Proactive Diabetes Case Management
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Proactive Diabetes Case Management|
|Study Completion Date:||August 2002|
Despite a growing array of therapeutic options and efficacious treatment strategies to prevent or delay some of the most severe complications of type 2 diabetes, there continue to be many individuals with outcomes that are far from optimal. Interventions to improve diabetes care by educating providers and patients have been disappointing. In the past several years, case management has been widely advocated as a cost-effective approach to coordinate diabetes care and improve outcomes, although there is little rigorous evidence demonstrating the benefits of this type of intervention.
This study had the following specific aims: 1) to evaluate the effect of a targeted, proactive case management intervention for high risk veterans with type 2 diabetes on: a) glycemic control, b) intermediate cardiovascular outcomes, c) satisfaction, d) adherence to specific care standards, and e) short-term resource utilization; and 2) using Monte Carlo simulation models, to estimate the expected impact of changes in key processes of care and intermediate outcomes on end-stage outcomes.
This study was conducted as a prospective randomized controlled trial. Participating veterans with diabetes (N = 246) receiving care at two VAMCs were randomly assigned, stratified by site and baseline hemoglobin A1c (A1c), to the intervention or control group. The intervention consisted of two nurse practitioners who actively monitored and coordinated patient care, guided by approved treatment algorithms. Data for the study were collected through a baseline and exit examination, a baseline and exit survey, and the VA medical information system. The primary outcome measure was the change in glycemic control, as measured by A1c. Secondary outcomes included serum LDL, blood pressure, satisfaction, and resource utilization. The data were analyzed using univariate and bi-variate (t-test, Wilcoxon rank-sum, chi-square) methods as well as multivariable regression.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00013208
|United States, Michigan|
|VA Ann Arbor Healthcare System, Ann Arbor, MI|
|Ann Arbor, Michigan, United States, 48105|
|Principal Investigator:||Sarah L. Krein, PhD RN||VA Ann Arbor Healthcare System, Ann Arbor, MI|
|Principal Investigator:||Alan J. Pawlow, MD||John D. Dingell VA Medical Center, Detroit, MI|
|Principal Investigator:||Rodney A. Hayward, MD||VA Ann Arbor Healthcare System, Ann Arbor, MI|