Bosch Marije, McKenzie Joanne E, Mortimer Duncan, Tavender Emma J, Francis Jill J, Brennan Sue E, Knott Jonathan C, Ponsford Jennie L, Pearce Andrew, O'Connor Denise A, Grimshaw Jeremy M, Rosenfeld Jeffrey V, Gruen Russell L, Green Sally E
Department of Surgery, Central Clinical School, Monash University, Melbourne, Australia.
Trials. 2014 Jul 11;15:281. doi: 10.1186/1745-6215-15-281.
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.
Australian New Zealand Clinical Trials Registry ACTRN12612001286831 (date registered 12 December 2012).
轻度头部损伤患者常前往急诊科就诊。急诊科临床医生面临的挑战包括识别哪些患者患有创伤性脑损伤,以及哪些患者可以安全回家。创伤性脑损伤可能症状或体征不明显,但仍可能导致不良后果。尽管在国际上和澳大利亚都存在一些高质量的临床实践指南,但研究表明这些建议的实施情况并不一致。本试验的目的是测试一种有针对性的、基于理论和证据的实施干预措施的有效性,该措施旨在提高针对成年(18岁及以上)轻度头部损伤(脑震荡)后前往急诊科就诊患者的三项关键临床建议的采纳率,并与被动传播这些建议进行比较。主要目标是确定该干预措施是否能有效提高进行适当创伤后遗忘症筛查的患者比例。
方法/设计:本研究设计为整群随机试验。我们的目标是纳入34家澳大利亚24小时急诊科,将其随机分为干预组或对照组。对照组科室将收到最新的澳大利亚基于证据的轻度头部损伤患者急性管理临床实践指南。干预组将基于影响因素分析接受实施干预,这些因素包括当地利益相关者会议、确定每个科室的护理和医学意见领袖、培训培训者日以及意见领袖在3个月期间提供的标准化教育和互动工作坊。临床实践结果将由独立的病历审核员在干预实施后的2个月期间从病历中进行回顾性收集(患者层面的结果)。在同意参与的医院中,符合条件的患者将被招募参加由经过培训的研究人员进行的随访电话访谈。将进行成本效益分析和使用混合方法的过程评估。样本量计算基于每个科室平均纳入30名患者。结果评估者将对分组情况不知情。
澳大利亚新西兰临床试验注册中心ACTRN12612001286831(注册日期:2012年12月12日)。