Back to resultsColonoscopic Skill Acquisition and Transfer Via Simulated Curriculum of Progressive Training
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Progressive Group
Sponsored by
About this trial
This is an interventional health services research trial for Colorectal Cancer
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.
Sites / Locations
- St. Michael's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Progressive Group
High-Fidelity Group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Difference Between Progressive and High-Fidelity Groups on Clinical Colonoscopy Peformance (JAG/DOPS)
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.
Secondary Outcome Measures
Cognitive Knowledge of Endoscopy
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.
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
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.
Full Information
NCT ID
NCT02000180
First Posted
November 17, 2013
Last Updated
August 8, 2017
Sponsor
Unity Health Toronto
Collaborators
The Hospital for Sick Children
1. Study Identification
Unique Protocol Identification Number
NCT02000180
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?
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
June 2013 (Actual)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Unity Health Toronto
Collaborators
The Hospital for Sick Children
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Progressive Group
Arm Type
Experimental
Arm Description
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.
Arm Title
High-Fidelity Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Progressive Group
Primary Outcome Measure Information:
Title
Difference Between Progressive and High-Fidelity Groups on Clinical Colonoscopy Peformance (JAG/DOPS)
Description
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.
Time Frame
4-6 weeks post-intervention
Secondary Outcome Measure Information:
Title
Cognitive Knowledge of Endoscopy
Description
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.
Time Frame
Pre-training, immediate post-training
Title
Colonoscopy Specific-performance.
Description
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.
Time Frame
Pre-training, immediate post-training, and 4-6 weeks after training (delayed post-training)
Title
Colonoscopy Specific Performance, Communication Skills, and Global Performance on an Integrated Scenario
Description
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.
Time Frame
Immediate post-training and 4-6 weeks after training (delayed post-training)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samir C Grover, MD/MEd
Organizational Affiliation
Unity Health Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28366440
Citation
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.
Results Reference
derived
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Colonoscopic Skill Acquisition and Transfer Via Simulated Curriculum of Progressive Training
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