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Implementing evidence-based recommended practices for the management of patients with mild traumatic brain injuries in Australian emergency care departments: study protocol for a cluster randomised controlled trial

机译:在澳大利亚急诊部门中实施基于证据的推荐方法来治疗轻度颅脑外伤患者:整群随机对照试验的研究方案

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Background Mild head injuries commonly present to emergency departments. The challenges facing clinicians in emergency departments include identifying which patients have traumatic brain injury, and which patients can safely be sent home. Traumatic brain injuries may exist with subtle symptoms or signs, but can still lead to adverse outcomes. Despite the existence of several high quality clinical practice guidelines, internationally and in Australia, research shows inconsistent implementation of these recommendations. The aim of this trial is to test the effectiveness of a targeted, theory- and evidence-informed implementation intervention to increase the uptake of three key clinical recommendations regarding the emergency department management of adult patients (18?years of age or older) who present following mild head injuries (concussion), compared with passive dissemination of these recommendations. The primary objective is to establish whether the intervention is effective in increasing the percentage of patients for which appropriate post-traumatic amnesia screening is performed. Methods/design The design of this study is a cluster randomised trial. We aim to include 34 Australian 24-hour emergency departments, which will be randomised to an intervention or control group. Control group departments will receive a copy of the most recent Australian evidence-based clinical practice guideline on the acute management of patients with mild head injuries. The intervention group will receive an implementation intervention based on an analysis of influencing factors, which include local stakeholder meetings, identification of nursing and medical opinion leaders in each site, a train-the-trainer day and standardised education and interactive workshops delivered by the opinion leaders during a 3?month period of time. Clinical practice outcomes will be collected retrospectively from medical records by independent chart auditors over the 2?month period following intervention delivery (patient level outcomes). In consenting hospitals, eligible patients will be recruited for a follow-up telephone interview conducted by trained researchers. A cost-effectiveness analysis and process evaluation using mixed-methods will be conducted. Sample size calculations are based on including 30 patients on average per department. Outcome assessors will be blinded to group allocation. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12612001286831 (date registered 12 December 2012).
机译:背景技术轻度头部受伤通常出现在急诊科。急诊科的临床医生面临的挑战包括确定哪些患者患有脑外伤以及哪些患者可以安全地送回家。颅脑外伤可能伴有轻微症状或体征,但仍可能导致不良后果。尽管国际上和澳大利亚都有一些高质量的临床实践指南,但研究表明这些建议的实施不一致。该试验的目的是测试有针对性的,理论上有据可循的实施干预措施的有效性,以增加对就诊的成年患者(18岁或以上)急诊科管理的三项关键临床建议的采纳率轻度头部受伤(脑震荡)后,与被动传播这些建议相比。主要目标是确定干预措施是否有效地增加了进行了适当的创伤后健忘症筛查的患者的百分比。方法/设计本研究的设计是一项整群随机试验。我们的目标是包括34个澳大利亚的24小时急诊科,这些科室将随机分配给干预组或对照组。对照组的部门将收到一份澳大利亚最新的循证临床实践指南,以指导轻度颅脑损伤患者的急性治疗。干预小组将在对影响因素的分析的基础上接受实施干预,这些干预因素包括当地利益相关者会议,每个站点的护理和医学意见领袖的识别,培训师培训日以及由意见提供的标准化教育和互动讲习班领导者在3个月的时间内。干预实施后的2个月内,将由独立的图表审核员从病历中回顾性收集临床实践结果(患者水平的结果)。在同意的医院中,将招募合格的患者进行由受过训练的研究人员进行的电话随访。将使用混合方法进行成本效益分析和过程评估。样本量的计算基于每个部门平均包括30名患者。结果评估者对小组分配不了解。试验注册澳大利亚新西兰临床试验注册中心ACTRN12612001286831(注册日期为2012年12月12日)。

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