Clinical Trial

Improving Diabetes Care With Strategies For Addressing Health-Related Social Needs and Community Partnerships

Study acronym: THRIVE-DM
Recruiting
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Summary
The goal of this study is to develop, implement, and evaluate a patient-centered triage and referral model designed to improve health outcomes for individuals with uncontrolled type 2 diabetes mellitus (T2DM) and unmet health-related social needs. The intervention builds on the existing THRIVE infrastructure at Boston Medical Center (BMC), which includes screening for social needs and a resource referral guide. It integrates medical and social care by embedding a data-driven triage tool within the EPIC electronic health record system, engaging community health workers trained in population health, and initiating closed-loop EPIC integrated referrals to community-based organizations. This study will use a hybrid type 3 effectiveness-implementation trial design to evaluate the implementation of the THRIVE-DM intervention at the clinic level. Preliminary effectiveness will be assessed by comparing THRIVE-DM to usual care in its ability to increase patient connections to community-based organizations and improve clinical outcomes. Using a stratified randomization approach, the investigators will compare referral closure rates, receipt of social services, hemoglobin A1C levels, and patterns of health service utilization between patients enrolled in THRIVE-DM and those receiving standard care
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2025-06-20; most recent amendment 2025-12-26.
Status change: Not Yet Recruiting → Recruiting 2025-12-02
Trial Details
NCT Number NCT07043426
Lead Sponsor Boston Medical Center
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions Diabetes Mellitus, Type 2
Enrollment 900 participants
Start Date 2025-12-26
Primary Completion 2027-04 (estimated)
Study Completion 2027-04 (estimated)
Updated on ClinicalTrials.gov 2025-12-30