Interventions to de-implement unnecessary antibiotic prescribing for ear infections (DISAPEAR Trial): protocol for a cluster-randomized trial.

BACKGROUND: Watchful waiting management for acute otitis media (AOM), where an antibiotic is used only if the child's symptoms worsen or do not improve over the subsequent 2-3 days, is an effective approach to reduce antibiotic exposure for children with AOM. However, studies to compare the effectiveness of interventions to promote watchful waiting are lacking. The objective of this study is to compare the effectiveness and implementation outcomes of two pragmatic, patient-centered interventions designed to facilitate use of watchful waiting in clinical practice. METHODS: This will be a cluster-randomized trial utilizing a hybrid implementation-effectiveness design. Thirty-three primary care or urgent care clinics will be randomized to one of two interventions: a health systems-level intervention alone or a health systems-level intervention combined with use of a shared decision-making aid. The health systems-level intervention will include engagement of a clinician champion at each clinic, changes to electronic health record antibiotic orders to facilitate delayed antibiotic prescriptions as part of a watchful waiting strategy, quarterly feedback reports detailing clinicians' use of watchful waiting individually and compared with peers, and virtual learning sessions for clinicians. The hybrid intervention will include the health systems-level intervention plus a shared decision-making aid designed to inform decision-making between parents and clinicians with best available evidence. The primary outcomes will be whether an antibiotic was ultimately taken by the child and parent satisfaction with their child's care. We will explore the differences in implementation effectiveness by patient population served, clinic type, clinical setting, and organization. The fidelity, acceptability, and perceived appropriateness of the interventions among different clinician types, patient populations, and clinical settings will be compared. We will also conduct formative qualitative interviews and surveys with clinicians and administrators, focus groups and surveys of parents of patients with AOM, and engagement of two stakeholder advisory councils to further inform the interventions. DISCUSSION: This study will compare the effectiveness of two pragmatic interventions to promote use of watchful waiting for children with AOM to reduce antibiotic exposure and increase parent satisfaction, thus informing national antibiotic stewardship policy development. CLINICAL TRIAL REGISTRATION: NCT06034080.

PA experiences in clinical trials.

OBJECTIVE: Physician associate/assistant (PA) experience in clinical trials is poorly documented in medical literature. This survey aimed to describe the characteristics and experiences of PAs in clinical trial research. METHODS: We performed descriptive analyses of data gathered in 2022 by the American Academy of Physician Associates and published in the organization's annual Salary Report, specifically of respondents who indicated experience in traditional and/or decentralized clinical trials. RESULTS: About 73% of PAs eligible for the clinical trials survey indicated they were either involved in clinical trials or had been involved in the past and were interested in working in clinical trials in the future. PAs often serve in subinvestigator roles and perform various clinical trial tasks regardless of previous research experience. CONCLUSIONS: PAs working in clinical trials demonstrated broad responsibilities and skills in the research setting. They leveraged benefits to working in clinical trials despite institutional barriers. Clinical research may fit into numerous PAs' practices and let them contribute to medical advancements.

The Role of Telehealth in Improving Care Connections and Outcomes for Community Health Center Patients with Diabetes.

INTRODUCTION: Does telehealth decrease health disparities by improving connections to care or simply result in new barriers for vulnerable populations who often lack access to technology? This study aims to better understand the role of telehealth and social determinants of health in improving care connections and outcomes for Community Health Center patients with diabetes. METHODS: This retrospective analysis of Electronic Health Record (EHR) data examined the relationship between telehealth utilization and glycemic control and consistency of connection to the health care team ("connectivity"). EHR data were collected from 20 Community Health Centers from July 1, 2019 through December 31, 2021. Descriptive statistics were calculated, and multivariable linear regression was used to assess the associations between telehealth use and engagement in care and glycemic control. RESULTS: The adjusted analysis found positive, statistically significant associations between telehealth use and each of the 2 primary outcomes. Telehealth use was associated with 0.89 additional months of hemoglobin A1c (HbA1c) control (95% confidence interval [CI], 0.73 to 1.04) and 4.49 additional months of connection to care (95% CI, 4.27 to 4.70). DISCUSSION: The demonstrated increased engagement in primary care for telehealth users is significant and encouraging as Community Health Center populations are at greater risk of lapses in care and loss to follow up. CONCLUSIONS: Telehealth can be a highly effective, patient-centered form of care for people with diabetes. Telehealth can play a critical role in keeping vulnerable patients with diabetes connected to their care team and involved in care and may be an important tool for reducing health disparities.

Promoting REproductive Planning And REadiness in Diabetes (PREPARED) Study protocol: a clinic-randomised controlled trial testing a technology-based strategy to promote preconception care for women with type 2 diabetes.

INTRODUCTION: Women with type 2 diabetes (T2DM) are more likely to experience adverse reproductive outcomes, yet preconception care can significantly reduce these risks. For women with T2DM, preconception care includes reproductive planning and patient education on: (1) the importance of achieving glycaemic control before pregnancy, (2) using effective contraception until pregnancy is desired, (3) discontinuing teratogenic medications if pregnancy could occur, (4) taking folic acid, and (5) managing cardiovascular and other risks. Despite its importance, few women with T2DM receive recommended preconception care. METHODS AND ANALYSIS: We are conducting a two-arm, clinic-randomised trial at 51 primary care practices in Chicago, Illinois to evaluate a technology-based strategy to 'hardwire' preconception care for women of reproductive age with T2DM (the PREPARED (Promoting REproductive Planning And REadiness in Diabetes) strategy) versus usual care. PREPARED leverages electronic health record (EHR) technology before and during primary care visits to: (1) promote medication safety, (2) prompt preconception counselling and reproductive planning, and (3) deliver patient-friendly educational tools to reinforce counselling. Post-visit, text messaging is used to: (4) encourage healthy lifestyle behaviours. English and Spanish-speaking women, aged 18-44 years, with T2DM will be enrolled (N=840; n=420 per arm) and will receive either PREPARED or usual care based on their clinic's assignment. Data will be collected from patient interviews and the EHR. Outcomes include haemoglobin A1c (primary), reproductive knowledge and self-management behaviours. We will use generalised linear mixed-effects models (GLMMs) to evaluate the impact of PREPARED on these outcomes. GLMMs will include a fixed effect for treatment assignment (PREPARED vs usual care) and random clinic effects. ETHICS AND DISSEMINATION: This study was approved by the Northwestern University Institutional Review Board (STU00214604). Study results will be published in journals with summaries shared online and with participants upon request. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT04976881).

Process of Engaging Community and Scientific Partners in the Development of the CIRCL-Chicago Study Protocol.

Objectives: Hypertension affects 1 in 3 adults in the United States and disproportionately affects African Americans. Kaiser Permanente demonstrated that a "bundle" of evidence-based interventions significantly increased blood pressure control rates. This paper describes a multiyear process of developing the protocol for a trial of the Kaiser bundle for implementation in under-resourced urban communities experiencing cardiovascular health disparities during the planning phase of this biphasic award (UG3/UH3). Methods: The protocol was developed by a collaboration of faith-based community members, representatives from community health center practice-based research networks, and academic scientists with expertise in health disparities, implementation science, community-engaged research, social care interventions, and health informatics. Scientists from the National Institutes of Health and the other grantees of the Disparities Elimination through Coordinated Interventions to Prevent and Control Heart and Lung Disease Risk (DECIPHeR) Alliance also contributed to developing our protocol. Results: The protocol is a hybrid type 3 effectiveness-implementation study using a parallel cluster randomized trial to test the impact of practice facilitation on implementation of the Kaiser bundle in community health centers compared with implementation without facilitation. A central strategy to the Kaiser bundle is to coordinate implementation via faith-based and other community organizations for recruitment and navigation of resources for health-related social risks. Conclusions: The proposed research has the potential to improve identification, diagnosis, and control of blood pressure among under-resourced communities by connecting community entities and healthcare organizations in new ways. Faith-based organizations are a trusted voice in African American communities that could be instrumental for eliminating disparities.