Skip to main content
Clinical Trials/NCT07196007
NCT07196007Not yet recruitingNot Applicable

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

Mary Lacy1 site in 1 country12,000 target enrollmentStarted: March 10, 2026Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
12,000
Locations
1
Primary Endpoint
Number of participants screened for social needs

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •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

Arms & Interventions

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.

Intervention: Community-Clinical Intervention (Behavioral)

Usual Care

No Intervention

Clinics randomized to the control arm will receive usual care

Outcomes

Primary Outcomes

Number of participants screened for social needs

Time Frame: Baseline, month 6 and month 12

Number of participants screened for social needs intervention compared to control

Number of referrals to community based organization by primary care clinic

Time Frame: Baseline, month 6 and month 12

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

Secondary Outcomes

  • 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)

Investigators

Sponsor
Mary Lacy
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Mary Lacy

Assistant Professor

University of Kentucky

Study Sites (1)

Loading locations...

Similar Trials