Back to resultsA Randomized Control Trial of a Simulation-based Curriculum to Enhance Skills in Colonoscopy
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Curriculum Group
Self-directed learning group
Sponsored by
About this trial
This is an interventional diagnostic trial for Colorectal Cancer
Eligibility Criteria
Inclusion Criteria:
- Trainee endoscopists from the gastroenterology and general surgery programs at the University of Toronto
Exclusion Criteria:
- Greater than 20 colonoscopies performed
Sites / Locations
- St. Michael's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Curriculum Group
Self-directed learning group
Arm Description
The curriculum group will undergo a comprehensive curriculum in colonoscopy utilizing a virtual reality (VR) colonoscopic simulator. This curriculum involves 6 hours of interactive, small-group didactic teaching on colonoscopy interlaced with 8 hours of supervised one-on-one endoscopy VR simulation training with experienced endoscopists.
The self-directed group will receive 8 hours of colonoscopic virtual reality (VR) simulation practice with an experienced endoscopist present, but without structured training.
Outcomes
Primary Outcome Measures
Transfer of Skills to Clinical Colonoscopy
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. These were measured across two endoscopic procedures, performed consecutively within two weeks of completion of the course. Data from two procedures were used to limit the influence of spurious findings from single procedures.
Secondary Outcome Measures
Retention of Clinical Skills
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 during an integrated scenario. A change in these ratings before and after intervention is the secondary outcome.
Full Information
NCT ID
NCT01991522
First Posted
November 18, 2013
Last Updated
February 19, 2018
Sponsor
Unity Health Toronto
1. Study Identification
Unique Protocol Identification Number
NCT01991522
Brief Title
A Randomized Control Trial of a Simulation-based Curriculum to Enhance Skills in Colonoscopy
Official Title
A Comprehensive Simulation-based Curriculum as a Means to Enhance Technical and Non-technical Skills in Colonoscopy: a Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
June 2011 (Actual)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Unity Health Toronto
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Colonoscopy is a commonly used medical procedure. Medical and surgical residents learning colonoscopy typically learn the procedure experientially but simulation based teaching is increasingly being integrated into training programs. The optimal manner to teach colonoscopy on virtual-reality simulators is uncertain. We aim to test a curriculum in simulation-based colonoscopy with self-directed learning on simulators.
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
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Curriculum Group
Arm Type
Experimental
Arm Description
The curriculum group will undergo a comprehensive curriculum in colonoscopy utilizing a virtual reality (VR) colonoscopic simulator. This curriculum involves 6 hours of interactive, small-group didactic teaching on colonoscopy interlaced with 8 hours of supervised one-on-one endoscopy VR simulation training with experienced endoscopists.
Arm Title
Self-directed learning group
Arm Type
Active Comparator
Arm Description
The self-directed group will receive 8 hours of colonoscopic virtual reality (VR) simulation practice with an experienced endoscopist present, but without structured training.
Intervention Type
Behavioral
Intervention Name(s)
Curriculum Group
Intervention Type
Behavioral
Intervention Name(s)
Self-directed learning group
Primary Outcome Measure Information:
Title
Transfer of Skills to Clinical Colonoscopy
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. These were measured across two endoscopic procedures, performed consecutively within two weeks of completion of the course. Data from two procedures were used to limit the influence of spurious findings from single procedures.
Time Frame
less than 2 weeks
Secondary Outcome Measure Information:
Title
Retention of Clinical Skills
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 during an integrated scenario. A change in these ratings before and after intervention is the secondary outcome.
Time Frame
4-6 weeks after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Trainee endoscopists from the gastroenterology and general surgery programs at the University of Toronto
Exclusion Criteria:
Greater than 20 colonoscopies performed
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samir C Grover, MD
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
M5B1W8
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26007221
Citation
Grover SC, Garg A, Scaffidi MA, Yu JJ, Plener IS, Yong E, Cino M, Grantcharov TP, Walsh CM. Impact of a simulation training curriculum on technical and nontechnical skills in colonoscopy: a randomized trial. Gastrointest Endosc. 2015 Dec;82(6):1072-9. doi: 10.1016/j.gie.2015.04.008. Epub 2015 May 23.
Results Reference
derived
Learn more about this trial
A Randomized Control Trial of a Simulation-based Curriculum to Enhance Skills in Colonoscopy
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