Protocol for the DECIDE+ trial: a quasi-experimental hybrid effectiveness-implementation study of social support and...

Cardiovascular disease (CVD) is the leading cause of death in the USA, with significant disparities affecting racial/ethnic minority populations particularly in Philadelphia. Although effective self-management can improve outcomes for those with CVD risk factors, social and economic barriers often impede implementation of recommended health behaviours in underserved communities. This study aims to (1) determine the effectiveness of the Decision-making Education for Choices in Diabetes Everyday (DECIDE)+ intervention in improving CVD self-management skills among Philadelphia residents with CVD risk factors and unmet social needs compared with standard community health worker (CHW) engagement and (2) assess the reach, adoption, fidelity and maintenance of DECIDE+.

Using a type 1 hybrid effectiveness-implementation design, this quasi-experimental study will compare outcomes between participants who enrol in the DECIDE+ group (n=250) or receive standard CHW services (n=250). DECIDE+ combines a structured nine-session problem-solving programme for chronic disease management with ongoing CHW support addressing social needs. Both groups will be randomly assigned to either monthly or biweekly CHW follow-up to examine the impact of contact frequency on health behaviour outcomes. Primary outcomes include CVD self-management skills measured by the Self-care of Chronic Illness Inventory. Implementation outcomes will be assessed through a mixed-methods approach including structured interviews with CHWs and analysis of programme-level data.

This study was approved by the University of Pennsylvania Institutional Review Board (Protocol #856216). Written informed consent is obtained from all participants prior to enrolment. This pragmatic trial addresses cardiovascular health disparities by simultaneously enhancing problem-solving skills for chronic disease management and addressing social and environmental barriers to effective self-management. The study will provide valuable insights into the effectiveness of multilevel CHW-delivered interventions and optimal implementation strategies in real-world community settings. Findings will be disseminated through peer-reviewed publications and scientific conference presentations.

NCT06732102.