Investigating racial and gender disparities in virtual randomized clinical trial enrollment: Insights from the BE ACTIVE study.

Randomized clinical trials (RCTs) often suffer from a lack of representation from historically marginalized populations, and it is uncertain whether virtual RCTs (vRCTs) enhance representativeness or if elements of their consent and enrollment processes may instead contribute to underrepresentation of these groups. In this study, we aimed to identify disparities in enrollment demographics in a vRCT, the BE ACTIVE study, which recruited patients within a single health system. We discovered that the proportions of eligible patients who were randomized differed significantly by gender and race/ethnicity (men 1.2%, women 2.0%, P < .001; White 1.8%, Black 1.3%, Hispanic 0.7%, Asian 0.9%; P < .001), and compared with White patients, non-White patients were less likely to have a valid email address on file and were less likely to click on the email link to the study webpage and begin enrollment.

Drivers of Inpatient Subspecialty Consultation Among Pediatric Hospitalists: A Qualitative Study.

BACKGROUND AND OBJECTIVE: Inpatient subspecialty consultation is often medically necessary but in some cases may represent overuse. While pediatric consultation patterns have been described using observational data, qualitative methods may generate knowledge about contextual determinants of consultation behavior. Our objective was to understand how pediatric hospitalists make decisions about subspecialty consultation. METHODS: This qualitative study took place at a large academic children's hospital as part of an explanatory sequential mixed-methods design (QUAN → qual). We conducted semistructured interviews with a purposive sample of previously identified high-consulting (top quartile) and low-consulting (bottom quartile) pediatric hospitalists. Interviews were conducted virtually, and audio recordings were transcribed. Two analysts coded transcripts using an integrated approach and established high interrater reliability (κ > 0.75). We organized findings using the Social Ecological Model. RESULTS: Participants (n = 12) included high-(n = 6) and low-(n = 6) consulting hospitalists. Our respondents identified considerations including patient characteristics, confidence in their own competence and that of their team, and perceived helpfulness of consultants. Participants viewed consultation requests as being strongly influenced by a desire to maintain relationships with families. Specific to this context, the hospital's elite reputation was believed to influence families to expect consultations. Other considerations included medicolegal risk, clinical pathways, and availability of secure text messaging to facilitate informal "curbside" conversations with subspecialists. CONCLUSIONS: Decision-making around pediatric subspecialty consultation is complex and influenced by factors unrelated to a patient's clinical need. Efforts to reduce low-value consultation must account for the social and organizational dynamics that promote consultation.

Managing institutional conflicts: Stakeholder accounts of communication between conflict of interest and technology transfer offices.

There have been repeated calls for academic institutions to develop policies and procedures to manage institutional conflicts of interest (ICOI) arising from technology transfer activities. While prior research has examined adoption of ICOI policies by medical schools and universities, little is known about how these institutions handle ICOI in practice, hindering the development of evidence-based recommendations to improve ICOI management. To address this gap, we conducted semi-structured interviews with 25 senior administrators responsible for research integrity and conflict of interest issues at academic institutions. Data were analyzed using a descriptive qualitative content analysis approach, combining flexible coding to index the interview data with close examination, interpretation, and synthesis of coded content. Participants identified communication and information sharing between conflict of interest (COI) and technology transfer (TT) offices as a critical factor in the effective management of ICOI and suggested several strategies to strengthen coordination between these offices. These findings suggest that academic research institutions could strengthen COI programs by taking measures to improve communication and information sharing between COI and TT offices.

Effect of Gamification, Financial Incentives, or Both to Increase Physical Activity Among Patients at High Risk of Cardiovascular Events: The BE ACTIVE Randomized Controlled Trial.

BACKGROUND: Physical activity is associated with a lower risk of major adverse cardiovascular events, but few individuals achieve guideline-recommended levels of physical activity. Strategies informed by behavioral economics increase physical activity, but their longer-term effectiveness is uncertain. We sought to determine the effect of behaviorally designed gamification, loss-framed financial incentives, or their combination on physical activity compared with attention control over 12-month intervention and 6-month postintervention follow-up periods. METHODS: Between May 2019 and January 2024, participants with clinical atherosclerotic cardiovascular disease or a 10-year risk of myocardial infarction, stroke, or cardiovascular death of ≥7.5% by the Pooled Cohort equation were enrolled in a pragmatic randomized clinical trial. Participants received a wearable device to track daily steps, established a baseline, selected a step goal increase, and were randomly assigned to control (n=151), behaviorally designed gamification (n=304), loss-framed financial incentives (n=302), or gamification+financial incentives (n=305). The primary outcome of the trial was the change in mean daily steps from baseline through the 12-month intervention period. RESULTS: A total of 1062 patients (mean±SD age, 67±8; 61% female; 31% non-White) were enrolled. Compared with control subjects, participants had significantly greater increases in mean daily steps from baseline during the 12-month intervention in the gamification arm (adjusted difference, 538.0 [95% CI, 186.2-889.9]; P=0.0027), financial incentives arm (adjusted difference, 491.8 [95% CI, 139.6-844.1]; P=0.0062), and gamification+financial incentives arm (adjusted difference, 868.0 [95% CI, 516.3-1219.7]; P<0.0001). During the 6-month follow-up, physical activity remained significantly greater in the gamification+financial incentives arm than in the control arm (adjusted difference, 576.2 [95% CI, 198.5-954]; P=0.0028), but it was not significantly greater in the gamification (adjusted difference, 459.8 [95% CI, 82.0-837.6]; P=0.0171) or financial incentives (adjusted difference, 327.9 [95% CI, -50.2 to 706]; P=0.09) arms after adjustment for multiple comparisons. CONCLUSIONS: Behaviorally designed gamification, loss-framed financial incentives, and the combination of both increased physical activity compared with control over a 12-month intervention period, with the largest effect in gamification+financial incentives. These interventions could be a useful component of strategies to reduce cardiovascular risk in high-risk patients. REGISTRATION: URL: https://clinicaltrials.gov; Unique Identifier: NCT03911141.

Drivers of inappropriate use of antimicrobials in South Asia: A systematic review of qualitative literature.

Antimicrobial resistance is a global public health crisis. Effective antimicrobial stewardship requires an understanding of the factors and context that contribute to inappropriate use of antimicrobials. The goal of this qualitative systematic review was to synthesize themes across levels of the social ecological framework that drive inappropriate use of antimicrobials in South Asia. In September 2023, we conducted a systematic search using the electronic databases PubMed and Embase. Search terms, identified a priori, were related to research methods, topic, and geographic location. We identified 165 articles from the initial search and 8 upon reference review (n = 173); after removing duplicates and preprints (n = 12) and excluding those that did not meet eligibility criteria (n = 115), 46 articles were included in the review. We assessed methodological quality using the qualitative Critical Appraisal Skills Program checklist. The studies represented 6 countries in South Asia, and included data from patients, health care providers, community members, and policy makers. For each manuscript, we wrote a summary memo to extract the factors that impede antimicrobial stewardship. We coded memos using NVivo software; codes were organized by levels of the social ecological framework. Barriers were identified at multiple levels including the patient (self-treatment with antimicrobials; perceived value of antimicrobials), the provider (antimicrobials as a universal therapy; gaps in knowledge and skills; financial or reputational incentives), the clinical setting (lack of resources; poor regulation of the facility), the community (access to formal health care; informal drug vendors; social norms), and policy (absence of a regulatory framework; poor implementation of existing policies). This study is the first to succinctly identify a range of norms, behaviors, and policy contexts driving inappropriate use of antimicrobials in South Asia, emphasizing the importance of working across multiple sectors to design and implement approaches specific to the region.

Protocol for a parallel cluster randomized trial of a participatory tailored approach to reduce overuse of antibiotics at hospital discharge: the ROAD home trial.

BACKGROUND: Antibiotic overuse at hospital discharge is common, costly, and harmful. While discharge-specific antibiotic stewardship interventions are effective, they are resource-intensive and often infeasible for hospitals with resource constraints. This weakness impacts generalizability of stewardship interventions and has health equity implications as not all patients have access to the benefits of stewardship based on where they receive care. There may be different pathways to improve discharge antibiotic prescribing that vary widely in feasibility. Supporting hospitals in selecting interventions tailored to their context may be an effective approach to feasibly reduce antibiotic overuse at discharge across diverse hospitals. The objective of this study is to evaluate the effectiveness of the Reducing Overuse of Antibiotics at Discharge Home multicomponent implementation strategy ("ROAD Home") on antibiotic overuse at discharge for community-acquired pneumonia and urinary tract infection. METHODS: This 4-year two-arm parallel cluster-randomized trial will include three phases: baseline (23 months), intervention (12 months), and postintervention (12 months). Forty hospitals recruited from the Michigan Hospital Medicine Safety Consortium will undergo covariate-constrained randomization with half randomized to the ROAD Home implementation strategy and half to a "stewardship as usual" control. ROAD Home is informed by the integrated-Promoting Action on Research Implementation in Health Services Framework and includes (1) a baseline needs assessment to create a tailored suite of potential stewardship interventions, (2) supported decision-making in selecting interventions to implement, and (3) external facilitation following an implementation blueprint. The primary outcome is baseline-adjusted days of antibiotic overuse at discharge. Secondary outcomes include 30-day patient outcomes and antibiotic-associated adverse events. A mixed-methods concurrent process evaluation will identify contextual factors influencing the implementation of tailored interventions, and assess implementation outcomes including acceptability, feasibility, fidelity, and sustainment. DISCUSSION: Reducing antibiotic overuse at discharge across hospitals with varied resources requires tailoring of interventions. This trial will assess whether a multicomponent implementation strategy that supports hospitals in selecting evidence-based stewardship interventions tailored to local context leads to reduced overuse of antibiotics at discharge. Knowledge gained during this study could inform future efforts to implement stewardship in diverse hospitals and promote equity in access to the benefits of quality improvement initiatives. TRIAL REGISTRATION: Clinicaltrials.gov NCT06106204 on 10/30/23.

Parent and Clinician Views on Not Using Antibiotics for Mild Community-Acquired Pneumonia.

OBJECTIVES: Preschool-aged children with mild community-acquired pneumonia (CAP) routinely receive antibiotics even though most infections are viral. We sought to identify barriers to the implementation of a "no antibiotic" strategy for mild CAP in young children. METHODS: Qualitative study using semistructured interviews conducted in a large pediatric hospital in the United States from January 2021 to July 2021. Parents of young children diagnosed with mild CAP in the previous 3 years and clinicians practicing in outpatient settings (pediatric emergency department, community emergency department, general pediatrics offices) were included. RESULTS: Interviews were conducted with 38 respondents (18 parents, 20 clinicians). No parent heard of the no antibiotic strategy, and parents varied in their support for the approach. Degree of support related to their desire to avoid unnecessary medications, trust in clinicians, the emotional difficulty of caring for a sick child, desire for relief of suffering, willingness to accept the risk of unnecessary antibiotics, and judgment about the child's illness severity. Eleven (55%) clinicians were familiar with guidelines specifying a no antibiotic strategy. They identified challenges in not using antibiotics, including diagnostic uncertainty, consequences of undertreatment, parental expectations, follow-up concerns, and acceptance of the risks of unnecessary antibiotic treatment of many children if it means avoiding adverse outcomes for some children. CONCLUSIONS: Although both parents and clinicians expressed broad support for the judicious use of antibiotics, pneumonia presents stewardship challenges. Interventions will need to consider the emotional, social, and logistical aspects of managing pneumonia, in addition to developing techniques to improve diagnosis.

Excellence in Antibiotic Stewardship: A mixed methods study comparing High, Medium, and Low Performing Hospitals.

BACKGROUND: Despite antibiotic stewardship programs existing in most acute care hospitals, there continues to be variation in appropriate antibiotic use. While existing research examines individual prescriber behavior, contextual reasons for variation are poorly understood. METHODS: We conducted an explanatory, sequential mixed methods study of a purposeful sample of 7 hospitals with varying discharge antibiotic overuse. For each hospital, we conducted surveys, document analysis, and semi-structured interviews with antibiotic stewardship and clinical stakeholders. Data were analyzed separately and mixed during the interpretation phase, where each hospital was examined as a case, with findings organized across cases using a strengths, weaknesses, opportunities, and threats framework to identify factors accounting for differences in antibiotic overuse across hospitals. RESULTS: Surveys included 85 respondents. Interviews included 90 respondents (31 hospitalists, 33 clinical pharmacists, 14 stewardship leaders, 12 hospital leaders). On surveys, clinical pharmacists at hospitals with lower antibiotic overuse were more likely to report feeling: respected by hospitalist colleagues (p=0.001), considered valuable team members (p=0.001), comfortable recommending antibiotic changes (p=0.02). Based on mixed-methods analysis, hospitals with low antibiotic overuse had four distinguishing characteristics: a) robust knowledge of and access to antibiotic stewardship guidance, b) high quality clinical pharmacist-physician relationships, c) tools and infrastructure to support stewardship, and d) highly engaged Infectious Diseases physicians who advocated stewardship principles. CONCLUSION: This mixed-method study demonstrates the importance of organizational context for high performance in stewardship and suggests improving antimicrobial stewardship requires attention to knowledge, interactions, and relationships between clinical teams and infrastructure that supports stewardship and team interactions.