Methodological progress note: Stepped-wedge cluster randomized trial design

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Burek, Alina G
Ullman, Amanda
Brousseau, David C
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2024
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Abstract

Hospitalists are often involved in quality and research efforts to improve care delivery in the inpatient setting.1 To assess the effectiveness of these efforts, new healthcare delivery initiatives may be evaluated by comparing clinical outcomes between patients who received the intervention and those who received usual care, which is commonly used as a control. Healthcare redesign and improvements often require complex interventions involving multiple components; therefore, simple study designs may not be appropriate.2 For example, in 2021, Schnipper et al.3 implemented a multifaceted intervention to improve the transition of care from hospital to ambulatory settings. This intervention had multiple components, including pharmacist-led medication reconciliation, patient education and coaching, post-discharge follow-up, and health information technology (HIT) enhancements. A traditional randomized controlled trial (RCT) at the individual level would have been impractical or impossible because some of the components required implementation at the hospital level (e.g., hospital-wide implementation of HIT) or primary care practice (e.g., education and coaching for all patients in a practice to avoid contamination). In situations when randomization at the individual level is impractical or not possible, randomization can be performed at the level of a group of individuals (cluster).2 Schnipper et al.3 used a stepped-wedge cluster randomized trial (SW-CRT) design, which is the primary focus of this methodological progress note. SW designs are becoming increasingly popular in hospital-based research studies, and hospitalists should be prepared to understand, participate in, and even lead large multisite CRTs.

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Journal of Hospital Medicine

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This publication has been entered in Griffith Research Online as an advance online version.

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Burek, AG; Ullman, A; Brousseau, DC, Methodological progress note: Stepped-wedge cluster randomized trial design, Journal of Hospital Medicine, 2024

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