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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Stroke, Acute

Intervention / Treatment
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* Behavioral: AI-aided clinical feedback system coupled with multi-aspect intervention basd on Behaviour Change Wheel model


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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<br>* 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.<br>|
| No Intervention: Control<br>AI-aided clinical feedback system only | |

What is the study measuring?
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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 |