NCT07196007

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

Leveraging Community-clinical Linkages to Address Unmet Social Needs for People With Diabetes Living in Rural Settings

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 12,000 (estimated)
• Sponsor: Mary Lacy · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

This study will convene clinical and community partners to complete a rapid process improvement workshop (RPIW) to co-create scalable strategies to address unmet social needs and to implement the developed strategy in primary care clinics in two rural communities in Kentucky. Results from the RPIW will be used to design an implementation template with specific implementation strategies tailored to each unique community-clinical linkage (CCL). While implementation strategies will be tailored to each CCL, the overarching intervention components for all CCL include: 1) patient navigators; 2) health information technology; and 3) quality improvement support to clinical and community partners. The finalized intervention will then be rolled out across partner clinics using a parallel-group cluster design that facilitates pragmatic randomization. The effect of the intervention on referrals will be assessed by comparing referrals between intervention and control clinics. Secondary effectiveness outcomes include status of social needs (improved or not), patient-reported quality of life, and diabetes control (A1c \< 9.0% controlled vs A1c =9% uncontrolled). To evaluate implementation outcomes, we will use a mixed methods approach to examine process factors that affect reach, acceptance, and fidelity of the CCL intervention. This approach allows us to examine which strategies can be replicated and scaled up for implementation in other communities.

Conditions

• Diabetes
• Diabetes Mellitus

Interventions

Type	Name	Description
BEHAVIORAL	Community-Clinical Intervention	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.

Timeline

• Start date: 2026-03-10
• Primary completion: 2027-03-01
• Completion: 2027-10-01
• First posted: 2025-09-29
• Last updated: 2026-03-27

Locations

1 site across 1 country: United States