Leveraging Community-clinical Linkages to Address Unmet Social Needs for People With Diabetes Living in Rural Settings
Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:
• staff at the intervention or comparison clinic
• age 18 or older,
• is a patient at the intervention or comparison clinic
• diagnosed with diabetes
Locations
United States
Kentucky
University of Kentucky
RECRUITING
Lexington
Contact Information
Primary
Carol R White, MPH
crwhit3@uky.edu
859-562-2684
Backup
Mary Lacy Leigh, PhD
mary.lacy@uky.edu
Time Frame
Start Date: 2026-03-10
Estimated Completion Date: 2027-10
Participants
Target number of participants: 12000
Treatments
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
Related Therapeutic Areas
Sponsors
Collaborators: Centers for Disease Control and Prevention
Leads: Mary Lacy