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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests THRIVE-DM, a program that links medical care with community services, compared with usual care. It is for people with poorly controlled type 2 diabetes and unmet social needs that affect their health. Researchers will look at how well the program connects people to services and improves their health.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have type 2 diabetes confirmed by a current medical record diagnosis, at least two billing codes in the past 2 years, or an HbA1c result of 6.5% or higher in the past 2 years.
  • Have an HbA1c result of 9% or higher at screening. HbA1c is a blood test that shows average blood sugar levels.
  • Have been checked for social needs that affect health during a General Internal Medicine visit in the past 3 months, with at least one unmet need found.

Who can't join

  • Are enrolled in Complex Care Management (CCM), a care support program.
  • Are receiving hospice care, which provides comfort care near the end of life.
  • Have died.
  • Have type 1 diabetes.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 sites (1)

MA