Research Project
6665226
DESCRIPTION (provided by applicant): The primary aim of the proposed randomized controlled trial (RCT) is to test the effectiveness of a collaborative management intervention in improving the overall well being of high risk indigent diabetic patients who receive their care in a hospital-based internal medicine clinic. The emphasis of the model is to place the patient at the center of complex evaluation and treatment planning. Major components of the model include: 1) patient-centered assessment and teaching that are appropriate for low-literacy levels and economically disadvantaged patients, 2) development of customized evidence-based treatment recommendations in response to patient?s preferences, beliefs and needs; 3) proactively monitored care delivery coordinated by an Advanced Practice Nurse care manager (APN-CM) that addresses physical and psychosocial problems; 4) integration of generalist and specialist care through informed multi-disciplinary collaborative management of patients, and 5) education to improve self efficacy and promote productive patient and clinician encounters. The intervention will follow a timetable that includes an intensive patient-centered management phase during the first six months and a stepped down maintenance phase during the second six months to assess sustainability of change. Two primary hypotheses will be tested using 80 patients randomly assigned to usual care plus education and 80 patients randomly assigned to the collaborative management-intervention. First, a difference in overall well being between the intervention and control groups will be tested at six months. Second, we will test whether the superiority of the intervention is sustained during the second six months in which management intensity is stepped down. A comprehensive measure of overall well being of high-risk diabetic patients will be obtained at the 6-month and 12-month measurements. Overall well being will be measured through multiple endpoints defined by the following 5 domains: Glycemic control, Hospitalization days, Quality of life, Quality of evidence-based management, and Quality of patient self-management. Comparison of the intervention and control groups across these domains will be accomplished using a global hypothesis testing strategy for the multiple endpoints that is ideally suited to diabetes care management trials.
