Surgical EducationNCT04700384
Effectiveness of an Artificial Intelligent Tutoring System in Simulation Training
A study testing Virtual Operative Assistant Training and Remote-Based Expert Instructor Training in people with Surgical Education, run by McGill University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Surgical Education
- What is being tested?
- Virtual Operative Assistant Training and Remote-Based Expert Instructor Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteCanada
- Study dates
- 15 Jan 2021to 15 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
-
Trial locations and contacts
1 site in 1 country.
Canada1 site
Neurosurgical Simulation and Artificial Intelligence Learning Centre
Montreal, Quebec, H3A 2B4
About this study
Official title: Comparing the Virtual Operative Assistant to Expert-based Instruction in Surgical Education: A Randomized Controlled Trial
Brief Summary:
Background:
Read more
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
Read the 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:
- 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.
- Conditions
- Surgical Education
- Being tested
- Virtual Operative Assistant Training, Remote-Based Expert Instructor Training
- Keywords
- Virtual Reality, Simulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Operative Assistant TrainingBehavioural
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 TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | 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 Group - Virtual Operative Assistance Training | Experimental | 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. Receives: Behavioral: Virtual Operative Assistant Training |
| Experimental Group - remote-based expert Instructor Training | Experimental | 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. Receives: Behavioral: Remote-Based Expert Instructor Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in procedural performance .
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.
Measured: Day of Study
Change in learning
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.
Measured: Day of Study
Secondary outcomes (2)
Difference in the strength of emotions elicited
Measured using Duffy's Medical Emotions Scale (MES), before, during and after the intervention.
Measured: Day of Study
Difference in cognitive load
Measured using Leppink's Cognitive Load Index (CLI) after the intervention.
Measured: Day of Study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2021
- Study start15 Jan 2021
- Primary completion15 May 2021
- Study completion15 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Surgical EducationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rolando Del Maestro, MD, Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04700384
- Sponsor's protocol ID
- 2010-270, NEU-09-042
- Status last verified
- May 2021
- First submitted
- 6 Jan 2021
- Last updated
- 24 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data obtained from primary and secondary outcomes may be shared if other researchers have an interest in this data
Publications
Birkmeyer JD, Finks JF, O'Reilly A, Oerline M, Carlin AM, Nunn AR, Dimick J, Banerjee M, Birkmeyer NJ; Michigan Bariatric Surgery Collaborative. Surgical skill and complication rates after bariatric surgery. N Engl J Med. 2013 Oct 10;369(15):1434-42. doi: 10.1056/NEJMsa1300625.
PubMed 24106936Birkmeyer JD, Stukel TA, Siewers AE, Goodney PP, Wennberg DE, Lucas FL. Surgeon volume and operative mortality in the United States. N Engl J Med. 2003 Nov 27;349(22):2117-27. doi: 10.1056/NEJMsa035205.
PubMed 14645640Stulberg JJ, Huang R, Kreutzer L, Ban K, Champagne BJ, Steele SR, Johnson JK, Holl JL, Greenberg CC, Bilimoria KY. Association Between Surgeon Technical Skills and Patient Outcomes. JAMA Surg. 2020 Oct 1;155(10):960-968. doi: 10.1001/jamasurg.2020.3007.
PubMed 32838425Winkler-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.
PubMed 31373651Mirchi N, Bissonnette V, Yilmaz R, Ledwos N, Winkler-Schwartz A, Del Maestro RF. The Virtual Operative Assistant: An explainable artificial intelligence tool for simulation-based training in surgery and medicine. PLoS One. 2020 Feb 27;15(2):e0229596. doi: 10.1371/journal.pone.0229596. eCollection 2020.
PubMed 32106247Winkler-Schwartz A, Marwa I, Bajunaid K, Mullah M, Alotaibi FE, Bugdadi A, Sawaya R, Sabbagh AJ, Del Maestro R. A Comparison of Visual Rating Scales and Simulated Virtual Reality Metrics in Neurosurgical Training: A Generalizability Theory Study. World Neurosurg. 2019 Jul;127:e230-e235. doi: 10.1016/j.wneu.2019.03.059. Epub 2019 Mar 15.
PubMed 30880209Duffy, M.C., et al., Emotions in medical education: Examining the validity of the Medical Emotion Scale (MES) across authentic medical learning environments. Learning and Instruction, 2020. 70: p. 101150.
Leppink J, Paas F, Van der Vleuten CP, Van Gog T, Van Merrienboer JJ. Development of an instrument for measuring different types of cognitive load. Behav Res Methods. 2013 Dec;45(4):1058-72. doi: 10.3758/s13428-013-0334-1.
PubMed 23572251Fazlollahi AM, Bakhaidar M, Alsayegh A, Yilmaz R, Winkler-Schwartz A, Mirchi N, Langleben I, Ledwos N, Sabbagh AJ, Bajunaid K, Harley JM, Del Maestro RF. Effect of Artificial Intelligence Tutoring vs Expert Instruction on Learning Simulated Surgical Skills Among Medical Students: A Randomized Clinical Trial. JAMA Netw Open. 2022 Feb 1;5(2):e2149008. doi: 10.1001/jamanetworkopen.2021.49008.
PubMed 35191972
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Virtual Operative Assistant to Expert-based Instruction in Surgical Education: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04700384
- Acronym / sponsor ID
- 2010-270, NEU-09-042
- Conditions
- Surgical Education
- Keywords
- Virtual Reality, Simulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 15 May 2021 (actual)
- Study completion
- 15 May 2021 (actual)
- First posted
- 7 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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:
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –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 Group - Virtual Operative Assistance Training | Experimental | Behavioral: Virtual Operative Assistant TrainingExperimental 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. |
| Experimental Group - remote-based expert Instructor Training | Experimental | Behavioral: Remote-Based Expert Instructor Training25 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Operative Assistant TrainingIndividuals 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. | Behavioural | Experimental Group - Virtual Operative Assistance Training |
| Remote-Based Expert Instructor TrainingIndividuals 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. | Behavioural | Experimental Group - remote-based expert Instructor Training |
Primary outcome
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.
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.
2 secondary outcomes
Difference in the strength of emotions elicited
Time frame: Day of Study
Difference in cognitive load
Time frame: Day of Study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2021.
- Background: PubMed 24106936Birkmeyer JD, Finks JF, O'Reilly A, Oerline M, Carlin AM, Nunn AR, Dimick J, Banerjee M, Birkmeyer NJ; Michigan Bariatric Surgery Collaborative. Surgical skill and complication rates after bariatric surgery. N Engl J Med. 2013 Oct 10;369(15):1434-42. doi: 10.1056/NEJMsa1300625.
- Background: PubMed 14645640Birkmeyer JD, Stukel TA, Siewers AE, Goodney PP, Wennberg DE, Lucas FL. Surgeon volume and operative mortality in the United States. N Engl J Med. 2003 Nov 27;349(22):2117-27. doi: 10.1056/NEJMsa035205.
- Background: PubMed 32838425Stulberg JJ, Huang R, Kreutzer L, Ban K, Champagne BJ, Steele SR, Johnson JK, Holl JL, Greenberg CC, Bilimoria KY. Association Between Surgeon Technical Skills and Patient Outcomes. JAMA Surg. 2020 Oct 1;155(10):960-968. doi: 10.1001/jamasurg.2020.3007.
- Background: PubMed 31373651Winkler-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.
- Background: PubMed 32106247Mirchi N, Bissonnette V, Yilmaz R, Ledwos N, Winkler-Schwartz A, Del Maestro RF. The Virtual Operative Assistant: An explainable artificial intelligence tool for simulation-based training in surgery and medicine. PLoS One. 2020 Feb 27;15(2):e0229596. doi: 10.1371/journal.pone.0229596. eCollection 2020.
- Background: PubMed 30880209Winkler-Schwartz A, Marwa I, Bajunaid K, Mullah M, Alotaibi FE, Bugdadi A, Sawaya R, Sabbagh AJ, Del Maestro R. A Comparison of Visual Rating Scales and Simulated Virtual Reality Metrics in Neurosurgical Training: A Generalizability Theory Study. World Neurosurg. 2019 Jul;127:e230-e235. doi: 10.1016/j.wneu.2019.03.059. Epub 2019 Mar 15.
- BackgroundDuffy, M.C., et al., Emotions in medical education: Examining the validity of the Medical Emotion Scale (MES) across authentic medical learning environments. Learning and Instruction, 2020. 70: p. 101150.
- Background: PubMed 23572251Leppink J, Paas F, Van der Vleuten CP, Van Gog T, Van Merrienboer JJ. Development of an instrument for measuring different types of cognitive load. Behav Res Methods. 2013 Dec;45(4):1058-72. doi: 10.3758/s13428-013-0334-1.
- Derived from this study: PubMed 35191972Fazlollahi AM, Bakhaidar M, Alsayegh A, Yilmaz R, Winkler-Schwartz A, Mirchi N, Langleben I, Ledwos N, Sabbagh AJ, Bajunaid K, Harley JM, Del Maestro RF. Effect of Artificial Intelligence Tutoring vs Expert Instruction on Learning Simulated Surgical Skills Among Medical Students: A Randomized Clinical Trial. JAMA Netw Open. 2022 Feb 1;5(2):e2149008. doi: 10.1001/jamanetworkopen.2021.49008.
- Individual participant dataSharing planned: Yes. Data obtained from primary and secondary outcomes may be shared if other researchers have an interest in this data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rolando Del Maestro, MD principal investigator
McGill University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Operative Assistant Training and Remote-Based Expert Instructor Training in people with Surgical Education, run by McGill University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in procedural performance . (time frame: Day of Study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04700384, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2021.