scholarly journals Printed educational materials directed at Ontario family physicians do not improve adherence to guideline recommendations for diabetes management: a pragmatic, factorial, cluster randomized controlled trial [ISRCTN72772651]

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Alison H. Howie ◽  
Neil Klar ◽  
Danielle M. Nash ◽  
Jennifer N. Reid ◽  
Merrick Zwarenstein

Abstract Background Printed educational materials (PEMs) have long been used to inform clinicians on evidence-based practices. However, the evidence for their effects on patient care and outcomes is unclear. In Ontario, despite widely available clinical practice guidelines recommending antihypertensives and cholesterol-lowering agents for patients with diabetes, prescriptions remain low. We aimed to determine whether PEMs can influence physicians to intensify prescribing of these medications. Methods A pragmatic, 2 × 2 factorial, cluster randomized controlled trial was designed to ascertain the effect of two PEM formats on physician prescribing: a postcard-sized message (“outsert”) or a longer narrative article (“insert”). Ontario family physician practices (clusters) were randomly allocated to receive the insert, outsert, both or neither. Physicians were eligible if they were in active practice and their patients were included if they were over 65 years with a diabetes diagnosis; both were unaware of the trial. Administrative databases at ICES (formerly the Institute for Clinical Evaluative Sciences) were used to link patients to their physician and to analyse prescribing patterns at baseline and 1 year following PEM mailout. The primary outcome was intensification defined as the addition of a new antihypertensive or cholesterol-lowering agent, or dose increase of a current drug, measured at the patient level. Analyses were by intention-to-treat and accounted for the clustering of patients to physicians. Results We randomly assigned 4231 practices (39% of Ontario family physicians) with a total population of 185,526 patients (20% of patients with diabetes in Ontario primary care) to receive the insert, outsert, both, and neither; among these, 4118 practices were analysed (n = 1025, n = 1037, n = 1031, n = 1025, respectively). No significant treatment effect was found for the outsert (odds ratio (OR) 1.01, 95% confidence interval (CI) 0.98 to 1.04) or the insert (OR 0.99, 95% CI 0.96 to 1.02). Percent of intensification in the four arms was similar (approximately 46%). Adjustment for physician characteristics (e.g., age, sex, practice location) had no impact on these findings. Conclusions PEMs have no effect on physician’s adherence to recommendations for the management of diabetes-related complications in Ontario. Further research should investigate the effect of other strategies to narrow this evidence-to-practice gap. Trial registration ISRCTN72772651. Retrospectively registered 21 July 2005.

2021 ◽  
pp. 174077452110015
Author(s):  
Arielle Weir ◽  
Justin Presseau ◽  
Simon Kitto ◽  
Ian Colman ◽  
Simon Hatcher

Background Recruitment and engagement of clusters in a cluster randomized controlled trial can sometimes prove challenging. Identification of successful or unsuccessful strategies may be beneficial in guiding future researchers in conducting their cluster randomized controlled trial. This study aimed to identify strategies that could be used to facilitate the delivery of cluster randomized controlled trials in hospitals. Methods The study employed the Consolidated Framework for Implementation Research–Expert Recommendations for Implementing Change matching tool. The barriers and enablers to cluster randomized controlled trial conduct identified in our previously conducted studies served as a means of determinant identification for the conduct of cluster randomized controlled trials. These determinants were mapped to Consolidated Framework for Implementation Research constructs and then matched to Expert Recommendations for Implementing Change compilation strategies using the Consolidated Framework for Implementation Research–Expert Recommendations for Implementing Change matching tool. Results The Expert Recommendations for Implementing Change strategies matched to at least one determinant Consolidated Framework for Implementation Research construct were as follows: (1) ‘Identify and prepare champions’, (2) ‘Conduct local needs assessment’, (3) ‘Conduct educational meetings’, (4) ‘Inform local opinion leaders’, (5) ‘Build a coalition’, (6) ‘Promote adaptability’, (7) ‘Develop a formal implementation blueprint’, (8) ‘Involve patients/consumers and family members’, (9) ‘Obtain and use patients/consumers and family feedback’, (10) ‘Develop educational materials’, (11) ‘Promote network weaving’, (12) ‘Distribute educational materials’, (13) ‘Access new funding’ and (14) ‘Develop academic partnerships’. Conclusion This study was intended as a step in the research agenda aimed at facilitating cluster randomized controlled trial delivery in hospitals and can act as a resource for future researchers when planning their cluster randomized controlled trial, with the expectation that the strategies identified here will be tailored to each context.


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