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

NCT07196007 | Recruiting

• 2 other identifiers: 10038075D30124C20318
• Study Type: interventional
• Target: 12,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Diabetes Mellitus

Keywords

Unmet social needs

Outcome Measures

Primary Outcomes (2)

• Number of participants screened for social needs

  Number of participants screened for social needs intervention compared to control

  Baseline, month 6 and month 12

• Number of referrals to community based organization by primary care clinic

  Number of referrals to community based organization in intervention compared to control

  Baseline, month 6 and month 12

Secondary Outcomes (3)

• Change in Status of social needs

  Baseline, month 6 and month 12

• Change in Patient-Reported Outcomes Measurement Information System (PROMIS) -29

  Baseline, month 6 and month 12

• Percent of participants with A1c greater than or equal to 9.0%

  Baseline, month 6 and month 12

Study Arms (2)

Usual Screening Patients with Diabetes for Unmet Social Needs Plus a Community-Clinical Intervention

EXPERIMENTAL

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.

Behavioral: Community-Clinical Intervention

Usual Care

NO INTERVENTION

Clinics randomized to the control arm will receive usual care

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.

Usual Screening Patients with Diabetes for Unmet Social Needs Plus a Community-Clinical Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mary Lacy: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40506, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Beth Lacy Leigh

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carol R White, MPH

CONTACT

859-562-2684; crwhit3@uky.edu

Mary Lacy Leigh, PhD

CONTACT

mary.lacy@uky.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: A hybrid type 2 design to evaluate the effectiveness and implementation of a community-clinic linkage (CCL) intervention in primary care clinics and a mixed methods approach to examine process factors that affect reach, acceptance, and fidelity of the CCL intervention.

Study Record Dates

• First Submitted: September 19, 2025
• First Posted: September 29, 2025
• Study Start: March 10, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)