Implementation of a stepped wedge cluster randomized trial to evaluate a hospital mobility program.
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2020-10
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Abstract
Background
Stepped 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.Methods
Based 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.Results
Site 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).Conclusions
Future 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 registration
ClinicalsTrials.gov NCT03300336 . Prospectively registered on 3 October 2017.Type
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Hastings, Susan N, Karen M Stechuchak, Ashley Choate, Elizabeth P Mahanna, Courtney Van Houtven, Kelli D Allen, Virginia Wang, Nina Sperber, et al. (2020). Implementation of a stepped wedge cluster randomized trial to evaluate a hospital mobility program. Trials, 21(1). p. 863. 10.1186/s13063-020-04764-7 Retrieved from https://hdl.handle.net/10161/26136.
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Scholars@Duke
Susan Nicole Hastings
Courtney Harold Van Houtven
Dr. Courtney Van Houtven is a Professor in The Department of Population Health Science, Duke University School of Medicine and Duke-Margolis Center for Health Policy. She is also a Research Career Scientist in The Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), Durham Veterans Affairs Health Care System. Dr. Van Houtven’s aging and economics research interests encompass long-term care financing, intra-household decision-making, unpaid family and friend care, and home- and community-based services. She examines how family caregiving affects health care utilization, expenditures, health and work outcomes of care recipients and caregivers. She is also interested in understanding how best to support family caregivers to optimize caregiver and care recipient outcomes.
Dr. Van Houtven is co-PI on the QUERI Program Project, “Optimizing Function and Independence”, in which her caregiver skills training program developed as an RCT in VA, now called Caregivers FIRST, has been implemented at 125 VA sites nationally. The team will evaluate how intensification of an implementation strategy changes adoption. She directs the VA-CARES Evaluation Center, which evaluates the VA’s Caregiver Support Program. She leads a mixed methods R01 study as PI from the National Institute on Aging that will assess the value of "home time" for persons living with dementia and their caregivers (RF1 AG072364).
Areas of expertise: Health Services Research and Health Economics
Kelli Dominick Allen
- Improving care and outcomes for individuals with osteoarthritis and other musculoskeletal conditions with an emphasis on non-pharmacological therapies including physical activity, weight management, rehabilitation services, and pain coping
* Understanding rand reducing disparities in musculoskeletal conditions
* Musculoskeletal conditions in U.S. military Veterans
* Pragmatic clinical trials
* Adaptive interventions
Virginia Wang
Dr. Virginia Wang is an Associate Professor in Population Health Sciences and Medicine at the Duke University School of Medicine and Core Faculty in the Duke-Margolis Center for Health Policy. She is also a Core Investigator in the Health Services Research Center of Innovation to Accelerate Discovery and Practice Transformation at the Durham Veterans Affairs Health Care System. Dr. Wang received her PhD in Health Policy and Management, with a focus on organizational behavior. Her research examines organizational influences and policy on the provision of health services, provider strategy and performance, care coordination, and outcomes for patients with complex chronic disease.
Dr. Wang’s research has been supported by the Agency for Healthcare Research and Quality, National Institute of Diabetes and Digestive and Kidney Diseases, Department of Veterans Affairs, and the Centers for Medicare & Medicaid Services Office of Minority Health.
Areas of expertise: health services research, organizational behavior, health policy, implementation and program evaluation
Nina Sperber
My research career has centered on understanding how to improve delivery of new evidence-based practices in health care systems. I create study designs that integrate qualitative and quantitative methods (mixed-methods) and apply Implementation Science and System Science approaches. I currently have a developing body of academic work that uses participatory system dynamics modeling as a strategy to identify system level factors that affect development and implementation of equitable AI tools. For the VA health care system, I direct a cross-functional team that conducts rapid turnaround projects for high priority needs by VHA national, regional, and facility leaders.
Leah L Zullig
Leah L. Zullig, PhD, MPH is a health services researcher and an implementation scientist. She is a Professor in the Duke Department of Population Health Sciences and an investigator with the Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT) at the Durham Veterans Affairs Health Care System. Dr. Zullig leads INTERACT, the Implementation Science Research Collaborative, and is co-leader of Duke Cancer Institute's cancer prevention and control program.
Dr. Zullig’s overarching research interests address three domains: improving cancer care delivery and quality; promoting cancer survivorship and chronic disease management; and improving medication adherence. Throughout these three area of foci Dr. Zullig uses an implementation science lens with the goal of providing equitable care for all by implementing evidence-based practices in a variety of health care environments. She has authored over 200 peer-reviewed publications.
Dr. Zullig completed her BS in Health Promotion, her MPH in Public Health Administration, and her PhD in Health Policy.
Areas of expertise: Implementation Science, Health Measurement, Health Policy, Health Behavior, Telehealth, and Health Services Research
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