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Outcomes in Simulated Endoscopy Training

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ClinicalTrials.gov Identifier: NCT03495141
Recruitment Status : Recruiting
First Posted : April 11, 2018
Last Update Posted : April 11, 2018
Sponsor:
Information provided by (Responsible Party):
University of Oklahoma

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Impact of Supervision on Endoscopy Simulation Curriculum Behavioral: Supervision/Coaching Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Outcomes assessor will not know who was randomized to supervised versus unsupervised simulator training.
Primary Purpose: Other
Official Title: Simbionix GI Mentor Simulated Endoscopy Training
Actual Study Start Date : March 6, 2018
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

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




Primary Outcome Measures :
  1. Percentage of mucosa inspected [ Time Frame: through study completion, an average of 1 year ]
    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


Secondary Outcome Measures :
  1. Time to reach cecum [ Time Frame: through study completion, an average of 1 year ]
    Time to reach cecum after time of colonoscope insertion

  2. Participant satisfaction score [ Time Frame: through study completion, an average of 1 year ]
    Participants will be asked to self-report satisfaction with supervised and unsupervised endoscopic simultator experiences



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03495141


Contacts
Contact: William Tierney, MD 405-271-5428 William-Tierney@ouhsc.edu
Contact: Molly Disbrow, MD 405-559-1450 molly-disbrow@ouhsc.edu

Locations
United States, Oklahoma
University of Oklahoma Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Samantha Harbert    405-271-2045    Samantha-Harbert@ouhsc.edu   
Sponsors and Collaborators
University of Oklahoma
Investigators
Principal Investigator: William Tierney, MD University of Oklahoma

Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT03495141     History of Changes
Other Study ID Numbers: 8244
First Posted: April 11, 2018    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No