Multilevel System Intervention Based on Information Platform to Reduce Ischemic Stroke Recurrence Rate

Zhejiang University

Status: Not yet enrolling

Conditions: Quality Improvement; Acute Ischemic Stroke; Stroke Recrudescence

Treatments: Behavioral: multilevel system intervention based on information platform

Study type: Interventional

Funder types: Other

Identifiers

NCT05852080

MISA

Details and patient eligibility

About

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).

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

intervention arm

Experimental group

Description:

Hospitals in the intervention arm will receive a multilevel system intervention based on information platform

Treatment:

Behavioral: multilevel system intervention based on information platform

control arm

No Intervention group

Description:

Hospitals in the control arm will receive no intervention