Diabetes, Diabetes Mellitus
Conditions
Keywords
Unmet social needs
Brief summary
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
BEHAVIORALCommunity-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.
Sponsors
Mary Lacy
Centers for Disease Control and Prevention
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants screened for social needs | Baseline, month 6 and month 12 | Number of participants screened for social needs intervention compared to control |
| Number of referrals to community based organization by primary care clinic | Baseline, month 6 and month 12 | Number of referrals to community based organization in intervention compared to control |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Status of social needs | Baseline, month 6 and month 12 | 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. |
| Change in Patient-Reported Outcomes Measurement Information System (PROMIS) -29 | Baseline, month 6 and month 12 | 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. |
| Percent of participants with A1c greater than or equal to 9.0% | Baseline, month 6 and month 12 | Change in A1c level; Diabetes control (A1c \< 9.0% controlled vs A1c =9% uncontrolled) via Electronic Health Record extract |
Countries
United States
Contacts
CONTACTCarol R White, MPH
CONTACTMary Lacy Leigh, PhD
PRINCIPAL_INVESTIGATORBeth Lacy Leigh
University of Kentucky
Outcome results
None listed