Multilevel System Intervention Based on Information Platform to Reduce Stroke Recurrence Rate in Acute Ischemic Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Incidence rate of new ischemic stroke events
研究概览
简要总结
A prospective, multicenter and cluster randomised controlled trial will be conducted, using hospital as randomisation unit. Hospitals in Zhejiang Province, China, will be randomised into two arms (1:1): an intervention arm and a control arm. Hospitals in the intervention arm will receive a multilevel system intervention based on information platform, whereas hospitals in the control arm will receive no intervention. The randomisation will be conducted after baseline data collection. The following baseline data will be used for randomisation match: hospital classification, beds in stroke centre, and the number of acute ischemic stroke (AIS) patients within 7 days of stroke onset. Hospitals with <250 AIS cases per year will be excluded from the study. The primary outcome will be difference between intervention arm and control arm in the one-year stroke recurrence rate on the follow-up stage (post-intervention).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Patients of 18 years or older.
- •Patients admitted with neurological deficit consistent with ischemic stroke within 7 days of of symptoms onset. (*Symptom onset is defined by the "last seen normal" principle)
- •Confirmation of new ischemic stroke by objective modality of CT scan and MRI (had relevant lesions on DWI).
- •Informed consent from patient or legally authorised representative (primarily spouse, parents, adult children, otherwise indicated).
排除标准
- •Patients refuse to participate in this study.
- •Patients who losing his medical record of having the incomplete medical record
研究组 & 干预措施
intervention arm
Hospitals in the intervention arm will receive a multilevel system intervention based on information platform
干预措施: multilevel system intervention based on information platform (Behavioral)
control arm
Hospitals in the control arm will receive no intervention
结局指标
主要结局
Incidence rate of new ischemic stroke events
时间窗: 1 year
To evaluate the efficacy of intervention in reducing the risk of new ischemic stroke events at 1 year after initial symptom onset.
次要结局
- All-cause mortality(1, 3, 5 years)
- Incidence rate of new clinical vascular events (ischemic stroke, hemorrhagic stroke, myocardial infarction)(1, 3, 5 years)
- The percentage of stroke of undetermined cause at discharge(1 year)
- Incidence rate of new ischemic stroke events(3, 5 years)
- Rate of blood vessel assessment within one week of hospitalization(1 year)
- Rate of antithrombotic therapy at discharge(1 year)
- Rate of anticoagulant treatment for patients with atrial fibrillation at discharge(1 year)