Work Flow Improvement in Pre-procedural Management of Acute Ischemic Stroke With Endovascular Treatment: a Multi-centre, Cluster Randomised, Open Label, Parallel Controlled Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 664
- 试验地点
- 1
- 主要终点
- Rate of reaching the standard arrival-to-groin Puncture time
研究概览
简要总结
The study is the second phase of Endovascular Treatment Key Technique and Emergency Work Flow Improvement of Acute Ischemic Stroke (ANGEL-ACT).
During the first phase of the ANGEL-ACT (NCT03370939, a prospective multi-center registry study), problems and difficulties in the emergency work flow of acute ischemic stroke care in China have been identified, such as inadequate pre-hospital notification, delay of in-hospital diagnosis and treatment, difficulty in treatment consent, lack of professional training of endovascular treatment,etc., especially in the delay of in-hospital diagnosis and treatment.
ANGEL-ACT II is a cluster randomized, parallel controlled study. The aim of this study was to evaluate the effectiveness of multi-modal medical quality improvement measures on the delay of hospital-level emergency work flow of acute ischemic stroke management as well as its impact on patient prognosis. The interventional measures include emergency work flow management app on smartphone, specialized training, assessment of quality improvement outcomes and feedback on a regular basis.
详细描述
This is a prospective, multi-centre, cluster randomized, open label, parallel controlled study that enrolled patients with acute ischemic stroke who underwent endovascular treatment in about 34 hospitals in China. The ratio Interventional arm control arm is 1:1, which means 17 hospitals and 332 participants in each arm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
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
- •Investigational Sites Inclusion Criteria:
- •Participated in the ANGEL-ACT registry study
- •Secondary or tertiary hospitals
- •Available of emergency department and neurology ward for stroke patients
- •Must have 24 hours × 7 days emergency department for stroke
- •Capable of rt-PA thrombolysis and endovascular treatment
- •Investigational Sites
排除标准
- •Endovascular treatment volume < 20 per year
- •Unwillingness to participate ANGEL-ACT II and follow the protocol
- •Currently participating other stroke treatment improving program/project or similar clinical studies
- •Participant Inclusion Criteria
- •Age ≥ 18 years old
- •Admitted from emergency or outpatient department;
- •Acue ischemic stroke with large artery occlusion
- •Within 24 hours after the onset, and eligible for endovascular treatment.
- •The patient or legal representative give written informed consent
- •Participant Exclusion Criteria:
- •Unsuitable for this study investigators' discretion
- •Progressive stroke or in-hospital stroke
研究组 & 干预措施
Interventional Site
The process below will be allocated in Interventional Sites:
- At each interventional sites, implementing full assessment of current emergency work flow of acute ischemic stroke patients who eligible for endovascular treatment. All interventional sites would undergo assessment in order to form a baseline.
- Drafting intervention approaches based on the assessment results of all interventional sites. These approaches are executable, reproducible, and measurable.
- Emergency work flow management APP would be installed on smartphones of designated personnel at each interventional sites.
- Both intervention approaches and APP would be incorporated with original work flow at each interventional site.
- Training sessions would be held in interventional sites or online every 3 month once the patient enrolment begin.
- Outcome data would be analysed and dispatched every 3 month for each interventional sites.
干预措施: ANGEL Intervention Package and Toolbox (Behavioral)
Control Site
The control site would not undergo any emergency work flow modification for acute ischemic stroke patients who eligible for endovascular treatment.
结局指标
主要结局
Rate of reaching the standard arrival-to-groin Puncture time
时间窗: From the time of arrival at the emergency department until the time of successful groin puncture, assessed up to 12 hours
The percentage of reaching the guideline recommended time target for acute ischemic stroke patients who eligible for endovascular treatment.
次要结局
- Rate of complications related to the procedure(24 hours after the procedure)
- Time from groin puncture to recanalization(From the time of successful groin puncture until the time of the recanalization of the occluded artery, assessed up to 4 hours)
- Time from symptom onset to recanalization(From the time of symptom onset until the time of of the recanalization of the occluded artery, assessed up to 48 hours)
- Rate of symptomatic intracerebral hemorrhage within 24 hours after the procedure(24 hours within the procedure ended)
- Time from arrival to groin puncture(From the time of arrival at the emergency department until the time of successful groin puncture, assessed up to 12 hours)
- Time from arrival to recanalization(From the time of arrival at the emergency department until the time of the recanalization of the occluded artery, assessed up to 48 hours)
- Modified Rankin Scale independence rate within 90 days after the procedure(90 days after enrolment)
- Time from arrival to imaging(From the time of arrival at the emergency department until the time of brain imaging, assessed up to 12 hours)
- Time from imaging to groin puncture(From the time of brain imaging until the time of successful groin puncture, assessed up to 12 hours)
- Recanalization rate immediately after the procedure(Immediately after the procedure)
- Recanalization rate 24 hours after the procedure(24 hours after the procedure)
- EQ-5D-3L 90 days after the procedure(90 days after the procedure)
- Rate of all cause mortality within 90 days after the procedure(90 days after enrolment)
研究者
Zhongrong Miao
Director of Department of interventional neurology
Beijing Tiantan Hospital