Endoscopy Simulation Clinical Trial
Official title:
Impact of a Simulation-based Training Curriculum of Non-technical Skills on Colonoscopy Performance
The investigators aim to test a curriculum of non-technical skills (NTS) training for simulation-based training of colonoscopy. There is no known literature to date on the optimal approach on how to teach NTS in endoscopy. The objectives are to evaluate a simulation-based curriculum to teach NTS, to explore the relationship between NTS and other domains of competency, and understand how NTS are acquired in endoscopic training.
This study will employ a randomized controlled two-arm design. All testing and training will
take place at St. Michael's Hospital (30 Bond Street, Toronto, Ontario). During the study
participants will be performing simulated lower endoscopic procedures on a virtual reality
(VR) endoscopy simulator.
Description of Simulation Devices used
Low-Fidelity Simulator (Bench Top Model): The low-fidelity simulator is a validated
bench-top endoscopy simulator that helps develop general endoscopic skills. The simulator is
comprised of a series of vertical wooden barriers with numbered targets (holes) conforming
to 27 different sequences of varying complexity. An Olympus paediatric videocolonoscope is
used to navigate the defined sequences as quickly and accurately as possible, with visual
output being displayed on a video monitor.
High-Fidelity Simulator: Virtual Reality Model: The high-fidelity simulator to be used for
testing and training is the EndoVR® virtual reality (VR) endoscopy simulator. It models
navigation through a colon, using a specialized endoscope that is inserted into a
computer-based module with a screen showing the colonic lumen of a virtual patient. It
provides both visual and haptic feedback related to the procedure. The VR simulator has a
number of standardized case-based scenarios of varying complexity for colonoscopy.
Details of experimental design
Baseline questionnaire: A written questionnaire will be administered to all participants at
the start of the project to collect demographic and background information including: age,
sex, level of training, previous endoscopy experience and nature of experience (if
applicable), and video game experience, which may correlate with baseline endoscopic skill.
Pre-test: All participants will then take part in a pre-test designed to assess their
baseline (1) knowledge of colonoscopy; (2) technical skills; and (3) non-technical skills.
No feedback will be provided at any point during the pre-test. The pre-test will consist of
the following:
Knowledge Test: A 30 minute (20 questions) multiple-choice question test designed to assess
participants' theoretical knowledge of colonoscopy, including indications, sedation, safety,
findings, pathology and follow-up.
VR Simulation Test: Participants baseline endoscopic technical proficiency will be will be
assessed through the completion of a colonoscopy procedure on the VR simulator. This
scenario simulates a screening colonoscopy, without the need for any type of intervention
such as biopsy. The procedure will be timed so that participants do not take longer than 30
minutes to complete the procedure. An expert rater will be present to assess performance,
but will not provide assistance. All participants will be videotaped in order to obtain
performance measures such that their faces are not captured to ensure anonymity. Prior to
starting the procedure, participants will complete a questionnaire to measure their
self-efficacy.
VR Simulation Based "Integrated Scenario" Test: Following the simulator-only test,
participants will complete an Integrated Scenario format test to assess their baseline
endoscopic non-technical proficiency. This test was modeled after another test during which
participants perform a colonoscopy procedure on the VR simulator while interacting with an
endoscopic nurse and a standardized patient (SP) portraying a patient. The simulated
procedure will mimic the setup of an endoscopic suite, as the VR simulator will be
positioned next to a patient bed. A standardized patient, who will receive instructions
regarding their medical role, will act out a scenario on colon cancer screening. Trainees
will be expected to explain the colonoscopy procedure, its benefits and risks, and obtain
procedural consent. The trainee will then carry out the procedure on the VR simulator while
responding to the patient and interacting with the standardized nurse (SN) as appropriate.
The SP will act out cues from the VR simulator if the simulator signals that the procedure
has exceeded its threshold for discomfort. The performance of all participants will be
videotaped (in a manner that their faces are not captured to ensure anonymity) in order to
obtain performance measures. Participants will be given a maximum of 45 minutes to complete
the procedure. Prior to starting the procedure, participants will complete a questionnaire
to measure their self-efficacy.
Training interventions: Subsequently participants will be randomized, using an online
randomization algorithm, to one of two groups (following a 1:1 allocation distribution)
Sample size calculation: A power analysis was computed using G*Power version 3.1.9. Using a
previous study that evaluated an NTS training curriculum in surgery as assessed by the
Non-Technical Skills for Surgeons (NOTSS) and OSANTS forms, we conducted the analysis using
the relevant effect size. Based on an effect size of 0.65 (effect size f), an alpha of 0.05
(two-tailed), a beta of 0.20, 2 groups, and 3 measurements, 16 participants are required to
achieve a power of greater than 0.80 using repeated measures ANOVA (between-factors).
Furthermore, a previous study comparing a curriculum in endoscopic simulation found that a
minimum of 15 participants per group was sufficient to detect a significant difference. To
accommodate for a projected 20% dropout and/or non-response that may occur, we therefore
plan to recruit a total of 36 participants.
Statistical analysis: Statistical analyses will be performed using Statistical Package for
the Social Sciences (SPSS) version 20. All statistical tests will be considered significant
at p < 0.05. Baseline Questionnaire: Patient demographics and baseline variables will be
compared between the two groups using Analysis of Variance (ANOVA) and chi-square tests for
continuous and categorical variables respectively. (b)Clinical Performance (Technical and
Non-Technical): Clinical performance during the live colonoscopies for each group will be
determined by comparing the scores from the DOPS, GiECAT, NAPCOMS, and Modified-OSANTS.
Specifically, a mixed factor 2 (NTS curriculum vs. TS curriculum) x 2 (procedure 1 vs.
procedure 2) ANOVA will be used to determine whether there is a difference based on the
rating scales. Tukey's honest significant difference (HSD) test will be used as a post-hoc
analysis to determine any significant differences.
Technical Performance: Technical performance on the simulator for each group will be
determined by comparing the scores from the DOPS, GiECAT, and GAGES. Specifically, a mixed
factor 2 (NTS curriculum vs. TS curriculum) x 3 (pretest, posttest, retention test) ANOVA
will be used to determine whether there is a difference based on the rating scales. Tukey
HSD test will be used as a post-hoc analysis to determine any significant differences.
Non-Technical Performance: Non-technical performance on the simulator for each group will be
determined by comparing the scores from the GiECAT and modified OSANTS. Specifically, a
mixed factor 2 (NTS curriculum vs. TS curriculum) x 3 (pretest, posttest, retention test)
ANOVA will be used to determine whether there is a difference based on the rating scales.
Tukey HSD test will be used as a post-hoc analysis to determine any significant differences.
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