Effectiveness of an Artificial Intelligent Tutoring System in Simulation Training

Sponsor
McGill University (Other)
Overall Status
Completed
CT.gov ID
NCT04700384
Collaborator
(none)
70
1
3
3.9
17.8

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Virtual Operative Assistant Training
  • Behavioral: Remote-Based Expert Instructor Training
N/A

Detailed Description

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:

  1. the VOA intelligent tutoring system (Group 2) or

  2. a remote-based expert instructor (Group 3)

Both compared to:
  1. 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized Controlled TrialRandomized Controlled Trial
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
Participants will not know the purpose of trial
Primary Purpose:
Health Services Research
Official Title:
Comparing the Virtual Operative Assistant to Expert-based Instruction in Surgical Education: A Randomized Controlled Trial
Actual Study Start Date :
Jan 15, 2021
Actual Primary Completion Date :
May 15, 2021
Actual Study Completion Date :
May 15, 2021

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control Group

Control Group - Baseline Training 25 Participants allocated. Individuals receive introductory information on using the simulator and the scenario. They perform 5 simple subpial tumour resections for practice and have 5 minutes per trial. After each attempt, the student takes a 5-minute break with no assessment or feedback on their performance. On their 6th attempt they have 13 minutes to perform a different realistic scenario.

Experimental: Experimental Group - Virtual Operative Assistance Training

Experimental Group - Virtual Operative Assistance Training 25 participants allocated. Individuals receive the same 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 Assistance Training assessment of their performance and audiovisual feedback.

Behavioral: Virtual Operative Assistant Training
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.

Experimental: Experimental Group - remote-based expert Instructor Training

25 participants allocated. 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.

Behavioral: Remote-Based Expert Instructor Training
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.

Outcome Measures

Primary Outcome Measures

  1. Change in procedural performance . [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 [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 Outcome Measures

  1. Difference in the strength of emotions elicited [Day of Study]

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

  2. Difference in cognitive load [Day of Study]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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.

-

Contacts and Locations

Locations

Site City State Country Postal Code
1 Neurosurgical Simulation and Artificial Intelligence Learning Centre Montreal Quebec Canada H3A 2B4

Sponsors and Collaborators

  • McGill University

Investigators

  • Principal Investigator: Rolando Del Maestro, MD, McGill

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
McGill University
ClinicalTrials.gov Identifier:
NCT04700384
Other Study ID Numbers:
  • 2010-270, NEU-09-042
First Posted:
Jan 7, 2021
Last Update Posted:
May 24, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by McGill University

Study Results

No Results Posted as of May 24, 2021