Title: Occupational support for Patients undergoing Arthroplasty of the Lower limb trial (OPAL)
Funder: Department of Health and Social Care

Abstract: Background to the research:_x000D_ Hip and knee joint replacements relieve pain and improve function in patients with arthritis. One in four patients are in work at the time of their hip or knee replacement surgery, equivalent to 50,000 people in the UK each year. Many patients get back to work after surgery, however, the time this takes varies considerably and lengthy recovery time can affect the patient’s physical and mental wellbeing. _x000D_ _x000D_ Patients receive little or no return-to-work advice from their hospital or GP, before or after surgery, specific to their individual needs and work situation. As part of an earlier research study (OPAL), commissioned by the National Institute for Health Research (NIHR), we developed an ‘occupational’ (that is, a back to work) programme that supports return-to-work after surgery. We now need to assess whether this is effective in supporting a timely, safe and sustained return-to-work after surgery. _x000D_ _x000D_ Aim(s) of the research:_x000D_ This research will evaluate the OPAL occupational support programme to find out whether it assists patients to make a timely, safe and sustained return-to-work and other normal activities after hip or knee joint replacement surgery._x000D_ _x000D_ Research plan:_x000D_ The occupational support programme we have developed provides personalised, targeted support for patients in a range of jobs. As part of the programme, patients receive a variety of resources to help them plan their return to work, including access to a trained dedicated co-ordinator who helps and supports them before and after surgery. _x000D_ _x000D_ The study will compare this occupational support programme against standard care._x000D_ _x000D_ All adults listed for elective primary hip or knee replacement from a minimum of 14 UK hospitals, who are in paid or unpaid work, will be invited to take part. They will be approached before their surgery either at their pre-assessment appointment or via a phone call to explain the study and take their consent. Consenting participants will then be randomly selected using a computer to receive either the OPAL support programme or standard care. This will allow a fair comparison between the two. We aim to recruit 742 participants over a 15-month period. _x000D_ _x000D_ We will ask participants to complete questionnaires for 12 months following surgery to document when and how they return to work, and their normal activities. From these, we will understand if the OPAL programme helps to reduce the length of time for full, sustained return-to-work. We will find out if there is a difference in the groups in time to return to any work, the speed and quality of their recovery, and if there was a need for additional workplace support. We will find out if the cost of care differs between the two groups, to determine whether one is better value for money for the NHS. We will also ask what those receiving and delivering the OPAL programme think about it and determine how it could be incorporated into routine NHS care, if successful. _x000D_ _x000D_ Patient and public involvement (PPI):_x000D_ The study has been developed with patient advisors who have experience of hip or knee arthritis. A patient advisory group, along with our PPI co-applicants, will remain involved in the research to develop patient facing documents, advise on any trial processes and suggest how best to report study findings to the public and patients.

Lay abstract: Background: Orthopaedic teams should deliver advice on return to work (RTW) for patients undergoing primary hip and knee replacement. Currently patients receive little or no information about RTW. There is a need for an occupational support intervention that encourages safe and sustained RTW which can be integrated into NHS practice. As part of earlier work (OPAL HTA15/28/02) we developed an occupational support programme for this specific patient group that comprised two core components: 1) provision of multimedia information resources; and 2) access to, and support from, a designated RTW co-ordinator. The OPAL study demonstrated that delivery of the intervention was feasible and may help improve time to RTW after surgery. We are now seeking to assess the intervention in this trial. _x000D_ _x000D_ Aims and Objectives: To assess whether an occupational support intervention for people undergoing elective primary hip and knee replacement, initiated prior to surgery, is effective in supporting a reduced time to full, sustained RTW compared to usual care and is a cost-effective use of NHS resources._x000D_ _x000D_ Methods: The study (OPAL2) will comprise an a) effectiveness trial, b) health economic analysis and c) assessment of implementation, fidelity and acceptability. We will undertake a multi-centre, individual level randomised superiority trial of the OPAL intervention versus ‘standard care’, with internal pilot (sample size = 742 (322 control group, 420 intervention group)). The study will be delivered at a minimum of 14 UK study sites. It will include adults (= 16 years) listed for elective primary hip or knee replacement in paid or unpaid work who intend to RTW after surgery. Patients will be followed up for 12 months after surgery. The primary outcome is time until ‘full’ sustained return to any work, defined as work resumption to the same hours as prior to joint replacement in any role, without any day of sick leave for a consecutive 4-week period. Secondary outcomes are: time to any RTW, measures of functional recovery to daily activities and social participation, number of ‘sick days’ between surgery and ‘full’ sustained RTW and the proportion of patients using workplace interventions, adaptions and modifications to facilitate their return. The health economic evaluation will assess the cost-effectiveness of the intervention versus usual care over a 12-month period. A mixed methods process evaluation will assess the implementation, fidelity and acceptability of the intervention, including participant adherence to the intervention and its component parts. _x000D_ _x000D_ Timelines for delivery: Total duration 44 months. Study set up (9 months); recruitment (15 months, including 6-month internal pilot); follow-up (14 months); analysis and dissemination (6 months)._x000D_ _x000D_ Anticipated impact and dissemination: If the intervention is found to be effective and cost-effective it has the potential to greatly improve patient care. Dissemination will focus on supporting the wider adoption and implementation of the intervention (if effective) and will target groups for whom the results (and implementation plan) will be relevant.

Research activity codes: 6.7 PHYSICAL
Health categories: MUSCULOSKELETAL