Improving Diabetes Care With Strategies For Addressing Health-Related Social Needs and Community Partnerships
NCT ID: NCT07043426
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
900 participants
INTERVENTIONAL
2025-12-26
2027-04-30
Brief Summary
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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
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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 receiving hospice care.
* Patients who are deceased
* Patients with Type 1 Diabetes Mellitus (T1DM).
18 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Boston Medical Center
OTHER
Responsible Party
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Principal Investigators
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Michael Fischer, MD
Role: PRINCIPAL_INVESTIGATOR
Boston Medical Center, Internal Medicine
Locations
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Boston Medical Center
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Micheal Fischer, MD
Role: primary
Other Identifiers
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H-45851
Identifier Type: -
Identifier Source: org_study_id