Protocol refinement for a diabetes pragmatic trial using the PRECIS-2 framework.

BACKGROUND: This report describes how we refined a protocol for a pragmatic comparative effectiveness study of two models of an evidence-based diabetes shared medical appointment intervention and used the PRECIS-2 rating system to evaluate these adaptations. METHODS: We report primary data collected between June and August 2019, and protocol refinements completed between 2018 and 2020. Twenty-two members of the study team collaborated in protocol refinement and completed the PRECIS-2 ratings of study pragmatism. We discuss study design refinements made to achieve the desired level of pragmatism vs. experimental control for each of the nine PRECIS-2 dimensions. Study team members received training on PRECIS-2 scoring and were asked to rate the study protocol on the nine PRECIS-2 dimensions. Ratings were compared using descriptive statistics. RESULTS: In general, the PRECIS-2 ratings revealed high levels of pragmatism, but somewhat less pragmatic ratings on the categories of Delivery and Organization (costs and resources). This variation was purposeful, and we provide the rationale for and steps taken to obtain the targeted level of pragmatism on each PRECIS-2 dimension, as well as detail design changes made to a) make the design more pragmatic and b) address COVID-19 issues. There was general agreement among team members and across different types of stakeholders on PRECIS-2 ratings. CONCLUSIONS: We discuss lessons learned from use of PRECIS-2 and experiences in refining the study to be maximally pragmatic on some dimensions and less so on other dimensions. This paper expands on prior research by describing actions to achieve higher levels of pragmatism and revise our protocol fit to the changed context. We make recommendations for future use of PRECIS-2 to help address changing context and other strategies for the planning of and transparent reporting on pragmatic research and comparative effectiveness research. TRIAL REGISTRATION: Clinicaltrials.gov Registration ID: NCT03590041 .

Adapting Diabetes Shared Medical Appointments to Fit Context for Practice-Based Research (PBR).

INTRODUCTION: Complex behavioral interventions such as diabetes shared medical appointments (SMAs) should be tested in pragmatic trials. Partnerships between dissemination and implementation scientists and practice-based research networks can support adaptation and implementation to ensure such interventions fit the context. This article describes adaptations to and implementation of the Targeted Training in Illness Management (TTIM) intervention to fit the primary care diabetes context. METHODS: The Invested in Diabetes pragmatic trial engaged 22 practice-based research network practices to compare 2 models of diabetes SMAs, based on TTIM. We used surveys, interviews, and observation to assess practice contextual factors, such as practice size, location, payer mix, change and work culture, motivation to participate, and clinical and administrative capacity. The enhanced Replicating Effective Programs framework was used to guide adaptations to TTIM and implementation in participating practices. RESULTS: Practices varied in size and patient demographics. All practices had integrated behavioral health, but limited health educators or prescribing providers. Adaptations to SMA delivery accommodated the need for flexibility in personnel and reduced scheduling burden. Adaptations to TTIM content were designed to fit general primary care diabetes and Spanish-speaking patients. CONCLUSION: Enhanced Replicating Effective Programs is a useful process framework for adaptation, implementation, and testing of diabetes SMAs in primary care. Adapting intervention content, delivery, and training to fit context can help ensure pragmatic trials have both internal and external validity. Attention to intervention fit to context can support continued practice engagement in research and sustainability of evidence-based interventions.

Correlates of Emergency Department Use by Individuals With Bipolar Disorder Enrolled in a Collaborative Care Implementation Study.

OBJECTIVE: The study assessed correlates of emergency department use among participants in a collaborative care program for bipolar disorder. METHODS: Community-based clinics from two states implemented Life Goals-Collaborative Care (LG-CC), an evidence-based model that includes self-management sessions and care management contacts. Logistic regression determined participant factors associated with emergency department use between six and 12 months after LG-CC implementation. RESULTS: Of 219 participants with baseline and 12-month data, 24% reported at least one emergency department visit. Participants with a recent homelessness history (odds ratio [OR]=3.76, p=.01) or five or more care management contacts (OR=2.62, p=.05) had a higher probability of visiting an emergency department, after the analyses were adjusted for demographic and clinical factors, including physical health score and hospitalization history. CONCLUSIONS: Participants in a collaborative care program who had a history of homelessness were more likely to use the emergency department, suggesting a greater need for more intensive care coordination.