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

NCT ID: NCT05852080

Last Updated: 2023-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2025-05-01

Brief Summary

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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).

Detailed Description

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Conditions

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Acute Ischemic Stroke Stroke Recrudescence Quality Improvement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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intervention arm

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

Group Type EXPERIMENTAL

multilevel system intervention based on information platform

Intervention Type BEHAVIORAL

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

control arm

Hospitals in the control arm will receive no intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zexin Chen

Role: PRINCIPAL_INVESTIGATOR

Tthe second affiliated hospital, school of medicine, Zhejiang University, China

Locations

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Min Lou

Hangzhou, Zhejiang, China

Site Status

Countries

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China

Central Contacts

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Min Lou, PhD

Role: CONTACT

+8613958007213

Facility Contacts

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Zexin Chen

Role: primary

13757118366

Other Identifiers

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MISA

Identifier Type: -

Identifier Source: org_study_id

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