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

Not Applicable

Not yet recruiting

• Conditions: Diabetes Mellitus, Type 2

• Registration Number: NCT07043426
• Lead Sponsor: Boston Medical Center

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-06-20
• Study First Submitted QC: 2025-06-20
• Study First Posted: 2025-06-29
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-27
• Last Update Posted: 2025-07-29
• Study Start: 2025-09-01
• Primary Completion: 2027-04
• Study Completion: 2027-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 900

Inclusion Criteria

• 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.

Exclusion Criteria

• Patients enrolled in Complex Care Management (CCM).
• Patients receiving hospice care.
• Patients who are deceased
• Patients with Type 1 Diabetes Mellitus (T1DM).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of participants that connect to Community-Based Organizations	3 months, 6 months, 3 months post intervention	Connection to Community-Based Organizations will be assessed through several sources and documented in REDCap
Number of participants that are helped by Community-Based Organizations	3 months, 6 months, 12 months post intervention	Data will be collected from participant interviews
Changes in HbA1c	3 months, 6 months, 12 months post intervention	HbA1c data will be extracted from the EPIC electronic health record (EHR).

Secondary Outcome Measures

Name	Time	Method
Number of participants hospitalized	3 months, 6 months, 12 months post intervention	Data will be obtained from the EHR.
Number of participants that had an emergency department visit	3 months, 6 months, 12 months post intervention	Data will be obtained from the EHR.

Trial Locations

Locations (1)

Boston Medical Center; 🇺🇸 Boston, Massachusetts, United States