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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

Study Type Interventional
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
Enrollment 37
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Progressive Group High-Fidelity Group
Hide Arm/Group 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.

Progressive 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.
Period Title: Overall Study
Started 18 19
Completed 18 19
Not Completed 0 0
Arm/Group Title Progressive Group High-Fidelity Group Total
Hide Arm/Group 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.

Progressive 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. Total of all reporting groups
Overall Number of Baseline Participants 18 19 37
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants 19 participants 37 participants
28.1  (3) 28.1  (2) 28.1  (2.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 19 participants 37 participants
Female
5
  27.8%
9
  47.4%
14
  37.8%
Male
13
  72.2%
10
  52.6%
23
  62.2%
Training program (gastroenterology, general surgery, or internal medicine)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 19 participants 37 participants
Gastroenterology
6
  33.3%
4
  21.1%
10
  27.0%
General surgery
11
  61.1%
14
  73.7%
25
  67.6%
Internal medicine
1
   5.6%
1
   5.3%
2
   5.4%
Endoscopic experience  
Mean (Standard Deviation)
Unit of measure:  Number of procedures
Number Analyzed 18 participants 19 participants 37 participants
Independent colonoscopies completed before trainin 0.8  (2.8) 0.2  (0.8) 0.5  (1.8)
Assisted colonoscopies completed before training 5.5  (13.7) 3.6  (3.4) 4.5  (8.5)
Indendent EGDs completed before training 1.8  (5.5) 0.9  (1.7) 1.3  (3.6)
Assisted EGDs completed before training 6  (13.5) 3.2  (4.6) 4.6  (9.0)
Independent colonoscopies completed after training 0.1  (0.3) 0  (0) 0.1  (0.1)
Assisted colonoscopies completed after training 1.5  (1.9) 2  (3.6) 1.7  (2.7)
Independent EGDs completed after training 0.4  (1) 0.2  (0.7) 0.3  (0.8)
Assisted EGDs completed after training 1.3  (2.3) 2  (3.5) 1.7  (2.9)
1.Primary Outcome
Title Difference Between Progressive and High-Fidelity Groups on Clinical Colonoscopy Peformance (JAG/DOPS)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Progressive Group High-Fidelity Group
Hide Arm/Group 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.

Progressive 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.
Overall Number of Participants Analyzed 18 19
Mean (Standard Deviation)
Unit of Measure: units on a scale
Procedure 1 68.2  (6.9) 59.0  (7.2)
Procedure 2 68.3  (6.1) 59.1  (8)
2.Secondary Outcome
Title Cognitive Knowledge of Endoscopy
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Progressive Group High-Fidelity Group
Hide Arm/Group 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.

Progressive 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.
Overall Number of Participants Analyzed 18 19
Mean (Standard Deviation)
Unit of Measure: percentage score on MCQ test
Pre-training 36.2  (14.4) 28.6  (12.6)
Immediate post-training 59.5  (6.8) 59.5  (5.4)
3.Secondary Outcome
Title Colonoscopy Specific-performance.
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Progressive Group High-Fidelity Group
Hide Arm/Group 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.

Progressive 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.
Overall Number of Participants Analyzed 18 19
Mean (Standard Deviation)
Unit of Measure: units on a scale
Pre-training 22.04  (21.18) 21.05  (22.61)
Immediate post-training 75.74  (16.99) 65.96  (13.90)
Delayed post-training 90.74  (12.71) 77.54  (16.92)
4.Secondary Outcome
Title Colonoscopy Specific Performance, Communication Skills, and Global Performance on an Integrated Scenario
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Progressive Group High-Fidelity Group
Hide Arm/Group 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.

Progressive 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.
Overall Number of Participants Analyzed 18 19
Mean (Standard Deviation)
Unit of Measure: units on a scale
Immediate post - Colonoscopy specific performance 68.88  (18.68) 56.69  (13.47)
Immediate post - Communication skills 73.89  (11.7) 67.89  (14.27)
Immediate post - Global performance 73.15  (12.6) 66.75  (8.94)
Delayed post - Colonoscopy specific performance 87.08  (11.77) 75.20  (17.30)
Delayed post - communication skills 83.33  (11.25) 69.21  (13.15)
Delayed post - global performance 80.13  (11.82) 70.33  (9.60)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Progressive Group High-Fidelity Group
Hide Arm/Group 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.

Progressive 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.
All-Cause Mortality
Progressive Group High-Fidelity Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Progressive Group High-Fidelity Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/19 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Progressive Group High-Fidelity Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/19 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Samir C. Grover
Organization: St. Michael's
Phone: 4168645628
EMail: samir.grover@utoronto.ca
Layout table for additonal information
Responsible Party: Samir Grover, St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT02000180     History of Changes
Other Study ID Numbers: 13-060
First Submitted: November 17, 2013
First Posted: December 4, 2013
Results First Submitted: April 28, 2017
Results First Posted: February 19, 2018
Last Update Posted: February 19, 2018