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

Mary Lacy

Status: Not yet enrolling

Conditions: Diabetes; Diabetes Mellitus

Treatments: Behavioral: Community-Clinical Intervention

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT07196007

100380

75D30124C20318 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12,000 participants in 2 patient groups

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

Experimental group

Description:

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.

Treatment:

Behavioral: Community-Clinical Intervention

Usual Care

No Intervention group

Description:

Clinics randomized to the control arm will receive usual care