Title: REST: A prospective randomised feasibility study assessing the impact of a tailored sleep intervention in patients undergoing total knee replacement
Funder: Department of Health and Social Care

Abstract: Research question Is it feasible to conduct a randomised controlled trial (RCT) to evaluate the clinical and cost-effectiveness of a non-pharmacological complex sleep intervention for improving long-term pain outcomes after total knee replacement (TKR)? Background In the UK approximately 20,000 patients experience chronic pain after TKR each year. Chronic pain after TKR impacts all dimensions of patient quality of life. Studies have shown that patients experience functional limitations, reduced activity levels, anxiety, depression, and poorer general health. Treatment and investigations for ongoing primary TKR pain come at increased cost to the NHS. Given the substantial negative impact of chronic pain after TKR and the increased use of NHS resources, there is a need to develop new approaches to reduce the proportion of patients who experience chronic post-operative pain. To address this issue we propose to test the feasibility of an RCT evaluating the clinical and cost-effectiveness of a pre-operative sleep assessment and complex intervention package for improving long-term pain after TKR. Aims and Objectives The key uncertainties this feasibility study will assess are: Is it feasible to recruit patients into the study? Will patients attend the clinic appointment? Will patients engage with the intervention and adhere to the agreed plan? Is the intervention acceptable to patients and health professionals? Do practitioners deliver the intervention as intended? Methods This study is a two centre feasibility study for an RCT, with embedded qualitative research and health economics. Pre-operative TKR patients will be identified from North Bristol NHS Trust and Cardiff and Vale University Health Board. Patients will be randomised to the sleep intervention or standard care. The intervention arm will received a tailored sleep assessment and behavioural intervention package delivered by an extended scope practitioner. Patients will be followed up at four-weeks to discuss progress and engagement. Patient reported outcomes will be assessed at baseline, one-week pre-surgery, and 3-months post-surgery. Questionnaires will measure: joint pain, neuropathic pain, sleep quality, psychological well-being, and general health and well-being. A nested qualitative study will explore acceptability of the intervention and feasibility of conducting an RCT. This will include interviews with participants in both arms, practitioners delivering the intervention, and fidelity assessment. Timelines for delivery A 22 month study with a two month set-up, 10 months recruitment and 10 months follow-up. Fidelity observations of intervention delivery will be conducted in the first five months. Practitioner interviews will take place at two time-points, post-training and post-intervention delivery. Patient interviews and analysis will be conducted using an iterative approach. Anticipated Impact and Dissemination Dissemination will be designed to engage a range of stakeholders through various routes. We will work with the PPI group to communicate findings to a lay audience and identify and priorities next steps. The results of this study will guide whether a full RCT to test the effectiveness of the complex, tailored sleep intervention is feasible. If the trial is found to be feasible, findings will inform the design of the future RCT and an application will be submitted to the NIHR HTA programme.

Lay abstract: Aim The aim of this research is to find out how best to design a randomised trial to test if we can improve sleep before knee replacement surgery and reduce long-term pain. Background Knee replacement is the second most common operation in the UK with over 100,000 performed yearly. Total knee replacement has good results and most people who have this operation have pain relief and improved function. However, around 20% experience long-term pain after surgery (pain for longer than 3-months). Long-term pain can cause problems with knee function, decreased activity, and can have a negative impact on well-being. The additional treatments and appointments needed to address long-term pain come at an increased cost to the NHS. People with higher levels of pain before their operation are more likely to have long-term pain afterwards. Sleep has a two-way relationship with pain. Reduced sleep causes increased pain and improvement of sleep has been shown to reduce both immediate and long-term pain in people with joint problems. Our aim is to find out how best to design a larger study to test a pre-operative sleep intervention for improving long-term pain. Design and methods The key questions this study will address are: Are patients willing to take part in the study? Will patients attend the clinic appointment? Will patients engage in the sleep intervention and adhere to the agreed plan? Do practitioners deliver the intervention as intended? We will conduct a two-centre study with qualitative research and health economics. Patients on the surgical waiting list will be recruited and randomised to receive either standard care or the sleep intervention. Patients taking part in the intervention will attend a one-to-one appointment with an healthcare practitioner to assess their sleep issues and needs. They will then be given tailored sleep advice and will be assigned to one of 3 existing sleep interventions based on the assessment and a shared decision: Cognitive-behavioural therapy for insomnia Relaxation Mindfulness An interview study with practitioners and patients will explore acceptability of delivering the intervention and the feasibility of a full trial. Data collection Patient reported data will be collected on: Joint pain Neuropathic pain Sleep quality Mood and well-being We will also collect data on: Recruitment rate Adherence and engagement with the intervention Health economics PPI The study was developed in collaboration with a musculoskeletal PPI group at Southmead Hospital. The development of this intervention followed the Medical Research Council guidance. It was guided by mixed-methods work with patients awaiting knee replacement, including focus groups, sleep assessment using monitors and diaries, and a systematic review of sleep interventions in chronic pain populations. Dissemination A study report participants Journal publications Presentations at conferences and seminars Information on charity websites

Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: MUSCULOSKELETAL