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Surgical EducationNCT06235788

Effect of Intelligent Tutor Induced Pausing on Learning Simulated Surgical Skills

A study testing Experimental Group ICEMS verbal feedback with pause group and Experimental Group ICEMS audio feedback with pause and expert video in people with Surgical Education, run by McGill University at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Traditional training of surgical technical skills relies on mentorship from experienced surgeons, who continuously evaluate and change trainee performance to prevent errors and potential patient harm by providing verbal instructions. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Surgical Education
What is being tested?
Experimental Group ICEMS verbal feedback with pause group and Experimental Group ICEMS audio feedback with pause and expert video
Could I receive a placebo?
No, everyone receives an active treatment
How many people
129 participants
Where
1 siteCanada
Study dates
30 Jan 2024to Sep 2024
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • First and second year medical students who are actively enrolled in any Quebec institution who do not meet the exclusion criteria.
  • Students actively enrolled in medical school in a preparatory year in any Quebec institution who do not meet the exclusion criteria.

Who cannot join

  • Participation in previous trials involving the NeuroVR (CAE Healthcare) simulator

Trial locations and contacts

1 site in 1 country.

Rolando F Del Maestro, MD, PhD contact

519 708 0346

rolando.del_maestro@mcgill.ca

Canada1 site, 1 recruiting
  • Neurosurgical Simulation and Artificial Intelligence Learning Centre

    Montreal, Quebec, H2X 4B3

    Rolando F Del Maestro, MD, PhD, 519 708 0346, rolando.del_maestro@mcgill.ca

    Vanja Davidovic, 6132964855, vanja.davidovic@mail.mcgill.ca

    Recruiting

Other trials in Canada

About this study

Official title: Effect of Intelligent Tutor Induced Pausing on Learning Simulated Surgical Skills Among Medical Students: A Randomized Controlled Trial

Traditional training of surgical technical skills relies on mentorship from experienced surgeons, who continuously evaluate and change trainee performance to prevent errors and potential patient harm by providing verbal instructions. These educators may also pause the procedure, explaining the risks associated with the trainee's actions, and may personally demonstrate proper techniques to the students. Studies examining pausing while providing medical care outline that these approaches allow for learning.

An artificial intelligent (AI) tutoring system, the Intelligent Continuous Expertise Monitoring System (ICEMS), improves learning in a surgical simulated operation by providing trainees with verbal instructions upon error identification. However, the effect of including a pause during this AI teaching has not been studied. Therefore, the ICEMS post-error identification methodology has been altered to include a pause with the intelligent tutor voice instruction.

The aim of this study is to determine the effect of pausing on surgical skill acquisition and transfer among pre-medical and medical students. This will be done by comparing their performance in repeated simulated tumour resection tasks.

Read the detailed description

Background: Surgical skill assessment is shifting from a quantitative, time-based approach towards a qualitative evaluation of a trainee's competency. During surgical procedures, instructors continuously monitor trainee performance and utilize various teaching methods focused on enhancing acquisition of surgical skills. One such method includes pausing the operation, either to outline the risks associated with the trainee's performance or to personally demonstrate the best practice technique(s). Pausing in such situations has been shown to allow learners to re-assess best practice, interrupt negative momentum, and allow for learning. Specifically, pausing after an error can prevent introduction of new information that may affect one's ability to reflect on their error and reduce stress before continuing.

Rationale: The ICEMS, an AI tutoring system, was developed by our group using a Long-Short Term Memory deep learning algorithm to assess surgical performance and provide guidance. This was then integrated with the NeuroVR simulation platform. Using this AI system, the provision of verbal feedback on error identification demonstrated the potential of intelligent tutoring to improve learning in two previous randomized control trials (RCTs). However, these RCTs did not incorporate pausing methodology post-error identification. To further emulate the mentorship of an experienced surgeon in a clinical setting, the ICEMS platform has been modified to both initiate pausing when learner error is identified and provide a video demonstrating expert performance.

Research aims: To compare the effect of incorporating a pause after intelligent tutor instruction to intelligent tutor instruction alone on medical and pre-medical students' surgical skill acquisition and skill transfer.

Hypotheses:

  1. The pause with video group will significantly improve the composite score between the first and sixth repetition of the practice scenario.
  2. The pause with video group will have a composite score statistically higher than the control group in the sixth repetition of the practice scenario.
  3. The pause with video group will have a composite score statistically non-inferior to the pause without video group in the sixth repetition of the practice scenario.
  4. The pause with video group will have a global OSATS score statistically higher than the control group in the realistic scenario.
  5. The pause with video group will have a global OSATS score statistically non-inferior to the pause without video group in the realistic scenario.
  6. The pause with video group will not elect a difference in emotional stress or cognitive load compared to the control group.

Specific objectives:

  1. To assess if the efficacy of AI mediated real-time tailored feedback combined with pausing methodology is statistically superior to AI mediated real-time tailored feedback alone in improving medical students' surgical skills on two virtual reality surgery tasks.
  2. To determine if different emotions and cognitive load are elicited by the pausing methodology as compared to only hearing the AI mediated feedback.

Design: A three-arm single blinded randomized controlled trial of AI feedback with pausing methodology and an expert demonstration video versus AI feedback with only pausing methodology versus AI feedback alone.

Setting: Neurosurgical Simulation and Artificial Intelligence Learning Centre.

Participants: Students who are enrolled in a Quebec medical school in a preparatory year, and first and second year.

Task: Using the NeuroVR surgical simulator by CAE Healthcare, resect a simulated practice tumour six times and a complex simulated realistic brain tumour once using an Ultrasonic Aspirator and Bipolar pincers while minimizing bleeding and preserving the surrounding, simulated healthy brain structures.

Intervention: A 90-minute training session where participants will have seven simulated subpial tumour resection attempts (six repetitions of a simple practice scenario and one attempt at a complex realistic scenario). All participants will receive auditory feedback from the ICEMS but will differ in what follows:

  1. Continuously perform the procedure (i.e., no pause) (Group 1);
  2. A pause followed by a reflection period (Group 2);
  3. A pause followed by an expert-level demonstration video and a reflection period (Group 3).

Auditory feedback will be based on 4 metrics:

  1. Instrument tip separation distance;
  2. Low bipolar force;
  3. High aspirator force;
  4. High bipolar force. Initially, feedback will only be given based on the first metric (instrument tip separation), but once a repetition is completed without receiving feedback, the subsequent repetition will assess the next metric in the list above, and so on and so forth.

Main outcomes and measures:

The two co-primary outcomes are:

  1. The improvement in surgical performance, as dictated by the composite score computed by the previously validated evaluation module of the ICEMS. Performance improvement is measured by the difference in composite score between each of the 6 repetitions of the practice scenario. Transfer of learning will be measured by the participant's composite score for the complex realistic scenario.
  2. The performance score of the participants in the complex realistic scenario, assessed by two blinded experts using the Objective Structured Assessment of Technical Skills (OSATS) global rating scale.

The secondary outcome is the differences in the strength of emotions elicited, measured before the practice scenario, immediately before the realistic scenario, and after completion of all attempts using the Duffy's Medical Emotional Scale (MES). Cognitive load will also be measured following completion of all tasks using Leppink's Cognitive Load Index (CLI). Both outcomes are measured using self-reports.

Statistical Analysis Plan: Participant data will be anonymized and stored. The ICEMS will assess the participant's surgical performance and provide a performance score at 0.2 second intervals throughout each repetition of the simulated surgical task. An average composite score will then be calculated for each repetition. Using ANCOVA, improvement in performance and participant learning will be assessed by comparing the composite score of the first practice scenario repetition (baseline) and the composite score of the sixth repetition (summative). Meanwhile, the composite score of the complex realistic scenario will be used to assess the transfer of learning using a one-way ANOVA. With an effect size of 0.25 and a significance of 0.05, a total sample size of 129 provides 80% power to detect a significant interaction.

Videos of participant performance in the complex realistic scenario will be evaluated by two blinded expert raters using the OSATS global rating scale. The OSATS score will be analyzed between groups using a one-way ANOVA to compare efficiency of learning and skill retention.

Emotional changes before, during, and after learning in the simulated scenarios will be evaluated using a two-way mixed ANOVA, while one-way ANOVA will be used to assess cognitive load after learning.

Being tested
Experimental Group ICEMS verbal feedback with pause group, Experimental Group ICEMS audio feedback with pause and expert video
Keywords
Artificial intelligence, Intelligent tutor, Clinical trial, Medical students, Competency-based feedback, Neurosurgery, Virtual reality

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Experimental Group ICEMS verbal feedback with pause groupBehavioural

    While performing the simulated procedure, if participants receive real-time verbal feedback based on the intelligent system error detection, they will be instructed to pause the task, putting their instruments down and reflecting for 22 seconds. A warning will be given when there are 7 seconds remaining in the reflection period so individuals can prepare to resume the task immediately.

  • Experimental Group ICEMS audio feedback with pause and expert videoBehavioural

    While performing the simulated procedure, if participants receive real-time verbal feedback based on the intelligent system error detection, they will be instructed to pause the task, putting their instruments down, turning their attention to a 9-second expert-level demonstration video, and reflecting for 13 seconds. A warning will be given when there are 7 seconds remaining in the reflection period so individuals can prepare to resume the task immediately.

Study groups in NCT06235788
Study groupRoleWhat they receive
Control Group Intelligent Continuous Expertise Monitoring System (ICEMS) only verbal feedback groupNo intervention43 participants. Individuals receive standard information. They perform 6 5-min practice scenario resections with a 5-min break between each one. The 7th attempt is the 13-min realistic scenario. Participants receive no feedback during the first repetition. They will then receive feedback on 4 metrics, one metric a time: instrument tip separation, low bipolar force, high aspirator force, high bipolar force. Once an attempt is completed without receiving feedback, the next repetition will assess the next metric in the list above. During the 5-min break after an attempt is completed without receiving feedback, participants can watch an optional expert-level demonstration video corresponding to the next metric. Participants receive no feedback during the 6th repetition. They will have no feedback in their 7th repetition, the realistic scenario.
Experimental Group ICEMS verbal feedback with pause groupExperimental43 participants. Individuals receive standard information. They perform 6 5-min practice scenario resections with a 5-min break between each one. The 7th attempt is the 13-min realistic scenario. Participants receive no feedback during the first repetition. They will then receive feedback on 4 metrics, one metric a time: instrument tip separation, low bipolar force, high aspirator force, high bipolar force. Once an attempt is completed without receiving feedback, the next repetition will assess the next metric in the list above. During the 5-min break after an attempt is completed without receiving feedback, participants can watch an optional expert-level demonstration video corresponding to the next metric. Participants receive no feedback during the 6th repetition. They will have no feedback in their 7th repetition, the realistic scenario.
Receives: Behavioral: Experimental Group ICEMS verbal feedback with pause group
Experimental Group ICEMS verbal feedback with pause and expert-level video demonstrationExperimental43 participants. Individuals receive standard information. They perform 6 5-min practice scenario resections with a 5-min break between each one. The 7th attempt is the 13-min realistic scenario. Participants receive no feedback during the first repetition. They will then receive feedback on 4 metrics, one metric a time: instrument tip separation, low bipolar force, high aspirator force, high bipolar force. Once an attempt is completed without receiving feedback, the next repetition will assess the next metric in the list above. During the 5-min break after an attempt is completed without receiving feedback, participants can watch an optional expert-level demonstration video corresponding to the next metric. Participants receive no feedback during the 6th repetition. They will have no feedback in their 7th repetition, the realistic scenario.
Receives: Behavioral: Experimental Group ICEMS audio feedback with pause and expert video

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in performance

    Evaluated by comparing the average composite-score, calculated by the ICEMS, from each practice scenario. Scores range from expert/skilled level (a score of 1.00) to novice/less-skilled level (a score of -1.00).

    Measured: 1 day of study

  2. Transfer of learning

    Evaluated by comparing the average composite-score, calculated by the ICEMS, from each practice scenario. Scores range from expert/skilled level (a score of 1.00) to novice/less-skilled level (a score of -1.00).

    Measured: 1 day of study

  3. Objective Structured Assessment of Technical Skills (OSATS) global rating scale

    Performance score of the participants in the complex realistic scenario, assessed by two blinded experts using the Objective Structured Assessment of Technical Skills (OSATS) global rating scale on a 7-point Likert scale (1= novice to 7 = expert). Efficacy in learning with pausing methodology and an expert-level demonstration video will be compared to pausing methodology alone and to no pausing methodology.

    Measured: 1 day of study

Secondary outcomes (2)
  1. Differences in strength of emotions elicited

    Measured by Duffy's Medical Emotional Scale (MES) before, during, and after learning. Participants will self-report the intensity of each emotion on a 5-point Likert scale (1 = not at all to 5 = very strong).

    Measured: 1 day of study

  2. Difference in Cognitive Load

    Measured using Leppink's Cognitive Load Index (CLI) after the intervention. Participants will self-report their level of agreement with each statement on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree).

    Measured: 1 day of study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Feb 2024
  2. Study start30 Jan 2024
  3. Primary completionSep 2024 (estimated)
  4. Study completionSep 2024 (estimated)

Resources

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
129 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06235788
Sponsor's protocol ID
2010-270, NEU-09-042-Trial 4
Status last verified
Feb 2024
First submitted
23 Jan 2024
Last updated
5 Feb 2024
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

  • Yilmaz R, Winkler-Schwartz A, Mirchi N, Reich A, Christie S, Tran DH, Ledwos N, Fazlollahi AM, Santaguida C, Sabbagh AJ, Bajunaid K, Del Maestro R. Continuous monitoring of surgical bimanual expertise using deep neural networks in virtual reality simulation. NPJ Digit Med. 2022 Apr 26;5(1):54. doi: 10.1038/s41746-022-00596-8.

    PubMed 35473961
  • Fazlollahi 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
  • Winkler-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 31373651
  • Lee JY, Szulewski A, Young JQ, Donkers J, Jarodzka H, van Merrienboer JJG. The medical pause: Importance, processes and training. Med Educ. 2021 Oct;55(10):1152-1160. doi: 10.1111/medu.14529. Epub 2021 May 1.

    PubMed 33772840

Questions about this trial

What is this clinical trial studying?

A study testing Experimental Group ICEMS verbal feedback with pause group and Experimental Group ICEMS audio feedback with pause and expert video 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.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2024. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Rolando F Del Maestro, MD, PhD (519 708 0346, rolando.del_maestro@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in performance (time frame: 1 day of study). The study lists 3 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 NCT06235788, which also lists 4 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 5 Feb 2024.

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