REMEDIES4D: REdesigning MEDication Intensification Effectiveness Study for Diabetes (Remedies4D)
The proposed research study aims to determine whether applying the University of Pittsburgh Medical Center Nurse-Directed Diabetes Management Protocols (NDMPs) leads to improved clinical outcome and process measures as recommended by American Diabetes Association (ADA), quality of life, treatment satisfaction and medication adherence for adults with diabetes, and favorable providers' satisfaction as compared to usual diabetes care. Furthermore, the cost-effectiveness of performing the NDMPs compared to usual diabetes care in primary care settings will also be assessed.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Redesigning Medication Intensification Effectiveness Study for Diabetes|
- Glycated hemoglobin (A1C) [ Time Frame: 1 year ] [ Designated as safety issue: No ]Change in HbA1c blood test
- Blood pressure (systolic and diastolic blood pressure [ Time Frame: 1 year ] [ Designated as safety issue: No ]Change in systolic and diastolic blood pressure reading
- Lipids (LDLc, HDLc, cholesterol, and triglyceride) [ Time Frame: 1 year ] [ Designated as safety issue: No ]Change in LDLc, HDLc, cholesterol, and triglyceride valuses
|Study Start Date:||April 2012|
|Estimated Study Completion Date:||July 2014|
|Estimated Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
|No Intervention: Usual Care|
|Experimental: Intervention Group, treatment algorithms||
Other: Treatment Algorithms
subjects in the intervention group will receive diabetes care from a well-trained registered nurse (RN) who will follow approved treatment algorithms/protocols for glycemia, high blood pressure, lipids and microalbuminuria.
This proposed study is a multi-practice, cluster-design, prospective randomized controlled trial with a total study intervention period of 12 months. This prospective randomized controlled trial will assess the effectiveness of performing NDMPs by the registered nurse supervised by a physician (the intervention group) in comparison with usual diabetes care (the usual care group) for adults with diabetes in primary care settings. The study population will be recruited from University of Pittsburgh Medical Center Community Medicine Inc. (CMI) primary care practices in urban and suburban communities surrounding Pittsburgh, PA. Among these CMI practices, ten practices receive diabetes education services from University of Pittsburgh Diabetes Institute and will be the intervention group. These diabetes education services will be enhanced by the addition of NDMPs intervention. In addition, we will select another 10 CMI practices to be the usual care group. This group receives standard diabetes education with no use of NDMPs. One-hundred and fifty participants will be recruited across practices within each study group (i.e., 300 in total). Outcomes assessed in this study include clinical outcome and process measures as recommended by ADA, participants' quality of life, treatment satisfaction, and medication adherence, and providers' satisfaction, and costs/expenditure. Assessments will be done at baseline, and three and 12 months after the study entry. Analysis of the study outcomes will be based on intention-to-treat to determine (1) within-group differences between the baseline and follow-up visits, and (2) between-group differences between the intervention group and the usual care group.
|United States, Pennsylvania|
|University of Pittsburgh Medical Center Community Medicine Inc. (UPMC CMI) Primary Care Practices|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Janice Zgibor, RPh PhD||University of Pittsburgh|