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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Ischemic Stroke
• Intervention / Treatment: Behavioral: improvement acute reperfusion treatment quality for stroke through spatiotemporal computing

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 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.

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zixiao Li, MD; Phone Number: 00861067013383; Email: lizixiao2008@hotmail.com
• Study Contact Backup: Name: Yongjun Wang, MD

Participation Criteria

Eligibility Criteria

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

Description

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

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: Improvement intervention; receive the following continuous improvement intervention for 6 months	Behavioral: improvement acute reperfusion treatment quality for stroke through spatiotemporal computing; Intelligent bracelet automatic positioning device and data feedback system based on spatiotemporal computing technology; Continuous in-hospital procedure improvement based on P-D-C-A cycle for AIS
No Intervention: Control group; Only information will be collected.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	mRS 0-1	Participants will be followed for 3 month after stroke onset.
Proportion of patients with 90-day independent functional outcome.	mRS 0-2	Participants will be followed for 3 month after stroke onset.
in-hospital mortality		Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
90-day mortality		Participants will be followed for 3 month after stroke onset.

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 18, 2024
• Primary Completion (Estimated): March 18, 2025
• Study Completion (Estimated): April 20, 2025

Study Registration Dates

• First Submitted: March 19, 2024
• First Submitted That Met QC Criteria: March 19, 2024
• First Posted (Actual): March 26, 2024

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: endovascular treatment; ischemic stroke; intravenous thrombolysis; medical quality; spatiotemporal computing
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Infarction; Brain Infarction; Stroke; Ischemic Stroke; Ischemia; Cerebral Infarction
• Other Study ID Numbers: KY 2023-184-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No