Improving Thrombolysis Implementation Based on Electronic Monitoring in Acute Ischemic Stroke (ITEM)

Study Overview
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Brief Summary
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A cluster randomized controlled trial will be conducted. Hospitals in Zhejiang Province, China, will be randomized into two arms (1:1): an intervention arm and a control arm. Hospitals in the intervention arm will receive a multilevel intervention based on the AACTT theory, whereas hospitals in the control arm will receive no intervention and maintain routine care. All the hospitals will receive electronic monitoring. Hospitals with no stroke center or with <20 cases received thrombolysis per year will be excluded from the study.

Official Title
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Improving Thrombolysis Implementation Based on Electronic Monitoring in Acute Ischemic Stroke (ITEM): a Cluster Randomized Controlled Trial

Conditions
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Thrombolysis Rate

Intervention / Treatment
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* Behavioral: Multilevel intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients presented with clinical signs of acute ischemic stroke within 4.5 hours of stroke onset Patient's age is >18 years Exclusion Criteria: Contraindication for intravenous thrombolysis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>receiving multilevel intervention, electronic monitoring and stroke registry participation | Behavioral: Multilevel intervention<br>* Multilevel intervention based on AACTT theory<br>|
| No Intervention: Control group<br>receiving routine care , electronic monitoring and stroke registry participation | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thrombolysis rate within 4.5 hours | The proportion of acute ischemic stroke patients within 4.5 hours of onset | Up to 4.5 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thrombolysis rate within 3 hours | The proportion of acute ischemic stroke patients within 3 hours of onset | Up to 3 hours | 
| Excellent neurological outcomes | Score of 0 to 1 on the modified Rankin Scale, on which scores range from 0 (no neurologic deficit) to 6 (death) | At 90 days | 
| Favorable neurological outcomes | Score of 0 to 1 on the modified Rankin Scale, on which scores range from 0 (no neurologic deficit) to 6 (death) | At 90 days | 
| modified Rankin Scale score | The distribution of modified Rankin Scale score at 90 days, on which scores range from 0 (no neurologic deficit) to 6 (death) | At 90 days | 
| All-cause death rate | All-cause death rate at 90 days | At 90 days | 
| Hemorrhagic transformation | the presence of hemorrhagic transformation is defined according to European Cooperative Acute Stroke Study (ECASS) II trial | At 7 days | 
| Symptomatic intracranial hemorrhage | Intracranial hemorrhage at 24 hours associated with an increase of ≥4 points of NIHSS score from baseline, according to European Cooperative Acute Stroke Study (ECASS) II trial | At 7 days | 
| Door-to-image time | The time between hospital arrival and the initiation of image | Up to 4.5 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute ischemic stroke, Electronic monitoring, Intravenous thrombolysis