Colorectal Cancer
Conditions
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.
Interventions
BEHAVIORALProgressive Group
Sponsors
The Hospital for Sick Children
Unity Health Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference Between Progressive and High-Fidelity Groups on Clinical Colonoscopy Peformance (JAG/DOPS) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive Knowledge of Endoscopy | Pre-training, immediate post-training | 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. | 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. |
| Colonoscopy Specific Performance, Communication Skills, and Global Performance on an Integrated Scenario | 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. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 18 |
| 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. | 19 |
| Total | 37 |
Baseline characteristics
| Characteristic | High-Fidelity Group | Total | Progressive Group |
|---|---|---|---|
| Age, Continuous | 28.1 years STANDARD_DEVIATION 2 | 28.1 years STANDARD_DEVIATION 2.5 | 28.1 years STANDARD_DEVIATION 3 |
| Endoscopic experience Assisted colonoscopies completed after training | 2 Number of procedures STANDARD_DEVIATION 3.6 | 1.7 Number of procedures STANDARD_DEVIATION 2.7 | 1.5 Number of procedures STANDARD_DEVIATION 1.9 |
| Endoscopic experience Assisted colonoscopies completed before training | 3.6 Number of procedures STANDARD_DEVIATION 3.4 | 4.5 Number of procedures STANDARD_DEVIATION 8.5 | 5.5 Number of procedures STANDARD_DEVIATION 13.7 |
| Endoscopic experience Assisted EGDs completed after training | 2 Number of procedures STANDARD_DEVIATION 3.5 | 1.7 Number of procedures STANDARD_DEVIATION 2.9 | 1.3 Number of procedures STANDARD_DEVIATION 2.3 |
| Endoscopic experience Assisted EGDs completed before training | 3.2 Number of procedures STANDARD_DEVIATION 4.6 | 4.6 Number of procedures STANDARD_DEVIATION 9 | 6 Number of procedures STANDARD_DEVIATION 13.5 |
| Endoscopic experience Indendent EGDs completed before training | 0.9 Number of procedures STANDARD_DEVIATION 1.7 | 1.3 Number of procedures STANDARD_DEVIATION 3.6 | 1.8 Number of procedures STANDARD_DEVIATION 5.5 |
| Endoscopic experience Independent colonoscopies completed after training | 0 Number of procedures STANDARD_DEVIATION 0 | 0.1 Number of procedures STANDARD_DEVIATION 0.1 | 0.1 Number of procedures STANDARD_DEVIATION 0.3 |
| Endoscopic experience Independent colonoscopies completed before trainin | 0.2 Number of procedures STANDARD_DEVIATION 0.8 | 0.5 Number of procedures STANDARD_DEVIATION 1.8 | 0.8 Number of procedures STANDARD_DEVIATION 2.8 |
| Endoscopic experience Independent EGDs completed after training | 0.2 Number of procedures STANDARD_DEVIATION 0.7 | 0.3 Number of procedures STANDARD_DEVIATION 0.8 | 0.4 Number of procedures STANDARD_DEVIATION 1 |
| Sex: Female, Male Female | 9 Participants | 14 Participants | 5 Participants |
| Sex: Female, Male Male | 10 Participants | 23 Participants | 13 Participants |
| Training program (gastroenterology, general surgery, or internal medicine) Gastroenterology | 4 Participants | 10 Participants | 6 Participants |
| Training program (gastroenterology, general surgery, or internal medicine) General surgery | 14 Participants | 25 Participants | 11 Participants |
| Training program (gastroenterology, general surgery, or internal medicine) Internal medicine | 1 Participants | 2 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 18 | 0 / 19 |
| serious Total, serious adverse events | 0 / 18 | 0 / 19 |
Outcome results
Primary
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.
Time frame: 4-6 weeks post-intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Progressive Group | 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 |
| Progressive Group | 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 |
| High-Fidelity Group | Difference Between Progressive and High-Fidelity Groups on Clinical Colonoscopy Peformance (JAG/DOPS) | Procedure 1 | 59.0 units on a scale | Standard Deviation 7.2 |
| High-Fidelity Group | Difference Between Progressive and High-Fidelity Groups on Clinical Colonoscopy Peformance (JAG/DOPS) | Procedure 2 | 59.1 units on a scale | Standard Deviation 8 |
Secondary
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.
Time frame: Pre-training, immediate post-training
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Progressive Group | Cognitive Knowledge of Endoscopy | Pre-training | 36.2 percentage score on MCQ test | Standard Deviation 14.4 |
| Progressive Group | Cognitive Knowledge of Endoscopy | Immediate post-training | 59.5 percentage score on MCQ test | Standard Deviation 6.8 |
| High-Fidelity Group | Cognitive Knowledge of Endoscopy | Pre-training | 28.6 percentage score on MCQ test | Standard Deviation 12.6 |
| High-Fidelity Group | Cognitive Knowledge of Endoscopy | Immediate post-training | 59.5 percentage score on MCQ test | Standard Deviation 5.4 |
Secondary
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.
Time frame: Pre-training, immediate post-training, and 4-6 weeks after training (delayed post-training)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Progressive Group | Colonoscopy Specific-performance. | Pre-training | 22.04 units on a scale | Standard Deviation 21.18 |
| Progressive Group | Colonoscopy Specific-performance. | Immediate post-training | 75.74 units on a scale | Standard Deviation 16.99 |
| Progressive Group | Colonoscopy Specific-performance. | Delayed post-training | 90.74 units on a scale | Standard Deviation 12.71 |
| High-Fidelity Group | Colonoscopy Specific-performance. | Pre-training | 21.05 units on a scale | Standard Deviation 22.61 |
| High-Fidelity Group | Colonoscopy Specific-performance. | Immediate post-training | 65.96 units on a scale | Standard Deviation 13.9 |
| High-Fidelity Group | Colonoscopy Specific-performance. | Delayed post-training | 77.54 units on a scale | Standard Deviation 16.92 |
Secondary
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.
Time frame: Immediate post-training and 4-6 weeks after training (delayed post-training)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Progressive Group | 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 |
| Progressive Group | 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 |
| Progressive Group | 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 |
| Progressive Group | 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 |
| Progressive Group | 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 |
| Progressive Group | 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 |
| High-Fidelity Group | Colonoscopy Specific Performance, Communication Skills, and Global Performance on an Integrated Scenario | Delayed post - communication skills | 69.21 units on a scale | Standard Deviation 13.15 |
| High-Fidelity Group | Colonoscopy Specific Performance, Communication Skills, and Global Performance on an Integrated Scenario | Immediate post - Colonoscopy specific performance | 56.69 units on a scale | Standard Deviation 13.47 |
| High-Fidelity Group | Colonoscopy Specific Performance, Communication Skills, and Global Performance on an Integrated Scenario | Delayed post - Colonoscopy specific performance | 75.20 units on a scale | Standard Deviation 17.3 |
| High-Fidelity Group | Colonoscopy Specific Performance, Communication Skills, and Global Performance on an Integrated Scenario | Immediate post - Communication skills | 67.89 units on a scale | Standard Deviation 14.27 |
| High-Fidelity Group | Colonoscopy Specific Performance, Communication Skills, and Global Performance on an Integrated Scenario | Delayed post - global performance | 70.33 units on a scale | Standard Deviation 9.6 |
| High-Fidelity Group | Colonoscopy Specific Performance, Communication Skills, and Global Performance on an Integrated Scenario | Immediate post - Global performance | 66.75 units on a scale | Standard Deviation 8.94 |