Clinical trial NCT02877420: Impact of a Simulation-based Training Curriculum of Non-technical Skills on Colonoscopy Performance
Official title: Impact of a Simulation-based Training Curriculum of Non-technical Skills on Colonoscopy Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endoscopy Simulation
Keywords: Endoscopy
Simulation Training
Non-technical Skills
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2016-08-24
Enrollment: 42
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Novice endoscopists from general surgery, gastroenterology, or pediatrics gastroenterology residency programs at the University of Toronto

Exclusion Criteria:

* If participants have performed more than 25 endoscopies

Primary outcomes:
measure: Difference in performance between two groups in clinical colonoscopy
timeFrame: During clinical colonoscopy 4-6 weeks after NTS training curriculum
Secondary outcomes:
measure: Differences in procedural knowledge
timeFrame: One day
measure: Technical performance on a VR simulated colonoscopy - JAG/DOPS
timeFrame: 4-6 weeks
measure: Technical performance on a VR simulated colonoscopy - GiECAT
timeFrame: 4-6 weeks
measure: Patient comfort during clinical colonoscopies
timeFrame: 4-6 weeks
measure: Non-technical performance on clinical colonoscopies
timeFrame: 4-6 weeks
measure: Clinical performance on clinical colonoscopies - GiECAT
timeFrame: 4-6 weeks
measure: Participant self-efficacy
timeFrame: 1 day
measure: Practice case length on simulator
timeFrame: 1 day
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St.Michael's Hospital
state: Ontario
Study officials:
affiliation: Unity Health Toronto
name: Samir C Grover, MD, MEd
role: PRINCIPAL_INVESTIGATOR
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