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Clinical Trials/NCT03317639
NCT03317639
Completed
Not Applicable

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 site in 1 country1,634 target enrollmentJanuary 1, 2018

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).

Registry
clinicaltrials.gov
Start Date
January 1, 2018
End Date
June 30, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Responsible Party
Sponsor

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)

Study Sites (1)

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