Health Literacy Intervention to Improve Diabetes Outcomes Among Rural Primary Care Patients
NCT ID: NCT02779556
Last Updated: 2021-12-15
Study Results
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View full resultsBasic Information
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COMPLETED
NA
756 participants
INTERVENTIONAL
2016-11-07
2020-02-12
Brief Summary
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The primary aims are to:
1. test the effectiveness of the ACP diabetes health literacy intervention to improve a range of diabetes-related outcomes among rural patients;
2. compared to usual care, evaluate whether the intervention reduces disparities by patient literacy level.
The secondary aims are to:
3. investigate whether a threshold or gradient effect exists between the amount of follow-up counseling (number of action plans) and intervention effectiveness;
4. 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
5. assess the costs associated with implementing the intervention from a health system perspective.
Detailed Description
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1. a diabetes guide that uses plain language and descriptive photographs to teach core diabetes concepts and empower patients to initiate behavior change;
2. a brief counseling strategy to assist patients in developing short-term, explicit and attainable goals for behavior change ('action plans');
3. 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;
4. 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:
1. test the effectiveness of the ACP diabetes health literacy intervention to improve a range of diabetes-related outcomes among rural patients;
2. compared to usual care, evaluate whether the intervention reduces disparities by patient literacy level.
The secondary aims are to:
3. investigate whether a threshold or gradient effect exists between the amount of follow-up counseling (number of action plans) and intervention effectiveness;
4. 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
5. assess the costs associated with implementing the intervention from a health system perspective.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Enhanced Usual Care
ADA Living Well with Diabetes Workbook, 15 minute in-person counseling, follow-up every 3 months
ADA Living Well with Diabetes Workbook
American Diabetes Association (ADA) Living Well with Diabetes Workbook
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
ACP Living with Diabetes Guide
American Colleges of Physicians (ACP) Living Well with Diabetes Guide
Interventions
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ACP Living with Diabetes Guide
American Colleges of Physicians (ACP) Living Well with Diabetes Guide
ADA Living Well with Diabetes Workbook
American Diabetes Association (ADA) Living Well with Diabetes Workbook
Eligibility Criteria
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Inclusion Criteria
* 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
* hearing impairments
* cognitive impairments
21 Years
ALL
Yes
Sponsors
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Northwestern University
OTHER
Louisiana State University Health Sciences Center Shreveport
OTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
University of Arkansas
OTHER
Responsible Party
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Principal Investigators
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Kristie Hadden, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Arkansas
Locations
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UAMS Family Medical Center Northwest
Fayetteville, Arkansas, United States
UAMS Family Medical Center Fort Smith
Fort Smith, Arkansas, United States
UAMS Family Medical Center Jonesboro
Jonesboro, Arkansas, United States
UAMS Family Medical Center Magnolia
Magnolia, Arkansas, United States
UAMS Family Medical Center Pine Bluff
Pine Bluff, Arkansas, United States
UAMS Family Medical Center Texarkana
Texarkana, Arkansas, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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204290
Identifier Type: -
Identifier Source: org_study_id