Leveraging Community-clinical Linkages to Address Unmet Social Needs for People With Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Community-Clinical Intervention.
- Who it may be relevant to
- Registry conditions: Diabetes, Diabetes Mellitus. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Leveraging Community-clinical Linkages to Address Unmet Social Needs for People With Diabetes Living in Rural Settings
Overview
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.
Interventions
- Behavioral 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 measures
- 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]
Secondary outcome measures (3)
- Change in Status of social needs [Time frame: Baseline, month 6 and month 12]
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS) -29 [Time frame: Baseline, month 6 and month 12]
- Percent of participants with A1c greater than or equal to 9.0% [Time frame: Baseline, month 6 and month 12]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United States · 1 center
- University of Kentucky — Lexington
Identifiers
NCT: NCT07196007 · 100380 · 75D30124C20318