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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | receiving multilevel intervention, electronic monitoring and stroke registry participation |
|
| Control group | No Intervention | receiving routine care , electronic monitoring and stroke registry participation |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multilevel intervention | Behavioral | Multilevel intervention based on AACTT theory |
|
| 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 |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| the proportion of acute ischemic stroke patients with Door-to-Needle Time≤60min | Difference between intervention arm and control arm in the percentage of patients receiving thrombolysis within 60 minutes of stroke onset | Up to 4.5 hours |
| Door-to-needle time |
Inclusion Criteria:
Exclusion Criteria:
Contraindication for intravenous thrombolysis
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Min Lou, PhD | Contact | 13958007213 | loumingxc@vip.sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Zexin Chen | Ethics committee the second affiliated hospital, school of medicine, Zhejiang University, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Second Affiliated Hospital, School of Medicine, Zhejiang University | Recruiting | Hangzhou | Zhejiang | China |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| 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 |
The time between hospital arrival and the initiation of IVT
| Up to 4.5 hours |
| Onset-to-needle time | The time between the symptom onset and the initiation of IVT | Up to 24 hours |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |