Recruiting

Community-Clinical Linkage

Sponsor:

Mary Lacy

Code:

NCT07196007

Conditions

Diabetes

Diabetes Mellitus

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Community-Clinical Intervention

Study Details

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

Study ID

NCT07196007

Start date

Mar 10, 2026

Status verified date

Feb, 2026

Completion date

Oct, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Clinic/Staff Inclusion Criteria:

  • staff at the intervention or comparison clinic

Participant Inclusion Criteria:

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

Clinic/Staff Exclusion Criteria:

  • staff not at the intervention or comparison clinic

Participant Exclusion Criteria:

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

Study Design

Enrollment

12000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

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

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.

Primary outcome measure

  • Number of participants screened for social needs [ Time Frame: Baseline, month 6 and month 12 ]
  • Number of referrals to community based organization by primary care clinic [ Time Frame: Baseline, month 6 and month 12 ]

Central Contacts and Locations

Central contacts

Carol R White, MPH

859-562-2684crwhit3@uky.edu

Mary Lacy Leigh, PhD

mary.lacy@uky.edu

Locations

University of Kentucky

Recruiting

Lexington, Kentucky, United States, 40506

Contacts

Mary E Lacy, PhD

8595621126mary.lacy@uky.edu

More Information

Sponsor

Mary Lacy

Last update posted

Mar 27, 2026

Last verified

Feb, 2026

Keywords

  • Unmet social needs

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mary Lacy on 2026-03-27.