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OPAL Report Clean V4 Nov 2019 This is a repository copy of Occupational advice for Patients undergoing Arthroplasty of the Lower limb: An intervention development and feasibility study (The OPAL Study). White Rose Research Online URL for this paper: https://eprints.whiterose.ac.uk/157218/ Version: Accepted Version Article: Baker, Paul, Coole, Carol, Drummond, Avril et al. (14 more authors) (2020) Occupational advice for Patients undergoing Arthroplasty of the Lower limb: An intervention development and feasibility study (The OPAL Study). NIHR Journals Library. pp. 1-444. https://doi.org/10.3310/hta24450 Reuse Items deposited in White Rose Research Online are protected by copyright, with all rights reserved unless indicated otherwise. They may be downloaded and/or printed for private study, or other acts as permitted by national copyright laws. The publisher or other rights holders may allow further reproduction and re-use of the full text version. This is indicated by the licence information on the White Rose Research Online record for the item. Takedown If you consider content in White Rose Research Online to be in breach of UK law, please notify us by emailing [email protected] including the URL of the record and the reason for the withdrawal request. [email protected] https://eprints.whiterose.ac.uk/ Title Occupational advice for Patients undergoing Arthroplasty of the Lower limb: An intervention development and feasibility study (The OPAL Study) Author list Paul Baker 1,3, Carol Coole 2, Avril Drummond 2, Sayeed Khan 4, Catriona McDaid 3, Catherine Hewitt 3, Lucksy Kottam 1, Sarah Ronaldson 3, Elizabeth Coleman 3, David McDonald 5,6, Fiona Nouri 2, Melanie Narayanasamy 2, Iain McNamara 7, Judith Fitch 8, Louise Thomson 2, Gerry Richardson 9, Amar Rangan 1,3,10. Affiliations 1. South Tees Hospitals NHS Foundation Trust, Middlesbrough, UK 2. School of Health Sciences, Faculty of Medicine & Health Sciences, University of Nottingham, UK 3. York Trials Unit, Department of Health Sciences, University of York, UK 4. MakeUK, The Manufacturers’ Organisation, Broadway House, London, UK 5. Whole System Patient Flow Programme, Scottish Government, Scotland, UK 6. NMAHP Research Unit, Glasgow Caledonian University, Glasgow, UK 7. Norfolk and Norwich University Hospital NHS Foundation Trust, Norwich, UK 8. British Orthopaedic Association Patient Liaison Group, Royal College of Surgeons of England, London, UK 9. Centre for Health Economics, University of York, UK 10. University of Oxford, Oxford, UK Corresponding author [email protected] South Tees Hospitals NHS Foundation Trust, James Cook University Hospital, Marton Road, Middlesbrough, TS4 3BW. Tel: 01642 854479 Key words Occupational advice, vocational rehabilitation, return to work, hip replacement, knee replacement, intervention mapping, employment, work, systematic review, qualitative, cohort study, feasibility Word Count = 50,232 1 Competing interests Paul Baker: NICE guideline committee member: Hip, knee and shoulder replacement clinical guideline Carol Coole: No conflicts of interest declared Avril Drummond: Member of the HEE/NIHR Selection Panel for the Senior Clinical and Clinical Academic Lectureships Sayeed Khan: No conflicts of interest declared Catriona McDaid: Member of the National Institute of Health Research (NIHR) Health Technology Assessment (HTA) and Efficacy and Mechanism Evaluation (EME) Editorial Board. Catherine Hewitt: Member of the HTA Commissioning Board Lucksy Kottam: No conflicts of interest declared Sarah Ronaldson: No conflicts of interest declared Elizabeth Coleman: No conflicts of interest declared David McDonald: No conflicts of interest declared Fiona Nouri: No conflicts of interest declared Melanie Narayanasamy: No conflicts of interest declared Iain McNamara: No conflicts of interest declared Judith Fitch: No conflicts of interest declared Louise Thomson: Member of the NICE Public Health Advisory Committee on Workplace Health Gerry Richardson: No conflicts of interest declared Amar Rangan: NIHR grant holder (Partial Rotator Cuff Tear Repair Trial (PRO CURE Trial) – NIHR- HTA Project 128043 (Co-Investigator) - Subject to DOH contracting; UKFROST – NIHR-HTA Project 13/26/01 (CI); ProFHER Trial – NIHR-HTA Project 06/404/53 (CI); HUSH trial - NIHR-HTA Project 127817 (Co-Investigator); Patch Augmented Rotator Cuff Repair - feasibility study - NIHR-HTA Project 15/103 (Co-Investigator); Treatment of first time anterior shoulder dislocation, CPRD analysis - NIHR-HTA Project 14/160/01 (Co-Investigator); SWIFFT Trial - NIHR-HTA Project 11/36/37 (Co-Investigator); DRAFFT Trial - NIHR-HTA Project 08/116/97 (Co-Investigator); PRESTO feasibility study – NIHR-HTA Project 15/154/07 (Mentor to CI); Evidence Synthesis on the frozen shoulder NIHR-HTA Project 09/13/02 (Co-Investigator)); ORUK research grant holder; Research and educational grants to institution from DePuy (A Johnson & Johnson company) 2 Abstract Background Hip and knee replacements are regularly performed for patients who work. There is little evidence about these patients’ needs and the factors influencing their return to work. There is a paucity of guidance to help patients return to work after surgery and a need for structured occupational advice to enable them to return to work safely and effectively. Objective(s) To develop an occupational advice intervention to support early recovery to usual activities including work which is tailored to the requirements of patients undergoing hip and knee replacements. To test the acceptability, practicality and feasibility of this intervention within current care frameworks Design An intervention mapping (IM) approach was used to develop the intervention. The research methods employed were: rapid evidence synthesis; qualitative interviews with patients and stakeholders; prospective cohort study; survey of clinical practice; modified Delphi consensus process. The developed intervention was implemented and assessed during the final feasibility stage of the IM process. Setting Orthopaedic departments within NHS secondary care. Participants Patients in work, and intending to return to work following primary elective hip and knee replacement surgery; healthcare professionals and employers. Interventions Occupational advice intervention. Main outcome measures Development of an occupational advice intervention. Fidelity of the developed intervention when delivered in a clinical setting. Patient and clinician perspectives of the intervention. Preliminary assessments of intervention effectiveness and cost. Results A cohort study (154 patients), 110 stakeholder interviews, survey of practice (152 respondents) and evidence synthesis provided the necessary information to develop the intervention. The intervention included information resources, personalized return to work plan and co-ordination from the healthcare team to support the delivery of 13 patient and 20 staff performance objectives (POs). To support delivery, a range of tools (e.g. occupational checklists, patient workbooks, employer information), roles (e.g. return-to-work coordinator) and training resources were created. Feasibility was assessed in 21 of the 26 patients recruited from 3 NHS trusts. Adherence with the defined performance objectives was 75% for patient POs and 74% for staff POs. The intervention was generally well received although the short timeframe available for implementation and concurrent research evaluation led to some confusion amongst patients and those delivering the intervention regarding its purpose and the roles and responsibilities of key staff. Limitations Implementation and uptake of the intervention was not standardized and was limited by the study timeframe. Evaluation of the intervention involved a small number of patients which limited the ability to assess it. 3 Conclusions The developed occupational advice intervention supports best practice. Evaluation demonstrated good rates of adherence against defined performance objectives. However, a number of operational and implementation issues require further attention Future work The intervention warrants a randomised controlled trial to assess its clinical and cost effectiveness to improve rates and timing of sustained return to work after surgery. This research should include the development of a robust implementation strategy to ensure adoption is sustained. Funding This project was funded by the NIHR Health Technology Assessment programme (project number 15/28/02) Trial Registrations International Standard Randomised Controlled Trials Number Trial ID: ISRCTN27426982 International prospective register of systematic reviews (PROSPERO) Registration: CRD42016045235 4 Table of contents Page Table of contents 5 List of Tables 8 List of Figures 12 List of Abbreviations 13 Plain English Summary 14 Scientific Summary 15 Chapter 1: Background and Study Introduction 21 1.1 Is there a need for an occupational advice intervention for hip and knee replacement patients? 21 1.2 Current evidence relating to return to work after hip and knee replacement 22 1.3 Summary of the current literature – Key points 23 1.4 The OPAL study 24 1.5 Aims and Objectives 25 Chapter 2: Methodological overview – OPAL Intervention Mapping Framework 27 2.1 Intervention mapping 27 2.2 The OPAL Intervention mapping process 27 2.3 Stakeholder engagement strategy 30 2.4 Data collection and handling 31 2.5 Project Management 31 2.6 Ethics approval 32 2.7 Project registration 32 2.8 Protocol management and version history 32 2.9 Patient and Public involvement
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