Clinical trial NCT02779556: Health Literacy Intervention to Improve Diabetes Outcomes Among Rural Primary Care Patients
Official title: Health Literacy Intervention to Improve Diabetes Outcomes Among Rural Primary Care Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: Health Literacy
Diabetes
Lead sponsor: University of Arkansas
Sponsor class: OTHER
Collaborators: name: Northwestern University
name: Louisiana State University Health Sciences Center Shreveport
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2016-05-20
Enrollment: 756
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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: 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.

Eligibility 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

Primary outcomes:
measure: Hemoglobin A1C (HbA1C)
timeFrame: Six months
measure: Hemoglobin A1C (HbA1C)
timeFrame: Twelve months
Secondary outcomes:
measure: Diabetes Knowledge
timeFrame: Three months
measure: Diabetes Knowledge (0-13)
timeFrame: Six months
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: UAMS Family Medical Center Northwest
state: Arkansas
city: Fort Smith
country: United States
facility: UAMS Family Medical Center Fort Smith
state: Arkansas
city: Jonesboro
country: United States
facility: UAMS Family Medical Center Jonesboro
state: Arkansas
city: Magnolia
country: United States
facility: UAMS Family Medical Center Magnolia
state: Arkansas
city: Pine Bluff
country: United States
facility: UAMS Family Medical Center Pine Bluff
state: Arkansas
city: Texarkana
country: United States
facility: UAMS Family Medical Center Texarkana
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Kristie Hadden, PhD
role: PRINCIPAL_INVESTIGATOR
References: