Williams Aled L, Phillips Ceri J, Watkins Alan, Rushton Alison B
Musculoskeletal Physiotherapy Service, Cardiff and Vale University Health Board, University Hospital of Wales, Heath Park, Cardiff, Wales CF14 4XW, UK.
Trials. 2014 Oct 25;15:409. doi: 10.1186/1745-6215-15-409.
Despite persistent calls to measure the effectiveness of educational interventions on patient outcomes, few studies have been conducted. Within musculoskeletal physiotherapy, the effects of postgraduate clinical mentoring on physiotherapist performance have been assessed, but the impact of this mentoring on patient outcomes remains unknown. The objective of this trial is to assess the effectiveness of a work-based mentoring programme to facilitate physiotherapist clinical reasoning on patient outcomes in musculoskeletal physiotherapy.
METHODS/DESIGN: A stepped wedge cluster randomised controlled trial (CRCT) has been designed to recruit a minimum of 12 senior physiotherapists who work in musculoskeletal outpatient departments of a large National Health Service (NHS) organization. Participating physiotherapists will be randomised by cluster to receive the intervention at three time periods. Patients will be blinded to whether their physiotherapist has received the intervention. The primary outcome measure will be the Patient-Specific Functional Scale; secondary outcome measures will include the EQ-5D, patient activation, patient satisfaction and physiotherapist performance. Sample size considerations used published methods describing stepped wedge designs, conventional values of 0.80 for statistical power and 0.05 for statistical significance, and pragmatic groupings of 12 participating physiotherapists in three clusters. Based on an intergroup difference of 1.0 on the PSFS with a standard deviation of 2.0, 10 patients are required to complete outcome measures per physiotherapist, at time period 1 (prior to intervention roll-out) and at each of time periods 2, 3 and 4, giving a sample size of 480 patients. To account for the potential loss to follow-up of 33%, 720 sets of patient outcomes will be collected.All physiotherapist participants will receive 150 hours of mentored clinical practice as the intervention and usual in-service training as control. Consecutive, consenting patients attending treatment by the participating physiotherapists during data collection periods will complete outcome measures at baseline, discharge and 12 months post-baseline. The lead researcher will be blinded to the allocation of the physiotherapist when analyzing outcome data; statistical analysis will involve classical linear models incorporating both an intervention effect and a random intercept term to reflect systematic differences among clusters.
Assigned 31 July 2012: ISRCTN79599220.
尽管一直有人呼吁衡量教育干预对患者治疗效果的影响，但相关研究却很少。在肌肉骨骼物理治疗领域，已对研究生临床指导对物理治疗师表现的影响进行了评估，但这种指导对患者治疗效果的影响仍不清楚。本试验的目的是评估一项基于工作的指导计划在促进肌肉骨骼物理治疗中物理治疗师临床推理对患者治疗效果方面的有效性。
方法/设计：已设计一项阶梯式楔形整群随机对照试验（CRCT），以招募至少12名在一家大型国家医疗服务体系（NHS）机构的肌肉骨骼门诊工作的资深物理治疗师。参与的物理治疗师将按整群随机分组，在三个时间段接受干预。患者将不知道他们的物理治疗师是否接受了干预。主要结局指标将是患者特定功能量表；次要结局指标将包括EQ-5D、患者激活度、患者满意度和物理治疗师表现。样本量的考虑采用已发表的描述阶梯式楔形设计的方法、统计功效为0.80和统计显著性为0.05的常规值，以及将12名参与的物理治疗师分为三个整群的实用分组方式。基于PSFS上组间差异为1.0且标准差为2.0，在第1时间段（干预推出前）以及第2、3和4时间段的每个时间段，每位物理治疗师需要10名患者完成结局测量，得出样本量为480名患者。为考虑到33%的潜在失访情况，将收集720套患者结局数据。所有参与的物理治疗师将接受150小时的指导临床实践作为干预，以及常规在职培训作为对照。在数据收集期间，由参与的物理治疗师治疗的连续、同意参与的患者将在基线、出院时和基线后12个月完成结局测量。在分析结局数据时，首席研究员将对物理治疗师的分组情况保持盲态；统计分析将涉及经典线性模型，该模型纳入干预效应和随机截距项以反映整群之间的系统差异。
于2012年7月31日分配：ISRCTN79599220。
