Outcomes in Simulated Endoscopy Training

Simbionix GI Mentor Simulated Endoscopy Training

Eligible participants are those who are members of the general surgery residency pediatric gastroenterology fellowship, and adult gastroenterology fellowship. Through a randomized-controlled trial, participants will fill out a baseline set of demographic information including year of training, approximate number of colonoscopies to date, specialty, age, sex and handedness. Participation in this activity is completely voluntary. Trainees will be randomized to one of two groups. Either first participating in an unassisted colonoscopy module twice and then taking a questionnaire and then transitioning to a supervised/coached colonoscopy module session twice and taking a questionnaire, versus the reverse, in which the participant first partakes in a supervised/coached colonoscopy module session twice and then transitions to performing a colonoscopy module twice, unassisted. Objective measures will be assessed by the module software and supervising faculty. Specifically, using individuals' survey responses to see if early supervision improves survey scores. Survey questions focus on student learning, completing module objectives and faculty performance in simulation. The survey will also ask subjects to self-rate their scores and comfort level with endoscopy skills. Survey responses will not be linked to an individuals' performance in their program training and endoscopy coaches will not be made aware of the survey responses.

Study Overview

• Status: Recruiting
• Conditions: Impact of Supervision on Endoscopy Simulation Curriculum
• Intervention / Treatment: Behavioral: Supervision/Coaching

Detailed Description

This will be a randomized controlled trial in which eligible participants will be members of the general surgery residency and adult gastroenterology fellowship. Investigators will ask all consenting participants to fill out a baseline set of demographic information including their year of training, the approximate number of colonoscopies to date, specialty, age, sex and dominant-handedness. Additional questions to be asked will inquire about the participant's experience in regard to the unassisted and supervision/coached colonoscopy module experience. Participation in this activity is completely voluntary, and the participating trainee is under no obligation to complete or finish the simulation or subsequent surveys The participant will be randomized to one of two groups. A computer program will make this random assignment. Neither the participant nor their physician coach will be able to choose which group they will be in. Participants will either first partake in an unassisted colonoscopy module twice (case one and case two) and then transition to a supervised/coached colonoscopy module session twice (case three and case four). The alternative is in which the participant first partakes in a supervised/coached colonoscopy module session twice (case one and case two) and then transitions to performing an unassisted colonoscopy module twice (case three and case four). A questionnaire examining training experience will be administered after case # 4 in both groups. This survey will take approximately 5 minutes to complete. Other objective measures will be assessed by supervising faculty and other metrics acquired through the simulator software. Individuals' survey responses will be used to see if early supervision improves trainee satisfaction and perceptions on survey scores. Participants will attend one individual training session date that will satisfy the designed simulation experience. The trainee can stop participating in this study at any time and participation in the study is voluntary and trainees may choose not to participate. It is important to note that refusal to participate will not affect a learner's access to the training center and will not affect their standing in their respective training program. The results will not be included in their official training record. Note no prior procedural or technical knowledge is required. Enrollment will continue for the 2018-2019 academic year and possibly academic years thereafter.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: William Tierney, MD; Phone Number: 405-271-5428; Email: William-Tierney@ouhsc.edu
• Study Contact Backup: Name: Molly Disbrow, MD; Phone Number: 405-559-1450; Email: molly-disbrow@ouhsc.edu

Study Locations

• United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Recruiting
      • University of Oklahoma
      • Contact: Samantha Harbert; Phone Number: 405-271-2045; Email: Samantha-Harbert@ouhsc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Consenting trainees of adult and pediatric gastroenterology fellowships and general surgery residencies at the University of Oklahoma Health Sciences Center.

Exclusion Criteria:

• Unwilling to consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Supervised; Participants first take part in supervised/coached colonoscopy module session twice (case one and case two) and then transition to performing an unassisted colonoscopy module twice (case three and case four).	Behavioral: Supervision/Coaching; Supervision involves coaching the trainee on insertion and withdrawal technique in a standard colonoscopy in a novice trainee
Active Comparator: Unsupervised; Participants will either first partake in an unsupervised colonoscopy module twice (case one and case two) and then transition to a supervised/coached colonoscopy module session twice (case three and case four).	Behavioral: Supervision/Coaching; Supervision involves coaching the trainee on insertion and withdrawal technique in a standard colonoscopy in a novice trainee

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of mucosa inspected	The primary outcome will be the difference in percentage of mucosa inspected between the two study groups based on the report of the simulator after each of 4 predefined cases	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to reach cecum	Time to reach cecum after time of colonoscope insertion	through study completion, an average of 1 year
Participant satisfaction score	Participants will be asked to self-report satisfaction with supervised and unsupervised endoscopic simulator experiences	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: University of Oklahoma
• Investigators: Principal Investigator: William Tierney, MD, University of Oklahoma

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2018
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: March 13, 2018
• First Submitted That Met QC Criteria: April 10, 2018
• First Posted (Actual): April 11, 2018

Study Record Updates

• Last Update Posted (Actual): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 8244

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Participant data will only be known to PI and co-investigator (this writer) and de-identified data will be used for statistical analysis.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No