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

Stroke, Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05874596
• Other study ID #: OPTIMAL
• Status: Recruiting
• Phase: N/A
• Start date: June 22, 2023
• Est. completion date: September 1, 2024

Study information

• Verified date: April 2023
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Min Lou, PhD
• Phone: +8613958007213
• Email: loumingxc[@]vip.sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1221
• Est. completion date: September 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke
• Stroke, Acute

Intervention

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.

Locations

Country	Name	City	State
China	Second Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

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