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Trial record 83 of 318 for:    colon cancer | ( Map: Canada )

Colonoscopic Skill Acquisition and Transfer Via Simulated Curriculum of Progressive Training

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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:
Collaborator:
The Hospital for Sick Children
Information provided by (Responsible Party):
Samir Grover, St. Michael's Hospital, Toronto

Tracking Information
First Submitted Date  ICMJE November 17, 2013
First Posted Date  ICMJE December 4, 2013
Results First Submitted Date  ICMJE April 28, 2017
Results First Posted Date  ICMJE February 19, 2018
Last Update Posted Date February 19, 2018
Actual Study Start Date  ICMJE June 2013
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE
 (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  ICMJE
 (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  ICMJE Colonoscopic Skill Acquisition and Transfer Via Simulated Curriculum of Progressive Training
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE Behavioral: Progressive Group
Study Arms  ICMJE
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 8, 2017)
37
Original Estimated Enrollment  ICMJE
 (submitted: November 26, 2013)
23
Actual Study Completion Date  ICMJE July 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02000180
Other Study ID Numbers  ICMJE 13-060
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Samir Grover, St. Michael's Hospital, Toronto
Study Sponsor  ICMJE St. Michael's Hospital, Toronto
Collaborators  ICMJE The Hospital for Sick Children
Investigators  ICMJE
Principal Investigator: Samir C Grover, MD/MEd St. Michael's Hospital, Toronto
PRS Account St. Michael's Hospital, Toronto
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP