The Improve Acute Reperfusion Treatment Quality for Ischemic Stroke Through Spatiotemporal Computing in China — IMPROVE-II  

Acute Ischemic Stroke Clinical Trial

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

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

This study intends to construct the goal-oriented integrated intervention model, namely the preset first aid of acute ischemic stroke (AIS) process is the key time node in the target, through the intelligent bracelet automatic positioning, feedback system with real-time data as the carrier, through the P (Plan)-D (Do)-C (Check)-A (Act) cycle for continuous improvement, so as to shorten the delay time of reperfusion therapy and improve the rate of intravenous thrombolysis in AIS patients.

Then a multicenter, evaluator-blind, cluster-randomized controlled study aims to verify the validity and safety of this FAST model. This study will recruit 20 secondary or tertiary hospitals that meet the inclusion criteria, mainly distributed in the Beijing-Tianjin-Hebei-Shanxi-Neimenggu region. After 2 months of baseline information collection, 10 hospitals will be selected and then randomly assigned to the control and intervention groups. Then, the intervention groups will install intelligent bracelet automatic positioning device and data feedback system based on spatiotemporal computing for 2 months. We will conduct training to ensure that only trained caregivers and researchers master the use of the application to maintain the integrity of the intervention, and all participants in the study will maintain the conventional procedure during this period. The FAST model intervention based on spatiotemporal computing technology should be uniformly started after installation and training in each intervention group hospital. As the knowledge gained from the training may affect the identification of AIS patients, the duration of the training will keep as short as possible, and the data collected during the time period receiving the training is not used for final analysis, in an effort to reduce possible contamination of the data. The intervention group will receive continuous intervention with a goal-oriented integrated intervention model based the spatiotemporal computing technology for 6 months and collect information, mainly the critical time information of the AIS reperfusion therapy process. In the control group, only information will be collected.

We will compare the critical treatment time information, Door to Needle time and Door to Puncture time, etc., between the two groups and conduct a 3-month follow-up. ;

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

• NCT number: NCT06330051
• Study type: Interventional
• Source: Beijing Tiantan Hospital
• Contact: Zixiao Li, MD
• Phone: 00861067013383
• Email: lizixiao2008@hotmail.com
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 18, 2024
• Completion date: April 20, 2025