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

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

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.

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.

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