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NCT05874596 | UNKNOWN | Stroke, Acute


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

Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Condition or disease

Stroke, Acute

Intervention/treatment

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

Phase

NA

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
Estimated Enrollment : 1221 participants
Masking : DOUBLE
Primary Purpose : TREATMENT
Official Title : Whole-process Quality Improvement of Patients With Acute Ischemic Stroke Undergoing Endovascular Treatment Based on an Artificial Intelligence-aided Clinical Feedback System
Actual Study Start Date : 2023-06-22
Estimated Primary Completion Date : 2024-06-01
Estimated Study Completion Date : 2024-09-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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

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

Location Details

NCT05874596


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Locations


RECRUITING

China,

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, China,

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