Protocol for a process evaluation: face-to-face physiotherapy compared with a supported home exercise programme for the management of musculoskeletal conditions: the REFORM trial

Hannah G Withers; Hueiming Liu; Joanne V Glinsky; Jackie Chu; Matthew D Jennings; Alison J Hayes; Ian J Starkey; Blake A Palmer; Lukas Szymanek; Jackson J Cruwys; David Wong; Kitty Duong; Anne Barnett; Matthew J Tindall; Barbara R Lucas; Tara E Lambert; Deborah A Taylor; Catherine Sherrington; Manuela L Ferreira; Christopher G Maher; Joshua R Zadro; Lisa A Harvey

doi:10.1136/bmjopen-2021-057790

Protocol for a process evaluation: face-to-face physiotherapy compared with a supported home exercise programme for the management of musculoskeletal conditions: the REFORM trial

BMJ Open. 2022 Jul 5;12(7):e057790. doi: 10.1136/bmjopen-2021-057790.

Authors

Hannah G Withers¹, Hueiming Liu², Joanne V Glinsky¹, Jackie Chu¹, Matthew D Jennings³, Alison J Hayes⁴, Ian J Starkey⁵, Blake A Palmer⁵, Lukas Szymanek⁶, Jackson J Cruwys⁶, David Wong⁷, Kitty Duong⁷, Anne Barnett⁸, Matthew J Tindall⁸, Barbara R Lucas⁹, Tara E Lambert⁹, Deborah A Taylor⁹, Catherine Sherrington¹⁰, Manuela L Ferreira¹¹, Christopher G Maher¹², Joshua R Zadro¹², Lisa A Harvey¹³

Affiliations

¹ John Walsh Centre for Rehabilitation Research, Northern Sydney Local Health District, The University of Sydney, Kolling Institute, Sydney, NSW, Australia.
² The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.
³ Physiotherapy Department, South Western Sydney Local Health District, Liverpool, New South Wales, Australia.
⁴ School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.
⁵ Physiotherapy Department, Blacktown and Mount Druitt Hospital, Blacktown, New South Wales, Australia.
⁶ Physiotherapy Department, Campbelltown Hospital, Campbelltown, New South Wales, Australia.
⁷ Physiotherapy Department, Liverpool Hospital, Liverpool, New South Wales, Australia.
⁸ Physiotherapy Department, Bankstown Hospital, Bankstown, New South Wales, Australia.
⁹ Physiotherapy Department, Royal North Shore Hospital, St Leonards, New South Wales, Australia.
¹⁰ Institute for Musculoskeletal Health, The University of Sydney, Sydney, New South Wales, Australia.
¹¹ Sydney Musculoskeletal Health, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.
¹² Institute for Musculoskeletal Health, School of Public Health, The University of Sydney, Camperdown, New South Wales, Australia.
¹³ John Walsh Centre for Rehabilitation Research, Northern Sydney Local Health District, The University of Sydney, Kolling Institute, Sydney, NSW, Australia l.harvey@usyd.edu.au.

Abstract

Introduction: The REFORM (REhabilitation FOR Musculoskeletal conditions) trial is a non-inferiority randomised controlled trial (n=210) designed to determine whether a supported home exercise programme is as good or better than a course of face-to-face physiotherapy for the management of some musculoskeletal conditions. The trial is currently being conducted across Sydney government hospitals in Australia. This process evaluation will run alongside the REFORM trial. It combines qualitative and quantitative data to help explain the trial results and determine the feasibility of rolling out supported home exercise programmes in settings similar to the REFORM trial.

Methods and analysis: Two theoretical frameworks underpin our process evaluation methodology: the Realist framework (context, mechanism, outcomes) considers the causal assumptions as to why a supported home exercise programme may be as good or better than face-to-face physiotherapy in terms of the context, mechanisms and outcomes of the trial. The RE-AIM framework describes the Reach, Effectiveness, Adoption, Implementation and Maintenance of the intervention. These two frameworks will be broadly used to guide this process evaluation using a mixed-methods approach. For example, qualitative data will be derived from interviews with patients, healthcare professionals and stakeholders, and quantitative data will be collected to determine the cost and feasibility of providing supported home exercise programmes. These data will be analysed iteratively before the analysis of the trial results and will be triangulated with the results of the primary and secondary outcomes.

Ethics and dissemination: This trial will be conducted in accordance with the National Health and Medical Research Council National Statement on Ethical Conduct in Human Research (2018) and the Note for Good Clinical Practice (CPMP/ICH-135/95). Ethical approval was obtained on 17 March 2017 from the Northern Sydney Local Health District Human Research Ethics Committee (trial number: HREC/16HAWKE/431-RESP/16/287) with an amendment for the process evaluation approved on 4 February 2020. The results of the process evaluation will be disseminated through publications in peer-reviewed journals and presentations at scientific conferences.

Trial registration number: ACTRN12619000065190.

Keywords: health informatics; musculoskeletal disorders; protocols & guidelines; rehabilitation medicine; telemedicine.

Publication types

Clinical Trial Protocol
Comparative Study
Research Support, Non-U.S. Gov't

MeSH terms

Ambulatory Care
Australia
Exercise Therapy* / methods
Feasibility Studies
Humans
Musculoskeletal Diseases* / rehabilitation
Program Evaluation
Randomized Controlled Trials as Topic
Self Care

Associated data

ANZCTR/ACTRN12619000065190