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

NCT ID: NCT03578107

Last Updated: 2021-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15895 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-01

Study Completion Date

2020-10-31

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.

Detailed Description

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Conditions

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Ischemic Stroke

Keywords

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acute ischemic stroke IV-tPA endovascular treatment intervention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Improvement intervention1

receive the following improvement intervention for 18 months:

Group Type OTHER

improvement of quality of stroke care

Intervention Type BEHAVIORAL

1. hospital tool kits for quality improvement of reperfusion therapy ;
2. organizational stakeholder and opinion leader meetings;
3. data monitoring and feedback reports;
4. webinar for hospital teams

Improvement intervention2

receive the following improvement intervention for 12 months:

Group Type OTHER

improvement of quality of stroke care

Intervention Type BEHAVIORAL

1. hospital tool kits for quality improvement of reperfusion therapy ;
2. organizational stakeholder and opinion leader meetings;
3. data monitoring and feedback reports;
4. webinar for hospital teams

Improvement intervention3

receive the following improvement intervention for 6 months:

Group Type OTHER

improvement of quality of stroke care

Intervention Type BEHAVIORAL

1. hospital tool kits for quality improvement of reperfusion therapy ;
2. organizational stakeholder and opinion leader meetings;
3. data monitoring and feedback reports;
4. webinar for hospital teams

Interventions

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improvement of quality of stroke care

1. hospital tool kits for quality improvement of reperfusion therapy ;
2. organizational stakeholder and opinion leader meetings;
3. data monitoring and feedback reports;
4. webinar for hospital teams

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Heart Association

OTHER

Sponsor Role collaborator

Beijing Tiantan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yongjun Wang

Executive Vice-President

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yongjun Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Beijing Tiantan Hospital

Locations

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Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status

Countries

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China

References

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Wang CJ, Gu HQ, Zong LX, Zhang XM, Zhou Q, Jiang Y, Li H, Meng X, Yang X, Wang M, Huo XC, Wangqin RQ, Bei YZ, Qi XH, Liu XY, Hu SQ, Wang ZM, Zhao XQ, Wang YL, Liu LP, Ma XD, Morgan L, Xian Y, Schwamm LH, Wang YJ, Li ZX; IMPROVE Stroke Care in China investigators. Effectiveness of a Quality Improvement Intervention on Reperfusion Treatment for Patients With Acute Ischemic Stroke: A Stepped-Wedge Cluster Randomized Clinical Trial. JAMA Netw Open. 2023 Jun 1;6(6):e2316465. doi: 10.1001/jamanetworkopen.2023.16465.

Reference Type DERIVED
PMID: 37266940 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35354662 (View on PubMed)

Other Identifiers

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KY 2018-044-01

Identifier Type: -

Identifier Source: org_study_id