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NCT Number: NCT07043426

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

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

Recruiting

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location status: Recruiting

Location contact

Micheal Fischer, MD

CONTACT

[email protected]

617-414-7288

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

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.

Primary outcomes

  1. Number of participants that connect to Community-Based Organizations

    Time frame: 3 months, 6 months, 3 months post intervention

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

  2. Number of participants that are helped by Community-Based Organizations

    Time frame: 3 months, 6 months, 12 months post intervention

    Data will be collected from participant interviews

  3. Changes in HbA1c

    Time frame: 3 months, 6 months, 12 months post intervention

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

Secondary outcomes

  1. Number of participants hospitalized

    Time frame: 3 months, 6 months, 12 months post intervention

    Data will be obtained from the EHR.

  2. Number of participants that had an emergency department visit

    Time frame: 3 months, 6 months, 12 months post intervention

    Data will be obtained from the EHR.

Study contacts

Contact information is provided by the study sponsor or research team.

Michael Fischer, MD

CONTACT

[email protected]

617-414-7288

Uma Khemraj, MS

CONTACT

[email protected]

617-414-7288

Sponsors and collaborators

Lead sponsor

Boston Medical Center

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

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

Acronym: THRIVE-DM

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 29, 2025
Registry last updated
Dec 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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