Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02779556 |
| Other study ID # |
204290 |
| Secondary ID |
1R01DK107572-01A |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 7, 2016 |
| Est. completion date |
February 12, 2020 |
Study information
| Verified date |
December 2021 |
| Source |
University of Arkansas |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
