Testing the Efficacy of an Artificial Intelligence Real-Time Coaching SystemSystemSimulatioTraining of Medical Students
1 other identifier
interventional
98
1 country
1
Brief Summary
Background: Trainees learn surgical technical skills through apprenticeship model working closely with surgeons and given increased responsibility in patient cases under expert supervision. However, factors such as surgeons' busy schedule, number of available patient cases, patient safety and lack of objectivity and standardization in training pose strong limitations. Virtual reality surgical simulators integrated with artificial intelligence (AI) systems provide a standardized realistic simulation environment and detailed performance data that allows accurate quantitation of surgical skills and tailored feedback. These platforms make repetitive practice of surgical skills possible in a risk-free environment. The Intelligent Continuous Monitoring System (ICEMS), a deep learning application integrated in NeuroVR simulation platform, was developed to assess surgical performance continuously in 0.2 second intervals and provide coaching and risk detection. Although a predictive validity for assessment module was provided previously, the effectiveness of real-time coaching and risk detection ability with this AI system remains to be explored. The objective of this study is to compare the error-oriented intelligent feedback provided by the ICEMS to in-person expert instruction in surgical simulation training by monitoring the improvement of medical student technical skills on a series of virtual reality tumor resection tasks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 20, 2021
CompletedFirst Posted
Study publicly available on registry
December 23, 2021
CompletedStudy Start
First participant enrolled
January 5, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 3, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 3, 2022
CompletedAugust 8, 2022
August 1, 2022
4 months
December 20, 2021
August 4, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in performance
Performance will be measured using the composite-score assessed by the ICEMS system
1 Day of Study
Transfer of learning
Performance on the complex realistic scenario will be evaluated by the composite-score assessed by the ICEMS system.
1 Day of Study
Secondary Outcomes (3)
Objective Structured Assessment of Technical Skills (OSATS) global rating scale
1 Day of Study
Differences in strength of emotions elicited
1 Day of Study
Difference in Cognitive Load
1 Day of study
Study Arms (3)
Control Group No-expert mediated post hoc benchmark group
NO INTERVENTION30 participants. Individuals receive identical introductory information,same time, to perform, same scenarios as other groups. Students receive their scores on 5 performance metrics compared to expert performance benchmarks. Scores are presented in the 5 minute breaks between tasks. Student goal is to be within the benchmark in all five metrics.
Experimental Group - Intelligent Continuous Expertise Monitoring System group
EXPERIMENTAL30 Participants. Introductory information provided on simulator and scenario. They perform 5 simple practice subpial tumor resections with 5 minutes per trial. On 6th attempt 13 minutes to perform a complex realistic scenario. During first practice task, participants receive no feedback. For the subsequent 4 practice tasks participants will receive real-time auditory feedback instruction by the intelligent system. After each of the 5 attempts, a student takes a 5-minute break. During each of the 5 breaks the participants will be shown the errors they made during the task by the intelligent system regarding five performance metrics monitored. After seeing each error outline, the participant will be shown a video demonstration to learn how to expertly perform on each performance metric. On their 6th attempt they will perform on the realistic scenario without any feedback given.
Experimental Group In-person expert-mediated instruction group
EXPERIMENTAL30 Participants. Introductory information provided on simulator and scenario. They perform 5 simple practice subpial tumor resections with 5 minutes per trial. On 6th attempt 13 minutes to perform a complex realistic scenario. During first practice task participants receive no feedback. For the subsequent 4 practice tasks participants receive real-time auditory feedback instruction by in-person expert during the task. After each of the 5 tasks, students takes a 5-minute break. During each of the 5 breaks the in-person expert provides feedback to the participant based on their OSATS score assessment during the previous trial. If the expert feels it is appropriate the expert will demonstrate how to do the specific procedure which has been found to be a concern on the simulator themselves so the participant can understand how to improve their performance. On their 6th attempt they will perform on the realistic scenario without any feedback given.
Interventions
During each of the practice task they will receive real-time auditory feedback instructed by the intelligent system. After each attempt, a student takes a 5-minute break. They will be shown the errors they made during the task regarding five performance metrics. After seeing each error, they will be shown video demonstration to learn how to expertly perform at each performance metrics. On their 6th attempt they will perform on the realistic scenario without any feedback given.
During each of the practice task, students will receive verbal feedback from the expert instructor present in the room. After each task, experts will summarize their performance and outline the errors the student made. Based on the student's performance, expert will demonstrate how to expertly perform the task in the simulation, and how to improve their performance in the next attempt. Students will perform the 6th attempt on the realistic scenario without any instruction given.
Eligibility Criteria
You may not qualify if:
- Participation in previous trials involving the NeuroVR (CAE Healthcare) simulator.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Montreal Neurological Institute and Hospital
Montreal, Quebec, H3A 2B4, Canada
Related Publications (4)
Delorme S, Laroche D, DiRaddo R, Del Maestro RF. NeuroTouch: a physics-based virtual simulator for cranial microneurosurgery training. Neurosurgery. 2012 Sep;71(1 Suppl Operative):32-42. doi: 10.1227/NEU.0b013e318249c744.
PMID: 22233921BACKGROUNDBrightwell A, Grant J. Competency-based training: who benefits? Postgrad Med J. 2013 Feb;89(1048):107-10. doi: 10.1136/postgradmedj-2012-130881. Epub 2012 Sep 27.
PMID: 23019588BACKGROUNDChan J, Pangal DJ, Cardinal T, Kugener G, Zhu Y, Roshannai A, Markarian N, Sinha A, Anandkumar A, Hung A, Zada G, Donoho DA. A systematic review of virtual reality for the assessment of technical skills in neurosurgery. Neurosurg Focus. 2021 Aug;51(2):E15. doi: 10.3171/2021.5.FOCUS21210.
PMID: 34333472BACKGROUNDWinkler-Schwartz A, Yilmaz R, Mirchi N, Bissonnette V, Ledwos N, Siyar S, Azarnoush H, Karlik B, Del Maestro R. Machine Learning Identification of Surgical and Operative Factors Associated With Surgical Expertise in Virtual Reality Simulation. JAMA Netw Open. 2019 Aug 2;2(8):e198363. doi: 10.1001/jamanetworkopen.2019.8363.
PMID: 31373651BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Rolando Del Maestro, MD
McGill
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- Double (Participant and Expert Rater) Participants do not know the performance metrics used in calculation of their final composite-score, only that they will be learning and practicing technical skills used in neurosurgery while receiving feedback from an instructor or an intelligent system, in subpial tumor resection procedures. Experts do not know to which group the video performance they are rating belongs, for the OSATS rating.
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Neurosurgical Simulation and Artificial Intelligence Learning Centre
Study Record Dates
First Submitted
December 20, 2021
First Posted
December 23, 2021
Study Start
January 5, 2022
Primary Completion
May 3, 2022
Study Completion
May 3, 2022
Last Updated
August 8, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- Data will be available for 5 years after completion of trial.
- Access Criteria
- Researchers wanting access to the data will need to contact the principal investigator of the trial. Dr. Rolando Del Maestro
Data obtained from primary and secondary outcomes may be shared if other researchers have an interest in this data.