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

Ischemic Stroke Clinical Trial

Official title:

Improve Acute Reperfusion Treatment Quality for Stroke in China

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03578107
• Other study ID #: KY 2018-044-01
• Status: Completed
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: October 31, 2020

Study information

• Verified date: October 2021
• Source: Beijing Tiantan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15895
• Est. completion date: October 31, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Hospitals:

1. Voluntary.

2. Hospitals from CSCA.

3. Secondary or tertiary public hospitals with an emergency department and neurologic wards that receive patients with AIS.

4. Have a 24*7 on-call stroke team.

5. Have the capacity of IV rt-PA thrombolytic therapy or/and endovascular treatment.

6. Implement at least 10 patients' rt-PA or/and endovascular treatment during the last year.

7. Admit at least 5 patients of acute ischemic stroke within 24 hours after onset each month.

8. Have full desire to improve the procedure of treatment of acute ischemic stroke.

9. 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:

1. Hospitals that can not comply with the protocol and finish the research.

2. Grade-one hospitals and non cerebral vascular disease specialized hospitals.

3. Hospitals involved in other stroke care quality improvement projects or relevant clinical trials. Patients: 1)Patients refuse to participate in this study

Related Conditions & MeSH terms

• Ischemic Stroke
• Stroke

Intervention

Behavioral:
• improvement of quality of stroke care
hospital tool kits for quality improvement of reperfusion therapy ; organizational stakeholder and opinion leader meetings; data monitoring and feedback reports; webinar for hospital teams

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital, Capital Medical University	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital	American Heart Association

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	door-to-puncture time		participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Secondary	in-hospital mortality		participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Secondary	3-month disability(mRS=3 )		patients will be followed up at 3 months