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Preoperative Behavioural Intervention versus standard care to Reduce Drinking before elective orthopaedic Surgery (PRE-OP BIRDS): protocol for a multicentre pilot randomised controlled trial

机译:术前行为干预与标准护理以减少择期骨科手术前饮酒(PRE-OP BIRDS):一项多中心飞行员随机对照试验的方案

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Evidence suggests that increased preoperative alcohol consumption increases the risk of postoperative complications; therefore, a reduction or cessation in alcohol intake before surgery may reduce perioperative risk. Preoperative assessment presents an opportunity to intervene to optimise patients for surgery. This multicentre, two-arm, parallel group, individually randomised controlled trial will investigate whether a definitive trial of a brief behavioural intervention aimed at reducing preoperative alcohol consumption is feasible and acceptable to healthcare professionals responsible for its delivery and the preoperative elective orthopaedic patient population.MethodsScreening will be conducted by trained healthcare professionals at three hospitals in the North East of England. Eligible patients (those aged 18 or over, listed for elective hip or knee arthroplasty surgery and scoring 5 or more or reporting consumption of six or more units on a single occasion at least weekly on the alcohol screening tool) who enrol in the trial will be randomised on a one-to-one non-blinded basis to either treatment as usual or brief behavioural intervention delivered in the pre-assessment clinic. Patients will be followed up 1–2?days pre-surgery, 1–5?days post-surgery (as an in-patient), 6?weeks post-surgery, and 6?months post intervention. Feasibility will be assessed through rates of screening, eligibility, recruitment, and retention to 6-month follow-up. An embedded qualitative study will explore the acceptability of study methods to patients and staff.DiscussionThis pilot randomised controlled trial will establish the feasibility and acceptability of trial procedures reducing uncertainties ahead of a definitive randomised controlled trial to establish the effectiveness of brief behavioural intervention to reduce alcohol consumption in the preoperative period and the potential impact on perioperative complications.Trial registrationReference number ISRCTN36257982.
机译:有证据表明,术前饮酒增加会增加术后并发症的风险。因此,手术前减少或停止饮酒可能会降低围手术期的风险。术前评估提供了干预机会,可以优化患者的手术条件。这项多中心,两臂,平行组的个体随机对照试验将研究针对减少术前饮酒的简短行为干预的明确试验是否可行,并且对于负责其分娩和术前选修整形外科患者的医疗保健专业人员是否可接受。方法筛查将由英格兰东北三所医院的训练有素的医疗保健专业人员进行。参加试验的符合条件的患者(年龄在18岁或18岁以上,进行选择性髋关节或膝关节置换术且得分5以上或在至少一次每周一次使用酒精筛查工具报告消耗6个以上单位的情况下)的患者将是在一对一的非盲基础上随机分配至常规治疗或在评估前诊所进行短暂的行为干预。将对患者进行手术前1-2天,手术后1-5天(作为住院病人),手术后6周和干预后6个月的随访。可行性将通过筛选,资格,招募和保留至6个月随访的比率进行评估。一项嵌入式定性研究将探讨研究方法对患者和医务人员的可接受性。讨论此先导性随机对照试验将确定试验程序的可行性和可接受性,从而在确定性的随机对照试验之前确定最终的行为干预措施以减少饮酒,从而减少不确定性。术前消耗量及其对围手术期并发症的潜在影响。注册号:ISRCTN36257982。

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