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

NCT ID: NCT07196007

Last Updated: 2025-11-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 12000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2027-10-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Community-Clinical Intervention

Intervention Type: 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.

Usual Care

Clinics randomized to the control arm will receive usual care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• staff at the intervention or comparison clinic

• age 18 or older,
• is a patient at the intervention or comparison clinic
• diagnosed with diabetes

Exclusion Criteria

• staff not at the intervention or comparison clinic

• being under the age of 18,
• not a patient at the intervention or comparison clinic
• not diagnosed with diabetes

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mary Lacy

OTHER

Sponsor Role: lead

Centers for Disease Control and Prevention

FED

Sponsor Role: collaborator

Responsible Party

Mary Lacy

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Beth Lacy Leigh

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

University of Kentucky

Lexington, Kentucky, United States

Countries

United States

Central Contacts

Carol R White, MPH

Role: CONTACT

crwhit3@uky.edu

859-562-2684

Mary Lacy Leigh, PhD

Role: CONTACT

mary.lacy@uky.edu

Facility Contacts

Beth Lacy, PhD

Role: primary

mary.lacy@uky.edu

Other Identifiers

75D30124C20318

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

100380

Identifier Type: -

Identifier Source: org_study_id