Leveraging Community-clinical Linkages to Address Unmet Social Needs for People With Diabetes

Part of paid clinical trials in Lexington, Kentucky.

Sponsor
Mary Lacy
Study ID
NCT07196007
Status
Recruiting
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Conditions

  • Diabetes
  • Diabetes Mellitus

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Community-Clinical Intervention — BEHAVIORAL
    The intervention involves enhancing usual care for screening patients with diabetes for unmet social needs and referring those who screen positive to a Community Health Worker. Patients who screen positive for unmet social needs will work with CHWs to be connected to community organizations.

Study Details

This study is a hybrid type 2 design to evaluate the effectiveness and implementation of a community-clinical linkage intervention in primary clinics to address unmet social needs for patients with diabetes living in rural communities. The study will take place in two rural communities in Kentucky, one in eastern Kentucky and one in western Kentucky.

Key Dates

Start date
Mar 10, 2026
Status verified
Feb 2026
Primary completion
Mar 31, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
12,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Usual Screening Patients with Diabetes for Unmet Social Needs Plus a Community-Clinical Intervention
    The intervention will be developed by community-clinical partners and then implemented in primary care clinics in two rural communities in Kentucky. Intervention components include patient navigation using a Community Health Worker (CHW), health information technology (HIT) and quality improvement (QI) support to both clinical and community partners. Patients who screen positive for unmet social needs will work with CHWs to be connected to community organizations. The HIT support component includes implementing the Kentucky Health Information Exchange referral communication tool between clinics and community organizations and using the Kynect resource directory to refer patients to location-specific social services and community resources. The QI component includes identifying a quality improvement team and site champion, one-on-one calls with a QI advisor, action periods to test QI strategies, and support to validate health outcomes and social needs screening data.
  • No Intervention: Usual Care
    Clinics randomized to the control arm will receive usual care

Primary Outcome Measure

Number of participants screened for social needs [ Time Frame: Baseline, month 6 and month 12 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of KentuckyLexingtonKentucky40506
Mary E Lacy, PhD
[email protected]
8595621126

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By research site
University of Kentucky· Lexington, KY

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