An educational toolkit designed to improve care of patients with diabetes was not effective, Baiju R Shah and colleagues (University of Toronto) found in a cluster randomized trial conducted in 2009-2011. During 10 months of follow-up, patients of Canadian family physicians who had been cluster-randomized to receive the toolkit did not receive improved care and their outcomes did not differ compared with patients of physicians who did not receive the toolkit. All 933,789 people aged ≥40 years with diagnosed diabetes in Ontario, Canada, were studied using population-level administrative databases and evaluated for the primary outcome in the administrative data study, death or non-fatal myocardial infarction. This composite outcome occurred in 11,736 (2.5%) patients in the intervention group and 11,536 (2.5%) in the control group (p = 0.77). Additional clinical outcome data was collected from a random sample of 1,592 high risk patients. The primary outcome in this clinical data study was use of a statin; this occurred in 700 (88.1%) patients in the intervention group and 725 (90.1%) in the control group (p = 0.26). Other secondary outcomes, including other clinical events, were also not improved by the intervention. In a few cases the educational toolkit was actually associated with slightly worse process-of-care outcomes. A limitation was that a very high proportion of the high risk patients in the clinical study group were already prescribed statins. The authors conclude, “The results of this study highlight the need for a rigorous and scientifically based approach to the development, dissemination, and evaluation of quality improvement interventions.”
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