Multilevel System Intervention Based on Information Platform to Reduce Ischemic Stroke Recurrence Rate
- Conditions
- Acute Ischemic StrokeStroke RecrudescenceQuality Improvement
- Interventions
- Behavioral: multilevel system intervention based on information platform
- Registration Number
- NCT05852080
- Lead Sponsor
- Second Affiliated Hospital, School of Medicine, Zhejiang University
- Brief Summary
A prospective, multicenter and cluster randomised controlled trial will be conducted, using hospital as randomisation unit. Hospitals in Zhejiang Province, China, will be randomised into two arms (1:1): an intervention arm and a control arm. Hospitals in the intervention arm will receive a multilevel system intervention based on information platform, whereas hospitals in the control arm will receive no intervention. The randomisation will be conducted after baseline data collection. The following baseline data will be used for randomisation match: hospital classification, beds in stroke centre, and the number of acute ischemic stroke (AIS) patients within 7 days of stroke onset. Hospitals with \<250 AIS cases per year will be excluded from the study. The primary outcome will be difference between intervention arm and control arm in the one-year stroke recurrence rate on the follow-up stage (post-intervention).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 60
- Patients of 18 years or older.
- Patients admitted with neurological deficit consistent with ischemic stroke within 7 days of of symptoms onset. (*Symptom onset is defined by the "last seen normal" principle)
- Confirmation of new ischemic stroke by objective modality of CT scan and MRI (had relevant lesions on DWI).
- Informed consent from patient or legally authorised representative (primarily spouse, parents, adult children, otherwise indicated).
- Patients refuse to participate in this study.
- Patients who losing his medical record of having the incomplete medical record
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description intervention arm multilevel system intervention based on information platform Hospitals in the intervention arm will receive a multilevel system intervention based on information platform
- Primary Outcome Measures
Name Time Method Incidence rate of new ischemic stroke events 1 year To evaluate the efficacy of intervention in reducing the risk of new ischemic stroke events at 1 year after initial symptom onset.
- Secondary Outcome Measures
Name Time Method All-cause mortality 1, 3, 5 years All-cause mortality
Incidence rate of new clinical vascular events (ischemic stroke, hemorrhagic stroke, myocardial infarction) 1, 3, 5 years incidence rate of new clinical vascular events (ischemic stroke, hemorrhagic stroke, myocardial infarction) at 1, 3, 5 years after initial symptom onset.
The percentage of stroke of undetermined cause at discharge 1 year The percentage of stroke of undetermined cause at discharge
Incidence rate of new ischemic stroke events 3, 5 years Incidence rate of new ischemic stroke events at 3, 5 years after initial symptom onset.
Rate of blood vessel assessment within one week of hospitalization 1 year The rate of patients with cerebral infarction hospitalized for 1 week who had completed the evaluation of the blood vessels in the neck and cranial (such as the ultrasound of the blood vessels in the neck or cranial, CT or MR angiography, or DSA) in the total number of cerebral infarction patients hospitalized in the same period
Rate of antithrombotic therapy at discharge 1 year The rate of patients with cerebral infarction who received antithrombotic drugs (such as aspirin, other antiplatelet agents, heparin, warfarin or new oral anticoagulants) at discharge in the total number of hospitalized patients with cerebral infarction in the same period.
Rate of anticoagulant treatment for patients with atrial fibrillation at discharge 1 year The rate of patients with cerebral infarction complicated with atrial fibrillation who received anticoagulants (e.g., heparin, low molecular heparin, warfarin, new oral anticoagulants) at discharge in the total number of patients with cerebral infarction complicated with atrial fibrillation treated in hospital in the same period
Trial Locations
- Locations (1)
Min Lou
🇨🇳Hangzhou, Zhejiang, China