Trial Outcomes & Findings for Colonoscopic Skill Acquisition and Transfer Via Simulated Curriculum of Progressive Training (NCT NCT02000180)
NCT ID: NCT02000180
Last Updated: 2018-02-19
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
37 participants
Primary outcome timeframe
4-6 weeks post-intervention
Results posted on
2018-02-19
Participant Flow
Participant milestones
| Measure |
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.
Progressive Group
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
19
|
|
Overall Study
COMPLETED
|
18
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Colonoscopic Skill Acquisition and Transfer Via Simulated Curriculum of Progressive Training
Baseline characteristics by cohort
| Measure |
Progressive Group
n=18 Participants
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
|
High-Fidelity Group
n=19 Participants
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
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
28.1 years
STANDARD_DEVIATION 3 • n=5 Participants
|
28.1 years
STANDARD_DEVIATION 2 • n=7 Participants
|
28.1 years
STANDARD_DEVIATION 2.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Training program (gastroenterology, general surgery, or internal medicine)
Gastroenterology
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Training program (gastroenterology, general surgery, or internal medicine)
General surgery
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Training program (gastroenterology, general surgery, or internal medicine)
Internal medicine
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Endoscopic experience
Independent colonoscopies completed before trainin
|
0.8 Number of procedures
STANDARD_DEVIATION 2.8 • n=5 Participants
|
0.2 Number of procedures
STANDARD_DEVIATION 0.8 • n=7 Participants
|
0.5 Number of procedures
STANDARD_DEVIATION 1.8 • n=5 Participants
|
|
Endoscopic experience
Assisted colonoscopies completed before training
|
5.5 Number of procedures
STANDARD_DEVIATION 13.7 • n=5 Participants
|
3.6 Number of procedures
STANDARD_DEVIATION 3.4 • n=7 Participants
|
4.5 Number of procedures
STANDARD_DEVIATION 8.5 • n=5 Participants
|
|
Endoscopic experience
Indendent EGDs completed before training
|
1.8 Number of procedures
STANDARD_DEVIATION 5.5 • n=5 Participants
|
0.9 Number of procedures
STANDARD_DEVIATION 1.7 • n=7 Participants
|
1.3 Number of procedures
STANDARD_DEVIATION 3.6 • n=5 Participants
|
|
Endoscopic experience
Assisted EGDs completed before training
|
6 Number of procedures
STANDARD_DEVIATION 13.5 • n=5 Participants
|
3.2 Number of procedures
STANDARD_DEVIATION 4.6 • n=7 Participants
|
4.6 Number of procedures
STANDARD_DEVIATION 9.0 • n=5 Participants
|
|
Endoscopic experience
Independent colonoscopies completed after training
|
0.1 Number of procedures
STANDARD_DEVIATION 0.3 • n=5 Participants
|
0 Number of procedures
STANDARD_DEVIATION 0 • n=7 Participants
|
0.1 Number of procedures
STANDARD_DEVIATION 0.1 • n=5 Participants
|
|
Endoscopic experience
Assisted colonoscopies completed after training
|
1.5 Number of procedures
STANDARD_DEVIATION 1.9 • n=5 Participants
|
2 Number of procedures
STANDARD_DEVIATION 3.6 • n=7 Participants
|
1.7 Number of procedures
STANDARD_DEVIATION 2.7 • n=5 Participants
|
|
Endoscopic experience
Independent EGDs completed after training
|
0.4 Number of procedures
STANDARD_DEVIATION 1 • n=5 Participants
|
0.2 Number of procedures
STANDARD_DEVIATION 0.7 • n=7 Participants
|
0.3 Number of procedures
STANDARD_DEVIATION 0.8 • n=5 Participants
|
|
Endoscopic experience
Assisted EGDs completed after training
|
1.3 Number of procedures
STANDARD_DEVIATION 2.3 • n=5 Participants
|
2 Number of procedures
STANDARD_DEVIATION 3.5 • n=7 Participants
|
1.7 Number of procedures
STANDARD_DEVIATION 2.9 • n=5 Participants
|
PRIMARY outcome
Timeframe: 4-6 weeks post-interventionThe 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.
Outcome measures
| Measure |
Progressive Group
n=18 Participants
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
|
High-Fidelity Group
n=19 Participants
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.
|
|---|---|---|
|
Difference Between Progressive and High-Fidelity Groups on Clinical Colonoscopy Peformance (JAG/DOPS)
Procedure 1
|
68.2 units on a scale
Standard Deviation 6.9
|
59.0 units on a scale
Standard Deviation 7.2
|
|
Difference Between Progressive and High-Fidelity Groups on Clinical Colonoscopy Peformance (JAG/DOPS)
Procedure 2
|
68.3 units on a scale
Standard Deviation 6.1
|
59.1 units on a scale
Standard Deviation 8
|
SECONDARY outcome
Timeframe: Pre-training, immediate post-trainingAssessed 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.
Outcome measures
| Measure |
Progressive Group
n=18 Participants
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
|
High-Fidelity Group
n=19 Participants
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.
|
|---|---|---|
|
Cognitive Knowledge of Endoscopy
Immediate post-training
|
59.5 percentage score on MCQ test
Standard Deviation 6.8
|
59.5 percentage score on MCQ test
Standard Deviation 5.4
|
|
Cognitive Knowledge of Endoscopy
Pre-training
|
36.2 percentage score on MCQ test
Standard Deviation 14.4
|
28.6 percentage score on MCQ test
Standard Deviation 12.6
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Progressive Group
n=18 Participants
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
|
High-Fidelity Group
n=19 Participants
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.
|
|---|---|---|
|
Colonoscopy Specific-performance.
Pre-training
|
22.04 units on a scale
Standard Deviation 21.18
|
21.05 units on a scale
Standard Deviation 22.61
|
|
Colonoscopy Specific-performance.
Immediate post-training
|
75.74 units on a scale
Standard Deviation 16.99
|
65.96 units on a scale
Standard Deviation 13.90
|
|
Colonoscopy Specific-performance.
Delayed post-training
|
90.74 units on a scale
Standard Deviation 12.71
|
77.54 units on a scale
Standard Deviation 16.92
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Progressive Group
n=18 Participants
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
|
High-Fidelity Group
n=19 Participants
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.
|
|---|---|---|
|
Colonoscopy Specific Performance, Communication Skills, and Global Performance on an Integrated Scenario
Immediate post - Colonoscopy specific performance
|
68.88 units on a scale
Standard Deviation 18.68
|
56.69 units on a scale
Standard Deviation 13.47
|
|
Colonoscopy Specific Performance, Communication Skills, and Global Performance on an Integrated Scenario
Immediate post - Communication skills
|
73.89 units on a scale
Standard Deviation 11.7
|
67.89 units on a scale
Standard Deviation 14.27
|
|
Colonoscopy Specific Performance, Communication Skills, and Global Performance on an Integrated Scenario
Immediate post - Global performance
|
73.15 units on a scale
Standard Deviation 12.6
|
66.75 units on a scale
Standard Deviation 8.94
|
|
Colonoscopy Specific Performance, Communication Skills, and Global Performance on an Integrated Scenario
Delayed post - Colonoscopy specific performance
|
87.08 units on a scale
Standard Deviation 11.77
|
75.20 units on a scale
Standard Deviation 17.30
|
|
Colonoscopy Specific Performance, Communication Skills, and Global Performance on an Integrated Scenario
Delayed post - communication skills
|
83.33 units on a scale
Standard Deviation 11.25
|
69.21 units on a scale
Standard Deviation 13.15
|
|
Colonoscopy Specific Performance, Communication Skills, and Global Performance on an Integrated Scenario
Delayed post - global performance
|
80.13 units on a scale
Standard Deviation 11.82
|
70.33 units on a scale
Standard Deviation 9.60
|
Adverse Events
Progressive Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
High-Fidelity Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place