NCT07043426Recruiting
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
Source: ClinicalTrials.gov · Last updated 30 Dec 2025
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 900 (estimated)
- First submitted
- 20 Jun 2025
- Start date
- 26 Dec 2025
- Primary completion date
- Apr 2027
- Lead sponsor
- Boston Medical Center
- Diseases
- Type 2 diabetes
- NCT number
- NCT07043426
What you commit to
- Study type: Interventional
- Planned participants: 900
- From 26 Dec 2025 to the primary completion date, Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients receiving hospice care.
Other illness
- Patients with Type 1 Diabetes Mellitus (T1DM).
Other
- Patients enrolled in Complex Care Management (CCM).
- Patients who are deceased
Who the study is looking for
- Diagnosis: Must have a diagnosis of Type 2 Diabetes Mellitus (T2DM), confirmed by a current diagnosis in the medical record or at least two billing codes in the last two years, or an HbA1c level ≥6.5% in the last two years.
- Uncontrolled T2DM: Must have an HbA1c ≥9% at the time of screening.
- Health-Related Social Needs: Must have been screened for health related social needs (HRSNs) during a General Internal Medicine (GIM) visit in the last 3 months and screened positive for at least one HRSN.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Boston Medical Center Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.