improved the safety of their schools, and supported the ongoing use of saliva testing for SARS-CoV-2 on their school campuses. Children aged 6 years and older were able to provide adequate saliva samples, and children felt happier and less nervous after the process, indicating repeatability. Our findings highlight the feasibility of an integrated on-site saliva testing model for primary school campuses. Further research is needed to determine the scalability of such a model and whether the added compliance and safety of on-site testing compensates for the potential loss of learning time that testing during school hours would require.

Corresponding author: Ayaz Virji, MD, New York University Abu Dhabi, PO Box 129188, Abu Dhabi, United Arab Emirates; av102@nyu.edu.

Financial disclosures: None.

From Health Center, New York University Abu Dhabi, Abu Dhabi, United Arab Emirates (Dr. Virji and Aisha Al Hamiz), Public Health, Abu Dhabi Public Health Center, Abu Dhabi, United Arab Emirates (Drs. Al Hajeri, Al Shehhi, Al Memari, and Ahlam Al Maskari), College of Medicine and Health Sciences, Khalifa University, Abu Dhabi, United Arab Emirates, Department of Medicine, Sheikh Shakhbout Medical City, Abu Dhabi, United Arab Emirates (Dr. Alhajri), Public Health Research Center, New York University Abu Dhabi, Abu Dhabi, United Arab Emirates, Oxford University Hospitals NHS Foundation Trust, Oxford, England, and the MRC Epidemiology Unit, University of Cambridge, Cambridge, England (Dr. Ali).

Objective: The pandemic has forced closures of primary schools, resulting in loss of learning time on a global scale. In addition to face coverings, social distancing, and hand hygiene, an efficient testing method is important to mitigate the spread of COVID-19 in schools. We evaluated the feasibility of a saliva-based SARS-CoV-2 polymerase chain reaction testing program among 18 primary schools in the Emirate of Abu Dhabi, United Arab Emirates. Qualitative results show that children 4 to 5 years old had difficulty producing an adequate saliva specimen compared to those 6 to 12 years old.

Methods: A short training video on saliva collection beforehand helps demystify the process for students and parents alike. Informed consent was challenging yet should be done beforehand by school health nurses or other medical professionals to reassure parents and maximize participation.

Results: Telephone interviews with school administrators resulted in an 83% response rate. Overall, 93% of school administrators had a positive experience with saliva testing and felt the program improved the safety of their schools. The ongoing use of saliva testing for SARS-CoV-2 was supported by 73% of respondents.

Conclusion: On-campus saliva testing is a feasible option for primary schools to screen for COVID-19 in their student population to help keep their campuses safe and open for learning.

Keywords: COVID-19; saliva testing; mitigation; primary school.

The COVID-19 pandemic is a leading cause of morbidity and mortality worldwide and continues to exhaust health care resources on a large scale.¹ Efficient testing is critical to identify cases early and to help mitigate the deleterious effects of the pandemic.² Saliva polymerase chain reaction (PCR) nucleic acid amplification testing (NAAT) is more comfortable than nasopharyngeal (NP) NAAT and has been validated as a test for SARS-CoV-2.¹ Although children are less susceptible to severe disease, primary schools are considered a vector for transmission and community spread.³ Efficient and scalable methods of routine testing are needed globally to help keep schools open. Saliva testing has proven a useful resource for this population.^4,5

Abu Dhabi is the largest Emirate in the United Arab Emirates (UAE), with an estimated population of 2.5 million.⁶ The first case of COVID-19 was discovered in the UAE on January 29, 2020.⁷ The UAE has been recognized worldwide for its robust pandemic response. Along with the coordinated and swift application of public health measures, the country has one of the highest COVID-19 testing rates per capita and one of the highest vaccination rates worldwide.^8,9 The Abu Dhabi Public Health Center (ADPHC) works alongside the Ministry of Education (MOE) to establish testing, quarantine, and general safety guidelines for primary schools. In December 2020, the ADPHC partnered with a local, accredited diagnostic laboratory to test the feasibility of a saliva-based screening program for COVID-19 directly on school campuses for 18 primary schools in the Emirate.

Saliva-based PCR testing for COVID-19 was approved for use in schools in the UAE on January 24, 2021.¹⁰ As part of a greater mitigation strategy to reduce both school-based transmission and, hence, community spread, the ADPHC focused its on-site testing program on children aged 4 to 12 years. The program required collaboration among medical professionals, school administrators and teachers, students, and parents. Our study evaluates the feasibility of implementing a saliva-based COVID-19 screening program directly on primary school campuses involving children as young as 4 years of age.

Methods

The ADPHC, in collaboration with G42 Biogenix Labs, conducted a saliva SARS-CoV-2 NAAT testing program in 18 primary schools in the Emirate. Schools were selected based on outbreak prevalence at the time and focused on “hot spot” areas. The school on-site saliva testing program included children aged 4 to 12 years old in a “bubble” attendance model during the school day. This model involved children being assigned to groups or “pods.” This allowed us to limit a potential outbreak to a single pod, as opposed to risk exposing the entire school, should a single student test positive. The well-established SalivaDirect protocol developed at Yale University was used for testing and included an RNA extraction-free, RT-qPCR method for SARS-CoV-2 detection.¹¹

We conducted a qualitative study involving telephone interviews of school administrators to evaluate their experience with the ADPHC testing program at their schools. In addition, we interviewed the G42 Biogenix Lab providers to understand the logistics that supported on-campus collection of saliva specimens for this age group. We also gathered the attitudes of school children before and after testing. This study was reviewed and approved by the Abu Dhabi Health Research and Technology Committee and the Institutional Review Board (IRB), New York University Abu Dhabi (NYUAD).

Sample and recruitment

The original sample collection of saliva specimens was performed by the ADPHC in collaboration with G42 Biogenix Lab providers on school campuses between December 6 and December 10, 2020. During this time, schools operated in a hybrid teaching model, where learning took place both online and in person. Infection control measures were deployed based on ADPHC standards and guidelines. Nurses utilized appropriate patient protective equipment, frequent hand hygiene, and social distancing during the collection process. Inclusion criteria included asymptomatic students aged 4 to 12 years attending in-person classes on campus. Students with respiratory symptoms who were asked to stay home or those not attending in-person classes were excluded.

 

 

Data collection

Data with regard to school children’s attitudes before and after testing were compiled through an online survey sent randomly to participants postintervention. Data from school administrators were collected through video and telephone interviews between April 14 and April 29, 2021. We first interviewed G42 Biogenix Lab providers to obtain previously acquired qualitative and quantitative data, which were collected during the intervention itself. After obtaining this information, we designed a questionnaire and proceeded with a structured interview process for school officials.

We interviewed school principals and administrators to collect their overall experiences with the saliva testing program. Before starting each interview, we established the interviewees preferred language, either English or Arabic. We then introduced the meeting attendees and provided study details, aims, and objectives, and described collaborating entities. We obtained verbal informed consent from a script approved by the NYUAD IRB and then proceeded with the interview, which included 4 questions. The first 3 questions were answered on a 5-point Likert scale model that consisted of 5 answer options: 5 being completely agree, 4 agree, 3 somewhat agree, 2 somewhat disagree, and 1 completely disagree. The fourth question invited open-ended feedback and comments on the following statements:

1. I believe the COVID-19 saliva testing program improved the safety for my school campus.
2. Our community had an overall positive experience with the COVID saliva testing.
3. We would like to continue a saliva-based COVID testing program on our school campus.
4. Please provide any additional comments you feel important about the program.

During the interview, we transcribed the answers as the interviewee was answering. We then translated those in Arabic into English and collected the data in 1 Excel spreadsheet. School interviewees and school names were de-identified in the collection and storage process.

Results

A total of 2011 saliva samples were collected from 18 different primary school campuses. Samples were sent the same day to G42 Biogenix Labs in Abu Dhabi for COVID PCR testing. A team consisting of 5 doctors providing general oversight, along with 2 to 6 nurses per site, were able to manage the collection process for all 18 school campuses. Samples were collected between 8 am and 2 pm and required variation among sites depending on factors such as staff availability and class schedules. Additional scheduling challenges included compliance with public safety mandates involving the maintenance of defined “safety bubbles” that forbid certain personnel from moving between floors, and the avoidance of mixing students from different classes.

Sample stations were set up in either the school auditorium or gymnasium to ensure appropriate crowd control and ventilation. Teachers and other school staff, including public safety, were able to manage lines and the shuttling of students back and forth from classes to testing stations, which allowed medical staff to focus on sample collection.

Informed consent was obtained by prior electronic communication to parents from school staff, asking them to agree to allow their child to participate in the testing program. Informed consent was identified as a challenge: Getting parents to understand that saliva testing was more comfortable than NP testing, and that the results were only being used to help keep the school safe, took time. School staff are used to obtaining consent from parents for field trips, but this was clearly more challenging for them.

The saliva collection process per child took more time than expected. Children fasted for 45 minutes before saliva collection. We used an active drool technique, which required children to pool saliva in their mouth then express it into a collection tube. Adults can generally do this on command, but we found it took 10 to 12 minutes per child. Saliva production was cued by asking the children to think about food, and by showing them pictures and TV commercials depicting food. Children 4 to 5 years old had more difficulty with the process despite active cueing, while those 6 to 12 years old had an easier time with the process. We collected data on a cohort of 80 children regarding their attitudes pre (Figure 1) and post collection (Figure 2). Children felt happier, less nervous, and less scared after collection than before collection. This trend reassured us that future collections would be easier for students.

A total of 15 of 18 school principals completed the telephone interview, yielding a response rate of 83%. Overall, 93% of the school principals agreed or completely agreed that the COVID-19 saliva testing program improved school safety; 93% agreed or completely agreed that they had an overall positive experience with the program; and 73% supported the ongoing use of saliva testing in their schools (Table 1). Administrators’ open-ended comments on their experience were positive overall (Table 2).

Discussion

By March 2020, many kindergarten to grade 12 public and private schools suspended in-person classes due to the pandemic and turned to online learning platforms. The negative impact of school closures on academic achievement is projected to be significant.^7,12,13 Ensuring schools can stay open and run operations safely will require routine SARS-CoV-2 testing. Our study investigated the feasibility of routine saliva testing on children aged 4 to 12 years on their school campuses. The ADPHC school on-site saliva testing program involved bringing lab providers onto 18 primary school campuses and required cooperation among parents, students, school administrators, and health care professionals.

Children younger than 6 years had difficulty producing an adequate saliva specimen, whereas those 6 to 12 years did so with relative ease when cued by thoughts or pictures of food while waiting in line for collection. Schools considering on-site testing programs should consider the age range of 6 to 12 years as a viable age range for saliva screening. Children should fast for a minimum of 45 minutes prior to saliva collection and should be cued by thoughts of food, food pictures, or food commercials. Setting up a sampling station close to the cafeteria where students can smell meal preparation may also help.^14,15 Sampling before breakfast or lunch, when children are potentially at their hungriest, should also be considered.

The greatest challenge was obtaining informed consent from parents who were not yet familiar with the reliability of saliva testing as a tool for SARS-CoV-2 screening or with the saliva collection process as a whole. Informed consent was initially done electronically, lacking direct human interaction to answer parents’ questions. Parents who refused had a follow-up call from the school nurse to further explain the logistics and rationale for saliva screening. Having medical professionals directly answer parents’ questions was helpful. Parents were reassured that the process was painless, confidential, and only to be used for school safety purposes. Despite school administrators being experienced in obtaining consent from parents for field trips, obtaining informed consent for a medical testing procedure is more complicated, and parents aren’t accustomed to providing such consent in a school environment. Schools considering on-site testing should ensure that their school nurse or other health care providers are on the front line obtaining informed consent and allaying parents’ fears.

School staff were able to effectively provide crowd control for testing, and children felt at ease being in a familiar environment. Teachers and public safety officers are well-equipped at managing the shuttling of students to class, to lunch, to physical education, and, finally, to dismissal. They were equally equipped at handling the logistics of students to and from testing, including minimizing crowds and helping students feel at ease during the process. This effective collaboration allowed the lab personnel to focus on sample collection and storage, while school staff managed all other aspects of the children’s safety and care.

Conclusion

Overall, school administrators had a positive experience with the testing program, felt the program improved the safety of their schools, and supported the ongoing use of saliva testing for SARS-CoV-2 on their school campuses. Children aged 6 years and older were able to provide adequate saliva samples, and children felt happier and less nervous after the process, indicating repeatability. Our findings highlight the feasibility of an integrated on-site saliva testing model for primary school campuses. Further research is needed to determine the scalability of such a model and whether the added compliance and safety of on-site testing compensates for the potential loss of learning time that testing during school hours would require.

Corresponding author: Ayaz Virji, MD, New York University Abu Dhabi, PO Box 129188, Abu Dhabi, United Arab Emirates; av102@nyu.edu.

Financial disclosures: None.

From Health Center, New York University Abu Dhabi, Abu Dhabi, United Arab Emirates (Dr. Virji and Aisha Al Hamiz), Public Health, Abu Dhabi Public Health Center, Abu Dhabi, United Arab Emirates (Drs. Al Hajeri, Al Shehhi, Al Memari, and Ahlam Al Maskari), College of Medicine and Health Sciences, Khalifa University, Abu Dhabi, United Arab Emirates, Department of Medicine, Sheikh Shakhbout Medical City, Abu Dhabi, United Arab Emirates (Dr. Alhajri), Public Health Research Center, New York University Abu Dhabi, Abu Dhabi, United Arab Emirates, Oxford University Hospitals NHS Foundation Trust, Oxford, England, and the MRC Epidemiology Unit, University of Cambridge, Cambridge, England (Dr. Ali).

Objective: The pandemic has forced closures of primary schools, resulting in loss of learning time on a global scale. In addition to face coverings, social distancing, and hand hygiene, an efficient testing method is important to mitigate the spread of COVID-19 in schools. We evaluated the feasibility of a saliva-based SARS-CoV-2 polymerase chain reaction testing program among 18 primary schools in the Emirate of Abu Dhabi, United Arab Emirates. Qualitative results show that children 4 to 5 years old had difficulty producing an adequate saliva specimen compared to those 6 to 12 years old.

Methods: A short training video on saliva collection beforehand helps demystify the process for students and parents alike. Informed consent was challenging yet should be done beforehand by school health nurses or other medical professionals to reassure parents and maximize participation.

Results: Telephone interviews with school administrators resulted in an 83% response rate. Overall, 93% of school administrators had a positive experience with saliva testing and felt the program improved the safety of their schools. The ongoing use of saliva testing for SARS-CoV-2 was supported by 73% of respondents.

Conclusion: On-campus saliva testing is a feasible option for primary schools to screen for COVID-19 in their student population to help keep their campuses safe and open for learning.

Keywords: COVID-19; saliva testing; mitigation; primary school.

The COVID-19 pandemic is a leading cause of morbidity and mortality worldwide and continues to exhaust health care resources on a large scale.¹ Efficient testing is critical to identify cases early and to help mitigate the deleterious effects of the pandemic.² Saliva polymerase chain reaction (PCR) nucleic acid amplification testing (NAAT) is more comfortable than nasopharyngeal (NP) NAAT and has been validated as a test for SARS-CoV-2.¹ Although children are less susceptible to severe disease, primary schools are considered a vector for transmission and community spread.³ Efficient and scalable methods of routine testing are needed globally to help keep schools open. Saliva testing has proven a useful resource for this population.^4,5

Abu Dhabi is the largest Emirate in the United Arab Emirates (UAE), with an estimated population of 2.5 million.⁶ The first case of COVID-19 was discovered in the UAE on January 29, 2020.⁷ The UAE has been recognized worldwide for its robust pandemic response. Along with the coordinated and swift application of public health measures, the country has one of the highest COVID-19 testing rates per capita and one of the highest vaccination rates worldwide.^8,9 The Abu Dhabi Public Health Center (ADPHC) works alongside the Ministry of Education (MOE) to establish testing, quarantine, and general safety guidelines for primary schools. In December 2020, the ADPHC partnered with a local, accredited diagnostic laboratory to test the feasibility of a saliva-based screening program for COVID-19 directly on school campuses for 18 primary schools in the Emirate.

Saliva-based PCR testing for COVID-19 was approved for use in schools in the UAE on January 24, 2021.¹⁰ As part of a greater mitigation strategy to reduce both school-based transmission and, hence, community spread, the ADPHC focused its on-site testing program on children aged 4 to 12 years. The program required collaboration among medical professionals, school administrators and teachers, students, and parents. Our study evaluates the feasibility of implementing a saliva-based COVID-19 screening program directly on primary school campuses involving children as young as 4 years of age.

Methods

The ADPHC, in collaboration with G42 Biogenix Labs, conducted a saliva SARS-CoV-2 NAAT testing program in 18 primary schools in the Emirate. Schools were selected based on outbreak prevalence at the time and focused on “hot spot” areas. The school on-site saliva testing program included children aged 4 to 12 years old in a “bubble” attendance model during the school day. This model involved children being assigned to groups or “pods.” This allowed us to limit a potential outbreak to a single pod, as opposed to risk exposing the entire school, should a single student test positive. The well-established SalivaDirect protocol developed at Yale University was used for testing and included an RNA extraction-free, RT-qPCR method for SARS-CoV-2 detection.¹¹

We conducted a qualitative study involving telephone interviews of school administrators to evaluate their experience with the ADPHC testing program at their schools. In addition, we interviewed the G42 Biogenix Lab providers to understand the logistics that supported on-campus collection of saliva specimens for this age group. We also gathered the attitudes of school children before and after testing. This study was reviewed and approved by the Abu Dhabi Health Research and Technology Committee and the Institutional Review Board (IRB), New York University Abu Dhabi (NYUAD).

Sample and recruitment

The original sample collection of saliva specimens was performed by the ADPHC in collaboration with G42 Biogenix Lab providers on school campuses between December 6 and December 10, 2020. During this time, schools operated in a hybrid teaching model, where learning took place both online and in person. Infection control measures were deployed based on ADPHC standards and guidelines. Nurses utilized appropriate patient protective equipment, frequent hand hygiene, and social distancing during the collection process. Inclusion criteria included asymptomatic students aged 4 to 12 years attending in-person classes on campus. Students with respiratory symptoms who were asked to stay home or those not attending in-person classes were excluded.

 

 

Data collection

Data with regard to school children’s attitudes before and after testing were compiled through an online survey sent randomly to participants postintervention. Data from school administrators were collected through video and telephone interviews between April 14 and April 29, 2021. We first interviewed G42 Biogenix Lab providers to obtain previously acquired qualitative and quantitative data, which were collected during the intervention itself. After obtaining this information, we designed a questionnaire and proceeded with a structured interview process for school officials.

We interviewed school principals and administrators to collect their overall experiences with the saliva testing program. Before starting each interview, we established the interviewees preferred language, either English or Arabic. We then introduced the meeting attendees and provided study details, aims, and objectives, and described collaborating entities. We obtained verbal informed consent from a script approved by the NYUAD IRB and then proceeded with the interview, which included 4 questions. The first 3 questions were answered on a 5-point Likert scale model that consisted of 5 answer options: 5 being completely agree, 4 agree, 3 somewhat agree, 2 somewhat disagree, and 1 completely disagree. The fourth question invited open-ended feedback and comments on the following statements:

1. I believe the COVID-19 saliva testing program improved the safety for my school campus.
2. Our community had an overall positive experience with the COVID saliva testing.
3. We would like to continue a saliva-based COVID testing program on our school campus.
4. Please provide any additional comments you feel important about the program.

During the interview, we transcribed the answers as the interviewee was answering. We then translated those in Arabic into English and collected the data in 1 Excel spreadsheet. School interviewees and school names were de-identified in the collection and storage process.

Results

A total of 2011 saliva samples were collected from 18 different primary school campuses. Samples were sent the same day to G42 Biogenix Labs in Abu Dhabi for COVID PCR testing. A team consisting of 5 doctors providing general oversight, along with 2 to 6 nurses per site, were able to manage the collection process for all 18 school campuses. Samples were collected between 8 am and 2 pm and required variation among sites depending on factors such as staff availability and class schedules. Additional scheduling challenges included compliance with public safety mandates involving the maintenance of defined “safety bubbles” that forbid certain personnel from moving between floors, and the avoidance of mixing students from different classes.

Sample stations were set up in either the school auditorium or gymnasium to ensure appropriate crowd control and ventilation. Teachers and other school staff, including public safety, were able to manage lines and the shuttling of students back and forth from classes to testing stations, which allowed medical staff to focus on sample collection.

Informed consent was obtained by prior electronic communication to parents from school staff, asking them to agree to allow their child to participate in the testing program. Informed consent was identified as a challenge: Getting parents to understand that saliva testing was more comfortable than NP testing, and that the results were only being used to help keep the school safe, took time. School staff are used to obtaining consent from parents for field trips, but this was clearly more challenging for them.

The saliva collection process per child took more time than expected. Children fasted for 45 minutes before saliva collection. We used an active drool technique, which required children to pool saliva in their mouth then express it into a collection tube. Adults can generally do this on command, but we found it took 10 to 12 minutes per child. Saliva production was cued by asking the children to think about food, and by showing them pictures and TV commercials depicting food. Children 4 to 5 years old had more difficulty with the process despite active cueing, while those 6 to 12 years old had an easier time with the process. We collected data on a cohort of 80 children regarding their attitudes pre (Figure 1) and post collection (Figure 2). Children felt happier, less nervous, and less scared after collection than before collection. This trend reassured us that future collections would be easier for students.

A total of 15 of 18 school principals completed the telephone interview, yielding a response rate of 83%. Overall, 93% of the school principals agreed or completely agreed that the COVID-19 saliva testing program improved school safety; 93% agreed or completely agreed that they had an overall positive experience with the program; and 73% supported the ongoing use of saliva testing in their schools (Table 1). Administrators’ open-ended comments on their experience were positive overall (Table 2).

Discussion

By March 2020, many kindergarten to grade 12 public and private schools suspended in-person classes due to the pandemic and turned to online learning platforms. The negative impact of school closures on academic achievement is projected to be significant.^7,12,13 Ensuring schools can stay open and run operations safely will require routine SARS-CoV-2 testing. Our study investigated the feasibility of routine saliva testing on children aged 4 to 12 years on their school campuses. The ADPHC school on-site saliva testing program involved bringing lab providers onto 18 primary school campuses and required cooperation among parents, students, school administrators, and health care professionals.

Children younger than 6 years had difficulty producing an adequate saliva specimen, whereas those 6 to 12 years did so with relative ease when cued by thoughts or pictures of food while waiting in line for collection. Schools considering on-site testing programs should consider the age range of 6 to 12 years as a viable age range for saliva screening. Children should fast for a minimum of 45 minutes prior to saliva collection and should be cued by thoughts of food, food pictures, or food commercials. Setting up a sampling station close to the cafeteria where students can smell meal preparation may also help.^14,15 Sampling before breakfast or lunch, when children are potentially at their hungriest, should also be considered.

The greatest challenge was obtaining informed consent from parents who were not yet familiar with the reliability of saliva testing as a tool for SARS-CoV-2 screening or with the saliva collection process as a whole. Informed consent was initially done electronically, lacking direct human interaction to answer parents’ questions. Parents who refused had a follow-up call from the school nurse to further explain the logistics and rationale for saliva screening. Having medical professionals directly answer parents’ questions was helpful. Parents were reassured that the process was painless, confidential, and only to be used for school safety purposes. Despite school administrators being experienced in obtaining consent from parents for field trips, obtaining informed consent for a medical testing procedure is more complicated, and parents aren’t accustomed to providing such consent in a school environment. Schools considering on-site testing should ensure that their school nurse or other health care providers are on the front line obtaining informed consent and allaying parents’ fears.

School staff were able to effectively provide crowd control for testing, and children felt at ease being in a familiar environment. Teachers and public safety officers are well-equipped at managing the shuttling of students to class, to lunch, to physical education, and, finally, to dismissal. They were equally equipped at handling the logistics of students to and from testing, including minimizing crowds and helping students feel at ease during the process. This effective collaboration allowed the lab personnel to focus on sample collection and storage, while school staff managed all other aspects of the children’s safety and care.

Conclusion

Overall, school administrators had a positive experience with the testing program, felt the program improved the safety of their schools, and supported the ongoing use of saliva testing for SARS-CoV-2 on their school campuses. Children aged 6 years and older were able to provide adequate saliva samples, and children felt happier and less nervous after the process, indicating repeatability. Our findings highlight the feasibility of an integrated on-site saliva testing model for primary school campuses. Further research is needed to determine the scalability of such a model and whether the added compliance and safety of on-site testing compensates for the potential loss of learning time that testing during school hours would require.

Corresponding author: Ayaz Virji, MD, New York University Abu Dhabi, PO Box 129188, Abu Dhabi, United Arab Emirates; av102@nyu.edu.

Financial disclosures: None.

Every day, more than 140,000 people in the United States are diagnosed with COVID-19. But no matter how curious they are about which variant they are fighting, none of them will find out.

Courtesy of Twitter

The country is dotted with labs that sequence the genomes of COVID-19 cases, and the Centers for Disease Control and Prevention tracks those results. But federal rules say those results are not allowed to make their way back to patients or doctors.

According to public health and infectious disease experts, this is unlikely to change any time soon.

“I know people want to know – I’ve had a lot of friends or family who’ve asked me how they can find out,” says Aubree Gordon, PhD, an epidemiology specialist at the University of Michigan, Ann Arbor. “I think it’s an interesting thing to find out, for sure. And it would certainly be nice to know. But because it probably isn’t necessary, there is little motivation to change the rules.”

Because the tests that are used have not been approved as diagnostic tools under the Clinical Laboratory Improvement Amendments program, which is overseen by the Centers for Medicare & Medicaid Services, they can only be used for research purposes.

In fact, the scientists doing the sequencing rarely have any patient information, Dr. Gordon says. For example, the Lauring Lab at University of Michigan – run by Adam Lauring, MD – focuses on viral evolution and currently tests for variants. But this is not done for the sake of the patient or the doctors treating the patient.

“The samples come in ... and they’ve been de-identified,”Dr. Gordon says. “This is just for research purposes. Not much patient information is shared with the researchers.”

But as of now, aside from sheer curiosity, there is not a reason to change this, says Timothy Brewer, MD, a professor of medicine and epidemiology at University of California, Los Angeles.

Although there are emerging variants – including the new Mu variant, also known as B.1.621 and recently classified as a “variant of interest” – the Delta variant accounts for about 99% of U.S. cases.

In addition, Dr. Brewer says, treatments are the same for all COVID-19 patients, regardless of the variant.

“There would have to be some clinical significance for there to be a good reason to give this information,” he says. “That would mean we would be doing something different treatment-wise depending on the variant. As of now, that is not the case.”

There is a loophole that allows labs to release variant information: They can develop their own tests. But they then must go through a lengthy validation process that proves their tests are as effective as the gold standard, says Mark Pandori, PhD, director of the Nevada State Public Health Laboratory.

But even with validation, it is too time-consuming and costly to sequence large numbers of cases, he says.

“The reason we’re not doing it routinely is there’s no way to do the genomic analysis on all the positives,” Dr. Pandori says. “It is about $110 dollars to do a sequence. It’s not like a standard PCR test.”

There is a hypothetical situation that may warrant the release of these results, Dr. Brewer says: If a variant emerges that evades vaccines.

“That would be a real public health issue,” he says. “You want to make sure there aren’t variants emerging somewhere that are escaping immunity.”

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

Every day, more than 140,000 people in the United States are diagnosed with COVID-19. But no matter how curious they are about which variant they are fighting, none of them will find out.

Courtesy of Twitter

The country is dotted with labs that sequence the genomes of COVID-19 cases, and the Centers for Disease Control and Prevention tracks those results. But federal rules say those results are not allowed to make their way back to patients or doctors.

According to public health and infectious disease experts, this is unlikely to change any time soon.

“I know people want to know – I’ve had a lot of friends or family who’ve asked me how they can find out,” says Aubree Gordon, PhD, an epidemiology specialist at the University of Michigan, Ann Arbor. “I think it’s an interesting thing to find out, for sure. And it would certainly be nice to know. But because it probably isn’t necessary, there is little motivation to change the rules.”

Because the tests that are used have not been approved as diagnostic tools under the Clinical Laboratory Improvement Amendments program, which is overseen by the Centers for Medicare & Medicaid Services, they can only be used for research purposes.

In fact, the scientists doing the sequencing rarely have any patient information, Dr. Gordon says. For example, the Lauring Lab at University of Michigan – run by Adam Lauring, MD – focuses on viral evolution and currently tests for variants. But this is not done for the sake of the patient or the doctors treating the patient.

“The samples come in ... and they’ve been de-identified,”Dr. Gordon says. “This is just for research purposes. Not much patient information is shared with the researchers.”

But as of now, aside from sheer curiosity, there is not a reason to change this, says Timothy Brewer, MD, a professor of medicine and epidemiology at University of California, Los Angeles.

Although there are emerging variants – including the new Mu variant, also known as B.1.621 and recently classified as a “variant of interest” – the Delta variant accounts for about 99% of U.S. cases.

In addition, Dr. Brewer says, treatments are the same for all COVID-19 patients, regardless of the variant.

“There would have to be some clinical significance for there to be a good reason to give this information,” he says. “That would mean we would be doing something different treatment-wise depending on the variant. As of now, that is not the case.”

There is a loophole that allows labs to release variant information: They can develop their own tests. But they then must go through a lengthy validation process that proves their tests are as effective as the gold standard, says Mark Pandori, PhD, director of the Nevada State Public Health Laboratory.

But even with validation, it is too time-consuming and costly to sequence large numbers of cases, he says.

“The reason we’re not doing it routinely is there’s no way to do the genomic analysis on all the positives,” Dr. Pandori says. “It is about $110 dollars to do a sequence. It’s not like a standard PCR test.”

There is a hypothetical situation that may warrant the release of these results, Dr. Brewer says: If a variant emerges that evades vaccines.

“That would be a real public health issue,” he says. “You want to make sure there aren’t variants emerging somewhere that are escaping immunity.”

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

Every day, more than 140,000 people in the United States are diagnosed with COVID-19. But no matter how curious they are about which variant they are fighting, none of them will find out.

Courtesy of Twitter

The country is dotted with labs that sequence the genomes of COVID-19 cases, and the Centers for Disease Control and Prevention tracks those results. But federal rules say those results are not allowed to make their way back to patients or doctors.

According to public health and infectious disease experts, this is unlikely to change any time soon.

“I know people want to know – I’ve had a lot of friends or family who’ve asked me how they can find out,” says Aubree Gordon, PhD, an epidemiology specialist at the University of Michigan, Ann Arbor. “I think it’s an interesting thing to find out, for sure. And it would certainly be nice to know. But because it probably isn’t necessary, there is little motivation to change the rules.”

Because the tests that are used have not been approved as diagnostic tools under the Clinical Laboratory Improvement Amendments program, which is overseen by the Centers for Medicare & Medicaid Services, they can only be used for research purposes.

In fact, the scientists doing the sequencing rarely have any patient information, Dr. Gordon says. For example, the Lauring Lab at University of Michigan – run by Adam Lauring, MD – focuses on viral evolution and currently tests for variants. But this is not done for the sake of the patient or the doctors treating the patient.

“The samples come in ... and they’ve been de-identified,”Dr. Gordon says. “This is just for research purposes. Not much patient information is shared with the researchers.”

But as of now, aside from sheer curiosity, there is not a reason to change this, says Timothy Brewer, MD, a professor of medicine and epidemiology at University of California, Los Angeles.

Although there are emerging variants – including the new Mu variant, also known as B.1.621 and recently classified as a “variant of interest” – the Delta variant accounts for about 99% of U.S. cases.

In addition, Dr. Brewer says, treatments are the same for all COVID-19 patients, regardless of the variant.

“There would have to be some clinical significance for there to be a good reason to give this information,” he says. “That would mean we would be doing something different treatment-wise depending on the variant. As of now, that is not the case.”

There is a loophole that allows labs to release variant information: They can develop their own tests. But they then must go through a lengthy validation process that proves their tests are as effective as the gold standard, says Mark Pandori, PhD, director of the Nevada State Public Health Laboratory.

But even with validation, it is too time-consuming and costly to sequence large numbers of cases, he says.

“The reason we’re not doing it routinely is there’s no way to do the genomic analysis on all the positives,” Dr. Pandori says. “It is about $110 dollars to do a sequence. It’s not like a standard PCR test.”

There is a hypothetical situation that may warrant the release of these results, Dr. Brewer says: If a variant emerges that evades vaccines.

“That would be a real public health issue,” he says. “You want to make sure there aren’t variants emerging somewhere that are escaping immunity.”

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

The White House has filled in more details of its newly announced plans to blunt the impact of COVID-19 in the United States.

The emergency rule ordering large employers to require COVID-19 vaccines or weekly tests for their workers could be ready “within weeks,” officials said in a news briefing Sept. 10.

Labor Secretary Martin Walsh will oversee the Occupational Safety and Health Administration as the agency drafts what’s known as an emergency temporary standard, similar to the one that was issued a few months ago to protect health care workers during the pandemic.

The rule should be ready within weeks, said Jeff Zients, coordinator of the White House COVID-19 response team.

He said the ultimate goal of the president’s plan is to increase vaccinations as quickly as possible to keep schools open, the economy recovering, and to decrease hospitalizations and deaths from COVID.

Mr. Zients declined to set hard numbers around those goals, but other experts did.

“What we need to get to is 85% to 90% population immunity, and that’s going to be immunity both from vaccines and infections, before that really begins to have a substantial dampening effect on viral spread,” Ashish Jha, MD, dean of the Brown University School of Public Health, Providence, R.I., said on a call with reporters Sept. 9.

He said immunity needs to be that high because the Delta variant is so contagious.

Mandates are seen as the most effective way to increase immunity and do it quickly.

David Michaels, PhD, an epidemiologist and professor at George Washington University, Washington, says OSHA will have to work through a number of steps to develop the rule.

“OSHA will have to write a preamble explaining the standard, its justifications, its costs, and how it will be enforced,” says Dr. Michaels, who led OSHA for the Obama administration. After that, the rule will be reviewed by the White House. Then employers will have some time – typically 30 days – to comply.

In addition to drafting the standard, OSHA will oversee its enforcement.

Companies that refuse to follow the standard could be fined $13,600 per violation, Mr. Zients said.

Dr. Michaels said he doesn’t expect enforcement to be a big issue, and he said we’re likely to see the rule well before it is final.

“Most employers are law-abiding. When OSHA issues a standard, they try to meet whatever those requirements are, and generally that starts to happen when the rule is announced, even before it goes into effect,” he said.

The rule may face legal challenges as well. Several governors and state attorneys general, as well as the Republican National Committee, have promised lawsuits to stop the vaccine mandates.

Critics of the new mandates say they impinge on personal freedom and impose burdens on businesses.

But the president hit back at that notion Sept. 10.

“Look, I am so disappointed that, particularly some of the Republican governors, have been so cavalier with the health of these kids, so cavalier of the health of their communities,” President Biden told reporters.

“I don’t know of any scientist out there in this field who doesn’t think it makes considerable sense to do the six things I’ve suggested.”

Yet, others feel the new requirements didn’t go far enough.

“These are good steps in the right direction, but they’re not enough to get the job done,” said Leana Wen, MD, in an op-ed for The Washington Post.

Dr. Wen, an expert in public health, wondered why President Biden didn’t mandate vaccinations for plane and train travel. She was disappointed that children 12 and older weren’t required to be vaccinated, too.

“There are mandates for childhood immunizations in every state. The coronavirus vaccine should be no different,” she wrote.

Vaccines remain the cornerstone of U.S. plans to control the pandemic.

On Sept. 10, there was new research from the CDC and state health departments showing that the COVID-19 vaccines continue to be highly effective at preventing severe illness and death.

But the study also found that the vaccines became less effective in the United States after Delta became the dominant cause of infections here.

The study, which included more than 600,000 COVID-19 cases, analyzed breakthrough infections – cases where people got sick despite being fully vaccinated – in 13 jurisdictions in the United States between April 4 and July 17, 2021.

Epidemiologists compared breakthrough infections between two distinct points in time: Before and after the period when the Delta variant began causing most infections.

From April 4 to June 19, fully vaccinated people made up just 5% of cases, 7% of hospitalizations, and 8% of deaths. From June 20 to July 17, 18% of cases, 14% of hospitalizations, and 16% of deaths occurred in fully vaccinated people.

“After the week of June 20, 2021, when the SARS-CoV-2 Delta variant became predominant, the percentage of fully vaccinated persons among cases increased more than expected,” the study authors wrote.

Even after Delta swept the United States, fully vaccinated people were 5 times less likely to get a COVID-19 infection and more than 10 times less likely to be hospitalized or die from one.

“As we have shown in study after study, vaccination works,” CDC Director Rochelle Walensky, MD, said during the White House news briefing.

“We have the scientific tools we need to turn the corner on this pandemic. Vaccination works and will protect us from the severe complications of COVID-19,” she said.

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

The White House has filled in more details of its newly announced plans to blunt the impact of COVID-19 in the United States.

The emergency rule ordering large employers to require COVID-19 vaccines or weekly tests for their workers could be ready “within weeks,” officials said in a news briefing Sept. 10.

Labor Secretary Martin Walsh will oversee the Occupational Safety and Health Administration as the agency drafts what’s known as an emergency temporary standard, similar to the one that was issued a few months ago to protect health care workers during the pandemic.

The rule should be ready within weeks, said Jeff Zients, coordinator of the White House COVID-19 response team.

He said the ultimate goal of the president’s plan is to increase vaccinations as quickly as possible to keep schools open, the economy recovering, and to decrease hospitalizations and deaths from COVID.

Mr. Zients declined to set hard numbers around those goals, but other experts did.

“What we need to get to is 85% to 90% population immunity, and that’s going to be immunity both from vaccines and infections, before that really begins to have a substantial dampening effect on viral spread,” Ashish Jha, MD, dean of the Brown University School of Public Health, Providence, R.I., said on a call with reporters Sept. 9.

He said immunity needs to be that high because the Delta variant is so contagious.

Mandates are seen as the most effective way to increase immunity and do it quickly.

David Michaels, PhD, an epidemiologist and professor at George Washington University, Washington, says OSHA will have to work through a number of steps to develop the rule.

“OSHA will have to write a preamble explaining the standard, its justifications, its costs, and how it will be enforced,” says Dr. Michaels, who led OSHA for the Obama administration. After that, the rule will be reviewed by the White House. Then employers will have some time – typically 30 days – to comply.

In addition to drafting the standard, OSHA will oversee its enforcement.

Companies that refuse to follow the standard could be fined $13,600 per violation, Mr. Zients said.

Dr. Michaels said he doesn’t expect enforcement to be a big issue, and he said we’re likely to see the rule well before it is final.

“Most employers are law-abiding. When OSHA issues a standard, they try to meet whatever those requirements are, and generally that starts to happen when the rule is announced, even before it goes into effect,” he said.

The rule may face legal challenges as well. Several governors and state attorneys general, as well as the Republican National Committee, have promised lawsuits to stop the vaccine mandates.

Critics of the new mandates say they impinge on personal freedom and impose burdens on businesses.

But the president hit back at that notion Sept. 10.

“Look, I am so disappointed that, particularly some of the Republican governors, have been so cavalier with the health of these kids, so cavalier of the health of their communities,” President Biden told reporters.

“I don’t know of any scientist out there in this field who doesn’t think it makes considerable sense to do the six things I’ve suggested.”

Yet, others feel the new requirements didn’t go far enough.

“These are good steps in the right direction, but they’re not enough to get the job done,” said Leana Wen, MD, in an op-ed for The Washington Post.

Dr. Wen, an expert in public health, wondered why President Biden didn’t mandate vaccinations for plane and train travel. She was disappointed that children 12 and older weren’t required to be vaccinated, too.

“There are mandates for childhood immunizations in every state. The coronavirus vaccine should be no different,” she wrote.

Vaccines remain the cornerstone of U.S. plans to control the pandemic.

On Sept. 10, there was new research from the CDC and state health departments showing that the COVID-19 vaccines continue to be highly effective at preventing severe illness and death.

But the study also found that the vaccines became less effective in the United States after Delta became the dominant cause of infections here.

The study, which included more than 600,000 COVID-19 cases, analyzed breakthrough infections – cases where people got sick despite being fully vaccinated – in 13 jurisdictions in the United States between April 4 and July 17, 2021.

Epidemiologists compared breakthrough infections between two distinct points in time: Before and after the period when the Delta variant began causing most infections.

From April 4 to June 19, fully vaccinated people made up just 5% of cases, 7% of hospitalizations, and 8% of deaths. From June 20 to July 17, 18% of cases, 14% of hospitalizations, and 16% of deaths occurred in fully vaccinated people.

“After the week of June 20, 2021, when the SARS-CoV-2 Delta variant became predominant, the percentage of fully vaccinated persons among cases increased more than expected,” the study authors wrote.

Even after Delta swept the United States, fully vaccinated people were 5 times less likely to get a COVID-19 infection and more than 10 times less likely to be hospitalized or die from one.

“As we have shown in study after study, vaccination works,” CDC Director Rochelle Walensky, MD, said during the White House news briefing.

“We have the scientific tools we need to turn the corner on this pandemic. Vaccination works and will protect us from the severe complications of COVID-19,” she said.

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

The White House has filled in more details of its newly announced plans to blunt the impact of COVID-19 in the United States.

The emergency rule ordering large employers to require COVID-19 vaccines or weekly tests for their workers could be ready “within weeks,” officials said in a news briefing Sept. 10.

Labor Secretary Martin Walsh will oversee the Occupational Safety and Health Administration as the agency drafts what’s known as an emergency temporary standard, similar to the one that was issued a few months ago to protect health care workers during the pandemic.

The rule should be ready within weeks, said Jeff Zients, coordinator of the White House COVID-19 response team.

He said the ultimate goal of the president’s plan is to increase vaccinations as quickly as possible to keep schools open, the economy recovering, and to decrease hospitalizations and deaths from COVID.

Mr. Zients declined to set hard numbers around those goals, but other experts did.

“What we need to get to is 85% to 90% population immunity, and that’s going to be immunity both from vaccines and infections, before that really begins to have a substantial dampening effect on viral spread,” Ashish Jha, MD, dean of the Brown University School of Public Health, Providence, R.I., said on a call with reporters Sept. 9.

He said immunity needs to be that high because the Delta variant is so contagious.

Mandates are seen as the most effective way to increase immunity and do it quickly.

David Michaels, PhD, an epidemiologist and professor at George Washington University, Washington, says OSHA will have to work through a number of steps to develop the rule.

“OSHA will have to write a preamble explaining the standard, its justifications, its costs, and how it will be enforced,” says Dr. Michaels, who led OSHA for the Obama administration. After that, the rule will be reviewed by the White House. Then employers will have some time – typically 30 days – to comply.

In addition to drafting the standard, OSHA will oversee its enforcement.

Companies that refuse to follow the standard could be fined $13,600 per violation, Mr. Zients said.

Dr. Michaels said he doesn’t expect enforcement to be a big issue, and he said we’re likely to see the rule well before it is final.

“Most employers are law-abiding. When OSHA issues a standard, they try to meet whatever those requirements are, and generally that starts to happen when the rule is announced, even before it goes into effect,” he said.

The rule may face legal challenges as well. Several governors and state attorneys general, as well as the Republican National Committee, have promised lawsuits to stop the vaccine mandates.

Critics of the new mandates say they impinge on personal freedom and impose burdens on businesses.

But the president hit back at that notion Sept. 10.

“Look, I am so disappointed that, particularly some of the Republican governors, have been so cavalier with the health of these kids, so cavalier of the health of their communities,” President Biden told reporters.

“I don’t know of any scientist out there in this field who doesn’t think it makes considerable sense to do the six things I’ve suggested.”

Yet, others feel the new requirements didn’t go far enough.

“These are good steps in the right direction, but they’re not enough to get the job done,” said Leana Wen, MD, in an op-ed for The Washington Post.

Dr. Wen, an expert in public health, wondered why President Biden didn’t mandate vaccinations for plane and train travel. She was disappointed that children 12 and older weren’t required to be vaccinated, too.

“There are mandates for childhood immunizations in every state. The coronavirus vaccine should be no different,” she wrote.

Vaccines remain the cornerstone of U.S. plans to control the pandemic.

On Sept. 10, there was new research from the CDC and state health departments showing that the COVID-19 vaccines continue to be highly effective at preventing severe illness and death.

But the study also found that the vaccines became less effective in the United States after Delta became the dominant cause of infections here.

The study, which included more than 600,000 COVID-19 cases, analyzed breakthrough infections – cases where people got sick despite being fully vaccinated – in 13 jurisdictions in the United States between April 4 and July 17, 2021.

Epidemiologists compared breakthrough infections between two distinct points in time: Before and after the period when the Delta variant began causing most infections.

From April 4 to June 19, fully vaccinated people made up just 5% of cases, 7% of hospitalizations, and 8% of deaths. From June 20 to July 17, 18% of cases, 14% of hospitalizations, and 16% of deaths occurred in fully vaccinated people.

“After the week of June 20, 2021, when the SARS-CoV-2 Delta variant became predominant, the percentage of fully vaccinated persons among cases increased more than expected,” the study authors wrote.

Even after Delta swept the United States, fully vaccinated people were 5 times less likely to get a COVID-19 infection and more than 10 times less likely to be hospitalized or die from one.

“As we have shown in study after study, vaccination works,” CDC Director Rochelle Walensky, MD, said during the White House news briefing.

“We have the scientific tools we need to turn the corner on this pandemic. Vaccination works and will protect us from the severe complications of COVID-19,” she said.

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

Several weeks ago, I received a call from my brother who, though not a health care professional, wanted me to know he thought the public was being too critical of scientists and physicians who “are giving us the best advice they can about COVID. People think they should have all the answers. But this virus is complicated, and they don’t always know what is going to happen next.” What makes his charitable read of the public health situation remarkable is that he is a COVID-19 survivor of one of the first reported cases of Guillain-Barre syndrome, which several expert neurologists believe is the result of COVID-19. Like so many other COVID-19 long-haul patients, he is left with lingering symptoms and residual deficits.¹

I use this personal story as the overture to this piece on why I am changing my opinion regarding a COVID-19 mandate for federal practitioners. In June I raised ethical concerns about compelling vaccination especially for service members of color based on a current and historical climate of mistrust and discrimination in health care that compulsory vaccination could exacerbate.² Instead, I followed the lead of Secretary of Defense J. Lloyd Austin III and advocated continued education and encouragement for vaccine-hesitant troops.³ So in 2 months what has so radically changed to lead Secretary Austin and US Department of Veterans Affairs (VA) Secretary Denis R. McDonough to mandate vaccination for their workforce?^4,5

I am calling the change the Delta Factor. This is not to be confused with the spy-thrillers that ironically involved rescuing a scientist! The Delta Factor is a catch-all phrase to cover the protean public health impacts of the devastating COVID-19 Delta variant now ravaging the country. Depending on the area of the country as of mid-August, the Centers for Disease Control and Prevention (CDC) estimated that 80% to > 90% of new cases were the Delta variant.⁶ An increasing number of these cases sadly are in children.⁷

According to the CDC, the Delta variant is more than twice as contagious as index or subsequent strains: making it about as contagious as chicken pox. The unvaccinated are the most susceptible to Delta and may develop more serious illness and risk of death than with other strains. Those who are fully vaccinated can still contract the virus although usually with milder cases. More worrisome is that individuals with these breakthrough infections have the same viral load as those without vaccinations, rendering them vectors of transmission, although for a shorter time than unvaccinated persons.⁸

The VA first mandated vaccination among its health care employees in July and then expanded it to all staff in August.⁹ The US Department of Defense (DoD) mandatory vaccination was announced prior to US Food and Drug Administration’s (FDA) full approval of the Pfizer-BioNTech vaccine.¹⁰ Secretary Austin asked President Biden to grant a waiver to permit mandatory vaccination even without full FDA approval, and Biden has indicated his support, but the full approval expedited the time line for implementation.¹¹

Both agencies directly referenced Delta as a primary reason for their vaccination mandates. The VA argued that the mandate was necessary to protect the safety of veterans, while the DoD noted that vaccination was essential to ensure the health of the fighting force. In his initial announcement, Secretary McDonough explicitly mentioned the Delta variant as a primary reason for his decision. noting “it’s the best way to keep veterans safe, especially as the Delta variant spreads across the country.”⁴ Similarly, Secretary Austin declared, “We will also be keeping a close eye on infection rates, which are on the rise now due to the Delta variant and the impact these rates might have on our readiness.”⁵

VA and DoD leadership emphasized the safety and effectiveness of the vaccine and urged employees to voluntarily obtain the vaccine or obtain a religious or medical exemption. Those without such an exemption must adhere to masking, testing, and other restrictions.⁵ As anticipated in the earlier editorial, there has been opposition to the mandate from the workforce of the 2 agencies and their political supporters some of whom view vaccine mandates as violations of personal liberty and bodily integrity and for whom rampant disinformation has amplified entrenched distrust of the government.¹²

The decision to shift from voluntary to mandatory vaccination of federal employees responsible for the health care of veterans and the defense of citizens, which may seem draconian to some, is grounded in core public health ethical and legal principles. The first is the doctrine of the least restrictive alternative, which dictates that implemented public health policies should have the least infringement on individual liberties as possible.¹³ A corollary is that less coercive methods should be reasonably attempted before moving to more restrictive policies. Both agencies have struggled somewhat unsuccessfully to vaccinate employees even with extensive education, persuasion, and incentives. In July, the active-duty vaccination rates ranged from 58 to 77%; among VA employees it ranged from 59 to 85%, depending on the facility.¹⁴

Finally and most important, for a vaccine or other public health intervention to be ethically mandated it must have a high probability of attaining a serious purpose: here preventing the harms of sickness and death especially in the most vulnerable. In July, the White House COVID-19 Response Team reported that “preliminary data from several states over the last few months suggest that 99.5% of deaths from COVID-19 in the United States were in unvaccinated people” and were preventable.¹⁵ Ethically, even as mandates are implemented across the federal workforce, efforts to educate, encourage, and empower vaccination especially among disenfranchised cohorts must continue. But as a recently leaked CDC internal document acknowledged about the Delta Factor, “the war has changed” and so has my opinion about mandating vaccination among those upon whose service depends the life and security of us all.¹⁶

Several weeks ago, I received a call from my brother who, though not a health care professional, wanted me to know he thought the public was being too critical of scientists and physicians who “are giving us the best advice they can about COVID. People think they should have all the answers. But this virus is complicated, and they don’t always know what is going to happen next.” What makes his charitable read of the public health situation remarkable is that he is a COVID-19 survivor of one of the first reported cases of Guillain-Barre syndrome, which several expert neurologists believe is the result of COVID-19. Like so many other COVID-19 long-haul patients, he is left with lingering symptoms and residual deficits.¹

I use this personal story as the overture to this piece on why I am changing my opinion regarding a COVID-19 mandate for federal practitioners. In June I raised ethical concerns about compelling vaccination especially for service members of color based on a current and historical climate of mistrust and discrimination in health care that compulsory vaccination could exacerbate.² Instead, I followed the lead of Secretary of Defense J. Lloyd Austin III and advocated continued education and encouragement for vaccine-hesitant troops.³ So in 2 months what has so radically changed to lead Secretary Austin and US Department of Veterans Affairs (VA) Secretary Denis R. McDonough to mandate vaccination for their workforce?^4,5

I am calling the change the Delta Factor. This is not to be confused with the spy-thrillers that ironically involved rescuing a scientist! The Delta Factor is a catch-all phrase to cover the protean public health impacts of the devastating COVID-19 Delta variant now ravaging the country. Depending on the area of the country as of mid-August, the Centers for Disease Control and Prevention (CDC) estimated that 80% to > 90% of new cases were the Delta variant.⁶ An increasing number of these cases sadly are in children.⁷

According to the CDC, the Delta variant is more than twice as contagious as index or subsequent strains: making it about as contagious as chicken pox. The unvaccinated are the most susceptible to Delta and may develop more serious illness and risk of death than with other strains. Those who are fully vaccinated can still contract the virus although usually with milder cases. More worrisome is that individuals with these breakthrough infections have the same viral load as those without vaccinations, rendering them vectors of transmission, although for a shorter time than unvaccinated persons.⁸

The VA first mandated vaccination among its health care employees in July and then expanded it to all staff in August.⁹ The US Department of Defense (DoD) mandatory vaccination was announced prior to US Food and Drug Administration’s (FDA) full approval of the Pfizer-BioNTech vaccine.¹⁰ Secretary Austin asked President Biden to grant a waiver to permit mandatory vaccination even without full FDA approval, and Biden has indicated his support, but the full approval expedited the time line for implementation.¹¹

Both agencies directly referenced Delta as a primary reason for their vaccination mandates. The VA argued that the mandate was necessary to protect the safety of veterans, while the DoD noted that vaccination was essential to ensure the health of the fighting force. In his initial announcement, Secretary McDonough explicitly mentioned the Delta variant as a primary reason for his decision. noting “it’s the best way to keep veterans safe, especially as the Delta variant spreads across the country.”⁴ Similarly, Secretary Austin declared, “We will also be keeping a close eye on infection rates, which are on the rise now due to the Delta variant and the impact these rates might have on our readiness.”⁵

VA and DoD leadership emphasized the safety and effectiveness of the vaccine and urged employees to voluntarily obtain the vaccine or obtain a religious or medical exemption. Those without such an exemption must adhere to masking, testing, and other restrictions.⁵ As anticipated in the earlier editorial, there has been opposition to the mandate from the workforce of the 2 agencies and their political supporters some of whom view vaccine mandates as violations of personal liberty and bodily integrity and for whom rampant disinformation has amplified entrenched distrust of the government.¹²

The decision to shift from voluntary to mandatory vaccination of federal employees responsible for the health care of veterans and the defense of citizens, which may seem draconian to some, is grounded in core public health ethical and legal principles. The first is the doctrine of the least restrictive alternative, which dictates that implemented public health policies should have the least infringement on individual liberties as possible.¹³ A corollary is that less coercive methods should be reasonably attempted before moving to more restrictive policies. Both agencies have struggled somewhat unsuccessfully to vaccinate employees even with extensive education, persuasion, and incentives. In July, the active-duty vaccination rates ranged from 58 to 77%; among VA employees it ranged from 59 to 85%, depending on the facility.¹⁴

Finally and most important, for a vaccine or other public health intervention to be ethically mandated it must have a high probability of attaining a serious purpose: here preventing the harms of sickness and death especially in the most vulnerable. In July, the White House COVID-19 Response Team reported that “preliminary data from several states over the last few months suggest that 99.5% of deaths from COVID-19 in the United States were in unvaccinated people” and were preventable.¹⁵ Ethically, even as mandates are implemented across the federal workforce, efforts to educate, encourage, and empower vaccination especially among disenfranchised cohorts must continue. But as a recently leaked CDC internal document acknowledged about the Delta Factor, “the war has changed” and so has my opinion about mandating vaccination among those upon whose service depends the life and security of us all.¹⁶

Several weeks ago, I received a call from my brother who, though not a health care professional, wanted me to know he thought the public was being too critical of scientists and physicians who “are giving us the best advice they can about COVID. People think they should have all the answers. But this virus is complicated, and they don’t always know what is going to happen next.” What makes his charitable read of the public health situation remarkable is that he is a COVID-19 survivor of one of the first reported cases of Guillain-Barre syndrome, which several expert neurologists believe is the result of COVID-19. Like so many other COVID-19 long-haul patients, he is left with lingering symptoms and residual deficits.¹

I use this personal story as the overture to this piece on why I am changing my opinion regarding a COVID-19 mandate for federal practitioners. In June I raised ethical concerns about compelling vaccination especially for service members of color based on a current and historical climate of mistrust and discrimination in health care that compulsory vaccination could exacerbate.² Instead, I followed the lead of Secretary of Defense J. Lloyd Austin III and advocated continued education and encouragement for vaccine-hesitant troops.³ So in 2 months what has so radically changed to lead Secretary Austin and US Department of Veterans Affairs (VA) Secretary Denis R. McDonough to mandate vaccination for their workforce?^4,5

I am calling the change the Delta Factor. This is not to be confused with the spy-thrillers that ironically involved rescuing a scientist! The Delta Factor is a catch-all phrase to cover the protean public health impacts of the devastating COVID-19 Delta variant now ravaging the country. Depending on the area of the country as of mid-August, the Centers for Disease Control and Prevention (CDC) estimated that 80% to > 90% of new cases were the Delta variant.⁶ An increasing number of these cases sadly are in children.⁷

According to the CDC, the Delta variant is more than twice as contagious as index or subsequent strains: making it about as contagious as chicken pox. The unvaccinated are the most susceptible to Delta and may develop more serious illness and risk of death than with other strains. Those who are fully vaccinated can still contract the virus although usually with milder cases. More worrisome is that individuals with these breakthrough infections have the same viral load as those without vaccinations, rendering them vectors of transmission, although for a shorter time than unvaccinated persons.⁸

The VA first mandated vaccination among its health care employees in July and then expanded it to all staff in August.⁹ The US Department of Defense (DoD) mandatory vaccination was announced prior to US Food and Drug Administration’s (FDA) full approval of the Pfizer-BioNTech vaccine.¹⁰ Secretary Austin asked President Biden to grant a waiver to permit mandatory vaccination even without full FDA approval, and Biden has indicated his support, but the full approval expedited the time line for implementation.¹¹

Both agencies directly referenced Delta as a primary reason for their vaccination mandates. The VA argued that the mandate was necessary to protect the safety of veterans, while the DoD noted that vaccination was essential to ensure the health of the fighting force. In his initial announcement, Secretary McDonough explicitly mentioned the Delta variant as a primary reason for his decision. noting “it’s the best way to keep veterans safe, especially as the Delta variant spreads across the country.”⁴ Similarly, Secretary Austin declared, “We will also be keeping a close eye on infection rates, which are on the rise now due to the Delta variant and the impact these rates might have on our readiness.”⁵

VA and DoD leadership emphasized the safety and effectiveness of the vaccine and urged employees to voluntarily obtain the vaccine or obtain a religious or medical exemption. Those without such an exemption must adhere to masking, testing, and other restrictions.⁵ As anticipated in the earlier editorial, there has been opposition to the mandate from the workforce of the 2 agencies and their political supporters some of whom view vaccine mandates as violations of personal liberty and bodily integrity and for whom rampant disinformation has amplified entrenched distrust of the government.¹²

The decision to shift from voluntary to mandatory vaccination of federal employees responsible for the health care of veterans and the defense of citizens, which may seem draconian to some, is grounded in core public health ethical and legal principles. The first is the doctrine of the least restrictive alternative, which dictates that implemented public health policies should have the least infringement on individual liberties as possible.¹³ A corollary is that less coercive methods should be reasonably attempted before moving to more restrictive policies. Both agencies have struggled somewhat unsuccessfully to vaccinate employees even with extensive education, persuasion, and incentives. In July, the active-duty vaccination rates ranged from 58 to 77%; among VA employees it ranged from 59 to 85%, depending on the facility.¹⁴

Finally and most important, for a vaccine or other public health intervention to be ethically mandated it must have a high probability of attaining a serious purpose: here preventing the harms of sickness and death especially in the most vulnerable. In July, the White House COVID-19 Response Team reported that “preliminary data from several states over the last few months suggest that 99.5% of deaths from COVID-19 in the United States were in unvaccinated people” and were preventable.¹⁵ Ethically, even as mandates are implemented across the federal workforce, efforts to educate, encourage, and empower vaccination especially among disenfranchised cohorts must continue. But as a recently leaked CDC internal document acknowledged about the Delta Factor, “the war has changed” and so has my opinion about mandating vaccination among those upon whose service depends the life and security of us all.¹⁶

Insurers Target Modifier -25

Modifier -25 allows reporting of both a minor procedure (ie, one with a 0- or 10-day global period) and a separate and distinct evaluation and management (E/M) service on the same date of service.¹ Because of the multicomplaint nature of dermatology, the ability to report a same-day procedure and an E/M service is critical for efficient, cost-effective, and patient-centered dermatologic care. However, it is well known that the use of modifier -25 has been under notable insurer scrutiny and is a common reason for medical record audits.^2,3 Some insurers have responded to increased utilization of modifier -25 by cutting reimbursement for claims that include both a procedure and an E/M service or by denying one of the services altogether.^4-6 The Centers for Medicare and Medicaid Services also have expressed concern about this coding combination with proposed cuts to reimbursement.⁷ Moreover, the Office of Inspector General has announced a work plan to investigate the frequent utilization of E/M codes and minor procedures by dermatologists.⁸ Clearly, modifier -25 is a continued target by insurers and regulators; therefore, dermatologists will want to make sure their coding and documentation meet all requirements and are updated for the new E/M codes for 2021.

The American Medical Association’s Current Procedural Terminology indicates that modifier -25 allows reporting of a “significant, separately identifiable evaluation and management service by the same physician or other qualified health care professional on the same day of a procedure or other service.”¹ Given that dermatology patients typically present with multiple concerns, dermatologists commonly evaluate and treat numerous conditions during one visit. Understanding what constitutes a separately identifiable E/M service is critical to bill accurately and to pass insurer audits.

Global Surgical Package

To appropriately bill both a procedure and an E/M service, the physician must indicate that the patient’s condition required an E/M service above and beyond the usual work of the procedure. The compilation of evaluation and work included in the payment for a procedure is called the global surgical package.⁹ In general, the global surgical package includes local or topical anesthesia; the surgical service/procedure itself; immediate postoperative care, including dictating the operative note; meeting/discussing the patient’s procedure with family and other physicians; and writing orders for the patient. For minor procedures (ie, those with either 0- or 10-day global periods), the surgical package also includes same-day E/M services associated with the decision to perform surgery. An appropriate history and physical examination as well as a discussion of the differential diagnosis, treatment options, and risk and benefits of treatment are all included in the payment of a minor procedure itself. Therefore, an evaluation to discuss a patient’s condition or change in condition, alternatives to treatment, or next steps after a diagnosis related to a treatment or diagnostic procedure should not be separately reported. Moreover, the fact that the patient is new to the physician is not in itself sufficient to allow reporting of an E/M service with these minor procedures. For major procedures (ie, those with 90-day postoperative periods), the decision for surgery is excluded from the global surgical package.

2021 E/M Codes Simplify Documentation

The biggest coding change of 2021 was the new E/M codes.¹⁰ Prior to this year, the descriptors of E/M services recognized 7 components to define the levels of E/M services¹¹: history and nature of the presenting problem; physical examination; medical decision-making (MDM); counseling; coordination of care; and time. Furthermore, history, physical examination, and MDM were all broken down into more granular elements that were summed to determine the level for each component; for example, the history of the presenting problem was defined as a chronological description of the development of the patient’s present illness, including the following elements: location, quality, severity, duration, timing, context, modifying factors, and associated signs and symptoms. Each of these categories would constitute bullet points to be summed to determine the level of history. Physical examination and MDM bullet points also would be summed to determine a proper coding level.¹¹ Understandably, this coding scheme was complicated and burdensome to medical providers.

The redefinition of the E/M codes for 2021 substantially simplified the determination of coding level and documentation.¹⁰ The revisions to the E/M office visit code descriptors and documentation standards are now centered around how physicians think and take care of patients and not on mandatory standards and checking boxes. The main changes involve MDM as the prime determinant of the coding level. Elements of MDM affecting coding for an outpatient or office visit now include only 3 components: the number and complexity of problems addressed in the encounter, the amount or complexity of data to be reviewed and analyzed, and the risk of complications or morbidity of patient management. Gone are the requirements from the earlier criteria requiring so many bullet points for the history, physical examination, and MDM.

Dermatologists may ask, “How does the new E/M coding structure affect reporting and documenting an E/M and a procedure on the same day?” The answer is that the determination of separate and distinct is basically unchanged with the new E/M codes; however, the documentation requirements for modifier -25 using the new E/M codes are simplified.

As always, the key to determining whether a separate and distinct E/M service was provided and subsequently documented is to deconstruct the medical note. All evaluation services associated with the procedure—making a clinical diagnosis or differential diagnosis, decision to perform surgery, and discussion of alternative treatments—should be removed from one’s documentation as shown in the example below. If a complete E/M service still exists, then an E/M may be billed in addition to the procedure. Physical examination of the treatment area is included in the surgical package. With the prior E/M criteria, physical examination of the procedural area could not be used again as a bullet point to count for the E/M level. However, with the new 2021 coding requirements, the documentation of a separate MDM will be sufficient to meet criteria because documentation of physical examination is not a requirement.

Modifier -25 Examples

Let’s examine a typical dermatologist medical note. An established patient presents to the dermatologist complaining of an itchy rash on the left wrist after a hiking trip. Treatment with topical hydrocortisone 1% did not help. The patient also complains of a growing tender lesion on the left elbow of 2 months’ duration. Physical examination reveals a linear vesicular eruption on the left wrist and a tender hyperkeratotic papule on the left elbow. No data is evaluated. A diagnosis of acute rhus dermatitis of the left wrist is made, and betamethasone cream is prescribed. The decision is made to perform a tangential biopsy of the lesion on the left elbow because of the suspicion for malignancy. The biopsy is performed the same day.

This case clearly illustrates performance of an E/M service in the treatment of rhus dermatitis, which is separate and distinct from the biopsy procedure; however, in evaluating whether the case meets the documentation requirements for modifier -25, the information in the medical note inclusive to the procedure’s global surgical package, including history associated with establishing the diagnosis, physical examination of the procedure area(s), and discussion of treatment options, is eliminated, leaving the following notes: An established patient presents to the dermatologist complaining of an itchy rash on the left wrist after a hiking trip. Treatment with topical hydrocortisone 1% did not help. No data is evaluated. A diagnosis of acute rhus dermatitis of the left wrist is made, and betamethasone cream is prescribed.

Because the physical examination of the body part (left arm) is included in the procedure’s global surgical package, the examination of the left wrist cannot be used as coding support for the E/M service. This makes a difference for coding level in the prior E/M coding requirements, which required examination bullet points. However, with the 2021 E/M codes, documentation of physical examination bullet points is irrelevant to the coding level. Therefore, qualifying for a modifier -25 claim is more straightforward in this case with the new code set. Because bullet points are not integral to the 2021 E/M codes, qualifying and properly documenting for a higher level of service will likely be more common in dermatology.

Final Thoughts

Frequent use of modifier -25 is a critical part of a high-quality and cost-effective dermatology practice. Same-day performance of minor procedures and E/M services allows for more rapid and efficient diagnosis and treatment of various conditions as well as minimizing unnecessary office visits. The new E/M codes for 2021 actually make the documentation of a separate and distinct E/M service less complicated because the bullet point requirements associated with the old E/M codes have been eliminated. Understanding how the new E/M code descriptors affect modifier -25 reporting and clear documentation of separate, distinct, and medically necessary E/M services will be needed due to increased insurer scrutiny and audits.

Insurers Target Modifier -25

Modifier -25 allows reporting of both a minor procedure (ie, one with a 0- or 10-day global period) and a separate and distinct evaluation and management (E/M) service on the same date of service.¹ Because of the multicomplaint nature of dermatology, the ability to report a same-day procedure and an E/M service is critical for efficient, cost-effective, and patient-centered dermatologic care. However, it is well known that the use of modifier -25 has been under notable insurer scrutiny and is a common reason for medical record audits.^2,3 Some insurers have responded to increased utilization of modifier -25 by cutting reimbursement for claims that include both a procedure and an E/M service or by denying one of the services altogether.^4-6 The Centers for Medicare and Medicaid Services also have expressed concern about this coding combination with proposed cuts to reimbursement.⁷ Moreover, the Office of Inspector General has announced a work plan to investigate the frequent utilization of E/M codes and minor procedures by dermatologists.⁸ Clearly, modifier -25 is a continued target by insurers and regulators; therefore, dermatologists will want to make sure their coding and documentation meet all requirements and are updated for the new E/M codes for 2021.

The American Medical Association’s Current Procedural Terminology indicates that modifier -25 allows reporting of a “significant, separately identifiable evaluation and management service by the same physician or other qualified health care professional on the same day of a procedure or other service.”¹ Given that dermatology patients typically present with multiple concerns, dermatologists commonly evaluate and treat numerous conditions during one visit. Understanding what constitutes a separately identifiable E/M service is critical to bill accurately and to pass insurer audits.

Global Surgical Package

To appropriately bill both a procedure and an E/M service, the physician must indicate that the patient’s condition required an E/M service above and beyond the usual work of the procedure. The compilation of evaluation and work included in the payment for a procedure is called the global surgical package.⁹ In general, the global surgical package includes local or topical anesthesia; the surgical service/procedure itself; immediate postoperative care, including dictating the operative note; meeting/discussing the patient’s procedure with family and other physicians; and writing orders for the patient. For minor procedures (ie, those with either 0- or 10-day global periods), the surgical package also includes same-day E/M services associated with the decision to perform surgery. An appropriate history and physical examination as well as a discussion of the differential diagnosis, treatment options, and risk and benefits of treatment are all included in the payment of a minor procedure itself. Therefore, an evaluation to discuss a patient’s condition or change in condition, alternatives to treatment, or next steps after a diagnosis related to a treatment or diagnostic procedure should not be separately reported. Moreover, the fact that the patient is new to the physician is not in itself sufficient to allow reporting of an E/M service with these minor procedures. For major procedures (ie, those with 90-day postoperative periods), the decision for surgery is excluded from the global surgical package.

2021 E/M Codes Simplify Documentation

The biggest coding change of 2021 was the new E/M codes.¹⁰ Prior to this year, the descriptors of E/M services recognized 7 components to define the levels of E/M services¹¹: history and nature of the presenting problem; physical examination; medical decision-making (MDM); counseling; coordination of care; and time. Furthermore, history, physical examination, and MDM were all broken down into more granular elements that were summed to determine the level for each component; for example, the history of the presenting problem was defined as a chronological description of the development of the patient’s present illness, including the following elements: location, quality, severity, duration, timing, context, modifying factors, and associated signs and symptoms. Each of these categories would constitute bullet points to be summed to determine the level of history. Physical examination and MDM bullet points also would be summed to determine a proper coding level.¹¹ Understandably, this coding scheme was complicated and burdensome to medical providers.

The redefinition of the E/M codes for 2021 substantially simplified the determination of coding level and documentation.¹⁰ The revisions to the E/M office visit code descriptors and documentation standards are now centered around how physicians think and take care of patients and not on mandatory standards and checking boxes. The main changes involve MDM as the prime determinant of the coding level. Elements of MDM affecting coding for an outpatient or office visit now include only 3 components: the number and complexity of problems addressed in the encounter, the amount or complexity of data to be reviewed and analyzed, and the risk of complications or morbidity of patient management. Gone are the requirements from the earlier criteria requiring so many bullet points for the history, physical examination, and MDM.

Dermatologists may ask, “How does the new E/M coding structure affect reporting and documenting an E/M and a procedure on the same day?” The answer is that the determination of separate and distinct is basically unchanged with the new E/M codes; however, the documentation requirements for modifier -25 using the new E/M codes are simplified.

As always, the key to determining whether a separate and distinct E/M service was provided and subsequently documented is to deconstruct the medical note. All evaluation services associated with the procedure—making a clinical diagnosis or differential diagnosis, decision to perform surgery, and discussion of alternative treatments—should be removed from one’s documentation as shown in the example below. If a complete E/M service still exists, then an E/M may be billed in addition to the procedure. Physical examination of the treatment area is included in the surgical package. With the prior E/M criteria, physical examination of the procedural area could not be used again as a bullet point to count for the E/M level. However, with the new 2021 coding requirements, the documentation of a separate MDM will be sufficient to meet criteria because documentation of physical examination is not a requirement.

Modifier -25 Examples

Let’s examine a typical dermatologist medical note. An established patient presents to the dermatologist complaining of an itchy rash on the left wrist after a hiking trip. Treatment with topical hydrocortisone 1% did not help. The patient also complains of a growing tender lesion on the left elbow of 2 months’ duration. Physical examination reveals a linear vesicular eruption on the left wrist and a tender hyperkeratotic papule on the left elbow. No data is evaluated. A diagnosis of acute rhus dermatitis of the left wrist is made, and betamethasone cream is prescribed. The decision is made to perform a tangential biopsy of the lesion on the left elbow because of the suspicion for malignancy. The biopsy is performed the same day.

This case clearly illustrates performance of an E/M service in the treatment of rhus dermatitis, which is separate and distinct from the biopsy procedure; however, in evaluating whether the case meets the documentation requirements for modifier -25, the information in the medical note inclusive to the procedure’s global surgical package, including history associated with establishing the diagnosis, physical examination of the procedure area(s), and discussion of treatment options, is eliminated, leaving the following notes: An established patient presents to the dermatologist complaining of an itchy rash on the left wrist after a hiking trip. Treatment with topical hydrocortisone 1% did not help. No data is evaluated. A diagnosis of acute rhus dermatitis of the left wrist is made, and betamethasone cream is prescribed.

Because the physical examination of the body part (left arm) is included in the procedure’s global surgical package, the examination of the left wrist cannot be used as coding support for the E/M service. This makes a difference for coding level in the prior E/M coding requirements, which required examination bullet points. However, with the 2021 E/M codes, documentation of physical examination bullet points is irrelevant to the coding level. Therefore, qualifying for a modifier -25 claim is more straightforward in this case with the new code set. Because bullet points are not integral to the 2021 E/M codes, qualifying and properly documenting for a higher level of service will likely be more common in dermatology.

Final Thoughts

Frequent use of modifier -25 is a critical part of a high-quality and cost-effective dermatology practice. Same-day performance of minor procedures and E/M services allows for more rapid and efficient diagnosis and treatment of various conditions as well as minimizing unnecessary office visits. The new E/M codes for 2021 actually make the documentation of a separate and distinct E/M service less complicated because the bullet point requirements associated with the old E/M codes have been eliminated. Understanding how the new E/M code descriptors affect modifier -25 reporting and clear documentation of separate, distinct, and medically necessary E/M services will be needed due to increased insurer scrutiny and audits.

Insurers Target Modifier -25

Modifier -25 allows reporting of both a minor procedure (ie, one with a 0- or 10-day global period) and a separate and distinct evaluation and management (E/M) service on the same date of service.¹ Because of the multicomplaint nature of dermatology, the ability to report a same-day procedure and an E/M service is critical for efficient, cost-effective, and patient-centered dermatologic care. However, it is well known that the use of modifier -25 has been under notable insurer scrutiny and is a common reason for medical record audits.^2,3 Some insurers have responded to increased utilization of modifier -25 by cutting reimbursement for claims that include both a procedure and an E/M service or by denying one of the services altogether.^4-6 The Centers for Medicare and Medicaid Services also have expressed concern about this coding combination with proposed cuts to reimbursement.⁷ Moreover, the Office of Inspector General has announced a work plan to investigate the frequent utilization of E/M codes and minor procedures by dermatologists.⁸ Clearly, modifier -25 is a continued target by insurers and regulators; therefore, dermatologists will want to make sure their coding and documentation meet all requirements and are updated for the new E/M codes for 2021.

The American Medical Association’s Current Procedural Terminology indicates that modifier -25 allows reporting of a “significant, separately identifiable evaluation and management service by the same physician or other qualified health care professional on the same day of a procedure or other service.”¹ Given that dermatology patients typically present with multiple concerns, dermatologists commonly evaluate and treat numerous conditions during one visit. Understanding what constitutes a separately identifiable E/M service is critical to bill accurately and to pass insurer audits.

Global Surgical Package

To appropriately bill both a procedure and an E/M service, the physician must indicate that the patient’s condition required an E/M service above and beyond the usual work of the procedure. The compilation of evaluation and work included in the payment for a procedure is called the global surgical package.⁹ In general, the global surgical package includes local or topical anesthesia; the surgical service/procedure itself; immediate postoperative care, including dictating the operative note; meeting/discussing the patient’s procedure with family and other physicians; and writing orders for the patient. For minor procedures (ie, those with either 0- or 10-day global periods), the surgical package also includes same-day E/M services associated with the decision to perform surgery. An appropriate history and physical examination as well as a discussion of the differential diagnosis, treatment options, and risk and benefits of treatment are all included in the payment of a minor procedure itself. Therefore, an evaluation to discuss a patient’s condition or change in condition, alternatives to treatment, or next steps after a diagnosis related to a treatment or diagnostic procedure should not be separately reported. Moreover, the fact that the patient is new to the physician is not in itself sufficient to allow reporting of an E/M service with these minor procedures. For major procedures (ie, those with 90-day postoperative periods), the decision for surgery is excluded from the global surgical package.

2021 E/M Codes Simplify Documentation

The biggest coding change of 2021 was the new E/M codes.¹⁰ Prior to this year, the descriptors of E/M services recognized 7 components to define the levels of E/M services¹¹: history and nature of the presenting problem; physical examination; medical decision-making (MDM); counseling; coordination of care; and time. Furthermore, history, physical examination, and MDM were all broken down into more granular elements that were summed to determine the level for each component; for example, the history of the presenting problem was defined as a chronological description of the development of the patient’s present illness, including the following elements: location, quality, severity, duration, timing, context, modifying factors, and associated signs and symptoms. Each of these categories would constitute bullet points to be summed to determine the level of history. Physical examination and MDM bullet points also would be summed to determine a proper coding level.¹¹ Understandably, this coding scheme was complicated and burdensome to medical providers.

The redefinition of the E/M codes for 2021 substantially simplified the determination of coding level and documentation.¹⁰ The revisions to the E/M office visit code descriptors and documentation standards are now centered around how physicians think and take care of patients and not on mandatory standards and checking boxes. The main changes involve MDM as the prime determinant of the coding level. Elements of MDM affecting coding for an outpatient or office visit now include only 3 components: the number and complexity of problems addressed in the encounter, the amount or complexity of data to be reviewed and analyzed, and the risk of complications or morbidity of patient management. Gone are the requirements from the earlier criteria requiring so many bullet points for the history, physical examination, and MDM.

Dermatologists may ask, “How does the new E/M coding structure affect reporting and documenting an E/M and a procedure on the same day?” The answer is that the determination of separate and distinct is basically unchanged with the new E/M codes; however, the documentation requirements for modifier -25 using the new E/M codes are simplified.

As always, the key to determining whether a separate and distinct E/M service was provided and subsequently documented is to deconstruct the medical note. All evaluation services associated with the procedure—making a clinical diagnosis or differential diagnosis, decision to perform surgery, and discussion of alternative treatments—should be removed from one’s documentation as shown in the example below. If a complete E/M service still exists, then an E/M may be billed in addition to the procedure. Physical examination of the treatment area is included in the surgical package. With the prior E/M criteria, physical examination of the procedural area could not be used again as a bullet point to count for the E/M level. However, with the new 2021 coding requirements, the documentation of a separate MDM will be sufficient to meet criteria because documentation of physical examination is not a requirement.

Modifier -25 Examples

Let’s examine a typical dermatologist medical note. An established patient presents to the dermatologist complaining of an itchy rash on the left wrist after a hiking trip. Treatment with topical hydrocortisone 1% did not help. The patient also complains of a growing tender lesion on the left elbow of 2 months’ duration. Physical examination reveals a linear vesicular eruption on the left wrist and a tender hyperkeratotic papule on the left elbow. No data is evaluated. A diagnosis of acute rhus dermatitis of the left wrist is made, and betamethasone cream is prescribed. The decision is made to perform a tangential biopsy of the lesion on the left elbow because of the suspicion for malignancy. The biopsy is performed the same day.

This case clearly illustrates performance of an E/M service in the treatment of rhus dermatitis, which is separate and distinct from the biopsy procedure; however, in evaluating whether the case meets the documentation requirements for modifier -25, the information in the medical note inclusive to the procedure’s global surgical package, including history associated with establishing the diagnosis, physical examination of the procedure area(s), and discussion of treatment options, is eliminated, leaving the following notes: An established patient presents to the dermatologist complaining of an itchy rash on the left wrist after a hiking trip. Treatment with topical hydrocortisone 1% did not help. No data is evaluated. A diagnosis of acute rhus dermatitis of the left wrist is made, and betamethasone cream is prescribed.

Because the physical examination of the body part (left arm) is included in the procedure’s global surgical package, the examination of the left wrist cannot be used as coding support for the E/M service. This makes a difference for coding level in the prior E/M coding requirements, which required examination bullet points. However, with the 2021 E/M codes, documentation of physical examination bullet points is irrelevant to the coding level. Therefore, qualifying for a modifier -25 claim is more straightforward in this case with the new code set. Because bullet points are not integral to the 2021 E/M codes, qualifying and properly documenting for a higher level of service will likely be more common in dermatology.

Final Thoughts

Frequent use of modifier -25 is a critical part of a high-quality and cost-effective dermatology practice. Same-day performance of minor procedures and E/M services allows for more rapid and efficient diagnosis and treatment of various conditions as well as minimizing unnecessary office visits. The new E/M codes for 2021 actually make the documentation of a separate and distinct E/M service less complicated because the bullet point requirements associated with the old E/M codes have been eliminated. Understanding how the new E/M code descriptors affect modifier -25 reporting and clear documentation of separate, distinct, and medically necessary E/M services will be needed due to increased insurer scrutiny and audits.

This fall, the Supreme Court of the United States (SCOTUS) will announce when they will hear oral arguments for Dobbs v Jackson Women’s Health Organization. The court will examine a Mississippi law, known as the “Gestational Age Act,” originally passed in 2018, that sought to “limit abortions to fifteen weeks’ gestation except in a medical emergency or in cases of severe fetal abnormality.”¹ This sets the stage for SCOTUS to make a major ruling on abortion, one which could affirm or upend landmark decisions and nearly 50 years of abortion legislative precedent. Additionally, SCOTUS’ recent decision to not intervene on Texas’ Senate Bill 8 (SB8), which essentially bans all abortions after 6 weeks’ gestational age, may foreshadow how this case will be decided. The current abortion restrictions in Texas and the implications of SB8 will be discussed in a forthcoming column.

SCOTUS and abortion rights

The decision to hear this case comes on the heels of another recent decision regarding a Louisiana law in June Medical Services v Russo. This case examined Louisiana Act 620, which would have required physicians to have hospital admitting privileges within 30 miles of where they provide abortion services.² The law was deemed constitutionally invalid, with the majority noting the law would have drastically burdened a woman’s right to access abortion services. The Court ruled similarly in 2016 in Whole Women’s Health (WWH) v Hellerstedt, in which WWH challenged Texas House Bill 2, a nearly identical law requiring admitting privileges for abortion care providers. In both of these cases, SCOTUS pointed to precedent set by Southeastern Pennsylvania v Casey, which established that it is unconstitutional for a state to create an “undue burden” on a woman’s right to abortion prior to fetal viability.³ The precedent to this, Roe v Wade, and 5 decades of abortion legislation set may be upended by a SCOTUS decision this next term.

Dobbs v Jackson

On March 19, 2018, Mississippi enacted the “Gestational Age Act” into law. The newly enacted law would limit abortions to 15 weeks’ gestation except in a medical emergency or in cases of severe fetal anomalies. Jackson Women’s Health Organization, the only licensed abortion provider in the state, challenged the constitutionality of the law with legal support from Center for Reproductive Rights (CRR). The US District Court for the Southern District of Mississippi granted summary judgement in favor of the clinic and placed an injunction on the law’s enforcement. The state appealed to the Fifth Circuit Court of Appeals, which upheld the district court decision in a 3-0 decision in November 2019. Mississippi appealed to the Supreme Court, with their petition focusing on multiple questions from the appeals process. After repeatedly rescheduling the case, and multiple reviews in conference, SCOTUS agreed to hear the case. Most recently, the state has narrowed its argument, changing course, and attacking Roe v Wade directly. In a brief submitted in July 2021, the state argues the court should hold that all pre-viability prohibitions on elective abortions are constitutional.

Interestingly, during this time the Mississippi legislature also passed a law, House Bill 2116, also known as the “fetal heartbeat bill,” banning abortion with gestational ages after detection of a fetal heartbeat. This was also challenged, deemed unconstitutional, and affirmed on appeal by the Fifth US Circuit Court.

While recent challenges have focused on the “undue burden” state laws placed on those trying to access abortion care, this case will bring the issue of “viability” and gestational age limits to the forefront.^4,5 In addition to Roe v Wade, the Court will have the opportunity to reexamine other relevant precedent, such as Southeastern Pennsylvania v Casey, in considering the most recent arguments of the state. In this most recent brief, the state argues that the Court should, “reject viability as a barrier to prohibiting elective abortions” and that a “viability rule has no constitutional basis.” The state goes on to argue the “Constitution does not protect a right to abortion or limit States’ authority to restrict it.”⁶ The language and tone in this brief are more direct and aggressive than the states’ petition submitted last June.

However, the composition of the Court is different than in the past. This case will be argued with Justice Amy Coney Barrett seated in place of Justice Ruth Bader Ginsburg, who was a strong advocate for women’s rights.⁷ She joins Justices Neil Gorsuch and Brett Kavanaugh, also appointed by President Donald Trump and widely viewed as conservative judges, tipping the scales to a more conservative Supreme Court. This case will also be argued in a polarized political environment.^8,9 Given the conservative Supreme Court in the setting of an increasingly politically charged environment, reproductive right advocates are understandably worried that members of the anti-abortion movement view this as an opportunity to weaken or remove federal constitutional protections for abortion.

Continue to: Potential outcome of Dobbs v Jackson...

 

 

Potential outcome of Dobbs v Jackson

Should SCOTUS choose to rule in favor of Mississippi, it could severely weaken, or even overturn Roe v Wade. This would leave a legal path for states with pre-Roe abortion bans and currently unenforced post-Roe bans to take effect. These “trigger” laws are bans or severe restrictions on abortion providers and patients intended to take effect if Roe were to be overturned. Alternatively, the Court may overturn Southeastern Pennsylvania v Casey, but maintain Roe v Wade, essentially leaving the regulation of pre-viability abortion care to individual states. Currently 21 states have laws that would restrict the legal status of abortion.¹⁰ In addition, state legislatures are aggressively introducing abortion restrictions. As of June 2021, there have been 561 abortion restrictions, including 165 abortion bans, introduced across 47 states, putting 2021 on course to be the most devastating anti-abortion state legislative session in decades.¹¹

The damage caused by such restriction on abortion care would be significant. It would block or push access out of reach for many. The negative effects of such legislative action would most heavily burden those already marginalized by systemic, structural inequalities including those of low socioeconomic status, people of color, young people, those in rural communities, and members of the LGBTQ community. The medical community has long recognized the harm caused by restricting access to abortion care. Restriction of access to safe abortion care paradoxically has been shown not to decrease the incidence of abortion, but rather increases the number of unsafe abortions.¹² The American College of Obstetricians and Gynecologists (ACOG) acknowledge “individuals require access to safe, legal abortion” and that this represents “a necessary component for comprehensive health care.”^13,14 They joined the American Medical Association and other professional groups in a 2019 amicus brief to SCOTUS opposing restrictions on abortion access.¹⁵ In addition, government laws restricting access to abortion care undermine the fundamental relationship between a person and their physician, limiting a physician’s obligation to honor patient autonomy and provide appropriate medical care.

By taking up the question whether all pre-viability bans on elective abortions violate the Constitution, SCOTUS is indicating a possible willingness to revisit the central holding of abortion jurisprudence. Their decision regarding this case will likely be the most significant ruling regarding the legal status of abortion care in decades, and will significantly affect the delivery of abortion care in the future.

Action items

• Reach out to your representatives to support the Women’s Health Protection Act, an initiative introduced to Congress to protect access to abortion care. If you reside in a state where your federal representatives support the Women’s Health Protection Act, reach out to friends and colleagues in states without supportive elected officials and ask them to call their representatives and ask them to support the bill.
• Get involved with local grassroots groups fighting to protect abortion access.
• Continue to speak out against laws and policies designed to limit access to safe abortion care.
• Connect with your local ACOG chapter for more ways to become involved.
• As always, make sure you are registered to vote, and exercise your right whenever you can.

This fall, the Supreme Court of the United States (SCOTUS) will announce when they will hear oral arguments for Dobbs v Jackson Women’s Health Organization. The court will examine a Mississippi law, known as the “Gestational Age Act,” originally passed in 2018, that sought to “limit abortions to fifteen weeks’ gestation except in a medical emergency or in cases of severe fetal abnormality.”¹ This sets the stage for SCOTUS to make a major ruling on abortion, one which could affirm or upend landmark decisions and nearly 50 years of abortion legislative precedent. Additionally, SCOTUS’ recent decision to not intervene on Texas’ Senate Bill 8 (SB8), which essentially bans all abortions after 6 weeks’ gestational age, may foreshadow how this case will be decided. The current abortion restrictions in Texas and the implications of SB8 will be discussed in a forthcoming column.

SCOTUS and abortion rights

The decision to hear this case comes on the heels of another recent decision regarding a Louisiana law in June Medical Services v Russo. This case examined Louisiana Act 620, which would have required physicians to have hospital admitting privileges within 30 miles of where they provide abortion services.² The law was deemed constitutionally invalid, with the majority noting the law would have drastically burdened a woman’s right to access abortion services. The Court ruled similarly in 2016 in Whole Women’s Health (WWH) v Hellerstedt, in which WWH challenged Texas House Bill 2, a nearly identical law requiring admitting privileges for abortion care providers. In both of these cases, SCOTUS pointed to precedent set by Southeastern Pennsylvania v Casey, which established that it is unconstitutional for a state to create an “undue burden” on a woman’s right to abortion prior to fetal viability.³ The precedent to this, Roe v Wade, and 5 decades of abortion legislation set may be upended by a SCOTUS decision this next term.

Dobbs v Jackson

On March 19, 2018, Mississippi enacted the “Gestational Age Act” into law. The newly enacted law would limit abortions to 15 weeks’ gestation except in a medical emergency or in cases of severe fetal anomalies. Jackson Women’s Health Organization, the only licensed abortion provider in the state, challenged the constitutionality of the law with legal support from Center for Reproductive Rights (CRR). The US District Court for the Southern District of Mississippi granted summary judgement in favor of the clinic and placed an injunction on the law’s enforcement. The state appealed to the Fifth Circuit Court of Appeals, which upheld the district court decision in a 3-0 decision in November 2019. Mississippi appealed to the Supreme Court, with their petition focusing on multiple questions from the appeals process. After repeatedly rescheduling the case, and multiple reviews in conference, SCOTUS agreed to hear the case. Most recently, the state has narrowed its argument, changing course, and attacking Roe v Wade directly. In a brief submitted in July 2021, the state argues the court should hold that all pre-viability prohibitions on elective abortions are constitutional.

Interestingly, during this time the Mississippi legislature also passed a law, House Bill 2116, also known as the “fetal heartbeat bill,” banning abortion with gestational ages after detection of a fetal heartbeat. This was also challenged, deemed unconstitutional, and affirmed on appeal by the Fifth US Circuit Court.

While recent challenges have focused on the “undue burden” state laws placed on those trying to access abortion care, this case will bring the issue of “viability” and gestational age limits to the forefront.^4,5 In addition to Roe v Wade, the Court will have the opportunity to reexamine other relevant precedent, such as Southeastern Pennsylvania v Casey, in considering the most recent arguments of the state. In this most recent brief, the state argues that the Court should, “reject viability as a barrier to prohibiting elective abortions” and that a “viability rule has no constitutional basis.” The state goes on to argue the “Constitution does not protect a right to abortion or limit States’ authority to restrict it.”⁶ The language and tone in this brief are more direct and aggressive than the states’ petition submitted last June.

However, the composition of the Court is different than in the past. This case will be argued with Justice Amy Coney Barrett seated in place of Justice Ruth Bader Ginsburg, who was a strong advocate for women’s rights.⁷ She joins Justices Neil Gorsuch and Brett Kavanaugh, also appointed by President Donald Trump and widely viewed as conservative judges, tipping the scales to a more conservative Supreme Court. This case will also be argued in a polarized political environment.^8,9 Given the conservative Supreme Court in the setting of an increasingly politically charged environment, reproductive right advocates are understandably worried that members of the anti-abortion movement view this as an opportunity to weaken or remove federal constitutional protections for abortion.

Continue to: Potential outcome of Dobbs v Jackson...

 

 

Potential outcome of Dobbs v Jackson

Should SCOTUS choose to rule in favor of Mississippi, it could severely weaken, or even overturn Roe v Wade. This would leave a legal path for states with pre-Roe abortion bans and currently unenforced post-Roe bans to take effect. These “trigger” laws are bans or severe restrictions on abortion providers and patients intended to take effect if Roe were to be overturned. Alternatively, the Court may overturn Southeastern Pennsylvania v Casey, but maintain Roe v Wade, essentially leaving the regulation of pre-viability abortion care to individual states. Currently 21 states have laws that would restrict the legal status of abortion.¹⁰ In addition, state legislatures are aggressively introducing abortion restrictions. As of June 2021, there have been 561 abortion restrictions, including 165 abortion bans, introduced across 47 states, putting 2021 on course to be the most devastating anti-abortion state legislative session in decades.¹¹

The damage caused by such restriction on abortion care would be significant. It would block or push access out of reach for many. The negative effects of such legislative action would most heavily burden those already marginalized by systemic, structural inequalities including those of low socioeconomic status, people of color, young people, those in rural communities, and members of the LGBTQ community. The medical community has long recognized the harm caused by restricting access to abortion care. Restriction of access to safe abortion care paradoxically has been shown not to decrease the incidence of abortion, but rather increases the number of unsafe abortions.¹² The American College of Obstetricians and Gynecologists (ACOG) acknowledge “individuals require access to safe, legal abortion” and that this represents “a necessary component for comprehensive health care.”^13,14 They joined the American Medical Association and other professional groups in a 2019 amicus brief to SCOTUS opposing restrictions on abortion access.¹⁵ In addition, government laws restricting access to abortion care undermine the fundamental relationship between a person and their physician, limiting a physician’s obligation to honor patient autonomy and provide appropriate medical care.

By taking up the question whether all pre-viability bans on elective abortions violate the Constitution, SCOTUS is indicating a possible willingness to revisit the central holding of abortion jurisprudence. Their decision regarding this case will likely be the most significant ruling regarding the legal status of abortion care in decades, and will significantly affect the delivery of abortion care in the future.

Action items

• Reach out to your representatives to support the Women’s Health Protection Act, an initiative introduced to Congress to protect access to abortion care. If you reside in a state where your federal representatives support the Women’s Health Protection Act, reach out to friends and colleagues in states without supportive elected officials and ask them to call their representatives and ask them to support the bill.
• Get involved with local grassroots groups fighting to protect abortion access.
• Continue to speak out against laws and policies designed to limit access to safe abortion care.
• Connect with your local ACOG chapter for more ways to become involved.
• As always, make sure you are registered to vote, and exercise your right whenever you can.

This fall, the Supreme Court of the United States (SCOTUS) will announce when they will hear oral arguments for Dobbs v Jackson Women’s Health Organization. The court will examine a Mississippi law, known as the “Gestational Age Act,” originally passed in 2018, that sought to “limit abortions to fifteen weeks’ gestation except in a medical emergency or in cases of severe fetal abnormality.”¹ This sets the stage for SCOTUS to make a major ruling on abortion, one which could affirm or upend landmark decisions and nearly 50 years of abortion legislative precedent. Additionally, SCOTUS’ recent decision to not intervene on Texas’ Senate Bill 8 (SB8), which essentially bans all abortions after 6 weeks’ gestational age, may foreshadow how this case will be decided. The current abortion restrictions in Texas and the implications of SB8 will be discussed in a forthcoming column.

SCOTUS and abortion rights

The decision to hear this case comes on the heels of another recent decision regarding a Louisiana law in June Medical Services v Russo. This case examined Louisiana Act 620, which would have required physicians to have hospital admitting privileges within 30 miles of where they provide abortion services.² The law was deemed constitutionally invalid, with the majority noting the law would have drastically burdened a woman’s right to access abortion services. The Court ruled similarly in 2016 in Whole Women’s Health (WWH) v Hellerstedt, in which WWH challenged Texas House Bill 2, a nearly identical law requiring admitting privileges for abortion care providers. In both of these cases, SCOTUS pointed to precedent set by Southeastern Pennsylvania v Casey, which established that it is unconstitutional for a state to create an “undue burden” on a woman’s right to abortion prior to fetal viability.³ The precedent to this, Roe v Wade, and 5 decades of abortion legislation set may be upended by a SCOTUS decision this next term.

Dobbs v Jackson

On March 19, 2018, Mississippi enacted the “Gestational Age Act” into law. The newly enacted law would limit abortions to 15 weeks’ gestation except in a medical emergency or in cases of severe fetal anomalies. Jackson Women’s Health Organization, the only licensed abortion provider in the state, challenged the constitutionality of the law with legal support from Center for Reproductive Rights (CRR). The US District Court for the Southern District of Mississippi granted summary judgement in favor of the clinic and placed an injunction on the law’s enforcement. The state appealed to the Fifth Circuit Court of Appeals, which upheld the district court decision in a 3-0 decision in November 2019. Mississippi appealed to the Supreme Court, with their petition focusing on multiple questions from the appeals process. After repeatedly rescheduling the case, and multiple reviews in conference, SCOTUS agreed to hear the case. Most recently, the state has narrowed its argument, changing course, and attacking Roe v Wade directly. In a brief submitted in July 2021, the state argues the court should hold that all pre-viability prohibitions on elective abortions are constitutional.

Interestingly, during this time the Mississippi legislature also passed a law, House Bill 2116, also known as the “fetal heartbeat bill,” banning abortion with gestational ages after detection of a fetal heartbeat. This was also challenged, deemed unconstitutional, and affirmed on appeal by the Fifth US Circuit Court.

While recent challenges have focused on the “undue burden” state laws placed on those trying to access abortion care, this case will bring the issue of “viability” and gestational age limits to the forefront.^4,5 In addition to Roe v Wade, the Court will have the opportunity to reexamine other relevant precedent, such as Southeastern Pennsylvania v Casey, in considering the most recent arguments of the state. In this most recent brief, the state argues that the Court should, “reject viability as a barrier to prohibiting elective abortions” and that a “viability rule has no constitutional basis.” The state goes on to argue the “Constitution does not protect a right to abortion or limit States’ authority to restrict it.”⁶ The language and tone in this brief are more direct and aggressive than the states’ petition submitted last June.

However, the composition of the Court is different than in the past. This case will be argued with Justice Amy Coney Barrett seated in place of Justice Ruth Bader Ginsburg, who was a strong advocate for women’s rights.⁷ She joins Justices Neil Gorsuch and Brett Kavanaugh, also appointed by President Donald Trump and widely viewed as conservative judges, tipping the scales to a more conservative Supreme Court. This case will also be argued in a polarized political environment.^8,9 Given the conservative Supreme Court in the setting of an increasingly politically charged environment, reproductive right advocates are understandably worried that members of the anti-abortion movement view this as an opportunity to weaken or remove federal constitutional protections for abortion.

Continue to: Potential outcome of Dobbs v Jackson...

 

 

Potential outcome of Dobbs v Jackson

Should SCOTUS choose to rule in favor of Mississippi, it could severely weaken, or even overturn Roe v Wade. This would leave a legal path for states with pre-Roe abortion bans and currently unenforced post-Roe bans to take effect. These “trigger” laws are bans or severe restrictions on abortion providers and patients intended to take effect if Roe were to be overturned. Alternatively, the Court may overturn Southeastern Pennsylvania v Casey, but maintain Roe v Wade, essentially leaving the regulation of pre-viability abortion care to individual states. Currently 21 states have laws that would restrict the legal status of abortion.¹⁰ In addition, state legislatures are aggressively introducing abortion restrictions. As of June 2021, there have been 561 abortion restrictions, including 165 abortion bans, introduced across 47 states, putting 2021 on course to be the most devastating anti-abortion state legislative session in decades.¹¹

The damage caused by such restriction on abortion care would be significant. It would block or push access out of reach for many. The negative effects of such legislative action would most heavily burden those already marginalized by systemic, structural inequalities including those of low socioeconomic status, people of color, young people, those in rural communities, and members of the LGBTQ community. The medical community has long recognized the harm caused by restricting access to abortion care. Restriction of access to safe abortion care paradoxically has been shown not to decrease the incidence of abortion, but rather increases the number of unsafe abortions.¹² The American College of Obstetricians and Gynecologists (ACOG) acknowledge “individuals require access to safe, legal abortion” and that this represents “a necessary component for comprehensive health care.”^13,14 They joined the American Medical Association and other professional groups in a 2019 amicus brief to SCOTUS opposing restrictions on abortion access.¹⁵ In addition, government laws restricting access to abortion care undermine the fundamental relationship between a person and their physician, limiting a physician’s obligation to honor patient autonomy and provide appropriate medical care.

By taking up the question whether all pre-viability bans on elective abortions violate the Constitution, SCOTUS is indicating a possible willingness to revisit the central holding of abortion jurisprudence. Their decision regarding this case will likely be the most significant ruling regarding the legal status of abortion care in decades, and will significantly affect the delivery of abortion care in the future.

Action items

• Reach out to your representatives to support the Women’s Health Protection Act, an initiative introduced to Congress to protect access to abortion care. If you reside in a state where your federal representatives support the Women’s Health Protection Act, reach out to friends and colleagues in states without supportive elected officials and ask them to call their representatives and ask them to support the bill.
• Get involved with local grassroots groups fighting to protect abortion access.
• Continue to speak out against laws and policies designed to limit access to safe abortion care.
• Connect with your local ACOG chapter for more ways to become involved.
• As always, make sure you are registered to vote, and exercise your right whenever you can.

Globally, the United States has the highest per-capita cost of health care; total costs are expected to account for approximately 20% of the nation’s gross domestic product by 2025.¹ These rising costs have prompted residency programs and medical schools to incorporate business education into their curricula.^2-5 Although medical training is demanding—with little room to add curricular components—these business-focused curricula have consistently received positive feedback from residents.^5,6

In dermatology, more than 50% of residents opt to join a private practice upon graduation.⁷ In the United States, there also is an upward trend of practice acquisition and consolidation by private equity firms. Therefore, dermatology trainees are uniquely positioned to benefit from business education to make well-informed decisions about joining or starting a practice.Furthermore, whether in a private or academic setting, knowledge of foundational economics, business strategy, finance, marketing, and health care policy can equip dermatologists to more effectively advocate for local and national policies that benefit their patient population.⁷

We conducted a survey of dermatology program directors (PDs) to determine the availability of and perceptions regarding business education during residency training.

Materials and Methods

Institutional review board (Vanderbilt University Medical Center, Nashville, Tennessee) approval was obtained. The survey was distributed weekly during a 5-week period from July 2020 to August 2020 through the Research Electronic Data Capture survey application (www.project-redcap.org). Program director email addresses were obtained through the Accreditation Council for Graduate Medical Education (ACGME) program list. A PD was included in the survey if they were employed by an accredited US osteopathic or allopathic program and their email address was provided in the ACGME program list or on their program’s faculty web page; a PD was excluded if an email address was not provided in the ACGME program list or on their program’s faculty web page.

The 8-part questionnaire was designed to assess the following characteristics: details about the respondent’s residency program (institutional affiliation, number of residents), the respondent’s professional background (number of years as a PD, business training experience), resources for business education provided by the program, the respondent’s opinion about business education for residents, and the respondent’s perception of the most important topics to include in a dermatology curriculum’s business education component, which included economics/finance, health care policy/government, management, marketing, negotiation, private equity involvement in health care, business strategy, supply chain/operations, and technology/product development. Responses were kept anonymous. Categorical and continuous variables were analyzed with medians and proportions.

Results

Of the 139 surveys distributed, 35 were completed and returned (response rate, 25.2%). Most programs were university-affiliated (71.4%) or community-affiliated (22.9%). The median number of residents was 12. The respondents had a median of 5 years’ experience in their role. Most respondents (65.7%) had no business training, although 20.0% had completed undergraduate business coursework, and 8.6% had attended formal seminars on business topics; 5.7% were self-taught on business topics.

Business Education Availability
Approximately half (51.4%) of programs offered business training to residents, primarily through seminars or lectures (94.4%) and take-home modules (16.7%). None of the programs offered a formal gap year during which residents could pursue a professional business degree. Most respondents thought business education during residency was important (82.8%) and that programs should implement more training (57.1%). When asked whether residents were competent to handle business aspects of dermatology upon graduation, most respondents disagreed somewhat (22.9%) or were neutral (40.0%).

Topics for Business Education
The most important topics identified for inclusion in a business curriculum were economics or finance (68.6%), management (68.6%), and health care policy or government (57.1%). Other identified topics included negotiation (40.0%), private equity involvement in health care (40.0%), strategy (11.4%), supply chain or operations (11.4%), marketing (2.9%), and technology (2.9%).

Comment

Residency programs and medical schools in the United States have started to integrate formal business training into their curricula; however, the state of business training in dermatology has not been characterized. Overall, this survey revealed largely positive perceptions about business education and identified a demand for more resources.

Whereas most PDs identified business education as important, only one half (51.4%) of the representative programs offered structured training. Notably, most PDs did not agree that graduating residents were competent to handle the business demands of dermatology practice. These responses highlight a gap in the demand and resources available for business training.

Identifying Curricular Resources
During an already demanding residency, additional curricular components need to be beneficial and worthwhile. To avoid significant disruption, business training could take place in the form of online lectures or take-home modules. Most programs represented in the survey responses had an academic affiliation and therefore commonly have access to an affiliated graduate business school and/or hospital administrators who have clinical and business training.

Community dermatologists who own or run their own practice also are uniquely positioned to provide residents with practical, dermatology-specific business education. Programs can utilize their institutional and local colleagues to aid in curricular design and implementation. In addition, a potential long-term solution to obtaining resources for business education is to coordinate with a national dermatology organization to create standardized modules that are available to all residency programs.

Key Curriculum Topics
Our survey identified the most important topics to include in a business curriculum for dermatology residents. Economics and finance, management, and health care policy would be valuable to a trainee regardless of whether they ultimately choose a career in academia or private practice. A thorough understanding of complex health care policy reinforces knowledge about insurance and regional and national regulations, which could ultimately benefit patient care. As an example, the American Academy of Dermatology outlines several advocacy priorities such as Medicare reimbursement policies, access to dermatologic care through public and private insurance, medication access and pricing, and preservation of private practice in the setting of market consolidation. Having a better understanding of health care policy and business could better equip dermatologists to lead these often business-driven advocacy efforts to ultimately improve patient care and advance the specialty.⁸

Limitations
There were notable limitations to this survey, primarily related to its design. With a 25% response rate, there was the potential for response and selection biases; therefore, these results might not be generalizable to all programs. In addition, views held by PDs might not be consistent with those of other members of the dermatology community; for example, surveying residents, other faculty members, and dermatologists in private practice would have provided a more comprehensive characterization of the topic.

Conclusion

This study assessed residency program directors’ perceptions of business education in dermatology training. There appears to be an imbalance between the perceived importance of such education and the resources that are available to provide it. More attention is needed to address this gap to ensure that dermatologists are prepared to manage a rapidly changing health care environment. Results of this survey should encourage efforts to establish (1) a standardized, dermatology-specific business curriculum and (2) a plan to make that curriculum accessible to trainees and other members of the dermatology community.

Globally, the United States has the highest per-capita cost of health care; total costs are expected to account for approximately 20% of the nation’s gross domestic product by 2025.¹ These rising costs have prompted residency programs and medical schools to incorporate business education into their curricula.^2-5 Although medical training is demanding—with little room to add curricular components—these business-focused curricula have consistently received positive feedback from residents.^5,6

In dermatology, more than 50% of residents opt to join a private practice upon graduation.⁷ In the United States, there also is an upward trend of practice acquisition and consolidation by private equity firms. Therefore, dermatology trainees are uniquely positioned to benefit from business education to make well-informed decisions about joining or starting a practice.Furthermore, whether in a private or academic setting, knowledge of foundational economics, business strategy, finance, marketing, and health care policy can equip dermatologists to more effectively advocate for local and national policies that benefit their patient population.⁷

We conducted a survey of dermatology program directors (PDs) to determine the availability of and perceptions regarding business education during residency training.

Materials and Methods

Institutional review board (Vanderbilt University Medical Center, Nashville, Tennessee) approval was obtained. The survey was distributed weekly during a 5-week period from July 2020 to August 2020 through the Research Electronic Data Capture survey application (www.project-redcap.org). Program director email addresses were obtained through the Accreditation Council for Graduate Medical Education (ACGME) program list. A PD was included in the survey if they were employed by an accredited US osteopathic or allopathic program and their email address was provided in the ACGME program list or on their program’s faculty web page; a PD was excluded if an email address was not provided in the ACGME program list or on their program’s faculty web page.

The 8-part questionnaire was designed to assess the following characteristics: details about the respondent’s residency program (institutional affiliation, number of residents), the respondent’s professional background (number of years as a PD, business training experience), resources for business education provided by the program, the respondent’s opinion about business education for residents, and the respondent’s perception of the most important topics to include in a dermatology curriculum’s business education component, which included economics/finance, health care policy/government, management, marketing, negotiation, private equity involvement in health care, business strategy, supply chain/operations, and technology/product development. Responses were kept anonymous. Categorical and continuous variables were analyzed with medians and proportions.

Results

Of the 139 surveys distributed, 35 were completed and returned (response rate, 25.2%). Most programs were university-affiliated (71.4%) or community-affiliated (22.9%). The median number of residents was 12. The respondents had a median of 5 years’ experience in their role. Most respondents (65.7%) had no business training, although 20.0% had completed undergraduate business coursework, and 8.6% had attended formal seminars on business topics; 5.7% were self-taught on business topics.

Business Education Availability
Approximately half (51.4%) of programs offered business training to residents, primarily through seminars or lectures (94.4%) and take-home modules (16.7%). None of the programs offered a formal gap year during which residents could pursue a professional business degree. Most respondents thought business education during residency was important (82.8%) and that programs should implement more training (57.1%). When asked whether residents were competent to handle business aspects of dermatology upon graduation, most respondents disagreed somewhat (22.9%) or were neutral (40.0%).

Topics for Business Education
The most important topics identified for inclusion in a business curriculum were economics or finance (68.6%), management (68.6%), and health care policy or government (57.1%). Other identified topics included negotiation (40.0%), private equity involvement in health care (40.0%), strategy (11.4%), supply chain or operations (11.4%), marketing (2.9%), and technology (2.9%).

Comment

Residency programs and medical schools in the United States have started to integrate formal business training into their curricula; however, the state of business training in dermatology has not been characterized. Overall, this survey revealed largely positive perceptions about business education and identified a demand for more resources.

Whereas most PDs identified business education as important, only one half (51.4%) of the representative programs offered structured training. Notably, most PDs did not agree that graduating residents were competent to handle the business demands of dermatology practice. These responses highlight a gap in the demand and resources available for business training.

Identifying Curricular Resources
During an already demanding residency, additional curricular components need to be beneficial and worthwhile. To avoid significant disruption, business training could take place in the form of online lectures or take-home modules. Most programs represented in the survey responses had an academic affiliation and therefore commonly have access to an affiliated graduate business school and/or hospital administrators who have clinical and business training.

Community dermatologists who own or run their own practice also are uniquely positioned to provide residents with practical, dermatology-specific business education. Programs can utilize their institutional and local colleagues to aid in curricular design and implementation. In addition, a potential long-term solution to obtaining resources for business education is to coordinate with a national dermatology organization to create standardized modules that are available to all residency programs.

Key Curriculum Topics
Our survey identified the most important topics to include in a business curriculum for dermatology residents. Economics and finance, management, and health care policy would be valuable to a trainee regardless of whether they ultimately choose a career in academia or private practice. A thorough understanding of complex health care policy reinforces knowledge about insurance and regional and national regulations, which could ultimately benefit patient care. As an example, the American Academy of Dermatology outlines several advocacy priorities such as Medicare reimbursement policies, access to dermatologic care through public and private insurance, medication access and pricing, and preservation of private practice in the setting of market consolidation. Having a better understanding of health care policy and business could better equip dermatologists to lead these often business-driven advocacy efforts to ultimately improve patient care and advance the specialty.⁸

Limitations
There were notable limitations to this survey, primarily related to its design. With a 25% response rate, there was the potential for response and selection biases; therefore, these results might not be generalizable to all programs. In addition, views held by PDs might not be consistent with those of other members of the dermatology community; for example, surveying residents, other faculty members, and dermatologists in private practice would have provided a more comprehensive characterization of the topic.

Conclusion

This study assessed residency program directors’ perceptions of business education in dermatology training. There appears to be an imbalance between the perceived importance of such education and the resources that are available to provide it. More attention is needed to address this gap to ensure that dermatologists are prepared to manage a rapidly changing health care environment. Results of this survey should encourage efforts to establish (1) a standardized, dermatology-specific business curriculum and (2) a plan to make that curriculum accessible to trainees and other members of the dermatology community.

Globally, the United States has the highest per-capita cost of health care; total costs are expected to account for approximately 20% of the nation’s gross domestic product by 2025.¹ These rising costs have prompted residency programs and medical schools to incorporate business education into their curricula.^2-5 Although medical training is demanding—with little room to add curricular components—these business-focused curricula have consistently received positive feedback from residents.^5,6

In dermatology, more than 50% of residents opt to join a private practice upon graduation.⁷ In the United States, there also is an upward trend of practice acquisition and consolidation by private equity firms. Therefore, dermatology trainees are uniquely positioned to benefit from business education to make well-informed decisions about joining or starting a practice.Furthermore, whether in a private or academic setting, knowledge of foundational economics, business strategy, finance, marketing, and health care policy can equip dermatologists to more effectively advocate for local and national policies that benefit their patient population.⁷

We conducted a survey of dermatology program directors (PDs) to determine the availability of and perceptions regarding business education during residency training.

Materials and Methods

Institutional review board (Vanderbilt University Medical Center, Nashville, Tennessee) approval was obtained. The survey was distributed weekly during a 5-week period from July 2020 to August 2020 through the Research Electronic Data Capture survey application (www.project-redcap.org). Program director email addresses were obtained through the Accreditation Council for Graduate Medical Education (ACGME) program list. A PD was included in the survey if they were employed by an accredited US osteopathic or allopathic program and their email address was provided in the ACGME program list or on their program’s faculty web page; a PD was excluded if an email address was not provided in the ACGME program list or on their program’s faculty web page.

The 8-part questionnaire was designed to assess the following characteristics: details about the respondent’s residency program (institutional affiliation, number of residents), the respondent’s professional background (number of years as a PD, business training experience), resources for business education provided by the program, the respondent’s opinion about business education for residents, and the respondent’s perception of the most important topics to include in a dermatology curriculum’s business education component, which included economics/finance, health care policy/government, management, marketing, negotiation, private equity involvement in health care, business strategy, supply chain/operations, and technology/product development. Responses were kept anonymous. Categorical and continuous variables were analyzed with medians and proportions.

Results

Of the 139 surveys distributed, 35 were completed and returned (response rate, 25.2%). Most programs were university-affiliated (71.4%) or community-affiliated (22.9%). The median number of residents was 12. The respondents had a median of 5 years’ experience in their role. Most respondents (65.7%) had no business training, although 20.0% had completed undergraduate business coursework, and 8.6% had attended formal seminars on business topics; 5.7% were self-taught on business topics.

Business Education Availability
Approximately half (51.4%) of programs offered business training to residents, primarily through seminars or lectures (94.4%) and take-home modules (16.7%). None of the programs offered a formal gap year during which residents could pursue a professional business degree. Most respondents thought business education during residency was important (82.8%) and that programs should implement more training (57.1%). When asked whether residents were competent to handle business aspects of dermatology upon graduation, most respondents disagreed somewhat (22.9%) or were neutral (40.0%).

Topics for Business Education
The most important topics identified for inclusion in a business curriculum were economics or finance (68.6%), management (68.6%), and health care policy or government (57.1%). Other identified topics included negotiation (40.0%), private equity involvement in health care (40.0%), strategy (11.4%), supply chain or operations (11.4%), marketing (2.9%), and technology (2.9%).

Comment

Residency programs and medical schools in the United States have started to integrate formal business training into their curricula; however, the state of business training in dermatology has not been characterized. Overall, this survey revealed largely positive perceptions about business education and identified a demand for more resources.

Whereas most PDs identified business education as important, only one half (51.4%) of the representative programs offered structured training. Notably, most PDs did not agree that graduating residents were competent to handle the business demands of dermatology practice. These responses highlight a gap in the demand and resources available for business training.

Identifying Curricular Resources
During an already demanding residency, additional curricular components need to be beneficial and worthwhile. To avoid significant disruption, business training could take place in the form of online lectures or take-home modules. Most programs represented in the survey responses had an academic affiliation and therefore commonly have access to an affiliated graduate business school and/or hospital administrators who have clinical and business training.

Community dermatologists who own or run their own practice also are uniquely positioned to provide residents with practical, dermatology-specific business education. Programs can utilize their institutional and local colleagues to aid in curricular design and implementation. In addition, a potential long-term solution to obtaining resources for business education is to coordinate with a national dermatology organization to create standardized modules that are available to all residency programs.

Key Curriculum Topics
Our survey identified the most important topics to include in a business curriculum for dermatology residents. Economics and finance, management, and health care policy would be valuable to a trainee regardless of whether they ultimately choose a career in academia or private practice. A thorough understanding of complex health care policy reinforces knowledge about insurance and regional and national regulations, which could ultimately benefit patient care. As an example, the American Academy of Dermatology outlines several advocacy priorities such as Medicare reimbursement policies, access to dermatologic care through public and private insurance, medication access and pricing, and preservation of private practice in the setting of market consolidation. Having a better understanding of health care policy and business could better equip dermatologists to lead these often business-driven advocacy efforts to ultimately improve patient care and advance the specialty.⁸

Limitations
There were notable limitations to this survey, primarily related to its design. With a 25% response rate, there was the potential for response and selection biases; therefore, these results might not be generalizable to all programs. In addition, views held by PDs might not be consistent with those of other members of the dermatology community; for example, surveying residents, other faculty members, and dermatologists in private practice would have provided a more comprehensive characterization of the topic.

Conclusion

This study assessed residency program directors’ perceptions of business education in dermatology training. There appears to be an imbalance between the perceived importance of such education and the resources that are available to provide it. More attention is needed to address this gap to ensure that dermatologists are prepared to manage a rapidly changing health care environment. Results of this survey should encourage efforts to establish (1) a standardized, dermatology-specific business curriculum and (2) a plan to make that curriculum accessible to trainees and other members of the dermatology community.