Trial Outcomes & Findings for A Randomized Control Trial of a Simulation-based Curriculum to Enhance Skills in Colonoscopy (NCT NCT01991522)

NCT ID: NCT01991522

Last Updated: 2018-11-05

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. 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.

Recruitment status

COMPLETED

Study phase

Target enrollment

33 participants

Primary outcome timeframe

less than 2 weeks

Results posted on

2018-11-05

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	16	17
Overall Study COMPLETED	16	17
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Curriculum Group n=16 Participants 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.	Self-directed Learning Group n=17 Participants The self-directed group will receive 8 hours of colonoscopic virtual reality (VR) simulation practice with an experienced endoscopist present, but without structured training.	Total n=33 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=16 Participants	0 Participants n=17 Participants	0 Participants n=33 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=16 Participants	17 Participants n=17 Participants	33 Participants n=33 Participants
Age, Categorical >=65 years	0 Participants n=16 Participants	0 Participants n=17 Participants	0 Participants n=33 Participants
Age, Continuous	28.4 years STANDARD_DEVIATION 1.3 • n=16 Participants	29.7 years STANDARD_DEVIATION 3.8 • n=17 Participants	29.1 years STANDARD_DEVIATION 2.9 • n=33 Participants
Sex: Female, Male Female	9 Participants n=16 Participants	4 Participants n=17 Participants	13 Participants n=33 Participants
Sex: Female, Male Male	7 Participants n=16 Participants	13 Participants n=17 Participants	20 Participants n=33 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Training program (gastroenterology, general surgery, or internal medicine) Gastroenterology	8 Participants n=16 Participants	4 Participants n=17 Participants	12 Participants n=33 Participants
Training program (gastroenterology, general surgery, or internal medicine) General surgery	8 Participants n=16 Participants	11 Participants n=17 Participants	19 Participants n=33 Participants
Training program (gastroenterology, general surgery, or internal medicine) Internal Medicine	0 Participants n=16 Participants	2 Participants n=17 Participants	2 Participants n=33 Participants
Number of independent colonoscopies performed	0.6 colonoscopies STANDARD_DEVIATION 2.5 • n=16 Participants	0.7 colonoscopies STANDARD_DEVIATION 2.9 • n=17 Participants	0.65 colonoscopies STANDARD_DEVIATION 2.7 • n=33 Participants
Number of assisted colonoscopies performed	2.7 Colonoscopies STANDARD_DEVIATION 7.7 • n=16 Participants	0.8 Colonoscopies STANDARD_DEVIATION 1.5 • n=17 Participants	1.7 Colonoscopies STANDARD_DEVIATION 4.5 • n=33 Participants

PRIMARY outcome

Timeframe: less than 2 weeks

Outcome measures

Outcome measures
Measure	Curriculum Group n=16 Participants 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.	Self-directed Learning Group n=17 Participants The self-directed group will receive 8 hours of colonoscopic virtual reality (VR) simulation practice with an experienced endoscopist present, but without structured training.
Transfer of Skills to Clinical Colonoscopy Procedure 1	72.2 units on a scale Standard Deviation 10.9	31.8 units on a scale Standard Deviation 14.8
Transfer of Skills to Clinical Colonoscopy Procedure 2	71.9 units on a scale Standard Deviation 16.7	32.3 units on a scale Standard Deviation 18.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Curriculum Group n=16 Participants 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.	Self-directed Learning Group n=17 Participants The self-directed group will receive 8 hours of colonoscopic virtual reality (VR) simulation practice with an experienced endoscopist present, but without structured training.
Retention of Clinical Skills Colonoscopy-specific performance	67 units on a scale Standard Deviation 12.1	54.3 units on a scale Standard Deviation 14.3
Retention of Clinical Skills Communication skills	83.1 units on a scale Standard Deviation 5.7	75.9 units on a scale Standard Deviation 9.7
Retention of Clinical Skills Global performance	69.4 units on a scale Standard Deviation 7	63.5 units on a scale Standard Deviation 8.8

Adverse Events

Curriculum Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Self-directed Learning 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

Dr. Samir C. Grover

St. Michael's

Phone: 416-864-5628

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place