Title: Development and process evaluation of a pre-operative education and prehabilitation digital intervention for patients awaiting total knee replacement: a Virtual Knee School
Funder: Health Education England

Abstract: Background This project is focused on improving the quality and efficiency of pre-operative total knee replacement (TKR) care, a key priority from clinical and economic perspectives. The annual UK demand for TKRs is anticipated to rise to over 94,783 by 2020. TKRs are predominantly undertaken in older adults due to osteoarthritis. Patients awaiting TKR often face long delays whilst enduring significant pain and functional limitations. These problems negatively impact post-operative outcomes. Approximately 20% of patients who undergo TKR are not satisfied with post-operative outcomes. Systematic review findings highlight providing pre-operative TKR education and prehabilitation (pre-operative exercise therapy) could improve post-operative outcomes. At present however, the UK lacks agreed guidelines in this area. Current pre-operative TKR services vary across the UK, are costly for the NHS and often fail to meet patients' needs. Delivering pre-operative TKR care via digital interventions presents an innovative solution to these problems. Recent studies suggest TKR digital interventions are clinically- and cost-effective; however currently available interventions have significant limitations. These include requiring health professionals' input, which limits their efficiency. Furthermore, it is unclear how most existing TKR digital interventions were developed, despite thorough patient-centred design being known to be crucial to the effectiveness of digital interventions. This project seeks to address these issues through rigorously developing a novel TKR digital intervention that is fully automated and patient-centred. Aim To develop a pre-operative TKR education and prehabilitation digital intervention, the 'Virtual Knee School' (VKS), and explore its implementation and acceptability among patients awaiting TKR. Objectives To develop evidence- and consensus-based pre-operative TKR education and prehabilitation recommendations. To explore potential barriers/facilitators to engagement with the VKS. To use theoretical modeling to guide the design/description/evaluation of the VKS. To develop the VKS using an evidence-, person- and theory-based approach. To explore the implementation and acceptability of the VKS.Methods/timeline This project will involve a multiphase mixed methods approach consisting of five phases. Modified Delphi study to develop pre-operative TKR education and prehabilitation recommendations (months 0-8). Focus groups with patients awaiting TKR to identify patients' perspectives of potential barriers/facilitators to engagement with the VKS (months 6-12). Theoretical modelling for the VKS (guiding principles, behavioural analysis, logic model) (months 7-16). Development and iterative refinement of the VKS based on the findings of phases 1-3 and think aloud interviews with patients awaiting TKR (months 12-23). Process evaluation to explore the implementation and acceptability of the VKS among patients awaiting TKR (months 22-31).Anticipated impact Improve the quality, efficiency, accessibility and cost-effectiveness of pre-operative TKR care. Provide the vital underpinning research required prior to developing a feasibility study and associated randomised controlled trial investigating the clinical- and cost-effectiveness of the VKS. I will pursue this post-doctorally by applying for appropriate funding (e.g. NIHR Clinical Lectureship/RfPB scheme).Dissemination The dissemination strategy will be finalised with patient representatives. It is anticipated to include: presentations, publications, plain English summaries and social media posts. Dissemination will be targeted towards patients and the public, key health professional groups (e.g. orthopaedic surgeons) and relevant organisations/groups (e.g. Clinical Commissioning Groups).

Lay abstract: Aim The main aim of this research is to develop a website that provides pre-operative education and exercises for patients who are waiting for total knee replacement (TKR) surgery. This website will be called the 'Virtual Knee School' (VKS). The VKS could improve the pre-operative care of patients waiting for TKR surgery and patients' recovery after TKR surgery; and reduce NHS costs. This research is the important first step that will allow us later to undertake future studies investigating whether the VKS approach achieves these benefits. BackgroundTotal knee replacement (TKR) is a very commonly performed operation. The number of TKRs undertaken in the UK each year is increasing and is expected to be over 94,783 by 2020. TKR surgery is usually undertaken in older people with knee osteoarthritis, a painful joint condition. Patients waiting for TKR surgery often face long delays. During this time patients have pain and can find daily activities difficult. We know that the more problems patients have with pain and daily activities before TKR surgery the worse their recovery is after surgery. Providing pre-operative education and exercises to patients waiting for TKR surgery may improve these problems. However, the UK does not have agreed recommendations in this area. Current pre-operative TKR services vary across the UK and generally involve group classes (often called 'knee schools'). Research suggests though, that these services do not necessarily meet patients' needs, while the staff and facilities they require are expensive for the NHS. Recent research suggests providing TKR care using websites or mobile applications ('apps') may improve patients' recovery after surgery and reduce NHS costs. However, currently available websites/apps have significant limitations. These include requiring health professionals' input, which makes them expensive to provide. It is important to involve patients during every stage of website/app development, but it is not clear how most currently available TKR websites/apps were developed. We aim to address these issues by using evidence, patient feedback and theory to develop a new website, the 'Virtual Knee School' (VKS). The VKS will provide pre-operative TKR education and exercises without requiring health professionals' input. Methods This research will involve five stages: A list of pre-operative TKR care recommendations will be developed using an approach known as a Delphi study. This will involve asking a group of experts (including patients) to complete a series of on-line questionnaires until they agree which recommendations are important. Focus group discussions with patients waiting for TKR surgery will be used to explore what might encourage patients to use the VKS or prevent them from using it. The findings of phases 1-2 and appropriate theory (ideas about what affects people's behaviour) will be used to identify what the VKS should include. The findings of phases 1-3 will be used to develop an early version of the VKS. Interviews with patients waiting for TKR surgery will be used to gradually improve the VKS. Patients waiting for TKR surgery will be given access to the VKS for 4 weeks. Information about how patients use the VKS will be collected. Questionnaires and interviews will be used to explore whether patients think the VKS is acceptable.Patient and Public Involvement (PPI) Members of the Leeds Biomedical Research Centre (BRC) PPI group have played an important role in developing this research, for example by sharing their views about TKR services and websites/apps. We will continue PPI throughout this research by: Involving two patient representatives in the project advisory group. Involving the Leeds BRC PPI group.Dissemination We will share this research through: Professional publications/presentations. Presentation to the Leeds BRC PPI group. Plain English summaries for participants. Social media.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS
Health categories: MUSCULOSKELETAL