Title: Pre-Operative Behavioural Intervention to Reduce Drinking before elective orthopaedic Surgery (Pre-Op BIRDS)
Funder: Department of Health and Social Care

Abstract: Our study has two linked phases: 1. Feasibility work will: assess acceptability of screening and brief intervention aimed at reducing alcohol consumption to patients listed for elective primary hip or knee arthroplasty and to nurses; characterise usual care; and define and manualise a screening and brief alcohol intervention protocol. Adult patients due to have elective primary hip or knee arthroplasty, will be consented to being interviewed by a researcher. Structured by a topic guide, in-depth interviews will explore views on materials and procedures. Sampling will be purposive, seeking to achieve maximum variation in terms of patients’ age, gender, drinking status and socio-economic status (via postcodes); and nurses’ clinical experience. Sample size will be determined by data saturation (ongoing analysis indicating no new themes). We envisage 8-10 patients/4 nurse interviews lasting up to 60 minutes each. Interviews will be audio-recorded and fully transcribed (verbatim) and NVivo software will aid indexing and charting. Thematic analysis will be structured by the Framework approach (recommended for qualitative work linked to quantitative studies) and Normalization Process Theory will help us consider factors affecting intervention delivery. The intervention will be optimised and manualised and training materials developed and behaviour change techniques described to increase replicability. 2: An external pilot RCT will involve a two-arm, three-centre trial of screening and brief alcohol intervention in risky drinkers who are scheduled for joint arthroplasty. Forty patients will be recruited and randomised into each condition with the intention of achieving 30 per arm at 6 month post-intervention. Eligible patients will be =>18 years, listed for elective primary hip/knee arthroplasty and able to give informed consent. Exclusion criteria will be: patients needing sequential bilateral joint replacement; patients displaying current (active) withdrawal from alcohol; patients with severe psychiatric disorder requiring medical therapy and severe cognitive impairment/dementia impacting on ability to interact with intervention and increasing likelihood of postoperative delirium. Screening will occur at the initial orthopaedic assessment by a nurse who will not be involved in subsequent patient interventions. Alcohol consumption will be screened by using the Alcohol Use Disorders Identification Test (AUDIT). Risky drinking will be defined as scoring =>8 on AUDIT (score range 0-40) plus weekly or daily drinking of 6 or more units in a session (judged by AUDIT item 3). An initial verbal expression of interest at this visit will be confirmed by phone/email contact up to one week after receiving study information. Full written consent will be obtained at the preoperative assessment clinic visit occurring some 6 weeks after the surgical outpatient visit. This will be followed by remote electronic randomisation that allocates either usual care (comparator group) or a brief alcohol intervention (which will include a single 30 minute 1:1 brief intervention based on a customised version of the "How Much is too Much ?" programme). In addition, all intervention patients will be given the opportunity to undergo a second intervention at 1-2 weeks before surgery. Maximal follow-up will be 6 months post-assessment. Success criteria will be based on recruitment, retention and acceptability outcomes

Lay abstract: The National Institute for Health and Care Clinical Excellence (NICE) recognises that major surgery often represents the only treatment for worsening arthritis. As the population ages, the majority of patients undergoing elective knee and hip replacement surgery are over 65 years of age. Unfortunately, older patients have an increased risk of complications following surgery when compared to their younger counterparts. The reasons for this are unclear but chronological age should not in itself be a barrier to performing surgery. Preoperative detection and reduction of risk factors known to increase complications after surgery, especially in older patients, is becoming increasingly important. For this reason, preoperative assessment clinics are becoming common in the UK. These clinics provide an underutilised, early opportunity to develop interventions that reduce risk of surgery and ultimately improve outcome. Excess preoperative alcohol consumption is a known to be associated with increased complications after surgery, which prevent early recovery and prolong rehabilitation. Therefore any therapy that successfully reduces alcohol consumption before surgery will likely have major implications for patient benefit. The detection of high alcohol consumption, followed by techniques that aim to support patients to reduce alcohol intake through changing attitudes and behaviours, have been successful in reducing consumption levels, in other clinical situations, including accident and emergency, general practice and some hospital wards. These techniques have considerable potential in reducing alcohol consumption before surgery. The present study aims to tailor a detection and brief behaviour-change intervention to an orthopaedic population being referred for major joint surgery. Use of the preoperative assessment clinic will provide a dedicated workforce applying the process at a much earlier stage in the surgical pathway than previously described, thereby hoping to maximise the potential benefit of the intervention. The research will be in two phases: Phase 1:This phase will take place at a preoperative assessment clinic in the North East of England. The first objective will be to establish a nurse-administered preoperative screening tool, to detect higher levels of alcohol consumption in orthopaedic surgical patients. Secondly, one or two conversations between individual patients and dedicated preoperative assessment nurses, will aim to motivate and support the patient to think about and plan a change in drinking habits before surgery. The ease with which these processes are integrated into the surgical pathway and the acceptability of the process to both nurses and patients will be assessed. Phase 2:The optimised screening and behavioural intervention will be applied in a study that will take place in up to three hospitals in the Tyne and Wear area. The intervention will be tested against usual management before surgery . The overall objective of this phase is to provide information to inform a much larger study to promote preoperative alcohol reduction in the orthopaedic population. In summary, the overall proposal is to develop an acceptable screening and behavioural intervention, which can be applied in the early stages of the surgical pathway, and to rehearse the processes for a larger trial.

Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: CANCER AND NEOPLASMS;CARDIOVASCULAR;MUSCULOSKELETAL;ORAL AND GASTROINTESTINAL;STROKE