Whole-process Quality Improvement of Endovascular Treatment Basd on an AI-aided Clinical Feedback System
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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 |
Outcome Measures
Primary Outcome Measures
- Ratio of favorable functional outcome at 3 month [3 months]
Ratio of patients with mRS > 2 at 3-month follow up
Secondary Outcome Measures
- Ratio of good functional outcome at 3 month [3 months]
Ratio of patients with mRS > 1 at 3-month follow up
- mRS score at 3 month [3 months]
mRS score at 3-month follow up
- Mortality at 3 month [3 months]
Mortality at 3-month follow up
- Ratio of hemorrhagic transformation at 24 hour [24 hours]
Ratio of hemorrhagic transformation at 24 hour after EVT
- Ratio of symptomatic intracranial hemorrhage at 24 hour [24 hours]
Ratio of symptomatic intracranial hemorrhage at 24 hour after EVT
- Door to groin puncture time [24 hours]
Time interval between admission and groin puncture
- Ratio of door to groin puncture time < 90 min [24 hours]
Time interval between admission and groin puncture <90 min
- Ratio of door to groin puncture time < 60 min [24 hours]
Time interval between admission and groin puncture <60 min
- Procedural duration [24 hours]
Time interval between groin puncture and last time of digital subtraction angiography
- Ratio of successful reperfusion [24 hours]
Ratio of patients achieving modified thrombolysis in cerebral infarction (mTICI) 2b or 3
Other Outcome Measures
- Ratio of favorable functional outcome at 3 month in patients within 6 hours of stroke onset [3 months]
Ratio of mRS > 2 at 3 month follow-up in patients within 6 hours of stroke onset
- Door to groin puncture time in patients within 6 hours of stroke onset [24 hours]
Time interval between admission and groin puncture in patients within 6 hours of stroke onset
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Second Affiliated Hospital, School of Medicine, Zhejiang University | Hangzhou | China |
Sponsors and Collaborators
- 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 Documents (Full-Text)
None provided.More Information
Publications
None provided.- OPTIMAL