Hospital Processes Reengineering of Intravenous Thrombolysis in Acute Ischemic Stroke in China (PROMISE)
2016年2月4日 更新者：Anding Xu、First Affiliated Hospital of Jinan University
PROMISE is a prospective, nationwide, multicenter, longitudinal cohort study, focusing on hospital intravenous thrombolysis process reengineering for acute ischemic stroke (AIS).
With a proposed "Reengineered Process Framework" for intravenous thrombolysis process by the PROMISE study steering committee, about 30 medical centers enters would be recruited nationwide, and each center would include consecutive AIS patients with an onset-to-door time (ODT) of less than 3.5 h.
The investigators hypothesize that the proposed "Reengineered Process Framework" is suitable and feasible for hospitals in mainland of China; the rate of intravenous rt-PA thrombolysis in ischemic stroke patients with an ODT of less than 3.5 h would be more than 20% or be increased by 40% as compared with baseline; the proportion of patients with a door-to-needle (DNT) time of less than 60 min would be more than 20%, or be with an increase by ≥ 40% as compared with baseline.
研究概览
地位
完全的
详细说明
- After reviewing domestic and international clinical research literature, the PROMISE study steering committee constructed the "Reengineered Process Framework" for intravenous thrombolysis process with business process reengineering theory. The suggested "Reengineered Process Framework" is regarded as feasible and suitable for hospitals in mainland of China.
- The study period is 12 months, of which the first 3 months is the baseline period. After 3 months, all centers should develop new thrombolytic processes according to the "Reengineered Process Framework". The new processes are gradually implemented since the 4th month with continues care quality improvements.
- The "Reengineered Process Framework" adopts a form of comprehensive package, proposes unified key points of process reengineering, provides a series of supporting, standardized tools for process management, and establishes a real-time key performance indicator (KPI) monitoring feedback system, etc.
- Supporting, standardized tools includes: rapid identification tools of suspected stroke for medical personnel in the emergency system; stroke team building programs; real-time feedback form of KPI; standardized thrombolysis informed consent form and informed conversation public service advertising posters; suggested indications and contraindications for intravenous thrombolysis; standard operation procedure of intravenous rt-PA thrombolysis, etc.
With these methods, it is expected to raise the thrombolytic rate for patients arrived at medical center within 3.5 hours after the onset, and to shorten the door to needle time in China.
研究类型
观察性的
注册 (实际的)
2178
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
AIS patients with an onset-to-door time of less than 3.5 h
描述
Inclusion Criteria:
- All AIS patients with an onset-to-door time of less than 3.5 h of onset; informed consent
Exclusion Criteria:
- Complete remission of symptoms and signs, in consideration for patients with transient ischemic attack;
- Silent cerebral infarction without symptoms or signs;
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 观测模型：队列
- 时间观点：预期
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
rt-PA
patients treated with rt-PA, followed strategies were used: advance hospital notification by EMS, stroke team notification, key performance indicators feedback form, standard informed consent procedures, performance of thrombolysis at CT-room.
|
Advance hospital notification by EMS
stroke team notification
a "key performance indicators real-time feedback form" as continuing quality improvement
standard informed consent procedures with public poster of thrombolysis
performance of thrombolysis at CT-room or emergency room
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The thrombolysis rate of patients treated with rt-PA
大体时间：within 4.5 hours
|
The rate of intravenous rt-PA thrombolysis in ischemic stroke patients with an ODT of less than 3.5 h: ≥ 20%, with an increase over the baseline ≥ 40%
|
within 4.5 hours
|
|
The rate of DNT less than 60 min within the patients treated with rt-PA
大体时间：within 4.5 hours
|
The rate of patients with a door-to-needle (DNT) time of less than 60 min for intravenous rt-PA thrombolysis: ≥20%, with an increase over the baseline ≥ 40%
|
within 4.5 hours
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
intravenous rt-PA thrombolysis with an ODT of less than 2 h
大体时间：3 hours
|
intravenous rt-PA thrombolysis in ischemic stroke patients with an onset-to-door time(ODT) of less than 2 h
|
3 hours
|
|
death or dependence at 3-month
大体时间：90 days
|
"death or dependence at 3-month" was defined as modified Rankin Scale(mRS) score 3-6 points.
|
90 days
|
|
favorable outcome at 3-month
大体时间：90 days
|
"favorable outcome at 3-month" was defined as mRS 0-1 points.
|
90 days
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅：ANDING XU, Prof、Stroke Center, The First Affiliated Hospital,Jinan University Guanzghou
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2014年7月1日
初级完成 (实际的)
2015年12月1日
研究完成 (实际的)
2015年12月1日
研究注册日期
首次提交
2014年10月26日
首先提交符合 QC 标准的
2015年12月11日
首次发布 (估计)
2015年12月16日
研究记录更新
最后更新发布 (估计)
2016年2月5日
上次提交的符合 QC 标准的更新
2016年2月4日
最后验证
2016年2月1日
更多信息
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