Implementation of a stepped wedge cluster randomized trial to evaluate a hospital mobility program

Trials

Ashley Choate¹  Karen M. Stechuchak¹  Elizabeth P. Mahanna¹  Cynthia J. Coffman²  Kelli D. Allen³  Nina Sperber⁴  Leah Zullig⁴  Hayden B. Bosworth⁴  Virginia Wang⁴  Courtney Van Houtven⁵  Susan N. Hastings⁶ 

[1] Center of Innovation to Accelerate Discovery and Practice Transformation, Durham VA Health Care System, Durham, NC, USA;Center of Innovation to Accelerate Discovery and Practice Transformation, Durham VA Health Care System, Durham, NC, USA;Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, NC, USA;Center of Innovation to Accelerate Discovery and Practice Transformation, Durham VA Health Care System, Durham, NC, USA;Department of Medicine and Thurston Arthritis Research Center, University of North Carolina, Chapel Hill, NC, USA;Center of Innovation to Accelerate Discovery and Practice Transformation, Durham VA Health Care System, Durham, NC, USA;Department of Medicine, Duke University School of Medicine, Durham, NC, USA;Department of Population Health Sciences, Duke University School of Medicine, Durham, NC, USA;Center of Innovation to Accelerate Discovery and Practice Transformation, Durham VA Health Care System, Durham, NC, USA;Department of Population Health Sciences, Duke University School of Medicine, Durham, NC, USA;Center of Innovation to Accelerate Discovery and Practice Transformation, Durham VA Health Care System, Durham, NC, USA;Geriatrics Research, Education and Clinical Center, Durham VA Health Care System, Durham, NC, USA;Department of Medicine, Duke University School of Medicine, Durham, NC, USA;Department of Population Health Sciences, Duke University School of Medicine, Durham, NC, USA;Center for Aging, Duke University School of Medicine, Durham, NC, USA;

关键词: Stepped wedge;    Mobility;    Pragmatic trials;   

DOI  :  10.1186/s13063-020-04764-7

来源: Springer

【 摘 要 】

BackgroundStepped wedge cluster randomized trials (SW-CRT) are increasingly used to evaluate new clinical programs, yet there is limited guidance on practical aspects of applying this design. We report our early experiences conducting a SW-CRT to examine an inpatient mobility program (STRIDE) in the Veterans Health Administration (VHA). We provide recommendations for future research using this design to evaluate clinical programs.MethodsBased on data from study records and reflections from the investigator team, we describe and assess the design and initial stages of a SW-CRT, from site recruitment to program launch in 8 VHA hospitals.ResultsSite recruitment consisted of thirty 1-h conference calls with representatives from 22 individual VAs who expressed interest in implementing STRIDE. Of these, 8 hospitals were enrolled and randomly assigned in two stratified blocks (4 hospitals per block) to a STRIDE launch date. Block 1 randomization occurred in July 2017 with first STRIDE launch in December 2017; block 2 randomization occurred in April 2018 with first STRIDE launch in January 2019. The primary study outcome of discharge destination will be assessed using routinely collected data in the electronic health record (EHR). Within randomized blocks, two hospitals per sequence launched STRIDE approximately every 3 months with primary outcome assessment paused during the 3-month time period of program launch. All sites received 6–8 implementation support calls, according to a pre-specified schedule, from the time of recruitment to program launch, and all 8 sites successfully launched within their assigned 3-month window. Seven of the eight sites initially started with a limited roll out (for example on one ward) or modified version of STRIDE (for example, using existing staff to conduct walks until new positions were filled).ConclusionsFuture studies should incorporate sufficient time for site recruitment and carefully consider the following to inform design of SW-CRTs to evaluate rollout of a new clinical program: (1) whether a blocked randomization fits study needs, (2) the amount of time and implementation support sites will need to start their programs, and (3) whether clinical programs are likely to include a “ramp-up” period. Successful execution of SW-CRT designs requires both adherence to rigorous design principles and also careful consideration of logistical requirements for timing of program roll out.Trial registrationClinicalsTrials.gov NCT03300336. Prospectively registered on 3 October 2017.

【 授权许可】

CC BY