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

Whole-process Quality Improvement of Patients With Acute Ischemic Stroke Undergoing Endovascular Treatment Based on an Artificial Intelligence-aided Clinical Feedback System

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke, Acute
• Intervention / Treatment: Behavioral: AI-aided clinical feedback system coupled with multi-aspect intervention basd on Behaviour Change Wheel model

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.

• Study Type: Interventional
• Enrollment (Estimated): 1221
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Min Lou, PhD; Phone Number: +8613958007213; Email: loumingxc@vip.sina.com

Study Locations

• China
  • Hangzhou, China
    • Recruiting
    • Second Affiliated Hospital, School of Medicine, Zhejiang University
    • Contact: Min Lou, PhD; Phone Number: 8657187784811; Email: loumingxc@vip.sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; AI-aided clinical feedback system coupled with multi-aspect intervention based on the Behaviour Change Wheel model	Behavioral: AI-aided clinical feedback system coupled with multi-aspect intervention basd on Behaviour Change Wheel model; 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.
No Intervention: Control; AI-aided clinical feedback system only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ratio of favorable functional outcome at 3 month	Ratio of patients with mRS > 2 at 3-month follow up	3 months

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ratio of favorable functional outcome at 3 month in patients within 6 hours of stroke onset	Ratio of mRS > 2 at 3 month follow-up in patients within 6 hours of stroke onset	3 months
Door to groin puncture time in patients within 6 hours of stroke onset	Time interval between admission and groin puncture in patients within 6 hours of stroke onset	24 hours

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Principal Investigator: Zexin Chen, Ethics committee the second affiliated hospital, school of medicine, Zhejiang University, China

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: May 2, 2023
• First Submitted That Met QC Criteria: May 24, 2023
• First Posted (Actual): May 25, 2023

Study Record Updates

• Last Update Posted (Actual): July 3, 2023
• Last Update Submitted That Met QC Criteria: June 28, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: OPTIMAL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No