Recruiting

THRIVE-DM

Sponsor:

Boston Medical Center

Code:

NCT07043426

Conditions

Diabetes Mellitus, Type 2

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

THRIVE-DM

Standard of care

Study Details

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

Conditions

Diabetes Mellitus, Type 2

Study ID

NCT07043426

Start date

Dec 26, 2025

Status verified date

Dec, 2025

Completion date

Apr, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

900 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Intervention- THRIVE-DM

Participants randomized to the intervention group will receive care through the enhanced THRIVE-DM model. A Community Health Worker (CHW) will utilize the triage tool - an EPIC based tool- an EPIC based tool that categorizes patients into Low-SS or High-SS classifications based on their HRSN complexity and self-efficacy proxies.

active comparator: Control- Standard of care

Participants randomized to the control group will be evaluated under an intention-to-treat framework. These participants will continue to receive routine clinical care.

Interventions

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.

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.

Primary outcome measure

  • Number of participants that connect to Community-Based Organizations [ Time Frame: 3 months, 6 months, 3 months post intervention ]
  • Number of participants that are helped by Community-Based Organizations [ Time Frame: 3 months, 6 months, 12 months post intervention ]
  • Changes in HbA1c [ Time Frame: 3 months, 6 months, 12 months post intervention ]

Central Contacts and Locations

Central contacts

Michael Fischer, MD

617-414-7288Michael.Fischer@bmc.org

Uma Khemraj, MS

617-414-7288Uma.Khemraj@bmc.org

Locations

Boston Medical Center

Recruiting

Boston, Massachusetts, United States, 02118

Contacts

Micheal Fischer, MD

617-414-7288Michael.Fischer@bmc.org

More Information

Sponsor

Boston Medical Center

Last update posted

Dec 30, 2025

Last verified

Dec, 2025

Keywords

  • THRIVE-DM
  • Community-based organizations
  • Triage

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston Medical Center on 2025-12-30.