Health Policy

Botulinum toxin is said to be the most lethal substance known. Inhaling just 1-3 nanograms of toxin per kilogram of body mass constitutes a lethal dose. 

Now the Centers for Disease Control and Prevention has published the first comprehensive guide to the diagnosis and treatment of botulism. The CDC has been working on these guidelines since 2015, initially establishing a technical development group and steering committee to prioritize topics for review and make recommendations. Since then, the agency published 15 systematic reviews in  Clinical Infectious Diseases early in 2018. The reviews addressed the recognition of botulism clinically, treatment with botulinum antitoxin, and complications from that treatment. They also looked at the epidemiology of botulism outbreaks and botulism in the special populations of vulnerable pediatric and pregnant patients.

In 2016, the CDC held two extended forums and convened a workshop with 72 experts. In addition to the more standard topics of diagnosis and treatment, attention was given to crisis standards of care, caring for multiple patients at once, and ethical considerations in management.

Amesh Adalja, MD, senior scholar, Johns Hopkins Center for Health Security, Baltimore, said in an interview that the new guidance “was really specific [and] was meant to address the gap in guidance for mass casualty settings.”

While clinicians are used to focusing on an individual patient, in times of crises, with multiple patients from a food-borne outbreak or a bioterrorism attack, the focus must shift to the population rather than the individual. The workshop explored issues of triaging, adding beds, and caring for patients when a hospital is overwhelmed with an acute influx of severely ill patients.

Such a mass casualty event is similar to the stress encountered this past year with COVID-19 patients swamping the hospitals, which had too little oxygen, too few ventilators, and too few staff members to care for the sudden influx of critically ill patients.
 

Diagnosis

Leslie Edwards, MHS, BSN, a CDC epidemiologist and botulism expert, said that “botulism is rare and [so] could be difficult to diagnose.” The CDC “wanted to highlight some of those key clinical factors” to speed recognition.

Hospitals and health officials are being urged to develop crisis protocols as part of emergency preparedness plans. And clinicians should be able to recognize four major syndromes: botulism from food, wounds, and inhalation, as well as iatrogenic botulism (from exposure via injection of the neurotoxin).

Botulism has a characteristic and unusual pattern of symptoms, which begin with cranial nerve palsies. Then there is typically a descending, symmetric flaccid paralysis. Symptoms might progress to respiratory failure and death. Other critical clues that implicate botulism include a lack of sensory deficits and the absence of pain.

Symptoms are most likely to be mistaken for myasthenia gravis or Guillain-Barré syndrome, but the latter has an ascending paralysis. Cranial nerve involvement can present as blurred vision, ptosis (drooping lid), diplopia (double vision), ophthalmoplegia (weak eye muscles), or difficulty with speech and swallowing. Shortness of breath and abdominal discomfort can also occur. Respiratory failure may occur from weakness or paralysis of cranial nerves. Cranial nerve signs and symptoms in the absence of fever, along with a descending paralysis, should strongly suggest the diagnosis.

With food-borne botulism, vomiting occurs in half the patients. Improperly sterilized home-canned food is the major risk factor. While the toxin is rapidly destroyed by heat, the bacterial spores are not. Wound botulism is most commonly associated with the injection of drugs, particularly black tar heroin.

Dr. Edwards stressed that “time is of the essence when it comes to botulism diagnostics and treating. Timely administration of the botulism antitoxin early in the course of illness can arrest the progression of paralysis and possibly avert the need for intubation or ventilation.”

It’s essential to note that botulism is an urgent diagnosis that has to be made on clinical grounds. Lab assays for botulinum neurotoxins take too long and are only conducted in public health laboratories. The decision to use antitoxin must not be delayed to wait for confirmation.

Clinicians should immediately contact the local or state health department’s emergency on-call team if botulism is suspected. They will arrange for expert consultation.
 

Treatment

Botulinum antitoxin is the only specific therapy for this infection. If given early – preferably within 24-48 hours of symptom onset – it can stop the progression of paralysis. But antitoxin will not reverse existing paralysis. If paralysis is still progressing outside of that 24- to 48-hour window, the antitoxin should still provide benefit. The antitoxin is available only through state health departments and a request to the CDC.

Botulism antitoxin is made from horse serum and therefore may cause a variety of allergic reactions. The risk for anaphylaxis is less than 2%, far lower than the mortality from untreated botulism.

While these guidelines have an important focus on triaging and treating mass casualties from botulism, it’s important to note that food-borne outbreaks and prevention issues are covered elsewhere on the CDC site.

Dr. Edwards has disclosed no relevant financial relationships. Dr. Adalja is a consultant for Emergent BioSolutions, which makes the heptavalent botulism antitoxin.

Dr. Stone is an infectious disease specialist and author of “Resilience: One Family’s Story of Hope and Triumph Over Evil” and of “Conducting Clinical Research,” the essential guide to the topic. You can find her at drjudystone.com or on Twitter @drjudystone.

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

Botulinum toxin is said to be the most lethal substance known. Inhaling just 1-3 nanograms of toxin per kilogram of body mass constitutes a lethal dose. 

Now the Centers for Disease Control and Prevention has published the first comprehensive guide to the diagnosis and treatment of botulism. The CDC has been working on these guidelines since 2015, initially establishing a technical development group and steering committee to prioritize topics for review and make recommendations. Since then, the agency published 15 systematic reviews in  Clinical Infectious Diseases early in 2018. The reviews addressed the recognition of botulism clinically, treatment with botulinum antitoxin, and complications from that treatment. They also looked at the epidemiology of botulism outbreaks and botulism in the special populations of vulnerable pediatric and pregnant patients.

In 2016, the CDC held two extended forums and convened a workshop with 72 experts. In addition to the more standard topics of diagnosis and treatment, attention was given to crisis standards of care, caring for multiple patients at once, and ethical considerations in management.

Amesh Adalja, MD, senior scholar, Johns Hopkins Center for Health Security, Baltimore, said in an interview that the new guidance “was really specific [and] was meant to address the gap in guidance for mass casualty settings.”

While clinicians are used to focusing on an individual patient, in times of crises, with multiple patients from a food-borne outbreak or a bioterrorism attack, the focus must shift to the population rather than the individual. The workshop explored issues of triaging, adding beds, and caring for patients when a hospital is overwhelmed with an acute influx of severely ill patients.

Such a mass casualty event is similar to the stress encountered this past year with COVID-19 patients swamping the hospitals, which had too little oxygen, too few ventilators, and too few staff members to care for the sudden influx of critically ill patients.
 

Diagnosis

Leslie Edwards, MHS, BSN, a CDC epidemiologist and botulism expert, said that “botulism is rare and [so] could be difficult to diagnose.” The CDC “wanted to highlight some of those key clinical factors” to speed recognition.

Hospitals and health officials are being urged to develop crisis protocols as part of emergency preparedness plans. And clinicians should be able to recognize four major syndromes: botulism from food, wounds, and inhalation, as well as iatrogenic botulism (from exposure via injection of the neurotoxin).

Botulism has a characteristic and unusual pattern of symptoms, which begin with cranial nerve palsies. Then there is typically a descending, symmetric flaccid paralysis. Symptoms might progress to respiratory failure and death. Other critical clues that implicate botulism include a lack of sensory deficits and the absence of pain.

Symptoms are most likely to be mistaken for myasthenia gravis or Guillain-Barré syndrome, but the latter has an ascending paralysis. Cranial nerve involvement can present as blurred vision, ptosis (drooping lid), diplopia (double vision), ophthalmoplegia (weak eye muscles), or difficulty with speech and swallowing. Shortness of breath and abdominal discomfort can also occur. Respiratory failure may occur from weakness or paralysis of cranial nerves. Cranial nerve signs and symptoms in the absence of fever, along with a descending paralysis, should strongly suggest the diagnosis.

With food-borne botulism, vomiting occurs in half the patients. Improperly sterilized home-canned food is the major risk factor. While the toxin is rapidly destroyed by heat, the bacterial spores are not. Wound botulism is most commonly associated with the injection of drugs, particularly black tar heroin.

Dr. Edwards stressed that “time is of the essence when it comes to botulism diagnostics and treating. Timely administration of the botulism antitoxin early in the course of illness can arrest the progression of paralysis and possibly avert the need for intubation or ventilation.”

It’s essential to note that botulism is an urgent diagnosis that has to be made on clinical grounds. Lab assays for botulinum neurotoxins take too long and are only conducted in public health laboratories. The decision to use antitoxin must not be delayed to wait for confirmation.

Clinicians should immediately contact the local or state health department’s emergency on-call team if botulism is suspected. They will arrange for expert consultation.
 

Treatment

Botulinum antitoxin is the only specific therapy for this infection. If given early – preferably within 24-48 hours of symptom onset – it can stop the progression of paralysis. But antitoxin will not reverse existing paralysis. If paralysis is still progressing outside of that 24- to 48-hour window, the antitoxin should still provide benefit. The antitoxin is available only through state health departments and a request to the CDC.

Botulism antitoxin is made from horse serum and therefore may cause a variety of allergic reactions. The risk for anaphylaxis is less than 2%, far lower than the mortality from untreated botulism.

While these guidelines have an important focus on triaging and treating mass casualties from botulism, it’s important to note that food-borne outbreaks and prevention issues are covered elsewhere on the CDC site.

Dr. Edwards has disclosed no relevant financial relationships. Dr. Adalja is a consultant for Emergent BioSolutions, which makes the heptavalent botulism antitoxin.

Dr. Stone is an infectious disease specialist and author of “Resilience: One Family’s Story of Hope and Triumph Over Evil” and of “Conducting Clinical Research,” the essential guide to the topic. You can find her at drjudystone.com or on Twitter @drjudystone.

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

Botulinum toxin is said to be the most lethal substance known. Inhaling just 1-3 nanograms of toxin per kilogram of body mass constitutes a lethal dose. 

Now the Centers for Disease Control and Prevention has published the first comprehensive guide to the diagnosis and treatment of botulism. The CDC has been working on these guidelines since 2015, initially establishing a technical development group and steering committee to prioritize topics for review and make recommendations. Since then, the agency published 15 systematic reviews in  Clinical Infectious Diseases early in 2018. The reviews addressed the recognition of botulism clinically, treatment with botulinum antitoxin, and complications from that treatment. They also looked at the epidemiology of botulism outbreaks and botulism in the special populations of vulnerable pediatric and pregnant patients.

In 2016, the CDC held two extended forums and convened a workshop with 72 experts. In addition to the more standard topics of diagnosis and treatment, attention was given to crisis standards of care, caring for multiple patients at once, and ethical considerations in management.

Amesh Adalja, MD, senior scholar, Johns Hopkins Center for Health Security, Baltimore, said in an interview that the new guidance “was really specific [and] was meant to address the gap in guidance for mass casualty settings.”

While clinicians are used to focusing on an individual patient, in times of crises, with multiple patients from a food-borne outbreak or a bioterrorism attack, the focus must shift to the population rather than the individual. The workshop explored issues of triaging, adding beds, and caring for patients when a hospital is overwhelmed with an acute influx of severely ill patients.

Such a mass casualty event is similar to the stress encountered this past year with COVID-19 patients swamping the hospitals, which had too little oxygen, too few ventilators, and too few staff members to care for the sudden influx of critically ill patients.
 

Diagnosis

Leslie Edwards, MHS, BSN, a CDC epidemiologist and botulism expert, said that “botulism is rare and [so] could be difficult to diagnose.” The CDC “wanted to highlight some of those key clinical factors” to speed recognition.

Hospitals and health officials are being urged to develop crisis protocols as part of emergency preparedness plans. And clinicians should be able to recognize four major syndromes: botulism from food, wounds, and inhalation, as well as iatrogenic botulism (from exposure via injection of the neurotoxin).

Botulism has a characteristic and unusual pattern of symptoms, which begin with cranial nerve palsies. Then there is typically a descending, symmetric flaccid paralysis. Symptoms might progress to respiratory failure and death. Other critical clues that implicate botulism include a lack of sensory deficits and the absence of pain.

Symptoms are most likely to be mistaken for myasthenia gravis or Guillain-Barré syndrome, but the latter has an ascending paralysis. Cranial nerve involvement can present as blurred vision, ptosis (drooping lid), diplopia (double vision), ophthalmoplegia (weak eye muscles), or difficulty with speech and swallowing. Shortness of breath and abdominal discomfort can also occur. Respiratory failure may occur from weakness or paralysis of cranial nerves. Cranial nerve signs and symptoms in the absence of fever, along with a descending paralysis, should strongly suggest the diagnosis.

With food-borne botulism, vomiting occurs in half the patients. Improperly sterilized home-canned food is the major risk factor. While the toxin is rapidly destroyed by heat, the bacterial spores are not. Wound botulism is most commonly associated with the injection of drugs, particularly black tar heroin.

Dr. Edwards stressed that “time is of the essence when it comes to botulism diagnostics and treating. Timely administration of the botulism antitoxin early in the course of illness can arrest the progression of paralysis and possibly avert the need for intubation or ventilation.”

It’s essential to note that botulism is an urgent diagnosis that has to be made on clinical grounds. Lab assays for botulinum neurotoxins take too long and are only conducted in public health laboratories. The decision to use antitoxin must not be delayed to wait for confirmation.

Clinicians should immediately contact the local or state health department’s emergency on-call team if botulism is suspected. They will arrange for expert consultation.
 

Treatment

Botulinum antitoxin is the only specific therapy for this infection. If given early – preferably within 24-48 hours of symptom onset – it can stop the progression of paralysis. But antitoxin will not reverse existing paralysis. If paralysis is still progressing outside of that 24- to 48-hour window, the antitoxin should still provide benefit. The antitoxin is available only through state health departments and a request to the CDC.

Botulism antitoxin is made from horse serum and therefore may cause a variety of allergic reactions. The risk for anaphylaxis is less than 2%, far lower than the mortality from untreated botulism.

While these guidelines have an important focus on triaging and treating mass casualties from botulism, it’s important to note that food-borne outbreaks and prevention issues are covered elsewhere on the CDC site.

Dr. Edwards has disclosed no relevant financial relationships. Dr. Adalja is a consultant for Emergent BioSolutions, which makes the heptavalent botulism antitoxin.

Dr. Stone is an infectious disease specialist and author of “Resilience: One Family’s Story of Hope and Triumph Over Evil” and of “Conducting Clinical Research,” the essential guide to the topic. You can find her at drjudystone.com or on Twitter @drjudystone.

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

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%.

 

 

HbA_1c

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%.

 

 

HbA_1c

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%.

 

 

HbA_1c

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.

 

 

Results

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.

 

 

Results

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.

 

 

Results

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

 

 

Methods

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

 

 

Methods

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

 

 

Methods

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.

The U.S. Department of Health and Human Services will inject billions of dollars into programs designed to address mental health and substance use disorders, including $3 billion released to states as of May 18, said federal officials.

The American Rescue Plan, a COVID-relief package signed into law in March, contained the money, which will be divided equally between the Community Mental Health Services Block Grant Program and the Substance Abuse Prevention and Treatment Block Grant Program, said Tom Coderre, Acting Assistant Secretary for Mental Health and Substance Use, in a call with reporters.

The award amounts will vary by state.

The mental health program helps states and territories provide services for children with serious emotional issues and adults with serious mental illness.

The substance use program provides money to plan, implement, and evaluate prevention, intervention, treatment, and recovery services.

‘A huge step forward’

The American Psychiatric Association welcomed the new money and the return of the council.

“In the wake of the pandemic an unprecedented, and as of yet untold, number of Americans are faced with mental health and substance use disorders, particularly in communities impacted by structural racism,” said APA President Vivian Pender, MD, in a statement. “With the creation of this Council and this investment in mental health, the administration is taking a huge step forward.” 

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

The U.S. Department of Health and Human Services will inject billions of dollars into programs designed to address mental health and substance use disorders, including $3 billion released to states as of May 18, said federal officials.

The American Rescue Plan, a COVID-relief package signed into law in March, contained the money, which will be divided equally between the Community Mental Health Services Block Grant Program and the Substance Abuse Prevention and Treatment Block Grant Program, said Tom Coderre, Acting Assistant Secretary for Mental Health and Substance Use, in a call with reporters.

The award amounts will vary by state.

The mental health program helps states and territories provide services for children with serious emotional issues and adults with serious mental illness.

The substance use program provides money to plan, implement, and evaluate prevention, intervention, treatment, and recovery services.

‘A huge step forward’

The American Psychiatric Association welcomed the new money and the return of the council.

“In the wake of the pandemic an unprecedented, and as of yet untold, number of Americans are faced with mental health and substance use disorders, particularly in communities impacted by structural racism,” said APA President Vivian Pender, MD, in a statement. “With the creation of this Council and this investment in mental health, the administration is taking a huge step forward.” 

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

The U.S. Department of Health and Human Services will inject billions of dollars into programs designed to address mental health and substance use disorders, including $3 billion released to states as of May 18, said federal officials.

The American Rescue Plan, a COVID-relief package signed into law in March, contained the money, which will be divided equally between the Community Mental Health Services Block Grant Program and the Substance Abuse Prevention and Treatment Block Grant Program, said Tom Coderre, Acting Assistant Secretary for Mental Health and Substance Use, in a call with reporters.

The award amounts will vary by state.

The mental health program helps states and territories provide services for children with serious emotional issues and adults with serious mental illness.

The substance use program provides money to plan, implement, and evaluate prevention, intervention, treatment, and recovery services.

‘A huge step forward’

The American Psychiatric Association welcomed the new money and the return of the council.

“In the wake of the pandemic an unprecedented, and as of yet untold, number of Americans are faced with mental health and substance use disorders, particularly in communities impacted by structural racism,” said APA President Vivian Pender, MD, in a statement. “With the creation of this Council and this investment in mental health, the administration is taking a huge step forward.” 

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

People who are fully vaccinated against COVID-19 are no longer required to wear masks or physically distance, regardless of location or size of the gathering, the CDC announced on May 13.

“Anyone who is fully vaccinated can participate in indoor and outdoor activities, large or small, without wearing a mask or physically distancing,” CDC director Rochelle Walensky, MD, said at a press briefing. “We have all longed for this moment when we can get back to some sense of normalcy.

“This is an exciting and powerful moment,” she added, “It could only happen because of the work from so many who made sure we had the rapid administration of three safe and effective vaccines.”

Dr. Walensky cited three large studies on the effectiveness of COVID-19 vaccines against the original virus and its variants. One study from Israel found the vaccine to be 97% effective against symptomatic infection.

Those who are symptomatic should still wear masks, Dr. Walensky said, and those who are immunocompromised should talk to their doctors for further guidance. The CDC still advises travelers to wear masks while on airplanes or trains.

The COVID-19 death rates are now the lowest they have been since April 2020.

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

People who are fully vaccinated against COVID-19 are no longer required to wear masks or physically distance, regardless of location or size of the gathering, the CDC announced on May 13.

“Anyone who is fully vaccinated can participate in indoor and outdoor activities, large or small, without wearing a mask or physically distancing,” CDC director Rochelle Walensky, MD, said at a press briefing. “We have all longed for this moment when we can get back to some sense of normalcy.

“This is an exciting and powerful moment,” she added, “It could only happen because of the work from so many who made sure we had the rapid administration of three safe and effective vaccines.”

Dr. Walensky cited three large studies on the effectiveness of COVID-19 vaccines against the original virus and its variants. One study from Israel found the vaccine to be 97% effective against symptomatic infection.

Those who are symptomatic should still wear masks, Dr. Walensky said, and those who are immunocompromised should talk to their doctors for further guidance. The CDC still advises travelers to wear masks while on airplanes or trains.

The COVID-19 death rates are now the lowest they have been since April 2020.

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

People who are fully vaccinated against COVID-19 are no longer required to wear masks or physically distance, regardless of location or size of the gathering, the CDC announced on May 13.

“Anyone who is fully vaccinated can participate in indoor and outdoor activities, large or small, without wearing a mask or physically distancing,” CDC director Rochelle Walensky, MD, said at a press briefing. “We have all longed for this moment when we can get back to some sense of normalcy.

“This is an exciting and powerful moment,” she added, “It could only happen because of the work from so many who made sure we had the rapid administration of three safe and effective vaccines.”

Dr. Walensky cited three large studies on the effectiveness of COVID-19 vaccines against the original virus and its variants. One study from Israel found the vaccine to be 97% effective against symptomatic infection.

Those who are symptomatic should still wear masks, Dr. Walensky said, and those who are immunocompromised should talk to their doctors for further guidance. The CDC still advises travelers to wear masks while on airplanes or trains.

The COVID-19 death rates are now the lowest they have been since April 2020.

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

The Biden administration is reversing a Trump-era policy that allowed health care providers to bar services to lesbian, gay, bisexual, transgender, or queer (LGBTQ) patients.

The U.S. Department of Health and Human Services gave notice on Monday that it would interpret the Affordable Care Act’s Section 1557 – which bars discrimination on the basis of sex – to include discrimination on the basis of sexual orientation or gender identity. The department said its position is consistent with a June 2020 U.S. Supreme Court ruling in Bostock v. Clayton County, GA. The ruling determined that the Civil Rights Act’s prohibition of employment discrimination on the basis of sex includes sexual orientation and gender identity.

“The mission of our Department is to enhance the health and well-being of all Americans, no matter their gender identity or sexual orientation,” said HHS Assistant Secretary for Health Rachel Levine, MD, in a statement released Monday.

“All people need access to health care services to fix a broken bone, protect their heart health, and screen for cancer risk,” she said. “No one should be discriminated against when seeking medical services because of who they are.”

Many physician organizations applauded the decision.

“The Biden administration did the right thing by terminating a short-lived effort to allow discrimination based on gender or sexual orientation when seeking health care,” said Susan R. Bailey, MD, president of the American Medical Association, in a statement.

When, in 2019, the Trump administration proposed to allow providers to deny care to LGBTQ people, the AMA said in a letter to the HHS that its interpretation “was contrary to the intent and the plain language of the law.”

Now, said Bailey, the AMA welcomes the Biden administration’s interpretation. It “is a victory for health equity and ends a dismal chapter in which a federal agency sought to remove civil rights protections,” she said.

An alliance of patient groups – including the American Cancer Society, the American Cancer Society Cancer Action Network, the American Heart Association, the American Lung Association, the Epilepsy Foundation, the National Multiple Sclerosis Society, and the National Organization for Rare Disorders – also applauded the new policy. “This community already faces significant health disparities,” the groups noted in a statement. People with chronic illness such as HIV and cancer “need to be able to access care quickly and without fear of discrimination,” they said.

The groups had filed a friend of the court brief in a case against the Trump administration rule.

“We welcome this positive step to ensure access is preserved without hindrance, as intended by the health care law,” they said.

Twenty-two states and Washington, D.C. – led by former California Attorney General Xavier Becerra, who is now HHS secretary – sued the Trump administration in July 2020, aiming to overturn the rule.

Chase Strangio, deputy director for Trans Justice with the American Civil Liberties Union LGBTQ & HIV Project, noted that the HHS announcement was crucial in the face of efforts in multiple states to bar health care for transgender youth. “The Biden administration has affirmed what courts have said for decades: Discrimination against LGBTQ people is against the law. It also affirms what transgender people have long said: Gender-affirming care is life-saving care,” he said in a statement.

Lambda Legal, which led another lawsuit against the Trump administration rule, said it welcomed the HHS action but noted in a statement by the organization’s senior attorney, Omar Gonzalez-Pagan, that it “does not address significant aspects of the Trump-era rule that we and others have challenged in court.”

The Trump rule also “limited the remedies available to people who face health disparities, limited access to health care for people with Limited English Proficiency, unlawfully incorporated religious exemptions, and dramatically reduced the number of health care entities and insurance subject to the rule, all of which today’s action does not address,” said Gonzalez-Pagan.

“We encourage Secretary Xavier Becerra and the Biden administration to take additional steps to ensure that all LGBTQ people are completely covered wherever and whenever they may encounter discrimination during some of the most delicate and precarious moments of their lives: When seeking health care,” he said.

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

The Biden administration is reversing a Trump-era policy that allowed health care providers to bar services to lesbian, gay, bisexual, transgender, or queer (LGBTQ) patients.

The U.S. Department of Health and Human Services gave notice on Monday that it would interpret the Affordable Care Act’s Section 1557 – which bars discrimination on the basis of sex – to include discrimination on the basis of sexual orientation or gender identity. The department said its position is consistent with a June 2020 U.S. Supreme Court ruling in Bostock v. Clayton County, GA. The ruling determined that the Civil Rights Act’s prohibition of employment discrimination on the basis of sex includes sexual orientation and gender identity.

“The mission of our Department is to enhance the health and well-being of all Americans, no matter their gender identity or sexual orientation,” said HHS Assistant Secretary for Health Rachel Levine, MD, in a statement released Monday.

“All people need access to health care services to fix a broken bone, protect their heart health, and screen for cancer risk,” she said. “No one should be discriminated against when seeking medical services because of who they are.”

Many physician organizations applauded the decision.

“The Biden administration did the right thing by terminating a short-lived effort to allow discrimination based on gender or sexual orientation when seeking health care,” said Susan R. Bailey, MD, president of the American Medical Association, in a statement.

When, in 2019, the Trump administration proposed to allow providers to deny care to LGBTQ people, the AMA said in a letter to the HHS that its interpretation “was contrary to the intent and the plain language of the law.”

Now, said Bailey, the AMA welcomes the Biden administration’s interpretation. It “is a victory for health equity and ends a dismal chapter in which a federal agency sought to remove civil rights protections,” she said.

An alliance of patient groups – including the American Cancer Society, the American Cancer Society Cancer Action Network, the American Heart Association, the American Lung Association, the Epilepsy Foundation, the National Multiple Sclerosis Society, and the National Organization for Rare Disorders – also applauded the new policy. “This community already faces significant health disparities,” the groups noted in a statement. People with chronic illness such as HIV and cancer “need to be able to access care quickly and without fear of discrimination,” they said.

The groups had filed a friend of the court brief in a case against the Trump administration rule.

“We welcome this positive step to ensure access is preserved without hindrance, as intended by the health care law,” they said.

Twenty-two states and Washington, D.C. – led by former California Attorney General Xavier Becerra, who is now HHS secretary – sued the Trump administration in July 2020, aiming to overturn the rule.

Chase Strangio, deputy director for Trans Justice with the American Civil Liberties Union LGBTQ & HIV Project, noted that the HHS announcement was crucial in the face of efforts in multiple states to bar health care for transgender youth. “The Biden administration has affirmed what courts have said for decades: Discrimination against LGBTQ people is against the law. It also affirms what transgender people have long said: Gender-affirming care is life-saving care,” he said in a statement.

Lambda Legal, which led another lawsuit against the Trump administration rule, said it welcomed the HHS action but noted in a statement by the organization’s senior attorney, Omar Gonzalez-Pagan, that it “does not address significant aspects of the Trump-era rule that we and others have challenged in court.”

The Trump rule also “limited the remedies available to people who face health disparities, limited access to health care for people with Limited English Proficiency, unlawfully incorporated religious exemptions, and dramatically reduced the number of health care entities and insurance subject to the rule, all of which today’s action does not address,” said Gonzalez-Pagan.

“We encourage Secretary Xavier Becerra and the Biden administration to take additional steps to ensure that all LGBTQ people are completely covered wherever and whenever they may encounter discrimination during some of the most delicate and precarious moments of their lives: When seeking health care,” he said.

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

The Biden administration is reversing a Trump-era policy that allowed health care providers to bar services to lesbian, gay, bisexual, transgender, or queer (LGBTQ) patients.

The U.S. Department of Health and Human Services gave notice on Monday that it would interpret the Affordable Care Act’s Section 1557 – which bars discrimination on the basis of sex – to include discrimination on the basis of sexual orientation or gender identity. The department said its position is consistent with a June 2020 U.S. Supreme Court ruling in Bostock v. Clayton County, GA. The ruling determined that the Civil Rights Act’s prohibition of employment discrimination on the basis of sex includes sexual orientation and gender identity.

“The mission of our Department is to enhance the health and well-being of all Americans, no matter their gender identity or sexual orientation,” said HHS Assistant Secretary for Health Rachel Levine, MD, in a statement released Monday.

“All people need access to health care services to fix a broken bone, protect their heart health, and screen for cancer risk,” she said. “No one should be discriminated against when seeking medical services because of who they are.”

Many physician organizations applauded the decision.

“The Biden administration did the right thing by terminating a short-lived effort to allow discrimination based on gender or sexual orientation when seeking health care,” said Susan R. Bailey, MD, president of the American Medical Association, in a statement.

When, in 2019, the Trump administration proposed to allow providers to deny care to LGBTQ people, the AMA said in a letter to the HHS that its interpretation “was contrary to the intent and the plain language of the law.”

Now, said Bailey, the AMA welcomes the Biden administration’s interpretation. It “is a victory for health equity and ends a dismal chapter in which a federal agency sought to remove civil rights protections,” she said.

An alliance of patient groups – including the American Cancer Society, the American Cancer Society Cancer Action Network, the American Heart Association, the American Lung Association, the Epilepsy Foundation, the National Multiple Sclerosis Society, and the National Organization for Rare Disorders – also applauded the new policy. “This community already faces significant health disparities,” the groups noted in a statement. People with chronic illness such as HIV and cancer “need to be able to access care quickly and without fear of discrimination,” they said.

The groups had filed a friend of the court brief in a case against the Trump administration rule.

“We welcome this positive step to ensure access is preserved without hindrance, as intended by the health care law,” they said.

Twenty-two states and Washington, D.C. – led by former California Attorney General Xavier Becerra, who is now HHS secretary – sued the Trump administration in July 2020, aiming to overturn the rule.

Chase Strangio, deputy director for Trans Justice with the American Civil Liberties Union LGBTQ & HIV Project, noted that the HHS announcement was crucial in the face of efforts in multiple states to bar health care for transgender youth. “The Biden administration has affirmed what courts have said for decades: Discrimination against LGBTQ people is against the law. It also affirms what transgender people have long said: Gender-affirming care is life-saving care,” he said in a statement.

Lambda Legal, which led another lawsuit against the Trump administration rule, said it welcomed the HHS action but noted in a statement by the organization’s senior attorney, Omar Gonzalez-Pagan, that it “does not address significant aspects of the Trump-era rule that we and others have challenged in court.”

The Trump rule also “limited the remedies available to people who face health disparities, limited access to health care for people with Limited English Proficiency, unlawfully incorporated religious exemptions, and dramatically reduced the number of health care entities and insurance subject to the rule, all of which today’s action does not address,” said Gonzalez-Pagan.

“We encourage Secretary Xavier Becerra and the Biden administration to take additional steps to ensure that all LGBTQ people are completely covered wherever and whenever they may encounter discrimination during some of the most delicate and precarious moments of their lives: When seeking health care,” he said.

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

In 2016, results from the LEADER trial of liraglutide in patients with type 2 diabetes helped jump-start awareness of the potential role of this new class of drugs, the glucagonlike peptide–1 receptor agonists, for reducing cardiovascular events. The randomized, placebo-controlled trial enrolled more than 9000 patients at more than 400 sites in over 30 countries, and took nearly 6 years from the start of patient enrollment to publication of the landmark results.

In December 2020, an independent team of researchers published results from a study with a design identical to LEADER, but used data that came not from a massive, global, years-long trial but from already-existing numbers culled from three large U.S. insurance claim databases. The result of this emulation using real-world data was virtually identical to what the actual trial showed, replicating both the direction and statistical significance of the original finding of the randomized, controlled trial (RCT).

What if research proved that this sort of RCT emulation could reliably be done on a regular basis? What might it mean for regulatory decisions on drugs and devices that historically have been based entirely on efficacy evidence from RCTs?
 

Making the most of a sea of observational data

Medicine in the United States has become increasingly awash in a sea of observational data collected from sources that include electronic health records, insurance claims, and increasingly, personal-health monitoring devices.

The Food and Drug Administration is now in the process of trying to figure out how it can legitimately harness this tsunami of real-world data to make efficacy decisions, essentially creating a new category of evidence to complement traditional data from randomized trials. It’s an opportunity that agency staff and their outside advisors have been keen to seize, especially given the soaring cost of prospective, randomized trials.

Recognition of this untapped resource in part led to a key initiative, among many others, included in the 21st Century Cures Act, passed in December 2016. Among the Act’s mandates was that, by the end of 2021, the FDA would issue guidance on when drug sponsors could use real-world evidence (RWE) to either help support a new indication for an already approved drug or help satisfy postapproval study requirements.

The initiative recognizes that this approach is not appropriate for initial drug approvals, which remain exclusively reliant on evidence from RCTs. Instead, it seems best suited to support expanding indications for already approved drugs.

Although FDA staff have made progress in identifying the challenges and broadening their understanding of how to best handle real-world data that come from observing patients in routine practice, agency leaders stress that this complex issue will likely not be fully resolved by their guidance to be published later this year. The FDA released a draft of the guidance in May 2019.
 

Can RWE be ‘credible and reliable?’

“Whether observational, nonrandomized data can become credible enough to use is what we’re talking about. These are possibilities that need to be explained and better understood,” said Robert Temple, MD, deputy director for clinical science of the FDA Center for Drug Evaluation and Research.

“Since the 1970s, the FDA has recognized historical controls as legitimate, so it’s possible [for RWE] to be credible. The big test is when is it credible and reliable enough [to assess efficacy]?” wondered Dr. Temple during a 2-day workshop on the topic held mid-February and organized by Duke University’s Margolis Center for Health Policy.

“We’re approaching an inflection point regarding how observational studies are generated and used, but our evidentiary standards will not lower, and it will be a case-by-case decision” by the agency as they review future RWE submissions, said John Concato, MD, the FDA’s associate director for real-world evidence, during the workshop.

“We are working toward guidance development, but also looking down the road to what we need to do to enable this,” said Dr. Concato. “It’s a complicated issue. If it was easy, it would have already been fixed.” He added that the agency will likely release a “portfolio” of guidance for submitting real-world data and RWE. Real-world data are raw information that, when analyzed, become RWE.

In short, the FDA seems headed toward guidance that won’t spell out a pathway that guarantees success using RWE but will at least open the door to consideration of this unprecedented application.
 

Not like flipping a switch

The guidance will not activate acceptance of RWE all at once. “It’s not like a light switch,” cautioned Adam Kroetsch, MPP, research director for biomedical innovation and regulatory policy at Duke-Margolis in Washington, D.C. “It’s an evolutionary process,” and the upcoming guidance will provide “just a little more clarity” on what sorts of best practices using RWE the FDA will find persuasive. “It’s hard for the FDA to clearly say what it’s looking for until they see some good examples,” Dr. Kroetsch said in an interview.

What will change is that drug sponsors can submit using RWE, and the FDA “will have a more open-minded view,” predicted Sebastian Schneeweiss, MD, ScD, a workshop participant and chief of pharmacoepidemiology and pharmacoeconomics at Brigham and Women’s Hospital in Boston. “For the first time, a law required [the FDA] to take a serious look” at observational data for efficacy assessment.

“The FDA has had a bias against using RWE for evidence of efficacy but has long used it to understand drug safety. Now the FDA is trying to wrap its arms around how to best use RWE” for efficacy decisions, said Joseph S. Ross, MD, another workshop participant and professor of medicine and public health at Yale University, New Haven, Conn.

The agency’s cautious approach is reassuring, Dr. Ross noted in an interview. “There was worry that the 21st Century Cures Act would open the door to allowing real-world data to be used in ways that weren’t very reliable. Very quickly, the FDA started trying to figure out the best ways to use these data in reasonable ways.”
 

Duplicating RCTs with RWE

To help better understand the potential use of RWE, the FDA sponsored several demonstration projects. Researchers presented results from three of these projects during the workshop in February. All three examined whether RWE, plugged into the design of an actual RCT, can produce roughly similar results when similar patients are used.

A generally consistent finding from the three demonstration projects was that “when the data are fit for purpose” the emulated or duplicated analyses with RWE “can come to similar conclusions” as the actual RCTs, said Dr. Schneeweiss, who leads one of the demonstration projects, RCT DUPLICATE.

At the workshop he reported results from RWE duplications of 20 different RCTs using insurance claims data from U.S. patients. The findings came from 10 duplications already reported in Circulation in December 2020 (including a duplication of the LEADER trial), and an additional 10 as yet unpublished RCT duplications. In the next few months, the researchers intend to assess a final group of 10 more RCT duplications.

Workshop participants also presented results from two other FDA demonstration projects: the OPERAND program run by the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard; and the CERSI program based at Yale and the Mayo Clinic in Rochester, Minn. Both are smaller in scale than RCT DUPLICATE, incorporate lab data in addition to claims data, and in some cases test how well RWE can emulate RCTs that are not yet completed.

Collectively, results from these demonstration projects suggest that RWE can successfully emulate the results of an RCT, said Dr. Ross, a coinvestigator on the CERSI study. But the CERSI findings also highlighted how an RCT can fall short of clinical relevance.

“One of our most important findings was that RCTs don’t always represent real-world practice,” he said. His group attempted to replicate the 5,000-patient GRADE trial of four different drug options added to metformin in patients with type 2 diabetes. One of the four options included insulin glargine (Lantus), and the attempt to emulate the study with RWE hit the bump that no relevant real-world patients in their US claims database actually received the formulation.

That means the GRADE trial “is almost meaningless. It doesn’t reflect real-world practice,” Dr. Ross noted.

Results from the three demonstration projects “highlight the gaps we still have,” summed up Dr. Kroetsch. “They show where we need better data” from observational sources that function as well as data from RCTs.

Still, the demonstration project results are “an important step forward in establishing the validity of real-world evidence,” commented David Kerr, MBChB, an endocrinologist and director of research and innovation at the Sansum Diabetes Research Institute in Santa Barbara, Calif.
 

‘Target trials’ tether RWE

The target trial approach to designing an observational study is a key tool for boosting reliability and applicability of the results. The idea is to create a well-designed trial that could be the basis for a conventional RCT, and then use observational data to flesh out the target trial instead of collecting data from prospectively enrolled patients.

Designing observational studies that emulate target trials allows causal inferences, said Miguel A. Hernán, MD, DrPH, a professor of biostatistics and epidemiology at the Harvard School of Public Health, Boston. Plugging real-world data into the framework of an appropriately designed target trial substantially cuts the risk of a biased analysis, he explained during the workshop.

However, the approach has limitations. The target trial must be a pragmatic trial, and the approach does not work for placebo-controlled trials, although it can accommodate a usual-care control arm. It also usually precludes patient blinding, testing treatments not used in routine practice, and close monitoring of patients in ways that are uncommon in usual care.

The target trial approach received broad endorsement during the workshop as the future for observational studies destined for efficacy consideration by the FDA.

“The idea of prespecifying a target trial is a really fantastic place to start,” commented Robert Ball, MD, deputy director of the FDA Office of Surveillance and Epidemiology. “There is still a whole set of questions once the trial is prespecified, but prespecification would be a fantastic step forward,” he said during the workshop.

Participants also endorsed other important steps to boost the value of observational studies for regulatory reviews, including preregistering the study on a site such as clinicaltrials.gov; being fully transparent about the origins of observational data; using data that match the needs of the target trial; not reviewing the data in advance to avoid cherry picking and gaming the analysis; and reporting neutral or negative results when they occur, something often not currently done for observational analyses.

But although there was clear progress and much agreement among thought leaders at the workshop, FDA representatives stressed caution in moving forward.
 

“No easy answer”

“With more experience, we can learn what works and what doesn’t work in generating valid results from observational studies,” said Dr. Concato. “Although the observational results have upside potential, we need to learn more. There is no easy answer, no checklist for fit-for-use data, no off-the-shelf study design, and no ideal analytic method.”

Dr. Concato acknowledged that the FDA’s goal is clear given the 2016 legislation. “The FDA is embracing our obligations under the 21st Century Cures Act to evaluate use of real-world data and real-world evidence.”

He also suggested that researchers “shy away from a false dichotomy of RCTs or observational studies and instead think about how and when RCTs and observational studies can be designed and conducted to yield trustworthy results.” Dr. Concato’s solution: “a taxonomy of interventional or noninterventional studies.”

“The FDA is under enormous pressure to embrace real-world evidence, both because of the economics of running RCTs and because of the availability of new observational data from electronic health records, wearable devices, claims, etc.,” said Dr. Kerr, who did not participate in the workshop but coauthored an editorial that calls for using real-world data in regulatory decisions for drugs and devices for diabetes. These factors create an “irresistible force” spurring the FDA to consider observational, noninterventional data.

“I think the FDA really wants this to go forward,” Dr. Kerr added in an interview. “The FDA keeps telling us that clinical trials do not have enough women or patients from minority groups. Real-world data is a way to address that. This will not be the death of RCTs, but this work shines a light on the deficiencies of RCTs and how the deficiencies can be dealt with.”

Dr. Kroetsch has reported no relevant financial relationships. Dr. Schneeweiss has reported being a consultant to and holding equity in Aetion and receiving research funding from the FDA. Dr. Ross has reported receiving research funding from the FDA, Johnson & Johnson, and Medtronic. Dr. Hernán has reported being a consultant for Cytel. Dr. Kerr has reported being a consultant for Ascensia, EOFlow, Lifecare, Merck, Novo Nordisk, Roche Diagnostics, and Voluntis. Dr. Temple, Dr. Concato, and Dr. Ball are FDA employees.

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

In 2016, results from the LEADER trial of liraglutide in patients with type 2 diabetes helped jump-start awareness of the potential role of this new class of drugs, the glucagonlike peptide–1 receptor agonists, for reducing cardiovascular events. The randomized, placebo-controlled trial enrolled more than 9000 patients at more than 400 sites in over 30 countries, and took nearly 6 years from the start of patient enrollment to publication of the landmark results.

In December 2020, an independent team of researchers published results from a study with a design identical to LEADER, but used data that came not from a massive, global, years-long trial but from already-existing numbers culled from three large U.S. insurance claim databases. The result of this emulation using real-world data was virtually identical to what the actual trial showed, replicating both the direction and statistical significance of the original finding of the randomized, controlled trial (RCT).

What if research proved that this sort of RCT emulation could reliably be done on a regular basis? What might it mean for regulatory decisions on drugs and devices that historically have been based entirely on efficacy evidence from RCTs?
 

Making the most of a sea of observational data

Medicine in the United States has become increasingly awash in a sea of observational data collected from sources that include electronic health records, insurance claims, and increasingly, personal-health monitoring devices.

The Food and Drug Administration is now in the process of trying to figure out how it can legitimately harness this tsunami of real-world data to make efficacy decisions, essentially creating a new category of evidence to complement traditional data from randomized trials. It’s an opportunity that agency staff and their outside advisors have been keen to seize, especially given the soaring cost of prospective, randomized trials.

Recognition of this untapped resource in part led to a key initiative, among many others, included in the 21st Century Cures Act, passed in December 2016. Among the Act’s mandates was that, by the end of 2021, the FDA would issue guidance on when drug sponsors could use real-world evidence (RWE) to either help support a new indication for an already approved drug or help satisfy postapproval study requirements.

The initiative recognizes that this approach is not appropriate for initial drug approvals, which remain exclusively reliant on evidence from RCTs. Instead, it seems best suited to support expanding indications for already approved drugs.

Although FDA staff have made progress in identifying the challenges and broadening their understanding of how to best handle real-world data that come from observing patients in routine practice, agency leaders stress that this complex issue will likely not be fully resolved by their guidance to be published later this year. The FDA released a draft of the guidance in May 2019.
 

Can RWE be ‘credible and reliable?’

“Whether observational, nonrandomized data can become credible enough to use is what we’re talking about. These are possibilities that need to be explained and better understood,” said Robert Temple, MD, deputy director for clinical science of the FDA Center for Drug Evaluation and Research.

“Since the 1970s, the FDA has recognized historical controls as legitimate, so it’s possible [for RWE] to be credible. The big test is when is it credible and reliable enough [to assess efficacy]?” wondered Dr. Temple during a 2-day workshop on the topic held mid-February and organized by Duke University’s Margolis Center for Health Policy.

“We’re approaching an inflection point regarding how observational studies are generated and used, but our evidentiary standards will not lower, and it will be a case-by-case decision” by the agency as they review future RWE submissions, said John Concato, MD, the FDA’s associate director for real-world evidence, during the workshop.

“We are working toward guidance development, but also looking down the road to what we need to do to enable this,” said Dr. Concato. “It’s a complicated issue. If it was easy, it would have already been fixed.” He added that the agency will likely release a “portfolio” of guidance for submitting real-world data and RWE. Real-world data are raw information that, when analyzed, become RWE.

In short, the FDA seems headed toward guidance that won’t spell out a pathway that guarantees success using RWE but will at least open the door to consideration of this unprecedented application.
 

Not like flipping a switch

The guidance will not activate acceptance of RWE all at once. “It’s not like a light switch,” cautioned Adam Kroetsch, MPP, research director for biomedical innovation and regulatory policy at Duke-Margolis in Washington, D.C. “It’s an evolutionary process,” and the upcoming guidance will provide “just a little more clarity” on what sorts of best practices using RWE the FDA will find persuasive. “It’s hard for the FDA to clearly say what it’s looking for until they see some good examples,” Dr. Kroetsch said in an interview.

What will change is that drug sponsors can submit using RWE, and the FDA “will have a more open-minded view,” predicted Sebastian Schneeweiss, MD, ScD, a workshop participant and chief of pharmacoepidemiology and pharmacoeconomics at Brigham and Women’s Hospital in Boston. “For the first time, a law required [the FDA] to take a serious look” at observational data for efficacy assessment.

“The FDA has had a bias against using RWE for evidence of efficacy but has long used it to understand drug safety. Now the FDA is trying to wrap its arms around how to best use RWE” for efficacy decisions, said Joseph S. Ross, MD, another workshop participant and professor of medicine and public health at Yale University, New Haven, Conn.

The agency’s cautious approach is reassuring, Dr. Ross noted in an interview. “There was worry that the 21st Century Cures Act would open the door to allowing real-world data to be used in ways that weren’t very reliable. Very quickly, the FDA started trying to figure out the best ways to use these data in reasonable ways.”
 

Duplicating RCTs with RWE

To help better understand the potential use of RWE, the FDA sponsored several demonstration projects. Researchers presented results from three of these projects during the workshop in February. All three examined whether RWE, plugged into the design of an actual RCT, can produce roughly similar results when similar patients are used.

A generally consistent finding from the three demonstration projects was that “when the data are fit for purpose” the emulated or duplicated analyses with RWE “can come to similar conclusions” as the actual RCTs, said Dr. Schneeweiss, who leads one of the demonstration projects, RCT DUPLICATE.

At the workshop he reported results from RWE duplications of 20 different RCTs using insurance claims data from U.S. patients. The findings came from 10 duplications already reported in Circulation in December 2020 (including a duplication of the LEADER trial), and an additional 10 as yet unpublished RCT duplications. In the next few months, the researchers intend to assess a final group of 10 more RCT duplications.

Workshop participants also presented results from two other FDA demonstration projects: the OPERAND program run by the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard; and the CERSI program based at Yale and the Mayo Clinic in Rochester, Minn. Both are smaller in scale than RCT DUPLICATE, incorporate lab data in addition to claims data, and in some cases test how well RWE can emulate RCTs that are not yet completed.

Collectively, results from these demonstration projects suggest that RWE can successfully emulate the results of an RCT, said Dr. Ross, a coinvestigator on the CERSI study. But the CERSI findings also highlighted how an RCT can fall short of clinical relevance.

“One of our most important findings was that RCTs don’t always represent real-world practice,” he said. His group attempted to replicate the 5,000-patient GRADE trial of four different drug options added to metformin in patients with type 2 diabetes. One of the four options included insulin glargine (Lantus), and the attempt to emulate the study with RWE hit the bump that no relevant real-world patients in their US claims database actually received the formulation.

That means the GRADE trial “is almost meaningless. It doesn’t reflect real-world practice,” Dr. Ross noted.

Results from the three demonstration projects “highlight the gaps we still have,” summed up Dr. Kroetsch. “They show where we need better data” from observational sources that function as well as data from RCTs.

Still, the demonstration project results are “an important step forward in establishing the validity of real-world evidence,” commented David Kerr, MBChB, an endocrinologist and director of research and innovation at the Sansum Diabetes Research Institute in Santa Barbara, Calif.
 

‘Target trials’ tether RWE

The target trial approach to designing an observational study is a key tool for boosting reliability and applicability of the results. The idea is to create a well-designed trial that could be the basis for a conventional RCT, and then use observational data to flesh out the target trial instead of collecting data from prospectively enrolled patients.

Designing observational studies that emulate target trials allows causal inferences, said Miguel A. Hernán, MD, DrPH, a professor of biostatistics and epidemiology at the Harvard School of Public Health, Boston. Plugging real-world data into the framework of an appropriately designed target trial substantially cuts the risk of a biased analysis, he explained during the workshop.

However, the approach has limitations. The target trial must be a pragmatic trial, and the approach does not work for placebo-controlled trials, although it can accommodate a usual-care control arm. It also usually precludes patient blinding, testing treatments not used in routine practice, and close monitoring of patients in ways that are uncommon in usual care.

The target trial approach received broad endorsement during the workshop as the future for observational studies destined for efficacy consideration by the FDA.

“The idea of prespecifying a target trial is a really fantastic place to start,” commented Robert Ball, MD, deputy director of the FDA Office of Surveillance and Epidemiology. “There is still a whole set of questions once the trial is prespecified, but prespecification would be a fantastic step forward,” he said during the workshop.

Participants also endorsed other important steps to boost the value of observational studies for regulatory reviews, including preregistering the study on a site such as clinicaltrials.gov; being fully transparent about the origins of observational data; using data that match the needs of the target trial; not reviewing the data in advance to avoid cherry picking and gaming the analysis; and reporting neutral or negative results when they occur, something often not currently done for observational analyses.

But although there was clear progress and much agreement among thought leaders at the workshop, FDA representatives stressed caution in moving forward.
 

“No easy answer”

“With more experience, we can learn what works and what doesn’t work in generating valid results from observational studies,” said Dr. Concato. “Although the observational results have upside potential, we need to learn more. There is no easy answer, no checklist for fit-for-use data, no off-the-shelf study design, and no ideal analytic method.”

Dr. Concato acknowledged that the FDA’s goal is clear given the 2016 legislation. “The FDA is embracing our obligations under the 21st Century Cures Act to evaluate use of real-world data and real-world evidence.”

He also suggested that researchers “shy away from a false dichotomy of RCTs or observational studies and instead think about how and when RCTs and observational studies can be designed and conducted to yield trustworthy results.” Dr. Concato’s solution: “a taxonomy of interventional or noninterventional studies.”

“The FDA is under enormous pressure to embrace real-world evidence, both because of the economics of running RCTs and because of the availability of new observational data from electronic health records, wearable devices, claims, etc.,” said Dr. Kerr, who did not participate in the workshop but coauthored an editorial that calls for using real-world data in regulatory decisions for drugs and devices for diabetes. These factors create an “irresistible force” spurring the FDA to consider observational, noninterventional data.

“I think the FDA really wants this to go forward,” Dr. Kerr added in an interview. “The FDA keeps telling us that clinical trials do not have enough women or patients from minority groups. Real-world data is a way to address that. This will not be the death of RCTs, but this work shines a light on the deficiencies of RCTs and how the deficiencies can be dealt with.”

Dr. Kroetsch has reported no relevant financial relationships. Dr. Schneeweiss has reported being a consultant to and holding equity in Aetion and receiving research funding from the FDA. Dr. Ross has reported receiving research funding from the FDA, Johnson & Johnson, and Medtronic. Dr. Hernán has reported being a consultant for Cytel. Dr. Kerr has reported being a consultant for Ascensia, EOFlow, Lifecare, Merck, Novo Nordisk, Roche Diagnostics, and Voluntis. Dr. Temple, Dr. Concato, and Dr. Ball are FDA employees.

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

In 2016, results from the LEADER trial of liraglutide in patients with type 2 diabetes helped jump-start awareness of the potential role of this new class of drugs, the glucagonlike peptide–1 receptor agonists, for reducing cardiovascular events. The randomized, placebo-controlled trial enrolled more than 9000 patients at more than 400 sites in over 30 countries, and took nearly 6 years from the start of patient enrollment to publication of the landmark results.

In December 2020, an independent team of researchers published results from a study with a design identical to LEADER, but used data that came not from a massive, global, years-long trial but from already-existing numbers culled from three large U.S. insurance claim databases. The result of this emulation using real-world data was virtually identical to what the actual trial showed, replicating both the direction and statistical significance of the original finding of the randomized, controlled trial (RCT).

What if research proved that this sort of RCT emulation could reliably be done on a regular basis? What might it mean for regulatory decisions on drugs and devices that historically have been based entirely on efficacy evidence from RCTs?
 

Making the most of a sea of observational data

Medicine in the United States has become increasingly awash in a sea of observational data collected from sources that include electronic health records, insurance claims, and increasingly, personal-health monitoring devices.

The Food and Drug Administration is now in the process of trying to figure out how it can legitimately harness this tsunami of real-world data to make efficacy decisions, essentially creating a new category of evidence to complement traditional data from randomized trials. It’s an opportunity that agency staff and their outside advisors have been keen to seize, especially given the soaring cost of prospective, randomized trials.

Recognition of this untapped resource in part led to a key initiative, among many others, included in the 21st Century Cures Act, passed in December 2016. Among the Act’s mandates was that, by the end of 2021, the FDA would issue guidance on when drug sponsors could use real-world evidence (RWE) to either help support a new indication for an already approved drug or help satisfy postapproval study requirements.

The initiative recognizes that this approach is not appropriate for initial drug approvals, which remain exclusively reliant on evidence from RCTs. Instead, it seems best suited to support expanding indications for already approved drugs.

Although FDA staff have made progress in identifying the challenges and broadening their understanding of how to best handle real-world data that come from observing patients in routine practice, agency leaders stress that this complex issue will likely not be fully resolved by their guidance to be published later this year. The FDA released a draft of the guidance in May 2019.
 

Can RWE be ‘credible and reliable?’

“Whether observational, nonrandomized data can become credible enough to use is what we’re talking about. These are possibilities that need to be explained and better understood,” said Robert Temple, MD, deputy director for clinical science of the FDA Center for Drug Evaluation and Research.

“Since the 1970s, the FDA has recognized historical controls as legitimate, so it’s possible [for RWE] to be credible. The big test is when is it credible and reliable enough [to assess efficacy]?” wondered Dr. Temple during a 2-day workshop on the topic held mid-February and organized by Duke University’s Margolis Center for Health Policy.

“We’re approaching an inflection point regarding how observational studies are generated and used, but our evidentiary standards will not lower, and it will be a case-by-case decision” by the agency as they review future RWE submissions, said John Concato, MD, the FDA’s associate director for real-world evidence, during the workshop.

“We are working toward guidance development, but also looking down the road to what we need to do to enable this,” said Dr. Concato. “It’s a complicated issue. If it was easy, it would have already been fixed.” He added that the agency will likely release a “portfolio” of guidance for submitting real-world data and RWE. Real-world data are raw information that, when analyzed, become RWE.

In short, the FDA seems headed toward guidance that won’t spell out a pathway that guarantees success using RWE but will at least open the door to consideration of this unprecedented application.
 

Not like flipping a switch

The guidance will not activate acceptance of RWE all at once. “It’s not like a light switch,” cautioned Adam Kroetsch, MPP, research director for biomedical innovation and regulatory policy at Duke-Margolis in Washington, D.C. “It’s an evolutionary process,” and the upcoming guidance will provide “just a little more clarity” on what sorts of best practices using RWE the FDA will find persuasive. “It’s hard for the FDA to clearly say what it’s looking for until they see some good examples,” Dr. Kroetsch said in an interview.

What will change is that drug sponsors can submit using RWE, and the FDA “will have a more open-minded view,” predicted Sebastian Schneeweiss, MD, ScD, a workshop participant and chief of pharmacoepidemiology and pharmacoeconomics at Brigham and Women’s Hospital in Boston. “For the first time, a law required [the FDA] to take a serious look” at observational data for efficacy assessment.

“The FDA has had a bias against using RWE for evidence of efficacy but has long used it to understand drug safety. Now the FDA is trying to wrap its arms around how to best use RWE” for efficacy decisions, said Joseph S. Ross, MD, another workshop participant and professor of medicine and public health at Yale University, New Haven, Conn.

The agency’s cautious approach is reassuring, Dr. Ross noted in an interview. “There was worry that the 21st Century Cures Act would open the door to allowing real-world data to be used in ways that weren’t very reliable. Very quickly, the FDA started trying to figure out the best ways to use these data in reasonable ways.”
 

Duplicating RCTs with RWE

To help better understand the potential use of RWE, the FDA sponsored several demonstration projects. Researchers presented results from three of these projects during the workshop in February. All three examined whether RWE, plugged into the design of an actual RCT, can produce roughly similar results when similar patients are used.

A generally consistent finding from the three demonstration projects was that “when the data are fit for purpose” the emulated or duplicated analyses with RWE “can come to similar conclusions” as the actual RCTs, said Dr. Schneeweiss, who leads one of the demonstration projects, RCT DUPLICATE.

At the workshop he reported results from RWE duplications of 20 different RCTs using insurance claims data from U.S. patients. The findings came from 10 duplications already reported in Circulation in December 2020 (including a duplication of the LEADER trial), and an additional 10 as yet unpublished RCT duplications. In the next few months, the researchers intend to assess a final group of 10 more RCT duplications.

Workshop participants also presented results from two other FDA demonstration projects: the OPERAND program run by the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard; and the CERSI program based at Yale and the Mayo Clinic in Rochester, Minn. Both are smaller in scale than RCT DUPLICATE, incorporate lab data in addition to claims data, and in some cases test how well RWE can emulate RCTs that are not yet completed.

Collectively, results from these demonstration projects suggest that RWE can successfully emulate the results of an RCT, said Dr. Ross, a coinvestigator on the CERSI study. But the CERSI findings also highlighted how an RCT can fall short of clinical relevance.

“One of our most important findings was that RCTs don’t always represent real-world practice,” he said. His group attempted to replicate the 5,000-patient GRADE trial of four different drug options added to metformin in patients with type 2 diabetes. One of the four options included insulin glargine (Lantus), and the attempt to emulate the study with RWE hit the bump that no relevant real-world patients in their US claims database actually received the formulation.

That means the GRADE trial “is almost meaningless. It doesn’t reflect real-world practice,” Dr. Ross noted.

Results from the three demonstration projects “highlight the gaps we still have,” summed up Dr. Kroetsch. “They show where we need better data” from observational sources that function as well as data from RCTs.

Still, the demonstration project results are “an important step forward in establishing the validity of real-world evidence,” commented David Kerr, MBChB, an endocrinologist and director of research and innovation at the Sansum Diabetes Research Institute in Santa Barbara, Calif.
 

‘Target trials’ tether RWE

The target trial approach to designing an observational study is a key tool for boosting reliability and applicability of the results. The idea is to create a well-designed trial that could be the basis for a conventional RCT, and then use observational data to flesh out the target trial instead of collecting data from prospectively enrolled patients.

Designing observational studies that emulate target trials allows causal inferences, said Miguel A. Hernán, MD, DrPH, a professor of biostatistics and epidemiology at the Harvard School of Public Health, Boston. Plugging real-world data into the framework of an appropriately designed target trial substantially cuts the risk of a biased analysis, he explained during the workshop.

However, the approach has limitations. The target trial must be a pragmatic trial, and the approach does not work for placebo-controlled trials, although it can accommodate a usual-care control arm. It also usually precludes patient blinding, testing treatments not used in routine practice, and close monitoring of patients in ways that are uncommon in usual care.

The target trial approach received broad endorsement during the workshop as the future for observational studies destined for efficacy consideration by the FDA.

“The idea of prespecifying a target trial is a really fantastic place to start,” commented Robert Ball, MD, deputy director of the FDA Office of Surveillance and Epidemiology. “There is still a whole set of questions once the trial is prespecified, but prespecification would be a fantastic step forward,” he said during the workshop.

Participants also endorsed other important steps to boost the value of observational studies for regulatory reviews, including preregistering the study on a site such as clinicaltrials.gov; being fully transparent about the origins of observational data; using data that match the needs of the target trial; not reviewing the data in advance to avoid cherry picking and gaming the analysis; and reporting neutral or negative results when they occur, something often not currently done for observational analyses.

But although there was clear progress and much agreement among thought leaders at the workshop, FDA representatives stressed caution in moving forward.
 

“No easy answer”

“With more experience, we can learn what works and what doesn’t work in generating valid results from observational studies,” said Dr. Concato. “Although the observational results have upside potential, we need to learn more. There is no easy answer, no checklist for fit-for-use data, no off-the-shelf study design, and no ideal analytic method.”

Dr. Concato acknowledged that the FDA’s goal is clear given the 2016 legislation. “The FDA is embracing our obligations under the 21st Century Cures Act to evaluate use of real-world data and real-world evidence.”

He also suggested that researchers “shy away from a false dichotomy of RCTs or observational studies and instead think about how and when RCTs and observational studies can be designed and conducted to yield trustworthy results.” Dr. Concato’s solution: “a taxonomy of interventional or noninterventional studies.”

“The FDA is under enormous pressure to embrace real-world evidence, both because of the economics of running RCTs and because of the availability of new observational data from electronic health records, wearable devices, claims, etc.,” said Dr. Kerr, who did not participate in the workshop but coauthored an editorial that calls for using real-world data in regulatory decisions for drugs and devices for diabetes. These factors create an “irresistible force” spurring the FDA to consider observational, noninterventional data.

“I think the FDA really wants this to go forward,” Dr. Kerr added in an interview. “The FDA keeps telling us that clinical trials do not have enough women or patients from minority groups. Real-world data is a way to address that. This will not be the death of RCTs, but this work shines a light on the deficiencies of RCTs and how the deficiencies can be dealt with.”

Dr. Kroetsch has reported no relevant financial relationships. Dr. Schneeweiss has reported being a consultant to and holding equity in Aetion and receiving research funding from the FDA. Dr. Ross has reported receiving research funding from the FDA, Johnson & Johnson, and Medtronic. Dr. Hernán has reported being a consultant for Cytel. Dr. Kerr has reported being a consultant for Ascensia, EOFlow, Lifecare, Merck, Novo Nordisk, Roche Diagnostics, and Voluntis. Dr. Temple, Dr. Concato, and Dr. Ball are FDA employees.

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

Federal guidance on indoor mask use may change soon, Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said on May 9.

He was asked whether it’s time to start relaxing indoor mask requirements.

“I think so, and I think you’re going to probably be seeing that as we go along and as more people get vaccinated,” Dr. Fauci said on ABC News’s This Week.Nearly 150 million adults in the United States – or about 58% of the adult population – have received at least one COVID-19 vaccine dose, according to the latest CDC tally. About 113 million adults, or 44%, are considered fully vaccinated.

“The CDC will be, you know, almost in real time … updating their recommendations and their guidelines,” Dr. Fauci said.

In April, the CDC relaxed its guidance for those who have been vaccinated against COVID-19. Those who have gotten a shot don’t need to wear a mask outdoors or in small indoor gatherings with other vaccinated people, but both vaccinated and unvaccinated people are still advised to wear masks in indoor public spaces.

“We do need to start being more liberal as we get more people vaccinated,” Dr. Fauci said. “As you get more people vaccinated, the number of cases per day will absolutely go down.”

The United States is averaging about 43,000 cases per day, he said, adding that the cases need to be “much, much lower.” When the case numbers drop and vaccination numbers increase, the risk of infection will fall dramatically indoors and outdoors, he said.

Even after the pandemic, though, wearing masks could become a seasonal habit, Dr. Fauci said May 9 on NBC News’s Meet the Press.“I think people have gotten used to the fact that wearing masks, clearly if you look at the data, it diminishes respiratory diseases. We’ve had practically a nonexistent flu season this year,” he said.

“So it is conceivable that as we go on, a year or 2 or more from now, that during certain seasonal periods when you have respiratory-borne viruses like the flu, people might actually elect to wear masks to diminish the likelihood that you’ll spread these respiratory-borne diseases,” he said.

Dr. Fauci was asked about indoor mask guidelines on May 9 after former FDA Commissioner Scott Gottlieb, MD, said face mask requirements should be relaxed.

“Certainly outdoors, we shouldn’t be putting limits on gatherings anymore,” Dr. Gottlieb said on CBS News’s Face the Nation.“The states where prevalence is low, vaccination rates are high, we have good testing in place, and we’re identifying infections, I think we could start lifting these restrictions indoors as well, on a broad basis,” he said.

Lifting pandemic-related restrictions in areas where they’re no longer necessary could also encourage people to implement them again if cases increase during future surges, such as this fall or winter, Dr. Gottlieb said.

At the same time, Americans should continue to follow CDC guidance and wait for new guidelines before changing their indoor mask use, Jeffrey Zients, the White House COVID-19 response coordinator, said on CNN’s State of the Union on May 9.

“We all want to get back to a normal lifestyle,” he said. “I think we’re on the path to do that, but stay disciplined, and let’s take advantage of the new privilege of being vaccinated and not wearing masks outdoors, for example, unless you’re in a crowded place.”

Mr. Zients pointed to President Joe Biden’s goal for 70% of adults to receive at least one vaccine dose by July 4.

“As we all move toward that 70% goal, there will be more and more advantages to being vaccinated,” he said. “And if you’re not vaccinated, you’re not protected.”

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

Federal guidance on indoor mask use may change soon, Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said on May 9.

He was asked whether it’s time to start relaxing indoor mask requirements.

“I think so, and I think you’re going to probably be seeing that as we go along and as more people get vaccinated,” Dr. Fauci said on ABC News’s This Week.Nearly 150 million adults in the United States – or about 58% of the adult population – have received at least one COVID-19 vaccine dose, according to the latest CDC tally. About 113 million adults, or 44%, are considered fully vaccinated.

“The CDC will be, you know, almost in real time … updating their recommendations and their guidelines,” Dr. Fauci said.

In April, the CDC relaxed its guidance for those who have been vaccinated against COVID-19. Those who have gotten a shot don’t need to wear a mask outdoors or in small indoor gatherings with other vaccinated people, but both vaccinated and unvaccinated people are still advised to wear masks in indoor public spaces.

“We do need to start being more liberal as we get more people vaccinated,” Dr. Fauci said. “As you get more people vaccinated, the number of cases per day will absolutely go down.”

The United States is averaging about 43,000 cases per day, he said, adding that the cases need to be “much, much lower.” When the case numbers drop and vaccination numbers increase, the risk of infection will fall dramatically indoors and outdoors, he said.

Even after the pandemic, though, wearing masks could become a seasonal habit, Dr. Fauci said May 9 on NBC News’s Meet the Press.“I think people have gotten used to the fact that wearing masks, clearly if you look at the data, it diminishes respiratory diseases. We’ve had practically a nonexistent flu season this year,” he said.

“So it is conceivable that as we go on, a year or 2 or more from now, that during certain seasonal periods when you have respiratory-borne viruses like the flu, people might actually elect to wear masks to diminish the likelihood that you’ll spread these respiratory-borne diseases,” he said.

Dr. Fauci was asked about indoor mask guidelines on May 9 after former FDA Commissioner Scott Gottlieb, MD, said face mask requirements should be relaxed.

“Certainly outdoors, we shouldn’t be putting limits on gatherings anymore,” Dr. Gottlieb said on CBS News’s Face the Nation.“The states where prevalence is low, vaccination rates are high, we have good testing in place, and we’re identifying infections, I think we could start lifting these restrictions indoors as well, on a broad basis,” he said.

Lifting pandemic-related restrictions in areas where they’re no longer necessary could also encourage people to implement them again if cases increase during future surges, such as this fall or winter, Dr. Gottlieb said.

At the same time, Americans should continue to follow CDC guidance and wait for new guidelines before changing their indoor mask use, Jeffrey Zients, the White House COVID-19 response coordinator, said on CNN’s State of the Union on May 9.

“We all want to get back to a normal lifestyle,” he said. “I think we’re on the path to do that, but stay disciplined, and let’s take advantage of the new privilege of being vaccinated and not wearing masks outdoors, for example, unless you’re in a crowded place.”

Mr. Zients pointed to President Joe Biden’s goal for 70% of adults to receive at least one vaccine dose by July 4.

“As we all move toward that 70% goal, there will be more and more advantages to being vaccinated,” he said. “And if you’re not vaccinated, you’re not protected.”

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

Federal guidance on indoor mask use may change soon, Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said on May 9.

He was asked whether it’s time to start relaxing indoor mask requirements.

“I think so, and I think you’re going to probably be seeing that as we go along and as more people get vaccinated,” Dr. Fauci said on ABC News’s This Week.Nearly 150 million adults in the United States – or about 58% of the adult population – have received at least one COVID-19 vaccine dose, according to the latest CDC tally. About 113 million adults, or 44%, are considered fully vaccinated.

“The CDC will be, you know, almost in real time … updating their recommendations and their guidelines,” Dr. Fauci said.

In April, the CDC relaxed its guidance for those who have been vaccinated against COVID-19. Those who have gotten a shot don’t need to wear a mask outdoors or in small indoor gatherings with other vaccinated people, but both vaccinated and unvaccinated people are still advised to wear masks in indoor public spaces.

“We do need to start being more liberal as we get more people vaccinated,” Dr. Fauci said. “As you get more people vaccinated, the number of cases per day will absolutely go down.”

The United States is averaging about 43,000 cases per day, he said, adding that the cases need to be “much, much lower.” When the case numbers drop and vaccination numbers increase, the risk of infection will fall dramatically indoors and outdoors, he said.

Even after the pandemic, though, wearing masks could become a seasonal habit, Dr. Fauci said May 9 on NBC News’s Meet the Press.“I think people have gotten used to the fact that wearing masks, clearly if you look at the data, it diminishes respiratory diseases. We’ve had practically a nonexistent flu season this year,” he said.

“So it is conceivable that as we go on, a year or 2 or more from now, that during certain seasonal periods when you have respiratory-borne viruses like the flu, people might actually elect to wear masks to diminish the likelihood that you’ll spread these respiratory-borne diseases,” he said.

Dr. Fauci was asked about indoor mask guidelines on May 9 after former FDA Commissioner Scott Gottlieb, MD, said face mask requirements should be relaxed.

“Certainly outdoors, we shouldn’t be putting limits on gatherings anymore,” Dr. Gottlieb said on CBS News’s Face the Nation.“The states where prevalence is low, vaccination rates are high, we have good testing in place, and we’re identifying infections, I think we could start lifting these restrictions indoors as well, on a broad basis,” he said.

Lifting pandemic-related restrictions in areas where they’re no longer necessary could also encourage people to implement them again if cases increase during future surges, such as this fall or winter, Dr. Gottlieb said.

At the same time, Americans should continue to follow CDC guidance and wait for new guidelines before changing their indoor mask use, Jeffrey Zients, the White House COVID-19 response coordinator, said on CNN’s State of the Union on May 9.

“We all want to get back to a normal lifestyle,” he said. “I think we’re on the path to do that, but stay disciplined, and let’s take advantage of the new privilege of being vaccinated and not wearing masks outdoors, for example, unless you’re in a crowded place.”

Mr. Zients pointed to President Joe Biden’s goal for 70% of adults to receive at least one vaccine dose by July 4.

“As we all move toward that 70% goal, there will be more and more advantages to being vaccinated,” he said. “And if you’re not vaccinated, you’re not protected.”

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