Colorectal Cancer
Conditions
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.
Interventions
BEHAVIORALCurriculum Group
BEHAVIORALSelf-directed learning group
Sponsors
Unity Health Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Trainee endoscopists from the gastroenterology and general surgery programs at the University of Toronto
Exclusion criteria
* Greater than 20 colonoscopies performed
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Transfer of Skills to Clinical Colonoscopy | less than 2 weeks | 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
| Measure | Time frame | Description |
|---|---|---|
| Retention of Clinical Skills | 4-6 weeks after 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 during an integrated scenario. A change in these ratings before and after intervention is the secondary outcome. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Curriculum Group 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. | 16 |
| Self-directed Learning Group The self-directed group will receive 8 hours of colonoscopic virtual reality (VR) simulation practice with an experienced endoscopist present, but without structured training. | 17 |
| Total | 33 |
Baseline characteristics
| Characteristic | Total | Curriculum Group | Self-directed Learning Group |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 33 Participants | 16 Participants | 17 Participants |
| Age, Continuous | 29.1 years STANDARD_DEVIATION 2.9 | 28.4 years STANDARD_DEVIATION 1.3 | 29.7 years STANDARD_DEVIATION 3.8 |
| Number of assisted colonoscopies performed | 1.7 Colonoscopies STANDARD_DEVIATION 4.5 | 2.7 Colonoscopies STANDARD_DEVIATION 7.7 | 0.8 Colonoscopies STANDARD_DEVIATION 1.5 |
| Number of independent colonoscopies performed | 0.65 colonoscopies STANDARD_DEVIATION 2.7 | 0.6 colonoscopies STANDARD_DEVIATION 2.5 | 0.7 colonoscopies STANDARD_DEVIATION 2.9 |
| Race and Ethnicity Not Collected | 0 Participants | — | — |
| Sex: Female, Male Female | 13 Participants | 9 Participants | 4 Participants |
| Sex: Female, Male Male | 20 Participants | 7 Participants | 13 Participants |
| Training program (gastroenterology, general surgery, or internal medicine) Gastroenterology | 12 Participants | 8 Participants | 4 Participants |
| Training program (gastroenterology, general surgery, or internal medicine) General surgery | 19 Participants | 8 Participants | 11 Participants |
| Training program (gastroenterology, general surgery, or internal medicine) Internal Medicine | 2 Participants | 0 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 16 | 0 / 17 |
| serious Total, serious adverse events | 0 / 16 | 0 / 17 |
Outcome results
Primary
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.
Time frame: less than 2 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Curriculum Group | Transfer of Skills to Clinical Colonoscopy | Procedure 1 | 72.2 units on a scale | Standard Deviation 10.9 |
| Curriculum Group | Transfer of Skills to Clinical Colonoscopy | Procedure 2 | 71.9 units on a scale | Standard Deviation 16.7 |
| Self-directed Learning Group | Transfer of Skills to Clinical Colonoscopy | Procedure 1 | 31.8 units on a scale | Standard Deviation 14.8 |
| Self-directed Learning Group | Transfer of Skills to Clinical Colonoscopy | Procedure 2 | 32.3 units on a scale | Standard Deviation 18.3 |
Secondary
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.
Time frame: 4-6 weeks after intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Curriculum Group | Retention of Clinical Skills | Colonoscopy-specific performance | 67 units on a scale | Standard Deviation 12.1 |
| Curriculum Group | Retention of Clinical Skills | Communication skills | 83.1 units on a scale | Standard Deviation 5.7 |
| Curriculum Group | Retention of Clinical Skills | Global performance | 69.4 units on a scale | Standard Deviation 7 |
| Self-directed Learning Group | Retention of Clinical Skills | Colonoscopy-specific performance | 54.3 units on a scale | Standard Deviation 14.3 |
| Self-directed Learning Group | Retention of Clinical Skills | Communication skills | 75.9 units on a scale | Standard Deviation 9.7 |
| Self-directed Learning Group | Retention of Clinical Skills | Global performance | 63.5 units on a scale | Standard Deviation 8.8 |