Abstract
BackgroundThere is evidence to suggest that delivery of diabetes self-management support by diabetes educators in primary care may improve patient care processes and patient clinical outcomes; however, the evaluation of such a model in primary care is nonexistent in Canada. This article describes the design for the evaluation of the implementation of Mobile Diabetes Education Teams (MDETs) in primary care settings in Canada.Methods/designThis study will use a non-blinded, cluster-randomized controlled trial stepped wedge design to evaluate the Mobile Diabetes Education Teams' intervention in improving patient clinical and care process outcomes. A total of 1,200 patient charts at participating primary care sites will be reviewed for data extraction. Eligible patients will be those aged ≥18, who have type 2 diabetes and a hemoglobin A1c (HbA1c) of ≥8%. Clusters (that is, primary care sites) will be randomized to the intervention and control group using a block randomization procedure within practice size as the blocking factor. A stepped wedge design will be used to sequentially roll out the intervention so that all clusters eventually receive the intervention. The time at which each cluster begins the intervention is randomized to one of the four roll out periods (0, 6, 12, and 18 months). Clusters that are randomized into the intervention later will act as the control for those receiving the intervention earlier. The primary outcome measure will be the difference in the proportion of patients who achieve the recommended HbA1c target of ≤7% between intervention and control groups. Qualitative work (in-depth interviews with primary care physicians, MDET educators and patients; and MDET educators’ field notes and debriefing sessions) will be undertaken to assess the implementation process and effectiveness of the MDET intervention.Trial registrationClinicalTrials.gov NCT01553266
Highlights
There is evidence to suggest that delivery of diabetes self-management support by diabetes educators in primary care may improve patient care processes and patient clinical outcomes; the evaluation of such a model in primary care is nonexistent in Canada
The few studies that exist on the delivery of diabetes selfmanagement support (DSMS) in primary care have found that DSMS has numerous benefits on patient clinical and care process outcomes, such as an improvement in patient knowledge [12,13,14]; a reduction in body weight [13], hemoglobin A1c (HbA1c) [12,13,14,15,16], cholesterol [14,15,16,17], fasting blood glucose [13,18], self-blood glucose monitoring [16] and blood pressure [18]; and improved primary care physician (PCP) adherence to diabetes clinical practice guidelines [14,17]
We assume that the increasing prevalence of diabetes, combined with its complexity, rapidly evolving medical therapies and the requirement for patient self-management will lead to a growing demand for shared care across disciplines that target improvements in diabetes care and management [55]
Summary
Diabetes mellitus is a chronic illness that requires a lifelong commitment to complex lifestyle modifications involving nutrition management, a physically active lifestyle, regular self-monitoring of blood glucose and adherence to medications and/or insulin therapy. The few studies that exist on the delivery of DSMS in primary care have found that DSMS has numerous benefits on patient clinical and care process outcomes, such as an improvement in patient knowledge [12,13,14]; a reduction in body weight [13], HbA1c [12,13,14,15,16], cholesterol [14,15,16,17], fasting blood glucose [13,18], self-blood glucose monitoring [16] and blood pressure [18]; and improved primary care physician (PCP) adherence to diabetes clinical practice guidelines [14,17] None of these studies have been conducted within a Canadian setting. (iii) An increase in the proportion of referrals to and patients’ utilization of DEPs in the intervention group compared to one year prior to the start of the intervention
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