An interventional study of Non-Technical Skills Training Curriculum and Conventional Simulation Training Group in Endoscopy Simulation, sponsored by Unity Health Toronto. Completed at 1 site in Canada. Per ClinicalTrials.gov, last updated 2017-05-02.
Sponsored by Unity Health Toronto · Not applicable, Interventional, and Other
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.
Unity Health Toronto is the lead sponsor of 434 studies on the registry; 76 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
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Exclusion Criteria:
This group will receive 4 hours of small-group and hands-on sessions and 1 hour of didactic NTS sessions. Participants will watch a video that demonstrates ideal endoscopic performance. They will use the E-NTS Checklist during the integrated scenario training. This checklist targets NTS. The group will be given 7 hours of expert-assisted instruction on the low-fidelity simulator (1 hour) and the high-fidelity VR simulator (6 hours). Six modules of increasing difficulty in colonoscopy and polypectomy will be taught with feedback from an expert endoscopist who will demonstrate techniques, answer questions and provide individualized performance feedback with a focus on NTS. The last three hours on the high fidelity simulator will be an integrated scenario (IG) featuring standardized patient (SP) and standardized nurse (SN). Feedback will be given after each IG by the instructor, SP and SN. Participants can view the E-NTS Checklist before and after each case.
Other: Non-Technical Skills Training Curriculum
This group will receive 4 hours of small-group and hands-on sessions on colonoscopy theory from an expert endoscopist. The core curriculum is designed on the basis of the American Society for Gastrointestinal Endoscopy colonoscopy curriculum and an endoscopic training textbook. This curriculum has been shown to be effective when compared to self-regulated learning on the simulator. The sessions will be interlaced with eight hours of expert-assisted instruction on both the low-fidelity simulator (1 hour) and on the high-fidelity VR simulator (7 hours). Six modules of increasing difficulty in colonoscopy and polypectomy will be taught with feedback from an expert endoscopist. The expert will demonstrate techniques, answer questions and provide feedback on global performance. Feedback, in the form of performance metrics, will be provided by the simulator upon completion/failure of each module.
Other: Conventional Simulation Training Group
Difference in performance between two groups in clinical colonoscopy
Each videotaped clinical colonoscopy will be independently assessed by two experienced endoscopists using the Joint Advisory Group for GI Endoscopy Direct Observation of Procedural Skills (JAG/DOPS). The raters will be blinded to the group assignment. Training on how to use the tool will be provided for raters by the investigators of the study.
Time frame: During clinical colonoscopy 4-6 weeks after NTS training curriculum
Differences in procedural knowledge
Assessed through multiple choice question tests
Time frame: One day
Technical performance on a VR simulated colonoscopy - JAG/DOPS
Assessed through a Joint Advisory Group for GI Endoscopy Direct Observation of Procedural Skills (JAG/DOPS).
Time frame: 4-6 weeks
Technical performance on a VR simulated colonoscopy - GiECAT
Assessed through the Gastrointestinal Endoscopy Competency Assessment Tool for Pediatric Colonoscopy (GiECAT).
Time frame: 4-6 weeks
Patient comfort during clinical colonoscopies
Assessed through Nurse-Assessed Patient Comfort Score (NAPCOMS).
Time frame: 4-6 weeks
Non-technical performance on clinical colonoscopies
Assessed through the Modified Objective Structured Assessment of Nontechnical Skills (MOSANTS)
Time frame: 4-6 weeks
Clinical performance on clinical colonoscopies - GiECAT
Assessed through GiECAT
Time frame: 4-6 weeks
Participant self-efficacy
Assessed through an adapted scale based on the General Self-Efficacy Scale.
Time frame: 1 day
Practice case length on simulator
Assessed through a time measurement of the length of the case. Experienced endoscopists will assess participants' colonoscopy-specific skills, technical skills and non-technical skills during the pre-training, immediate and delayed post-training simulation-based assessments
Time frame: 1 day
Plan to share: No
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