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
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Sponsor:
St. Michael's Hospital, Toronto
Collaborator:
The Hospital for Sick Children
Information provided by (Responsible Party):
Samir Grover, St. Michael's Hospital, Toronto
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Tracking Information | ||||
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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 |
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.
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Original Primary Outcome Measures ICMJE |
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.
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Change History | Complete list of historical versions of study NCT02000180 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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.
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures |
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.
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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 |
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Condition ICMJE | Colorectal Cancer | |||
Intervention ICMJE | Behavioral: Progressive Group | |||
Study Arms ICMJE |
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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. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
37 | |||
Original Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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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 |
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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 |