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临床试验/NCT02877420
NCT02877420已完成不适用

Impact of a Simulation-based Training Curriculum of Non-technical Skills on Colonoscopy Performance

Unity Health Toronto1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2015年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
42
试验地点
1
主要终点
Difference in performance between two groups in clinical colonoscopy

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Investigator, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者
是

入选标准

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

排除标准

  • •If participants have performed more than 25 endoscopies

研究组 & 干预措施

Non-Technical Skills Training Curriculum

Experimental

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.

干预措施: Non-Technical Skills Training Curriculum (Other)

Conventional Simulation Training Group

Active Comparator

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.

干预措施: Conventional Simulation Training Group (Other)

结局指标

主要结局

Difference in performance between two groups in clinical colonoscopy

时间窗: During clinical colonoscopy 4-6 weeks after NTS training curriculum

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.

次要结局

  • Technical performance on a VR simulated colonoscopy - GiECAT(4-6 weeks)
  • Participant self-efficacy(1 day)
  • Patient comfort during clinical colonoscopies(4-6 weeks)
  • Differences in procedural knowledge(One day)
  • Clinical performance on clinical colonoscopies - GiECAT(4-6 weeks)
  • Practice case length on simulator(1 day)
  • Technical performance on a VR simulated colonoscopy - JAG/DOPS(4-6 weeks)
  • Non-technical performance on clinical colonoscopies(4-6 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Samir Grover

MD, MEd, FRCPC

Unity Health Toronto

研究点 (1)

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