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.
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 at 3 month.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,289
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.
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, China
Ratio of favorable functional outcome at 3 month
Ratio of patients with mRS ≤ 3 at 3-month follow up
Time frame: 3 months
Ratio of good functional outcome at 3 month
Ratio of patients with mRS ≤2 at 3-month follow up
Time frame: 3 months
mRS score at 3 month
mRS score at 3-month follow up
Time frame: 3 months
Mortality at 3 month
Mortality at 3-month follow up
Time frame: 3 months
Ratio of hemorrhagic transformation at 24 hour
Ratio of hemorrhagic transformation at 24 hour after EVT
Time frame: 24 hours
Ratio of symptomatic intracranial hemorrhage at 24 hour
Ratio of symptomatic intracranial hemorrhage at 24 hour after EVT
Time frame: 24 hours
Door to groin puncture time
Time interval between admission and groin puncture
Time frame: 24 hours
Ratio of door to groin puncture time < 90 min
Time interval between admission and groin puncture \<90 min
Time frame: 24 hours
Ratio of door to groin puncture time < 60 min
Time interval between admission and groin puncture \<60 min
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Time frame: 24 hours
Procedural duration
Time interval between groin puncture and last time of digital subtraction angiography
Time frame: 24 hours
Ratio of successful reperfusion
Ratio of patients achieving modified thrombolysis in cerebral infarction (mTICI) 2b or 3
Time frame: 24 hours