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

NCT05852080 | Unknown

• 1 other identifier: MISA
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Acute Ischemic Stroke; Stroke Recrudescence; Quality Improvement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Incidence rate of new ischemic stroke events

  3, 5 years

• Incidence rate of new clinical vascular events (ischemic stroke, hemorrhagic stroke, myocardial infarction)

  1, 3, 5 years

• All-cause mortality

  1, 3, 5 years

• The percentage of stroke of undetermined cause at discharge

  1 year

• Rate of antithrombotic therapy at discharge

  1 year

Study Arms (2)

intervention arm

EXPERIMENTAL

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

Behavioral: multilevel system intervention based on information platform

control arm

NO INTERVENTION

Hospitals in the control arm will receive no intervention

Interventions

multilevel system intervention based on information platform 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

intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Patients refuse to participate in this study.
• Patients who losing his medical record of having the incomplete medical record

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Min Lou

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Zexin Chen

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Min Lou, PhD

CONTACT

+8613958007213; loumingxc@vip.sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2023
• First Posted: May 10, 2023
• Study Start: May 1, 2023
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: May 10, 2023

Record last verified: 2023-04

Locations

CN (1)