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

Primary Purpose

Acute Ischemic Stroke, Stroke Recrudescence, Quality Improvement

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
multilevel system intervention based on information platform
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Ischemic Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Min Lou

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

intervention arm

control arm

Arm Description

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

Hospitals in the control arm will receive no intervention

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Incidence rate of new ischemic stroke events
Incidence rate of new ischemic stroke events at 3, 5 years after initial symptom onset.
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.
All-cause mortality
All-cause mortality
The percentage of stroke of undetermined cause at discharge
The percentage of stroke of undetermined cause at discharge
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.
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
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

Full Information

First Posted
May 2, 2023
Last Updated
May 2, 2023
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT05852080
Brief Title
Multilevel System Intervention Based on Information Platform to Reduce Ischemic Stroke Recurrence Rate
Official Title
Multilevel System Intervention Based on Information Platform to Reduce Stroke Recurrence Rate in Acute Ischemic Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 1, 2023 (Anticipated)
Primary Completion Date
May 1, 2025 (Anticipated)
Study Completion Date
May 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischemic Stroke, Stroke Recrudescence, Quality Improvement

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
intervention arm
Arm Type
Experimental
Arm Description
Hospitals in the intervention arm will receive a multilevel system intervention based on information platform
Arm Title
control arm
Arm Type
No Intervention
Arm Description
Hospitals in the control arm will receive no intervention
Intervention Type
Behavioral
Intervention Name(s)
multilevel system intervention based on information platform
Intervention Description
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
Primary Outcome Measure Information:
Title
Incidence rate of new ischemic stroke events
Description
To evaluate the efficacy of intervention in reducing the risk of new ischemic stroke events at 1 year after initial symptom onset.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Incidence rate of new ischemic stroke events
Description
Incidence rate of new ischemic stroke events at 3, 5 years after initial symptom onset.
Time Frame
3, 5 years
Title
Incidence rate of new clinical vascular events (ischemic stroke, hemorrhagic stroke, myocardial infarction)
Description
incidence rate of new clinical vascular events (ischemic stroke, hemorrhagic stroke, myocardial infarction) at 1, 3, 5 years after initial symptom onset.
Time Frame
1, 3, 5 years
Title
All-cause mortality
Description
All-cause mortality
Time Frame
1, 3, 5 years
Title
The percentage of stroke of undetermined cause at discharge
Description
The percentage of stroke of undetermined cause at discharge
Time Frame
1 year
Title
Rate of antithrombotic therapy at discharge
Description
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.
Time Frame
1 year
Title
Rate of anticoagulant treatment for patients with atrial fibrillation at discharge
Description
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
Time Frame
1 year
Title
Rate of blood vessel assessment within one week of hospitalization
Description
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
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Min Lou, PhD
Phone
+8613958007213
Email
loumingxc@vip.sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zexin Chen
Organizational Affiliation
Tthe second affiliated hospital, school of medicine, Zhejiang University, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Min Lou
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zexin Chen
Phone
13757118366
Email
HREC2013@126.com

12. IPD Sharing Statement

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

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