One Step at a Time: Design and Rationale for Stepped-Wedge Cluster Randomized Trials.

Stepped-wedge cluster randomized trials provide researchers with an opportunity to simultaneously implement and evaluate systemic interventions in real-world settings. This study design may have advantages compared with other cluster randomized trial (CRT) designs by optimizing feasibility and uptake when resources or personnel are limited. We present strengths, limitations, and key considerations when deciding whether to use a stepped-wedge design. Statistical analysis of stepped-wedge trials differs from that of traditional CRTs and should account for changes in outcome measures due to the intervention separate from those due to secular or time-based trends. We conclude with an example of a stepped-wedge study at 26 hospitals that helped to establish the effectiveness and safety of the Eat, Sleep, Console approach to neonatal opioid withdrawal syndrome.