An interventional study of Community-Clinical Intervention in Diabetes and Diabetes Mellitus, sponsored by Mary Lacy. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-27.
Sponsored by Mary Lacy · Not applicable, Interventional, and Health services research
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's planned enrollment of 12,000 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Mary Lacy is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Clinic/Staff Inclusion Criteria:
Participant Inclusion Criteria:
Clinic/Staff Exclusion Criteria:
Participant Exclusion Criteria:
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.
Behavioral: Community-Clinical Intervention
Clinics randomized to the control arm will receive usual care
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.
Number of participants screened for social needs
Number of participants screened for social needs intervention compared to control
Time frame: Baseline, month 6 and month 12
Number of referrals to community based organization by primary care clinic
Number of referrals to community based organization in intervention compared to control
Time frame: Baseline, month 6 and month 12
Change in Status of social needs
Change in status of social needs, answered by a yes/no question as to accessed or not. Social needs include food insecurity, housing instability, difficulty with utilities, transportation issues, and intimate partner violence. Data will be reported as aggregate across needs.
Time frame: Baseline, month 6 and month 12
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) -29
The PROMIS - 29 measures health-related quality of life across seven domains. Scores are standardized on a T-score metric, with a mean of 50 and a standard deviation of 10 in a referent population. A higher score means more of the concept being measured.
Time frame: Baseline, month 6 and month 12
Percent of participants with A1c greater than or equal to 9.0%
Change in A1c level; Diabetes control (A1c \< 9.0% controlled vs A1c =9% uncontrolled) via Electronic Health Record extract
Time frame: Baseline, month 6 and month 12
Plan to share: No
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Mary Lacy