Protocol for the DECIDE+ trial: a quasi-experimental hybrid effectiveness-implementation study of social support and CVD self-management through community health workers in Philadelphia.
This paper describes the protocol for a quasi-experimental hybrid effectiveness-implementation study (DECIDE+) comparing a nine-session CHW-delivered problem-solving programme for CVD self-management against standard CHW services among Philadelphia residents with CVD risk factors and unmet social needs.
Key Findings
Methods
The DECIDE+ trial uses a type 1 hybrid effectiveness-implementation design to simultaneously evaluate intervention effectiveness and implementation outcomes.
The study is classified as a 'type 1 hybrid effectiveness-implementation design,' prioritizing effectiveness while also assessing implementation.
The quasi-experimental design compares two groups rather than using randomization to group assignment.
Implementation outcomes assessed include reach, adoption, fidelity, and maintenance of the DECIDE+ programme.
A mixed-methods approach is used for implementation outcomes, including structured interviews with CHWs and analysis of programme-level data.
Methods
The DECIDE+ intervention combines a structured nine-session problem-solving programme with ongoing community health worker support addressing social needs.
DECIDE+ stands for Decision-making Education for Choices in Diabetes Everyday.
The programme targets Philadelphia residents with CVD risk factors and unmet social needs.
The intervention builds on a structured problem-solving curriculum for chronic disease management.
Community health workers (CHWs) provide the intervention, combining both clinical self-management support and social needs addressing.
Methods
The study will enroll 500 total participants split equally between the DECIDE+ group and a standard CHW services comparison group.
The DECIDE+ group will include n=250 participants.
The standard CHW services (comparison) group will include n=250 participants.
The target population is Philadelphia residents with CVD risk factors and unmet social needs.
The study was approved by the University of Pennsylvania Institutional Review Board (Protocol #856216) and registered as NCT06732102.
Methods
Both study groups will be randomly assigned to either monthly or biweekly CHW follow-up contact to examine the effect of contact frequency on health behaviour outcomes.
This within-study randomization specifically addresses CHW contact frequency rather than intervention assignment.
The two contact frequency conditions are monthly versus biweekly CHW follow-up.
This design element allows examination of whether more frequent contact independently influences health behaviour outcomes.
This applies to both the DECIDE+ and standard CHW services groups.
Methods
The primary outcome of the trial is CVD self-management skills, measured using the Self-care of Chronic Illness Inventory.
The Self-care of Chronic Illness Inventory is the designated primary outcome measurement tool.
The study aims to determine the effectiveness of DECIDE+ in improving CVD self-management skills.
CVD is described as the leading cause of death in the USA, with significant disparities affecting racial/ethnic minority populations particularly in Philadelphia.
Social and economic barriers are identified as key impediments to implementation of recommended health behaviours in underserved communities.
Background
The study addresses cardiovascular health disparities in Philadelphia, a city where racial/ethnic minority populations are disproportionately affected by CVD.
The paper identifies Philadelphia specifically as a location with significant CVD disparities affecting racial/ethnic minority populations.
The study targets communities with both CVD risk factors and unmet social needs, reflecting a multilevel approach to health disparities.
The pragmatic trial is designed to operate in 'real-world community settings.'
Findings are planned for dissemination through peer-reviewed publications and scientific conference presentations.
What This Means
This research describes the design and protocol for a study called DECIDE+, which is testing a community health worker (CHW)-delivered programme to help people in Philadelphia better manage their cardiovascular disease (CVD) risk factors. CVD is the leading cause of death in the United States, and people in Philadelphia from racial and ethnic minority backgrounds face particularly high rates of CVD. Many people with CVD risk factors struggle to follow health recommendations because of social and economic challenges, such as food insecurity or housing instability. DECIDE+ tries to address this by combining a structured nine-session programme that teaches problem-solving skills for managing chronic disease with ongoing CHW support to address these social barriers.
The study will enroll 500 people total — 250 in the DECIDE+ programme and 250 who receive standard CHW services for comparison. Within each group, participants will be randomly assigned to check in with their CHW either monthly or every two weeks, so researchers can also learn whether how often people hear from their CHW makes a difference in health outcomes. The main outcome researchers will measure is how well participants are able to manage their own cardiovascular health, using a validated survey tool. Researchers will also look at how well the programme was carried out in the real world — for example, whether CHWs were able to deliver it as intended and whether the programme could be sustained over time.
This research suggests that community health workers may be a promising way to deliver health behaviour support that addresses both medical self-management and social needs at the same time. By studying both whether the programme works and how well it can be put into practice, the findings could inform how similar programmes are rolled out in other underserved communities facing cardiovascular health disparities.
Bonett S, Alvarez C, Clemmons A, Thomas G, Villarruel A, Tan A, et al.. (2026). Protocol for the DECIDE+ trial: a quasi-experimental hybrid effectiveness-implementation study of social support and CVD self-management through community health workers in Philadelphia.. BMJ open. https://doi.org/10.1136/bmjopen-2026-121732