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Whole-process Quality Improvement of Endovascular Treatment Basd on an AI-aided Clinical Feedback System

Primary Purpose

Stroke, Acute

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
AI-aided clinical feedback system coupled with multi-aspect intervention basd on Behaviour Change Wheel model
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Acute

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age > 18 AIS patients receiving EVT within 24 hours of stroke onset Written informed consent is obtained Exclusion Criteria: Patients refuse to participate in this study

Sites / Locations

  • Second Affiliated Hospital, School of Medicine, Zhejiang UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

AI-aided clinical feedback system coupled with multi-aspect intervention based on the Behaviour Change Wheel model

AI-aided clinical feedback system only

Outcomes

Primary Outcome Measures

Ratio of favorable functional outcome at 3 month
Ratio of patients with mRS > 2 at 3-month follow up

Secondary Outcome Measures

Ratio of good functional outcome at 3 month
Ratio of patients with mRS > 1 at 3-month follow up
mRS score at 3 month
mRS score at 3-month follow up
Mortality at 3 month
Mortality at 3-month follow up
Ratio of hemorrhagic transformation at 24 hour
Ratio of hemorrhagic transformation at 24 hour after EVT
Ratio of symptomatic intracranial hemorrhage at 24 hour
Ratio of symptomatic intracranial hemorrhage at 24 hour after EVT
Door to groin puncture time
Time interval between admission and groin puncture
Ratio of door to groin puncture time < 90 min
Time interval between admission and groin puncture <90 min
Ratio of door to groin puncture time < 60 min
Time interval between admission and groin puncture <60 min
Procedural duration
Time interval between groin puncture and last time of digital subtraction angiography
Ratio of successful reperfusion
Ratio of patients achieving modified thrombolysis in cerebral infarction (mTICI) 2b or 3

Full Information

First Posted
May 2, 2023
Last Updated
June 28, 2023
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT05874596
Brief Title
Whole-process Quality Improvement of Endovascular Treatment Basd on an AI-aided Clinical Feedback System
Official Title
Whole-process Quality Improvement of Patients With Acute Ischemic Stroke Undergoing Endovascular Treatment Based on an Artificial Intelligence-aided Clinical Feedback System
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 22, 2023 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
Endovascular treatment (EVT) is the standard treatment for acute ischemic stroke (AIS) caused by large vessel occlusion (LVO) according to current guidelines. However, while a rapidly-growing number of stroke centers become capable of performing EVT, the general quality of EVT remains unsatisfied, resulting in a considerable proportion of patients who could not reach functional independence. Our pre-established artificial intelligence (AI)-aided clinical feedback system could dynamically record and report key timepoints of EVT in-hospital process. Combined with multi-aspect intervention via remote/on-site surveillance and education, this may be a potential solution for quality improvement of EVT. Therefore, the aim of the study is to evaluate whether an AI-aided clinical feedback system coupled with multi-aspect intervention could improve the quality of EVT. Twenty hospitals with annual EVT cases > 30 will be 1:1 randomized into intervention group and control group. The intervention group will receive AI-based clinical feedback system coupled with multi-aspect intervention, including remote/on-site surveillance and education regarding in-hospital workflow and surgical procedures of EVT. The control group only deploys AI-aided clinical feedback system. The primary outcome is the ratio of good functional outcome (mRS > 2) at 3 month.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Acute

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
1221 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
AI-aided clinical feedback system coupled with multi-aspect intervention based on the Behaviour Change Wheel model
Arm Title
Control
Arm Type
No Intervention
Arm Description
AI-aided clinical feedback system only
Intervention Type
Behavioral
Intervention Name(s)
AI-aided clinical feedback system coupled with multi-aspect intervention basd on Behaviour Change Wheel model
Intervention Description
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.
Primary Outcome Measure Information:
Title
Ratio of favorable functional outcome at 3 month
Description
Ratio of patients with mRS > 2 at 3-month follow up
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Ratio of good functional outcome at 3 month
Description
Ratio of patients with mRS > 1 at 3-month follow up
Time Frame
3 months
Title
mRS score at 3 month
Description
mRS score at 3-month follow up
Time Frame
3 months
Title
Mortality at 3 month
Description
Mortality at 3-month follow up
Time Frame
3 months
Title
Ratio of hemorrhagic transformation at 24 hour
Description
Ratio of hemorrhagic transformation at 24 hour after EVT
Time Frame
24 hours
Title
Ratio of symptomatic intracranial hemorrhage at 24 hour
Description
Ratio of symptomatic intracranial hemorrhage at 24 hour after EVT
Time Frame
24 hours
Title
Door to groin puncture time
Description
Time interval between admission and groin puncture
Time Frame
24 hours
Title
Ratio of door to groin puncture time < 90 min
Description
Time interval between admission and groin puncture <90 min
Time Frame
24 hours
Title
Ratio of door to groin puncture time < 60 min
Description
Time interval between admission and groin puncture <60 min
Time Frame
24 hours
Title
Procedural duration
Description
Time interval between groin puncture and last time of digital subtraction angiography
Time Frame
24 hours
Title
Ratio of successful reperfusion
Description
Ratio of patients achieving modified thrombolysis in cerebral infarction (mTICI) 2b or 3
Time Frame
24 hours
Other Pre-specified Outcome Measures:
Title
Ratio of favorable functional outcome at 3 month in patients within 6 hours of stroke onset
Description
Ratio of mRS > 2 at 3 month follow-up in patients within 6 hours of stroke onset
Time Frame
3 months
Title
Door to groin puncture time in patients within 6 hours of stroke onset
Description
Time interval between admission and groin puncture in patients within 6 hours of stroke onset
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age > 18 AIS patients receiving EVT within 24 hours of stroke onset Written informed consent is obtained Exclusion Criteria: Patients refuse to participate in this study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Min Lou, PhD
Phone
+8613958007213
Email
loumingxc@vip.sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zexin Chen
Organizational Affiliation
Ethics committee the second affiliated hospital, school of medicine, Zhejiang University, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Second Affiliated Hospital, School of Medicine, Zhejiang University
City
Hangzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min Lou, PhD
Phone
8657187784811
Email
loumingxc@vip.sina.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Whole-process Quality Improvement of Endovascular Treatment Basd on an AI-aided Clinical Feedback System

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