Recipient organisationSouth Tees Hospitals NHS Foundation Trust
Funding£1.7M
PeriodJun 2022 — Jan 2027
In plain English
AI plain-English summary
Every year, thousands of people in the UK have hip or knee replacements and then receive almost no guidance on when or how to safely return to work. This trial tests whether a structured occupational support programme—including multimedia information and a dedicated return-to-work coordinator—can help patients get back to their jobs faster and more sustainably after surgery. The problem is clear: orthopaedic teams are expected to advise on return to work, but in practice patients get little or no information. This leaves many struggling to resume their roles, risking prolonged sick leave or an unsafe return. The OPAL2 trial will recruit 742 adults across at least 14 NHS sites, randomly assigning them to either the support programme or standard care, and track them for 12 months after surgery. The primary measure is time to a full, sustained return to work—defined as resuming pre-surgery hours without any sick leave for four consecutive weeks. If the intervention proves effective and cost-effective, it could transform a routine gap in NHS care into a standard, integrated service. For patients, that means less financial strain and a smoother transition back to daily life. For employers and the health service, it means fewer lost workdays and a better use of resources. The study also includes a health economic analysis and a process evaluation to assess how well the programme works in practice.
View original technical description
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. 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. 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. 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). 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.
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