Implementation of a novel stratified PAthway of CarE for common musculoskeletal (MSK) conditions in primary care: protocol for a multicentre pragmatic randomised controlled trial (the PACE MSK trial)

Trudy Rebbeck; Kerrie Evans; Paulo Ferreira; Darren Beales; Michele Sterling; Kim L Bennell; Ian Cameron; Michael Nicholas; Carrie Ritchie; Gwen Jull; Julia Treleaven; Lyndal Trevena; Kathryn Refshauge; Luke Connelly; Nadine Foster; Deborah Black; Paul Hodges; Manuela Ferreira; Tim J Shaw; Milena Simic

doi:10.1136/bmjopen-2021-057705

Implementation of a novel stratified PAthway of CarE for common musculoskeletal (MSK) conditions in primary care: protocol for a multicentre pragmatic randomised controlled trial (the PACE MSK trial)

BMJ Open. 2021 Dec 30;11(12):e057705. doi: 10.1136/bmjopen-2021-057705.

Authors

Trudy Rebbeck^{1

2}, Kerrie Evans^{3

4}, Paulo Ferreira¹, Darren Beales⁵, Michele Sterling^{6

7}, Kim L Bennell⁸, Ian Cameron¹, Michael Nicholas⁹, Carrie Ritchie^{6

7}, Gwen Jull¹⁰, Julia Treleaven¹⁰, Lyndal Trevena¹, Kathryn Refshauge¹, Luke Connelly¹¹, Nadine Foster^{12

13}, Deborah Black¹, Paul Hodges¹⁰, Manuela Ferreira^{1

9}, Tim J Shaw¹, Milena Simic¹

Affiliations

¹ School of Health Sciences, Faculty of Medicine and Health, The University of Sydney, Camperdown, New South Wales, Australia.
² John Walsh Centre for Rehabilitation Research, New South Wales, Australia, Kolling Institute, Northern Sydney Local Health District and Faculty of Medicine and Health, The University of Sydney, St Leonards, New South Wales, Australia.
³ School of Health Sciences, Faculty of Medicine and Health, The University of Sydney, Camperdown, New South Wales, Australia kerrie.evans@sydney.edu.au.
⁴ Healthia Limited, Brisbane, Queensland, Australia.
⁵ School of Physiotherapy and Exercise Science, Curtin University, Perth, Western Australia, Australia.
⁶ RECOVER Injury Research Centre, The University of Queensland, Brisbane, Queensland, Australia.
⁷ NHMRC Centre of Research Excellence in Road Traffic Injury Recovery, The University of Queensland, Brisbane, Queensland, The University of Queensland, Brisbane, Queensland, Australia.
⁸ Centre for Health, Exercise and Sports Medicine, The University of Melbourne, Melbourne, Victoria, Australia.
⁹ Pain Management Research Institute, Kolling Institute, Northern Sydney Local Health District and Faculty of Medicine and Health, The University of Sydney, St Leonards, New South Wales, Australia.
¹⁰ Faculty of Health and Behavioural Sciences, The University of Queensland, Brisbane, Queensland, Australia.
¹¹ Department of Sociology and Business Law, The University of Queensland, Centre for the Business and Economics of Health, The University of Bologna, Bologna, Emilia-Romagna, Italy.
¹² Primary Care Centre Versus Arthritis, School of Medicine, Keele University, Keele, UK.
¹³ Surgical, Treatment and Rehabilitation Service (STARS) Education and Research Alliance, The University of Queensland and Metro North Hospital and Health Service, Brisbane, Queensland, Australia.

Abstract

Introduction: Musculoskeletal (MSK) conditions constitute the highest burden of disease globally, with healthcare services often utilised inappropriately and overburdened. The aim of this trial is to evaluate the effectiveness of a novel clinical PAthway of CarE programme (PACE programme), where care is provided based on people's risk of poor outcome.

Methods and analysis: Multicentre randomised controlled trial. 716 people with MSK conditions (low back pain, neck pain or knee osteoarthritis) will be recruited in primary care. They will be stratified for risk of a poor outcome (low risk/high risk) using the Short Form Örebro Musculoskeletal Pain Screening Questionnaire (SF-ÖMSPQ) then randomised to usual care (n=358) or the PACE programme (n=358). Participants at low risk in the PACE programme will receive up to 3 sessions of guideline based care from their primary healthcare professional (HCP) supported by a custom designed website (mypainhub.com). Those at high risk will be referred to an allied health MSK specialist who will conduct a comprehensive patient-centred assessment then liaise with the primary HCP to determine further care. Primary outcome (SF 12-item PCS) and secondary outcomes (eg, pain self-efficacy, psychological health) will be collected at baseline, 3, 6 and 12 months. Cost-effectiveness will be measured as cost per quality-adjusted life-year gained. Health economic analysis will include direct and indirect costs. Analyses will be conducted on an intention-to-treat basis. Primary and secondary outcomes will be analysed independently, using generalised linear models. Qualitative and mixed-methods studies embedded within the trial will evaluate patient experience, health professional practice and interprofessional collaboration.

Ethics and dissemination: Ethics approval has been received from the following Human Research Ethics Committees: The University of Sydney (2018/926), The University of Queensland (2019000700/2018/926), University of Melbourne (1954239), Curtin University (HRE2019-0263) and Northern Sydney Local Health District (2019/ETH03632). Dissemination of findings will occur via peer-reviewed publications, conference presentations and social media.

Trial registration number: ACTRN12619000871145.

Keywords: musculoskeletal disorders; quality in health care; rehabilitation medicine.

Publication types

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

MeSH terms

Cost-Benefit Analysis
Critical Pathways
Humans
Low Back Pain*
Multicenter Studies as Topic
Musculoskeletal Diseases* / therapy
Primary Health Care
Quality of Life
Randomized Controlled Trials as Topic
Self Efficacy