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

May 2, 2023 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

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

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intervention arm
Hospitals in the intervention arm will receive a multilevel system intervention based on information platform
Behavioral: multilevel system intervention based on information platform
  1. Standardized templates of medical record
  2. 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.
  3. Team collaboration based on video conferencing: hospitals will receive corresponding suggestions for their improvement from experts online.
  4. Enhanced feedback incentives
No Intervention: control arm
Hospitals in the control arm will receive no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence rate of new ischemic stroke events
Time Frame: 3, 5 years
Incidence rate of new ischemic stroke events at 3, 5 years after initial symptom onset.
3, 5 years
Incidence rate of new clinical vascular events (ischemic stroke, hemorrhagic stroke, myocardial infarction)
Time Frame: 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.
1, 3, 5 years
All-cause mortality
Time Frame: 1, 3, 5 years
All-cause mortality
1, 3, 5 years
The percentage of stroke of undetermined cause at discharge
Time Frame: 1 year
The percentage of stroke of undetermined cause at discharge
1 year
Rate of antithrombotic therapy at discharge
Time Frame: 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.
1 year
Rate of anticoagulant treatment for patients with atrial fibrillation at discharge
Time Frame: 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
1 year
Rate of blood vessel assessment within one week of hospitalization
Time Frame: 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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

  • Principal Investigator: Zexin Chen, Tthe second affiliated hospital, school of medicine, Zhejiang University, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2023

Primary Completion (Anticipated)

May 1, 2025

Study Completion (Anticipated)

May 1, 2025

Study Registration Dates

First Submitted

May 2, 2023

First Submitted That Met QC Criteria

May 2, 2023

First Posted (Actual)

May 10, 2023

Study Record Updates

Last Update Posted (Actual)

May 10, 2023

Last Update Submitted That Met QC Criteria

May 2, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MISA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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