Improving In-hospital Stroke Service Utilisation (MISSION) in China: A Cluster Randomised Trial of Interventions to Shorten Door to Needle Times
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,634
- 试验地点
- 1
- 主要终点
- Difference in the percentage of patients who Door-to-Needle Time≤60min
研究概览
简要总结
A 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 multi-components intervention based on the Behaviour Change Wheel model, whereas hospitals in the control arm will receive no intervention and maintain existing care. The randomisation will be conducted after one-year baseline data collection. The following baseline data will be used for randomisation match: hospital classification, beds in stroke centre, thrombolysis patient number, and percentage of patients receiving thrombolysis within 60 minutes of stroke onset. Hospitals with no stroke centre or with <20 cases received thrombolysis per year will be excluded from the study. The primary outcome will be difference between intervention arm and control arm in the percentage of patients receiving thrombolysis within 60 minutes of stroke onset 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
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •AIS patients receiving IVT within 4.5 hours
排除标准
- •Patients who are not willing to attend this trial
结局指标
主要结局
Difference in the percentage of patients who Door-to-Needle Time≤60min
时间窗: Up to 24 hours
Difference between intervention arm and control arm in the percentage of patients receiving thrombolysis within 60 minutes of stroke onset on the follow-up stage
次要结局
- Onset-to-needle time(Up to 24 hours)
- modified Rankin Scale score at discharge(Up to 3 month)
- Door-to-needle time(Up to 24 hours)
- Death(Up to 3 month)
- Symptomatic intracranial hemorrhage(At 24 hours)
- Favorable neurological outcomes(At 90 days)
