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

NCT06330051 | Completed

• 1 other identifier: KY 2023-184-02
• Study Type: interventional
• Target: 2,219
• Locations: 1 country
• Sites: 1

Brief Summary

This study intends to construct the goal-oriented integrated intervention model through the intelligent bracelet automatic positioning and feedback system based spatiotemporal computing technology (FAST model) to promote the reconstruction of workflow in stroke centers and to shorten in-hospital delay of reperfusion treatment for AIS patients. This is a multicenter, cluster-randomized controlled study aims to verify the efficacy and safety of the FAST model.

Conditions

Acute Ischemic Stroke

Keywords

ischemic stroke; intravenous thrombolysis; endovascular treatment; medical quality; spatiotemporal computing

Outcome Measures

Primary Outcomes (1)

• The Door to Needle time (DNT) for intravenous thrombolytic therapy in eligible patients within 4.5 hours of onset.

  Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.

Secondary Outcomes (8)

• The Door to Puncture time (DPT) for endovascular treatment within 6 hours of onset in eligible patients admitted to hospital within 4.5 hours of onset.

  Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.

• The rate of intravenous thrombolytic therapy in eligible patients within 4.5 hours of onset.

  Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.

• The rate of endovascular treatment within 6 hours of onset in eligible patients admitted to hospital within 4.5 hours of onset.

  Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.

• Incidence of symptomatic intracranial hemorrhage (sICH) within 36 hours of receiving reperfusion therapy.

  Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.

• Proportion of patients with 90-day favorable functional outcome.

  Participants will be followed for 3 month after stroke onset.

Study Arms (2)

Improvement intervention

EXPERIMENTAL

receive the following continuous improvement intervention for 8months

Behavioral: The goal-oriented integrated intervention model through the intelligent bracelet automatic positioning and feedback system based spatiotemporal computing technology (FAST model)

Control group

NO INTERVENTION

Only information will be collected.

Interventions

The goal-oriented integrated intervention model through the intelligent bracelet automatic positioning and feedback system based spatiotemporal computing technology (FAST model) BEHAVIORAL

Spatiotemporal computing technology: Spatiotemporal positioning devices are installed in the emergency environment of the intervention hospitals in advance. Duration at each node of AIS patients wearing an intelligent bracelet will be calculated and displayed via the "Green Fast" mobile application. Time Target: According to the standardized procedure, we will preset the target times at the key nodes of reperfusion therapy workflow in the system in advance. Alert: Reminders or alerts will be triggered if duration at the node exceeds predefined targets. Feedback: The system is equipped with procedure feedback function to managers and users. The teams of intevention hospital will organize periodic regular meetings weekly and trial management group will participate in the meetings every two weeks. Using the data provided by the "Green Fast", problems existing in the treatment workflow will be identified and solved. A continuous PDCA cycle will be conducted for quality improvement.

Improvement intervention

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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 (Defined as no measurable neurologic deficit, or NIHSS≤3 with only one of the following isolated symptoms: 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

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

WuQing People's Hospital

Tianjin, Tianjin Municipality, 301799, 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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: After 3 months of baseline information collection, 20 hospitals will be randomly assigned to the control and intervention groups according to baseline DNT to reduce the imbalance between the two groups. We will not indicate to any hospital the grouping type of other hospitals. If the selected hospital is unable to complete the study for some reason during the operation, the hospital will be replaced with an eligible hospital of the same capacity. Masking of study and hospital personnel to assignment will be not possible because of the nature of the intervention. However, centralized follow-up interviewers assigned to assess the follow outcomes will be masked.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: March 26, 2024
• Study Start: March 18, 2024
• Primary Completion: October 13, 2025
• Study Completion: January 13, 2026
• Last Updated: June 29, 2026

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)