Back to resultsImprove Acute Reperfusion Treatment Quality for Stroke in China, IMPROVE: Stroke Care in China
Primary Purpose
Ischemic Stroke
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
improvement of quality of stroke care
Sponsored by
About this trial
This is an interventional health services research trial for Ischemic Stroke focused on measuring acute ischemic stroke, IV-tPA, endovascular treatment, intervention
Eligibility Criteria
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
Sites / Locations
- Beijing Tiantan Hospital, Capital Medical University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
Improvement intervention1
Improvement intervention2
Improvement intervention3
Arm Description
receive the following improvement intervention for 18 months：
receive the following improvement intervention for 12 months：
receive the following improvement intervention for 6 months：
Outcomes
Primary Outcome Measures
The adherence rate of guidelines for IV-tPA and/or endovascular treatment in eligible patients.
Secondary Outcome Measures
proportional change of intravenous thrombolytic therapy in eligible patients 4.5h after the onset
proportional change of endovascular treatment in eligible patients 6h after the onset
time from arrival to hospitals to intravenous thrombolytic therapy
door-to-puncture time
in-hospital mortality
3-month disability（mRS≥3 ）
Full Information
NCT ID
NCT03578107
First Posted
June 24, 2018
Last Updated
October 26, 2021
Sponsor
Beijing Tiantan Hospital
Collaborators
American Heart Association
1. Study Identification
Unique Protocol Identification Number
NCT03578107
Brief Title
Improve Acute Reperfusion Treatment Quality for Stroke in China, IMPROVE: Stroke Care in China
Official Title
Improve Acute Reperfusion Treatment Quality for Stroke in China
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
July 31, 2020 (Actual)
Study Completion Date
October 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Tiantan Hospital
Collaborators
American Heart Association
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke
Keywords
acute ischemic stroke, IV-tPA, endovascular treatment, intervention
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
15895 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Improvement intervention1
Arm Type
Other
Arm Description
receive the following improvement intervention for 18 months：
Arm Title
Improvement intervention2
Arm Type
Other
Arm Description
receive the following improvement intervention for 12 months：
Arm Title
Improvement intervention3
Arm Type
Other
Arm Description
receive the following improvement intervention for 6 months：
Intervention Type
Behavioral
Intervention Name(s)
improvement of quality of stroke care
Intervention Description
hospital tool kits for quality improvement of reperfusion therapy ;
organizational stakeholder and opinion leader meetings;
data monitoring and feedback reports；
webinar for hospital teams
Primary Outcome Measure Information:
Title
The adherence rate of guidelines for IV-tPA and/or endovascular treatment in eligible patients.
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Secondary Outcome Measure Information:
Title
proportional change of intravenous thrombolytic therapy in eligible patients 4.5h after the onset
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Title
proportional change of endovascular treatment in eligible patients 6h after the onset
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Title
time from arrival to hospitals to intravenous thrombolytic therapy
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Title
door-to-puncture time
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Title
in-hospital mortality
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Title
3-month disability（mRS≥3 ）
Time Frame
patients will be followed up at 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yongjun Wang, MD
Organizational Affiliation
Beijing Tiantan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Tiantan Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35354662
Citation
Li Z, Wang C, Zhang X, Zong L, Zhou H, Gu H, Jiang Y, Pan Y, Meng X, Zhou Q, Zhao H, Yang X, Wang M, Xiong Y, Zhao X, Wang Y, Liu L, Ma X, Morgan L, Xian Y, Schwamm LH, Wang Y. Rationale and design of a stepped wedge cluster randomised trial to improve acute reperfusion treatment quality for stroke: IMPROVE stroke care in China. Stroke Vasc Neurol. 2022 Oct;7(5):451-456. doi: 10.1136/svn-2021-001461. Epub 2022 Mar 30.
Results Reference
derived
Learn more about this trial
Improve Acute Reperfusion Treatment Quality for Stroke in China, IMPROVE: Stroke Care in China
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