Primary care renewal: regional faculty development and organizational change

BACKGROUND: Many reports, including the Future of Family Medicine, have called for change in primary care, but few have defined, implemented, and evaluated mechanisms to address such change. The regional, interdisciplinary Primary Care Renewal Project was designed to address problems in primary care practice and teaching related to practice management, compensation, increasing responsibility for teaching, and faculty development. METHODS: Twelve northeastern US medical schools assembled a conference attended by teams of key stakeholders representing both clinical and educational missions. Teams developed and implemented an institutional plan to address identified needs. Outcome data was collected during, and for 1 year after, the conference. RESULTS: Findings demonstrate novel ways of improving learning experiences, coordinating and centralizing planning efforts, and addressing faculty needs. The magnitude of organizational change ranged from establishing new administrative units with significant institutional authority (eg, restructuring dean\u27s office) to enhancing the strategic planning process and refining mission statements to reflect emphasis on primary care. CONCLUSIONS: A well-planned, regional interdisciplinary effort that fosters the development of concrete plans can be associated with significant change in medical education. A central theme emerged--that primary care medicine will survive only if institutions align their educational and clinical missions and foster system-wide change

“You're Really Gonna Kick Us All Out?” Sustaining Safe Spaces for Community-Based HIV Prevention and Control among Black Men Who Have Sex with Men

Black men who have sex with men (BMSM) experience among the highest rates of HIV infection in the United States. We conducted a community-based ethnography in New York City to identify the structural and environmental factors that influence BMSMs vulnerability to HIV and their engagement with HIV prevention services. Methods included participant observation at community-based organizations (CBOs) in New York City, in-depth interviews with 31 BMSM, and 17 key informant interviews. Our conceptual framework shows how creating and sustaining safe spaces could be a critical environmental approach to reduce vulnerability to HIV among BMSM. Participant observation, in-depth and key informant interviews revealed that fear and mistrust characterized men’s relation to social and public institutions, such as churches, schools, and the police. This fear and mistrust created HIV vulnerability among the BMSM in our sample by challenging engagement with services. Our findings suggest that to be successful, HIV prevention efforts must address these structural and environmental vulnerabilities. Among the CBOs that we studied, “safe spaces” emerged as an important tool for addressing these environmental vulnerabilities. CBOs used safe spaces to provide social support, to address stigma, to prepare men for the workforce, and to foster a sense of community among BMSM. In addition, safe spaces were used for HIV and STI testing and treatment campaigns. Our ethnographic findings suggest that safe spaces represent a promising but so far under-utilized part of HIV prevention infrastructure. Safe spaces seem integral to high impact comprehensive HIV prevention efforts, and may be considered more appropriately as part of HIV capacity-building rather than being nested within program-specific funding structures

Effect of Hydrocortisone on Mortality and Organ Support in Patients With Severe COVID-19: The REMAP-CAP COVID-19 Corticosteroid Domain Randomized Clinical Trial.

Importance: Evidence regarding corticosteroid use for severe coronavirus disease 2019 (COVID-19) is limited. Objective: To determine whether hydrocortisone improves outcome for patients with severe COVID-19. Design, Setting, and Participants: An ongoing adaptive platform trial testing multiple interventions within multiple therapeutic domains, for example, antiviral agents, corticosteroids, or immunoglobulin. Between March 9 and June 17, 2020, 614 adult patients with suspected or confirmed COVID-19 were enrolled and randomized within at least 1 domain following admission to an intensive care unit (ICU) for respiratory or cardiovascular organ support at 121 sites in 8 countries. Of these, 403 were randomized to open-label interventions within the corticosteroid domain. The domain was halted after results from another trial were released. Follow-up ended August 12, 2020. Interventions: The corticosteroid domain randomized participants to a fixed 7-day course of intravenous hydrocortisone (50 mg or 100 mg every 6 hours) (n = 143), a shock-dependent course (50 mg every 6 hours when shock was clinically evident) (n = 152), or no hydrocortisone (n = 108). Main Outcomes and Measures: The primary end point was organ support-free days (days alive and free of ICU-based respiratory or cardiovascular support) within 21 days, where patients who died were assigned -1 day. The primary analysis was a bayesian cumulative logistic model that included all patients enrolled with severe COVID-19, adjusting for age, sex, site, region, time, assignment to interventions within other domains, and domain and intervention eligibility. Superiority was defined as the posterior probability of an odds ratio greater than 1 (threshold for trial conclusion of superiority >99%). Results: After excluding 19 participants who withdrew consent, there were 384 patients (mean age, 60 years; 29% female) randomized to the fixed-dose (n = 137), shock-dependent (n = 146), and no (n = 101) hydrocortisone groups; 379 (99%) completed the study and were included in the analysis. The mean age for the 3 groups ranged between 59.5 and 60.4 years; most patients were male (range, 70.6%-71.5%); mean body mass index ranged between 29.7 and 30.9; and patients receiving mechanical ventilation ranged between 50.0% and 63.5%. For the fixed-dose, shock-dependent, and no hydrocortisone groups, respectively, the median organ support-free days were 0 (IQR, -1 to 15), 0 (IQR, -1 to 13), and 0 (-1 to 11) days (composed of 30%, 26%, and 33% mortality rates and 11.5, 9.5, and 6 median organ support-free days among survivors). The median adjusted odds ratio and bayesian probability of superiority were 1.43 (95% credible interval, 0.91-2.27) and 93% for fixed-dose hydrocortisone, respectively, and were 1.22 (95% credible interval, 0.76-1.94) and 80% for shock-dependent hydrocortisone compared with no hydrocortisone. Serious adverse events were reported in 4 (3%), 5 (3%), and 1 (1%) patients in the fixed-dose, shock-dependent, and no hydrocortisone groups, respectively. Conclusions and Relevance: Among patients with severe COVID-19, treatment with a 7-day fixed-dose course of hydrocortisone or shock-dependent dosing of hydrocortisone, compared with no hydrocortisone, resulted in 93% and 80% probabilities of superiority with regard to the odds of improvement in organ support-free days within 21 days. However, the trial was stopped early and no treatment strategy met prespecified criteria for statistical superiority, precluding definitive conclusions. Trial Registration: ClinicalTrials.gov Identifier: NCT02735707

Effect of angiotensin-converting enzyme inhibitor and angiotensin receptor blocker initiation on organ support-free days in patients hospitalized with COVID-19

IMPORTANCE Overactivation of the renin-angiotensin system (RAS) may contribute to poor clinical outcomes in patients with COVID-19. Objective To determine whether angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) initiation improves outcomes in patients hospitalized for COVID-19. DESIGN, SETTING, AND PARTICIPANTS In an ongoing, adaptive platform randomized clinical trial, 721 critically ill and 58 non–critically ill hospitalized adults were randomized to receive an RAS inhibitor or control between March 16, 2021, and February 25, 2022, at 69 sites in 7 countries (final follow-up on June 1, 2022). INTERVENTIONS Patients were randomized to receive open-label initiation of an ACE inhibitor (n = 257), ARB (n = 248), ARB in combination with DMX-200 (a chemokine receptor-2 inhibitor; n = 10), or no RAS inhibitor (control; n = 264) for up to 10 days. MAIN OUTCOMES AND MEASURES The primary outcome was organ support–free days, a composite of hospital survival and days alive without cardiovascular or respiratory organ support through 21 days. The primary analysis was a bayesian cumulative logistic model. Odds ratios (ORs) greater than 1 represent improved outcomes. RESULTS On February 25, 2022, enrollment was discontinued due to safety concerns. Among 679 critically ill patients with available primary outcome data, the median age was 56 years and 239 participants (35.2%) were women. Median (IQR) organ support–free days among critically ill patients was 10 (–1 to 16) in the ACE inhibitor group (n = 231), 8 (–1 to 17) in the ARB group (n = 217), and 12 (0 to 17) in the control group (n = 231) (median adjusted odds ratios of 0.77 [95% bayesian credible interval, 0.58-1.06] for improvement for ACE inhibitor and 0.76 [95% credible interval, 0.56-1.05] for ARB compared with control). The posterior probabilities that ACE inhibitors and ARBs worsened organ support–free days compared with control were 94.9% and 95.4%, respectively. Hospital survival occurred in 166 of 231 critically ill participants (71.9%) in the ACE inhibitor group, 152 of 217 (70.0%) in the ARB group, and 182 of 231 (78.8%) in the control group (posterior probabilities that ACE inhibitor and ARB worsened hospital survival compared with control were 95.3% and 98.1%, respectively). CONCLUSIONS AND RELEVANCE In this trial, among critically ill adults with COVID-19, initiation of an ACE inhibitor or ARB did not improve, and likely worsened, clinical outcomes. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT0273570

Positive effects of a clinical performance assessment program

Since 1986, there has been a clinical performance assessment program for fourth-year students at the University of Massachusetts Medical School. Students interact with several standardized patients (SPs) and complete other tasks such as interpretation of electrocardiograms and interpretation of X-rays. Scores are generated both by checklists and rating forms completed by the SPs and by paperwork completed by the students at the end of each encounter. Since 1986, students have been asked how frequently they have been observed by faculty and residents as they interacted with actual patients; the students report that such observations have markedly increased. Since 1989, there has been increased feedback to students by the attending faculty during and following clinical rotations. Although it is difficult to claim cause and effect, it is clear that since the inception of this exercise, the faculty have made a conscious effort to improve students\u27 clinical skills by providing increased observation and feedback

Results of a survey on the use of standardized patients to teach and evaluate clinical skills

In 1989, a survey was sent to each U.S. and Canadian medical school requesting information about how standardized patients are used for teaching and evaluating clinical skills, and 95% of the schools responded. Although there was widespread use of standardized patients throughout the curricula, the role and training of these patients varied markedly within a given school as well as across schools. One outcome of this survey is the development of a network to share resources, protocols, and training material to enhance the development of this educational strategy

Effective Goals-of-Care Conversations: From Skills Training to Bedside

Introduction Goals-of-care (GOC) conversations are essential to ensure high-quality care for people with serious illness. We developed a simulation experience to train internal medicine residents in GOC conversations near end of life, followed by a real-life GOC conversation as a Mini-Clinical Evaluation Exercise (Mini-CEX) including direct feedback from participating patients. Methods The 3-hour simulation session trained teams of two learners each to interact with standardized patients portraying a patient with end-stage heart failure and an accompanying family member. Residents completed pre- and postsurveys regarding their self-assessed abilities and confidence in conducting these conversations. Piloted in 2016, the Mini-CEX was completed in 2017 with 28 residents 3–9 months after simulation. Patients and participating family members were invited to complete an optional, deidentified survey of their experience. Results From 2015 to 2017, 84 residents completed simulation training. Ninety percent of postsurvey responders felt more prepared to conduct GOC conversations after simulation compared to 42% before training. Eighty percent or more reported confidence in discussing GOC (previously 67%), prognosis (previously 62%), and hospice (previously 49%). Analysis of Mini-CEX scores revealed that the majority of residents' skills were the same or improved compared with their performance in simulation; more than 70% demonstrated improvement in ensuring patients' comfort, displaying empathy, and recognizing/responding to emotion. Almost all patients and families reported feeling heard and satisfied with their conversation with the resident. Discussion This curriculum was well received, and initial data support its effectiveness in enhancing residents' self-perceived confidence and interpersonal skills in real-world patient encounters

Expert communication training for providers in community health centers

BACKGROUND: Community health center (CHC) clinicians describe significant challenges in delivering care for populations with complex health needs. INTERVENTION: A three-workshop series was presented to 102 providers working in CHCs. Training focused on four areas identified through online needs assessment: challenging interactions; patient perspective; health literacy; and motivational interviewing. EVALUATION METHODS: A retrospective pre-post evaluation measured self-perceived change in content knowledge in all four areas. Participants documented commitments to change behaviors across workshops, which were analyzed for recurring themes. RESULTS: Paired t-tests documented improvement in all four content areas. Content analysis of commitments yielded four themes: empowering patients, structuring care, understanding patients, and reflecting purposefully. Of the sixty-eight percent of participants responding to post-workshop queries about their commitments (n=70), 94% report having fully implemented changes in practice behavior or planning to do so. CONCLUSIONS: Providers at CHCs benefit from opportunities to learn and reflect together about communication challenges in practice