Improving stroke prevention therapy for patients with atrial fibrillation in primary care: protocol for a pragmatic, clu
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Improving stroke prevention therapy for patients with atrial fibrillation in primary care: protocol for a pragmatic, clusterrandomized trial Theresa M. Lee1,2*, Noah M. Ivers1,2,3,4,5, Sacha Bhatia1,2,5,7, Debra A. Butt4,6, Paul Dorian7,8, Liisa Jaakkimainen1,2,4,9, Kori Leblanc10,11, Dan Legge1, Dante Morra7,10,12, Alissia Valentinis4,13, Laura Wing1, Jacqueline Young1 and Karen Tu1,2,4,14
Abstract Background: The prevalence of atrial fibrillation (AF) is growing as the population ages, and at least 15% of ischemic strokes are attributed to AF. However, many high-risk AF patients are not offered guideline-recommended stroke prevention therapy due to a variety of system, provider, and patient-level barriers. Methods: We will conduct a pragmatic, cluster-randomized controlled trial randomizing primary care clinics to test a “toolkit” of quality improvement interventions in primary care. In keeping with the recommendations of the chronic care model to simultaneously activate patients and facilitate proactive care by providers, the toolkit includes provider-focused strategies (education, audit and feedback, electronic decision support, and reminders) plus patient-directed strategies (educational letters and reminders). The trial will include two feedback cycles at baseline and approximately 6 months and a final data collection at approximately 12 months. The study will be powered to show a difference of 10% in the primary outcome of proportion of patients receiving guideline-recommended stroke prevention therapy. Analysis will follow the intention-to-treat principle and will be blind to treatment allocation. Unit of analysis will be the patient; models will use generalized estimating equations to account for clustering at the clinical level. Discussion: Stroke prevention therapy using anticoagulation in patients with AF is known to reduce strokes by two thirds or more in clinical trials, but most studies indicate under-use of this treatment in real-world practice. If the toolkit successfully improves care for patients with AF, stakeholders will be engaged to facilitate broader application to maximize the potential to improve patient outcomes. The intervention toolkit tested in this project could also provide a model to improve quality of care for other chronic cardiovascular conditions managed in primary care. Trial registration: ClinicalTrials.gov (NCT01927445). Registered August 14, 2014 at https://clinicaltrials.gov/. Keywords: Atrial fibrillation, Stroke prevention, Multifaceted intervention, Cluster-randomized trial
* Correspondence: [email protected] 1 Institute for Clinical Evaluation Sciences, 2075 Bayview Ave, Toronto, ON M4N 3M5, Canada 2 Institute of Health Policy, Management and Evaluation, University of Toronto, 155 College Street, Suite 425, Toronto, ON M5T 3M6, Canada Full list of author information is available at the end of the article © The Author(s). 2016 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 Internationa
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