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

Boston Medical Center (BMC)

Status: Enrolling

Conditions: Diabetes Mellitus, Type 2

Treatments: Other: Standard of care; Other: THRIVE-DM

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07043426

H-45851

1R01DK140570-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Enrollment: 900 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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900 participants in 2 patient groups

Intervention- THRIVE-DM

Experimental group

Description:

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.

Treatment:

Other: THRIVE-DM

Control- Standard of care

Active Comparator group

Description:

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

Treatment:

Other: Standard of care