Whole-process Quality Improvement of Endovascular Treatment Basd on an AI-aided Clinical Feedback System
1 other identifier
interventional
1,289
1 country
1
Brief Summary
A clustered randomized control trial to evaluate whether multi-aspect intervention based on an AI-aided clinical feedback system could improve the quality of EVT and functional outcome of patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 2, 2023
CompletedFirst Posted
Study publicly available on registry
May 25, 2023
CompletedStudy Start
First participant enrolled
June 30, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 5, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 8, 2024
CompletedNovember 20, 2025
July 1, 2023
2 months
May 2, 2023
November 17, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Ratio of favorable functional outcome at 3 month
Ratio of patients with mRS ≤ 3 at 3-month follow up
3 months
Secondary Outcomes (10)
Ratio of good functional outcome at 3 month
3 months
mRS score at 3 month
3 months
Mortality at 3 month
3 months
Ratio of hemorrhagic transformation at 24 hour
24 hours
Ratio of symptomatic intracranial hemorrhage at 24 hour
24 hours
- +5 more secondary outcomes
Other Outcomes (2)
Ratio of favorable functional outcome at 3 month in patients within 6 hours of stroke onset
3 months
Door to groin puncture time in patients within 6 hours of stroke onset
24 hours
Study Arms (2)
Intervention
EXPERIMENTALAI-aided clinical feedback system coupled with multi-aspect intervention based on the Behaviour Change Wheel model
Control
NO INTERVENTIONAI-aided clinical feedback system only
Interventions
Interventions are developed on a psychological model, the Behaviour Change Wheel (BCW) .The fundamental of BCW consists of three essential elements: capability, motivation, and opportunity. Improving individual's capability, providing motivation, and increasing opportunities are goals of behaviour change intervention. To achieve the goals, 9 intervention components have been proposed in the BCW framework, and 6 components will be used in current study.
Eligibility Criteria
You may qualify if:
- Age \> 18
- AIS patients receiving EVT within 24 hours of stroke onset
- Written informed consent is obtained
You may not qualify if:
- Patients refuse to participate in this study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zexin Chen
Ethics committee the second affiliated hospital, school of medicine, Zhejiang University, China
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 2, 2023
First Posted
May 25, 2023
Study Start
June 30, 2024
Primary Completion
September 5, 2024
Study Completion
December 8, 2024
Last Updated
November 20, 2025
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share