Clinical trial NCT03578107: 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
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Stroke
Keywords: acute ischemic stroke
IV-tPA
endovascular treatment
intervention
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2018-07-05
Enrollment: 15895
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: The adherence rate of guidelines for IV-tPA and/or endovascular treatment in eligible patients.
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Secondary outcomes:
measure: proportional change of intravenous thrombolytic therapy in eligible patients 4.5h after the onset
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
measure: proportional change of endovascular treatment in eligible patients 6h after the onset
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
measure: time from arrival to hospitals to intravenous thrombolytic therapy
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
measure: door-to-puncture time
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
measure: in-hospital mortality
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
measure: 3-month disability（mRS≥3 ）
timeFrame: patients will be followed up at 3 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Tiantan Hospital
name: Yongjun Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.