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临床试验/NCT03228251
NCT03228251已完成不适用

Simulation-based Training of Rapid Evaluation and Management for Acute Stroke (STREAM) - Multicentric Prospective Interventional Study for the Improvement of Acute Stroke Care

Johann Wolfgang Goethe University Hospital7 个研究点 分布在 1 个国家目标入组 379 人开始时间: 2017年10月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
379
试验地点
7
主要终点
Median "door-to-needle" time (median and 25-75 % interquartile range) in a pretest-posttest observation

研究概览

简要总结

Acute stroke care is highly time critical for thrombolysis as well as thrombectomy. In both scenarios, each minute lost reduces the therapeutic efficacy. Therefore, an optimal implementation of these effective therapies into daily clinical practice is of utmost importance for the translation of the evidence from clinical trials into good clinical outcomes in routine care. In acute stroke therapy, the patient is cared for by an interdisciplinary team and often has to undergo several handovers between different caregivers with possible interface problems.

To facilitate a smooth workflow, the investigator developed an interdisciplinary stroke team algorithm and implemented regular simulation-based team trainings at the investigators institution. This multimodal intervention markedly improved the "door-to-needle" time for thrombolysis (time from the patient's arrival in the emergency department to the start of the tissue plasminogen activator (tPA) infusion) which is the most relevant benchmark parameter for acute stroke care. The investigators monthly stroke team training had a positive effect on the perceived degree of safety and staff satisfaction among the employees of the investigators departments.

The investigator plans to investigate the benefits of the multimodal intervention of a stroke team algorithm with regular stroke team simulation training in a controlled prospective pretest-posttest trial design at seven leading stroke centers in Germany. The investigator hypothesize that the implementation of a stroke team algorithm (defined team, defined tasks) and regular stroke team training with a focus on efficient team work and communication will improve process times, patient safety and staff satisfaction.

In the pretest period, the participating seven centers (tertiary care university hospitals with thrombectomy capacity 24/7/365) record the data of all consecutive patients receiving thrombolysis and/or thrombectomy during a three month period. Afterwards 3-4 leading employees of different professional backgrounds (e.g. senior neurologist of the stroke unit, neurointerventionalist, head nurse of emergency department) will be invited to a joint "train-the-trainer" seminar at the sponsors institution where the participating centers present their algorithm to the participants of all seven stroke centers for discussion to invite suggestions for streamlining and improvement and a train-the-trainer course of stroke simulation. After the seminar, the principal investigator and stroke team trainer will visit all centers for one in situ stroke team simulation training and provide teaching materials. Afterwards, each center will be invited to schedule two additional stroke team trainings a with stroke team trainer that will be led by e.g. the senior neurologist from the respective stroke unit with the aim of permanently starting up regular stroke team simulation. In the posttest period, the participating seven centers again record the data of all consecutive patients receiving thrombolysis and/or thrombectomy during a three month time period.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

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

  • •thrombolysis/thrombectomy in one of the seven participating stroke centers following EMS referral
  • •written informed consent from the patient and/or his/her legal representative.

排除标准

  • •in-hospital stroke
  • •referred for thrombectomy by another Hospital.

结局指标

主要结局

Median "door-to-needle" time (median and 25-75 % interquartile range) in a pretest-posttest observation

时间窗: up to 1 hour

次要结局

  • Median thrombectomy process times of patients receiving thrombectomy in a before-after observation(up to 2 hours)

研究者

发起方
Johann Wolfgang Goethe University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Waltraud Pfeilschifter

Prof. Dr. med.

Johann Wolfgang Goethe University Hospital

研究点 (7)

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