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NCT02779556 | Completed | Diabetes


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

University of Arkansas

Brief Summary:

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.

Condition or disease

Diabetes

Intervention/treatment

ACP Living with Diabetes Guide

ADA Living Well with Diabetes Workbook

Phase

Not Applicable

Detailed Description:

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.

Study Type : Interventional
Estimated Enrollment : 756 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Health Literacy Intervention to Improve Diabetes Outcomes Among Rural Primary Care Patients
Actual Study Start Date : November 7, 2016
Estimated Primary Completion Date : February 12, 2020
Estimated Study Completion Date : February 12, 2020
Arm Intervention/treatment

Other: Enhanced Usual Care

ADA Living Well with Diabetes Workbook, 15 minute in-person counseling, follow-up every 3 months

Other: ADA Living Well with Diabetes Workbook

Other: Intervention

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

Ages Eligible for Study: 21 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Accepts Healthy Volunteers
Criteria
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

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

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

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Locations


Not yet recruiting

United States, Arkansas

UAMS Family Medical Center Northwest

Fayetteville, Arkansas, United States, 72703

Not yet recruiting

United States, Arkansas

UAMS Family Medical Center Fort Smith

Fort Smith, Arkansas, United States, 72901

Not yet recruiting

United States, Arkansas

UAMS Family Medical Center Jonesboro

Jonesboro, Arkansas, United States, 72401

Not yet recruiting

United States, Arkansas

UAMS Family Medical Center Magnolia

Magnolia, Arkansas, United States, 71753

Not yet recruiting

United States, Arkansas

UAMS Family Medical Center Pine Bluff

Pine Bluff, Arkansas, United States, 71603

Not yet recruiting

United States, Arkansas

UAMS Family Medical Center Texarkana

Texarkana, Arkansas, United States, 71854

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