Improving stroke prevention therapy for patients with atrial fibrillation in primary care: protocol for a pragmatic, cluster-randomized trial

Abstract

BackgroundThe 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.MethodsWe 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.DiscussionStroke 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 registrationClinicalTrials.gov (NCT01927445). Registered August 14, 2014 at https://clinicaltrials.gov/.Electronic supplementary materialThe online version of this article (doi:10.1186/s13012-016-0523-2) contains supplementary material, which is available to authorized users.

Patient- and Physician-Level Factors Associated With Adherence to C-CHANGE Recommendations in Primary Care Settings in Ontario

“…Patient attributes: These included age groups, sex, rurality of residence (rural vs non-rural), socioeconomic status (approximated by neighbourhood income quintiles), comorbidity index (based on resource utilization bands calculated from the Johns Hopkins Adjusted Clinical Group Case Mix System 13 ), body mass index (BMI) category, and medical history. Patients’ medical history was either based on previously validated algorithms (presence or absence of atrial fibrillation, 14 chronic kidney disease (CKD), 9 coronary artery disease [CAD], 10 diabetes, 15 , 16 hypertension, 9 stroke, 17 or congestive heart failure [CHF] 18 ).…”

Improving Care for Patients With or at Risk for Chronic Kidney Disease Using Electronic Medical Record Interventions: A Pragmatic Cluster-Randomized Trial Protocol

“…Our comparison group will be an active control group for a second clinical trial on atrial fibrillation. 27 We will report the study in accordance with the Consolidated Standards of Reporting Trials (CONSORT) extensions for cluster trials, pragmatic trials, and trials of nonpharmacological interventions. 28 - 30 We will also use the Template for Intervention Description and Replication (TIDieR) guidelines to describe the intervention.…”

“…We are concomitantly conducting a similar trial with an atrial fibrillation toolkit, such that consenting physicians will be randomized to either the CKD intervention group or the atrial fibrillation group (ie, an active control group). 27 Thus, the intervention group for CKD will serve as the atrial fibrillation control group and vice versa.…”

The role of magnesium sulfate in the intensive care unit

“…Magnesium sulfate was suggested by some authors to be efficacious in cardiac operations such as atrial fibrillation (AF), coronary artery bypass surgery and heart valve surgeries (Gu et al, 2012[ 53 ]; Lee et al, 2016[ 90 ]; Lip, 2016[ 93 ]; Mazurek and Lip, 2017[ 102 ]; Talkachova et al, 2016[ 150 ]; Treggiari-Venzi et al, 2000[ 154 ]). Low serum Mg level and older age have been reported as risk factors for AF (Treggiari-Venzi et al, 2000[ 154 ]).…”