Group physical therapy for knee osteoarthritis: protocol for a hybrid type III effectiveness-implementation trial.
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2023-10
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Abstract
Background
Knee osteoarthritis (OA) is a leading cause of chronic pain and disability and one of the most common conditions treated in outpatient physical therapy (PT). Because of the high and growing prevalence of knee OA, there is a need for efficient approaches for delivering exercise-based PT to patients with knee OA. A prior randomized controlled trial (RCT) showed that a 6-session Group Physical Therapy Program for Knee OA (Group PT) yields equivalent or greater improvements in pain and functional outcomes compared with traditional individual PT, while requiring fewer clinician hours per patient to deliver. This manuscript describes the protocol for a hybrid type III effectiveness-implementation trial comparing two implementation packages to support delivery of Group PT.Methods
In this 12-month embedded trial, a minimum of 16 Veterans Affairs Medical Centers (VAMCs) will be randomized to receive one of two implementation support packages for their Group PT programs: a standard, low-touch support based on Replicating Effective Programs (REP) versus enhanced REP (enREP), which adds tailored, high-touch support if sites do not meet Group PT adoption and sustainment benchmarks at 6 and 9 months following launch. Implementation outcomes, including penetration (primary), adoption, and fidelity, will be assessed at 6 and 12 months (primary assessment time point). Additional analyses will include patient-level effectiveness outcomes (pain, function, satisfaction) and staffing and labor costs. A robust qualitative evaluation of site implementation context and experience, as well as site-led adaptations to the Group PT program, will be conducted.Discussion
To our knowledge, this study is the first to evaluate the impact of tailored, high-touch implementation support on implementation outcomes when compared to standardized, low-touch support for delivering a PT-based intervention. The Group PT program has strong potential to become a standard offering for PT, improving function and pain-related outcomes for patients with knee OA. Results will provide information regarding the effectiveness and value of this implementation approach and a deeper understanding of how healthcare systems can support wide-scale adoption of Group PT.Trial registration
This study was registered on March 7, 2022 at ClinicalTrials.gov (identifier NCT05282927 ).Type
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Publication Info
Webb, Sara, Connor Drake, Cynthia J Coffman, Caitlin Sullivan, Nina Sperber, Matthew Tucker, Leah L Zullig, Jaime M Hughes, et al. (2023). Group physical therapy for knee osteoarthritis: protocol for a hybrid type III effectiveness-implementation trial. Implementation science communications, 4(1). p. 125. 10.1186/s43058-023-00502-7 Retrieved from https://hdl.handle.net/10161/29302.
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Scholars@Duke
![Coffman](https://scholars.duke.edu/profile-images/thumbnail200/0202046.jpg)
Cynthia Jan Coffman
![Sperber](https://scholars.duke.edu/profile-images/thumbnail200/0544963.jpg)
Nina Sperber
My research career has centered on understanding how to improve delivery of new evidence-based practices in health care systems. I work in health services research and development for the VA health care system and have an academic appointment with the Duke University School of Medicine. 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.
![Zullig](https://scholars.duke.edu/profile-images/thumbnail200/0453220.jpg)
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’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 150 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
![Kaufman](https://scholars.duke.edu/profile-images/thumbnail200/0727515.jpg)
Brystana G. Kaufman
Areas of Expertise: Health Economics, Health Policy, and Health Services Research
Dr. Kaufman is a health services researcher focused on improving the value of care for older adults. Her research is driven by a passion for whole-person models of care that integrate traditional clinical services with behavioral health, socioeconomic and social supports to address older adults’ diverse needs and reflect their preferences for care. Her research evaluates patient outcomes, resource use, and cost-effectiveness of value-based payment models and novel care strategies that impact seriously ill adults and their care partners.
Dr. Kaufman received her Master of Science in Public Health and PhD in Health Policy and Management from the Gillings School of Global Public Health at the University of North Carolina-Chapel Hill. Prior to joining the Department of Population Health Sciences, she completed a pre-doctoral fellowship at the Duke Clinical Research Institute and post-doctoral fellowship at the Margolis Center for Health Policy.
![Hastings](https://scholars.duke.edu/profile-images/thumbnail200/0304085.jpg)
Susan Nicole Hastings
![Van Houtven](https://scholars.duke.edu/profile-images/thumbnail200/0147016.jpg)
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
![Hoenig](https://scholars.duke.edu/profile-images/thumbnail200/0116565.jpg)
Helen Marie Hoenig
- General Focus and Goals of Research: Dr. Hoenig's research focuses on rehabilitation, and more specifically on assistive technology and teletechnology. Patient populations of interest include geriatric patients with diverse medical problems including stroke, spinal and/or musculoskeletal disorders.
2. Specific Approaches or Techniques: Randomized controlled trials, epidemiological studies including large data base analyses and survey research. Clinical trials include studies of the effects of motorized scooters in persons with difficulty walking, methods for providing wheelchairs, and telerehabilitation for exercise & functional mobility training in the home. Epidemiological studies and survey research have examined use of assistive technology and other coping strategies to disability.
4. Special areas of expertise/national recognition: Rehabilitation health services research, geriatric rehabilitation, assistive technology outcomes, telerehabilitation.
KEY WORDS/PHRASES: Rehabilitation, Process and Outcomes Research, Assistive Technology, Telehealth, Activities of Daily Living, Geriatrics, Disability.
![Wang](https://scholars.duke.edu/profile-images/thumbnail200/0490887.jpg)
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![Allen](https://scholars.duke.edu/profile-images/thumbnail200/0099415.jpg)
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
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