THRIVE-DM: Improving Diabetes Care With Strategies For Addressing Health-Related Social Needs and Community Partnerships
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Boston Medical Center
- Enrollment
- 900
- Locations
- 1
- Primary Endpoint
- Number of participants that connect to Community-Based Organizations
Study Overview
Brief Summary
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
Arms & Interventions
Intervention- THRIVE-DM
Participants randomized to the intervention group will receive care through the enhanced THRIVE-DM model. A Community Health Worker (CHW) will utilize the triage tool - an EPIC based tool- an EPIC based tool that categorizes patients into Low-SS or High-SS classifications based on their HRSN complexity and self-efficacy proxies.
Intervention: THRIVE-DM (Other)
Control- Standard of care
Participants randomized to the control group will be evaluated under an intention-to-treat framework. These participants will continue to receive routine clinical care.
Intervention: Standard of care (Other)
Outcomes
Primary Outcomes
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
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
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
- Number of participants hospitalized(3 months, 6 months, 12 months post intervention)
- Number of participants that had an emergency department visit(3 months, 6 months, 12 months post intervention)