Rationale and development of a randomized pragmatic trial to improve diabetes outcomes in patient-centered medical homes serving rural patients

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 can be readily implemented and sustained in rural clinics with limited resources that disproportionately care for patients with limited literacy. Researchers on our team developed an evidence-based, patient-centered, low literacy intervention promoting diabetes self-care that includes: 1) the American College of Physicians (ACP) 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'); and 3) a training module for health coaches that prepares them to assume educator/counselor roles with the Diabetes Guide as a teaching tool. While the intervention has previously been field tested and found to significantly improve patient knowledge, self-efficacy, and engagement in related health behaviors, its optimal implementation is not known. This project took advantage of a unique opportunity to modify and disseminate the ACP health literacy intervention among patients with type 2 diabetes cared for at rural clinics in Arkansas that are Patient-Centered Medical Homes (PCMH). These practices all had health coaches that could be leveraged to provide chronic disease self-management mostly via phone, but also at the point-of-care. Hence we conducted a patient-randomized, pragmatic clinical trial in 6 rural PCMHs in Arkansas, targeting individuals with uncontrolled type 2 diabetes.