Health Literacy Intervention to Improve Diabetes Outcomes Among Rural Primary Care Patients

Study Overview
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Brief Summary
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The researchers will conduct a patient-randomized, pragmatic clinical trial among 6 rural PCMHs in Arkansas, targeting individuals with uncontrolled type 2 diabetes. The primary aims are to: test the effectiveness of the ACP diabetes health literacy intervention to improve a range of diabetes-related outcomes among rural patients; compared to usual care, evaluate whether the intervention reduces disparities by patient literacy level. The secondary aims are to: investigate whether a threshold or gradient effect exists between the amount of follow-up counseling (number of action plans) and intervention effectiveness; determine the fidelity of all intervention components, and explore any identified patient, provider (physician, nurse, health coach), and/or health system barriers to implementation; and assess the costs associated with implementing the intervention from a health system perspective.

Detailed Description
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The investigators will test the effectiveness and fidelity of embedding the American College of Physicians (ACP) diabetes health literacy intervention among patient-centered medical homes throughout rural Arkansas. Proper diabetes self-care requires patients to have considerable knowledge, a range of skills, and to sustain multiple health behaviors. Self-management interventions are needed that have been designed for individuals with lower literacy skills, that can be readily implemented and sustained among rural clinics with limited resources that disproportionately care for patients with limited literacy. Researchers on the team developed an evidence-based, patient-centered, low literacy ACP intervention promoting diabetes self-care that includes: a diabetes guide that uses plain language and descriptive photographs to teach core diabetes concepts and empower patients to initiate behavior change; a brief counseling strategy to assist patients in developing short-term, explicit and attainable goals for behavior change ('action plans'); a training module for physicians, nurses, and medical assistants that prepares providers to assume educator/counselor roles with the Diabetes Guide as a teaching tool; electronic tracking and monitoring tools for primary care practices. While the intervention has previously been field tested and found to significantly improve patient knowledge, self-efficacy, and engagement in related health behaviors, it has not yet been comprehensively tested in practices, and its optimal implementation is not known. The investigators now have a unique opportunity to learn from prior evaluation, modify and disseminate an ACP health literacy intervention among patients with type 2 diabetes cared at rural clinics in Arkansas that are Patient-Centered Medical Homes (PCMH). These practices are embedding care coordination services that can be leveraged to improve chronic disease management. All are supervised by a new University of Arkansas for Medical Sciences (UAMS) Center for Health Literacy. The investigators' revised intervention will blend outsourced and clinic-based approaches and redeploy health coaches for counseling self-management mostly via phone, but also at the point-of-care. This is a feasible way to reach rural, vulnerable patients. The investigators will conduct a patient-randomized, pragmatic clinical trial among 6 rural PCMHs in Arkansas, targeting individuals with uncontrolled type 2 diabetes. The primary aims are to: test the effectiveness of the ACP diabetes health literacy intervention to improve a range of diabetes-related outcomes among rural patients; compared to usual care, evaluate whether the intervention reduces disparities by patient literacy level. The secondary aims are to: investigate whether a threshold or gradient effect exists between the amount of follow-up counseling (number of action plans) and intervention effectiveness; determine the fidelity of all intervention components, and explore any identified patient, provider (physician, nurse, health coach), and/or health system barriers to implementation; and assess the costs associated with implementing the intervention from a health system perspective.

Official Title
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Health Literacy Intervention to Improve Diabetes Outcomes Among Rural Primary Care Patients

Conditions
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Diabetes

Intervention / Treatment
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* Other: ACP Living with Diabetes Guide
* Other: ADA Living Well with Diabetes Workbook


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 21 years of age or older English speaking active patient at regional family medical center study site confirmed diagnosis of type 2 diabetes as documented in the electronic health record recent Hemoglobin A1c reading of >7.5% and less than or equal to 10% Exclusion Criteria: uncorrectable visual impairments hearing impairments cognitive impairments

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Enhanced Usual Care<br>ADA Living Well with Diabetes Workbook, 15 minute in-person counseling, follow-up every 3 months | Other: ADA Living Well with Diabetes Workbook<br>* American Diabetes Association (ADA) Living Well with Diabetes Workbook<br>|
| Other: Intervention<br>ACP Living with Diabetes Guide, 15 minute in-person counseling , 15 minute follow-up counseling (3, 6, and 9 months), monthly phone calls after 3 months | Other: ACP Living with Diabetes Guide<br>* American Colleges of Physicians (ACP) Living Well with Diabetes Guide<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1C (HbA1C) | HbA1C will be obtained from patients' electronic health records, defined as the value closest to 6 months post baseline. The hemoglobin A1c (HbA1c) value ranges from approximately 4 to 14% where higher HbA1c value means worse outcome. | Six months | 
| Hemoglobin A1C (HbA1C) | HbA1C will be obtained from patients' electronic health records, defined as the value closest to 12 months post baseline. The hemoglobin A1c (HbA1c) value ranges from approximately 4 to 14% where higher HbA1c value means worse outcome. | Twelve months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diabetes Knowledge | A self-reported Diabetes Knowledge Questionnaire that uses 13 multiple choice questions will be administered. Total scores range from 0-13 where higher scores demonstrate more knowledge. | Three months | 
| Diabetes Knowledge (0-13) | A self-reported Diabetes Knowledge Questionnaire that uses 13 multiple choice questions will be administered. Total scores range from 0-13 where higher scores demonstrate more knowledge. | Six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Health Literacy, Diabetes