Improving Diabetes Care With Strategies For Addressing Health-Related Social Needs and Community Partnerships
Recruiting · NCT07043426 · Interventional (participants receive a specific treatment) · Lead sponsor: Boston Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
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
Who can take part
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).
Where it is running
1 location listed across 1 US state.
- Boston Medical Center - Boston, Massachusetts, United States