Improve Acute Reperfusion Treatment Quality for Stroke in China, IMPROVE: Stroke Care in China

Study Overview
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Brief Summary
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In order to bridge the great gaps, Chinese Stroke Association (CSA) and American Heart Association (AHA) sought to develop, conduct, and assess a multifaceted quality improvement intervention to increase the adherent rate of IV tPA and ET and improve 3-month clinical outcomes for these patients through our cluster-randomized stepped-wedge IMPROVE: Stroke in China trial.

Official Title
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Improve Acute Reperfusion Treatment Quality for Stroke in China

Conditions
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Ischemic Stroke

Intervention / Treatment
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* Behavioral: improvement of quality of stroke care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hospitals： Voluntary. Hospitals from CSCA. Secondary or tertiary public hospitals with an emergency department and neurologic wards that receive patients with AIS. Have a 24*7 on-call stroke team. Have the capacity of IV rt-PA thrombolytic therapy or/and endovascular treatment. Implement at least 10 patients' rt-PA or/and endovascular treatment during the last year. Admit at least 5 patients of acute ischemic stroke within 24 hours after onset each month. Have full desire to improve the procedure of treatment of acute ischemic stroke. Have good cooperation among Neurology department, Emergency department, Interventional department, Neurosurgery department, Laboratory and Radiology department. Patients： Patients who are ≥18 years old were eligible for inclusion if they presented with acute ischemic stroke diagnosed by CT and/or MRI and arrived at hospital within 6 hours after symptom onset. Exclusion Criteria: Hospitals： Hospitals that can not comply with the protocol and finish the research. Grade-one hospitals and non cerebral vascular disease specialized hospitals. Hospitals involved in other stroke care quality improvement projects or relevant clinical trials. Patients： 1）Patients refuse to participate in this study

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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Improvement intervention1<br>receive the following improvement intervention for 18 months： | Behavioral: improvement of quality of stroke care<br>* hospital tool kits for quality improvement of reperfusion therapy ; organizational stakeholder and opinion leader meetings; data monitoring and feedback reports； webinar for hospital teams<br>|
| Other: Improvement intervention2<br>receive the following improvement intervention for 12 months： | Behavioral: improvement of quality of stroke care<br>* hospital tool kits for quality improvement of reperfusion therapy ; organizational stakeholder and opinion leader meetings; data monitoring and feedback reports； webinar for hospital teams<br>|
| Other: Improvement intervention3<br>receive the following improvement intervention for 6 months： | Behavioral: improvement of quality of stroke care<br>* hospital tool kits for quality improvement of reperfusion therapy ; organizational stakeholder and opinion leader meetings; data monitoring and feedback reports； webinar for hospital teams<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The adherence rate of guidelines for IV-tPA and/or endovascular treatment in eligible patients. |  | participants will be followed for the duration of hospital stay, an expected average of 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportional change of intravenous thrombolytic therapy in eligible patients 4.5h after the onset |  | participants will be followed for the duration of hospital stay, an expected average of 2 weeks | 
| proportional change of endovascular treatment in eligible patients 6h after the onset |  | participants will be followed for the duration of hospital stay, an expected average of 2 weeks | 
| time from arrival to hospitals to intravenous thrombolytic therapy |  | participants will be followed for the duration of hospital stay, an expected average of 2 weeks | 
| door-to-puncture time |  | participants will be followed for the duration of hospital stay, an expected average of 2 weeks | 
| in-hospital mortality |  | participants will be followed for the duration of hospital stay, an expected average of 2 weeks | 
| 3-month disability（mRS≥3 ） |  | patients will be followed up at 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute ischemic stroke, IV-tPA, endovascular treatment, intervention