Occupational support for patients undergoing hip or knee replacement
| ISRCTN | ISRCTN13694911 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13694911 |
| IRAS number | 320809 |
| Secondary identifying numbers | CPMS 55035, NIHR133880, IRAS 320809 |
- Submission date
- 30/01/2023
- Registration date
- 09/02/2023
- Last edited
- 12/02/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Musculoskeletal Diseases
Plain English Summary
Background and study aims
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. A lengthy recovery time can affect patients’ physical and mental wellbeing. Patients receive little or no return-to-work support from their hospital or GP specific to their individual needs and work situation. As part of an earlier research study we developed an ‘occupational’ (back-to- work) programme (known as OPAL) 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.
The OPAL occupational support programme provides personalised, targeted support for people in a range of jobs. As part of the programme, patients receive a variety of resources to help them plan their return-to-work. This includes access to a trained co-ordinator who helps and supports them before and after surgery. We will compare the OPAL occupational support programme against standard care.
Who can participate?
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.
What does the study involve?
Consenting participants will be randomly assigned (using a computer) to receive either the OPAL programme or standard care. We aim to recruit 742 participants over 15 months. We will ask participants to complete questionnaires for 12 months following surgery in relation to 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 until full, sustained return-to-work. 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.
What are the possible benefits and risks of participating?
Individual participants may not benefit directly from this research. Those in the intervention group have access to a) a website which support key aspects of returning to work, and b) a return-to-work coordinator (RTWC) who provides 1:1 support and helps the participant understand and interact with the information and guidance provided.This approach provides greater support than a typical standard care approach of sign-posting.
For participants in the standard care group, although there is no direct benefit, they are participating in research that could help to update the current approach to benefit future patients.
Where is the study run from?
South Tees Hospitals NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
June 2022 to January 2026
Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK).
Who is the main contact?
Lucy Sheehan, lucy.sheehan@york.ac.uk
Contact information
Principal Investigator
South Tees Hospitals NHS Foundation Trust
James Cook Hospital
Marton Road
Middlesborough
TS4 3BW
United Kingdom
| Phone | +44 1642 850850. Ext 54168 |
|---|---|
| paul.baker1@nhs.net |
Public
York Trials Unit
Ground Floor ARRC Building
Department of Health Sciences
University of York
Heslington
York
YO10 5DD
United Kingdom
| Phone | None available |
|---|---|
| lucy.sheehan@york.ac.uk |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home, Hospital, Internet/virtual, Telephone |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | Occupational support for Patients undergoing Arthroplasty of the Lower limb trial (OPAL trial) |
| Study acronym | OPAL |
| Study hypothesis | We aim to evaluate the OPAL occupational support programme to find out whether it assists patients to make a timely, safe and sustained return-to-work and normal activities after hip or knee joint replacement surgery. The OPAL feasibility study is registered on ISRCTN at https://www.isrctn.com/ISRCTN27426982 |
| Ethics approval(s) | Approval 09/02/2023, West Midlands - Edgbaston Research Ethics Committee (Barlow House, 3rd Floor, 4 Minshull Street, Manchester, M1 3DZ, UK; +44 2071048070; edgbaston.rec@hra.nhs.uk), ref: 23/WM/0013 |
| Condition | Occupational support for patients undergoing arthroplasty of the lower limb |
| Intervention | The OPAL trial is a two-arm multi-centre, randomised, superiority trial with parallel groups. Patients will be allocated to a) the OPAL support intervention or b) standard care. There will be a 6-month internal pilot, and embedded economic and process evaluations. The trial will assess the effect on time to full, sustained RTW of the OPAL occupational support intervention versus standard care in 742 people undergoing elective primary hip and knee replacement in the UK. The risk of group contamination is low due to the experimental intervention being tailored to participants and being delivered when patients are physically separated. Allocation will be on a 1:1 ratio (intervention : control). Randomisation will be carried out using a secure web-based randomisation system (REDCap) ensuring allocation concealment and stratified by site with randomly permuted blocks of randomly varying size. Stratification by surgical site (hip or knee joint) will be included within the randomisation process. The randomisation service will require the recording of information and a check of patient eligibility to avoid inappropriate entry of patients into the trial. This will be conducted by local site teams including clinicians and research nurses. The randomisation system will provide an immediate allocation and a confirmation email. The email confirming randomised allocation will be sent to the PI and all authorised users of the randomisation system at the recruiting site. The local site team/treating clinician will inform the participant of their group allocation. For the Process evaluation and to address important issues of fidelity and acceptability of the intervention, we will undertake the following: - Qualitative observations of the RTWC during an initial appointment with a sample of participants pre-surgery (n=15-20) to understand how the intervention is implemented in practice. - Qualitative interviews with trial participants from the intervention arm (n=15-20). Participants will be purposively sampled to ensure maximum variation (on the basis of age, gender, job role and site) to ascertain the acceptability of the interventions, ease of use and perceived impact of the intervention. - Interviews with a sample of trial participants’ employers (n=5) will be conducted to understand key stakeholder perspectives. - Interviews with RTWCs (n=14) will be conducted on two occasions. At the start of the study brief interviews will be conducted regarding reasons for applying for the position, expectations for the post/intervention, anticipated barriers and facilitators to using the intervention. At the end of the intervention period, RTWCs will be asked about their experience of delivering the service, interfacing with other service providers and to highlight challenges/facilitators associated with service delivery. - Interviews with service leaders/key stakeholders (n=15-20) including clinicians, and commissioners will be conducted at two time points: during project set up to discuss current provision, how the new intervention will fit within existing services and how this will be funded; and at end of trial to discuss incorporating trial findings into service development. |
| Intervention type | Behavioural |
| Primary outcome measure | 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. This is measured monthly via questionnaire. |
| Secondary outcome measures | 1. Time to any return to work, measured monthly via questionnaire. 2. Measures of functional recovery to daily activities and social participation using the following: 2.1. Oxford hip/knee score (OKS/OHS) - at baseline, 3, 6, 9, and 12 months. 2.2. Lower extremity functional scale (LEFS) - at baseline, 3, 6, 9, and 12 months. 2.3. PROMIS social participation short form questionnaires (social roles and activities questionnaire, satisfaction with participation in social roles questionnaires) - at baseline, 3, 6, 9, and 12 months. 3. Number of ‘sick days’ between surgery and ‘full’ sustained return to work - measured monthly via questionnaire. 4. Participant adherence to the intervention and the intervention’s physical rehabilitation programme - self-reported Likert scales upon achieving the primary outcome. 5. Proportion of participants using workplace interventions, adaptions and modifications to facilitate their RTW measured by questionnaire upon achieving the primary outcome. 6. Health-related quality of life measured via EQ-5D-5L at baseline, 3, 6, 9, and 12 months. 7. Work Productivity measured via Work Limitations Questionnaire at baseline, 3, 6, 9, and 12 months. |
| Overall study start date | 01/06/2022 |
| Overall study end date | 31/01/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 742; UK Sample Size: 742 |
| Participant inclusion criteria | Adults (>=16 years) listed for elective primary hip or knee replacement in paid or unpaid work who intend to RTW after surgery. |
| Participant exclusion criteria | 1. Patients undergoing emergency arthroplasty (e.g. for trauma). 2. Adults listed for elective ankle replacement. 3. Adults planned to undergo further surgery within the 6 months after their joint replacement. Added 07/06/2024: 4. Patients listed for bilateral knee replacements. |
| Recruitment start date | 19/04/2023 |
| Recruitment end date | 01/06/2025 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
- Wales
Study participating centres
Derby
DE22 3NE
United Kingdom
Sunderland
SR4 7TP
United Kingdom
C Floor, Huntsmnan Building
Herries Road
Sheffield
S5 7AU
United Kingdom
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
Colney Lane
Colney
Norwich
NR4 7UY
United Kingdom
Gorleston
Great Yarmouth
NR31 6LA
United Kingdom
Middlesbrough
TS4 3BW
United Kingdom
North Shields
NE29 8NH
United Kingdom
Hartlepool
TS24 9AH
United Kingdom
Stanmore
HA7 4LP
United Kingdom
Carshalton
SM5 1AA
United Kingdom
London
E1 2ES
United Kingdom
Headington
Oxford
OX3 9DU
United Kingdom
2-4 Waterloo Place
Edinburgh
EH1 3EG
United Kingdom
Hamilton
ML3 0TA
United Kingdom
Darlington
DL3 6HX
United Kingdom
London
SE1 9RT
United Kingdom
Pontypridd
CF37 1LB
United Kingdom
Sponsor information
Hospital/treatment centre
James Cook University Hospital
Marton Road
Middlesbrough
TS4 3BW
England
United Kingdom
| Phone | +44 7972086421 |
|---|---|
| jane.greenaway@nhs.net | |
| Website | http://southtees.nhs.uk/ |
"ROR" |
https://ror.org/02js17r36 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 31/01/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Protocol file | version 3.0 | 15/04/2024 | 10/06/2024 | No | No |
| Protocol article | 16/09/2024 | 26/09/2024 | Yes | No |
Additional files
Editorial Notes
12/02/2025: The following changes were made:
1. The recruitment end date was changed from 01/02/2025 to 01/06/2025.
2. The Leicester Royal Infirmary and Royal Devon & Exeter Hospital (wonford) were removed from the study participating centres.
3. The University Hospital of Hartlepool, Royal National Orthopaedic Hospital, St Helier Hospital, Royal London Hospital, John Radcliffe Hospital, NHS Lothian, NHS Lanarkshire, Darlington Memorial Hospital, Guys Hospital and Dewi Sant Hospital were added to the the study participating centres.
4. United Kingdom - Scotland and United Kingdom - Wales were added as Countries of recruitment.
26/09/2024: Publication reference added.
26/07/2024: The recruitment end date was changed from 31/07/2024 to 01/02/2025.
10/06/2024: The following changes were made to the study record:
1. The recruitment start date was changed from 31/03/2023 to 19/04/2023.
2. The recruitment end date was changed from 31/05/2024 to 31/07/2024.
3. Protocol file added.
07/06/2024: Exclusion criterion added.
01/09/2023: The public contact was replaced and the plain English summary was amended accordingly.
30/01/2023: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
