Impact Of A Training Program And Organization On The Management Of Stroke In The Acute Phase (AVC-II)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,238
- 试验地点
- 1
- 主要终点
- Admission - brain imaging time
研究概览
简要总结
Acute stroke management represents a true medical emergency that requires prompt diagnosis and urgent treatment. In a previous exhaustive cohort study conducted in the Rhône region, France (AVC69) (Porthault et al. 2013) the investigators observed that only a small percentage of patients could access to thrombolysis in time. In this cohort of 1306 patients treated in one of the emergency department of the Rhone region for a suspected stroke, 84% of patients reached hospital through an emergency department instead of going directly to a stroke unit. Among those patients, only 2% were finally thrombolysed. A significant part of patients arrived in the emergency department too late to be thrombolysed. However, among the subset of ischemic stroke patients who reach emergency department less than 3 hours after symptoms onset, and who had no clinical or radiological exclusion criteria for thrombolysis, only 15 % were thrombolysed. The hypothesis was that an intervention designed to improve ED professional's knowledge and skills and to develop together efficient clinical pathway would decrease door-to imaging time and consequently door-to needle time and eventually improve overall thrombolysis rate.
The investigators have conducted a cluster randomized controlled stepped wedge trial. All adult patients with suspected stroke arriving in one of the participating ED were included in the study along five successive four-month periods. The program featured: development of written materials (booklets) and video (film), and one day session of standardized training for trainers, at least one nurse and one physician of all EDs, with formal presentation to improve knowledge, and simulation to improve skills for using the "FAST" tool (nurses) and the "NIHSS" score (ED physicians). Additionally, a clinical pathway was developed to adapt general evidence based guidelines to the local organization. The primary outcome is the door-to imaging time.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All adult patients admitted to one of the participating ED for suspected ischemic stroke less than or equal to 4 hours from symptoms onset were included in the study.
排除标准
- •age below 18
- •admission to the ED more than 4 hours after symptoms onset or unknown time of first symptoms
结局指标
主要结局
Admission - brain imaging time
时间窗: Hour 24
Admission period - thrombolysis time (door-to-needle time)
时间窗: Hour 24
Admission- arrival at stroke unit time
时间窗: Hour 24
Brain imaging time - arrival at stroke unit time
时间窗: Hour 24
次要结局
- Proportion of cerebral hemorrhage after thrombolysis(Hour 24)
- Number of ED where the clinical pathway was actually set up(1 year)
- proportion of patients thrombolysed(Hour 24)
- Proportion of deaths(Hour 24)
- Proportion of professionals who received training(1 year)
- Number of collective trainings organized in each ED by the local trainers(1 year)
- proportion of use of diagnostic and stroke severity tools ("FAST" and NIHSS)(Hour 24)