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

NCT03578107 | Completed DMC

• 1 other identifier: KY 2018-044-01
• Study Type: interventional
• Target: 15,895
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Stroke

Keywords

acute ischemic stroke; IV-tPA; endovascular treatment; intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

Study Arms (3)

Improvement intervention1

OTHER

receive the following improvement intervention for 18 months：

Behavioral: improvement of quality of stroke care

Improvement intervention2

OTHER

receive the following improvement intervention for 12 months：

Behavioral: improvement of quality of stroke care

Improvement intervention3

OTHER

receive the following improvement intervention for 6 months：

Behavioral: improvement of quality of stroke care

Interventions

improvement of quality of stroke care 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 intervention1; Improvement intervention2; Improvement intervention3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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：
• ）Patients refuse to participate in this study

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead
• American Heart Association: collaborator

Study Sites (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

Location

Related Publications (2)

• 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.

  PMID: 37266940 DERIVED

• 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.

  PMID: 35354662 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Yongjun Wang, MD

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive Vice-President

Study Record Dates

• First Submitted: June 24, 2018
• First Posted: July 5, 2018
• Study Start: July 1, 2018
• Primary Completion: July 31, 2020
• Study Completion: October 31, 2020
• Last Updated: November 2, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)