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

Official title

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

Overview

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

Interventions

• Other THRIVE-DM
  Low-SS and High-SS will be referred by the CHW to appropriate community-based organizations through the THRIVE Directory. High-SS participants will also receive additional support from a patient navigator (PN), who will follow up to facilitate service connection and address barriers to engagement. CHWs and PNs will coordinate care to ensure services are aligned with the patient's assessed needs.
• Other Standard of care
  Standard of care may include support from the primary care team, health related social needs (HRSN) screening via the THRIVE screener, printed resource guides, and referrals to community-based organizations initiated at the discretion of clinic staff using the THRIVE Directory.

Primary outcome measures

• Number of participants that connect to Community-Based Organizations [Time frame: 3 months, 6 months, 3 months post intervention]
• Number of participants that are helped by Community-Based Organizations [Time frame: 3 months, 6 months, 12 months post intervention]
• Changes in HbA1c [Time frame: 3 months, 6 months, 12 months post intervention]

Secondary outcome measures (2)

• Number of participants hospitalized [Time frame: 3 months, 6 months, 12 months post intervention]
• Number of participants that had an emergency department visit [Time frame: 3 months, 6 months, 12 months post intervention]

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Health services research

Study locations

United States · 1 center

• Boston Medical Center — Boston

Identifiers

NCT: NCT07043426 · H-45851 · 1R01DK140570-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗