Stroke, Acute
Conditions
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.
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 at 3 month.
Interventions
BEHAVIORALAI-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.
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ratio of favorable functional outcome at 3 month | 3 months | Ratio of patients with mRS ≤ 3 at 3-month follow up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ratio of good functional outcome at 3 month | 3 months | Ratio of patients with mRS ≤2 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 |
| 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 |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Outcome results
None listed