NCT07043426

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 900 (estimated)
• Sponsor: Boston Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
OTHER	THRIVE-DM	Low-SS and High-SS will be referred by the CHW to appropriate community-based organizations through the THRIVE Directory. High-SS participants will also receive additional support from a patient navigator (PN), who will follow up to facilitate service connection and address barriers to engagement. CHWs and PNs will coordinate care to ensure services are aligned with the patient's assessed needs.
OTHER	Standard of care	Standard of care may include support from the primary care team, health related social needs (HRSN) screening via the THRIVE screener, printed resource guides, and referrals to community-based organizations initiated at the discretion of clinic staff using the THRIVE Directory.

Timeline

• Start date: 2025-12-26
• Primary completion: 2027-04-01
• Completion: 2027-04-01
• First posted: 2025-06-29
• Last updated: 2025-12-30

Locations

1 site across 1 country: United States