TY - JOUR
T1 - Occupational support following arthroplasty of the lower limb (OPAL)
T2 - trial protocol for a UK-wide phase III randomised controlled trial
AU - Sheehan, Lucy
AU - Woodward, Amie
AU - Archer, Marion
AU - Jordan, Carol
AU - Martland, Maisie
AU - McDonald, David A
AU - Parkinson, Gill
AU - Watkins, Lou
AU - Adamson, Joy
AU - Drummond, Avril
AU - Hewison, Ann
AU - Keding, Ada
AU - Kottam, Lucksy
AU - Madan, Ira
AU - McDaid, Catriona
AU - Reed, Mike
AU - Sinclair, Lesley
AU - Smith, Toby O
AU - Thomson, Louise
AU - Wu, Qi
AU - Baker, Paul
N1 - © Author(s) (or their employer(s)) 2024.
PY - 2024/9/16
Y1 - 2024/9/16
N2 - 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 National Health Service 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 with usual care in patients undergoing hip and knee replacement.METHODS AND ANALYSIS: This is a multicentre, 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 coordinator. The primary outcome is time until 'full' sustained RTW without sick leave for a consecutive 4-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, 3, 6, 9 and 12-month follow-up time points, 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.TRIAL REGISTRATION NUMBER: ISRCTN13694911.
AB - 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 National Health Service 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 with usual care in patients undergoing hip and knee replacement.METHODS AND ANALYSIS: This is a multicentre, 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 coordinator. The primary outcome is time until 'full' sustained RTW without sick leave for a consecutive 4-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, 3, 6, 9 and 12-month follow-up time points, 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.TRIAL REGISTRATION NUMBER: ISRCTN13694911.
KW - Humans
KW - Return to Work
KW - Arthroplasty, Replacement, Knee/rehabilitation
KW - United Kingdom
KW - Arthroplasty, Replacement, Hip/rehabilitation
KW - Cost-Benefit Analysis
U2 - 10.1136/bmjopen-2024-085962
DO - 10.1136/bmjopen-2024-085962
M3 - Article
C2 - 39284693
SN - 2044-6055
VL - 14
JO - BMJ Open
JF - BMJ Open
IS - 9
M1 - e085962
ER -