Improving In-hospital Stroke Service Utilisation (MISSION) in China: A Cluster Randomised Trial of Interventions to Shorten Door to Needle Times
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Thrombolytic Therapy
- Sponsor
- Second Affiliated Hospital, School of Medicine, Zhejiang University
- Enrollment
- 1634
- Locations
- 1
- Primary Endpoint
- Difference in the percentage of patients who Door-to-Needle Time≤60min
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •AIS patients receiving IVT within 4.5 hours
Exclusion Criteria
- •Patients who are not willing to attend this trial
Outcomes
Primary Outcomes
Difference in the percentage of patients who Door-to-Needle Time≤60min
Time Frame: 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
Secondary Outcomes
- 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)