Group physical therapy for knee osteoarthritis: protocol for a hybrid type III effectiveness-implementation trial

Sara Webb; Connor Drake; Cynthia J Coffman; Caitlin Sullivan; Nina Sperber; Matthew Tucker; Leah L Zullig; Jaime M Hughes; Brystana G Kaufman; John A Pura; Livia Anderson; Susan N Hastings; Courtney H Van Houtven; Lauren M Abbate; Helen Hoenig; Lindsay A Ballengee; Virginia Wang; Kelli D Allen

doi:10.1186/s43058-023-00502-7

Group physical therapy for knee osteoarthritis: protocol for a hybrid type III effectiveness-implementation trial

Implement Sci Commun. 2023 Oct 12;4(1):125. doi: 10.1186/s43058-023-00502-7.

Authors

Sara Webb¹, Connor Drake^{1

2}, Cynthia J Coffman^{1

3}, Caitlin Sullivan¹, Nina Sperber^{1

2}, Matthew Tucker¹, Leah L Zullig^{1

2}, Jaime M Hughes^{1

4

5}, Brystana G Kaufman^{1

2

6}, John A Pura^{1

7}, Livia Anderson¹, Susan N Hastings^{1

2

8

9

10}, Courtney H Van Houtven^{1

2

6}, Lauren M Abbate^{1

11}, Helen Hoenig^{1

8

10

12}, Lindsay A Ballengee², Virginia Wang^{1

2

6

10}, Kelli D Allen^{13

14}

Affiliations

¹ Center of Innovation to Accelerate Discovery and Practice Transformation, Durham VA Health Care System, Durham, NC, USA.
² Department of Population Health Sciences, Duke University School of Medicine, Durham, NC, USA.
³ Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, NC, USA.
⁴ Department of Implementation Science, Wake Forest University School of Medicine, Winston-Salem, NC, USA.
⁵ Section On Gerontology and Geriatric Medicine, Division of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC, USA.
⁶ Margolis Center for Health Policy, Duke University, Durham, NC, USA.
⁷ AstraZeneca, Durham, NC, USA.
⁸ Center for the Study of Aging and Human Development, Duke University School of Medicine, Durham, NC, USA.
⁹ Geriatric Research, Education, and Clinical Center, Durham VA Health Care System, Durham, NC, USA.
¹⁰ Department of Medicine, Duke University School of Medicine, Durham, NC, USA.
¹¹ VA Eastern Colorado Geriatric Research Education and Clinical Center and University of Colorado School of Medicine, Aurora, CO, USA.
¹² Physical Medicine and Rehabilitation Services, Durham VA Health Care System, Durham, NC, USA.
¹³ Center of Innovation to Accelerate Discovery and Practice Transformation, Durham VA Health Care System, Durham, NC, USA. kdallen@email.unc.edu.
¹⁴ Department of Medicine & Thurston Arthritis Research Center, University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, NC, USA. kdallen@email.unc.edu.

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 ).

Keywords: Functional independence; Group physical therapy; Implementation science; Osteoarthritis of knee; Physical therapy; Veterans.

Associated data

ClinicalTrials.gov/NCT05282927

Grants and funding

QUE 20-023/Quality Enhancement Research Initiative