Occupational support following Arthroplasty of the lower limb (OPAL): trial protocol for a UK wide phase III randomised controlled trial

Sheehan, Lucy; Woodward, Amie; Adamson, Joy; Archer, Marion; Drummond, Avril; Hewison, Ann; Jordan, Carol; Keding, Ada; Kottam, Lucksy; Madan, Ira; Martland, Maisie; McDaid, Catriona; McDonald, David A; Parkinson, Gill; Reed, Mike; Sinclair, Lesley; Smith, Toby O.; Thomson, Louise; Watkins, Lou; Wu, Qi; Baker, Paul

Abstract

Background
In the UK, one in four patients are in work at the time of their hip or knee replacement surgery. These patients receive little support about their return to work (RTW). There is a need for an occupational support intervention that encourages safe and sustained RTW which can be integrated into NHS practice. We developed a two-arm intervention trial, based on a feasibility study, to assess whether an occupational support intervention (the OPAL (Occupational support for Patients undergoing Arthroplasty of the Lower limb) intervention) is effective in supporting a reduced time to full, sustained RTW compared to usual care in patients undergoing hip and knee replacement.

Methods and analysis
This is a multi-centre, individually randomised controlled superiority trial comparing the OPAL intervention to usual care. 742 working adults listed for elective primary hip or knee replacement, who intend to RTW, will be randomised to the OPAL intervention or usual care. The intervention comprises: 1) multimedia information resources; and 2) support from a designated RTW co-ordinator. The primary outcome is time until ‘full’ sustained RTW without sick leave for a consecutive four-week period. Secondary outcomes are: time to any RTW, measures of functional recovery, number of ‘sick days’ between surgery and ‘full’ sustained RTW and the use of workplace modifications to facilitate their return. A health economic evaluation and a mixed methods process evaluation will assess cost-effectiveness and the implementation, fidelity and acceptability of the intervention respectively. Outcomes will be collected at baseline, three, six, nine and 12-month follow-up timepoints, as well as a monthly RTW questionnaire.

Ethics and dissemination
Dissemination will focus on supporting the wider adoption and implementation of the intervention (if effective) and will target groups for whom the results will be relevant. This trial was approved by West Midlands – Edgbaston REC 23/WM/0013.
Clinical Trial Registry: ISRCTN13694911.

Citation

Sheehan, L., Woodward, A., Adamson, J., Archer, M., Drummond, A., Hewison, A., Jordan, C., Keding, A., Kottam, L., Madan, I., Martland, M., McDaid, C., McDonald, D. A., Parkinson, G., Reed, M., Sinclair, L., Smith, T. O., Thomson, L., Watkins, L., Wu, Q., & Baker, P. (in press). Occupational support following Arthroplasty of the lower limb (OPAL): trial protocol for a UK wide phase III randomised controlled trial. BMJ Open,

• Journal Article Type: Article
• Acceptance Date: Aug 30, 2024
• Deposit Date: Sep 2, 2024
• Journal: BMJ Open
• Electronic ISSN: 2044-6055
• Publisher: BMJ Publishing Group
• Peer Reviewed: Peer Reviewed
• Public URL: https://nottingham-repository.worktribe.com/output/39163511