跳至主要内容
临床试验/NCT03495141
NCT03495141招募中不适用

Simbionix GI Mentor Simulated Endoscopy Training

University of Oklahoma1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年3月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
1
主要终点
Percentage of mucosa inspected

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

盲法说明

Outcomes assessor will not know who was randomized to supervised versus unsupervised simulator training.

入排标准

年龄范围
22 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • Unwilling to consent.

研究组 & 干预措施

Supervised

Active Comparator

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).

干预措施: Supervision/Coaching (Behavioral)

Unsupervised

Active Comparator

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).

干预措施: Supervision/Coaching (Behavioral)

结局指标

主要结局

Percentage of mucosa inspected

时间窗: 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

次要结局

  • Time to reach cecum(through study completion, an average of 1 year)
  • Participant satisfaction score(through study completion, an average of 1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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