RecruitingNot ApplicableNCT06330051

The Improve Acute Reperfusion Treatment Quality for Ischemic Stroke Through Spatiotemporal Computing in China

The Improve Acute Reperfusion Treatment Quality for Ischemic Stroke Through Spatiotemporal Computing in China (IMPROVE-II ) -A Multicenter, Evaluator-Blind, Cluster-Randomized Controlled Study


Sponsor

Beijing Tiantan Hospital

Enrollment

1,280 participants

Start Date

Mar 18, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study intends to construct the goal-oriented integrated intervention model for AIS in-hospital procedure through the spatiotemporal positioning and the P-D-C-A cycle for continuous improvement (FAST model). Then a multicenter, evaluator-blind, cluster-randomized controlled study aims to verify the validity and safety of this FAST model.


Eligibility

Min Age: 18 Years

Inclusion Criteria8

  • Hospitals#
  • Secondary or tertiary public hospitals with an emergency department that receive patients with AIS.
  • Admit at least 50 patients of AIS within 4.5 hours after onset each month.
  • Have the capacity of intravenous thrombolytic therapy or/and endovascular treatment.
  • Voluntarily participate in this research and cooperate with the installation of bluetooth positioning device and the improvement of AIS emergency procedures.
  • Have good cooperation relationship among the department of Neurology, Emergency, Interventional department, Neurosurgery department, Laboratory department and Radiology department.
  • Have ability to establish or participate in the establishment of patient information database and arrange a person responsible for the collection of case information.
  • Patients# Patients who are ≥18 years old are eligible for inclusion if they present with AIS diagnosed by CT and/or MRI, arrive at hospital within 4.5 hours after symptom onset, sign the informed consent form and agree to follow up until 3 months after stroke onset.

Exclusion Criteria8

  • Hospitals#
  • Hospital that unable to cooperate and complete the research.
  • Hospitals that are participating in other AIS medical quality improvement projects or related clinical trials.
  • Patients#
  • Patients refuse to sign informed consent and follow up until 3 months after stroke onset.
  • Patients with mild nondisabling stroke symptoms (Defined as NIHSS≤3, as any of the following: isolated facial paralysis; mild cortical blindness; mild hemianesthesia; mild hemiataxia.)
  • Life expectancy three-months or less by judgment of the investigator.
  • Participation in any interventional study that may affect the outcome

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Interventions

BEHAVIORALimprovement acute reperfusion treatment quality for stroke through spatiotemporal computing

1. Intelligent bracelet automatic positioning device and data feedback system based on spatiotemporal computing technology 2. Continuous in-hospital procedure improvement based on P-D-C-A cycle for AIS


Locations(1)

WuQing People's Hospital

Tianjin, Tianjin Municipality, China

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NCT06330051


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