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

NCT ID: NCT06330051

Last Updated: 2025-06-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1280 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-18
• Study Completion Date: 2025-09-18

Brief 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.

Detailed 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 3 months of baseline information collection, 20 hospitals will be randomly assigned to the control and intervention groups. Then, the intervention group will install intelligent bracelet automatic positioning device and data feedback system based on spatiotemporal computing for 4 months. 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. 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. During this 4-month period, both the control group and the intervention group will cease data collection, entering a phase of silence in the study. The FAST model intervention based on spatiotemporal computing technology will uniformly start after installation and training in each intervention group hospital. The intervention group will receive continuous intervention with a goal-oriented integrated intervention model based the spatiotemporal computing technology for 8 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.

Conditions

Acute Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Improvement intervention

receive the following continuous improvement intervention for 8months

Group Type: EXPERIMENTAL

improvement acute reperfusion treatment quality for stroke through spatiotemporal computing

Intervention Type: BEHAVIORAL

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

Control group

Only information will be collected.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

improvement 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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

Hospitals#

1. Secondary or tertiary public hospitals with an emergency department that receive patients with AIS.

2. Admit at least 50 patients of AIS within 4.5 hours after onset each month.

3. Have the capacity of intravenous thrombolytic therapy or/and endovascular treatment.

4. Voluntarily participate in this research and cooperate with the installation of bluetooth positioning device and the improvement of AIS emergency procedures.

5. Have good cooperation relationship among the department of Neurology, Emergency, Interventional department, Neurosurgery department, Laboratory department and Radiology department.

6. 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 Criteria

Hospitals#

1. Hospital that unable to cooperate and complete the research.

2. Hospitals that are participating in other AIS medical quality improvement projects or related clinical trials.

Patients#

1. Patients refuse to sign informed consent and follow up until 3 months after stroke onset.

2. 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.)

3. Life expectancy three-months or less by judgment of the investigator.

4. Participation in any interventional study that may affect the outcome

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Tiantan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zi-Xiao Li

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

WuQing People's Hospital

Tianjin, Tianjin Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zixiao Li, MD

Role: CONTACT

lizixiao2008@hotmail.com

00861067013383

Yongjun Wang, MD

Role: CONTACT

Facility Contacts

Zhi-Tie Han

Role: primary

1261998270@qq.com

86-13512996102

Other Identifiers

KY 2023-184-02

Identifier Type: -

Identifier Source: org_study_id