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

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:

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.

Study Overview

• Status: Completed
• Conditions: Diabetes
• Intervention / Treatment: Other: ADA Living Well with Diabetes Workbook; Other: ACP Living with Diabetes Guide

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:

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.

• Study Type: Interventional
• Enrollment (Actual): 756
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Fayetteville, Arkansas, United States, 72703
      • UAMS Family Medical Center Northwest
    • Fort Smith, Arkansas, United States, 72901
      • UAMS Family Medical Center Fort Smith
    • Jonesboro, Arkansas, United States, 72401
      • UAMS Family Medical Center Jonesboro
    • Magnolia, Arkansas, United States, 71753
      • UAMS Family Medical Center Magnolia
    • Pine Bluff, Arkansas, United States, 71603
      • UAMS Family Medical Center Pine Bluff
    • Texarkana, Arkansas, United States, 71854
      • UAMS Family Medical Center Texarkana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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; American Diabetes Association (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; American Colleges of Physicians (ACP) Living Well with Diabetes Guide

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Arkansas
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Northwestern University; Louisiana State University Health Sciences Center Shreveport
• Investigators: Principal Investigator: Kristie Hadden, PhD, University of Arkansas

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2016
• Primary Completion (Actual): February 12, 2020
• Study Completion (Actual): February 12, 2020

Study Registration Dates

• First Submitted: May 4, 2016
• First Submitted That Met QC Criteria: May 18, 2016
• First Posted (Estimate): May 20, 2016

Study Record Updates

• Last Update Posted (Actual): December 15, 2021
• Last Update Submitted That Met QC Criteria: December 14, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Diabetes; Health Literacy
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: 204290; 1R01DK107572-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The investigators are committed to the open and timely dissemination of the research outcomes. Plans for sharing resources with the scientific community include presentations and publications in peer-reviewed journals. The final data set will be made available to NIH investigators upon request. Consulting with program officer to ensure data sharing compliance.
• IPD Sharing Time Frame: This will be available 6 months after publication of main study results.
• IPD Sharing Access Criteria: Require an NIH investigator with an IRB approved protocol, to conduct secondary data analysis of the available dataset.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No