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Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible 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).

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Eligible participants will be categorized into low social services need (Low-SS) and high social services need (High-SS) and then randomized into intervention or control arms using block randomization in REDCap.
Primary Purpose
Health Services Research
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
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.
  • 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.
Active Comparator
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.
  • 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.

Recruiting Locations

Boston Medical Center
Boston 4930956, Massachusetts 6254926 02118
Contact:
Micheal Fischer, MD
617-414-7288
Michael.Fischer@bmc.org

More Details

Status
Recruiting
Sponsor
Boston Medical Center

Study Contact

Michael Fischer, MD
617-414-7288
Michael.Fischer@bmc.org

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.