Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07043426

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

Led by Boston Medical Center · Updated on 2025-12-30

900

Participants Needed

1

Research Sites

65 weeks

Total Duration

On this page

Sponsors

B

Boston Medical Center

Lead Sponsor

N

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

Collaborating Sponsor

AI-Summary

What this Trial Is 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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Must have a diagnosis of Type 2 Diabetes Mellitus confirmed by medical records or HbA1c 6.5% in the last two years
  • Must have uncontrolled Type 2 Diabetes Mellitus with HbA1c 69% at screening
  • Must have been screened for health-related social needs during a General Internal Medicine visit in the last 3 months and have at least one positive result
Not Eligible

You will not qualify if you...

  • Currently enrolled in Complex Care Management
  • Receiving hospice care
  • Deceased
  • Diagnosed with Type 1 Diabetes Mellitus

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Boston Medical Center

Boston, Massachusetts, United States, 02118

Actively Recruiting

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Research Team

M

Michael Fischer, MD

CONTACT

U

Uma Khemraj, MS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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