I will never forget the first time I cared for a patient who tested positive for COVID-19. It was March 2020, and I was evaluating a patient in the emergency department (ED). At the time we knew very little about this virus and how it is transmitted. We had all seen the images from Wuhan, China, and had appropriate fear of the lethality of the virus, but there was not yet a clear understanding as to how best to keep health care practitioners safe as they cared for patients with COVID-19.

That evening I received a page that a middle-aged man who had tested positive for COVID-19 was in the ED with fever, cough, and hypoxia. As a hospitalist, my role is to care for these patients, those admitted to stay overnight in the hospital. Before going to see the patient, I watched a video on how to properly don personal protective equipment (PPE). I walked to the ED and suited up with a surgical mask, goggles, disposable gown, and gloves. I was very conscious of the amount of time I spent in that patient’s room, and tried to stand at the foot of the bed as much as possible so as to maximize the distance between our faces when we talked.

Upon finishing my assessment, I took off my PPE and exited the room but kept wondering if I had done so correctly. That night when I came home, I slept in the guest bedroom to minimize the risk of transmission of the virus to my wife. For the next 7 days I was terrified that I had been exposed to the virus, worried that I hadn’t worn my mask properly, or that I exposed myself to contamination when taking off my goggles and gown. I was hyperaware of my breathing and temperature, wondering if that scratch in my throat was the first sign of something worse. I never did develop any symptoms of illness but the amount of stress I felt that week was enormous.

Over the subsequent weeks I became much more comfortable with putting on and taking off PPE since the volume of COVID patients kept increasing to the point that more than 80% of the hospital patient census consisted of COVID-19 infections. Those patient interactions became less awkward once I could stop worrying about the PPE and focus on providing patient care.

Unfortunately, patient after patient entered the hospital, all with the same symptoms: cough, fever, and hypoxia. Medically there was little decision-making necessary as care was mostly supportive with supplemental oxygen to give these patients time to recover. Instead, I focused on understanding each patient’s symptoms and thinking about what could be offered to relieve bothersome symptoms. These patients were isolated in their hospital rooms – denied visitors and their interactions with hospital staff involved layers and layers of protective barrier. I sought to overcome those physical barriers through personal connection – learning about a patient’s hobbies, asking about their families, or reminiscing about one of their favorite trips.

Despite this supportive care, many patients ended up intubated in the intensive care unit. Many eventually improved, and we celebrated those individuals – a victory at a time. We even counted the COVID discharges with a running tally; first 10, then a few dozen, and eventually the number climbed into the triple digits. But not every patient was so fortunate. Hearing about a 40-something who passed away hit too close to home – what if that were me?

The hospitalists I work with rose to the occasion. We feared the virus but still showed up for work because the patients needed us and we had job obligations to honor. Everyone else was stuck at home during lockdown but we still got in our cars and drove to the hospital, suited up in our PPE, and cared for terrified patients that were struggling to breathe.

There was a satisfaction in having a job to do and being able to contribute during this time of global crisis. Staying busy gave our minds something to focus on and helped us feel a sense of purpose. Some of us stayed late to coordinate staffing. Others helped to disseminate practice guidelines and clinical knowledge. While others lent a hand wherever they could to pitch in. That sense of camaraderie served as plenty of motivation.

During the early stages of the pandemic, there was a sense that this crisis that would end after a few months and life would return to normal. By May, we experienced a dramatic decline in the number of hospitalized patients with COVID-19, which resulted in a real sense of optimism. But soon it became apparent that this pandemic was not going away anytime soon.

Cases nationwide began rising again over the summer. We saw a steady trickle of new admissions at our hospital month after month until the fall when the rate of admissions accelerated again. The hospital reactivated our surge plan, increased staffing, and confronted the new surge with growing dread. That first surge was all endorphins – but fatigue set in by the time the second wave hit. The volunteerism and sense of “we are in this together” just did not exist anymore. The stories about health care heroes in the broader community waned and the outside world seemingly had moved on from thinking about the pandemic.

Yet we remained, caring for patients with cough, fever, and low oxygen saturation. It was like living through a movie we had already seen before. We knew what we were supposed to do and we followed the script. But now it felt too much like a routine.

It has been a very long 14 months since I first cared for a patient with COVID-19. For much of this time it felt like we were just stuck on a treadmill, passing the time but not making any significant progress towards a post-COVID future state. How many times over this year did we push that date forward in our minds when “life would go back to normal”?

Now, we have reason for hope. More than 100 million Americans have been vaccinated and that number rises daily. The vaccines are remarkably effective, they are making a real difference in reducing the number of patients with COVID-19 at the hospital, and our level of daily anxiety is lower. There is still much uncertainty about the future, but at least we can feel proud of our service over the last year — proud of showing up and donning that PPE. And so, we continue one patient at a time.

Corresponding author: James A. Colbert, MD, Attending Hospitalist, Newton-Wellesley Hospital, 2014 Washington St, Newton, MA, 02462, Senior Medical Director, Blue Cross Blue Shield of Massachusetts; [email protected].

Financial disclosures: None.

I will never forget the first time I cared for a patient who tested positive for COVID-19. It was March 2020, and I was evaluating a patient in the emergency department (ED). At the time we knew very little about this virus and how it is transmitted. We had all seen the images from Wuhan, China, and had appropriate fear of the lethality of the virus, but there was not yet a clear understanding as to how best to keep health care practitioners safe as they cared for patients with COVID-19.

That evening I received a page that a middle-aged man who had tested positive for COVID-19 was in the ED with fever, cough, and hypoxia. As a hospitalist, my role is to care for these patients, those admitted to stay overnight in the hospital. Before going to see the patient, I watched a video on how to properly don personal protective equipment (PPE). I walked to the ED and suited up with a surgical mask, goggles, disposable gown, and gloves. I was very conscious of the amount of time I spent in that patient’s room, and tried to stand at the foot of the bed as much as possible so as to maximize the distance between our faces when we talked.

Upon finishing my assessment, I took off my PPE and exited the room but kept wondering if I had done so correctly. That night when I came home, I slept in the guest bedroom to minimize the risk of transmission of the virus to my wife. For the next 7 days I was terrified that I had been exposed to the virus, worried that I hadn’t worn my mask properly, or that I exposed myself to contamination when taking off my goggles and gown. I was hyperaware of my breathing and temperature, wondering if that scratch in my throat was the first sign of something worse. I never did develop any symptoms of illness but the amount of stress I felt that week was enormous.

Over the subsequent weeks I became much more comfortable with putting on and taking off PPE since the volume of COVID patients kept increasing to the point that more than 80% of the hospital patient census consisted of COVID-19 infections. Those patient interactions became less awkward once I could stop worrying about the PPE and focus on providing patient care.

Unfortunately, patient after patient entered the hospital, all with the same symptoms: cough, fever, and hypoxia. Medically there was little decision-making necessary as care was mostly supportive with supplemental oxygen to give these patients time to recover. Instead, I focused on understanding each patient’s symptoms and thinking about what could be offered to relieve bothersome symptoms. These patients were isolated in their hospital rooms – denied visitors and their interactions with hospital staff involved layers and layers of protective barrier. I sought to overcome those physical barriers through personal connection – learning about a patient’s hobbies, asking about their families, or reminiscing about one of their favorite trips.

Despite this supportive care, many patients ended up intubated in the intensive care unit. Many eventually improved, and we celebrated those individuals – a victory at a time. We even counted the COVID discharges with a running tally; first 10, then a few dozen, and eventually the number climbed into the triple digits. But not every patient was so fortunate. Hearing about a 40-something who passed away hit too close to home – what if that were me?

The hospitalists I work with rose to the occasion. We feared the virus but still showed up for work because the patients needed us and we had job obligations to honor. Everyone else was stuck at home during lockdown but we still got in our cars and drove to the hospital, suited up in our PPE, and cared for terrified patients that were struggling to breathe.

There was a satisfaction in having a job to do and being able to contribute during this time of global crisis. Staying busy gave our minds something to focus on and helped us feel a sense of purpose. Some of us stayed late to coordinate staffing. Others helped to disseminate practice guidelines and clinical knowledge. While others lent a hand wherever they could to pitch in. That sense of camaraderie served as plenty of motivation.

During the early stages of the pandemic, there was a sense that this crisis that would end after a few months and life would return to normal. By May, we experienced a dramatic decline in the number of hospitalized patients with COVID-19, which resulted in a real sense of optimism. But soon it became apparent that this pandemic was not going away anytime soon.

Cases nationwide began rising again over the summer. We saw a steady trickle of new admissions at our hospital month after month until the fall when the rate of admissions accelerated again. The hospital reactivated our surge plan, increased staffing, and confronted the new surge with growing dread. That first surge was all endorphins – but fatigue set in by the time the second wave hit. The volunteerism and sense of “we are in this together” just did not exist anymore. The stories about health care heroes in the broader community waned and the outside world seemingly had moved on from thinking about the pandemic.

Yet we remained, caring for patients with cough, fever, and low oxygen saturation. It was like living through a movie we had already seen before. We knew what we were supposed to do and we followed the script. But now it felt too much like a routine.

It has been a very long 14 months since I first cared for a patient with COVID-19. For much of this time it felt like we were just stuck on a treadmill, passing the time but not making any significant progress towards a post-COVID future state. How many times over this year did we push that date forward in our minds when “life would go back to normal”?

Now, we have reason for hope. More than 100 million Americans have been vaccinated and that number rises daily. The vaccines are remarkably effective, they are making a real difference in reducing the number of patients with COVID-19 at the hospital, and our level of daily anxiety is lower. There is still much uncertainty about the future, but at least we can feel proud of our service over the last year — proud of showing up and donning that PPE. And so, we continue one patient at a time.

Corresponding author: James A. Colbert, MD, Attending Hospitalist, Newton-Wellesley Hospital, 2014 Washington St, Newton, MA, 02462, Senior Medical Director, Blue Cross Blue Shield of Massachusetts; [email protected].

Financial disclosures: None.

I will never forget the first time I cared for a patient who tested positive for COVID-19. It was March 2020, and I was evaluating a patient in the emergency department (ED). At the time we knew very little about this virus and how it is transmitted. We had all seen the images from Wuhan, China, and had appropriate fear of the lethality of the virus, but there was not yet a clear understanding as to how best to keep health care practitioners safe as they cared for patients with COVID-19.

That evening I received a page that a middle-aged man who had tested positive for COVID-19 was in the ED with fever, cough, and hypoxia. As a hospitalist, my role is to care for these patients, those admitted to stay overnight in the hospital. Before going to see the patient, I watched a video on how to properly don personal protective equipment (PPE). I walked to the ED and suited up with a surgical mask, goggles, disposable gown, and gloves. I was very conscious of the amount of time I spent in that patient’s room, and tried to stand at the foot of the bed as much as possible so as to maximize the distance between our faces when we talked.

Upon finishing my assessment, I took off my PPE and exited the room but kept wondering if I had done so correctly. That night when I came home, I slept in the guest bedroom to minimize the risk of transmission of the virus to my wife. For the next 7 days I was terrified that I had been exposed to the virus, worried that I hadn’t worn my mask properly, or that I exposed myself to contamination when taking off my goggles and gown. I was hyperaware of my breathing and temperature, wondering if that scratch in my throat was the first sign of something worse. I never did develop any symptoms of illness but the amount of stress I felt that week was enormous.

Over the subsequent weeks I became much more comfortable with putting on and taking off PPE since the volume of COVID patients kept increasing to the point that more than 80% of the hospital patient census consisted of COVID-19 infections. Those patient interactions became less awkward once I could stop worrying about the PPE and focus on providing patient care.

Unfortunately, patient after patient entered the hospital, all with the same symptoms: cough, fever, and hypoxia. Medically there was little decision-making necessary as care was mostly supportive with supplemental oxygen to give these patients time to recover. Instead, I focused on understanding each patient’s symptoms and thinking about what could be offered to relieve bothersome symptoms. These patients were isolated in their hospital rooms – denied visitors and their interactions with hospital staff involved layers and layers of protective barrier. I sought to overcome those physical barriers through personal connection – learning about a patient’s hobbies, asking about their families, or reminiscing about one of their favorite trips.

Despite this supportive care, many patients ended up intubated in the intensive care unit. Many eventually improved, and we celebrated those individuals – a victory at a time. We even counted the COVID discharges with a running tally; first 10, then a few dozen, and eventually the number climbed into the triple digits. But not every patient was so fortunate. Hearing about a 40-something who passed away hit too close to home – what if that were me?

The hospitalists I work with rose to the occasion. We feared the virus but still showed up for work because the patients needed us and we had job obligations to honor. Everyone else was stuck at home during lockdown but we still got in our cars and drove to the hospital, suited up in our PPE, and cared for terrified patients that were struggling to breathe.

There was a satisfaction in having a job to do and being able to contribute during this time of global crisis. Staying busy gave our minds something to focus on and helped us feel a sense of purpose. Some of us stayed late to coordinate staffing. Others helped to disseminate practice guidelines and clinical knowledge. While others lent a hand wherever they could to pitch in. That sense of camaraderie served as plenty of motivation.

During the early stages of the pandemic, there was a sense that this crisis that would end after a few months and life would return to normal. By May, we experienced a dramatic decline in the number of hospitalized patients with COVID-19, which resulted in a real sense of optimism. But soon it became apparent that this pandemic was not going away anytime soon.

Cases nationwide began rising again over the summer. We saw a steady trickle of new admissions at our hospital month after month until the fall when the rate of admissions accelerated again. The hospital reactivated our surge plan, increased staffing, and confronted the new surge with growing dread. That first surge was all endorphins – but fatigue set in by the time the second wave hit. The volunteerism and sense of “we are in this together” just did not exist anymore. The stories about health care heroes in the broader community waned and the outside world seemingly had moved on from thinking about the pandemic.

Yet we remained, caring for patients with cough, fever, and low oxygen saturation. It was like living through a movie we had already seen before. We knew what we were supposed to do and we followed the script. But now it felt too much like a routine.

It has been a very long 14 months since I first cared for a patient with COVID-19. For much of this time it felt like we were just stuck on a treadmill, passing the time but not making any significant progress towards a post-COVID future state. How many times over this year did we push that date forward in our minds when “life would go back to normal”?

Now, we have reason for hope. More than 100 million Americans have been vaccinated and that number rises daily. The vaccines are remarkably effective, they are making a real difference in reducing the number of patients with COVID-19 at the hospital, and our level of daily anxiety is lower. There is still much uncertainty about the future, but at least we can feel proud of our service over the last year — proud of showing up and donning that PPE. And so, we continue one patient at a time.

Corresponding author: James A. Colbert, MD, Attending Hospitalist, Newton-Wellesley Hospital, 2014 Washington St, Newton, MA, 02462, Senior Medical Director, Blue Cross Blue Shield of Massachusetts; [email protected].

Financial disclosures: None.

From Titus Family Department of Clinical Pharmacy, School of Pharmacy, University of Southern California, Los Angeles, CA (Drs. Chu and Ma and Mimi Lou), and Department of Family Medicine, Keck Medicine, University of Southern California, Los Angeles, CA (Dr. Suh).

Objective: The objective of this study is to describe HbA_1c changes in patients who maintained continuous pharmacist care vs patients who had a gap in pharmacist care of 3 months or longer. 

Methods: This retrospective study was conducted from October 1, 2018, to September 30, 2019. Electronic health record data from an academic-affiliated, safety-net resident physician primary care clinic were collected to observe HbA_1c changes between patients with continuous pharmacist care and patients who had a gap of 3 months or longer in pharmacist care. A total of 189 patients met the inclusion criteria and were divided into 2 groups: those with continuous care and those with gaps in care. Data were analyzed using the Mann-Whitney test for continuous variables and the χ² (or Fisher exact) test for categorical variables. The differences-in-differences model was used to compare the changes in HbA_1c between the 2 groups.

Results: There was no significant difference in changes in HbA_1c between the continuous care group and the gaps in care group, although the mean magnitude of HbA_1c changes was numerically greater in the continuous care group (-1.48% vs -0.97%). Overall, both groups showed improvement in their HbA_1c levels and had similar numbers of primary care physician visits and acute care utilizations, while the gaps in care group had longer duration with pharmacists and between the adjacent pharmacist visits.

Conclusion: Maintaining continuous, regular visits with a pharmacist at a safety-net resident physician primary care clinic did not show a significant difference in HbA_1c changes compared to having gaps in pharmacist care. Future studies on socioeconomic and behavioral burden on HbA_1c improvement and on pharmacist visits in these populations should be explored.

Keywords: clinical pharmacist; diabetes management; continuous visit; primary care clinic.

Pharmacists have unique skills in identifying and resolving problems related to the safety and efficacy of drug therapy while addressing medication adherence and access for patients. Their expertise is especially important to meet the care needs of a growing population with chronic conditions amidst a primary care physician shortage.¹ As health care systems move toward value-based care, emphasis on improvement in quality and health measures have become central in care delivery. Pharmacists have been integrated into team-based care in primary care settings, but the value-based shift has opened more opportunities for pharmacists to address unmet quality standards.^2-5

Many studies have reported that the integration of pharmacists into team-based care improves health outcomes and reduces overall health care costs.^6-9 Specifically, when pharmacists were added to primary care teams to provide diabetes management, hemoglobin HbA_1c levels were reduced compared to teams without pharmacists.^10-13 Offering pharmacist visits as often as every 2 weeks to 3 months, with each patient having an average of 4.7 visits, resulted in improved therapeutic outcomes.^3,7 During visits, pharmacists address the need for additional drug therapy, deprescribe unnecessary therapy, correct insufficient doses or durations, and switch patients to more cost-efficient drug therapy.⁹ Likewise, patients who visit pharmacists in addition to seeing their primary care physician can have medication-related concerns resolved and improve their therapeutic outcomes.^10,11

Not much is known about the magnitude of HbA_1c change based on the regularity of pharmacist visits. Although pharmacists offer follow-up appointments in reasonable time intervals, patients do not keep every appointment for a variety of reasons, including forgetfulness, personal issues, and a lack of transportation.¹⁴ Such missed appointments can negatively impact health outcomes.^14-16 The purpose of this study is to describe HbA_1c changes in patients who maintained continuous, regular pharmacist visits without a 3-month gap and in patients who had history of inconsistent pharmacist visits with a gap of 3 months or longer. Furthermore, this study describes the frequency of health care utilization for these 2 groups.

Methods

Setting

The Internal Medicine resident physician primary care clinic is 1 of 2 adult primary care clinics at an academic, urban, public medical center. It is in the heart of East Los Angeles, where predominantly Spanish-speaking and minority populations reside. The clinic has approximately 19000 empaneled patients and is the largest resident primary care clinic in the public health system. The clinical pharmacy service addresses unmet quality standards, specifically HbA_1c. The clinical pharmacists are co-located and collaborate with resident physicians, attending physicians, care managers, nurses, social workers, and community health workers at the clinic. They operate under collaborative practice agreements with prescriptive authority, except for controlled substances, specialty drugs, and antipsychotic medications.

Pharmacist visit

Patients are primarily referred by resident physicians to clinical pharmacists when their HbA_1c level is above 8% for an extended period, when poor adherence and low health literacy are evident regardless of HbA_1c level, or when a complex medication regimen requires comprehensive medication review and reconciliation. The referral occurs through warm handoff by resident physicians as well as clinic nurses, and it is embedded in the clinic flow. Patients continue their visits with resident physicians for issues other than their referral to clinical pharmacists. The visits with pharmacists are appointment-based, occur independently from resident physician visits, and continue until the patient’s HbA_1c level or adherence is optimized. Clinical pharmacists continue to follow up with patients who may have reached their target HbA_1c level but still are deemed unstable due to inconsistency in their self-management and medication adherence.

After the desirable HbA_1c target is achieved along with full adherence to medications and self-management, clinical pharmacists will hand off patients back to resident physicians. At each visit, pharmacists perform a comprehensive medication assessment and reconciliation that includes adjusting medication therapy, placing orders for necessary laboratory tests and prescriptions, and assessing medication adherence. They also evaluate patients’ signs and symptoms for hyperglycemic complications, hypoglycemia, and other potential treatment-related adverse events. These are all within the pharmacist’s scope of practice in comprehensive medication management. Patient education is provided with the teach-back method and includes lifestyle modifications and medication counseling (Table 1). Pharmacists offer face-to-face visits as frequently as every 1 to 2 weeks to every 4 to 6 weeks, depending on the level of complexity and the severity of a patient’s conditions and medications. For patients whose HbA_1c has reached the target range but have not been deemed stable, pharmacists continue to check in with them every 2 months. Phone visits are also utilized as an additional care delivery method for patients having difficulty showing up for face-to-face visits or needing quick assessment of medication adherence and responses to changes in drug treatment in between the face-to-face visits. The maximal interval between pharmacist visits is offered no longer than every 8 weeks. Patients are contacted via phone or mail by the nursing staff to reschedule if they miss their appointments with pharmacists. Every pharmacy visit is documented in the patient’s electronic medical record.

Study design

This is a retrospective study describing the HbA_1c changes in a patient group that maintained pharmacist visits, with each interval less than 3 months, and in another group, who had a history of a 3-month or longer gap between pharmacist visits. The data were obtained from patients’ electronic medical records during the study period of October 1, 2018, and September 30, 2019, and collected using a HIPAA-compliant, electronic data storage website, REDCap. The institutional review board approval was obtained under HS-19-00929. Patients 18 years and older who were referred by primary care resident physicians for diabetes management, and had 2 or more visits with a pharmacist within the study period, were included. Patients were excluded if they had only 1 HbA_1c drawn during the study period, were referred to a pharmacist for reasons other than diabetes management, were concurrently managed by an endocrinologist, had only 1 visit with a pharmacist, or had no visits with their primary care resident physician for over a year. The patients were then divided into 2 groups: continuous care cohort (CCC) and gap in care cohort (GCC). Both face-to-face and phone visits were counted as pharmacist visits for each group.

Outcomes

The primary outcome was the change in HbA_1c from baseline between the 2 groups. Baseline HbA_1c was considered as the HbA_1c value obtained within 3 months prior to, or within 1 month, of the first visit with the pharmacist during the study period. The final HbA_1c was considered the value measured within 1 month of, or 3 months after, the patient’s last visit with the pharmacist during the study period.

Several subgroup analyses were conducted to examine the relationship between HbA_1c and each group. Among patients whose baseline HbA_1c was ≥ 8%, we looked at the percentage of patients reaching HbA_1c < 8%, the percentage of patients showing any level of improvement in HbA_1c, and the change in HbA_1c for each group. We also looked at the percentage of patients with baseline HbA_1c < 8% maintaining the level throughout the study period and the change in HbA_1c for each group. Additionally, we looked at health care utilization, which included pharmacist visits, primary care physician visits, emergency room and urgent care visits, and hospitalizations for each group. The latter 3 types of utilization were grouped as acute care utilization and further analyzed for visit reasons, which were subsequently categorized as diabetes related and non-diabetes related. The diabetes related reasons linking to acute care utilization were defined as any episodes related to hypoglycemia, diabetic ketoacidosis (DKA), hyperosmolar hyperglycemic state (HHS), foot ulcers, retinopathy, and osteomyelitis infection. All other reasons leading to acute care utilization were categorized as non-diabetes related.

Statistical analysis

Descriptive analyses were conducted using the Mann-Whitney test for continuous data and χ² (or Fisher exact) test for categorical data. A basic difference-in-differences (D-I-D) method was used to compare the changes of HbA_1c between the CCC and GCC over 2 time points: baseline and final measurements. The repeated measures ANOVA was used for analyzing D-I-D. P < .05 was considered significant. Statistical analyses were performed using SAS version 9.4 (SAS Institute, Cary, NC).

Results

Baseline data

A total of 1272 patients were identified within the study period, and 189 met the study inclusion criteria. The CCC included 132 patients, the GCC 57. The mean age of patients in both groups was similar at 57 years old (P = .39). Most patients had Medicaid as their primary insurance. About one-third of patients in each group experienced clinical atherosclerotic cardiovascular disease, and about 12% overall had chronic kidney disease stage 3 and higher. The average number of days that patients were under pharmacist care during the study period was longer in the GCC compared to the CCC, and it was statistically significant (P < .001) (Table 2). The mean ± SD baseline HbA_1c for the CCC and GCC was 10.0% ± 2.0% and 9.9% ± 1.7%, respectively, and the difference was not statistically significant (P = .93). About 86% of patients in the CCC and 90% in the GCC had a baseline HbA_1c of ≥ 8%.

The mean change in HbA_1c between the 2 groups was not statistically significant (-1.5% ± 2.0% in the CCC vs -1.0% ± 2.1% in the GCC, P = .36) (Table 3). However, an absolute mean HbA_1c reduction of 1.3% was observed in both groups combined at the end of the study. Figure 1 shows a D-I-D model of the 2 groups. Based on the output, the P value of .11 on the interaction term (time*group) indicates that the D-I-D in HbA_1c change from baseline to final between the CCC and GCC is not statistically different. However, the magnitude of the difference calculated from the LSMEANS results showed a trend. The HbA_1c from baseline to final measurement of patients in the GCC declined by 0.97 percentage points (from 9.94% to 8.97%), while those in the CCC saw their HbA_1c decline by 1.48 percentage points (from 9.96% to 8.48%), for a D-I-D of 0.51. In other words, those in the GCC had an HbA_1c that decreased by 0.51% less than that of patients in the CCC, suggesting that the CCC shows a steeper line declining from baseline to final HbA_1c compared to the GCC, whose line declines less sharply.

In the subgroup analysis of patients whose baseline HbA_1c was ≥ 8%, about 42% in the CCC and 37% in the GCC achieved an HbA_1c < 8% (P = .56) (Table 4). Approximately 83% of patients in the CCC had some degree of HbA_1c improvement—the final HbA_1c was lower than their baseline HbA_1c—whereas this was observed in about 75% of patients in the GCC (P = .19). Of patients whose baseline HbA_1c was < 8%, there was no significant difference in proportion of patients maintaining an HbA_1c < 8% between the groups (P = .57), although some increases in HbA_1c and HbA_1c changes were observed in the GCC (Table 5).

Health care utilization

Patients in the CCC visited pharmacists 5 times on average over 12 months, whereas patients in the GCC had an average of 6 visits (5 ± 2.6 in the CCC vs 6 ± 2.6 in the GCC, P = .01) (Table 6). The mean length between any 2 adjacent visits was significantly different, averaging about 33 days in the CCC compared to 64 days in the GCC (33.2 ± 10 in the CCC vs 63.7 ± 39.4 in the GCC, P < .001). As shown in Figure 2, the GCC shows wider ranges between any adjacent pharmacy visits throughout until the 10th visit. Both groups had a similar number of visits with primary care physicians during the same time period (4.6 ± 1.86 in the CCC vs 4.3 ± 2.51 in the GCC, P = .44). About 30% of patients in the CCC and 47% in the GCC had at least 1 visit to the emergency room or urgent care or had at least 1 hospital admission, for a total of 124 acute care utilizations between the 2 groups combined. Only a small fraction of acute care visits with or without hospitalizations were related to diabetes and its complications (23.1% in the CCC vs 22.0% in the GCC).

Discussion

This is a real-world study that describes HbA_1c changes in patients who maintained pharmacy visits regularly and in those who had a history of a 3-month or longer gap in pharmacy visits. Although the study did not show statistically significant differences in HbA_1c reduction between the 2 groups, pharmacists’ care, overall, provided mean HbA_1c reductions of 1.3%. This result is consistent with those from multiple previous studies.^10-13 It is worth noting that the final HbA_1c was numerically lower in patients who followed up with pharmacists regularly than in patients with gaps in visits, with a difference of about 0.5 percentage points. This difference is considered clinically significant,¹⁷ and potentially could be even greater if the study duration was longer, as depicted by the slope of HbA_1c reductions in the D-I-D model (Figure 1).

Previous studies have shown that pharmacist visits are conducted in shorter intervals than primary care physician visits to provide closer follow-up and to resolve any medication-related problems that may hinder therapeutic outcome improvements.^3-4,7-9 Increasing access via pharmacists is particularly important in this clinic, where resident physician continuity and access is challenging. The pharmacist-driven program described in this study does not deviate from the norm, and this study confirms that pharmacist care, regardless of gaps in pharmacist visits, may still be beneficial.

Another notable finding from this study was that although the average number of pharmacist visits per patient was significantly different, this difference of 1 visit did not result in a statistically significant improvement in HbA_1c. In fact, the average number of pharmacist visits per patient seemed to be within the reported range by Choe et al in a similar setting.⁷ Conversely, patients with a history of a gap in pharmacist visits spent longer durations under pharmacist care compared to those who had continuous follow-up. This could mean that it may take longer times or 1 additional visit to achieve similar HbA_1c results with continuous pharmacist care. Higher number of visits with pharmacists in the group with the history of gaps between pharmacist visits could have been facilitated by resident physicians, as both groups had a similar number of visits with them. Although this is not conclusive, identifying the optimal number of visits with pharmacists in this underserved population could be beneficial in strategizing pharmacist visits. Acute care utilization was not different between the 2 groups, and most cases that led to acute care utilization were not directly related to diabetes or its complications.

The average HbA_1c at the end of the study did not measure < 8%, a target that was reached by less than half of patients from each group; however, this study is a snapshot of a series of ongoing clinical pharmacy services. About 25% of our patients started their first visit with a pharmacist less than 6 months from the study end date, and these patients may not have had enough time with pharmacists for their HbA_1c to reach below the target goal. In addition, most patients in this clinic were enrolled in public health plans and may carry a significant burden of social and behavioral factors that can affect diabetes management.^18,19 These patients may need longer care by pharmacists along with other integrated services, such as behavioral health and social work, to achieve optimal HbA_1c levels.²⁰

There are several limitations to this study, including the lack of a propensity matched control group of patients who only had resident physician visits; thus, it is hard to test the true impact of continuous or intermittent pharmacist visits on the therapeutic outcomes. The study also does not address potential social, economic, and physical environment factors that might have contributed to pharmacist visits and to overall diabetes care. These factors can negatively impact diabetes control and addressing them could help with an individualized diabetes management approach.^17,18 Additionally, by nature of being a descriptive study, the results may be subject to undetermined confounding factors.

Conclusion

Patients maintaining continuous pharmacist visits do not have statistically significant differences in change in HbA_1c compared to patients who had a history of 3-month or longer gaps in pharmacist visits at a resident physician primary care safety-net clinic. However, patients with diabetes will likely derive a benefit in HbA_1c reduction regardless of regularity of pharmacist care. This finding still holds true in collaboration with resident physicians who also regularly meet with patients.

The study highlights that it is important to integrate clinical pharmacists into primary care teams for improved therapeutic outcomes. It is our hope that regular visits to pharmacists can be a gateway for behavioral health and social work referrals, thereby addressing pharmacist-identified social barriers. Furthermore, exploration of socioeconomic and behavioral barriers to pharmacist visits is necessary to address and improve the patient experience, health care delivery, and health outcomes.

Acknowledgments: The authors thank Roxanna Perez, PharmD, Amy Li, and Julie Dopheide, PharmD, BCPP, FASHP for their contributions to this project.

Corresponding author: Michelle Koun Lee Chu, PharmD, BCACP, APh, Titus Family Department of Clinical Pharmacy, School of Pharmacy, University of Southern California, 1985 Zonal Ave, Los Angeles, CA 90089-9121; [email protected].

Financial disclosures: None.

From Titus Family Department of Clinical Pharmacy, School of Pharmacy, University of Southern California, Los Angeles, CA (Drs. Chu and Ma and Mimi Lou), and Department of Family Medicine, Keck Medicine, University of Southern California, Los Angeles, CA (Dr. Suh).

Objective: The objective of this study is to describe HbA_1c changes in patients who maintained continuous pharmacist care vs patients who had a gap in pharmacist care of 3 months or longer. 

Methods: This retrospective study was conducted from October 1, 2018, to September 30, 2019. Electronic health record data from an academic-affiliated, safety-net resident physician primary care clinic were collected to observe HbA_1c changes between patients with continuous pharmacist care and patients who had a gap of 3 months or longer in pharmacist care. A total of 189 patients met the inclusion criteria and were divided into 2 groups: those with continuous care and those with gaps in care. Data were analyzed using the Mann-Whitney test for continuous variables and the χ² (or Fisher exact) test for categorical variables. The differences-in-differences model was used to compare the changes in HbA_1c between the 2 groups.

Results: There was no significant difference in changes in HbA_1c between the continuous care group and the gaps in care group, although the mean magnitude of HbA_1c changes was numerically greater in the continuous care group (-1.48% vs -0.97%). Overall, both groups showed improvement in their HbA_1c levels and had similar numbers of primary care physician visits and acute care utilizations, while the gaps in care group had longer duration with pharmacists and between the adjacent pharmacist visits.

Conclusion: Maintaining continuous, regular visits with a pharmacist at a safety-net resident physician primary care clinic did not show a significant difference in HbA_1c changes compared to having gaps in pharmacist care. Future studies on socioeconomic and behavioral burden on HbA_1c improvement and on pharmacist visits in these populations should be explored.

Keywords: clinical pharmacist; diabetes management; continuous visit; primary care clinic.

Pharmacists have unique skills in identifying and resolving problems related to the safety and efficacy of drug therapy while addressing medication adherence and access for patients. Their expertise is especially important to meet the care needs of a growing population with chronic conditions amidst a primary care physician shortage.¹ As health care systems move toward value-based care, emphasis on improvement in quality and health measures have become central in care delivery. Pharmacists have been integrated into team-based care in primary care settings, but the value-based shift has opened more opportunities for pharmacists to address unmet quality standards.^2-5

Many studies have reported that the integration of pharmacists into team-based care improves health outcomes and reduces overall health care costs.^6-9 Specifically, when pharmacists were added to primary care teams to provide diabetes management, hemoglobin HbA_1c levels were reduced compared to teams without pharmacists.^10-13 Offering pharmacist visits as often as every 2 weeks to 3 months, with each patient having an average of 4.7 visits, resulted in improved therapeutic outcomes.^3,7 During visits, pharmacists address the need for additional drug therapy, deprescribe unnecessary therapy, correct insufficient doses or durations, and switch patients to more cost-efficient drug therapy.⁹ Likewise, patients who visit pharmacists in addition to seeing their primary care physician can have medication-related concerns resolved and improve their therapeutic outcomes.^10,11

Not much is known about the magnitude of HbA_1c change based on the regularity of pharmacist visits. Although pharmacists offer follow-up appointments in reasonable time intervals, patients do not keep every appointment for a variety of reasons, including forgetfulness, personal issues, and a lack of transportation.¹⁴ Such missed appointments can negatively impact health outcomes.^14-16 The purpose of this study is to describe HbA_1c changes in patients who maintained continuous, regular pharmacist visits without a 3-month gap and in patients who had history of inconsistent pharmacist visits with a gap of 3 months or longer. Furthermore, this study describes the frequency of health care utilization for these 2 groups.

Methods

Setting

The Internal Medicine resident physician primary care clinic is 1 of 2 adult primary care clinics at an academic, urban, public medical center. It is in the heart of East Los Angeles, where predominantly Spanish-speaking and minority populations reside. The clinic has approximately 19000 empaneled patients and is the largest resident primary care clinic in the public health system. The clinical pharmacy service addresses unmet quality standards, specifically HbA_1c. The clinical pharmacists are co-located and collaborate with resident physicians, attending physicians, care managers, nurses, social workers, and community health workers at the clinic. They operate under collaborative practice agreements with prescriptive authority, except for controlled substances, specialty drugs, and antipsychotic medications.

Pharmacist visit

Patients are primarily referred by resident physicians to clinical pharmacists when their HbA_1c level is above 8% for an extended period, when poor adherence and low health literacy are evident regardless of HbA_1c level, or when a complex medication regimen requires comprehensive medication review and reconciliation. The referral occurs through warm handoff by resident physicians as well as clinic nurses, and it is embedded in the clinic flow. Patients continue their visits with resident physicians for issues other than their referral to clinical pharmacists. The visits with pharmacists are appointment-based, occur independently from resident physician visits, and continue until the patient’s HbA_1c level or adherence is optimized. Clinical pharmacists continue to follow up with patients who may have reached their target HbA_1c level but still are deemed unstable due to inconsistency in their self-management and medication adherence.

After the desirable HbA_1c target is achieved along with full adherence to medications and self-management, clinical pharmacists will hand off patients back to resident physicians. At each visit, pharmacists perform a comprehensive medication assessment and reconciliation that includes adjusting medication therapy, placing orders for necessary laboratory tests and prescriptions, and assessing medication adherence. They also evaluate patients’ signs and symptoms for hyperglycemic complications, hypoglycemia, and other potential treatment-related adverse events. These are all within the pharmacist’s scope of practice in comprehensive medication management. Patient education is provided with the teach-back method and includes lifestyle modifications and medication counseling (Table 1). Pharmacists offer face-to-face visits as frequently as every 1 to 2 weeks to every 4 to 6 weeks, depending on the level of complexity and the severity of a patient’s conditions and medications. For patients whose HbA_1c has reached the target range but have not been deemed stable, pharmacists continue to check in with them every 2 months. Phone visits are also utilized as an additional care delivery method for patients having difficulty showing up for face-to-face visits or needing quick assessment of medication adherence and responses to changes in drug treatment in between the face-to-face visits. The maximal interval between pharmacist visits is offered no longer than every 8 weeks. Patients are contacted via phone or mail by the nursing staff to reschedule if they miss their appointments with pharmacists. Every pharmacy visit is documented in the patient’s electronic medical record.

Study design

This is a retrospective study describing the HbA_1c changes in a patient group that maintained pharmacist visits, with each interval less than 3 months, and in another group, who had a history of a 3-month or longer gap between pharmacist visits. The data were obtained from patients’ electronic medical records during the study period of October 1, 2018, and September 30, 2019, and collected using a HIPAA-compliant, electronic data storage website, REDCap. The institutional review board approval was obtained under HS-19-00929. Patients 18 years and older who were referred by primary care resident physicians for diabetes management, and had 2 or more visits with a pharmacist within the study period, were included. Patients were excluded if they had only 1 HbA_1c drawn during the study period, were referred to a pharmacist for reasons other than diabetes management, were concurrently managed by an endocrinologist, had only 1 visit with a pharmacist, or had no visits with their primary care resident physician for over a year. The patients were then divided into 2 groups: continuous care cohort (CCC) and gap in care cohort (GCC). Both face-to-face and phone visits were counted as pharmacist visits for each group.

Outcomes

The primary outcome was the change in HbA_1c from baseline between the 2 groups. Baseline HbA_1c was considered as the HbA_1c value obtained within 3 months prior to, or within 1 month, of the first visit with the pharmacist during the study period. The final HbA_1c was considered the value measured within 1 month of, or 3 months after, the patient’s last visit with the pharmacist during the study period.

Several subgroup analyses were conducted to examine the relationship between HbA_1c and each group. Among patients whose baseline HbA_1c was ≥ 8%, we looked at the percentage of patients reaching HbA_1c < 8%, the percentage of patients showing any level of improvement in HbA_1c, and the change in HbA_1c for each group. We also looked at the percentage of patients with baseline HbA_1c < 8% maintaining the level throughout the study period and the change in HbA_1c for each group. Additionally, we looked at health care utilization, which included pharmacist visits, primary care physician visits, emergency room and urgent care visits, and hospitalizations for each group. The latter 3 types of utilization were grouped as acute care utilization and further analyzed for visit reasons, which were subsequently categorized as diabetes related and non-diabetes related. The diabetes related reasons linking to acute care utilization were defined as any episodes related to hypoglycemia, diabetic ketoacidosis (DKA), hyperosmolar hyperglycemic state (HHS), foot ulcers, retinopathy, and osteomyelitis infection. All other reasons leading to acute care utilization were categorized as non-diabetes related.

Statistical analysis

Descriptive analyses were conducted using the Mann-Whitney test for continuous data and χ² (or Fisher exact) test for categorical data. A basic difference-in-differences (D-I-D) method was used to compare the changes of HbA_1c between the CCC and GCC over 2 time points: baseline and final measurements. The repeated measures ANOVA was used for analyzing D-I-D. P < .05 was considered significant. Statistical analyses were performed using SAS version 9.4 (SAS Institute, Cary, NC).

Results

Baseline data

A total of 1272 patients were identified within the study period, and 189 met the study inclusion criteria. The CCC included 132 patients, the GCC 57. The mean age of patients in both groups was similar at 57 years old (P = .39). Most patients had Medicaid as their primary insurance. About one-third of patients in each group experienced clinical atherosclerotic cardiovascular disease, and about 12% overall had chronic kidney disease stage 3 and higher. The average number of days that patients were under pharmacist care during the study period was longer in the GCC compared to the CCC, and it was statistically significant (P < .001) (Table 2). The mean ± SD baseline HbA_1c for the CCC and GCC was 10.0% ± 2.0% and 9.9% ± 1.7%, respectively, and the difference was not statistically significant (P = .93). About 86% of patients in the CCC and 90% in the GCC had a baseline HbA_1c of ≥ 8%.

The mean change in HbA_1c between the 2 groups was not statistically significant (-1.5% ± 2.0% in the CCC vs -1.0% ± 2.1% in the GCC, P = .36) (Table 3). However, an absolute mean HbA_1c reduction of 1.3% was observed in both groups combined at the end of the study. Figure 1 shows a D-I-D model of the 2 groups. Based on the output, the P value of .11 on the interaction term (time*group) indicates that the D-I-D in HbA_1c change from baseline to final between the CCC and GCC is not statistically different. However, the magnitude of the difference calculated from the LSMEANS results showed a trend. The HbA_1c from baseline to final measurement of patients in the GCC declined by 0.97 percentage points (from 9.94% to 8.97%), while those in the CCC saw their HbA_1c decline by 1.48 percentage points (from 9.96% to 8.48%), for a D-I-D of 0.51. In other words, those in the GCC had an HbA_1c that decreased by 0.51% less than that of patients in the CCC, suggesting that the CCC shows a steeper line declining from baseline to final HbA_1c compared to the GCC, whose line declines less sharply.

In the subgroup analysis of patients whose baseline HbA_1c was ≥ 8%, about 42% in the CCC and 37% in the GCC achieved an HbA_1c < 8% (P = .56) (Table 4). Approximately 83% of patients in the CCC had some degree of HbA_1c improvement—the final HbA_1c was lower than their baseline HbA_1c—whereas this was observed in about 75% of patients in the GCC (P = .19). Of patients whose baseline HbA_1c was < 8%, there was no significant difference in proportion of patients maintaining an HbA_1c < 8% between the groups (P = .57), although some increases in HbA_1c and HbA_1c changes were observed in the GCC (Table 5).

Health care utilization

Patients in the CCC visited pharmacists 5 times on average over 12 months, whereas patients in the GCC had an average of 6 visits (5 ± 2.6 in the CCC vs 6 ± 2.6 in the GCC, P = .01) (Table 6). The mean length between any 2 adjacent visits was significantly different, averaging about 33 days in the CCC compared to 64 days in the GCC (33.2 ± 10 in the CCC vs 63.7 ± 39.4 in the GCC, P < .001). As shown in Figure 2, the GCC shows wider ranges between any adjacent pharmacy visits throughout until the 10th visit. Both groups had a similar number of visits with primary care physicians during the same time period (4.6 ± 1.86 in the CCC vs 4.3 ± 2.51 in the GCC, P = .44). About 30% of patients in the CCC and 47% in the GCC had at least 1 visit to the emergency room or urgent care or had at least 1 hospital admission, for a total of 124 acute care utilizations between the 2 groups combined. Only a small fraction of acute care visits with or without hospitalizations were related to diabetes and its complications (23.1% in the CCC vs 22.0% in the GCC).

Discussion

This is a real-world study that describes HbA_1c changes in patients who maintained pharmacy visits regularly and in those who had a history of a 3-month or longer gap in pharmacy visits. Although the study did not show statistically significant differences in HbA_1c reduction between the 2 groups, pharmacists’ care, overall, provided mean HbA_1c reductions of 1.3%. This result is consistent with those from multiple previous studies.^10-13 It is worth noting that the final HbA_1c was numerically lower in patients who followed up with pharmacists regularly than in patients with gaps in visits, with a difference of about 0.5 percentage points. This difference is considered clinically significant,¹⁷ and potentially could be even greater if the study duration was longer, as depicted by the slope of HbA_1c reductions in the D-I-D model (Figure 1).

Previous studies have shown that pharmacist visits are conducted in shorter intervals than primary care physician visits to provide closer follow-up and to resolve any medication-related problems that may hinder therapeutic outcome improvements.^3-4,7-9 Increasing access via pharmacists is particularly important in this clinic, where resident physician continuity and access is challenging. The pharmacist-driven program described in this study does not deviate from the norm, and this study confirms that pharmacist care, regardless of gaps in pharmacist visits, may still be beneficial.

Another notable finding from this study was that although the average number of pharmacist visits per patient was significantly different, this difference of 1 visit did not result in a statistically significant improvement in HbA_1c. In fact, the average number of pharmacist visits per patient seemed to be within the reported range by Choe et al in a similar setting.⁷ Conversely, patients with a history of a gap in pharmacist visits spent longer durations under pharmacist care compared to those who had continuous follow-up. This could mean that it may take longer times or 1 additional visit to achieve similar HbA_1c results with continuous pharmacist care. Higher number of visits with pharmacists in the group with the history of gaps between pharmacist visits could have been facilitated by resident physicians, as both groups had a similar number of visits with them. Although this is not conclusive, identifying the optimal number of visits with pharmacists in this underserved population could be beneficial in strategizing pharmacist visits. Acute care utilization was not different between the 2 groups, and most cases that led to acute care utilization were not directly related to diabetes or its complications.

The average HbA_1c at the end of the study did not measure < 8%, a target that was reached by less than half of patients from each group; however, this study is a snapshot of a series of ongoing clinical pharmacy services. About 25% of our patients started their first visit with a pharmacist less than 6 months from the study end date, and these patients may not have had enough time with pharmacists for their HbA_1c to reach below the target goal. In addition, most patients in this clinic were enrolled in public health plans and may carry a significant burden of social and behavioral factors that can affect diabetes management.^18,19 These patients may need longer care by pharmacists along with other integrated services, such as behavioral health and social work, to achieve optimal HbA_1c levels.²⁰

There are several limitations to this study, including the lack of a propensity matched control group of patients who only had resident physician visits; thus, it is hard to test the true impact of continuous or intermittent pharmacist visits on the therapeutic outcomes. The study also does not address potential social, economic, and physical environment factors that might have contributed to pharmacist visits and to overall diabetes care. These factors can negatively impact diabetes control and addressing them could help with an individualized diabetes management approach.^17,18 Additionally, by nature of being a descriptive study, the results may be subject to undetermined confounding factors.

Conclusion

Patients maintaining continuous pharmacist visits do not have statistically significant differences in change in HbA_1c compared to patients who had a history of 3-month or longer gaps in pharmacist visits at a resident physician primary care safety-net clinic. However, patients with diabetes will likely derive a benefit in HbA_1c reduction regardless of regularity of pharmacist care. This finding still holds true in collaboration with resident physicians who also regularly meet with patients.

The study highlights that it is important to integrate clinical pharmacists into primary care teams for improved therapeutic outcomes. It is our hope that regular visits to pharmacists can be a gateway for behavioral health and social work referrals, thereby addressing pharmacist-identified social barriers. Furthermore, exploration of socioeconomic and behavioral barriers to pharmacist visits is necessary to address and improve the patient experience, health care delivery, and health outcomes.

Acknowledgments: The authors thank Roxanna Perez, PharmD, Amy Li, and Julie Dopheide, PharmD, BCPP, FASHP for their contributions to this project.

Corresponding author: Michelle Koun Lee Chu, PharmD, BCACP, APh, Titus Family Department of Clinical Pharmacy, School of Pharmacy, University of Southern California, 1985 Zonal Ave, Los Angeles, CA 90089-9121; [email protected].

Financial disclosures: None.

From Titus Family Department of Clinical Pharmacy, School of Pharmacy, University of Southern California, Los Angeles, CA (Drs. Chu and Ma and Mimi Lou), and Department of Family Medicine, Keck Medicine, University of Southern California, Los Angeles, CA (Dr. Suh).

Objective: The objective of this study is to describe HbA_1c changes in patients who maintained continuous pharmacist care vs patients who had a gap in pharmacist care of 3 months or longer. 

Methods: This retrospective study was conducted from October 1, 2018, to September 30, 2019. Electronic health record data from an academic-affiliated, safety-net resident physician primary care clinic were collected to observe HbA_1c changes between patients with continuous pharmacist care and patients who had a gap of 3 months or longer in pharmacist care. A total of 189 patients met the inclusion criteria and were divided into 2 groups: those with continuous care and those with gaps in care. Data were analyzed using the Mann-Whitney test for continuous variables and the χ² (or Fisher exact) test for categorical variables. The differences-in-differences model was used to compare the changes in HbA_1c between the 2 groups.

Results: There was no significant difference in changes in HbA_1c between the continuous care group and the gaps in care group, although the mean magnitude of HbA_1c changes was numerically greater in the continuous care group (-1.48% vs -0.97%). Overall, both groups showed improvement in their HbA_1c levels and had similar numbers of primary care physician visits and acute care utilizations, while the gaps in care group had longer duration with pharmacists and between the adjacent pharmacist visits.

Conclusion: Maintaining continuous, regular visits with a pharmacist at a safety-net resident physician primary care clinic did not show a significant difference in HbA_1c changes compared to having gaps in pharmacist care. Future studies on socioeconomic and behavioral burden on HbA_1c improvement and on pharmacist visits in these populations should be explored.

Keywords: clinical pharmacist; diabetes management; continuous visit; primary care clinic.

Pharmacists have unique skills in identifying and resolving problems related to the safety and efficacy of drug therapy while addressing medication adherence and access for patients. Their expertise is especially important to meet the care needs of a growing population with chronic conditions amidst a primary care physician shortage.¹ As health care systems move toward value-based care, emphasis on improvement in quality and health measures have become central in care delivery. Pharmacists have been integrated into team-based care in primary care settings, but the value-based shift has opened more opportunities for pharmacists to address unmet quality standards.^2-5

Many studies have reported that the integration of pharmacists into team-based care improves health outcomes and reduces overall health care costs.^6-9 Specifically, when pharmacists were added to primary care teams to provide diabetes management, hemoglobin HbA_1c levels were reduced compared to teams without pharmacists.^10-13 Offering pharmacist visits as often as every 2 weeks to 3 months, with each patient having an average of 4.7 visits, resulted in improved therapeutic outcomes.^3,7 During visits, pharmacists address the need for additional drug therapy, deprescribe unnecessary therapy, correct insufficient doses or durations, and switch patients to more cost-efficient drug therapy.⁹ Likewise, patients who visit pharmacists in addition to seeing their primary care physician can have medication-related concerns resolved and improve their therapeutic outcomes.^10,11

Not much is known about the magnitude of HbA_1c change based on the regularity of pharmacist visits. Although pharmacists offer follow-up appointments in reasonable time intervals, patients do not keep every appointment for a variety of reasons, including forgetfulness, personal issues, and a lack of transportation.¹⁴ Such missed appointments can negatively impact health outcomes.^14-16 The purpose of this study is to describe HbA_1c changes in patients who maintained continuous, regular pharmacist visits without a 3-month gap and in patients who had history of inconsistent pharmacist visits with a gap of 3 months or longer. Furthermore, this study describes the frequency of health care utilization for these 2 groups.

Methods

Setting

The Internal Medicine resident physician primary care clinic is 1 of 2 adult primary care clinics at an academic, urban, public medical center. It is in the heart of East Los Angeles, where predominantly Spanish-speaking and minority populations reside. The clinic has approximately 19000 empaneled patients and is the largest resident primary care clinic in the public health system. The clinical pharmacy service addresses unmet quality standards, specifically HbA_1c. The clinical pharmacists are co-located and collaborate with resident physicians, attending physicians, care managers, nurses, social workers, and community health workers at the clinic. They operate under collaborative practice agreements with prescriptive authority, except for controlled substances, specialty drugs, and antipsychotic medications.

Pharmacist visit

Patients are primarily referred by resident physicians to clinical pharmacists when their HbA_1c level is above 8% for an extended period, when poor adherence and low health literacy are evident regardless of HbA_1c level, or when a complex medication regimen requires comprehensive medication review and reconciliation. The referral occurs through warm handoff by resident physicians as well as clinic nurses, and it is embedded in the clinic flow. Patients continue their visits with resident physicians for issues other than their referral to clinical pharmacists. The visits with pharmacists are appointment-based, occur independently from resident physician visits, and continue until the patient’s HbA_1c level or adherence is optimized. Clinical pharmacists continue to follow up with patients who may have reached their target HbA_1c level but still are deemed unstable due to inconsistency in their self-management and medication adherence.

After the desirable HbA_1c target is achieved along with full adherence to medications and self-management, clinical pharmacists will hand off patients back to resident physicians. At each visit, pharmacists perform a comprehensive medication assessment and reconciliation that includes adjusting medication therapy, placing orders for necessary laboratory tests and prescriptions, and assessing medication adherence. They also evaluate patients’ signs and symptoms for hyperglycemic complications, hypoglycemia, and other potential treatment-related adverse events. These are all within the pharmacist’s scope of practice in comprehensive medication management. Patient education is provided with the teach-back method and includes lifestyle modifications and medication counseling (Table 1). Pharmacists offer face-to-face visits as frequently as every 1 to 2 weeks to every 4 to 6 weeks, depending on the level of complexity and the severity of a patient’s conditions and medications. For patients whose HbA_1c has reached the target range but have not been deemed stable, pharmacists continue to check in with them every 2 months. Phone visits are also utilized as an additional care delivery method for patients having difficulty showing up for face-to-face visits or needing quick assessment of medication adherence and responses to changes in drug treatment in between the face-to-face visits. The maximal interval between pharmacist visits is offered no longer than every 8 weeks. Patients are contacted via phone or mail by the nursing staff to reschedule if they miss their appointments with pharmacists. Every pharmacy visit is documented in the patient’s electronic medical record.

Study design

This is a retrospective study describing the HbA_1c changes in a patient group that maintained pharmacist visits, with each interval less than 3 months, and in another group, who had a history of a 3-month or longer gap between pharmacist visits. The data were obtained from patients’ electronic medical records during the study period of October 1, 2018, and September 30, 2019, and collected using a HIPAA-compliant, electronic data storage website, REDCap. The institutional review board approval was obtained under HS-19-00929. Patients 18 years and older who were referred by primary care resident physicians for diabetes management, and had 2 or more visits with a pharmacist within the study period, were included. Patients were excluded if they had only 1 HbA_1c drawn during the study period, were referred to a pharmacist for reasons other than diabetes management, were concurrently managed by an endocrinologist, had only 1 visit with a pharmacist, or had no visits with their primary care resident physician for over a year. The patients were then divided into 2 groups: continuous care cohort (CCC) and gap in care cohort (GCC). Both face-to-face and phone visits were counted as pharmacist visits for each group.

Outcomes

The primary outcome was the change in HbA_1c from baseline between the 2 groups. Baseline HbA_1c was considered as the HbA_1c value obtained within 3 months prior to, or within 1 month, of the first visit with the pharmacist during the study period. The final HbA_1c was considered the value measured within 1 month of, or 3 months after, the patient’s last visit with the pharmacist during the study period.

Several subgroup analyses were conducted to examine the relationship between HbA_1c and each group. Among patients whose baseline HbA_1c was ≥ 8%, we looked at the percentage of patients reaching HbA_1c < 8%, the percentage of patients showing any level of improvement in HbA_1c, and the change in HbA_1c for each group. We also looked at the percentage of patients with baseline HbA_1c < 8% maintaining the level throughout the study period and the change in HbA_1c for each group. Additionally, we looked at health care utilization, which included pharmacist visits, primary care physician visits, emergency room and urgent care visits, and hospitalizations for each group. The latter 3 types of utilization were grouped as acute care utilization and further analyzed for visit reasons, which were subsequently categorized as diabetes related and non-diabetes related. The diabetes related reasons linking to acute care utilization were defined as any episodes related to hypoglycemia, diabetic ketoacidosis (DKA), hyperosmolar hyperglycemic state (HHS), foot ulcers, retinopathy, and osteomyelitis infection. All other reasons leading to acute care utilization were categorized as non-diabetes related.

Statistical analysis

Descriptive analyses were conducted using the Mann-Whitney test for continuous data and χ² (or Fisher exact) test for categorical data. A basic difference-in-differences (D-I-D) method was used to compare the changes of HbA_1c between the CCC and GCC over 2 time points: baseline and final measurements. The repeated measures ANOVA was used for analyzing D-I-D. P < .05 was considered significant. Statistical analyses were performed using SAS version 9.4 (SAS Institute, Cary, NC).

Results

Baseline data

A total of 1272 patients were identified within the study period, and 189 met the study inclusion criteria. The CCC included 132 patients, the GCC 57. The mean age of patients in both groups was similar at 57 years old (P = .39). Most patients had Medicaid as their primary insurance. About one-third of patients in each group experienced clinical atherosclerotic cardiovascular disease, and about 12% overall had chronic kidney disease stage 3 and higher. The average number of days that patients were under pharmacist care during the study period was longer in the GCC compared to the CCC, and it was statistically significant (P < .001) (Table 2). The mean ± SD baseline HbA_1c for the CCC and GCC was 10.0% ± 2.0% and 9.9% ± 1.7%, respectively, and the difference was not statistically significant (P = .93). About 86% of patients in the CCC and 90% in the GCC had a baseline HbA_1c of ≥ 8%.

The mean change in HbA_1c between the 2 groups was not statistically significant (-1.5% ± 2.0% in the CCC vs -1.0% ± 2.1% in the GCC, P = .36) (Table 3). However, an absolute mean HbA_1c reduction of 1.3% was observed in both groups combined at the end of the study. Figure 1 shows a D-I-D model of the 2 groups. Based on the output, the P value of .11 on the interaction term (time*group) indicates that the D-I-D in HbA_1c change from baseline to final between the CCC and GCC is not statistically different. However, the magnitude of the difference calculated from the LSMEANS results showed a trend. The HbA_1c from baseline to final measurement of patients in the GCC declined by 0.97 percentage points (from 9.94% to 8.97%), while those in the CCC saw their HbA_1c decline by 1.48 percentage points (from 9.96% to 8.48%), for a D-I-D of 0.51. In other words, those in the GCC had an HbA_1c that decreased by 0.51% less than that of patients in the CCC, suggesting that the CCC shows a steeper line declining from baseline to final HbA_1c compared to the GCC, whose line declines less sharply.

In the subgroup analysis of patients whose baseline HbA_1c was ≥ 8%, about 42% in the CCC and 37% in the GCC achieved an HbA_1c < 8% (P = .56) (Table 4). Approximately 83% of patients in the CCC had some degree of HbA_1c improvement—the final HbA_1c was lower than their baseline HbA_1c—whereas this was observed in about 75% of patients in the GCC (P = .19). Of patients whose baseline HbA_1c was < 8%, there was no significant difference in proportion of patients maintaining an HbA_1c < 8% between the groups (P = .57), although some increases in HbA_1c and HbA_1c changes were observed in the GCC (Table 5).

Health care utilization

Patients in the CCC visited pharmacists 5 times on average over 12 months, whereas patients in the GCC had an average of 6 visits (5 ± 2.6 in the CCC vs 6 ± 2.6 in the GCC, P = .01) (Table 6). The mean length between any 2 adjacent visits was significantly different, averaging about 33 days in the CCC compared to 64 days in the GCC (33.2 ± 10 in the CCC vs 63.7 ± 39.4 in the GCC, P < .001). As shown in Figure 2, the GCC shows wider ranges between any adjacent pharmacy visits throughout until the 10th visit. Both groups had a similar number of visits with primary care physicians during the same time period (4.6 ± 1.86 in the CCC vs 4.3 ± 2.51 in the GCC, P = .44). About 30% of patients in the CCC and 47% in the GCC had at least 1 visit to the emergency room or urgent care or had at least 1 hospital admission, for a total of 124 acute care utilizations between the 2 groups combined. Only a small fraction of acute care visits with or without hospitalizations were related to diabetes and its complications (23.1% in the CCC vs 22.0% in the GCC).

Discussion

This is a real-world study that describes HbA_1c changes in patients who maintained pharmacy visits regularly and in those who had a history of a 3-month or longer gap in pharmacy visits. Although the study did not show statistically significant differences in HbA_1c reduction between the 2 groups, pharmacists’ care, overall, provided mean HbA_1c reductions of 1.3%. This result is consistent with those from multiple previous studies.^10-13 It is worth noting that the final HbA_1c was numerically lower in patients who followed up with pharmacists regularly than in patients with gaps in visits, with a difference of about 0.5 percentage points. This difference is considered clinically significant,¹⁷ and potentially could be even greater if the study duration was longer, as depicted by the slope of HbA_1c reductions in the D-I-D model (Figure 1).

Previous studies have shown that pharmacist visits are conducted in shorter intervals than primary care physician visits to provide closer follow-up and to resolve any medication-related problems that may hinder therapeutic outcome improvements.^3-4,7-9 Increasing access via pharmacists is particularly important in this clinic, where resident physician continuity and access is challenging. The pharmacist-driven program described in this study does not deviate from the norm, and this study confirms that pharmacist care, regardless of gaps in pharmacist visits, may still be beneficial.

Another notable finding from this study was that although the average number of pharmacist visits per patient was significantly different, this difference of 1 visit did not result in a statistically significant improvement in HbA_1c. In fact, the average number of pharmacist visits per patient seemed to be within the reported range by Choe et al in a similar setting.⁷ Conversely, patients with a history of a gap in pharmacist visits spent longer durations under pharmacist care compared to those who had continuous follow-up. This could mean that it may take longer times or 1 additional visit to achieve similar HbA_1c results with continuous pharmacist care. Higher number of visits with pharmacists in the group with the history of gaps between pharmacist visits could have been facilitated by resident physicians, as both groups had a similar number of visits with them. Although this is not conclusive, identifying the optimal number of visits with pharmacists in this underserved population could be beneficial in strategizing pharmacist visits. Acute care utilization was not different between the 2 groups, and most cases that led to acute care utilization were not directly related to diabetes or its complications.

The average HbA_1c at the end of the study did not measure < 8%, a target that was reached by less than half of patients from each group; however, this study is a snapshot of a series of ongoing clinical pharmacy services. About 25% of our patients started their first visit with a pharmacist less than 6 months from the study end date, and these patients may not have had enough time with pharmacists for their HbA_1c to reach below the target goal. In addition, most patients in this clinic were enrolled in public health plans and may carry a significant burden of social and behavioral factors that can affect diabetes management.^18,19 These patients may need longer care by pharmacists along with other integrated services, such as behavioral health and social work, to achieve optimal HbA_1c levels.²⁰

There are several limitations to this study, including the lack of a propensity matched control group of patients who only had resident physician visits; thus, it is hard to test the true impact of continuous or intermittent pharmacist visits on the therapeutic outcomes. The study also does not address potential social, economic, and physical environment factors that might have contributed to pharmacist visits and to overall diabetes care. These factors can negatively impact diabetes control and addressing them could help with an individualized diabetes management approach.^17,18 Additionally, by nature of being a descriptive study, the results may be subject to undetermined confounding factors.

Conclusion

Patients maintaining continuous pharmacist visits do not have statistically significant differences in change in HbA_1c compared to patients who had a history of 3-month or longer gaps in pharmacist visits at a resident physician primary care safety-net clinic. However, patients with diabetes will likely derive a benefit in HbA_1c reduction regardless of regularity of pharmacist care. This finding still holds true in collaboration with resident physicians who also regularly meet with patients.

The study highlights that it is important to integrate clinical pharmacists into primary care teams for improved therapeutic outcomes. It is our hope that regular visits to pharmacists can be a gateway for behavioral health and social work referrals, thereby addressing pharmacist-identified social barriers. Furthermore, exploration of socioeconomic and behavioral barriers to pharmacist visits is necessary to address and improve the patient experience, health care delivery, and health outcomes.

Acknowledgments: The authors thank Roxanna Perez, PharmD, Amy Li, and Julie Dopheide, PharmD, BCPP, FASHP for their contributions to this project.

Corresponding author: Michelle Koun Lee Chu, PharmD, BCACP, APh, Titus Family Department of Clinical Pharmacy, School of Pharmacy, University of Southern California, 1985 Zonal Ave, Los Angeles, CA 90089-9121; [email protected].

Financial disclosures: None.

From the Fraser Health Authority, Surrey, BC, Canada (Drs. Yousefi and Paletta), and Catalyst Consulting Inc., Vancouver, BC, Canada (Elayne McIvor).

Objective: Despite the ongoing growth in the number of hospitalist programs in Canada, their impact on the quality of interprofessional communication, teamwork, and staff satisfaction is not well known. This study aimed to evaluate perceptions of frontline care providers and hospital managers about the impact of the implementation of 3 new hospitalist services on care quality, teamwork, and interprofessional communication.

Design: We used an online survey and semistructured interviews to evaluate respondents’ views on quality of interprofessional communication and collaboration, impact of the new services on quality of care, and overall staff satisfaction with the new inpatient care model.

Setting: Integrated Regional Health Authority in British Columbia, Canada.

Participants: Participants included hospital administrators, frontline care providers (across a range of professions), and hospital and community-based physicians.

Results: The majority of respondents reported high levels of satisfaction with their new hospital medicine services. They identified improvements in interprofessional collaboration and communication between hospitalists and other professionals, which were attributed to enhanced onsite presence of physicians. They also perceived improvements in quality of care and efficiency. On the other hand, they identified a number of challenges with the change process, and raised concerns about the impact of patient handoffs on care quality and efficiency.

Conclusion: Across 3 very different acute care settings, the implementation of a hospitalist service was widely perceived to have resulted in improved teamwork, quality of care, and interprofessional communication.

Keywords: hospital medicine; hospitalist; teamwork; interprofessional collaboration.

Fraser Health Authority (FH) is an integrated regional health system with one of the largest regional Hospital Medicine (HM) networks in Canada.⁹ Over the past 2 decades, FH has implemented a number of HM services in its acute care facilities across a range of small and large community and academic hospitals. More recently, 3 hospitalist services were implemented over a 2-year period: new HM services in a tertiary referral center (Site A, July 2016) and a small community hospital (Site B, December 2016), and reintroduction of a hospitalist service in a medium-sized community hospital (Site C, January 2017). This provided a unique opportunity to assess the impact of the implementation of the hospitalist model across a range of facilities. The main objectives of this evaluation were to understand the level of physician, nursing, allied staff, and hospital administration satisfaction with the new hospitalist model, as well as the perceived impact of the service on efficiency and quality of care. As such, FH engaged an external consultant (EM) to conduct a comprehensive evaluation of the introduction of its latest HM services.

Methods

Setting

Hospital medicine services are currently available in 10 of 12 acute care facilities within the FH system. The 3 sites described in this evaluation constitute the most recent sites where a hospitalist service was implemented.

Site A is a 272-bed tertiary referral center situated in a rapidly growing community. At the time of our evaluation, 21 Full Time Equivalent (FTE) hospitalists cared for an average of 126 patients, which constituted the majority of adult medical patients. Each day, 8 individuals rounded on admitted patients (average individual census: 16) with another person providing in-house, evening, and overnight coverage. An additional flexible shift during the early afternoon helped with Emergency Department (ED) admissions.

Site B is small, 45-bed community hospital in a semi-rural community. The hospitalist service began in December 2016, with 4 FTE hospitalists caring for an average of 28 patients daily. This constituted 2 hospitalists rounding daily on admitted patients, with on-call coverage provided from home.

Site C is a 188-bed community hospital with a hospitalist service initially introduced in 2005. In 2016, the program was disbanded and the site moved back to a primarily community-based model, in which family physicians in the community were invited to assume the care of hospitalized patients. However, the hospitalist program had to be reintroduced in January 2017 due to poor uptake among PCPs in the community. At the time of evaluation, 19 FTE hospitalists (with 7 hospitalists working daily) provided most responsible physician care to a daily census of 116 patients (average individual census: 16). The program also covered ED admissions in-house until midnight, with overnight call provided from home.

Approach

We adopted a utilization-focused evaluation approach to guide our investigation. In this approach, the assessment is deliberately planned and conducted in a way that it maximizes the likelihood that findings would be used by the organization to inform learning, adaptations, and decision-making.¹¹ To enable this, the evaluator identified the primary intended recipients and engaged them at the start of the evaluation process to understand the main intended uses of the project. Moreover, the evaluator ensured that these intended uses of the evaluation guided all other decisions made throughout the process.

We collected data using an online survey of the staff at the 3 facilities, complemented by a series of semistructured qualitative interviews with FH administrators and frontline providers.

Online survey

We conducted an open online survey of a broad range of stakeholders who worked in the 3 facilities. To develop the questionnaire, we searched our department’s archives for previous surveys conducted from 2001 to 2005. We also interviewed the regional HM program management team to identify priority areas and reached out to the local leadership of the 3 acute care facilities for their input and support of the project. We refined the survey through several iterations, seeking input from experts in the FH Department of Evaluation and Research. The final questionnaire contained 10 items, including a mix of closed- and open-ended questions (Appendix A).

To reach the target audience, we collaborated with each hospital’s local leadership as well as the Divisions of Family Practice (DFP) that support local community PCPs in each hospital community.¹⁰ Existing email lists were compiled to create a master electronic survey distribution list. The initial invitation and 3 subsequent reminders were disseminated to the following target groups: hospital physicians (both hospitalists and nonhospitalists), PCPs, nursing and other allied professionals, administrators, and DFP leadership.

The survey consent form, background information, questions, and online platform (SimpleSurvey, Montreal, QC) were approved by FH’s Privacy Department. All respondents were required to provide their consent and able to withdraw at any time. Survey responses were kept anonymous and confidential, with results captured automatically into a spreadsheet by the survey platform. As an incentive for participation, respondents had the opportunity to win 1 of 3 $100 Visa gift cards. Personal contact information provided for the prize draw was collected in a separate survey that could not link back to respondents’ answers. The survey was trialed several times by the evaluation team to address any technical challenges before dissemination to the targeted participants.

Qualitative interviews

We conducted semistructured interviews with a purposive sample of FH administrators and frontline providers (Appendix B). The interview questions broadly mirrored the survey but allowed for more in-depth exploration of constructs. Interviewees were recruited through email invitations to selected senior and mid-level local and regional administrators, asking interviewees to refer our team to other contacts, and inviting survey respondents to voluntarily participate in a follow-up interview. One of the authors (EM), a Credentialed Evaluator, conducted all the one-time interviews either in-person at the individual participant’s workplace or by telephone. She did not have pre-existing relationships with any of the interviewees. Interviews were recorded and transcribed for analysis. Interviewees were required to consent to participate and understood that they could withdraw at any point. They were not offered incentives to participate. Interviews were carried out until thematic saturation was reached.

Analysis

A content analysis approach was employed for all qualitative data, which included open-ended responses from the online survey and interview transcripts. One of the authors (EM) conducted the analysis. The following steps were followed in the inductive content analysis process: repeated reading of the raw data, generation of initial thematic codes, organizing and sorting codes into categories (ie, main vs subcategories), coding of all data, quantifying codes, and interpreting themes. When responding to open-ended questions, respondents often provided multiple answers per question. Each of the respondents’ answers were coded. In alignment with the inductive nature of the analysis process, themes emerged organically from the data rather than the researchers using preconceived theories and categories to code the text. This was achieved by postponing the review of relevant literature on the topic until after the analysis was complete and using an external evaluation consultant (with no prior relationship to FH and limited theoretical knowledge of the topic matter) to analyze the data. Descriptive statistics were run on quantitative data in SPSS (v.24, IBM, Armonk, NY). For survey responses to be included in the analysis, the respondents needed to indicate which site they worked at and were required to answer at least 1 other survey question. One interviewee was excluded from the analysis since they were not familiar with the hospitalist model at their site.

Ethics approval

The evaluation protocol was reviewed by FH Department of Evaluation and Research and was deemed exempt from formal research ethics review.

A total of 377 individuals responded to the online survey between January 8 and February 28, 2018 (response rate 14%). The distribution of respondents generally reflected the size of the respective acute care facilities. Compared to the overall sampled population, fewer nurses participated in the survey (45% vs 64%) while the rate of participation for Unit Clerks (14% vs 16%) and allied professionals (12% vs 16%) were similar.

Out of the 45 people approached for an interview, a total of 38 were conducted from January 3 to March 5, 2018 (response rate 84%). The interviews lasted an average of 42 minutes. Interviewees represented a range of administrative and health professional roles (Figure 1). Some interviewees held multiple positions.

Satisfaction with HM service

Across all sites, survey respondents reported high levels of satisfaction with their respective HM services and identified positive impacts on their job satisfaction (Figure 2). Almost all interviewees similarly expressed high satisfaction levels with their HM services (95%; n = 36).

Perceptions of HM service performance

Survey respondents rated the strength of hospitalists’ interprofessional communication and collaboration with other physicians and with care teams. Roughly two-thirds reported that overall hospitalist communication was “good” or “very good.” We also asked participants to rate the frequency at which hospitalists met best practice expectations related to interprofessional teamwork. Across all sites, similar proportions of respondents (23% to 39%) reported that these best practices were met “most of the time” or “always” (Figure 3). Survey questions also assessed perceptions of respondents about the quality and safety of care provided by hospitalists (Figure 4).

Perceptions of the impact of the HM service postimplementation

The majority of survey respondents reported improvements in the quality of communication, professional relationships, and coordination of inpatient care at transition points after the implementation of the HM service (Figure 5). This was also reflected in interviews, where some indicated that it was easier to communicate with hospitalists due to their on-site presence, accessibility, and 24/7 availability (n = 21). They also described improved collaboration within the care teams (n = 7), and easier communication with hospitalists because they were approachable, willing, and receptive (n = 4).

We also asked the survey respondents to assess the impact of the new hospitalist model on different dimensions of care quality, including patient satisfaction, patient experience, efficiency, and overall quality of care (Figure 6). Findings were comparable across these dimensions, with roughly 50-60% of respondents noting positive changes compared to before the implementation of the programs. However, most interviewees identified both positive and negative effects in these areas. Positive impacts included hospitalist on-site presence leading to better accessibility and timeliness of care (n = 5), hospitalists providing continuity to patients/families by working for weeklong rotations (n = 6), hospitalists being particularly skilled at managing complex clinical presentations (n = 2), and hospitalists being able to spend more time with patients (n = 2). On the other hand, some interviewees noted that patients and families did not like seeing multiple doctors due to frequent handoffs between hospitalists (n = 12). They also raised concerns that hospitalists did not know patients’ histories or had relationships with them, potentially leading to longer length of stay and unnecessary investigations (n = 8).

Site-to-site ratings of satisfaction and performance

Survey respondents’ satisfaction and performance ratings varied substantially site-to-site. Across all areas assessed, ratings were consistently highest at Site B (the smallest institution in our evaluation and the most recent addition to the HM network in the health authority). These differences were statistically significant across all survey questions asked.

Discussion

Findings from this study provide insight into the experiences of frontline health care professionals and administrators with the implementation of new HM services across a range of small to large acute care facilities. They indicate that the majority of respondents reported high levels of satisfaction with their hospitalist services. Most also indicated that the service had resulted in improvements compared to prior inpatient care models.

Over half of the survey respondents, and the majority of interviewees, reported a positive impact on interprofessional communication and collaboration. This was largely attributed to enhanced accessibility and availability of hospitalists:

• "Being on-site lends itself to better communication because they’re accessible. Hospitalists always answer the phone, but the general practitioners (GP) don’t always since they may be with other patients." (Dietician, Site A)
• "A big strength is that we have physician presence on the unit all day during scheduled hours, which makes us more accessible to nurses and more able to follow up on patients that we have concerns about." (Physician Leader, Site B)

However, the ratings dropped substantially when they were asked to assess adherence to specific best practices of such communication and collaboration, such as participation in daily check-ins or attendance at team care rounds (Figure 3). Interdisciplinary clinical rounds have been identified as a tool to improve the effectiveness of care teams.¹² A number of elements have been identified as key components of effective rounds.¹³ Bedside rounds have also been found to enhance communication and teamwork.^14,15 In our study, the discrepancy between overall high levels of satisfaction with hospitalists’ communication/collaboration despite low scores on participation in more concrete activities may illustrate the importance of informal and ad hoc opportunities for interactions between hospitalists and other care providers that result from the enhanced presence of hospitalists on care units.⁸ Outside of formal rounds, hospitalists have the ability to interact with other care providers throughout their shifts. Prior studies have shown that hospitalists spend a significant portion of their time communicating with other care team members throughout their workdays.¹⁶ At the same time, the amount of time spent on communication should be balanced against the need for provision of direct care at the bedside. Future research should aim to identify the right balance between these competing priorities, and to understand the nature and quality of the communication between various care providers.

We also aimed to understand the perceptions of study participants about the impact of the HM service on quality of care. Survey participants not only expressed reasonable satisfaction with various aspects of hospitalists’ performance, but also described a positive impact on care quality after the implementation of their new services. This was also reflected in the interviews:

• "The clinical knowledge of the new hospitalists is far better. Some are internal medicine trained, so they bring better knowledge and skills. I feel comfortable that they can take patients and manage them. I wasn’t always comfortable with doing that in the past." (Emergency Physician, Site C)
• "Hospitalists are really familiar with acute care and how it works. They’ve become more familiar with the discharge planning system and thus know more about the resources available. And even something as simple as knowing which forms to use." (Dietician, Site A)

It must be noted that these observations should ideally be corroborated through a robust before-after analysis of various quality measures. While such an analysis was beyond the scope of our current project, we have previously demonstrated that across our network (including the 3 sites included in our evaluation) hospitalist care is associated with lower mortality and readmission rates.⁴ Our findings appear to confirm previous suggestions that hospitalists’ dedicated focus on inpatient care may allow them to develop enhanced skills in the management of common conditions in the acute care setting¹⁷ which can be perceived to be of value to other hospital-based care providers.

The issue of frequent handover among hospitalists was the most commonly identified challenge by both survey respondents and interviewees:

• "They’re very reluctant to discharge patients if it’s their first day with the patient. Even if the previous hospitalist said they were ready for discharge, the new doc wants to run all of their own tests before they feel comfortable. Maybe it’s a trust issue between hospitalists when they hand patients over. It’s also being personally liable for patients if you discharge them." (Patient Care Coordinator, Site A)
• "Communication is an issue. There’s lots of turnover in hospitalists. Relationships were closer with GPs because we had so much more interaction with particular individuals." (Hospitalist Physician Leader, Site A)

It must be noted that we conducted our evaluation in a relatively short time span (within 2 years) after the 3 services were implemented. Developing trust among a large number of hospitalists newly recruited to these programs can take time and may be a factor that can explain the reluctance of some to discharge patients after handoffs. However, concerns about discontinuity of care inherent in the hospitalist model are not new.^18,19 Better continuity has been associated with higher probability of patient discharges²⁰ and improved outcomes.²¹ To address this challenge, the hospitalist community has focused on defining the core competencies associated with high quality handovers,²² and deliberate efforts to improve the quality of handoffs through quality improvement methodologies.²³ Our study participants similarly identified these measures as potential solutions. Despite this, addressing hospitalist continuity of care remains a pressing challenge for the broader hospitalist community.²⁴

Our evaluation has a number of methodological limitations. First, the survey response rate was only 14%, which raises questions about nonresponse bias and the representativeness of the findings to the larger population of interest. While the distribution of respondents was largely similar to the overall sampled population, a number of factors may have impacted our response rate. For example, we were only able to distribute our survey to health care providers’ institutional email addresses. Moreover, while we provided incentives for participation and sent out a number of reminders, we solely relied on one communication modality (ie, electronic communication) and did not utilize other methods (such as posters, reminder at meetings, in-person invitations). Second, while the survey included a number of open-ended questions, many of these responses were at times brief and difficult to interpret and were not included in the analysis. Third, all data collected were self-reported. For example, we could not corroborate comments about participation in interdisciplinary rounds by objective measures such as attendance records or direct observation. Self-report data is subjective in nature and is vulnerable to a range of biases, such as social desirability bias.²⁵ Finally, patient satisfaction and experience with hospitalist care were not assessed by patients themselves. Ideally, standardized cross-site indicators should validate our patient-related results.

As mentioned above, hospitalist performance ratings varied substantially from site-to-site and were consistently higher at Site B (a small community hospital in a semi-rural area), followed by Site C (a medium-sized community hospital) and Site A (a tertiary referral center). The variability in program ratings and perceived hospitalist impacts between sites could be due to a variety of factors, such as the degree of change between the past and current models at each site, differences in hospitalist hiring processes, hospital size and culture, and differences in service design and operations. It may also be related to the timing of the introduction of the HM service, as Site B was the most recent site where the service was established. As such, there may be an element of recall bias behind the observed discrepancies. This highlights the importance of local context on respondent perceptions and suggests that our results may not be generalizable to other institutions with different attributes and characteristics.

Conclusion

Findings from this study have demonstrated that the recent hospitalist services in our health system have improved overall levels of interprofessional communication and teamwork, as well as perceptions of care quality among the majority of participants who reported high levels of satisfaction with their programs. Our findings further highlight the issue of frequent handovers among hospitalists as a pressing and ongoing challenge.

Corresponding Author: Vandad Yousefi, MD, CCFP, Past Regional Department Head – Hospital Medicine, Fraser Health Authority, Central City Tower, Suite 400, 13450 – 102nd Ave, Surrey, BC V3T 0H1; [email protected].

Financial disclosures: This project was funded by the Fraser Health Authority, which provided the funding for hiring of the external consultant to design, implement, and analyze the results of the evaluation program in collaboration with the Regional Hospitalist Program at Fraser Health.

From the Fraser Health Authority, Surrey, BC, Canada (Drs. Yousefi and Paletta), and Catalyst Consulting Inc., Vancouver, BC, Canada (Elayne McIvor).

Objective: Despite the ongoing growth in the number of hospitalist programs in Canada, their impact on the quality of interprofessional communication, teamwork, and staff satisfaction is not well known. This study aimed to evaluate perceptions of frontline care providers and hospital managers about the impact of the implementation of 3 new hospitalist services on care quality, teamwork, and interprofessional communication.

Design: We used an online survey and semistructured interviews to evaluate respondents’ views on quality of interprofessional communication and collaboration, impact of the new services on quality of care, and overall staff satisfaction with the new inpatient care model.

Setting: Integrated Regional Health Authority in British Columbia, Canada.

Participants: Participants included hospital administrators, frontline care providers (across a range of professions), and hospital and community-based physicians.

Results: The majority of respondents reported high levels of satisfaction with their new hospital medicine services. They identified improvements in interprofessional collaboration and communication between hospitalists and other professionals, which were attributed to enhanced onsite presence of physicians. They also perceived improvements in quality of care and efficiency. On the other hand, they identified a number of challenges with the change process, and raised concerns about the impact of patient handoffs on care quality and efficiency.

Conclusion: Across 3 very different acute care settings, the implementation of a hospitalist service was widely perceived to have resulted in improved teamwork, quality of care, and interprofessional communication.

Keywords: hospital medicine; hospitalist; teamwork; interprofessional collaboration.

Fraser Health Authority (FH) is an integrated regional health system with one of the largest regional Hospital Medicine (HM) networks in Canada.⁹ Over the past 2 decades, FH has implemented a number of HM services in its acute care facilities across a range of small and large community and academic hospitals. More recently, 3 hospitalist services were implemented over a 2-year period: new HM services in a tertiary referral center (Site A, July 2016) and a small community hospital (Site B, December 2016), and reintroduction of a hospitalist service in a medium-sized community hospital (Site C, January 2017). This provided a unique opportunity to assess the impact of the implementation of the hospitalist model across a range of facilities. The main objectives of this evaluation were to understand the level of physician, nursing, allied staff, and hospital administration satisfaction with the new hospitalist model, as well as the perceived impact of the service on efficiency and quality of care. As such, FH engaged an external consultant (EM) to conduct a comprehensive evaluation of the introduction of its latest HM services.

Methods

Setting

Hospital medicine services are currently available in 10 of 12 acute care facilities within the FH system. The 3 sites described in this evaluation constitute the most recent sites where a hospitalist service was implemented.

Site A is a 272-bed tertiary referral center situated in a rapidly growing community. At the time of our evaluation, 21 Full Time Equivalent (FTE) hospitalists cared for an average of 126 patients, which constituted the majority of adult medical patients. Each day, 8 individuals rounded on admitted patients (average individual census: 16) with another person providing in-house, evening, and overnight coverage. An additional flexible shift during the early afternoon helped with Emergency Department (ED) admissions.

Site B is small, 45-bed community hospital in a semi-rural community. The hospitalist service began in December 2016, with 4 FTE hospitalists caring for an average of 28 patients daily. This constituted 2 hospitalists rounding daily on admitted patients, with on-call coverage provided from home.

Site C is a 188-bed community hospital with a hospitalist service initially introduced in 2005. In 2016, the program was disbanded and the site moved back to a primarily community-based model, in which family physicians in the community were invited to assume the care of hospitalized patients. However, the hospitalist program had to be reintroduced in January 2017 due to poor uptake among PCPs in the community. At the time of evaluation, 19 FTE hospitalists (with 7 hospitalists working daily) provided most responsible physician care to a daily census of 116 patients (average individual census: 16). The program also covered ED admissions in-house until midnight, with overnight call provided from home.

Approach

We adopted a utilization-focused evaluation approach to guide our investigation. In this approach, the assessment is deliberately planned and conducted in a way that it maximizes the likelihood that findings would be used by the organization to inform learning, adaptations, and decision-making.¹¹ To enable this, the evaluator identified the primary intended recipients and engaged them at the start of the evaluation process to understand the main intended uses of the project. Moreover, the evaluator ensured that these intended uses of the evaluation guided all other decisions made throughout the process.

We collected data using an online survey of the staff at the 3 facilities, complemented by a series of semistructured qualitative interviews with FH administrators and frontline providers.

Online survey

We conducted an open online survey of a broad range of stakeholders who worked in the 3 facilities. To develop the questionnaire, we searched our department’s archives for previous surveys conducted from 2001 to 2005. We also interviewed the regional HM program management team to identify priority areas and reached out to the local leadership of the 3 acute care facilities for their input and support of the project. We refined the survey through several iterations, seeking input from experts in the FH Department of Evaluation and Research. The final questionnaire contained 10 items, including a mix of closed- and open-ended questions (Appendix A).

To reach the target audience, we collaborated with each hospital’s local leadership as well as the Divisions of Family Practice (DFP) that support local community PCPs in each hospital community.¹⁰ Existing email lists were compiled to create a master electronic survey distribution list. The initial invitation and 3 subsequent reminders were disseminated to the following target groups: hospital physicians (both hospitalists and nonhospitalists), PCPs, nursing and other allied professionals, administrators, and DFP leadership.

The survey consent form, background information, questions, and online platform (SimpleSurvey, Montreal, QC) were approved by FH’s Privacy Department. All respondents were required to provide their consent and able to withdraw at any time. Survey responses were kept anonymous and confidential, with results captured automatically into a spreadsheet by the survey platform. As an incentive for participation, respondents had the opportunity to win 1 of 3 $100 Visa gift cards. Personal contact information provided for the prize draw was collected in a separate survey that could not link back to respondents’ answers. The survey was trialed several times by the evaluation team to address any technical challenges before dissemination to the targeted participants.

Qualitative interviews

We conducted semistructured interviews with a purposive sample of FH administrators and frontline providers (Appendix B). The interview questions broadly mirrored the survey but allowed for more in-depth exploration of constructs. Interviewees were recruited through email invitations to selected senior and mid-level local and regional administrators, asking interviewees to refer our team to other contacts, and inviting survey respondents to voluntarily participate in a follow-up interview. One of the authors (EM), a Credentialed Evaluator, conducted all the one-time interviews either in-person at the individual participant’s workplace or by telephone. She did not have pre-existing relationships with any of the interviewees. Interviews were recorded and transcribed for analysis. Interviewees were required to consent to participate and understood that they could withdraw at any point. They were not offered incentives to participate. Interviews were carried out until thematic saturation was reached.

Analysis

A content analysis approach was employed for all qualitative data, which included open-ended responses from the online survey and interview transcripts. One of the authors (EM) conducted the analysis. The following steps were followed in the inductive content analysis process: repeated reading of the raw data, generation of initial thematic codes, organizing and sorting codes into categories (ie, main vs subcategories), coding of all data, quantifying codes, and interpreting themes. When responding to open-ended questions, respondents often provided multiple answers per question. Each of the respondents’ answers were coded. In alignment with the inductive nature of the analysis process, themes emerged organically from the data rather than the researchers using preconceived theories and categories to code the text. This was achieved by postponing the review of relevant literature on the topic until after the analysis was complete and using an external evaluation consultant (with no prior relationship to FH and limited theoretical knowledge of the topic matter) to analyze the data. Descriptive statistics were run on quantitative data in SPSS (v.24, IBM, Armonk, NY). For survey responses to be included in the analysis, the respondents needed to indicate which site they worked at and were required to answer at least 1 other survey question. One interviewee was excluded from the analysis since they were not familiar with the hospitalist model at their site.

Ethics approval

The evaluation protocol was reviewed by FH Department of Evaluation and Research and was deemed exempt from formal research ethics review.

A total of 377 individuals responded to the online survey between January 8 and February 28, 2018 (response rate 14%). The distribution of respondents generally reflected the size of the respective acute care facilities. Compared to the overall sampled population, fewer nurses participated in the survey (45% vs 64%) while the rate of participation for Unit Clerks (14% vs 16%) and allied professionals (12% vs 16%) were similar.

Out of the 45 people approached for an interview, a total of 38 were conducted from January 3 to March 5, 2018 (response rate 84%). The interviews lasted an average of 42 minutes. Interviewees represented a range of administrative and health professional roles (Figure 1). Some interviewees held multiple positions.

Satisfaction with HM service

Across all sites, survey respondents reported high levels of satisfaction with their respective HM services and identified positive impacts on their job satisfaction (Figure 2). Almost all interviewees similarly expressed high satisfaction levels with their HM services (95%; n = 36).

Perceptions of HM service performance

Survey respondents rated the strength of hospitalists’ interprofessional communication and collaboration with other physicians and with care teams. Roughly two-thirds reported that overall hospitalist communication was “good” or “very good.” We also asked participants to rate the frequency at which hospitalists met best practice expectations related to interprofessional teamwork. Across all sites, similar proportions of respondents (23% to 39%) reported that these best practices were met “most of the time” or “always” (Figure 3). Survey questions also assessed perceptions of respondents about the quality and safety of care provided by hospitalists (Figure 4).

Perceptions of the impact of the HM service postimplementation

The majority of survey respondents reported improvements in the quality of communication, professional relationships, and coordination of inpatient care at transition points after the implementation of the HM service (Figure 5). This was also reflected in interviews, where some indicated that it was easier to communicate with hospitalists due to their on-site presence, accessibility, and 24/7 availability (n = 21). They also described improved collaboration within the care teams (n = 7), and easier communication with hospitalists because they were approachable, willing, and receptive (n = 4).

We also asked the survey respondents to assess the impact of the new hospitalist model on different dimensions of care quality, including patient satisfaction, patient experience, efficiency, and overall quality of care (Figure 6). Findings were comparable across these dimensions, with roughly 50-60% of respondents noting positive changes compared to before the implementation of the programs. However, most interviewees identified both positive and negative effects in these areas. Positive impacts included hospitalist on-site presence leading to better accessibility and timeliness of care (n = 5), hospitalists providing continuity to patients/families by working for weeklong rotations (n = 6), hospitalists being particularly skilled at managing complex clinical presentations (n = 2), and hospitalists being able to spend more time with patients (n = 2). On the other hand, some interviewees noted that patients and families did not like seeing multiple doctors due to frequent handoffs between hospitalists (n = 12). They also raised concerns that hospitalists did not know patients’ histories or had relationships with them, potentially leading to longer length of stay and unnecessary investigations (n = 8).

Site-to-site ratings of satisfaction and performance

Survey respondents’ satisfaction and performance ratings varied substantially site-to-site. Across all areas assessed, ratings were consistently highest at Site B (the smallest institution in our evaluation and the most recent addition to the HM network in the health authority). These differences were statistically significant across all survey questions asked.

Discussion

Findings from this study provide insight into the experiences of frontline health care professionals and administrators with the implementation of new HM services across a range of small to large acute care facilities. They indicate that the majority of respondents reported high levels of satisfaction with their hospitalist services. Most also indicated that the service had resulted in improvements compared to prior inpatient care models.

Over half of the survey respondents, and the majority of interviewees, reported a positive impact on interprofessional communication and collaboration. This was largely attributed to enhanced accessibility and availability of hospitalists:

• "Being on-site lends itself to better communication because they’re accessible. Hospitalists always answer the phone, but the general practitioners (GP) don’t always since they may be with other patients." (Dietician, Site A)
• "A big strength is that we have physician presence on the unit all day during scheduled hours, which makes us more accessible to nurses and more able to follow up on patients that we have concerns about." (Physician Leader, Site B)

However, the ratings dropped substantially when they were asked to assess adherence to specific best practices of such communication and collaboration, such as participation in daily check-ins or attendance at team care rounds (Figure 3). Interdisciplinary clinical rounds have been identified as a tool to improve the effectiveness of care teams.¹² A number of elements have been identified as key components of effective rounds.¹³ Bedside rounds have also been found to enhance communication and teamwork.^14,15 In our study, the discrepancy between overall high levels of satisfaction with hospitalists’ communication/collaboration despite low scores on participation in more concrete activities may illustrate the importance of informal and ad hoc opportunities for interactions between hospitalists and other care providers that result from the enhanced presence of hospitalists on care units.⁸ Outside of formal rounds, hospitalists have the ability to interact with other care providers throughout their shifts. Prior studies have shown that hospitalists spend a significant portion of their time communicating with other care team members throughout their workdays.¹⁶ At the same time, the amount of time spent on communication should be balanced against the need for provision of direct care at the bedside. Future research should aim to identify the right balance between these competing priorities, and to understand the nature and quality of the communication between various care providers.

We also aimed to understand the perceptions of study participants about the impact of the HM service on quality of care. Survey participants not only expressed reasonable satisfaction with various aspects of hospitalists’ performance, but also described a positive impact on care quality after the implementation of their new services. This was also reflected in the interviews:

• "The clinical knowledge of the new hospitalists is far better. Some are internal medicine trained, so they bring better knowledge and skills. I feel comfortable that they can take patients and manage them. I wasn’t always comfortable with doing that in the past." (Emergency Physician, Site C)
• "Hospitalists are really familiar with acute care and how it works. They’ve become more familiar with the discharge planning system and thus know more about the resources available. And even something as simple as knowing which forms to use." (Dietician, Site A)

It must be noted that these observations should ideally be corroborated through a robust before-after analysis of various quality measures. While such an analysis was beyond the scope of our current project, we have previously demonstrated that across our network (including the 3 sites included in our evaluation) hospitalist care is associated with lower mortality and readmission rates.⁴ Our findings appear to confirm previous suggestions that hospitalists’ dedicated focus on inpatient care may allow them to develop enhanced skills in the management of common conditions in the acute care setting¹⁷ which can be perceived to be of value to other hospital-based care providers.

The issue of frequent handover among hospitalists was the most commonly identified challenge by both survey respondents and interviewees:

• "They’re very reluctant to discharge patients if it’s their first day with the patient. Even if the previous hospitalist said they were ready for discharge, the new doc wants to run all of their own tests before they feel comfortable. Maybe it’s a trust issue between hospitalists when they hand patients over. It’s also being personally liable for patients if you discharge them." (Patient Care Coordinator, Site A)
• "Communication is an issue. There’s lots of turnover in hospitalists. Relationships were closer with GPs because we had so much more interaction with particular individuals." (Hospitalist Physician Leader, Site A)

It must be noted that we conducted our evaluation in a relatively short time span (within 2 years) after the 3 services were implemented. Developing trust among a large number of hospitalists newly recruited to these programs can take time and may be a factor that can explain the reluctance of some to discharge patients after handoffs. However, concerns about discontinuity of care inherent in the hospitalist model are not new.^18,19 Better continuity has been associated with higher probability of patient discharges²⁰ and improved outcomes.²¹ To address this challenge, the hospitalist community has focused on defining the core competencies associated with high quality handovers,²² and deliberate efforts to improve the quality of handoffs through quality improvement methodologies.²³ Our study participants similarly identified these measures as potential solutions. Despite this, addressing hospitalist continuity of care remains a pressing challenge for the broader hospitalist community.²⁴

Our evaluation has a number of methodological limitations. First, the survey response rate was only 14%, which raises questions about nonresponse bias and the representativeness of the findings to the larger population of interest. While the distribution of respondents was largely similar to the overall sampled population, a number of factors may have impacted our response rate. For example, we were only able to distribute our survey to health care providers’ institutional email addresses. Moreover, while we provided incentives for participation and sent out a number of reminders, we solely relied on one communication modality (ie, electronic communication) and did not utilize other methods (such as posters, reminder at meetings, in-person invitations). Second, while the survey included a number of open-ended questions, many of these responses were at times brief and difficult to interpret and were not included in the analysis. Third, all data collected were self-reported. For example, we could not corroborate comments about participation in interdisciplinary rounds by objective measures such as attendance records or direct observation. Self-report data is subjective in nature and is vulnerable to a range of biases, such as social desirability bias.²⁵ Finally, patient satisfaction and experience with hospitalist care were not assessed by patients themselves. Ideally, standardized cross-site indicators should validate our patient-related results.

As mentioned above, hospitalist performance ratings varied substantially from site-to-site and were consistently higher at Site B (a small community hospital in a semi-rural area), followed by Site C (a medium-sized community hospital) and Site A (a tertiary referral center). The variability in program ratings and perceived hospitalist impacts between sites could be due to a variety of factors, such as the degree of change between the past and current models at each site, differences in hospitalist hiring processes, hospital size and culture, and differences in service design and operations. It may also be related to the timing of the introduction of the HM service, as Site B was the most recent site where the service was established. As such, there may be an element of recall bias behind the observed discrepancies. This highlights the importance of local context on respondent perceptions and suggests that our results may not be generalizable to other institutions with different attributes and characteristics.

Conclusion

Findings from this study have demonstrated that the recent hospitalist services in our health system have improved overall levels of interprofessional communication and teamwork, as well as perceptions of care quality among the majority of participants who reported high levels of satisfaction with their programs. Our findings further highlight the issue of frequent handovers among hospitalists as a pressing and ongoing challenge.

Corresponding Author: Vandad Yousefi, MD, CCFP, Past Regional Department Head – Hospital Medicine, Fraser Health Authority, Central City Tower, Suite 400, 13450 – 102nd Ave, Surrey, BC V3T 0H1; [email protected].

Financial disclosures: This project was funded by the Fraser Health Authority, which provided the funding for hiring of the external consultant to design, implement, and analyze the results of the evaluation program in collaboration with the Regional Hospitalist Program at Fraser Health.

From the Fraser Health Authority, Surrey, BC, Canada (Drs. Yousefi and Paletta), and Catalyst Consulting Inc., Vancouver, BC, Canada (Elayne McIvor).

Objective: Despite the ongoing growth in the number of hospitalist programs in Canada, their impact on the quality of interprofessional communication, teamwork, and staff satisfaction is not well known. This study aimed to evaluate perceptions of frontline care providers and hospital managers about the impact of the implementation of 3 new hospitalist services on care quality, teamwork, and interprofessional communication.

Design: We used an online survey and semistructured interviews to evaluate respondents’ views on quality of interprofessional communication and collaboration, impact of the new services on quality of care, and overall staff satisfaction with the new inpatient care model.

Setting: Integrated Regional Health Authority in British Columbia, Canada.

Participants: Participants included hospital administrators, frontline care providers (across a range of professions), and hospital and community-based physicians.

Results: The majority of respondents reported high levels of satisfaction with their new hospital medicine services. They identified improvements in interprofessional collaboration and communication between hospitalists and other professionals, which were attributed to enhanced onsite presence of physicians. They also perceived improvements in quality of care and efficiency. On the other hand, they identified a number of challenges with the change process, and raised concerns about the impact of patient handoffs on care quality and efficiency.

Conclusion: Across 3 very different acute care settings, the implementation of a hospitalist service was widely perceived to have resulted in improved teamwork, quality of care, and interprofessional communication.

Keywords: hospital medicine; hospitalist; teamwork; interprofessional collaboration.

Fraser Health Authority (FH) is an integrated regional health system with one of the largest regional Hospital Medicine (HM) networks in Canada.⁹ Over the past 2 decades, FH has implemented a number of HM services in its acute care facilities across a range of small and large community and academic hospitals. More recently, 3 hospitalist services were implemented over a 2-year period: new HM services in a tertiary referral center (Site A, July 2016) and a small community hospital (Site B, December 2016), and reintroduction of a hospitalist service in a medium-sized community hospital (Site C, January 2017). This provided a unique opportunity to assess the impact of the implementation of the hospitalist model across a range of facilities. The main objectives of this evaluation were to understand the level of physician, nursing, allied staff, and hospital administration satisfaction with the new hospitalist model, as well as the perceived impact of the service on efficiency and quality of care. As such, FH engaged an external consultant (EM) to conduct a comprehensive evaluation of the introduction of its latest HM services.

Methods

Setting

Hospital medicine services are currently available in 10 of 12 acute care facilities within the FH system. The 3 sites described in this evaluation constitute the most recent sites where a hospitalist service was implemented.

Site A is a 272-bed tertiary referral center situated in a rapidly growing community. At the time of our evaluation, 21 Full Time Equivalent (FTE) hospitalists cared for an average of 126 patients, which constituted the majority of adult medical patients. Each day, 8 individuals rounded on admitted patients (average individual census: 16) with another person providing in-house, evening, and overnight coverage. An additional flexible shift during the early afternoon helped with Emergency Department (ED) admissions.

Site B is small, 45-bed community hospital in a semi-rural community. The hospitalist service began in December 2016, with 4 FTE hospitalists caring for an average of 28 patients daily. This constituted 2 hospitalists rounding daily on admitted patients, with on-call coverage provided from home.

Site C is a 188-bed community hospital with a hospitalist service initially introduced in 2005. In 2016, the program was disbanded and the site moved back to a primarily community-based model, in which family physicians in the community were invited to assume the care of hospitalized patients. However, the hospitalist program had to be reintroduced in January 2017 due to poor uptake among PCPs in the community. At the time of evaluation, 19 FTE hospitalists (with 7 hospitalists working daily) provided most responsible physician care to a daily census of 116 patients (average individual census: 16). The program also covered ED admissions in-house until midnight, with overnight call provided from home.

Approach

We adopted a utilization-focused evaluation approach to guide our investigation. In this approach, the assessment is deliberately planned and conducted in a way that it maximizes the likelihood that findings would be used by the organization to inform learning, adaptations, and decision-making.¹¹ To enable this, the evaluator identified the primary intended recipients and engaged them at the start of the evaluation process to understand the main intended uses of the project. Moreover, the evaluator ensured that these intended uses of the evaluation guided all other decisions made throughout the process.

We collected data using an online survey of the staff at the 3 facilities, complemented by a series of semistructured qualitative interviews with FH administrators and frontline providers.

Online survey

We conducted an open online survey of a broad range of stakeholders who worked in the 3 facilities. To develop the questionnaire, we searched our department’s archives for previous surveys conducted from 2001 to 2005. We also interviewed the regional HM program management team to identify priority areas and reached out to the local leadership of the 3 acute care facilities for their input and support of the project. We refined the survey through several iterations, seeking input from experts in the FH Department of Evaluation and Research. The final questionnaire contained 10 items, including a mix of closed- and open-ended questions (Appendix A).

To reach the target audience, we collaborated with each hospital’s local leadership as well as the Divisions of Family Practice (DFP) that support local community PCPs in each hospital community.¹⁰ Existing email lists were compiled to create a master electronic survey distribution list. The initial invitation and 3 subsequent reminders were disseminated to the following target groups: hospital physicians (both hospitalists and nonhospitalists), PCPs, nursing and other allied professionals, administrators, and DFP leadership.

The survey consent form, background information, questions, and online platform (SimpleSurvey, Montreal, QC) were approved by FH’s Privacy Department. All respondents were required to provide their consent and able to withdraw at any time. Survey responses were kept anonymous and confidential, with results captured automatically into a spreadsheet by the survey platform. As an incentive for participation, respondents had the opportunity to win 1 of 3 $100 Visa gift cards. Personal contact information provided for the prize draw was collected in a separate survey that could not link back to respondents’ answers. The survey was trialed several times by the evaluation team to address any technical challenges before dissemination to the targeted participants.

Qualitative interviews

We conducted semistructured interviews with a purposive sample of FH administrators and frontline providers (Appendix B). The interview questions broadly mirrored the survey but allowed for more in-depth exploration of constructs. Interviewees were recruited through email invitations to selected senior and mid-level local and regional administrators, asking interviewees to refer our team to other contacts, and inviting survey respondents to voluntarily participate in a follow-up interview. One of the authors (EM), a Credentialed Evaluator, conducted all the one-time interviews either in-person at the individual participant’s workplace or by telephone. She did not have pre-existing relationships with any of the interviewees. Interviews were recorded and transcribed for analysis. Interviewees were required to consent to participate and understood that they could withdraw at any point. They were not offered incentives to participate. Interviews were carried out until thematic saturation was reached.

Analysis

A content analysis approach was employed for all qualitative data, which included open-ended responses from the online survey and interview transcripts. One of the authors (EM) conducted the analysis. The following steps were followed in the inductive content analysis process: repeated reading of the raw data, generation of initial thematic codes, organizing and sorting codes into categories (ie, main vs subcategories), coding of all data, quantifying codes, and interpreting themes. When responding to open-ended questions, respondents often provided multiple answers per question. Each of the respondents’ answers were coded. In alignment with the inductive nature of the analysis process, themes emerged organically from the data rather than the researchers using preconceived theories and categories to code the text. This was achieved by postponing the review of relevant literature on the topic until after the analysis was complete and using an external evaluation consultant (with no prior relationship to FH and limited theoretical knowledge of the topic matter) to analyze the data. Descriptive statistics were run on quantitative data in SPSS (v.24, IBM, Armonk, NY). For survey responses to be included in the analysis, the respondents needed to indicate which site they worked at and were required to answer at least 1 other survey question. One interviewee was excluded from the analysis since they were not familiar with the hospitalist model at their site.

Ethics approval

The evaluation protocol was reviewed by FH Department of Evaluation and Research and was deemed exempt from formal research ethics review.

A total of 377 individuals responded to the online survey between January 8 and February 28, 2018 (response rate 14%). The distribution of respondents generally reflected the size of the respective acute care facilities. Compared to the overall sampled population, fewer nurses participated in the survey (45% vs 64%) while the rate of participation for Unit Clerks (14% vs 16%) and allied professionals (12% vs 16%) were similar.

Out of the 45 people approached for an interview, a total of 38 were conducted from January 3 to March 5, 2018 (response rate 84%). The interviews lasted an average of 42 minutes. Interviewees represented a range of administrative and health professional roles (Figure 1). Some interviewees held multiple positions.

Satisfaction with HM service

Across all sites, survey respondents reported high levels of satisfaction with their respective HM services and identified positive impacts on their job satisfaction (Figure 2). Almost all interviewees similarly expressed high satisfaction levels with their HM services (95%; n = 36).

Perceptions of HM service performance

Survey respondents rated the strength of hospitalists’ interprofessional communication and collaboration with other physicians and with care teams. Roughly two-thirds reported that overall hospitalist communication was “good” or “very good.” We also asked participants to rate the frequency at which hospitalists met best practice expectations related to interprofessional teamwork. Across all sites, similar proportions of respondents (23% to 39%) reported that these best practices were met “most of the time” or “always” (Figure 3). Survey questions also assessed perceptions of respondents about the quality and safety of care provided by hospitalists (Figure 4).

Perceptions of the impact of the HM service postimplementation

The majority of survey respondents reported improvements in the quality of communication, professional relationships, and coordination of inpatient care at transition points after the implementation of the HM service (Figure 5). This was also reflected in interviews, where some indicated that it was easier to communicate with hospitalists due to their on-site presence, accessibility, and 24/7 availability (n = 21). They also described improved collaboration within the care teams (n = 7), and easier communication with hospitalists because they were approachable, willing, and receptive (n = 4).

We also asked the survey respondents to assess the impact of the new hospitalist model on different dimensions of care quality, including patient satisfaction, patient experience, efficiency, and overall quality of care (Figure 6). Findings were comparable across these dimensions, with roughly 50-60% of respondents noting positive changes compared to before the implementation of the programs. However, most interviewees identified both positive and negative effects in these areas. Positive impacts included hospitalist on-site presence leading to better accessibility and timeliness of care (n = 5), hospitalists providing continuity to patients/families by working for weeklong rotations (n = 6), hospitalists being particularly skilled at managing complex clinical presentations (n = 2), and hospitalists being able to spend more time with patients (n = 2). On the other hand, some interviewees noted that patients and families did not like seeing multiple doctors due to frequent handoffs between hospitalists (n = 12). They also raised concerns that hospitalists did not know patients’ histories or had relationships with them, potentially leading to longer length of stay and unnecessary investigations (n = 8).

Site-to-site ratings of satisfaction and performance

Survey respondents’ satisfaction and performance ratings varied substantially site-to-site. Across all areas assessed, ratings were consistently highest at Site B (the smallest institution in our evaluation and the most recent addition to the HM network in the health authority). These differences were statistically significant across all survey questions asked.

Discussion

Findings from this study provide insight into the experiences of frontline health care professionals and administrators with the implementation of new HM services across a range of small to large acute care facilities. They indicate that the majority of respondents reported high levels of satisfaction with their hospitalist services. Most also indicated that the service had resulted in improvements compared to prior inpatient care models.

Over half of the survey respondents, and the majority of interviewees, reported a positive impact on interprofessional communication and collaboration. This was largely attributed to enhanced accessibility and availability of hospitalists:

• "Being on-site lends itself to better communication because they’re accessible. Hospitalists always answer the phone, but the general practitioners (GP) don’t always since they may be with other patients." (Dietician, Site A)
• "A big strength is that we have physician presence on the unit all day during scheduled hours, which makes us more accessible to nurses and more able to follow up on patients that we have concerns about." (Physician Leader, Site B)

However, the ratings dropped substantially when they were asked to assess adherence to specific best practices of such communication and collaboration, such as participation in daily check-ins or attendance at team care rounds (Figure 3). Interdisciplinary clinical rounds have been identified as a tool to improve the effectiveness of care teams.¹² A number of elements have been identified as key components of effective rounds.¹³ Bedside rounds have also been found to enhance communication and teamwork.^14,15 In our study, the discrepancy between overall high levels of satisfaction with hospitalists’ communication/collaboration despite low scores on participation in more concrete activities may illustrate the importance of informal and ad hoc opportunities for interactions between hospitalists and other care providers that result from the enhanced presence of hospitalists on care units.⁸ Outside of formal rounds, hospitalists have the ability to interact with other care providers throughout their shifts. Prior studies have shown that hospitalists spend a significant portion of their time communicating with other care team members throughout their workdays.¹⁶ At the same time, the amount of time spent on communication should be balanced against the need for provision of direct care at the bedside. Future research should aim to identify the right balance between these competing priorities, and to understand the nature and quality of the communication between various care providers.

We also aimed to understand the perceptions of study participants about the impact of the HM service on quality of care. Survey participants not only expressed reasonable satisfaction with various aspects of hospitalists’ performance, but also described a positive impact on care quality after the implementation of their new services. This was also reflected in the interviews:

• "The clinical knowledge of the new hospitalists is far better. Some are internal medicine trained, so they bring better knowledge and skills. I feel comfortable that they can take patients and manage them. I wasn’t always comfortable with doing that in the past." (Emergency Physician, Site C)
• "Hospitalists are really familiar with acute care and how it works. They’ve become more familiar with the discharge planning system and thus know more about the resources available. And even something as simple as knowing which forms to use." (Dietician, Site A)

It must be noted that these observations should ideally be corroborated through a robust before-after analysis of various quality measures. While such an analysis was beyond the scope of our current project, we have previously demonstrated that across our network (including the 3 sites included in our evaluation) hospitalist care is associated with lower mortality and readmission rates.⁴ Our findings appear to confirm previous suggestions that hospitalists’ dedicated focus on inpatient care may allow them to develop enhanced skills in the management of common conditions in the acute care setting¹⁷ which can be perceived to be of value to other hospital-based care providers.

The issue of frequent handover among hospitalists was the most commonly identified challenge by both survey respondents and interviewees:

• "They’re very reluctant to discharge patients if it’s their first day with the patient. Even if the previous hospitalist said they were ready for discharge, the new doc wants to run all of their own tests before they feel comfortable. Maybe it’s a trust issue between hospitalists when they hand patients over. It’s also being personally liable for patients if you discharge them." (Patient Care Coordinator, Site A)
• "Communication is an issue. There’s lots of turnover in hospitalists. Relationships were closer with GPs because we had so much more interaction with particular individuals." (Hospitalist Physician Leader, Site A)

It must be noted that we conducted our evaluation in a relatively short time span (within 2 years) after the 3 services were implemented. Developing trust among a large number of hospitalists newly recruited to these programs can take time and may be a factor that can explain the reluctance of some to discharge patients after handoffs. However, concerns about discontinuity of care inherent in the hospitalist model are not new.^18,19 Better continuity has been associated with higher probability of patient discharges²⁰ and improved outcomes.²¹ To address this challenge, the hospitalist community has focused on defining the core competencies associated with high quality handovers,²² and deliberate efforts to improve the quality of handoffs through quality improvement methodologies.²³ Our study participants similarly identified these measures as potential solutions. Despite this, addressing hospitalist continuity of care remains a pressing challenge for the broader hospitalist community.²⁴

Our evaluation has a number of methodological limitations. First, the survey response rate was only 14%, which raises questions about nonresponse bias and the representativeness of the findings to the larger population of interest. While the distribution of respondents was largely similar to the overall sampled population, a number of factors may have impacted our response rate. For example, we were only able to distribute our survey to health care providers’ institutional email addresses. Moreover, while we provided incentives for participation and sent out a number of reminders, we solely relied on one communication modality (ie, electronic communication) and did not utilize other methods (such as posters, reminder at meetings, in-person invitations). Second, while the survey included a number of open-ended questions, many of these responses were at times brief and difficult to interpret and were not included in the analysis. Third, all data collected were self-reported. For example, we could not corroborate comments about participation in interdisciplinary rounds by objective measures such as attendance records or direct observation. Self-report data is subjective in nature and is vulnerable to a range of biases, such as social desirability bias.²⁵ Finally, patient satisfaction and experience with hospitalist care were not assessed by patients themselves. Ideally, standardized cross-site indicators should validate our patient-related results.

As mentioned above, hospitalist performance ratings varied substantially from site-to-site and were consistently higher at Site B (a small community hospital in a semi-rural area), followed by Site C (a medium-sized community hospital) and Site A (a tertiary referral center). The variability in program ratings and perceived hospitalist impacts between sites could be due to a variety of factors, such as the degree of change between the past and current models at each site, differences in hospitalist hiring processes, hospital size and culture, and differences in service design and operations. It may also be related to the timing of the introduction of the HM service, as Site B was the most recent site where the service was established. As such, there may be an element of recall bias behind the observed discrepancies. This highlights the importance of local context on respondent perceptions and suggests that our results may not be generalizable to other institutions with different attributes and characteristics.

Conclusion

Findings from this study have demonstrated that the recent hospitalist services in our health system have improved overall levels of interprofessional communication and teamwork, as well as perceptions of care quality among the majority of participants who reported high levels of satisfaction with their programs. Our findings further highlight the issue of frequent handovers among hospitalists as a pressing and ongoing challenge.

Corresponding Author: Vandad Yousefi, MD, CCFP, Past Regional Department Head – Hospital Medicine, Fraser Health Authority, Central City Tower, Suite 400, 13450 – 102nd Ave, Surrey, BC V3T 0H1; [email protected].

Financial disclosures: This project was funded by the Fraser Health Authority, which provided the funding for hiring of the external consultant to design, implement, and analyze the results of the evaluation program in collaboration with the Regional Hospitalist Program at Fraser Health.

From Stamford Hospital, Stamford, CT.

Objective: This single-center, quasi-experimental study of adult patients admitted or transferred to a medical step-down unit with alcohol withdrawal diagnoses sought to determine if symptom–triggered therapy (STT) is more effective than combined fixed-scheduled (FS) and STT in severe alcohol withdrawal.

Methods: In the preintervention group (72 episodes), patients were treated with FS and STT based on physician preference. In the postintervention group (69 episodes), providers were required to utilize only the STT protocol.

Results: Implementation of the intervention was associated with a significant reduction in average (per patient) cumulative benzodiazepine dose, from 250 mg to 96 mg (P < .001) and a decrease in average length of stay from 8.0 days to 5.1 days (P < .001). Secondary safety measures included a reduction in the proportion of patients who experienced delirium tremens from 47.5% to 22.5% (P < .001), and a reduction in intubation rates from 13.8% to 1.3% (P = .003).

Conclusion: The STT protocol proved to be more effective and safer in treating severe alcohol withdrawal patients than usual care employing STT with FS. We believe the successful implementation of a STT protocol in high-acuity patients requires frequent monitoring to assess withdrawal severity combined with appropriate and timely dosing of benzodiazepines.

Keywords: alcohol withdrawal delirium; alcohol withdrawal syndrome; treatment protocol; benzodiazepine; lorazepam.

Management of severe alcohol withdrawal and delirium tremens (DT) is challenging and requires significant resources, including close monitoring and intensive treatment, frequently in an intensive care unit (ICU).¹ Early diagnosis and therapeutic intervention are important to limit potential complications associated with DT.² Benzodiazepines are first-line therapeutic agents, but the definition of optimal use and dosing regimens has been limited, due to a lack of randomized controlled trials. In lower acuity patients admitted to a detoxification unit, systematic symptom–triggered benzodiazepine therapy (STT) has been established to be more effective than fixed-schedule (FS) dosing.^3-5 Patients treated using STT require lower total benzodiazepine dosing and achieve shorter treatment durations. However, in higher-acuity patients admitted to general medical services, analyses have not shown an advantage of STT over combined FS and STT.⁶

The purpose of this study was to determine whether implementation of STT is more effective than FS dosing combined with episodic STT in the management of hospitalized high-acuity alcohol withdrawal patients. We conducted a preintervention and postintervention quasi-experimental study in the step-down unit (SDU) of a 305-bed community teaching hospital. The study population consisted of adult inpatients 18 years or older admitted or transferred to the 12-bed SDU with alcohol withdrawal, as defined by primary or secondary International Classification of Diseases, Tenth Revision diagnoses. SDU admission criteria included patients with prior DT or those who had received multiple doses of benzodiazepines in the emergency department. In-hospital transfer to the SDU was at the physician’s discretion, if the patient required escalating doses of benzodiazepines or the use of increasing resources, such as those for behavioral emergencies. The majority of patients admitted or transferred to the SDU were assigned to medical house staff teams under hospitalist supervision, and, on occasion, under community physicians. The nurse-to-patient ratio in the SDU was 1:3.

Study groups

The preintervention group consisted of 80 successive treatment episodes involving patients admitted or transferred to the SDU from December 2, 2015, to July 1, 2017. Patients were treated based upon physician preference, consisting of a scheduled dosing regimen with additional doses as needed. The postintervention group included 80 successive treatment episodes involving patients admitted or transferred to the SDU from October 1, 2017, to March 23, 2019. The STT protocol was used in all patients in the postintervention group.

In the preintervention group, fixed, scheduled doses of lorazepam or chlordiazepoxide and as-needed lorazepam were prescribed and adjusted based upon physician judgment. Monitoring of symptom severity was scored using the revised Clinical Institute Withdrawal Assessment for Alcohol scale (CIWA-Ar). Benzodiazepine dosing occurred if the CIWA-Ar score had increased 2 or more points from the last score.

In the postintervention group, the STT protocol included the creation of a standardized physician order set for benzodiazepine “sliding scale” administration. The STT protocol allowed for escalating doses for higher withdrawal scores. Symptom severity was scored using MINDS (Minnesota Detoxification Scale) criteria.¹ Lorazepam as-needed dosing was based upon MINDS scores. A MINDS score less than 10 resulted in no medication, MINDS 10-12 required 2 mg, MINDS 13-16 required 4 mg, MINDS 17-19 required 6 mg, and MINDS 20 required 8 mg and a call to the physician. Transfer to the ICU was recommended if the MINDS score was ≥ 20 for 3 consecutive hours. Monitoring intervals occurred more frequently at 30 minutes unless the MINDS score was less than 10. After 7 days, the MINDS protocol was recommended to be discontinued, as the patient might have had iatrogenic delirium.

The STT protocol was introduced during a didactic session for the hospitalists and a separate session for internal medicine and family residents. Each registered nurse working in the SDU was trained in the use of the STT protocol and MINDS during nursing huddles.

Patients were excluded from evaluation if they were transferred to the SDU after 7 or more days in the hospital, if they had stayed in the hospital more than 30 days, were chronically on benzodiazepine therapy (to avoid confounding withdrawal symptoms), or if they left the hospital against medical advice (AMA). To avoid bias in the results, the patients with early discontinuation of treatment were included in analyses of secondary outcomes, thus resulting in all 80 episodes analyzed.

Measures and data

The primary outcome measure was benzodiazepine dose intensity, expressed in total lorazepam-equivalents. Secondary measures included average length of stay (including general medical, surgical, and ICU days), seizure incidence, DT incidence, sitter use, behavioral emergency responses, rates of leaving AMA, intubation, transfer to the ICU, and death.

Benzodiazepine dosing and length of stay were obtained from the data warehouse of the hospital’s electronic health record (EHR; Meditech). Benzodiazepine dosing was expressed in total lorazepam-equivalents, with conversion as follows: lorazepam orally and intravenously 1 mg = chlordiazepoxide 25 mg = diazepam 5 mg. All other measures were obtained from chart review of the patients’ EMR entries. The Stamford Hospital Institutional Review Board approved this study.

Analysis

Data analyses for this study were performed using SPSS version 25.0 (IBM). Categorical data were reported as frequency (count) and percent within category. Continuous data were reported as mean (SD). Categorical data were analyzed using χ² analysis; continuous data were analyzed using t-tests. A P value of .05 was considered significant for each analysis.

Results

During the preintervention period, 72 episodes (58 patients) met inclusion criteria, and 69 episodes (55 patients) met inclusion criteria during the postintervention period. Ten patients were represented in both groups. Eight preintervention episodes were excluded from the primary analysis because the patient left AMA. Eleven postintervention episodes were excluded: 9 due to patients leaving AMA, 1 due to chronic benzodiazepine usage, and 1 due to transfer to the SDU unit after 7 days. Baseline characteristics and medication use profiles of the preintervention and postintervention groups are summarized in Table 1.

Implementation of the intervention was associated with a significant reduction in average (per patient) cumulative benzodiazepine dose, from 250 mg to 96 mg (P < .001), as shown in Table 2. Average length of stay decreased from 8.0 days to 5.1 days (P < .001). Secondary safety measures were notable for a reduction in DT incidence, from 47.5% to 22.5% (P < .001), and lower rates of intubation, from 13.8% to 1.3% (P = .003). Seven-day readmission rates were 0% preintervention and 1.4% postintervention.

Discussion

We found that hospitalized patients with severe alcohol withdrawal treated with STT required fewer benzodiazepines and had a lower length of stay than patients treated with a conventional combined STT and FS regimen. Implementation of the change from the STT and FS approach to the STT approach in the SDU resulted in concerns that waiting for symptoms to appear could result in more severe withdrawal and prolonged treatment.³ To address this, the intervention included monitoring and dosing every 30 minutes, as compared to monitoring and dosing every 1 hour preintervention. In addition, a sliding-scale approach to match alcohol withdrawal score with dosage was employed in postintervention patients.

Employment of the STT protocol also resulted in decreased complications, including lower rates of DT and transfer to the ICU. This new intervention resulted in significantly decreased time required to control severe symptoms. In the preintervention phase, if a patient’s symptoms escalated despite administration of the as-needed dose of benzodiazepine, there was often a delay in administration of additional doses due to the time needed for nurses to reach a physician and subsequent placement of a new order. In the postintervention phase, the STT protocol allowed nursing staff to give benzodiazepines without delay when needed. We believe this reduced the number of calls by nursing staff to physicians requesting additional medications, and that this improved teamwork when managing these patients.

As part of the intervention, a decision was made to use the MINDS scale rather than the CIWA-Ar scale to assess withdrawal severity. This was because the CIWA-Ar has only been validated in patients with uncomplicated alcohol withdrawal syndrome and has not been researched extensively in patients requiring ICU-level care.¹ MINDS assessment has proven to be reliable and reflects severity of withdrawal. Furthermore, MINDS requires less time to administer—3 to 5 minutes vs 5 to 15 minutes for the CIWA-Ar scale. CIWA-Ar, unlike MINDS, requires subjective input from the patient, which is less reliable for higher acuity patients. Our study is unique in that it focused on high-acuity patients and it showed both a significant reduction in quantity of benzodiazepines prescribed and length of stay. Previous studies on lower acuity patients in detoxification units have confirmed that STT is more effective than a FS approach.^3-5 In patients of higher acuity, STT has not proven to be superior.

A key lesson learned was the need for proper education of nursing staff. Concurrent nursing audits were necessary to ensure that scoring was performed in an accurate and timely manner. In addition, it was challenging to predict which patients might develop DTs versus those requiring a brief inpatient stay. While there was initial concern that an STT protocol could result in underdosing, we found that patients had fewer DT episodes and fewer ICU transfers.

This study had several limitations. These include a relatively small sample size and the data being less recent. As there has been no intervening change to the therapeutic paradigm of DT treatment, the findings remain pertinent to the present time. The study employed a simple pre/post design and was conducted in a single setting. We are not aware of any temporal or local trends likely to influence these results. Admissions and transfers to the SDU for severe alcohol withdrawal were based on physician discretion. However, patient characteristics in both groups were similar (Table 1). We note that the postintervention STT protocol allowed for more frequent benzodiazepine dosing, though benzodiazepine use did decrease. Different alcohol withdrawal scores (MINDS vs. CIWA-Ar) were used for postintervention and preintervention, although previous research has shown that MINDS and CIWA-Ar scores correlate well.⁷ Finally, some patients of higher acuity and complexity were excluded, potentially limiting the generalizability of our results.

Conclusion

Our STT protocol proved to be more effective and safer in treating severe alcohol withdrawal patients than usual care employing STT with FS. We believe the successful implementation of a STT protocol in high-acuity patients also requires frequent monitoring using the MINDS scale, integrated with benzodiazepine sliding-scale dosing to match symptom severity. This bundled approach resulted in a significant reduction of benzodiazepine usage and reduced length of stay. Timely treatment of these patients also reduced the percent of patients developing DTs, and reduced intubation rates and transfers to the ICU. Further studies may be warranted at other sites to confirm the effectiveness of this STT protocol.

Corresponding author: Paul W. Huang, MD, Stamford Hospital, One Hospital Plaza, PO Box 9317, Stamford, CT 06904; [email protected].

Financial disclosures: None.

From Stamford Hospital, Stamford, CT.

Objective: This single-center, quasi-experimental study of adult patients admitted or transferred to a medical step-down unit with alcohol withdrawal diagnoses sought to determine if symptom–triggered therapy (STT) is more effective than combined fixed-scheduled (FS) and STT in severe alcohol withdrawal.

Methods: In the preintervention group (72 episodes), patients were treated with FS and STT based on physician preference. In the postintervention group (69 episodes), providers were required to utilize only the STT protocol.

Results: Implementation of the intervention was associated with a significant reduction in average (per patient) cumulative benzodiazepine dose, from 250 mg to 96 mg (P < .001) and a decrease in average length of stay from 8.0 days to 5.1 days (P < .001). Secondary safety measures included a reduction in the proportion of patients who experienced delirium tremens from 47.5% to 22.5% (P < .001), and a reduction in intubation rates from 13.8% to 1.3% (P = .003).

Conclusion: The STT protocol proved to be more effective and safer in treating severe alcohol withdrawal patients than usual care employing STT with FS. We believe the successful implementation of a STT protocol in high-acuity patients requires frequent monitoring to assess withdrawal severity combined with appropriate and timely dosing of benzodiazepines.

Keywords: alcohol withdrawal delirium; alcohol withdrawal syndrome; treatment protocol; benzodiazepine; lorazepam.

Management of severe alcohol withdrawal and delirium tremens (DT) is challenging and requires significant resources, including close monitoring and intensive treatment, frequently in an intensive care unit (ICU).¹ Early diagnosis and therapeutic intervention are important to limit potential complications associated with DT.² Benzodiazepines are first-line therapeutic agents, but the definition of optimal use and dosing regimens has been limited, due to a lack of randomized controlled trials. In lower acuity patients admitted to a detoxification unit, systematic symptom–triggered benzodiazepine therapy (STT) has been established to be more effective than fixed-schedule (FS) dosing.^3-5 Patients treated using STT require lower total benzodiazepine dosing and achieve shorter treatment durations. However, in higher-acuity patients admitted to general medical services, analyses have not shown an advantage of STT over combined FS and STT.⁶

The purpose of this study was to determine whether implementation of STT is more effective than FS dosing combined with episodic STT in the management of hospitalized high-acuity alcohol withdrawal patients. We conducted a preintervention and postintervention quasi-experimental study in the step-down unit (SDU) of a 305-bed community teaching hospital. The study population consisted of adult inpatients 18 years or older admitted or transferred to the 12-bed SDU with alcohol withdrawal, as defined by primary or secondary International Classification of Diseases, Tenth Revision diagnoses. SDU admission criteria included patients with prior DT or those who had received multiple doses of benzodiazepines in the emergency department. In-hospital transfer to the SDU was at the physician’s discretion, if the patient required escalating doses of benzodiazepines or the use of increasing resources, such as those for behavioral emergencies. The majority of patients admitted or transferred to the SDU were assigned to medical house staff teams under hospitalist supervision, and, on occasion, under community physicians. The nurse-to-patient ratio in the SDU was 1:3.

Study groups

The preintervention group consisted of 80 successive treatment episodes involving patients admitted or transferred to the SDU from December 2, 2015, to July 1, 2017. Patients were treated based upon physician preference, consisting of a scheduled dosing regimen with additional doses as needed. The postintervention group included 80 successive treatment episodes involving patients admitted or transferred to the SDU from October 1, 2017, to March 23, 2019. The STT protocol was used in all patients in the postintervention group.

In the preintervention group, fixed, scheduled doses of lorazepam or chlordiazepoxide and as-needed lorazepam were prescribed and adjusted based upon physician judgment. Monitoring of symptom severity was scored using the revised Clinical Institute Withdrawal Assessment for Alcohol scale (CIWA-Ar). Benzodiazepine dosing occurred if the CIWA-Ar score had increased 2 or more points from the last score.

In the postintervention group, the STT protocol included the creation of a standardized physician order set for benzodiazepine “sliding scale” administration. The STT protocol allowed for escalating doses for higher withdrawal scores. Symptom severity was scored using MINDS (Minnesota Detoxification Scale) criteria.¹ Lorazepam as-needed dosing was based upon MINDS scores. A MINDS score less than 10 resulted in no medication, MINDS 10-12 required 2 mg, MINDS 13-16 required 4 mg, MINDS 17-19 required 6 mg, and MINDS 20 required 8 mg and a call to the physician. Transfer to the ICU was recommended if the MINDS score was ≥ 20 for 3 consecutive hours. Monitoring intervals occurred more frequently at 30 minutes unless the MINDS score was less than 10. After 7 days, the MINDS protocol was recommended to be discontinued, as the patient might have had iatrogenic delirium.

The STT protocol was introduced during a didactic session for the hospitalists and a separate session for internal medicine and family residents. Each registered nurse working in the SDU was trained in the use of the STT protocol and MINDS during nursing huddles.

Patients were excluded from evaluation if they were transferred to the SDU after 7 or more days in the hospital, if they had stayed in the hospital more than 30 days, were chronically on benzodiazepine therapy (to avoid confounding withdrawal symptoms), or if they left the hospital against medical advice (AMA). To avoid bias in the results, the patients with early discontinuation of treatment were included in analyses of secondary outcomes, thus resulting in all 80 episodes analyzed.

Measures and data

The primary outcome measure was benzodiazepine dose intensity, expressed in total lorazepam-equivalents. Secondary measures included average length of stay (including general medical, surgical, and ICU days), seizure incidence, DT incidence, sitter use, behavioral emergency responses, rates of leaving AMA, intubation, transfer to the ICU, and death.

Benzodiazepine dosing and length of stay were obtained from the data warehouse of the hospital’s electronic health record (EHR; Meditech). Benzodiazepine dosing was expressed in total lorazepam-equivalents, with conversion as follows: lorazepam orally and intravenously 1 mg = chlordiazepoxide 25 mg = diazepam 5 mg. All other measures were obtained from chart review of the patients’ EMR entries. The Stamford Hospital Institutional Review Board approved this study.

Analysis

Data analyses for this study were performed using SPSS version 25.0 (IBM). Categorical data were reported as frequency (count) and percent within category. Continuous data were reported as mean (SD). Categorical data were analyzed using χ² analysis; continuous data were analyzed using t-tests. A P value of .05 was considered significant for each analysis.

Results

During the preintervention period, 72 episodes (58 patients) met inclusion criteria, and 69 episodes (55 patients) met inclusion criteria during the postintervention period. Ten patients were represented in both groups. Eight preintervention episodes were excluded from the primary analysis because the patient left AMA. Eleven postintervention episodes were excluded: 9 due to patients leaving AMA, 1 due to chronic benzodiazepine usage, and 1 due to transfer to the SDU unit after 7 days. Baseline characteristics and medication use profiles of the preintervention and postintervention groups are summarized in Table 1.

Implementation of the intervention was associated with a significant reduction in average (per patient) cumulative benzodiazepine dose, from 250 mg to 96 mg (P < .001), as shown in Table 2. Average length of stay decreased from 8.0 days to 5.1 days (P < .001). Secondary safety measures were notable for a reduction in DT incidence, from 47.5% to 22.5% (P < .001), and lower rates of intubation, from 13.8% to 1.3% (P = .003). Seven-day readmission rates were 0% preintervention and 1.4% postintervention.

Discussion

We found that hospitalized patients with severe alcohol withdrawal treated with STT required fewer benzodiazepines and had a lower length of stay than patients treated with a conventional combined STT and FS regimen. Implementation of the change from the STT and FS approach to the STT approach in the SDU resulted in concerns that waiting for symptoms to appear could result in more severe withdrawal and prolonged treatment.³ To address this, the intervention included monitoring and dosing every 30 minutes, as compared to monitoring and dosing every 1 hour preintervention. In addition, a sliding-scale approach to match alcohol withdrawal score with dosage was employed in postintervention patients.

Employment of the STT protocol also resulted in decreased complications, including lower rates of DT and transfer to the ICU. This new intervention resulted in significantly decreased time required to control severe symptoms. In the preintervention phase, if a patient’s symptoms escalated despite administration of the as-needed dose of benzodiazepine, there was often a delay in administration of additional doses due to the time needed for nurses to reach a physician and subsequent placement of a new order. In the postintervention phase, the STT protocol allowed nursing staff to give benzodiazepines without delay when needed. We believe this reduced the number of calls by nursing staff to physicians requesting additional medications, and that this improved teamwork when managing these patients.

As part of the intervention, a decision was made to use the MINDS scale rather than the CIWA-Ar scale to assess withdrawal severity. This was because the CIWA-Ar has only been validated in patients with uncomplicated alcohol withdrawal syndrome and has not been researched extensively in patients requiring ICU-level care.¹ MINDS assessment has proven to be reliable and reflects severity of withdrawal. Furthermore, MINDS requires less time to administer—3 to 5 minutes vs 5 to 15 minutes for the CIWA-Ar scale. CIWA-Ar, unlike MINDS, requires subjective input from the patient, which is less reliable for higher acuity patients. Our study is unique in that it focused on high-acuity patients and it showed both a significant reduction in quantity of benzodiazepines prescribed and length of stay. Previous studies on lower acuity patients in detoxification units have confirmed that STT is more effective than a FS approach.^3-5 In patients of higher acuity, STT has not proven to be superior.

A key lesson learned was the need for proper education of nursing staff. Concurrent nursing audits were necessary to ensure that scoring was performed in an accurate and timely manner. In addition, it was challenging to predict which patients might develop DTs versus those requiring a brief inpatient stay. While there was initial concern that an STT protocol could result in underdosing, we found that patients had fewer DT episodes and fewer ICU transfers.

This study had several limitations. These include a relatively small sample size and the data being less recent. As there has been no intervening change to the therapeutic paradigm of DT treatment, the findings remain pertinent to the present time. The study employed a simple pre/post design and was conducted in a single setting. We are not aware of any temporal or local trends likely to influence these results. Admissions and transfers to the SDU for severe alcohol withdrawal were based on physician discretion. However, patient characteristics in both groups were similar (Table 1). We note that the postintervention STT protocol allowed for more frequent benzodiazepine dosing, though benzodiazepine use did decrease. Different alcohol withdrawal scores (MINDS vs. CIWA-Ar) were used for postintervention and preintervention, although previous research has shown that MINDS and CIWA-Ar scores correlate well.⁷ Finally, some patients of higher acuity and complexity were excluded, potentially limiting the generalizability of our results.

Conclusion

Our STT protocol proved to be more effective and safer in treating severe alcohol withdrawal patients than usual care employing STT with FS. We believe the successful implementation of a STT protocol in high-acuity patients also requires frequent monitoring using the MINDS scale, integrated with benzodiazepine sliding-scale dosing to match symptom severity. This bundled approach resulted in a significant reduction of benzodiazepine usage and reduced length of stay. Timely treatment of these patients also reduced the percent of patients developing DTs, and reduced intubation rates and transfers to the ICU. Further studies may be warranted at other sites to confirm the effectiveness of this STT protocol.

Corresponding author: Paul W. Huang, MD, Stamford Hospital, One Hospital Plaza, PO Box 9317, Stamford, CT 06904; [email protected].

Financial disclosures: None.

From Stamford Hospital, Stamford, CT.

Objective: This single-center, quasi-experimental study of adult patients admitted or transferred to a medical step-down unit with alcohol withdrawal diagnoses sought to determine if symptom–triggered therapy (STT) is more effective than combined fixed-scheduled (FS) and STT in severe alcohol withdrawal.

Methods: In the preintervention group (72 episodes), patients were treated with FS and STT based on physician preference. In the postintervention group (69 episodes), providers were required to utilize only the STT protocol.

Results: Implementation of the intervention was associated with a significant reduction in average (per patient) cumulative benzodiazepine dose, from 250 mg to 96 mg (P < .001) and a decrease in average length of stay from 8.0 days to 5.1 days (P < .001). Secondary safety measures included a reduction in the proportion of patients who experienced delirium tremens from 47.5% to 22.5% (P < .001), and a reduction in intubation rates from 13.8% to 1.3% (P = .003).

Conclusion: The STT protocol proved to be more effective and safer in treating severe alcohol withdrawal patients than usual care employing STT with FS. We believe the successful implementation of a STT protocol in high-acuity patients requires frequent monitoring to assess withdrawal severity combined with appropriate and timely dosing of benzodiazepines.

Keywords: alcohol withdrawal delirium; alcohol withdrawal syndrome; treatment protocol; benzodiazepine; lorazepam.

Management of severe alcohol withdrawal and delirium tremens (DT) is challenging and requires significant resources, including close monitoring and intensive treatment, frequently in an intensive care unit (ICU).¹ Early diagnosis and therapeutic intervention are important to limit potential complications associated with DT.² Benzodiazepines are first-line therapeutic agents, but the definition of optimal use and dosing regimens has been limited, due to a lack of randomized controlled trials. In lower acuity patients admitted to a detoxification unit, systematic symptom–triggered benzodiazepine therapy (STT) has been established to be more effective than fixed-schedule (FS) dosing.^3-5 Patients treated using STT require lower total benzodiazepine dosing and achieve shorter treatment durations. However, in higher-acuity patients admitted to general medical services, analyses have not shown an advantage of STT over combined FS and STT.⁶

The purpose of this study was to determine whether implementation of STT is more effective than FS dosing combined with episodic STT in the management of hospitalized high-acuity alcohol withdrawal patients. We conducted a preintervention and postintervention quasi-experimental study in the step-down unit (SDU) of a 305-bed community teaching hospital. The study population consisted of adult inpatients 18 years or older admitted or transferred to the 12-bed SDU with alcohol withdrawal, as defined by primary or secondary International Classification of Diseases, Tenth Revision diagnoses. SDU admission criteria included patients with prior DT or those who had received multiple doses of benzodiazepines in the emergency department. In-hospital transfer to the SDU was at the physician’s discretion, if the patient required escalating doses of benzodiazepines or the use of increasing resources, such as those for behavioral emergencies. The majority of patients admitted or transferred to the SDU were assigned to medical house staff teams under hospitalist supervision, and, on occasion, under community physicians. The nurse-to-patient ratio in the SDU was 1:3.

Study groups

The preintervention group consisted of 80 successive treatment episodes involving patients admitted or transferred to the SDU from December 2, 2015, to July 1, 2017. Patients were treated based upon physician preference, consisting of a scheduled dosing regimen with additional doses as needed. The postintervention group included 80 successive treatment episodes involving patients admitted or transferred to the SDU from October 1, 2017, to March 23, 2019. The STT protocol was used in all patients in the postintervention group.

In the preintervention group, fixed, scheduled doses of lorazepam or chlordiazepoxide and as-needed lorazepam were prescribed and adjusted based upon physician judgment. Monitoring of symptom severity was scored using the revised Clinical Institute Withdrawal Assessment for Alcohol scale (CIWA-Ar). Benzodiazepine dosing occurred if the CIWA-Ar score had increased 2 or more points from the last score.

In the postintervention group, the STT protocol included the creation of a standardized physician order set for benzodiazepine “sliding scale” administration. The STT protocol allowed for escalating doses for higher withdrawal scores. Symptom severity was scored using MINDS (Minnesota Detoxification Scale) criteria.¹ Lorazepam as-needed dosing was based upon MINDS scores. A MINDS score less than 10 resulted in no medication, MINDS 10-12 required 2 mg, MINDS 13-16 required 4 mg, MINDS 17-19 required 6 mg, and MINDS 20 required 8 mg and a call to the physician. Transfer to the ICU was recommended if the MINDS score was ≥ 20 for 3 consecutive hours. Monitoring intervals occurred more frequently at 30 minutes unless the MINDS score was less than 10. After 7 days, the MINDS protocol was recommended to be discontinued, as the patient might have had iatrogenic delirium.

The STT protocol was introduced during a didactic session for the hospitalists and a separate session for internal medicine and family residents. Each registered nurse working in the SDU was trained in the use of the STT protocol and MINDS during nursing huddles.

Patients were excluded from evaluation if they were transferred to the SDU after 7 or more days in the hospital, if they had stayed in the hospital more than 30 days, were chronically on benzodiazepine therapy (to avoid confounding withdrawal symptoms), or if they left the hospital against medical advice (AMA). To avoid bias in the results, the patients with early discontinuation of treatment were included in analyses of secondary outcomes, thus resulting in all 80 episodes analyzed.

Measures and data

The primary outcome measure was benzodiazepine dose intensity, expressed in total lorazepam-equivalents. Secondary measures included average length of stay (including general medical, surgical, and ICU days), seizure incidence, DT incidence, sitter use, behavioral emergency responses, rates of leaving AMA, intubation, transfer to the ICU, and death.

Benzodiazepine dosing and length of stay were obtained from the data warehouse of the hospital’s electronic health record (EHR; Meditech). Benzodiazepine dosing was expressed in total lorazepam-equivalents, with conversion as follows: lorazepam orally and intravenously 1 mg = chlordiazepoxide 25 mg = diazepam 5 mg. All other measures were obtained from chart review of the patients’ EMR entries. The Stamford Hospital Institutional Review Board approved this study.

Analysis

Data analyses for this study were performed using SPSS version 25.0 (IBM). Categorical data were reported as frequency (count) and percent within category. Continuous data were reported as mean (SD). Categorical data were analyzed using χ² analysis; continuous data were analyzed using t-tests. A P value of .05 was considered significant for each analysis.

Results

During the preintervention period, 72 episodes (58 patients) met inclusion criteria, and 69 episodes (55 patients) met inclusion criteria during the postintervention period. Ten patients were represented in both groups. Eight preintervention episodes were excluded from the primary analysis because the patient left AMA. Eleven postintervention episodes were excluded: 9 due to patients leaving AMA, 1 due to chronic benzodiazepine usage, and 1 due to transfer to the SDU unit after 7 days. Baseline characteristics and medication use profiles of the preintervention and postintervention groups are summarized in Table 1.

Implementation of the intervention was associated with a significant reduction in average (per patient) cumulative benzodiazepine dose, from 250 mg to 96 mg (P < .001), as shown in Table 2. Average length of stay decreased from 8.0 days to 5.1 days (P < .001). Secondary safety measures were notable for a reduction in DT incidence, from 47.5% to 22.5% (P < .001), and lower rates of intubation, from 13.8% to 1.3% (P = .003). Seven-day readmission rates were 0% preintervention and 1.4% postintervention.

Discussion

We found that hospitalized patients with severe alcohol withdrawal treated with STT required fewer benzodiazepines and had a lower length of stay than patients treated with a conventional combined STT and FS regimen. Implementation of the change from the STT and FS approach to the STT approach in the SDU resulted in concerns that waiting for symptoms to appear could result in more severe withdrawal and prolonged treatment.³ To address this, the intervention included monitoring and dosing every 30 minutes, as compared to monitoring and dosing every 1 hour preintervention. In addition, a sliding-scale approach to match alcohol withdrawal score with dosage was employed in postintervention patients.

Employment of the STT protocol also resulted in decreased complications, including lower rates of DT and transfer to the ICU. This new intervention resulted in significantly decreased time required to control severe symptoms. In the preintervention phase, if a patient’s symptoms escalated despite administration of the as-needed dose of benzodiazepine, there was often a delay in administration of additional doses due to the time needed for nurses to reach a physician and subsequent placement of a new order. In the postintervention phase, the STT protocol allowed nursing staff to give benzodiazepines without delay when needed. We believe this reduced the number of calls by nursing staff to physicians requesting additional medications, and that this improved teamwork when managing these patients.

As part of the intervention, a decision was made to use the MINDS scale rather than the CIWA-Ar scale to assess withdrawal severity. This was because the CIWA-Ar has only been validated in patients with uncomplicated alcohol withdrawal syndrome and has not been researched extensively in patients requiring ICU-level care.¹ MINDS assessment has proven to be reliable and reflects severity of withdrawal. Furthermore, MINDS requires less time to administer—3 to 5 minutes vs 5 to 15 minutes for the CIWA-Ar scale. CIWA-Ar, unlike MINDS, requires subjective input from the patient, which is less reliable for higher acuity patients. Our study is unique in that it focused on high-acuity patients and it showed both a significant reduction in quantity of benzodiazepines prescribed and length of stay. Previous studies on lower acuity patients in detoxification units have confirmed that STT is more effective than a FS approach.^3-5 In patients of higher acuity, STT has not proven to be superior.

A key lesson learned was the need for proper education of nursing staff. Concurrent nursing audits were necessary to ensure that scoring was performed in an accurate and timely manner. In addition, it was challenging to predict which patients might develop DTs versus those requiring a brief inpatient stay. While there was initial concern that an STT protocol could result in underdosing, we found that patients had fewer DT episodes and fewer ICU transfers.

This study had several limitations. These include a relatively small sample size and the data being less recent. As there has been no intervening change to the therapeutic paradigm of DT treatment, the findings remain pertinent to the present time. The study employed a simple pre/post design and was conducted in a single setting. We are not aware of any temporal or local trends likely to influence these results. Admissions and transfers to the SDU for severe alcohol withdrawal were based on physician discretion. However, patient characteristics in both groups were similar (Table 1). We note that the postintervention STT protocol allowed for more frequent benzodiazepine dosing, though benzodiazepine use did decrease. Different alcohol withdrawal scores (MINDS vs. CIWA-Ar) were used for postintervention and preintervention, although previous research has shown that MINDS and CIWA-Ar scores correlate well.⁷ Finally, some patients of higher acuity and complexity were excluded, potentially limiting the generalizability of our results.

Conclusion

Our STT protocol proved to be more effective and safer in treating severe alcohol withdrawal patients than usual care employing STT with FS. We believe the successful implementation of a STT protocol in high-acuity patients also requires frequent monitoring using the MINDS scale, integrated with benzodiazepine sliding-scale dosing to match symptom severity. This bundled approach resulted in a significant reduction of benzodiazepine usage and reduced length of stay. Timely treatment of these patients also reduced the percent of patients developing DTs, and reduced intubation rates and transfers to the ICU. Further studies may be warranted at other sites to confirm the effectiveness of this STT protocol.

Corresponding author: Paul W. Huang, MD, Stamford Hospital, One Hospital Plaza, PO Box 9317, Stamford, CT 06904; [email protected].

Financial disclosures: None.

From Western Sussex Hospitals NHS Foundation Trust, Physiotherapy Department, Chichester, UK (Richard J. Holmes), and Western Sussex Hospitals NHS Foundation Trust, Department of Occupational Therapy, Chichester, UK (Sophie Stratford).

Objective: Despite the benefits of early and frequent input from a neurologist, there is wide variation in the availability of this service, especially in district general hospitals, with many patients managed on clinically inappropriate wards. The purpose of this service evaluation was to explore the impact this had on patient care.

Methods: A retrospective service evaluation was undertaken at a National Health Service hospital by reviewing patient records over a 6-month period. Data related to demographics, processes within the patient’s care, and secondary complications were recorded. Findings were compared with those of stroke patients managed on a specialist stroke ward.

Results: A total of 63 patients were identified, with a mean age of 72 years. The mean length of stay was 25.9 days, with a readmission rate of 16.7%. Only 15.9% of patients were reviewed by a neurologist. There was a high rate of secondary complications, with a number of patients experiencing falls (11.1%), pressure ulcers (14.3%), and health care–acquired infections (33.3%) during their admission.

Conclusions: The lack of specialist input from a neurologist and the management of patients on clinically inappropriate wards may have negatively impacted length of stay, readmission rates, and the frequency of secondary complications.

Keywords: evaluation; clinical safety; neurology; patient-centered care; clinical outcomes; length of stay.

It is estimated that 10% of acute admissions to district general hospitals (DGHs) of the National Health Service (NHS) in the United Kingdom are due to a neurological problem other than stroke.¹ In 2011, a joint report from the Royal College of Physicians and the Association of British Neurologists (ABN) recommended that all of these patients should be admitted under the care of a neurologist and be regularly reviewed by a neurologist during their admission.² The rationale for this recommendation is clear. The involvement of a neurologist has been shown to improve accuracy of the diagnosis³ and significantly reduce length of stay.^4,5 Studies have also shown that the involvement of a neurologist has led to a change in the management plan in as high as 79%⁶ to 89%³ of cases, suggesting that a high proportion of neurological patients not seen by a neurologist are being managed suboptimally.

Despite this, a recent ABN survey of acute neurology services found ongoing wide variations in the availability of this specialist care, with a large proportion of DGHs having limited or no access to a neurologist and very few having dedicated neurology beds.⁷ While it is recognized that services have been structured in response to the reduced numbers of neurologists within the United Kingdom,⁸ it is prudent to assess the impact that such services have on patient care.

With this in mind, we planned to evaluate the current provision of care provided to neurological patients in a real-world setting. This was conducted in the context of a neurology liaison service at a DGH with no dedicated neurology beds.

Methods

A retrospective service evaluation was undertaken at a DGH in the southeast of England. The NHS hospital has neurologists on site who provide diagnostic and therapeutic consultations on the wards, but there are no dedicated beds for patients with neurological conditions. Patients requiring neurosurgical input are referred to a tertiary neurosciences center.

Patients were selected from the neurotherapy database if they were referred into the service between August 1, 2019, and January 31, 2020. The neurotherapy database was used as this was the only source that held thorough data on this patient group and allowed for the identification of patients who were not referred into the neurologist’s service. Patients were included if they had a new neurological condition as their primary diagnosis or if they had an exacerbation of an already established neurological condition. If a patient was admitted with more than 1 neurological diagnosis then the primary diagnosis for the admission was to be used in the analysis, though this did not occur during this evaluation. Patients with a primary diagnosis of a stroke were included if they were not managed on the acute stroke ward. Those managed on the stroke ward were excluded so that an analysis of patients managed on wards that were deemed clinically inappropriate could be undertaken. Patients were not included if they had a pre-existing neurological condition (ie, dementia, multiple sclerosis) but were admitted due to a non-neurological cause such as a fall or infection. All patients who met the criteria were included.

A team member independently reviewed each set of patient notes. Demographic data extracted from the medical notes included the patient’s age (on admission), gender, and diagnosis. Medical, nursing, and therapy notes were reviewed to identify secondary complications that arose during the patient’s admission. The secondary complications reviewed were falls (defined as the patient unexpectedly coming to the ground or other lower level), health care–acquired infections (HAIs) (defined as any infection acquired during the hospital admission), and pressure ulcers (defined as injuries to the skin or underlying tissue during the hospital admission). Other details, obtained from the patient administration system, included the length of stay (days), the number of ward moves the patient experienced, the speciality of the consultant responsible for the patient’s care, the discharge destination, and whether the patient was readmitted for any cause within 30 days. All data collected were stored on a password-protected computer and no patient-identifiable data were included.

The results were collated using descriptive statistics. The χ² test was used to compare categorical data between those patients who were and were not reviewed by a neurologist, and the Mann-Whitney U test was used to compare differences in the length of stay between these 2 groups.

No national data relating to this specific patient group were available within the literature. Therefore, to provide a comparator of neurological patients within the same hospital, data were collected on stroke patients managed on the stroke ward. This group was deemed most appropriate for comparison as they present with similar neurological symptoms but are cared for on a specialist ward. During the evaluation period, 284 stroke patients were admitted to the stroke ward. A sample of 75 patients was randomly selected using a random number generator, and the procedure for data collection was repeated. It was not appropriate to make direct comparative analysis on these 2 groups due to the inherent differences, but it was felt important to provide context with regards to what usual care was like on a specialist ward within the same hospital.

Ethical approval was not required as this was a service evaluation of routinely collected data within a single hospital site.

Results

In total, 63 patients were identified: 26 females and 37 males. The median age of patients was 74 years (range, 39-92 years). These demographic details and comparisons to stroke patients managed on a specialist ward can be seen in Table 1. To quantify the range of diagnoses, the condition groups defined by GIRFT Neurology Methodology⁹ were used. The most common diagnoses were tumors of the nervous system (25.4%) and traumatic brain and spine injury (23.8%). The other conditions included in the analysis can be seen in Table 2.

Despite having a neurological condition as their primary diagnosis, only 15.9% of patients were reviewed by a neurologist during their hospital admission. Patients were most commonly under the care of a geriatrician (60.3%), but they were also managed by orthopedics (12.6%), acute medicine (7.9%), respiratory (6.3%), cardiology (4.8%), gastroenterology (3.2%), and surgery (3.2%). One patient (1.6%) was managed by intensivists.

The average length of stay was 25.9 days (range, 2-78 days). This was more than double the average length of stay on the stroke ward (11.4 days) (Table 1) and the national average for patients with neurological conditions (9.78 days).¹⁰ During their stay, 33% had 2 or more ward moves, with 1 patient moving wards a total of 6 times. Just over half (52.4%) of the patients returned to their usual residence on discharge. The remainder were discharged to rehabilitation units (15.9%), nursing homes (14.3%), residential homes (6.3%), tertiary centers (4.8%), and hospice (1.6%). Unfortunately, 3 patients (4.8%) passed away. Of those still alive (n = 60), 16.7% were readmitted to the hospital within 30 days, compared to a readmission rate of 11% on the stroke ward. None of the patients who were readmitted were seen by a neurologist during their initial admission.

The frequency of secondary complications was reviewed as a measure of the multidisciplinary management of this patient group. It was noted that 11.1% had a fall on the ward, which was similar to a rate of 10.7% on the stroke ward. More striking was the fact that 14.3% of patients developed a pressure ulcer and 33.3% developed an HAI during their admission, compared with rates of 1.3% and 10.7%, respectively, on the stroke ward (Table 1).

There were no significant differences found in length of stay between those who were and were not reviewed by a neurologist (P = .73). This was also true for categorical data, whereby readmission rate (P = .13), frequency of falls (P = .22), frequency of pressure ulcers (P = .67), and HAIs (P = .81) all failed to show a significant difference between groups.

Discussion

The findings of this service evaluation show markedly poorer outcomes for neurological patients compared to stroke patients managed on a specialist stroke ward. It is suggested that these results are in part due to the lack of specialist input from a neurologist in the majority of cases and the fact that all were managed on clinically inappropriate wards. Only 15.9% of neurological patients were seen by a neurologist. This is a slight improvement compared to previous studies in DGHs that showed rates of 10%¹ and 11%,¹¹ but it is still a far cry from the goal of 100% set out in recommendations.² In addition, the increased readmission rate may be suggestive of suboptimal management, especially given that none of those readmitted had been reviewed by a neurologist. There are undoubtedly other factors that may influence readmissions, such as comorbidities, the severity/complexity of the condition, and the strength of community services. However, the impact of a lack of input from a specialist should not be underestimated, and further evaluation of this factor (with confounding factors controlled) would be beneficial.

The result of an extended length of stay was also a predictable outcome based on previous evidence.^4,5 With the potential for suboptimal management plans and inaccurate diagnoses, it is inevitable that the patient’s movement through the hospital system will be impeded. In our example, it is possible that the extended length of stay was influenced by the fact that patients included in the evaluation were managed on nonspecialist wards and a large proportion had multiple ward changes.

Given that the evidence clearly shows that stroke patients are most effectively managed by a multidisciplinary team (MDT) with specialist skills,¹² it is likely that other neurological patients, who have similar multifactorial needs, would also benefit. The patients in our evaluation were cared for by nursing staff who lacked specific skills and experience in neurology. The allied health professionals involved were specialists in neurotherapy but were not based on the ward and not directly linked to the ward MDT. A review by Epstein found that the benefits of having a MDT, in any speciality, working together on a ward included improved communication, reduced adverse events, and a reduced length of stay.¹³ This lack of an effective MDT approach may provide some explanation as to why the average length of stay and the rates of some secondary complications were at such elevated levels.

A systematic review exploring the impact of patients admitted to clinically inappropriate wards in a range of specialities found that these patients were associated with worse outcomes.¹⁴ This is supported by our findings, in which a higher rate of pressure ulcers and HAIs were observed when compared to rates in the specialist stroke ward. Again, a potential explanation for this is the impact of patients being managed by clinicians who lack the specialist knowledge of the patient group and the risks they face. Another explanation could be due to the high number of ward moves the patients experienced. Blay et al found that ward moves increased length of stay and carried an associated clinical risk, with the odds of falls and HAIs increasing with each move.¹⁵ A case example of this is apparent within our analysis in that the patient who experienced 6 ward moves not only had the longest length of stay (78 days), but also developed a pressure ulcer and 2 HAIs during their admission.

This service evaluation had a number of limitations that should be considered when interpreting the results. First, despite including all patients who met the criteria within the stipulated time frame, the sample size was relatively small, making it difficult to identify consistent patterns of behavior within the data.

Furthermore, caution should be applied when interpreting the comparators used, as the patient groups are not equivalent. The use of comparison against a standard is not a prerequisite in a service evaluation of this nature, but comparators were included to help frame the context for the reader. As such, they should only be used in this way rather than to make any firm conclusions.

Finally, as the evaluation was limited to the use of routinely collected data, there are several variables, other than those reported, which may have influenced the results. For example, it was not possible to ascertain certain demographic details, such as body mass index and socioeconomic factors, nor lifestyle factors such as smoking status, alcohol consumption, and exercise levels, all of which could impact negatively on the outcomes of interest. Furthermore, data were not collected on follow-up services after discharge to evaluate whether these had any impact on readmission rates.

Conclusion

This service evaluation highlights the potential impact of managing neurological patients on clinically inappropriate wards with limited input from a neurologist. There is the potential to ameliorate these impacts by cohorting these patients in neurologist-led beds with a specialist MDT. While there are limitations in the design of our study, including the lack of a controlled comparison, the small sample size, and the fact that this is an evaluation of a single service, the negative impacts to patients are concerning and warrant further investigation.

Corresponding author: Richard J. Holmes, MSc, Physiotherapy Department, St. Richard’s Hospital, Chichester, West Sussex, PO19 6SE; [email protected].

Financial disclosures: None.

From Western Sussex Hospitals NHS Foundation Trust, Physiotherapy Department, Chichester, UK (Richard J. Holmes), and Western Sussex Hospitals NHS Foundation Trust, Department of Occupational Therapy, Chichester, UK (Sophie Stratford).

Objective: Despite the benefits of early and frequent input from a neurologist, there is wide variation in the availability of this service, especially in district general hospitals, with many patients managed on clinically inappropriate wards. The purpose of this service evaluation was to explore the impact this had on patient care.

Methods: A retrospective service evaluation was undertaken at a National Health Service hospital by reviewing patient records over a 6-month period. Data related to demographics, processes within the patient’s care, and secondary complications were recorded. Findings were compared with those of stroke patients managed on a specialist stroke ward.

Results: A total of 63 patients were identified, with a mean age of 72 years. The mean length of stay was 25.9 days, with a readmission rate of 16.7%. Only 15.9% of patients were reviewed by a neurologist. There was a high rate of secondary complications, with a number of patients experiencing falls (11.1%), pressure ulcers (14.3%), and health care–acquired infections (33.3%) during their admission.

Conclusions: The lack of specialist input from a neurologist and the management of patients on clinically inappropriate wards may have negatively impacted length of stay, readmission rates, and the frequency of secondary complications.

Keywords: evaluation; clinical safety; neurology; patient-centered care; clinical outcomes; length of stay.

It is estimated that 10% of acute admissions to district general hospitals (DGHs) of the National Health Service (NHS) in the United Kingdom are due to a neurological problem other than stroke.¹ In 2011, a joint report from the Royal College of Physicians and the Association of British Neurologists (ABN) recommended that all of these patients should be admitted under the care of a neurologist and be regularly reviewed by a neurologist during their admission.² The rationale for this recommendation is clear. The involvement of a neurologist has been shown to improve accuracy of the diagnosis³ and significantly reduce length of stay.^4,5 Studies have also shown that the involvement of a neurologist has led to a change in the management plan in as high as 79%⁶ to 89%³ of cases, suggesting that a high proportion of neurological patients not seen by a neurologist are being managed suboptimally.

Despite this, a recent ABN survey of acute neurology services found ongoing wide variations in the availability of this specialist care, with a large proportion of DGHs having limited or no access to a neurologist and very few having dedicated neurology beds.⁷ While it is recognized that services have been structured in response to the reduced numbers of neurologists within the United Kingdom,⁸ it is prudent to assess the impact that such services have on patient care.

With this in mind, we planned to evaluate the current provision of care provided to neurological patients in a real-world setting. This was conducted in the context of a neurology liaison service at a DGH with no dedicated neurology beds.

Methods

A retrospective service evaluation was undertaken at a DGH in the southeast of England. The NHS hospital has neurologists on site who provide diagnostic and therapeutic consultations on the wards, but there are no dedicated beds for patients with neurological conditions. Patients requiring neurosurgical input are referred to a tertiary neurosciences center.

Patients were selected from the neurotherapy database if they were referred into the service between August 1, 2019, and January 31, 2020. The neurotherapy database was used as this was the only source that held thorough data on this patient group and allowed for the identification of patients who were not referred into the neurologist’s service. Patients were included if they had a new neurological condition as their primary diagnosis or if they had an exacerbation of an already established neurological condition. If a patient was admitted with more than 1 neurological diagnosis then the primary diagnosis for the admission was to be used in the analysis, though this did not occur during this evaluation. Patients with a primary diagnosis of a stroke were included if they were not managed on the acute stroke ward. Those managed on the stroke ward were excluded so that an analysis of patients managed on wards that were deemed clinically inappropriate could be undertaken. Patients were not included if they had a pre-existing neurological condition (ie, dementia, multiple sclerosis) but were admitted due to a non-neurological cause such as a fall or infection. All patients who met the criteria were included.

A team member independently reviewed each set of patient notes. Demographic data extracted from the medical notes included the patient’s age (on admission), gender, and diagnosis. Medical, nursing, and therapy notes were reviewed to identify secondary complications that arose during the patient’s admission. The secondary complications reviewed were falls (defined as the patient unexpectedly coming to the ground or other lower level), health care–acquired infections (HAIs) (defined as any infection acquired during the hospital admission), and pressure ulcers (defined as injuries to the skin or underlying tissue during the hospital admission). Other details, obtained from the patient administration system, included the length of stay (days), the number of ward moves the patient experienced, the speciality of the consultant responsible for the patient’s care, the discharge destination, and whether the patient was readmitted for any cause within 30 days. All data collected were stored on a password-protected computer and no patient-identifiable data were included.

The results were collated using descriptive statistics. The χ² test was used to compare categorical data between those patients who were and were not reviewed by a neurologist, and the Mann-Whitney U test was used to compare differences in the length of stay between these 2 groups.

No national data relating to this specific patient group were available within the literature. Therefore, to provide a comparator of neurological patients within the same hospital, data were collected on stroke patients managed on the stroke ward. This group was deemed most appropriate for comparison as they present with similar neurological symptoms but are cared for on a specialist ward. During the evaluation period, 284 stroke patients were admitted to the stroke ward. A sample of 75 patients was randomly selected using a random number generator, and the procedure for data collection was repeated. It was not appropriate to make direct comparative analysis on these 2 groups due to the inherent differences, but it was felt important to provide context with regards to what usual care was like on a specialist ward within the same hospital.

Ethical approval was not required as this was a service evaluation of routinely collected data within a single hospital site.

Results

In total, 63 patients were identified: 26 females and 37 males. The median age of patients was 74 years (range, 39-92 years). These demographic details and comparisons to stroke patients managed on a specialist ward can be seen in Table 1. To quantify the range of diagnoses, the condition groups defined by GIRFT Neurology Methodology⁹ were used. The most common diagnoses were tumors of the nervous system (25.4%) and traumatic brain and spine injury (23.8%). The other conditions included in the analysis can be seen in Table 2.

Despite having a neurological condition as their primary diagnosis, only 15.9% of patients were reviewed by a neurologist during their hospital admission. Patients were most commonly under the care of a geriatrician (60.3%), but they were also managed by orthopedics (12.6%), acute medicine (7.9%), respiratory (6.3%), cardiology (4.8%), gastroenterology (3.2%), and surgery (3.2%). One patient (1.6%) was managed by intensivists.

The average length of stay was 25.9 days (range, 2-78 days). This was more than double the average length of stay on the stroke ward (11.4 days) (Table 1) and the national average for patients with neurological conditions (9.78 days).¹⁰ During their stay, 33% had 2 or more ward moves, with 1 patient moving wards a total of 6 times. Just over half (52.4%) of the patients returned to their usual residence on discharge. The remainder were discharged to rehabilitation units (15.9%), nursing homes (14.3%), residential homes (6.3%), tertiary centers (4.8%), and hospice (1.6%). Unfortunately, 3 patients (4.8%) passed away. Of those still alive (n = 60), 16.7% were readmitted to the hospital within 30 days, compared to a readmission rate of 11% on the stroke ward. None of the patients who were readmitted were seen by a neurologist during their initial admission.

The frequency of secondary complications was reviewed as a measure of the multidisciplinary management of this patient group. It was noted that 11.1% had a fall on the ward, which was similar to a rate of 10.7% on the stroke ward. More striking was the fact that 14.3% of patients developed a pressure ulcer and 33.3% developed an HAI during their admission, compared with rates of 1.3% and 10.7%, respectively, on the stroke ward (Table 1).

There were no significant differences found in length of stay between those who were and were not reviewed by a neurologist (P = .73). This was also true for categorical data, whereby readmission rate (P = .13), frequency of falls (P = .22), frequency of pressure ulcers (P = .67), and HAIs (P = .81) all failed to show a significant difference between groups.

Discussion

The findings of this service evaluation show markedly poorer outcomes for neurological patients compared to stroke patients managed on a specialist stroke ward. It is suggested that these results are in part due to the lack of specialist input from a neurologist in the majority of cases and the fact that all were managed on clinically inappropriate wards. Only 15.9% of neurological patients were seen by a neurologist. This is a slight improvement compared to previous studies in DGHs that showed rates of 10%¹ and 11%,¹¹ but it is still a far cry from the goal of 100% set out in recommendations.² In addition, the increased readmission rate may be suggestive of suboptimal management, especially given that none of those readmitted had been reviewed by a neurologist. There are undoubtedly other factors that may influence readmissions, such as comorbidities, the severity/complexity of the condition, and the strength of community services. However, the impact of a lack of input from a specialist should not be underestimated, and further evaluation of this factor (with confounding factors controlled) would be beneficial.

The result of an extended length of stay was also a predictable outcome based on previous evidence.^4,5 With the potential for suboptimal management plans and inaccurate diagnoses, it is inevitable that the patient’s movement through the hospital system will be impeded. In our example, it is possible that the extended length of stay was influenced by the fact that patients included in the evaluation were managed on nonspecialist wards and a large proportion had multiple ward changes.

Given that the evidence clearly shows that stroke patients are most effectively managed by a multidisciplinary team (MDT) with specialist skills,¹² it is likely that other neurological patients, who have similar multifactorial needs, would also benefit. The patients in our evaluation were cared for by nursing staff who lacked specific skills and experience in neurology. The allied health professionals involved were specialists in neurotherapy but were not based on the ward and not directly linked to the ward MDT. A review by Epstein found that the benefits of having a MDT, in any speciality, working together on a ward included improved communication, reduced adverse events, and a reduced length of stay.¹³ This lack of an effective MDT approach may provide some explanation as to why the average length of stay and the rates of some secondary complications were at such elevated levels.

A systematic review exploring the impact of patients admitted to clinically inappropriate wards in a range of specialities found that these patients were associated with worse outcomes.¹⁴ This is supported by our findings, in which a higher rate of pressure ulcers and HAIs were observed when compared to rates in the specialist stroke ward. Again, a potential explanation for this is the impact of patients being managed by clinicians who lack the specialist knowledge of the patient group and the risks they face. Another explanation could be due to the high number of ward moves the patients experienced. Blay et al found that ward moves increased length of stay and carried an associated clinical risk, with the odds of falls and HAIs increasing with each move.¹⁵ A case example of this is apparent within our analysis in that the patient who experienced 6 ward moves not only had the longest length of stay (78 days), but also developed a pressure ulcer and 2 HAIs during their admission.

This service evaluation had a number of limitations that should be considered when interpreting the results. First, despite including all patients who met the criteria within the stipulated time frame, the sample size was relatively small, making it difficult to identify consistent patterns of behavior within the data.

Furthermore, caution should be applied when interpreting the comparators used, as the patient groups are not equivalent. The use of comparison against a standard is not a prerequisite in a service evaluation of this nature, but comparators were included to help frame the context for the reader. As such, they should only be used in this way rather than to make any firm conclusions.

Finally, as the evaluation was limited to the use of routinely collected data, there are several variables, other than those reported, which may have influenced the results. For example, it was not possible to ascertain certain demographic details, such as body mass index and socioeconomic factors, nor lifestyle factors such as smoking status, alcohol consumption, and exercise levels, all of which could impact negatively on the outcomes of interest. Furthermore, data were not collected on follow-up services after discharge to evaluate whether these had any impact on readmission rates.

Conclusion

This service evaluation highlights the potential impact of managing neurological patients on clinically inappropriate wards with limited input from a neurologist. There is the potential to ameliorate these impacts by cohorting these patients in neurologist-led beds with a specialist MDT. While there are limitations in the design of our study, including the lack of a controlled comparison, the small sample size, and the fact that this is an evaluation of a single service, the negative impacts to patients are concerning and warrant further investigation.

Corresponding author: Richard J. Holmes, MSc, Physiotherapy Department, St. Richard’s Hospital, Chichester, West Sussex, PO19 6SE; [email protected].

Financial disclosures: None.

From Western Sussex Hospitals NHS Foundation Trust, Physiotherapy Department, Chichester, UK (Richard J. Holmes), and Western Sussex Hospitals NHS Foundation Trust, Department of Occupational Therapy, Chichester, UK (Sophie Stratford).

Objective: Despite the benefits of early and frequent input from a neurologist, there is wide variation in the availability of this service, especially in district general hospitals, with many patients managed on clinically inappropriate wards. The purpose of this service evaluation was to explore the impact this had on patient care.

Methods: A retrospective service evaluation was undertaken at a National Health Service hospital by reviewing patient records over a 6-month period. Data related to demographics, processes within the patient’s care, and secondary complications were recorded. Findings were compared with those of stroke patients managed on a specialist stroke ward.

Results: A total of 63 patients were identified, with a mean age of 72 years. The mean length of stay was 25.9 days, with a readmission rate of 16.7%. Only 15.9% of patients were reviewed by a neurologist. There was a high rate of secondary complications, with a number of patients experiencing falls (11.1%), pressure ulcers (14.3%), and health care–acquired infections (33.3%) during their admission.

Conclusions: The lack of specialist input from a neurologist and the management of patients on clinically inappropriate wards may have negatively impacted length of stay, readmission rates, and the frequency of secondary complications.

Keywords: evaluation; clinical safety; neurology; patient-centered care; clinical outcomes; length of stay.

It is estimated that 10% of acute admissions to district general hospitals (DGHs) of the National Health Service (NHS) in the United Kingdom are due to a neurological problem other than stroke.¹ In 2011, a joint report from the Royal College of Physicians and the Association of British Neurologists (ABN) recommended that all of these patients should be admitted under the care of a neurologist and be regularly reviewed by a neurologist during their admission.² The rationale for this recommendation is clear. The involvement of a neurologist has been shown to improve accuracy of the diagnosis³ and significantly reduce length of stay.^4,5 Studies have also shown that the involvement of a neurologist has led to a change in the management plan in as high as 79%⁶ to 89%³ of cases, suggesting that a high proportion of neurological patients not seen by a neurologist are being managed suboptimally.

Despite this, a recent ABN survey of acute neurology services found ongoing wide variations in the availability of this specialist care, with a large proportion of DGHs having limited or no access to a neurologist and very few having dedicated neurology beds.⁷ While it is recognized that services have been structured in response to the reduced numbers of neurologists within the United Kingdom,⁸ it is prudent to assess the impact that such services have on patient care.

With this in mind, we planned to evaluate the current provision of care provided to neurological patients in a real-world setting. This was conducted in the context of a neurology liaison service at a DGH with no dedicated neurology beds.

Methods

A retrospective service evaluation was undertaken at a DGH in the southeast of England. The NHS hospital has neurologists on site who provide diagnostic and therapeutic consultations on the wards, but there are no dedicated beds for patients with neurological conditions. Patients requiring neurosurgical input are referred to a tertiary neurosciences center.

Patients were selected from the neurotherapy database if they were referred into the service between August 1, 2019, and January 31, 2020. The neurotherapy database was used as this was the only source that held thorough data on this patient group and allowed for the identification of patients who were not referred into the neurologist’s service. Patients were included if they had a new neurological condition as their primary diagnosis or if they had an exacerbation of an already established neurological condition. If a patient was admitted with more than 1 neurological diagnosis then the primary diagnosis for the admission was to be used in the analysis, though this did not occur during this evaluation. Patients with a primary diagnosis of a stroke were included if they were not managed on the acute stroke ward. Those managed on the stroke ward were excluded so that an analysis of patients managed on wards that were deemed clinically inappropriate could be undertaken. Patients were not included if they had a pre-existing neurological condition (ie, dementia, multiple sclerosis) but were admitted due to a non-neurological cause such as a fall or infection. All patients who met the criteria were included.

A team member independently reviewed each set of patient notes. Demographic data extracted from the medical notes included the patient’s age (on admission), gender, and diagnosis. Medical, nursing, and therapy notes were reviewed to identify secondary complications that arose during the patient’s admission. The secondary complications reviewed were falls (defined as the patient unexpectedly coming to the ground or other lower level), health care–acquired infections (HAIs) (defined as any infection acquired during the hospital admission), and pressure ulcers (defined as injuries to the skin or underlying tissue during the hospital admission). Other details, obtained from the patient administration system, included the length of stay (days), the number of ward moves the patient experienced, the speciality of the consultant responsible for the patient’s care, the discharge destination, and whether the patient was readmitted for any cause within 30 days. All data collected were stored on a password-protected computer and no patient-identifiable data were included.

The results were collated using descriptive statistics. The χ² test was used to compare categorical data between those patients who were and were not reviewed by a neurologist, and the Mann-Whitney U test was used to compare differences in the length of stay between these 2 groups.

No national data relating to this specific patient group were available within the literature. Therefore, to provide a comparator of neurological patients within the same hospital, data were collected on stroke patients managed on the stroke ward. This group was deemed most appropriate for comparison as they present with similar neurological symptoms but are cared for on a specialist ward. During the evaluation period, 284 stroke patients were admitted to the stroke ward. A sample of 75 patients was randomly selected using a random number generator, and the procedure for data collection was repeated. It was not appropriate to make direct comparative analysis on these 2 groups due to the inherent differences, but it was felt important to provide context with regards to what usual care was like on a specialist ward within the same hospital.

Ethical approval was not required as this was a service evaluation of routinely collected data within a single hospital site.

Results

In total, 63 patients were identified: 26 females and 37 males. The median age of patients was 74 years (range, 39-92 years). These demographic details and comparisons to stroke patients managed on a specialist ward can be seen in Table 1. To quantify the range of diagnoses, the condition groups defined by GIRFT Neurology Methodology⁹ were used. The most common diagnoses were tumors of the nervous system (25.4%) and traumatic brain and spine injury (23.8%). The other conditions included in the analysis can be seen in Table 2.

Despite having a neurological condition as their primary diagnosis, only 15.9% of patients were reviewed by a neurologist during their hospital admission. Patients were most commonly under the care of a geriatrician (60.3%), but they were also managed by orthopedics (12.6%), acute medicine (7.9%), respiratory (6.3%), cardiology (4.8%), gastroenterology (3.2%), and surgery (3.2%). One patient (1.6%) was managed by intensivists.

The average length of stay was 25.9 days (range, 2-78 days). This was more than double the average length of stay on the stroke ward (11.4 days) (Table 1) and the national average for patients with neurological conditions (9.78 days).¹⁰ During their stay, 33% had 2 or more ward moves, with 1 patient moving wards a total of 6 times. Just over half (52.4%) of the patients returned to their usual residence on discharge. The remainder were discharged to rehabilitation units (15.9%), nursing homes (14.3%), residential homes (6.3%), tertiary centers (4.8%), and hospice (1.6%). Unfortunately, 3 patients (4.8%) passed away. Of those still alive (n = 60), 16.7% were readmitted to the hospital within 30 days, compared to a readmission rate of 11% on the stroke ward. None of the patients who were readmitted were seen by a neurologist during their initial admission.

The frequency of secondary complications was reviewed as a measure of the multidisciplinary management of this patient group. It was noted that 11.1% had a fall on the ward, which was similar to a rate of 10.7% on the stroke ward. More striking was the fact that 14.3% of patients developed a pressure ulcer and 33.3% developed an HAI during their admission, compared with rates of 1.3% and 10.7%, respectively, on the stroke ward (Table 1).

There were no significant differences found in length of stay between those who were and were not reviewed by a neurologist (P = .73). This was also true for categorical data, whereby readmission rate (P = .13), frequency of falls (P = .22), frequency of pressure ulcers (P = .67), and HAIs (P = .81) all failed to show a significant difference between groups.

Discussion

The findings of this service evaluation show markedly poorer outcomes for neurological patients compared to stroke patients managed on a specialist stroke ward. It is suggested that these results are in part due to the lack of specialist input from a neurologist in the majority of cases and the fact that all were managed on clinically inappropriate wards. Only 15.9% of neurological patients were seen by a neurologist. This is a slight improvement compared to previous studies in DGHs that showed rates of 10%¹ and 11%,¹¹ but it is still a far cry from the goal of 100% set out in recommendations.² In addition, the increased readmission rate may be suggestive of suboptimal management, especially given that none of those readmitted had been reviewed by a neurologist. There are undoubtedly other factors that may influence readmissions, such as comorbidities, the severity/complexity of the condition, and the strength of community services. However, the impact of a lack of input from a specialist should not be underestimated, and further evaluation of this factor (with confounding factors controlled) would be beneficial.

The result of an extended length of stay was also a predictable outcome based on previous evidence.^4,5 With the potential for suboptimal management plans and inaccurate diagnoses, it is inevitable that the patient’s movement through the hospital system will be impeded. In our example, it is possible that the extended length of stay was influenced by the fact that patients included in the evaluation were managed on nonspecialist wards and a large proportion had multiple ward changes.

Given that the evidence clearly shows that stroke patients are most effectively managed by a multidisciplinary team (MDT) with specialist skills,¹² it is likely that other neurological patients, who have similar multifactorial needs, would also benefit. The patients in our evaluation were cared for by nursing staff who lacked specific skills and experience in neurology. The allied health professionals involved were specialists in neurotherapy but were not based on the ward and not directly linked to the ward MDT. A review by Epstein found that the benefits of having a MDT, in any speciality, working together on a ward included improved communication, reduced adverse events, and a reduced length of stay.¹³ This lack of an effective MDT approach may provide some explanation as to why the average length of stay and the rates of some secondary complications were at such elevated levels.

A systematic review exploring the impact of patients admitted to clinically inappropriate wards in a range of specialities found that these patients were associated with worse outcomes.¹⁴ This is supported by our findings, in which a higher rate of pressure ulcers and HAIs were observed when compared to rates in the specialist stroke ward. Again, a potential explanation for this is the impact of patients being managed by clinicians who lack the specialist knowledge of the patient group and the risks they face. Another explanation could be due to the high number of ward moves the patients experienced. Blay et al found that ward moves increased length of stay and carried an associated clinical risk, with the odds of falls and HAIs increasing with each move.¹⁵ A case example of this is apparent within our analysis in that the patient who experienced 6 ward moves not only had the longest length of stay (78 days), but also developed a pressure ulcer and 2 HAIs during their admission.

This service evaluation had a number of limitations that should be considered when interpreting the results. First, despite including all patients who met the criteria within the stipulated time frame, the sample size was relatively small, making it difficult to identify consistent patterns of behavior within the data.

Furthermore, caution should be applied when interpreting the comparators used, as the patient groups are not equivalent. The use of comparison against a standard is not a prerequisite in a service evaluation of this nature, but comparators were included to help frame the context for the reader. As such, they should only be used in this way rather than to make any firm conclusions.

Finally, as the evaluation was limited to the use of routinely collected data, there are several variables, other than those reported, which may have influenced the results. For example, it was not possible to ascertain certain demographic details, such as body mass index and socioeconomic factors, nor lifestyle factors such as smoking status, alcohol consumption, and exercise levels, all of which could impact negatively on the outcomes of interest. Furthermore, data were not collected on follow-up services after discharge to evaluate whether these had any impact on readmission rates.

Conclusion

This service evaluation highlights the potential impact of managing neurological patients on clinically inappropriate wards with limited input from a neurologist. There is the potential to ameliorate these impacts by cohorting these patients in neurologist-led beds with a specialist MDT. While there are limitations in the design of our study, including the lack of a controlled comparison, the small sample size, and the fact that this is an evaluation of a single service, the negative impacts to patients are concerning and warrant further investigation.

Corresponding author: Richard J. Holmes, MSc, Physiotherapy Department, St. Richard’s Hospital, Chichester, West Sussex, PO19 6SE; [email protected].

Financial disclosures: None.

There is an unmet need to standardize outcomes that are reported in clinical trials of rosacea, according to authors of a new systematic review of rosacea treatment studies.

“Rosacea is a chronic dermatologic condition that affects 16 million Americans,” one of the study authors, Sarah A. Ibrahim, told this news organization after the annual conference of the American Society for Laser Medicine and Surgery. “The features of rosacea, such as inflammatory lesions, redness, burning sensations, and swelling, can have a negative impact on the quality of life for many patients. Additionally, patients with rosacea are at an increased risk for other conditions such as autoimmune diseases, like inflammatory bowel disease.”

In an effort led by principal investigator Murad Alam, MD, vice chair of the department of dermatology at Northwestern University, Chicago, Ms. Ibrahim conducted a systematic review to identify all outcomes that have previously been reported in clinical trials of rosacea, as part of the development of the core outcome set established by the Measurement of Priority Outcome Variables in Dermatologic Surgery (IMPROVED) group. “This has not been done before and is an important first step in understanding what outcomes should be measured in every future clinical study of rosacea,” said Ms. Ibrahim, a medical student at Northwestern University, and predoctoral research fellow in Northwestern’s department of dermatology.

The researchers limited their analysis to randomized, controlled trials of rosacea interventions published between 2010 and 2020 and categorized outcomes into domains based on similar themes.

A total of 58 studies were included in the systematic review, of which 7 (12%) evaluated laser-based interventions. The researchers identified 55 unique outcomes that encompassed eight domains: Quality of life, treatment effects, patient perception of health, clinical assessment, acceptance of care, laboratory assessment, physiological skin assessment, and patient satisfaction. Of the eight domains, clinical assessment-related outcomes were measured in all studies. Nontransient erythema was the most commonly reported outcome (43 studies, 78%), followed by inflammatory lesions (36 studies, 65%) and telangiectasia (22 studies, 40%).

Outcomes pertaining to treatment effects such as adverse events were measured in 49 of the 55 studies (89%), while patient-reported outcomes were measured in 21 (38%). Quality of life and patient satisfaction were reported in 18 (33%) and 13 (24%) studies, respectively.

sruilk/shutterstock

“There were two main take-home messages of our study,” said Ms. Ibrahim, who presented the results at the meeting. “The first is that there is a wide range of outcomes that are reported in clinical trials of rosacea therapies. Second, that there is a need to standardize the outcomes that are reported in clinical trials of rosacea, in order to be able to combine the results from different studies to better understand which interventions for rosacea are most effective.”

She acknowledged certain limitations of the review, including that other trials related to the topic were not included. “Because of the date range and types of studies that we used to narrow down our search, it is possible that additional outcomes were reported in studies that were not included here,” she said.

“This is a very important study because rosacea is a very common condition and one that I have seen more frequently in clinic since the pandemic started,” said Omar Ibrahimi, PhD, MD, a dermatologist with the Connecticut Skin Institute in Stamford, who was asked to comment on the work. “One of the limitations with rosacea studies is that the studies done are often fairly small and the outcome measures are heterogenous. The current study by Ibrahim and coworkers does a wonderful job of highlighting the various outcomes measures used to measure the success of rosacea treatments with energy-based devices.”

This information, he added, “will be very useful for further research studies because it forms the basis for formulating a set of core outcome measures to judge treatment interventions with consensus input from a variety of key opinion leaders. This will prove to be valuable because if we can have a uniform set of outcome measures to judge rosacea treatments with then we will be able to compare the results from different studies better.”

Ms. Ibrahim and colleagues reported having no relevant financial disclosures. Dr. Ibrahimi disclosed that he has been a speaker for both Candela and Cutera and he is currently on the medical advisory board for Cutera.
 

[email protected]

There is an unmet need to standardize outcomes that are reported in clinical trials of rosacea, according to authors of a new systematic review of rosacea treatment studies.

“Rosacea is a chronic dermatologic condition that affects 16 million Americans,” one of the study authors, Sarah A. Ibrahim, told this news organization after the annual conference of the American Society for Laser Medicine and Surgery. “The features of rosacea, such as inflammatory lesions, redness, burning sensations, and swelling, can have a negative impact on the quality of life for many patients. Additionally, patients with rosacea are at an increased risk for other conditions such as autoimmune diseases, like inflammatory bowel disease.”

In an effort led by principal investigator Murad Alam, MD, vice chair of the department of dermatology at Northwestern University, Chicago, Ms. Ibrahim conducted a systematic review to identify all outcomes that have previously been reported in clinical trials of rosacea, as part of the development of the core outcome set established by the Measurement of Priority Outcome Variables in Dermatologic Surgery (IMPROVED) group. “This has not been done before and is an important first step in understanding what outcomes should be measured in every future clinical study of rosacea,” said Ms. Ibrahim, a medical student at Northwestern University, and predoctoral research fellow in Northwestern’s department of dermatology.

The researchers limited their analysis to randomized, controlled trials of rosacea interventions published between 2010 and 2020 and categorized outcomes into domains based on similar themes.

A total of 58 studies were included in the systematic review, of which 7 (12%) evaluated laser-based interventions. The researchers identified 55 unique outcomes that encompassed eight domains: Quality of life, treatment effects, patient perception of health, clinical assessment, acceptance of care, laboratory assessment, physiological skin assessment, and patient satisfaction. Of the eight domains, clinical assessment-related outcomes were measured in all studies. Nontransient erythema was the most commonly reported outcome (43 studies, 78%), followed by inflammatory lesions (36 studies, 65%) and telangiectasia (22 studies, 40%).

Outcomes pertaining to treatment effects such as adverse events were measured in 49 of the 55 studies (89%), while patient-reported outcomes were measured in 21 (38%). Quality of life and patient satisfaction were reported in 18 (33%) and 13 (24%) studies, respectively.

sruilk/shutterstock

“There were two main take-home messages of our study,” said Ms. Ibrahim, who presented the results at the meeting. “The first is that there is a wide range of outcomes that are reported in clinical trials of rosacea therapies. Second, that there is a need to standardize the outcomes that are reported in clinical trials of rosacea, in order to be able to combine the results from different studies to better understand which interventions for rosacea are most effective.”

She acknowledged certain limitations of the review, including that other trials related to the topic were not included. “Because of the date range and types of studies that we used to narrow down our search, it is possible that additional outcomes were reported in studies that were not included here,” she said.

“This is a very important study because rosacea is a very common condition and one that I have seen more frequently in clinic since the pandemic started,” said Omar Ibrahimi, PhD, MD, a dermatologist with the Connecticut Skin Institute in Stamford, who was asked to comment on the work. “One of the limitations with rosacea studies is that the studies done are often fairly small and the outcome measures are heterogenous. The current study by Ibrahim and coworkers does a wonderful job of highlighting the various outcomes measures used to measure the success of rosacea treatments with energy-based devices.”

This information, he added, “will be very useful for further research studies because it forms the basis for formulating a set of core outcome measures to judge treatment interventions with consensus input from a variety of key opinion leaders. This will prove to be valuable because if we can have a uniform set of outcome measures to judge rosacea treatments with then we will be able to compare the results from different studies better.”

Ms. Ibrahim and colleagues reported having no relevant financial disclosures. Dr. Ibrahimi disclosed that he has been a speaker for both Candela and Cutera and he is currently on the medical advisory board for Cutera.
 

[email protected]

There is an unmet need to standardize outcomes that are reported in clinical trials of rosacea, according to authors of a new systematic review of rosacea treatment studies.

“Rosacea is a chronic dermatologic condition that affects 16 million Americans,” one of the study authors, Sarah A. Ibrahim, told this news organization after the annual conference of the American Society for Laser Medicine and Surgery. “The features of rosacea, such as inflammatory lesions, redness, burning sensations, and swelling, can have a negative impact on the quality of life for many patients. Additionally, patients with rosacea are at an increased risk for other conditions such as autoimmune diseases, like inflammatory bowel disease.”

In an effort led by principal investigator Murad Alam, MD, vice chair of the department of dermatology at Northwestern University, Chicago, Ms. Ibrahim conducted a systematic review to identify all outcomes that have previously been reported in clinical trials of rosacea, as part of the development of the core outcome set established by the Measurement of Priority Outcome Variables in Dermatologic Surgery (IMPROVED) group. “This has not been done before and is an important first step in understanding what outcomes should be measured in every future clinical study of rosacea,” said Ms. Ibrahim, a medical student at Northwestern University, and predoctoral research fellow in Northwestern’s department of dermatology.

The researchers limited their analysis to randomized, controlled trials of rosacea interventions published between 2010 and 2020 and categorized outcomes into domains based on similar themes.

A total of 58 studies were included in the systematic review, of which 7 (12%) evaluated laser-based interventions. The researchers identified 55 unique outcomes that encompassed eight domains: Quality of life, treatment effects, patient perception of health, clinical assessment, acceptance of care, laboratory assessment, physiological skin assessment, and patient satisfaction. Of the eight domains, clinical assessment-related outcomes were measured in all studies. Nontransient erythema was the most commonly reported outcome (43 studies, 78%), followed by inflammatory lesions (36 studies, 65%) and telangiectasia (22 studies, 40%).

Outcomes pertaining to treatment effects such as adverse events were measured in 49 of the 55 studies (89%), while patient-reported outcomes were measured in 21 (38%). Quality of life and patient satisfaction were reported in 18 (33%) and 13 (24%) studies, respectively.

sruilk/shutterstock

“There were two main take-home messages of our study,” said Ms. Ibrahim, who presented the results at the meeting. “The first is that there is a wide range of outcomes that are reported in clinical trials of rosacea therapies. Second, that there is a need to standardize the outcomes that are reported in clinical trials of rosacea, in order to be able to combine the results from different studies to better understand which interventions for rosacea are most effective.”

She acknowledged certain limitations of the review, including that other trials related to the topic were not included. “Because of the date range and types of studies that we used to narrow down our search, it is possible that additional outcomes were reported in studies that were not included here,” she said.

“This is a very important study because rosacea is a very common condition and one that I have seen more frequently in clinic since the pandemic started,” said Omar Ibrahimi, PhD, MD, a dermatologist with the Connecticut Skin Institute in Stamford, who was asked to comment on the work. “One of the limitations with rosacea studies is that the studies done are often fairly small and the outcome measures are heterogenous. The current study by Ibrahim and coworkers does a wonderful job of highlighting the various outcomes measures used to measure the success of rosacea treatments with energy-based devices.”

This information, he added, “will be very useful for further research studies because it forms the basis for formulating a set of core outcome measures to judge treatment interventions with consensus input from a variety of key opinion leaders. This will prove to be valuable because if we can have a uniform set of outcome measures to judge rosacea treatments with then we will be able to compare the results from different studies better.”

Ms. Ibrahim and colleagues reported having no relevant financial disclosures. Dr. Ibrahimi disclosed that he has been a speaker for both Candela and Cutera and he is currently on the medical advisory board for Cutera.
 

[email protected]

The U.S. Food and Drug Administration has granted breakthrough therapy designation for Boehringer Ingelheim’s experimental agent for the treatment of cognitive impairment associated with schizophrenia (CIAS).

The drug, known as BI 425809, is a novel glycine transporter-1 inhibitor.

The company announced it will start the CONNEX phase 3 clinical trial program to assess the safety and efficacy of the drug for improving cognition for adults with schizophrenia.

The breakthrough therapy designation and the initiation of phase 3 testing are based on results from a phase 2 clinical trial published in The Lancet Psychiatry.

In the phase 2 trial, oral BI 425809, taken once daily, improved cognition after 12 weeks for patients with schizophrenia; doses of 10 mg and 25 mg showed the largest separation from placebo.

Impairment of cognitive function is a major burden for people with schizophrenia, and no pharmacologic treatments are currently approved for CIAS.

“Cognition is a fundamental aspect of everyday life, including problem solving, memory, and attention, which is why finding solutions for cognitive impairment is a key area of Boehringer Ingelheim mental health research,” Vikas Mohan Sharma, MS, with Boehringer Ingelheim, said in a news release.

“This breakthrough therapy designation further highlights the urgent need for novel treatments for people living with schizophrenia. By combining traditional treatment approaches with new and innovative technologies, we are developing targeted therapies that will help to ease the burden of mental health conditions and enable people living with these conditions to create more meaningful connections to their lives, loved ones, and society,” said Mr. Sharma.

The CONNEX clinical trial program is composed of three clinical trials – CONNEX-1, CONNEX-2, and CONNEX-3. All are phase 3 randomized, double-blind, placebo-controlled parallel group trials that will examine the efficacy and safety of BI 425809 taken once daily over a 26-week period for patients with schizophrenia.

The primary outcome measure is change from baseline in overall composite T-score of the Measurement and Treatment Research to Improve Cognition in Schizophrenia consensus cognitive battery.

The CONNEX trial program will use VeraSci’s Pathway electronic clinical outcome assessment platform, including VeraSci’s Virtual Reality Functional Capacity Assessment Tool (VRFCAT), which simulates key instrumental activities of daily living in a realistic interactive virtual environment, VeraSci explains in a news release announcing the partnership with Boehringer Ingelheim.

The VRFCAT is sensitive to functional capacity deficits and has been accepted into the FDA’s Clinical Outcome Assessment Qualification Program.

The CONNEX trials will also utilize speech biomarker technology from Aural Analytics, which will provide a “richer picture of trial participants’ cognition alongside more conventional clinical outcome measures,” Boehringer Ingelheim says.

“Several of the symptoms of schizophrenia are generated by cognitive and emotional processes that can be identified through disruptions in the outward flow of speech. Using innovative speech analytics may help to objectively assess the downstream consequences of these disruptions,” said Daniel Jones, Aural Analytics co-founder and CEO.

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

The U.S. Food and Drug Administration has granted breakthrough therapy designation for Boehringer Ingelheim’s experimental agent for the treatment of cognitive impairment associated with schizophrenia (CIAS).

The drug, known as BI 425809, is a novel glycine transporter-1 inhibitor.

The company announced it will start the CONNEX phase 3 clinical trial program to assess the safety and efficacy of the drug for improving cognition for adults with schizophrenia.

The breakthrough therapy designation and the initiation of phase 3 testing are based on results from a phase 2 clinical trial published in The Lancet Psychiatry.

In the phase 2 trial, oral BI 425809, taken once daily, improved cognition after 12 weeks for patients with schizophrenia; doses of 10 mg and 25 mg showed the largest separation from placebo.

Impairment of cognitive function is a major burden for people with schizophrenia, and no pharmacologic treatments are currently approved for CIAS.

“Cognition is a fundamental aspect of everyday life, including problem solving, memory, and attention, which is why finding solutions for cognitive impairment is a key area of Boehringer Ingelheim mental health research,” Vikas Mohan Sharma, MS, with Boehringer Ingelheim, said in a news release.

“This breakthrough therapy designation further highlights the urgent need for novel treatments for people living with schizophrenia. By combining traditional treatment approaches with new and innovative technologies, we are developing targeted therapies that will help to ease the burden of mental health conditions and enable people living with these conditions to create more meaningful connections to their lives, loved ones, and society,” said Mr. Sharma.

The CONNEX clinical trial program is composed of three clinical trials – CONNEX-1, CONNEX-2, and CONNEX-3. All are phase 3 randomized, double-blind, placebo-controlled parallel group trials that will examine the efficacy and safety of BI 425809 taken once daily over a 26-week period for patients with schizophrenia.

The primary outcome measure is change from baseline in overall composite T-score of the Measurement and Treatment Research to Improve Cognition in Schizophrenia consensus cognitive battery.

The CONNEX trial program will use VeraSci’s Pathway electronic clinical outcome assessment platform, including VeraSci’s Virtual Reality Functional Capacity Assessment Tool (VRFCAT), which simulates key instrumental activities of daily living in a realistic interactive virtual environment, VeraSci explains in a news release announcing the partnership with Boehringer Ingelheim.

The VRFCAT is sensitive to functional capacity deficits and has been accepted into the FDA’s Clinical Outcome Assessment Qualification Program.

The CONNEX trials will also utilize speech biomarker technology from Aural Analytics, which will provide a “richer picture of trial participants’ cognition alongside more conventional clinical outcome measures,” Boehringer Ingelheim says.

“Several of the symptoms of schizophrenia are generated by cognitive and emotional processes that can be identified through disruptions in the outward flow of speech. Using innovative speech analytics may help to objectively assess the downstream consequences of these disruptions,” said Daniel Jones, Aural Analytics co-founder and CEO.

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

The U.S. Food and Drug Administration has granted breakthrough therapy designation for Boehringer Ingelheim’s experimental agent for the treatment of cognitive impairment associated with schizophrenia (CIAS).

The drug, known as BI 425809, is a novel glycine transporter-1 inhibitor.

The company announced it will start the CONNEX phase 3 clinical trial program to assess the safety and efficacy of the drug for improving cognition for adults with schizophrenia.

The breakthrough therapy designation and the initiation of phase 3 testing are based on results from a phase 2 clinical trial published in The Lancet Psychiatry.

In the phase 2 trial, oral BI 425809, taken once daily, improved cognition after 12 weeks for patients with schizophrenia; doses of 10 mg and 25 mg showed the largest separation from placebo.

Impairment of cognitive function is a major burden for people with schizophrenia, and no pharmacologic treatments are currently approved for CIAS.

“Cognition is a fundamental aspect of everyday life, including problem solving, memory, and attention, which is why finding solutions for cognitive impairment is a key area of Boehringer Ingelheim mental health research,” Vikas Mohan Sharma, MS, with Boehringer Ingelheim, said in a news release.

“This breakthrough therapy designation further highlights the urgent need for novel treatments for people living with schizophrenia. By combining traditional treatment approaches with new and innovative technologies, we are developing targeted therapies that will help to ease the burden of mental health conditions and enable people living with these conditions to create more meaningful connections to their lives, loved ones, and society,” said Mr. Sharma.

The CONNEX clinical trial program is composed of three clinical trials – CONNEX-1, CONNEX-2, and CONNEX-3. All are phase 3 randomized, double-blind, placebo-controlled parallel group trials that will examine the efficacy and safety of BI 425809 taken once daily over a 26-week period for patients with schizophrenia.

The primary outcome measure is change from baseline in overall composite T-score of the Measurement and Treatment Research to Improve Cognition in Schizophrenia consensus cognitive battery.

The CONNEX trial program will use VeraSci’s Pathway electronic clinical outcome assessment platform, including VeraSci’s Virtual Reality Functional Capacity Assessment Tool (VRFCAT), which simulates key instrumental activities of daily living in a realistic interactive virtual environment, VeraSci explains in a news release announcing the partnership with Boehringer Ingelheim.

The VRFCAT is sensitive to functional capacity deficits and has been accepted into the FDA’s Clinical Outcome Assessment Qualification Program.

The CONNEX trials will also utilize speech biomarker technology from Aural Analytics, which will provide a “richer picture of trial participants’ cognition alongside more conventional clinical outcome measures,” Boehringer Ingelheim says.

“Several of the symptoms of schizophrenia are generated by cognitive and emotional processes that can be identified through disruptions in the outward flow of speech. Using innovative speech analytics may help to objectively assess the downstream consequences of these disruptions,” said Daniel Jones, Aural Analytics co-founder and CEO.

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

A new study suggests that private investor ownership of dermatology practices has little impact on spending, but does result in a small increase in the number of patients seen per dermatologist, and slightly higher reimbursement per clinician.

The authors reported that – with an average of five quarters postacquisition – there was no statistically significant differential between investor-owned and non–investor-owned practices “in total spending, overall use of dermatology procedures per patient, or specific high-volume and profitable procedures.”

Essentially, the study findings were equivocal, reported Robert Tyler Braun, PhD and his colleagues at Weill Cornell Medicine, New York. “The results provide mixed support for both proponents and opponents of private equity acquisitions,” they wrote in the study, which was published in Health Affairs.

But two dermatologists not involved with the study said the analysis has significant limitations, including a lack of pathology data, a lack of Medicare data, and a lack of insight into how advanced practice clinicians, such as nurse practitioners and physician assistants, were used by the private equity (PE)–owned practices. The study was not able to track “incident to billing.”

Leaving out Medicare data is a “huge oversight,” Joseph K. Francis, MD, a Mohs surgeon at the University of Florida, Gainesville, said in an interview. “The study is fundamentally flawed.”

“With all of these limitations, it’s difficult to draw meaningful conclusions,” agreed Clifford Perlis, MD, Mbe, of Keystone Dermatology in King of Prussia, Pa.

Both Dr. Francis and Dr. Perlis also questioned the influence of one of the study’s primary sponsors, the Physicians Foundation, formed out of the settlement of a class action lawsuit against third-party payers.

In addition, Dr. Francis and Dr. Perlis said they thought the study did not follow the PE-owned practices for a long enough period of time after acquisition to detect any differences, and that the dataset – looking at practice acquisitions from 2012 to 2017 – was too old to paint a reliable picture of the current state of PE-owned practices. Acquisitions have accelerated since 2017.

In March 2021, Harvard researchers reported in JAMA Health Forum that PE purchases in health care peaked in the first quarter of 2018 and surged to almost as high a level in the fourth quarter of 2020, with 153 deals announced in the second half of the year. Of the 153 acquisitions, 98, or 64%, were for physician practices or other health care services.

Dr. Braun said his study focused on 2012-2017 because it was an available data set. And, he defended the snapshot, saying that he and his colleagues had as much as 4 years of postacquisition data for the practices that were purchased in 2013. He acknowledged there were less data on practices purchased from 2014 to 2016.

“It is possible that our results would change with a longer postacquisition period,” Dr. Braun said in an interview. But, he said there was no way to predict whether that change “would look better or worse for private equity.”

 

Modest price increases

The authors analyzed data from the Health Care Cost Institute, which aggregates claims for some 50 million individuals insured by Aetna, Humana, and United Healthcare. The data do not include Medicare claims.

They examined dermatologists in practices bought between 2013 and 2016 and compared them to dermatologists who were in practices not owned by private equity. Each dermatologist had to have at least 2 years of data, and the authors compared preacquisition with postacquisition data for those in PE-owned practices.

They identified 64 practices – with 246 dermatologists – bought by private investors. Preacquisition, PE practices were larger than non-PE practices, with 4.2 clinicians (including advanced practitioners) per practice, compared with 1.7 in non–investor-owned practices.

The authors looked at volume and prices for routine office visits (CPT code 99213), biopsies (11101), excisions (11602), destruction of first lesion (cryotherapy; 17000), and Mohs micrographic surgery (17311).

Prices for a routine office visit rose nominally in the first quarter after acquisition (under $1), stayed at 0 in the second quarter, decreased in the third quarter, and was 0 again in the fourth quarter. It was not until the fifth quarter post acquisition that prices rose, increasing by 3% ($2.26), and then rising 5% ($3.20) in the ninth quarter.

Dr. Braun said the price increases make sense because practices get “rolled up” into larger platforms, theoretically giving them more negotiating leverage with insurers. And he said the paper’s results “are consistent with physician practice consolidation research – mainly hospitals acquiring practices – that prices increase after acquisition.” He acknowledged that the dermatology paper found “more modest effects,” than other studies.

Dr. Francis, however, said the increases are basically “pocket change,” and that they reflect a failed promise from private investors that clinicians in PE-owned practices will be paid more. The small differences in pay may also mean that insurers are likely not acquiescing to the theoretical leverage of larger dermatology entities.

PE-owned dermatologists saw about 5% more patients per quarter initially, rising to 17% more per quarter by eight quarters after purchase, according to the study.

The study reported a significant increase in Mohs surgery and cryotherapy in the first quarter post purchase, and a significant increase in biopsies after eight quarters. But Dr. Braun and colleagues concluded that total spending per patient did not change significantly after acquisition. “That says that maybe physicians aren’t changing their behaviors that much,” Dr. Braun said in an interview.

Dr. Perlis disagreed, noting that practices rarely change quickly. “Anecdotally, most groups that are taken over, nothing changes initially,” while the new owners are getting a feel for the practice.

He also said the paper erred in not addressing quality of and access to care. “Quality and patient satisfaction and access are also other important factors that need to be examined.”

Not benign players

Both Dr. Perlis and Dr. Francis said the study may have been improved by having a dermatologist as a coauthor. Dr. Braun countered that he and his colleagues consulted several dermatologists during the course of the study, and that they also conducted 30 interviews with proponents and opponents of PE ownership.

The authors warned of what they viewed as some disturbing trends in PE-owned practices, including what Dr. Braun called “stealth” consolidation – investors making small purchases that fall outside of federal regulation, and then amassing them into large entities.

He also commented that it was “alarming” that PE-owned practices were hiring a larger number of advanced practitioners. The authors also expressed concern about leveraged buyouts, in which investors require a practice to carry high debt loads that can eventually drive it into bankruptcy.

“These are not benign players,” said Dr. Francis. He noted that it took “an act of Congress to stop surprise billing,” a tactic employed by PE-owned health care entities. “Policy makers should be looking at what’s best for patients, especially Medicare and vulnerable patients.”

Dr. Perlis also has qualms about PE-owned practices. “The money to support returns to investors has to come from somewhere and that creates an inherent tension between patient care and optimizing revenue for investors,” he said. “It’s a pretty head-on conflict.”
 

A new study suggests that private investor ownership of dermatology practices has little impact on spending, but does result in a small increase in the number of patients seen per dermatologist, and slightly higher reimbursement per clinician.

The authors reported that – with an average of five quarters postacquisition – there was no statistically significant differential between investor-owned and non–investor-owned practices “in total spending, overall use of dermatology procedures per patient, or specific high-volume and profitable procedures.”

Essentially, the study findings were equivocal, reported Robert Tyler Braun, PhD and his colleagues at Weill Cornell Medicine, New York. “The results provide mixed support for both proponents and opponents of private equity acquisitions,” they wrote in the study, which was published in Health Affairs.

But two dermatologists not involved with the study said the analysis has significant limitations, including a lack of pathology data, a lack of Medicare data, and a lack of insight into how advanced practice clinicians, such as nurse practitioners and physician assistants, were used by the private equity (PE)–owned practices. The study was not able to track “incident to billing.”

Leaving out Medicare data is a “huge oversight,” Joseph K. Francis, MD, a Mohs surgeon at the University of Florida, Gainesville, said in an interview. “The study is fundamentally flawed.”

“With all of these limitations, it’s difficult to draw meaningful conclusions,” agreed Clifford Perlis, MD, Mbe, of Keystone Dermatology in King of Prussia, Pa.

Both Dr. Francis and Dr. Perlis also questioned the influence of one of the study’s primary sponsors, the Physicians Foundation, formed out of the settlement of a class action lawsuit against third-party payers.

In addition, Dr. Francis and Dr. Perlis said they thought the study did not follow the PE-owned practices for a long enough period of time after acquisition to detect any differences, and that the dataset – looking at practice acquisitions from 2012 to 2017 – was too old to paint a reliable picture of the current state of PE-owned practices. Acquisitions have accelerated since 2017.

In March 2021, Harvard researchers reported in JAMA Health Forum that PE purchases in health care peaked in the first quarter of 2018 and surged to almost as high a level in the fourth quarter of 2020, with 153 deals announced in the second half of the year. Of the 153 acquisitions, 98, or 64%, were for physician practices or other health care services.

Dr. Braun said his study focused on 2012-2017 because it was an available data set. And, he defended the snapshot, saying that he and his colleagues had as much as 4 years of postacquisition data for the practices that were purchased in 2013. He acknowledged there were less data on practices purchased from 2014 to 2016.

“It is possible that our results would change with a longer postacquisition period,” Dr. Braun said in an interview. But, he said there was no way to predict whether that change “would look better or worse for private equity.”

 

Modest price increases

The authors analyzed data from the Health Care Cost Institute, which aggregates claims for some 50 million individuals insured by Aetna, Humana, and United Healthcare. The data do not include Medicare claims.

They examined dermatologists in practices bought between 2013 and 2016 and compared them to dermatologists who were in practices not owned by private equity. Each dermatologist had to have at least 2 years of data, and the authors compared preacquisition with postacquisition data for those in PE-owned practices.

They identified 64 practices – with 246 dermatologists – bought by private investors. Preacquisition, PE practices were larger than non-PE practices, with 4.2 clinicians (including advanced practitioners) per practice, compared with 1.7 in non–investor-owned practices.

The authors looked at volume and prices for routine office visits (CPT code 99213), biopsies (11101), excisions (11602), destruction of first lesion (cryotherapy; 17000), and Mohs micrographic surgery (17311).

Prices for a routine office visit rose nominally in the first quarter after acquisition (under $1), stayed at 0 in the second quarter, decreased in the third quarter, and was 0 again in the fourth quarter. It was not until the fifth quarter post acquisition that prices rose, increasing by 3% ($2.26), and then rising 5% ($3.20) in the ninth quarter.

Dr. Braun said the price increases make sense because practices get “rolled up” into larger platforms, theoretically giving them more negotiating leverage with insurers. And he said the paper’s results “are consistent with physician practice consolidation research – mainly hospitals acquiring practices – that prices increase after acquisition.” He acknowledged that the dermatology paper found “more modest effects,” than other studies.

Dr. Francis, however, said the increases are basically “pocket change,” and that they reflect a failed promise from private investors that clinicians in PE-owned practices will be paid more. The small differences in pay may also mean that insurers are likely not acquiescing to the theoretical leverage of larger dermatology entities.

PE-owned dermatologists saw about 5% more patients per quarter initially, rising to 17% more per quarter by eight quarters after purchase, according to the study.

The study reported a significant increase in Mohs surgery and cryotherapy in the first quarter post purchase, and a significant increase in biopsies after eight quarters. But Dr. Braun and colleagues concluded that total spending per patient did not change significantly after acquisition. “That says that maybe physicians aren’t changing their behaviors that much,” Dr. Braun said in an interview.

Dr. Perlis disagreed, noting that practices rarely change quickly. “Anecdotally, most groups that are taken over, nothing changes initially,” while the new owners are getting a feel for the practice.

He also said the paper erred in not addressing quality of and access to care. “Quality and patient satisfaction and access are also other important factors that need to be examined.”

Not benign players

Both Dr. Perlis and Dr. Francis said the study may have been improved by having a dermatologist as a coauthor. Dr. Braun countered that he and his colleagues consulted several dermatologists during the course of the study, and that they also conducted 30 interviews with proponents and opponents of PE ownership.

The authors warned of what they viewed as some disturbing trends in PE-owned practices, including what Dr. Braun called “stealth” consolidation – investors making small purchases that fall outside of federal regulation, and then amassing them into large entities.

He also commented that it was “alarming” that PE-owned practices were hiring a larger number of advanced practitioners. The authors also expressed concern about leveraged buyouts, in which investors require a practice to carry high debt loads that can eventually drive it into bankruptcy.

“These are not benign players,” said Dr. Francis. He noted that it took “an act of Congress to stop surprise billing,” a tactic employed by PE-owned health care entities. “Policy makers should be looking at what’s best for patients, especially Medicare and vulnerable patients.”

Dr. Perlis also has qualms about PE-owned practices. “The money to support returns to investors has to come from somewhere and that creates an inherent tension between patient care and optimizing revenue for investors,” he said. “It’s a pretty head-on conflict.”
 

A new study suggests that private investor ownership of dermatology practices has little impact on spending, but does result in a small increase in the number of patients seen per dermatologist, and slightly higher reimbursement per clinician.

The authors reported that – with an average of five quarters postacquisition – there was no statistically significant differential between investor-owned and non–investor-owned practices “in total spending, overall use of dermatology procedures per patient, or specific high-volume and profitable procedures.”

Essentially, the study findings were equivocal, reported Robert Tyler Braun, PhD and his colleagues at Weill Cornell Medicine, New York. “The results provide mixed support for both proponents and opponents of private equity acquisitions,” they wrote in the study, which was published in Health Affairs.

But two dermatologists not involved with the study said the analysis has significant limitations, including a lack of pathology data, a lack of Medicare data, and a lack of insight into how advanced practice clinicians, such as nurse practitioners and physician assistants, were used by the private equity (PE)–owned practices. The study was not able to track “incident to billing.”

Leaving out Medicare data is a “huge oversight,” Joseph K. Francis, MD, a Mohs surgeon at the University of Florida, Gainesville, said in an interview. “The study is fundamentally flawed.”

“With all of these limitations, it’s difficult to draw meaningful conclusions,” agreed Clifford Perlis, MD, Mbe, of Keystone Dermatology in King of Prussia, Pa.

Both Dr. Francis and Dr. Perlis also questioned the influence of one of the study’s primary sponsors, the Physicians Foundation, formed out of the settlement of a class action lawsuit against third-party payers.

In addition, Dr. Francis and Dr. Perlis said they thought the study did not follow the PE-owned practices for a long enough period of time after acquisition to detect any differences, and that the dataset – looking at practice acquisitions from 2012 to 2017 – was too old to paint a reliable picture of the current state of PE-owned practices. Acquisitions have accelerated since 2017.

In March 2021, Harvard researchers reported in JAMA Health Forum that PE purchases in health care peaked in the first quarter of 2018 and surged to almost as high a level in the fourth quarter of 2020, with 153 deals announced in the second half of the year. Of the 153 acquisitions, 98, or 64%, were for physician practices or other health care services.

Dr. Braun said his study focused on 2012-2017 because it was an available data set. And, he defended the snapshot, saying that he and his colleagues had as much as 4 years of postacquisition data for the practices that were purchased in 2013. He acknowledged there were less data on practices purchased from 2014 to 2016.

“It is possible that our results would change with a longer postacquisition period,” Dr. Braun said in an interview. But, he said there was no way to predict whether that change “would look better or worse for private equity.”

 

Modest price increases

The authors analyzed data from the Health Care Cost Institute, which aggregates claims for some 50 million individuals insured by Aetna, Humana, and United Healthcare. The data do not include Medicare claims.

They examined dermatologists in practices bought between 2013 and 2016 and compared them to dermatologists who were in practices not owned by private equity. Each dermatologist had to have at least 2 years of data, and the authors compared preacquisition with postacquisition data for those in PE-owned practices.

They identified 64 practices – with 246 dermatologists – bought by private investors. Preacquisition, PE practices were larger than non-PE practices, with 4.2 clinicians (including advanced practitioners) per practice, compared with 1.7 in non–investor-owned practices.

The authors looked at volume and prices for routine office visits (CPT code 99213), biopsies (11101), excisions (11602), destruction of first lesion (cryotherapy; 17000), and Mohs micrographic surgery (17311).

Prices for a routine office visit rose nominally in the first quarter after acquisition (under $1), stayed at 0 in the second quarter, decreased in the third quarter, and was 0 again in the fourth quarter. It was not until the fifth quarter post acquisition that prices rose, increasing by 3% ($2.26), and then rising 5% ($3.20) in the ninth quarter.

Dr. Braun said the price increases make sense because practices get “rolled up” into larger platforms, theoretically giving them more negotiating leverage with insurers. And he said the paper’s results “are consistent with physician practice consolidation research – mainly hospitals acquiring practices – that prices increase after acquisition.” He acknowledged that the dermatology paper found “more modest effects,” than other studies.

Dr. Francis, however, said the increases are basically “pocket change,” and that they reflect a failed promise from private investors that clinicians in PE-owned practices will be paid more. The small differences in pay may also mean that insurers are likely not acquiescing to the theoretical leverage of larger dermatology entities.

PE-owned dermatologists saw about 5% more patients per quarter initially, rising to 17% more per quarter by eight quarters after purchase, according to the study.

The study reported a significant increase in Mohs surgery and cryotherapy in the first quarter post purchase, and a significant increase in biopsies after eight quarters. But Dr. Braun and colleagues concluded that total spending per patient did not change significantly after acquisition. “That says that maybe physicians aren’t changing their behaviors that much,” Dr. Braun said in an interview.

Dr. Perlis disagreed, noting that practices rarely change quickly. “Anecdotally, most groups that are taken over, nothing changes initially,” while the new owners are getting a feel for the practice.

He also said the paper erred in not addressing quality of and access to care. “Quality and patient satisfaction and access are also other important factors that need to be examined.”

Not benign players

Both Dr. Perlis and Dr. Francis said the study may have been improved by having a dermatologist as a coauthor. Dr. Braun countered that he and his colleagues consulted several dermatologists during the course of the study, and that they also conducted 30 interviews with proponents and opponents of PE ownership.

The authors warned of what they viewed as some disturbing trends in PE-owned practices, including what Dr. Braun called “stealth” consolidation – investors making small purchases that fall outside of federal regulation, and then amassing them into large entities.

He also commented that it was “alarming” that PE-owned practices were hiring a larger number of advanced practitioners. The authors also expressed concern about leveraged buyouts, in which investors require a practice to carry high debt loads that can eventually drive it into bankruptcy.

“These are not benign players,” said Dr. Francis. He noted that it took “an act of Congress to stop surprise billing,” a tactic employed by PE-owned health care entities. “Policy makers should be looking at what’s best for patients, especially Medicare and vulnerable patients.”

Dr. Perlis also has qualms about PE-owned practices. “The money to support returns to investors has to come from somewhere and that creates an inherent tension between patient care and optimizing revenue for investors,” he said. “It’s a pretty head-on conflict.”
 

Health workers already know that indoor air quality can be as important to human health as clean water and uncontaminated food. But before the COVID-19 pandemic, its importance in the prevention of respiratory illnesses outside of health circles was only whispered about.

Now, a team of nearly 40 scientists from 14 countries is calling for “a paradigm shift,” so that improvements in indoor air quality are viewed as essential to curb respiratory infections.

Most countries do not have indoor air-quality standards, the scientists point out in their recent report, and those that do often fall short in scope and enforcement.

“We expect everywhere in the world to have clean water flowing from our taps. In most parts of the developed world, it is happening and we take it completely for granted,” said lead investigator Lidia Morawska, PhD, of the International Laboratory for Air Quality and Health at the Queensland University of Technology in Brisbane, Australia.

But bacteria and viruses can circulate freely in the air, and “no one thinks about this, whatsoever, apart from health care facilities,” she said.

A first step is to recognize the risk posed by airborne pathogens, something not yet universally acknowledged. The investigators also want the World Health Organization to extend its guidelines to cover airborne pathogens, and for ventilation standards to include higher airflow and filtration rates.

Germany has been at the forefront of air-quality measures, Dr. Morawska said. Years ago, she observed a monitor showing the carbon dioxide level and relative humidity in the room where she was attending a meeting. The screen was accompanied by red, yellow, and green signals to communicate risk. Such indicators are also commonly displayed in German schools so teachers know when to open the windows or adjust the ventilation.
 

Monitors show carbon dioxide levels

But this is not yet being done in most other countries, Dr. Morawska said. Levels of carbon dioxide are one measure of indoor air quality, but they serve as a proxy for ventilation, she pointed out. Although the technology is available, sensors that can test a variety of components in a building in real time are not yet affordable.

Dr. Morawska envisions a future where the air quality numbers of the places people frequent are displayed so they know the risk for airborne transmission of respiratory illnesses. And people can begin to expect clean indoor air when they enter a business, office, or entertainment space and request changes when the air quality dips and improvement is needed, she said.

It is a daunting challenge to clean indoor air for several reasons. Air is not containable in the same way water is, which makes it difficult to trace contaminants. And infections transmitted through dirty water and food are usually evident immediately, whereas infections transmitted through airborne pathogens can take days to develop. Plus, the necessary infrastructure changes will be expensive.

However, the initial cost required to change the flow and quality of indoor air might be less than the cost of infections, the scientists pointed out. It is estimated that the global harm caused by COVID-19 alone costs $1 trillion each month.

“In the United States, the yearly cost – direct and indirect – of influenza has been calculated at $11.2 billion. For respiratory infections other than influenza, the yearly cost stood at $40 billion,” the team noted.

“If even half of this was caused by inhalation, we are still talking about massive costs,” said Dr. Morawska.
 

Bigger is not always better

It is tempting to see the solution as increased ventilation, said Ehsan Mousavi, PhD, assistant professor of construction science and management at Clemson (S.C.) University, who studies indoor air quality and ventilation in hospitals.

“We are ventilating the heck out of hospitals,” he said in an interview. But there is much debate about how much ventilation is the right amount. Too much and “you can blow pathogens into an open wound,” he explained. “Bigger is not always better.”

And there is still debate about the best mix of outside and recirculated air. An increase in the intake of outdoor air can refresh indoor air if it is clean, but that depends on where you live, he pointed out.

The mix used in most standard office buildings is 15% outside air and 85% recirculated air, Dr. Mousavi said. Boosting the percentage of outside air increases costs and energy use.

In fact, it can take five times more energy to ventilate hospital spaces than office spaces, he reported.

Engineers searching for clean-air solutions need to know what particulates are in the air and whether they are harmful to humans, but the sensors currently available can’t identify whether a virus is present in real time.

Samples have to be taken to a lab and, “by the time you know a virus was in the space, the moment is gone,” Dr. Mousavi explained.

More research is needed. “We need a reasonable answer that looks at the problem holistically, not just from the infectious disease perspective,” he said.
 

Hydrating indoor air

Research is making it clear that health care environments can play a significant role in patient recovery, according to Stephanie Taylor, MD. Dr. Taylor is president of Building4Health, which she founded to help businesses assess the quality of air in their buildings and find solutions. The company uses an algorithm to arrive at a health assessment score.

Air hydration is the most important aspect to target, she said.

Since the 1980s, research has shown that a relative humidity of 40%-60% is healthy for humans, she said. Currently, in an office building in a winter climate, the humidity level is more like 20%.

Canada is the first country to officially recommend the 40%-60% range for senior citizen centers and residential homes.

“Properly hydrated air supports our immune system and prevents skin problems and respiratory problems. It also inactivates many bacteria and viruses,” Dr. Taylor explained. Inhaling dry air compromises the ability of the body to restrict influenza virus infection, researchers showed in a 2019 study.

In the case of COVID-19, as virus particles attach to water molecules, they get bigger and heavier and eventually drop out of the breathing zone and onto surfaces where they can be wiped away, she explained.

But when the particles “are very small – like 5 microns in diameter – and you inhale them, they can lodge deep in the lungs,” she said.

In properly hydrated air, particles will be larger – about 10-20 microns when they attach to the water vapor – so they will get stuck in the nose or the back of the throat, where they can be washed away by mucous and not travel to the lungs.

“Indoor air metrics” can support our health or contribute to disease, “not just over time, but quickly, within minutes or hours,” she said.

No one expects the world’s building stock to suddenly upgrade to the ideal air quality. “But that doesn’t mean we shouldn’t move in that direction,” Dr. Taylor said. Changes can start small and gradually increase.
 

New research targets indoor air

Humidity is one of the key areas for current research, said Karl Rockne, PhD, director of the environmental engineering program at the National Science Foundation.

“When a virus comes out, it’s not just a naked virus, which is exceptionally small. It’s a virus encapsulated in liquid. And that’s why the humidity is so key. The degree of humidity can determine how fast the water evaporates from the particle,” he said in an interview.

In the wake of COVID-19, his institution is funding more cross-disciplinary research in biology, building science, architecture, and physics, he pointed out.

One such effort involved the development of a sensor that can capture live COVID-19 virus. This so-called “smoking gun,” which proved that the virus can spread through the air, took the combined expertise of professionals in medicine, engineering, and several other disciplines.

Currently, investigators are examining indoor air quality and water supplies in offices that have been left empty during the pandemic, and the effect they will have on human health. And others are looking at the way outside air quality affects indoor air quality, particularly where outdoor air quality is poor, such as in areas experiencing wildfires.

So will COVID-19 be the catalyst that finally drives changes to building design, regulation, and public expectations of air quality in the spaces where we spend close to 90% of our time?

“If not COVID, what else? It affected every country, every sector,” Dr. Morawska said. “There’s enough momentum now to do something about this. And enough realization there is a problem.”
 

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

Health workers already know that indoor air quality can be as important to human health as clean water and uncontaminated food. But before the COVID-19 pandemic, its importance in the prevention of respiratory illnesses outside of health circles was only whispered about.

Now, a team of nearly 40 scientists from 14 countries is calling for “a paradigm shift,” so that improvements in indoor air quality are viewed as essential to curb respiratory infections.

Most countries do not have indoor air-quality standards, the scientists point out in their recent report, and those that do often fall short in scope and enforcement.

“We expect everywhere in the world to have clean water flowing from our taps. In most parts of the developed world, it is happening and we take it completely for granted,” said lead investigator Lidia Morawska, PhD, of the International Laboratory for Air Quality and Health at the Queensland University of Technology in Brisbane, Australia.

But bacteria and viruses can circulate freely in the air, and “no one thinks about this, whatsoever, apart from health care facilities,” she said.

A first step is to recognize the risk posed by airborne pathogens, something not yet universally acknowledged. The investigators also want the World Health Organization to extend its guidelines to cover airborne pathogens, and for ventilation standards to include higher airflow and filtration rates.

Germany has been at the forefront of air-quality measures, Dr. Morawska said. Years ago, she observed a monitor showing the carbon dioxide level and relative humidity in the room where she was attending a meeting. The screen was accompanied by red, yellow, and green signals to communicate risk. Such indicators are also commonly displayed in German schools so teachers know when to open the windows or adjust the ventilation.
 

Monitors show carbon dioxide levels

But this is not yet being done in most other countries, Dr. Morawska said. Levels of carbon dioxide are one measure of indoor air quality, but they serve as a proxy for ventilation, she pointed out. Although the technology is available, sensors that can test a variety of components in a building in real time are not yet affordable.

Dr. Morawska envisions a future where the air quality numbers of the places people frequent are displayed so they know the risk for airborne transmission of respiratory illnesses. And people can begin to expect clean indoor air when they enter a business, office, or entertainment space and request changes when the air quality dips and improvement is needed, she said.

It is a daunting challenge to clean indoor air for several reasons. Air is not containable in the same way water is, which makes it difficult to trace contaminants. And infections transmitted through dirty water and food are usually evident immediately, whereas infections transmitted through airborne pathogens can take days to develop. Plus, the necessary infrastructure changes will be expensive.

However, the initial cost required to change the flow and quality of indoor air might be less than the cost of infections, the scientists pointed out. It is estimated that the global harm caused by COVID-19 alone costs $1 trillion each month.

“In the United States, the yearly cost – direct and indirect – of influenza has been calculated at $11.2 billion. For respiratory infections other than influenza, the yearly cost stood at $40 billion,” the team noted.

“If even half of this was caused by inhalation, we are still talking about massive costs,” said Dr. Morawska.
 

Bigger is not always better

It is tempting to see the solution as increased ventilation, said Ehsan Mousavi, PhD, assistant professor of construction science and management at Clemson (S.C.) University, who studies indoor air quality and ventilation in hospitals.

“We are ventilating the heck out of hospitals,” he said in an interview. But there is much debate about how much ventilation is the right amount. Too much and “you can blow pathogens into an open wound,” he explained. “Bigger is not always better.”

And there is still debate about the best mix of outside and recirculated air. An increase in the intake of outdoor air can refresh indoor air if it is clean, but that depends on where you live, he pointed out.

The mix used in most standard office buildings is 15% outside air and 85% recirculated air, Dr. Mousavi said. Boosting the percentage of outside air increases costs and energy use.

In fact, it can take five times more energy to ventilate hospital spaces than office spaces, he reported.

Engineers searching for clean-air solutions need to know what particulates are in the air and whether they are harmful to humans, but the sensors currently available can’t identify whether a virus is present in real time.

Samples have to be taken to a lab and, “by the time you know a virus was in the space, the moment is gone,” Dr. Mousavi explained.

More research is needed. “We need a reasonable answer that looks at the problem holistically, not just from the infectious disease perspective,” he said.
 

Hydrating indoor air

Research is making it clear that health care environments can play a significant role in patient recovery, according to Stephanie Taylor, MD. Dr. Taylor is president of Building4Health, which she founded to help businesses assess the quality of air in their buildings and find solutions. The company uses an algorithm to arrive at a health assessment score.

Air hydration is the most important aspect to target, she said.

Since the 1980s, research has shown that a relative humidity of 40%-60% is healthy for humans, she said. Currently, in an office building in a winter climate, the humidity level is more like 20%.

Canada is the first country to officially recommend the 40%-60% range for senior citizen centers and residential homes.

“Properly hydrated air supports our immune system and prevents skin problems and respiratory problems. It also inactivates many bacteria and viruses,” Dr. Taylor explained. Inhaling dry air compromises the ability of the body to restrict influenza virus infection, researchers showed in a 2019 study.

In the case of COVID-19, as virus particles attach to water molecules, they get bigger and heavier and eventually drop out of the breathing zone and onto surfaces where they can be wiped away, she explained.

But when the particles “are very small – like 5 microns in diameter – and you inhale them, they can lodge deep in the lungs,” she said.

In properly hydrated air, particles will be larger – about 10-20 microns when they attach to the water vapor – so they will get stuck in the nose or the back of the throat, where they can be washed away by mucous and not travel to the lungs.

“Indoor air metrics” can support our health or contribute to disease, “not just over time, but quickly, within minutes or hours,” she said.

No one expects the world’s building stock to suddenly upgrade to the ideal air quality. “But that doesn’t mean we shouldn’t move in that direction,” Dr. Taylor said. Changes can start small and gradually increase.
 

New research targets indoor air

Humidity is one of the key areas for current research, said Karl Rockne, PhD, director of the environmental engineering program at the National Science Foundation.

“When a virus comes out, it’s not just a naked virus, which is exceptionally small. It’s a virus encapsulated in liquid. And that’s why the humidity is so key. The degree of humidity can determine how fast the water evaporates from the particle,” he said in an interview.

In the wake of COVID-19, his institution is funding more cross-disciplinary research in biology, building science, architecture, and physics, he pointed out.

One such effort involved the development of a sensor that can capture live COVID-19 virus. This so-called “smoking gun,” which proved that the virus can spread through the air, took the combined expertise of professionals in medicine, engineering, and several other disciplines.

Currently, investigators are examining indoor air quality and water supplies in offices that have been left empty during the pandemic, and the effect they will have on human health. And others are looking at the way outside air quality affects indoor air quality, particularly where outdoor air quality is poor, such as in areas experiencing wildfires.

So will COVID-19 be the catalyst that finally drives changes to building design, regulation, and public expectations of air quality in the spaces where we spend close to 90% of our time?

“If not COVID, what else? It affected every country, every sector,” Dr. Morawska said. “There’s enough momentum now to do something about this. And enough realization there is a problem.”
 

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

Health workers already know that indoor air quality can be as important to human health as clean water and uncontaminated food. But before the COVID-19 pandemic, its importance in the prevention of respiratory illnesses outside of health circles was only whispered about.

Now, a team of nearly 40 scientists from 14 countries is calling for “a paradigm shift,” so that improvements in indoor air quality are viewed as essential to curb respiratory infections.

Most countries do not have indoor air-quality standards, the scientists point out in their recent report, and those that do often fall short in scope and enforcement.

“We expect everywhere in the world to have clean water flowing from our taps. In most parts of the developed world, it is happening and we take it completely for granted,” said lead investigator Lidia Morawska, PhD, of the International Laboratory for Air Quality and Health at the Queensland University of Technology in Brisbane, Australia.

But bacteria and viruses can circulate freely in the air, and “no one thinks about this, whatsoever, apart from health care facilities,” she said.

A first step is to recognize the risk posed by airborne pathogens, something not yet universally acknowledged. The investigators also want the World Health Organization to extend its guidelines to cover airborne pathogens, and for ventilation standards to include higher airflow and filtration rates.

Germany has been at the forefront of air-quality measures, Dr. Morawska said. Years ago, she observed a monitor showing the carbon dioxide level and relative humidity in the room where she was attending a meeting. The screen was accompanied by red, yellow, and green signals to communicate risk. Such indicators are also commonly displayed in German schools so teachers know when to open the windows or adjust the ventilation.
 

Monitors show carbon dioxide levels

But this is not yet being done in most other countries, Dr. Morawska said. Levels of carbon dioxide are one measure of indoor air quality, but they serve as a proxy for ventilation, she pointed out. Although the technology is available, sensors that can test a variety of components in a building in real time are not yet affordable.

Dr. Morawska envisions a future where the air quality numbers of the places people frequent are displayed so they know the risk for airborne transmission of respiratory illnesses. And people can begin to expect clean indoor air when they enter a business, office, or entertainment space and request changes when the air quality dips and improvement is needed, she said.

It is a daunting challenge to clean indoor air for several reasons. Air is not containable in the same way water is, which makes it difficult to trace contaminants. And infections transmitted through dirty water and food are usually evident immediately, whereas infections transmitted through airborne pathogens can take days to develop. Plus, the necessary infrastructure changes will be expensive.

However, the initial cost required to change the flow and quality of indoor air might be less than the cost of infections, the scientists pointed out. It is estimated that the global harm caused by COVID-19 alone costs $1 trillion each month.

“In the United States, the yearly cost – direct and indirect – of influenza has been calculated at $11.2 billion. For respiratory infections other than influenza, the yearly cost stood at $40 billion,” the team noted.

“If even half of this was caused by inhalation, we are still talking about massive costs,” said Dr. Morawska.
 

Bigger is not always better

It is tempting to see the solution as increased ventilation, said Ehsan Mousavi, PhD, assistant professor of construction science and management at Clemson (S.C.) University, who studies indoor air quality and ventilation in hospitals.

“We are ventilating the heck out of hospitals,” he said in an interview. But there is much debate about how much ventilation is the right amount. Too much and “you can blow pathogens into an open wound,” he explained. “Bigger is not always better.”

And there is still debate about the best mix of outside and recirculated air. An increase in the intake of outdoor air can refresh indoor air if it is clean, but that depends on where you live, he pointed out.

The mix used in most standard office buildings is 15% outside air and 85% recirculated air, Dr. Mousavi said. Boosting the percentage of outside air increases costs and energy use.

In fact, it can take five times more energy to ventilate hospital spaces than office spaces, he reported.

Engineers searching for clean-air solutions need to know what particulates are in the air and whether they are harmful to humans, but the sensors currently available can’t identify whether a virus is present in real time.

Samples have to be taken to a lab and, “by the time you know a virus was in the space, the moment is gone,” Dr. Mousavi explained.

More research is needed. “We need a reasonable answer that looks at the problem holistically, not just from the infectious disease perspective,” he said.
 

Hydrating indoor air

Research is making it clear that health care environments can play a significant role in patient recovery, according to Stephanie Taylor, MD. Dr. Taylor is president of Building4Health, which she founded to help businesses assess the quality of air in their buildings and find solutions. The company uses an algorithm to arrive at a health assessment score.

Air hydration is the most important aspect to target, she said.

Since the 1980s, research has shown that a relative humidity of 40%-60% is healthy for humans, she said. Currently, in an office building in a winter climate, the humidity level is more like 20%.

Canada is the first country to officially recommend the 40%-60% range for senior citizen centers and residential homes.

“Properly hydrated air supports our immune system and prevents skin problems and respiratory problems. It also inactivates many bacteria and viruses,” Dr. Taylor explained. Inhaling dry air compromises the ability of the body to restrict influenza virus infection, researchers showed in a 2019 study.

In the case of COVID-19, as virus particles attach to water molecules, they get bigger and heavier and eventually drop out of the breathing zone and onto surfaces where they can be wiped away, she explained.

But when the particles “are very small – like 5 microns in diameter – and you inhale them, they can lodge deep in the lungs,” she said.

In properly hydrated air, particles will be larger – about 10-20 microns when they attach to the water vapor – so they will get stuck in the nose or the back of the throat, where they can be washed away by mucous and not travel to the lungs.

“Indoor air metrics” can support our health or contribute to disease, “not just over time, but quickly, within minutes or hours,” she said.

No one expects the world’s building stock to suddenly upgrade to the ideal air quality. “But that doesn’t mean we shouldn’t move in that direction,” Dr. Taylor said. Changes can start small and gradually increase.
 

New research targets indoor air

Humidity is one of the key areas for current research, said Karl Rockne, PhD, director of the environmental engineering program at the National Science Foundation.

“When a virus comes out, it’s not just a naked virus, which is exceptionally small. It’s a virus encapsulated in liquid. And that’s why the humidity is so key. The degree of humidity can determine how fast the water evaporates from the particle,” he said in an interview.

In the wake of COVID-19, his institution is funding more cross-disciplinary research in biology, building science, architecture, and physics, he pointed out.

One such effort involved the development of a sensor that can capture live COVID-19 virus. This so-called “smoking gun,” which proved that the virus can spread through the air, took the combined expertise of professionals in medicine, engineering, and several other disciplines.

Currently, investigators are examining indoor air quality and water supplies in offices that have been left empty during the pandemic, and the effect they will have on human health. And others are looking at the way outside air quality affects indoor air quality, particularly where outdoor air quality is poor, such as in areas experiencing wildfires.

So will COVID-19 be the catalyst that finally drives changes to building design, regulation, and public expectations of air quality in the spaces where we spend close to 90% of our time?

“If not COVID, what else? It affected every country, every sector,” Dr. Morawska said. “There’s enough momentum now to do something about this. And enough realization there is a problem.”
 

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

Proton pump inhibitor (PPI) use can safely be reduced by deprescribing efforts coupled with patient and clinician education, according to a retrospective study involving more than 4 million veterans.

After 1 year, the intervention was associated with a significant reduction in PPI use without worsening of acid-related diseases, reported lead author Jacob E. Kurlander, MD, of the University of Michigan, Ann Arbor, and the VA Ann Arbor Healthcare System’s Center for Clinical Management Research.

“There’s increasing interest in interventions to reduce PPI use,” Dr. Kurlander said during his virtual presentation at the annual Digestive Disease Week® (DDW). “Many of the interventions have come in the form of patient and provider education, like the Choosing Wisely campaign put out by the American Board of Internal Medicine. However, in rigorous studies, few interventions have actually proven effective, and many of these studies lack data on clinical outcomes, so it’s difficult to ascertain the real clinical benefits, or even harms.”

In an effort to address this gap, the investigators conducted a retrospective, difference-in-difference study spanning 10 years, from 2009 to 2019. The 1-year intervention, implemented in August 2013, included refill restrictions for PPIs without documented indication for long-term use, voiding of PPI prescriptions not filled within 6 months, a quick-order option for H2-receptor antagonists, reports to identify high-dose PPI prescribing, and patient and clinician education.

The intervention group consisted of 192,607-250,349 veterans in Veteran Integrated Service Network 17, whereas the control group consisted of 3,775,978-4,360,908 veterans in other service networks (ranges in population size are due to variations across 6-month intervals of analysis). For each 6-month interval, patients were included if they had at least two primary care visits within the past 2 years, and excluded if they received primary care at three other sites that joined the intervention site after initial implementation.

The investigators analyzed three main outcomes: Proportion of veterans dispensed a PPI prescription from the VA at any dose; incidence proportion of hospitalization for upper GI diseases, including upper GI bleeding other than from esophageal varices or angiodysplasia, as well as nonbleeding acid peptic disease; and rates of primary care visits, gastroenterology visits, and esophagogastroduodenoscopies (EGDs).

The analysis was divided into a preimplementation period, lasting approximately 5 years, and a postimplementation period with a similar duration. In the postimplementation period, the intervention group had a 5.9% relative reduction in PPI prescriptions, compared with the control group (P < .001). During the same period, the intervention site did not have a significant increase in the rate of patients hospitalized for upper GI diseases, primary care visits, GI clinic visits, or EGDs.

In a subgroup analysis of patients coprescribed PPIs during time at high-risk for upper GI bleeding (that is, when they possessed at least two high-risk medications, such as warfarin), there was a 4.6% relative reduction in time with PPI gastroprotection among the intervention group, compared with the control group (P = .003). In a second sensitivity analysis, hospitalization for upper GI diseases in high-risk patients at least 65 years of age was not significantly different between groups.

“[This] multicomponent PPI deprescribing program led to sustained reductions in PPI use,” Dr. Kurlander concluded. “However, this blunt intervention also reduced appropriate use of PPIs for gastroprotection, raising some concerns about clinical quality of care, but this did not appear to cause any measurable clinical harm in terms of hospitalizations for upper GI diseases.”
 

Debate around ‘unnecessary PPI use’

According to Philip O. Katz, MD, professor of medicine and director of motility laboratories at Weill Cornell Medicine, New York, the study “makes an attempt to do what others have tried in different ways, which is to develop a mechanism to help reduce or discontinue proton pump inhibitors when people believe they’re not indicated.”

Yet this latter element – appropriate indication – drives an ongoing debate.

“This is a very controversial area,” Dr. Katz said in an interview. “The concept of using the lowest effective dose of medication needed for a symptom or a disease is not new, but the push to reducing or eliminating ‘unnecessary PPI use’ is one that I believe should be carefully discussed, and that we have a clear understanding of what constitutes unnecessary use. And quite honestly, I’m willing to state that I don’t believe that’s been well defined.”

Dr. Katz, who recently coauthored an article about PPIs, suggested that more prospective research is needed to identify which patients need PPIs and which don’t.

“What we really need are more studies that look at who really needs [PPIs] long term,” Dr. Katz said, “as opposed to doing it ad hoc.”

The study was funded by the U.S. Department of Veterans Affairs and the National Institute of Diabetes and Digestive and Kidney Diseases. The investigators reported no conflicts of interest. Dr. Katz is a consultant for Phathom Pharma.

Proton pump inhibitor (PPI) use can safely be reduced by deprescribing efforts coupled with patient and clinician education, according to a retrospective study involving more than 4 million veterans.

After 1 year, the intervention was associated with a significant reduction in PPI use without worsening of acid-related diseases, reported lead author Jacob E. Kurlander, MD, of the University of Michigan, Ann Arbor, and the VA Ann Arbor Healthcare System’s Center for Clinical Management Research.

“There’s increasing interest in interventions to reduce PPI use,” Dr. Kurlander said during his virtual presentation at the annual Digestive Disease Week® (DDW). “Many of the interventions have come in the form of patient and provider education, like the Choosing Wisely campaign put out by the American Board of Internal Medicine. However, in rigorous studies, few interventions have actually proven effective, and many of these studies lack data on clinical outcomes, so it’s difficult to ascertain the real clinical benefits, or even harms.”

In an effort to address this gap, the investigators conducted a retrospective, difference-in-difference study spanning 10 years, from 2009 to 2019. The 1-year intervention, implemented in August 2013, included refill restrictions for PPIs without documented indication for long-term use, voiding of PPI prescriptions not filled within 6 months, a quick-order option for H2-receptor antagonists, reports to identify high-dose PPI prescribing, and patient and clinician education.

The intervention group consisted of 192,607-250,349 veterans in Veteran Integrated Service Network 17, whereas the control group consisted of 3,775,978-4,360,908 veterans in other service networks (ranges in population size are due to variations across 6-month intervals of analysis). For each 6-month interval, patients were included if they had at least two primary care visits within the past 2 years, and excluded if they received primary care at three other sites that joined the intervention site after initial implementation.

The investigators analyzed three main outcomes: Proportion of veterans dispensed a PPI prescription from the VA at any dose; incidence proportion of hospitalization for upper GI diseases, including upper GI bleeding other than from esophageal varices or angiodysplasia, as well as nonbleeding acid peptic disease; and rates of primary care visits, gastroenterology visits, and esophagogastroduodenoscopies (EGDs).

The analysis was divided into a preimplementation period, lasting approximately 5 years, and a postimplementation period with a similar duration. In the postimplementation period, the intervention group had a 5.9% relative reduction in PPI prescriptions, compared with the control group (P < .001). During the same period, the intervention site did not have a significant increase in the rate of patients hospitalized for upper GI diseases, primary care visits, GI clinic visits, or EGDs.

In a subgroup analysis of patients coprescribed PPIs during time at high-risk for upper GI bleeding (that is, when they possessed at least two high-risk medications, such as warfarin), there was a 4.6% relative reduction in time with PPI gastroprotection among the intervention group, compared with the control group (P = .003). In a second sensitivity analysis, hospitalization for upper GI diseases in high-risk patients at least 65 years of age was not significantly different between groups.

“[This] multicomponent PPI deprescribing program led to sustained reductions in PPI use,” Dr. Kurlander concluded. “However, this blunt intervention also reduced appropriate use of PPIs for gastroprotection, raising some concerns about clinical quality of care, but this did not appear to cause any measurable clinical harm in terms of hospitalizations for upper GI diseases.”
 

Debate around ‘unnecessary PPI use’

According to Philip O. Katz, MD, professor of medicine and director of motility laboratories at Weill Cornell Medicine, New York, the study “makes an attempt to do what others have tried in different ways, which is to develop a mechanism to help reduce or discontinue proton pump inhibitors when people believe they’re not indicated.”

Yet this latter element – appropriate indication – drives an ongoing debate.

“This is a very controversial area,” Dr. Katz said in an interview. “The concept of using the lowest effective dose of medication needed for a symptom or a disease is not new, but the push to reducing or eliminating ‘unnecessary PPI use’ is one that I believe should be carefully discussed, and that we have a clear understanding of what constitutes unnecessary use. And quite honestly, I’m willing to state that I don’t believe that’s been well defined.”

Dr. Katz, who recently coauthored an article about PPIs, suggested that more prospective research is needed to identify which patients need PPIs and which don’t.

“What we really need are more studies that look at who really needs [PPIs] long term,” Dr. Katz said, “as opposed to doing it ad hoc.”

The study was funded by the U.S. Department of Veterans Affairs and the National Institute of Diabetes and Digestive and Kidney Diseases. The investigators reported no conflicts of interest. Dr. Katz is a consultant for Phathom Pharma.

Proton pump inhibitor (PPI) use can safely be reduced by deprescribing efforts coupled with patient and clinician education, according to a retrospective study involving more than 4 million veterans.

After 1 year, the intervention was associated with a significant reduction in PPI use without worsening of acid-related diseases, reported lead author Jacob E. Kurlander, MD, of the University of Michigan, Ann Arbor, and the VA Ann Arbor Healthcare System’s Center for Clinical Management Research.

“There’s increasing interest in interventions to reduce PPI use,” Dr. Kurlander said during his virtual presentation at the annual Digestive Disease Week® (DDW). “Many of the interventions have come in the form of patient and provider education, like the Choosing Wisely campaign put out by the American Board of Internal Medicine. However, in rigorous studies, few interventions have actually proven effective, and many of these studies lack data on clinical outcomes, so it’s difficult to ascertain the real clinical benefits, or even harms.”

In an effort to address this gap, the investigators conducted a retrospective, difference-in-difference study spanning 10 years, from 2009 to 2019. The 1-year intervention, implemented in August 2013, included refill restrictions for PPIs without documented indication for long-term use, voiding of PPI prescriptions not filled within 6 months, a quick-order option for H2-receptor antagonists, reports to identify high-dose PPI prescribing, and patient and clinician education.

The intervention group consisted of 192,607-250,349 veterans in Veteran Integrated Service Network 17, whereas the control group consisted of 3,775,978-4,360,908 veterans in other service networks (ranges in population size are due to variations across 6-month intervals of analysis). For each 6-month interval, patients were included if they had at least two primary care visits within the past 2 years, and excluded if they received primary care at three other sites that joined the intervention site after initial implementation.

The investigators analyzed three main outcomes: Proportion of veterans dispensed a PPI prescription from the VA at any dose; incidence proportion of hospitalization for upper GI diseases, including upper GI bleeding other than from esophageal varices or angiodysplasia, as well as nonbleeding acid peptic disease; and rates of primary care visits, gastroenterology visits, and esophagogastroduodenoscopies (EGDs).

The analysis was divided into a preimplementation period, lasting approximately 5 years, and a postimplementation period with a similar duration. In the postimplementation period, the intervention group had a 5.9% relative reduction in PPI prescriptions, compared with the control group (P < .001). During the same period, the intervention site did not have a significant increase in the rate of patients hospitalized for upper GI diseases, primary care visits, GI clinic visits, or EGDs.

In a subgroup analysis of patients coprescribed PPIs during time at high-risk for upper GI bleeding (that is, when they possessed at least two high-risk medications, such as warfarin), there was a 4.6% relative reduction in time with PPI gastroprotection among the intervention group, compared with the control group (P = .003). In a second sensitivity analysis, hospitalization for upper GI diseases in high-risk patients at least 65 years of age was not significantly different between groups.

“[This] multicomponent PPI deprescribing program led to sustained reductions in PPI use,” Dr. Kurlander concluded. “However, this blunt intervention also reduced appropriate use of PPIs for gastroprotection, raising some concerns about clinical quality of care, but this did not appear to cause any measurable clinical harm in terms of hospitalizations for upper GI diseases.”
 

Debate around ‘unnecessary PPI use’

According to Philip O. Katz, MD, professor of medicine and director of motility laboratories at Weill Cornell Medicine, New York, the study “makes an attempt to do what others have tried in different ways, which is to develop a mechanism to help reduce or discontinue proton pump inhibitors when people believe they’re not indicated.”

Yet this latter element – appropriate indication – drives an ongoing debate.

“This is a very controversial area,” Dr. Katz said in an interview. “The concept of using the lowest effective dose of medication needed for a symptom or a disease is not new, but the push to reducing or eliminating ‘unnecessary PPI use’ is one that I believe should be carefully discussed, and that we have a clear understanding of what constitutes unnecessary use. And quite honestly, I’m willing to state that I don’t believe that’s been well defined.”

Dr. Katz, who recently coauthored an article about PPIs, suggested that more prospective research is needed to identify which patients need PPIs and which don’t.

“What we really need are more studies that look at who really needs [PPIs] long term,” Dr. Katz said, “as opposed to doing it ad hoc.”

The study was funded by the U.S. Department of Veterans Affairs and the National Institute of Diabetes and Digestive and Kidney Diseases. The investigators reported no conflicts of interest. Dr. Katz is a consultant for Phathom Pharma.