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临床试验/NCT03317639
NCT03317639已完成不适用

Improving In-hospital Stroke Service Utilisation (MISSION) in China: A Cluster Randomised Trial of Interventions to Shorten Door to Needle Times

Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 1,634 人开始时间: 2018年1月1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
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

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)

研究者

发起方
Second Affiliated Hospital, School of Medicine, Zhejiang University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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