Human vs Machine: a RCT Comparing Traditional In-person Instruction, AI Versus VR for Learning Basic CCE

Human vs Machine: a Randomised Controlled Trial Comparing Traditional In-person Instruction, Artificial Intelligence Versus Virtual Reality for Learning Basic Critical Care Echocardiography

The aim of the study is to investigate if hands-on training for basic CCE with virtual reality simulators or guided by artificial intelligence is non-inferior to training by an experienced instructor.

Study Overview

• Status: Recruiting
• Conditions: Ultrasound
• Intervention / Treatment: Other: AI enabled ultrasound system for self-directed learning; Other: Simulator for self-directed learning; Other: traditional with human instructors

Detailed Description

Basic (Level 1) Critical care echocardiography (CCE) involves using an ultrasound device to qualitatively assess the heart at the bedside. It is increasingly being used at the bedside for diagnostics and screening of key differential diagnoses. Increasingly, CCE is being taught to more medical staff from many fields in medicine, including emergency medicine, anaesthesiology, intensive care medicine and even family medicine. There is a wealth of learning resources online but access to direct supervision by trainers and in-person courses is can be limited and costly. At the time of the study, one local medical school incorporated a lecture there is no credentialling pathway within local medical schools or institution. There has been increasing use of machine learning in medical imaging and deep learning algorithms are now able to guide image acquisition and allow novices with minimal training in echocardiography to obtain diagnostic-quality images. Artificial intelligence (AI) in echocardiography may improve image by novices. Ultrasound hardware that implement machine learning software in real-time can help with structure detection and identification, but more studies are needed to determine the extent that AI impacts learning.

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yie H Lau; Phone Number: 6563577771; Email: yie_hui_lau@ttsh.com.sg

Study Locations

• Singapore
  • Singapore, Singapore, 319581
    • Recruiting
    • Tan Tock Seng Hospital
    • Contact: Yie H Lau; Phone Number: 6563577771; Email: yie_hui_lau@ttsh.com.sg
    • Principal Investigator: Yie H Lau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Medical students will have limited clinical exposure to critical care echocardiography
• above the age of 21 years

Exclusion Criteria:

• prior attendance of a critical care echocardiography courses or
• refusal to participate in the study or complete both hands on sessions

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 22 medical students (AI); medical students randomised to this arm	Other: AI enabled ultrasound system for self-directed learning; use of the AI enabled ultrasound system for self-directed learning; Other Names: AI-enabled ultrasound system (Kosmos(TM))
Active Comparator: 22 medical students (Simulator); medical students randomised to this arm	Other: Simulator for self-directed learning; use of the simulator for self-directed learning
Active Comparator: 22 medical students (control); medical students randomised to this arm	Other: traditional with human instructors; Medical students who are randomised to this arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in image acquisition and structure identification at the end of 3 months.	The images acquired during that timeframe will be scored using the validated Rapid Assessment of Competency in Echocardiography Scale. The experienced CCE trainer who will score the subject will be blinded to which arm of the study the subject is in	3 months

Collaborators and Investigators

• Sponsor: Tan Tock Seng Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 4, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: April 4, 2024
• First Submitted That Met QC Criteria: April 8, 2024
• First Posted (Actual): April 9, 2024

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 8, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: artificial intelligence, echocardiography, POCUS
• Other Study ID Numbers: DSRB 2023/00640

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: local PDPA and data sharing rules

Drug and device information, study documents

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