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OpenTrials
Completed

NCT Number: NCT04700384

Effectiveness of an Artificial Intelligent Tutoring System in Simulation Training

Brief Summary:

Background:

Although surgical experience and technical skill are associated with better patient outcomes, quantitating surgical ability in the operating room is challenging. In surgical education, large datasets generated by high-fidelity virtual reality simulators can be employed by machine learning algorithms to objectively measure trainee performance and competence on expert benchmarks. This allows repetitive practice of surgical skills in safe and risk-free environments with immediate feedback.

Our group developed and has a patent pending for an intelligent tutoring system called the Virtual Operative Assistant (VOA). Utilizing an Artificial Intelligence (AI) support vector machine algorithm, the VOA assesses data derived from the NeuroVR (CAE Healthcare) simulator platform and provides individualized audiovisual feedback to improve learner performance during simulated brain tumor resections. The effectiveness of intelligent tutoring systems such as the VOA to the human surgical apprenticeship pedagogy remains to be elucidated.

The aim of this study is to compare the effectiveness and educational impact of personalized VOA feedback to expert instruction on medical student's technical skills learning of a virtual reality tumor resection procedure.

Specific Aims: 1) To assess if medical students receiving personalized VOA feedback statistically improve their surgical performance when compared to those having (a) no expert instructor feedback or (b) expert instructor-mediated feedback. 2) To outline if different emotions are elicited by the VOA intelligent tutoring system in medical students while performing this achievement task as compared to human instruction

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Key information

Conditions

Surgical Education

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Neurosurgical Simulation and Artificial Intelligence Learning Centre

Montreal, Quebec, H3A 2B4, Canada

About this study

Design: A three-arm partially blinded randomized controlled trial of VOA training versus remote-based expert instruction versus control.

Setting: Neurosurgical Simulation and Artificial Intelligence Learning Centre, Montreal Neurological Institute.

Participants: Eligible first- and second-year medical students from across the province of Quebec.

Task: Complete removal of a simulated tumour - distinguishable by colour and haptic properties - with minimal bleeding and damage to surrounding healthy brain using two surgical instruments (Cavitron Ultrasonic Aspirator and Bipolar pincers) of the NeuroVR (CAE Healthcare) surgical simulator.

Intervention: A single 75-minute training session, including six virtual subpial tumour resection attempts (five simple practice scenarios and one complex realistic scenario) with assessment and feedback from either:

  • the VOA intelligent tutoring system (Group 2) or
  • a remote-based expert instructor (Group 3)

Both compared to:

  • control group (Group 1) that receives no assessment or performance feedback.

To our knowledge this will be the first study to compare the effectiveness of an AI-powered intelligent tutoring system to expert instruction in the context of medical and surgical virtual reality simulation and assess the emotional response to such instruction. This study aims to begin to identify successful approaches to use this innovative technology in the medical educational curriculum and improve patient outcomes by augmenting safety, efficiency and competency of surgeons and other healthcare providers.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

• First- and second-year medical students from any Canadian institution who do not meet the exclusion criteria.

-

Exclusion criteria

• Participation in any of our group's previous trials involving the NeuroVR (CAE Healthcare) simulator.

-

Treatment and study plan

Virtual Operative Assistant Training

Behavioral

Individuals receive the same basic information, have the same amount of time and perform the same scenarios as the control group. In the 5-minutes between attempts, participant receive the Virtual Operative Assistant assessment of their performance and audiovisual feedback.

Remote-Based Expert Instructor Training

Behavioral

Individuals receive the same information, have the same amount of time and perform the same scenarios as the control group. Meanwhile, a trained instructor observes the participant's on-screen performance, that is live-streamed, remotely. Instructors are senior neurosurgery residents with extensive experience in performing and assessing this scenario. During the 5-minute feedback session, they chat with the student, discussing the performance and help in setting goals for the next trial.

Primary outcomes

  1. Change in procedural performance .

    Time frame: Day of Study

    Performance in each practice attempt is measured utilizing raw data from the simulator that is used for assessment by previously established AI algorithms on validated metrics.

  2. Change in learning

    Time frame: Day of Study

    Performance on the complex realistic scenario is evaluated by expert instructors using the Objective Structured Assessments of technical Skills (OSATS) Visual Rating Scale (weighted at 50%) and the AI assessment algorithms (weighted at 50%) creating a composite performance score.

Secondary outcomes

  1. Difference in the strength of emotions elicited

    Time frame: Day of Study

    Measured using Duffy's Medical Emotions Scale (MES), before, during and after the intervention.

  2. Difference in cognitive load

    Time frame: Day of Study

    Measured using Leppink's Cognitive Load Index (CLI) after the intervention.

Sponsors and collaborators

Lead sponsor

McGill University

Other

Registry information

Official study title

Comparing the Virtual Operative Assistant to Expert-based Instruction in Surgical Education: A Randomized Controlled Trial

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 7, 2021
Registry last updated
May 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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