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

Acute Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05852080
• Other study ID #: MISA
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: May 1, 2025

Study information

• Verified date: April 2023
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Min Lou, PhD
• Phone: +8613958007213
• Email: loumingxc[@]vip.sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: May 1, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Quality Improvement
• Recurrence
• Stroke

Intervention

Behavioral:
• multilevel system intervention based on information platform
Standardized templates of medical record Continuous medical quality control and feedback system: the hospital included in the study upload the medical records of all AIS patients by medical records scanning system. Quality control platform of Cerebral apoplexy in Zhejiang province extracts and analyze the data through the computer and calculates the percentage of stroke of undetermined cause. Team collaboration based on video conferencing: hospitals will receive corresponding suggestions for their improvement from experts online. Enhanced feedback incentives

Locations

Country	Name	City	State
China	Min Lou	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence rate of new ischemic stroke events	To evaluate the efficacy of intervention in reducing the risk of new ischemic stroke events at 1 year after initial symptom onset.	1 year
Secondary	Incidence rate of new ischemic stroke events	Incidence rate of new ischemic stroke events at 3, 5 years after initial symptom onset.	3, 5 years
Secondary	Incidence rate of new clinical vascular events (ischemic stroke, hemorrhagic stroke, myocardial infarction)	incidence rate of new clinical vascular events (ischemic stroke, hemorrhagic stroke, myocardial infarction) at 1, 3, 5 years after initial symptom onset.	1, 3, 5 years
Secondary	All-cause mortality	All-cause mortality	1, 3, 5 years
Secondary	The percentage of stroke of undetermined cause at discharge	The percentage of stroke of undetermined cause at discharge	1 year
Secondary	Rate of antithrombotic therapy at discharge	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.	1 year
Secondary	Rate of anticoagulant treatment for patients with atrial fibrillation at discharge	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	1 year
Secondary	Rate of blood vessel assessment within one week of hospitalization	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	1 year