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

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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).

Supplementary Information

The online version contains supplementary material available at 10.1186/s43058-023-00502-7.

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Most cited references 58

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Research electronic data capture (REDCap) is a novel workflow methodology and software solution designed for rapid development and deployment of electronic data capture tools to support clinical and translational research. We present: (1) a brief description of the REDCap metadata-driven software toolset; (2) detail concerning the capture and use of study-related metadata from scientific research teams; (3) measures of impact for REDCap; (4) details concerning a consortium network of domestic and international institutions collaborating on the project; and (5) strengths and limitations of the REDCap system. REDCap is currently supporting 286 translational research projects in a growing collaborative network including 27 active partner institutions.

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Three approaches to qualitative content analysis.

Hsiu-Fang Hsieh, Sarah Shannon (2016)

Content analysis is a widely used qualitative research technique. Rather than being a single method, current applications of content analysis show three distinct approaches: conventional, directed, or summative. All three approaches are used to interpret meaning from the content of text data and, hence, adhere to the naturalistic paradigm. The major differences among the approaches are coding schemes, origins of codes, and threats to trustworthiness. In conventional content analysis, coding categories are derived directly from the text data. With a directed approach, analysis starts with a theory or relevant research findings as guidance for initial codes. A summative content analysis involves counting and comparisons, usually of keywords or content, followed by the interpretation of the underlying context. The authors delineate analytic procedures specific to each approach and techniques addressing trustworthiness with hypothetical examples drawn from the area of end-of-life care.

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Is Open Access

Using the framework method for the analysis of qualitative data in multi-disciplinary health research

Nicola K Gale, Gemma Heath, Elaine Cameron … (2013)

Background The Framework Method is becoming an increasingly popular approach to the management and analysis of qualitative data in health research. However, there is confusion about its potential application and limitations. Discussion The article discusses when it is appropriate to adopt the Framework Method and explains the procedure for using it in multi-disciplinary health research teams, or those that involve clinicians, patients and lay people. The stages of the method are illustrated using examples from a published study. Summary Used effectively, with the leadership of an experienced qualitative researcher, the Framework Method is a systematic and flexible approach to analysing qualitative data and is appropriate for use in research teams even where not all members have previous experience of conducting qualitative research.

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Author and article information

Contributors

Kelli D. Allen: kdallen@email.unc.edu

Journal

Journal ID (nlm-ta): Implement Sci Commun

Journal ID (iso-abbrev): Implement Sci Commun

Title: Implementation Science Communications

Publisher: BioMed Central (London )

ISSN (Electronic): 2662-2211

Publication date (Electronic): 12 October 2023

Publication date PMC-release: 12 October 2023

Publication date Collection: 2023

Volume: 4

Electronic Location Identifier: 125

Affiliations

[1 ]Center of Innovation to Accelerate Discovery and Practice Transformation, Durham VA Health Care System, ( https://ror.org/02d29d188) Durham, NC USA

[2 ]GRID grid.26009.3d, ISNI 0000 0004 1936 7961, Department of Population Health Sciences, , Duke University School of Medicine, ; Durham, NC USA

[3 ]GRID grid.26009.3d, ISNI 0000 0004 1936 7961, Department of Biostatistics and Bioinformatics, , Duke University School of Medicine, ; Durham, NC USA

[4 ]Department of Implementation Science, Wake Forest University School of Medicine, ( https://ror.org/0207ad724) Winston-Salem, NC USA

[5 ]GRID grid.241167.7, ISNI 0000 0001 2185 3318, 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, ( https://ror.org/00py81415) Durham, NC USA

[7 ]GRID grid.418152.b, ISNI 0000 0004 0543 9493, AstraZeneca, ; Durham, NC USA

[8 ]GRID grid.26009.3d, ISNI 0000 0004 1936 7961, 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, ( https://ror.org/02d29d188) Durham, NC USA

[10 ]GRID grid.26009.3d, ISNI 0000 0004 1936 7961, 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, ( https://ror.org/01nh3sx96) Aurora, CO USA

[12 ]Physical Medicine and Rehabilitation Services, Durham VA Health Care System, ( https://ror.org/02d29d188) Durham, NC USA

[13 ]Department of Medicine & Thurston Arthritis Research Center, University of North Carolina at Chapel Hill School of Medicine, ( https://ror.org/0130frc33) Chapel Hill, NC USA

Author information

Sara Webb http://orcid.org/0009-0003-6009-8222

Article

Publisher ID: 502

DOI: 10.1186/s43058-023-00502-7

PMC ID: 10571277

PubMed ID: 37828564

SO-VID: cb18ca9b-31dd-4854-b708-1af29c29342c

License:

Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

History

Date received : 9 August 2023

Date accepted : 9 September 2023

Funding

Funded by: FundRef http://dx.doi.org/10.13039/100007181, Quality Enhancement Research Initiative;

Award ID: QUE 20-023

Award Recipient : Susan N. Hastings

Custom metadata

Keywords: osteoarthritis of knee,implementation science,group physical therapy,physical therapy,functional independence,veterans

Data availability:

Keywords: osteoarthritis of knee, implementation science, group physical therapy, physical therapy, functional independence, veterans

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

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Abstract

Background

Methods

Discussion

Trial registration

Supplementary Information

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2023 Research and Innovation Open Distance and eLearning (ODeL) Hybrid Conference

Most cited references 58

Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support.

Three approaches to qualitative content analysis.

Using the framework method for the analysis of qualitative data in multi-disciplinary health research

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