Ali Pay Intelligent Navigation Applet-aided Pre-hospital Triage for Non-emergency Medical Service Patients With Acute Ischemic Stroke (i-Path)

Ali Pay Intelligent Navigation Applet-aided Pre-hospital Triage for Non-emergency Medical Service Patients With Acute Ischemic Stroke: A Step-wedge Cluster Randomized Controlled Trial

According to the Bigdata Observatory platform for Stroke of China (BOSC), the proportion of patients with acute ischemic stroke (AIS) receiving intravenous thrombolysis or endovascular treatment in China is 5.64% and 1.45% respectively. One of the important reasons for the low treatment rate is the prolonged pre-hospital and in-hospital delay. Besides, for patients receiving reperfusion therapy, the prolonged pre-treatment delay is associated with unfavorable functional outcomes.

Although tons of efforts have been made to improve the efficiency of emergency medical system in the transportation of patients with AIS, little attention has been paid to patients who arrived at hospitals on their owns, which occupying approximately 2/3 of emergency patients. This leaves a huge gap in the pre-hospital management of patietns with AIS.

Therefore, the investigators plan to develop an intelligent navigation system for patients with AIS. For the convenience of public use, this system was carried on the applet of Ali Pay, which has over 1.1 billion users in China. This system comprises of three functional modules, namely stroke knowledge education, stroke recognition and hospital recommendation. The investigators aim to explore whether this intelligent navigatino system could shorten pre-hospital delay and improve functional outcomes of patients with AIS undergoing reperfusion therapy.

Study Overview

• Status: Recruiting
• Conditions: Acute Ischemic Stroke
• Intervention / Treatment: Device: Ali Pay intelligent navigation applet

Detailed Description

According to the Bigdata Observatory platform for Stroke of China (BOSC), the proportion of patients with acute ischemic stroke (AIS) receiving intravenous thrombolysis or endovascular treatment in China is 5.64% and 1.45% respectively. One of the important reasons for the low treatment rate is the prolonged pre-hospital and in-hospital delay. Besides, for patients receiving reperfusion therapy, the prolonged pre-treatment delay is associated with unfavorable functional outcomes.

Although tons of efforts have been made to improve the efficiency of emergency medical system in the transportation of patients with AIS, little attention has been paid to patients who arrived at hospitals on their owns, which occupying approximately 2/3 of emergency patients. This leaves a huge gap in the pre-hospital management of patietns with AIS.

Therefore, the investigators plan to develop an intelligent navigation system for patients with AIS. For the convenience of public use, this system was carried on the applet of Ali Pay, which has over 1.1 billion users in China. This system comprises of three functional modules, namely stroke knowledge education, stroke recognition and hospital recommendation.The investigators aim to explore whether this intelligent navigatino system could shorten pre-hospital delay and improve functional outcomes of patients with AIS undergoing reperfusion therapy.

• Study Type: Interventional
• Enrollment (Estimated): 20000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Min Lou, PhD, MD; Phone Number: 86057187783777; Email: lm99@zju.edu.cn

Study Locations

• China
  • Zhejing
    • Shaoxing, Zhejing, China, 312000
      • Recruiting
      • Shaoxing People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients diagnosed as acute ischemic stroke undergoing reperfusion therapy within 24 hours of onset

Exclusion Criteria:

• Patients transported to hospitals via emergency medical service
• Patients with in-hospital stroke

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ali Pay intelligent navigation applet group; Patients in regions with Ali Pay intelligent navigation applet being released would be classified as experimental arm. In this arm, patients have access to this applet. The intelligent navigation applet comprises of three function modules: Stroke knowledge public education: information regarding prevention and emergency treatment of stroke would be push to users' mobile phones regularly;; Stroke recognition: questionaires, voice interaction, and facial recognition are employed to identify patients with AIS and large vessel occlusion;; Hospital recommendation: this module combines real-time traffic and average in-hopital delay of each stroke center nearby, recommending the stroke center in which patients are mostly likely to receive reperfusion therapy	Device: Ali Pay intelligent navigation applet; The intelligent navigation applet comprises of three function modules: Stroke knowledge public education: information regarding prevention and emergency treatment of stroke would be push to users' mobile phones regularly;; Stroke recognition: questionaires, voice interaction, and facial recognition are employed to identify patients with AIS and large vessel occlusion;; Hospital recommendation: this module combines real-time traffic and average in-hopital delay of each stroke center nearby, recommending the stroke center in which patients are mostly likely to receive reperfusion therapy
No Intervention: Routine pre-hospital triage; Patients in regions without Ali Pay intelligent navigation applet being released would be classified as control arm. In this arm, patients do not have access to this applet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Modified rankin scale (mRS) scores of 0-2 at 90 days after reperfusion therapy	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified rankin scale (mRS) scores of 0-1 at 90 days after reperfusion therapy		90 days
Modified rankin scale (mRS) scores of 0-3 at 90 days after reperfusion therapy		90 days
Ordinal analysis of modified rankin scale (mRS) scores at 90 days after reperfusion therapy		90 days
Time interval between onset to treatment		1 day
Time interval between onset to hospital		1 day
Proportion of patients receiving reperfusion beyond time window	Intravenous thrombolysis: treatment initiated within 4.5 - 9 hours after onset Mechanical thrombectomy: treatment initiated within 6 - 24 hours after onset	1 day
Proportion of patients receiving mechanical thrombectomy		1 day

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2025
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: September 23, 2024
• First Submitted That Met QC Criteria: September 23, 2024
• First Posted (Actual): September 25, 2024

Study Record Updates

• Last Update Posted (Actual): August 8, 2025
• Last Update Submitted That Met QC Criteria: August 6, 2025
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: reperfusion therapy; pre-hospital triage
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Brain Infarction; Brain Ischemia; Infarction; Necrosis; Ischemic Stroke; Stroke; Cerebral Infarction; Ischemia
• Other Study ID Numbers: i-Path

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No