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Activity Number: 341 - Random Effects and Mixed Models
Type: Contributed
Date/Time: Tuesday, July 30, 2019 : 10:30 AM to 12:20 PM
Sponsor: Biometrics Section
Abstract #306732 Presentation
Title: A Stepped Wedge Design in Practice: Lessons Learned from the DECIDE-LVAD Trial
Author(s): Diane Fairclough* and Erin Leister Chaussee and Larry Allen
Companies: Colorado School of Public Health and Colorado School of Public Health and University of Colorado Denver, School of Medicine
Keywords: Stepped-wedge design; Cluster randomized trials

Stepped wedge (SW) designs are an alternative to traditional cluster randomized trials when evaluating implementation and dissemination of effective interventions. While this design has many advantages, there are challenges associated with its implementation. The goal of this paper is to illustrate some of these challenges based on real-world experience with a multicenter trial of a shared decision support for end-stage heart failure (DECIDE-LVAD) utilizing a stepped wedge design. The challenges encountered in this trial include 1) the need to start and end accrual and follow-up at the same time in all sites, 2) requirement of steady recruitment over time that is consistent with respect to patient characteristics (e.g. no selection bias), 3) avoiding contamination between the control and intervention phases with extended interventions and follow-up, and 4) limiting to settings where site specific temporal changes are unlikely. Based on these observations we propose a Checklist for feasibility of the stepped wedge design that is carefully evaluated in the early planning stages for trials in which a SW design is being considered.

Authors who are presenting talks have a * after their name.

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