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| ID | Type | Description | Link |
|---|---|---|---|
| 75D30124C20318 | Other Grant/Funding Number | CDC |
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| Name | Class |
|---|---|
| Centers for Disease Control and Prevention | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Usual Care | No Intervention | Clinics randomized to the control arm will receive usual care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Community-Clinical Intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants screened for social needs | Number of participants screened for social needs intervention compared to control | 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 | Baseline, month 6 and month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, month 6 and month 12 |
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Clinic/Staff Inclusion Criteria:
Participant Inclusion Criteria:
Clinic/Staff Exclusion Criteria:
Participant Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carol R White, MPH | Contact | 859-562-2684 | crwhit3@uky.edu | |
| Mary Lacy Leigh, PhD | Contact | mary.lacy@uky.edu |
| Name | Affiliation | Role |
|---|---|---|
| Beth Lacy Leigh | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky | Recruiting | Lexington | Kentucky | 40506 | United States |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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A hybrid type 2 design to evaluate the effectiveness and implementation of a community-clinic linkage (CCL) intervention in primary care clinics and a mixed methods approach to examine process factors that affect reach, acceptance, and fidelity of the CCL intervention.
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| 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. |
| 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 | Baseline, month 6 and month 12 |