RT Journal Article
SR Electronic
T1 Considerations Before Selecting a Stepped-Wedge Cluster Randomized Trial Design for a Practice Improvement Study
JF The Annals of Family Medicine
JO Ann Fam Med
FD American Academy of Family Physicians
SP 255
OP 261
DO 10.1370/afm.2810
VO 20
IS 3
A1 Ann M. Nguyen
A1 Charles M. Cleland
A1 L. Miriam Dickinson
A1 Michael P. Barry
A1 Samuel Cykert
A1 F. Daniel Duffy
A1 Anton J. Kuzel
A1 Stephan R. Lindner
A1 Michael L. Parchman
A1 Donna R. Shelley
A1 Theresa L. Walunas
YR 2022
UL http://www.annfammed.org/content/20/3/255.abstract
AB PURPOSE Despite the growing popularity of stepped-wedge cluster randomized trials (SW-CRTs) for practice-based research, the design’s advantages and challenges are not well documented. The objective of this study was to identify the advantages and challenges of the SW-CRT design for large-scale intervention implementations in primary care settings.METHODS The EvidenceNOW: Advancing Heart Health initiative, funded by the Agency for Healthcare Research and Quality, included a large collection of SW-CRTs. We conducted qualitative interviews with 17 key informants from EvidenceNOW grantees to identify the advantages and challenges of using SW-CRT design.RESULTS All interviewees reported that SW-CRT can be an effective study design for large-scale intervention implementations. Advantages included (1) incentivized recruitment, (2) staggered resource allocation, and (3) statistical power. Challenges included (1) time-sensitive recruitment, (2) retention, (3) randomization requirements and practice preferences, (4) achieving treatment schedule fidelity, (5) intensive data collection, (6) the Hawthorne effect, and (7) temporal trends.CONCLUSIONS The challenges experienced by EvidenceNOW grantees suggest that certain favorable real-world conditions constitute a context that increases the odds of a successful SW-CRT. An existing infrastructure can support the recruitment of many practices. Strong retention plans are needed to continue to engage sites waiting to start the intervention. Finally, study outcomes should be ones already captured in routine practice; otherwise, funders and investigators should assess the feasibility and cost of data collection.VISUAL ABSTRACT