A CLUSTER RANDOMIZATION TRIAL TO TEST THE EFFECTIVENESS OF A CLINICAL PATHWAY IN MANAGING ATRIAL FIBRILLATION IN THE EMERGENCY DEPARTMENT

Abstract

<p><strong>BACKGROUND: </strong></p> <p>Emergency Department (ED) visit rates for patients with symptomatic, recent onset atrial fibrillation or atrial flutter (RAFF) are on the rise, which in turn has resulted in high hospital admission rates (38-45%). Optimal management strategies need to be developed for reducing hospital admission rates.</p> <p><strong>STUDY QUESTION:</strong></p> <p>The primary objective of this study is to evaluate the effectiveness of a clinical pathway for the management of low-risk RAFF patients in the ED. The hypothesis is that an evidence-based clinical pathway will help ED physicians better manage AF patients and reduce hospital admissions.</p> <p><strong>STUDY DESIGN:</strong></p> <p>A prospective, blinded, stratified, two-arm cluster-randomized trial will be conducted. The intervention is a clinical pathway for the management of RAFF.</p> <p><strong>PRIMARY AND SECONDARY OUTCOMES:</strong></p> <p>The primary outcome of this trial will be the proportion of low-risk, RAAF patients admitted to the hospital from the ED. Secondary outcomes will include a range of safety outcomes.</p> <p><strong>STATISTICAL CONSIDERATIONS:</strong></p> <p>An intention-to-treat analysis will be conducted at the individual level using proportions and means according to the variable in question with an alpha level of 0.05 and power of 0.80 for the primary outcome. The cRCT (assuming a 30% RRR) will be conducted over a two year time period. A total of 13 clusters and 3500 ED visits will be recruited to each intervention arm.</p> <p><strong>SUMMARY:</strong></p> <p>This thesis explores the methodological issues relevant to the design of a cRCT evaluating a clinical pathway in the management of acute onset, low risk AF patients presenting to the ED.</p>