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

NCT07043426 | Recruiting

• 2 other identifiers: H-458511R01DK140570-01
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 1

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

Keywords

THRIVE-DM; Community-based organizations; Triage

Outcome Measures

Primary Outcomes (3)

• Number of participants that connect to Community-Based Organizations

  Connection to Community-Based Organizations will be assessed through several sources and documented in REDCap

  3 months, 6 months, 3 months post intervention

• Number of participants that are helped by Community-Based Organizations

  Data will be collected from participant interviews

  3 months, 6 months, 12 months post intervention

• Changes in HbA1c

  HbA1c data will be extracted from the EPIC electronic health record (EHR).

  3 months, 6 months, 12 months post intervention

Secondary Outcomes (2)

• Number of participants hospitalized

  3 months, 6 months, 12 months post intervention

• Number of participants that had an emergency department visit

  3 months, 6 months, 12 months post intervention

Study Arms (2)

Intervention- THRIVE-DM

EXPERIMENTAL

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.

Other: THRIVE-DM

Control- Standard of care

ACTIVE COMPARATOR

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

Other: Standard of care

Interventions

THRIVE-DM OTHER

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.

Intervention- THRIVE-DM

Standard of care OTHER

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.

Control- Standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Boston Medical Center: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Michael Fischer, MD

  Boston Medical Center, Internal Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Fischer, MD

CONTACT

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

Uma Khemraj, MS

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Eligible participants will be categorized into low social services need (Low-SS) and high social services need (High-SS) and then randomized into intervention or control arms using block randomization in REDCap.

Study Record Dates

• First Submitted: June 20, 2025
• First Posted: June 29, 2025
• Study Start: December 26, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)