RecruitingNot ApplicableNCT07043426

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

Sponsor

Boston Medical Center

Enrollment

900 participants

Start Date

Dec 26, 2025

Study Type

INTERVENTIONAL

Conditions

Diabetes Mellitus, Type 2

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

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a care coordination approach that helps people with poorly controlled type 2 diabetes address non-medical barriers to health — such as food insecurity, housing instability, or transportation problems — that may be preventing them from managing their diabetes effectively. The program connects patients with community resources alongside regular diabetes care. **You may be eligible if...** - You have been diagnosed with type 2 diabetes - Your HbA1c (a blood sugar control measure) is 9% or higher at screening — indicating your diabetes is not well controlled - You screened positive for at least one health-related social need (such as food or housing insecurity) during a recent clinic visit **You may NOT be eligible if...** - You are already enrolled in a Complex Care Management program - Your blood sugar is well controlled (HbA1c below 9%) - You have not screened positive for any social needs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERTHRIVE-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.

OTHERStandard 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.

Locations(1)

Boston Medical Center

Boston, Massachusetts, United States

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NCT07043426

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