Variations in stepped-wedge cluster randomized trial design: Insights from the Patient-Centered Care Transitions in Heart Failure trial

Publication date: February 2020Source: American Heart Journal, Volume 220Author(s): Rudy R. Unni, Shun Fu Lee, Lehana Thabane, Stuart Connolly, Harriette GC Van SpallThe stepped-wedge (SW) cluster randomized controlled trial, in which clusters cross over in a randomized sequence from control to intervention, is ideal for the implementation and testing of complex health service interventions. In certain cases however, implementation of the intervention may pose logistical challenges, and variations in SW design may be required.We examine the logistical and statistical implications of variations in SW design using the optimization of the Patient-Centered Care Transitions in Heart Failure trial for illustration. We review the following complete SW design variations: a typical SW design; an SW design with multiple clusters crossing over per period to achieve balanced cluster sizes at each step; hierarchical randomization to account for higher-level clustering effects; nested substudies to measure outcomes requiring a smaller sample size than the primary outcomes; and hybrid SW design, which combines parallel cluster with SW design to improve efficiency. We also reviewed 3 incomplete SW design variations in which data are collected in some but not all steps to ease measurement burden. These include designs with a learning period that improve fidelity to the intervention, designs with reduced measurements to minimize collection burden, and designs with early and late blocks to acco...
Source: American Heart Journal - Category: Cardiology Source Type: research