Multilevel System Intervention Based on Information Platform to Reduce Stroke Recurrence Rate in Acute Ischemic Stroke Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Incidence rate of new ischemic stroke events
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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).
Exclusion Criteria
- •Patients refuse to participate in this study.
- •Patients who losing his medical record of having the incomplete medical record
Outcomes
Primary Outcomes
Incidence rate of new ischemic stroke events
Time Frame: 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 Outcomes
- All-cause mortality(1, 3, 5 years)
- Incidence rate of new clinical vascular events (ischemic stroke, hemorrhagic stroke, myocardial infarction)(1, 3, 5 years)
- The percentage of stroke of undetermined cause at discharge(1 year)
- Incidence rate of new ischemic stroke events(3, 5 years)
- Rate of blood vessel assessment within one week of hospitalization(1 year)
- Rate of antithrombotic therapy at discharge(1 year)
- Rate of anticoagulant treatment for patients with atrial fibrillation at discharge(1 year)