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
David Wong,
Catherine Sherrington,
Manuela L Ferreira,
Christopher G Maher,
Hueiming Liu,
Joshua R Zadro,
Lisa A Harvey,
Hannah G Withers,
Joanne V Glinsky,
Jackie Chu,
Matthew D Jennings,
Alison J Hayes,
Ian J Starkey,
Blake A Palmer,
Lukas Szymanek,
Jackson J Cruwys,
Kitty Duong,
Anne Barnett,
Matthew J Tindall,
Barbara R Lucas,
Tara E Lambert,
Deborah A Taylor
Affiliations
David Wong
Physiotherapy Department, Liverpool Hospital, Liverpool, New South Wales, Australia
Catherine Sherrington
2 Institute for Musculoskeletal Health, The University of Sydney and Sydney Local Health District, Sydney, New South Wales, Australia
Manuela L Ferreira
Sydney Musculoskeletal Health, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia
Christopher G Maher
Faculty of Medicine and Health, School of Public Health, The University of Sydney, Sydney, New South Wales, Australia
Hueiming Liu
The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia
Joshua R Zadro
2 Sydney Musculoskeletal Health and Institute for Musculoskeletal Health, The University of Sydney, Sydney, New South Wales, Australia
Lisa A Harvey
John Walsh Centre for Rehabilitation Research, Northern Sydney Local Health District, The University of Sydney, Kolling Institute, Sydney, NSW, Australia
Hannah G Withers
John Walsh Centre for Rehabilitation Research, Northern Sydney Local Health District, The University of Sydney, Kolling Institute, Sydney, NSW, Australia
Joanne V Glinsky
John Walsh Centre for Rehabilitation Research, Northern Sydney Local Health District, The University of Sydney, Kolling Institute, Sydney, NSW, Australia
Jackie Chu
John Walsh Centre for Rehabilitation Research, Northern Sydney Local Health District, The University of Sydney, Kolling Institute, Sydney, NSW, Australia
Matthew D Jennings
Physiotherapy Department, South Western Sydney Local Health District, Liverpool, New South Wales, Australia
Alison J Hayes
School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia
Ian J Starkey
Physiotherapy Department, Blacktown and Mount Druitt Hospital, Blacktown, New South Wales, Australia
Blake A Palmer
Physiotherapy Department, Blacktown and Mount Druitt Hospital, Blacktown, New South Wales, Australia
Lukas Szymanek
Physiotherapy Department, Campbelltown Hospital, Campbelltown, New South Wales, Australia
Jackson J Cruwys
Physiotherapy Department, Campbelltown Hospital, Campbelltown, New South Wales, Australia
Kitty Duong
Physiotherapy Department, Liverpool Hospital, Liverpool, New South Wales, Australia
Anne Barnett
Physiotherapy Department, Bankstown Hospital, Bankstown, New South Wales, Australia
Matthew J Tindall
Physiotherapy Department, Bankstown Hospital, Bankstown, New South Wales, Australia
Barbara R Lucas
Physiotherapy Department, Royal North Shore Hospital, St Leonards, New South Wales, Australia
Tara E Lambert
Physiotherapy Department, Royal North Shore Hospital, St Leonards, New South Wales, Australia
Deborah A Taylor
Physiotherapy Department, Royal North Shore Hospital, St Leonards, New South Wales, Australia
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.
