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

NCT07043426 · Boston Medical Center
In plain English

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Official title
THRIVE-DM: Improving Diabetes Care With Strategies For Addressing Health-Related Social Needs and Community Partnerships
About this study
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
Eligibility criteria
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 target: 900 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-12-26
Estimated completion: 2027-04
Last updated: 2025-12-30
Interventions
Other: THRIVE-DMOther: Standard of care
Primary outcomes
  • Number of participants that connect to Community-Based Organizations (3 months, 6 months, 3 months post intervention)
  • Number of participants that are helped by Community-Based Organizations (3 months, 6 months, 12 months post intervention)
  • Changes in HbA1c (3 months, 6 months, 12 months post intervention)
Sponsor
Boston Medical Center · other
With: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Contacts & investigators
ContactMichael Fischer, MD · contact · Michael.Fischer@bmc.org · 617-414-7288
ContactUma Khemraj, MS · contact · Uma.Khemraj@bmc.org · 617-414-7288
InvestigatorMichael Fischer, MD · principal_investigator, Boston Medical Center, Internal Medicine
All locations (1)
Boston Medical CenterRecruiting
Boston, Massachusetts, United States