Colonoscopic Skill Acquisition and Transfer Via Simulated Curriculum of Progressive Training

• ClinicalTrials.gov Identifier: NCT02000180
• Recruitment Status: Completed
• First Posted: December 4, 2013
• Results First Posted: February 19, 2018
• Last Update Posted: February 19, 2018
• Sponsor: St. Michael's Hospital, Toronto
• Collaborator: The Hospital for Sick Children
• Information provided by (Responsible Party): Samir Grover, St. Michael's Hospital, Toronto

Tracking Information

• First Submitted Date: November 17, 2013
• First Posted Date: December 4, 2013
• Results First Submitted Date: April 28, 2017
• Results First Posted Date: February 19, 2018
• Last Update Posted Date: February 19, 2018
• Actual Study Start Date: June 2013
• Actual Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 8, 2017)

Difference Between Progressive and High-Fidelity Groups on Clinical Colonoscopy Peformance (JAG/DOPS) [ Time Frame: 4-6 weeks post-intervention ]

The Joint Advisory Group (JAG) Direct Observation of Procedural Skills (DOPS) tool is a tool to assess colonoscopic competency and includes ratings of the following domains: (i) assessment, consent and communication; (ii) safety and sedation; (iii) endoscopic skills during insertion and withdrawal; and, (iv) diagnostic and therapeutic ability. Scores range from 0-100, with higher scores representing higher colonoscopic competency. The tool will be used to assess participants before and after the intervention at a time of one week. A change in these ratings before and after intervention is the primary outcome.

Original Primary Outcome Measures (submitted: November 26, 2013)

Change in JAG/DOPS Expert Assessment scores [ Time Frame: Pre-intervention, Post-intervention at one week ]

The JAG/DOPS tool includes ratings of the following domains: (i) assessment, consent and communication; (ii) safety and sedation; (iii) endoscopic skills during insertion and withdrawal; and, (iv) diagnostic and therapeutic ability. The tool will be used to assess participants before and after the intervention at a time of one week. A change in these ratings before and after intervention is the primary outcome.

• Change History: Complete list of historical versions of study NCT02000180 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: August 8, 2017)

• Cognitive Knowledge of Endoscopy [ Time Frame: Pre-training, immediate post-training ]
  Assessed via a multiple-choice question test on the theory and practice of endoscopy. Scores range from 0-100 with higher scores representing a more knowledge of the theory and practice of endoscopy.
• Colonoscopy Specific-performance. [ Time Frame: Pre-training, immediate post-training, and 4-6 weeks after training (delayed post-training) ]
  The Joint Advisory Group (JAG) Direct Observation of Procedural Skills (DOPS) tool is a tool to assess colonoscopic competency and includes ratings of the following domains: (i) assessment, consent and communication; (ii) safety and sedation; (iii) endoscopic skills during insertion and withdrawal; and, (iv) diagnostic and therapeutic ability. Scores range from 0-100, with higher scores representing higher colonoscopic competency. The tool will be used to assess participants on virtual reality colonoscopy cases. A change in these ratings before and after intervention is a secondary outcome.
• Colonoscopy Specific Performance, Communication Skills, and Global Performance on an Integrated Scenario [ Time Frame: Immediate post-training and 4-6 weeks after training (delayed post-training) ]
  Technical skills, communication skills, and global performance assessed during an integrated scenario through the JAG DOPS tool, integrated scenario communication rating form (ISCRF), and integrated scenario global rating form (ISGRF) respectively. The JAG DOPS tool, as previously described, will be used to assess participants on integrated scenario colonoscopy cases. A change in these ratings before and after intervention is a secondary outcome. The ISCRF and ISGRF are tools which measure communication skills and global performance with a standardized nurse and standardized patient during a simulated colonoscopy. These tools can have scores from 0-100, with higher scores representing better performance.

Original Secondary Outcome Measures (submitted: November 26, 2013)

Change in Simulator Generated Metrics [ Time Frame: Pre-intervention, Post-intervention at one week ]

Computer generated performance data will be collected from the VR simulator, including (1) completion of procedure, (2) depth of insertion, (3) absence of perforation, (4) time to cecum, (5) simulated pain scores, (6) volume of insufflated air, (7) overall length of insertion, (8) percentage of time without discomfort, and (9) percentage of mucosa seen. These will be assessed before and after the intervention at a time of one week.

• Current Other Pre-specified Outcome Measures: Not Provided

Original Other Pre-specified Outcome Measures (submitted: November 26, 2013)

Change in The Integrated Procedural Performance Instrument (IPPI) Global Rating Scale [ Time Frame: Pre-intervention, Post-intervention at one week ]

Global clinical performance will be evaluated using the IPPI global rating scale, which assesses 11 dimensions on seven-point Likert scales. The tool will be used to assess participants before and after the intervention at a time of one week.

Descriptive Information

• Brief Title: Colonoscopic Skill Acquisition and Transfer Via Simulated Curriculum of Progressive Training
• Official Title: Do Progressive Levels of Simulation Fidelity Enhance Colonoscopic Skill Acquisition and Transfer in Novice Endoscopic Trainees?
• Brief Summary: It is hypothesized that a progressive simulated learning strategy will result in better global clinical performance (e.g., technical, communication) and transfer of endoscopic skill, as compared with a high-fidelity simulation strategy.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Investigator, Outcomes Assessor); Primary Purpose: Health Services Research
• Condition: Colorectal Cancer
• Intervention: Behavioral: Progressive Group

Study Arms

• Experimental: Progressive Group
  The progressive learning group will undertake 6 hours of interactive small-group didactic sessions, interlaced with up to 6 hours of self-directed instruction initially on the low-fidelity box simulator, with feedback provided one-on-one by an expert academic endoscopist. Participants in the progressive learning group can switch to the high-fidelity simulator at their discretion, but cannot return to the low-fidelity simulator. On the high fidelity VR simulator they can progress through six modules each in colonoscopy and endoscopic polypectomy in a self-directed fashion, with one-on-one feedback by an expert academic endoscopist. The endoscopy instructor will demonstrate techniques, answer questions and provide feedback. The entirety of this will be delivered over two days.
  Intervention: Behavioral: Progressive Group
• No Intervention: High-Fidelity Group
  The high-fidelity group will undertake 6 hours of interactive small-group didactic and hands-on sessions on the theory of colonoscopy, led by an expert academic gastroenterologist. The sessions will be interlaced with up to six hours of self-directed instruction on the high-fidelity VR simulator. Six task-specific modules of increasing difficulty in colonoscopy and colonoscopic polypectomy will be taught solely on the VR simulator with one-on-one feedback from an expert academic endoscopist. The endoscopy instructor will demonstrate techniques, answer questions and provide feedback as necessary. The entirety of this will be delivered over two days.

• Publications *: Grover SC, Scaffidi MA, Khan R, Garg A, Al-Mazroui A, Alomani T, Yu JJ, Plener IS, Al-Awamy M, Yong EL, Cino M, Ravindran NC, Zasowski M, Grantcharov TP, Walsh CM. Progressive learning in endoscopy simulation training improves clinical performance: a blinded randomized trial. Gastrointest Endosc. 2017 Nov;86(5):881-889. doi: 10.1016/j.gie.2017.03.1529. Epub 2017 Mar 31.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 8, 2017): 37
• Original Estimated Enrollment (submitted: November 26, 2013): 23
• Actual Study Completion Date: July 2014
• Actual Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• novice endoscopists from Adult Gastroenterology, Pediatric Gastroenterology, General Surgery training programs at University of Toronto

Exclusion Criteria:

• Trainees who have performed greater than 25 colonoscopies will be excluded to ensure all participants are novices.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT02000180
• Other Study ID Numbers: 13-060
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Samir Grover, St. Michael's Hospital, Toronto
• Study Sponsor: St. Michael's Hospital, Toronto
• Collaborators: The Hospital for Sick Children

Investigators

• Principal Investigator: Samir C Grover, MD/MEd; St. Michael's Hospital, Toronto

• PRS Account: St. Michael's Hospital, Toronto
• Verification Date: August 2017