Supervision for Endoscopy Training

Overseen By Molly Disbrow, MD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Oklahoma

Disqualifiers: Unwilling to consent

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if early supervision (coaching) enhances learning and comfort with colonoscopy skills for medical trainees. Participants will engage in both supervised and unsupervised colonoscopy practice modules to identify which method aids learning more effectively. The trial will assess their skills and confidence through surveys and software measurements. Medical trainees in adult and pediatric gastroenterology fellowships or general surgery residencies at the University of Oklahoma Health Sciences Center who are willing to participate fit well for this study. As an unphased trial, this study offers a unique opportunity to contribute to educational advancements in medical training.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this supervision/coaching method is safe for endoscopy training?

Research has shown that supervision or coaching during colonoscopy training is generally safe for new doctors. One study found that after 101 supervised procedures, trainees met the quality standards for colonoscopies. This indicates that with supervision, trainees can perform the procedure safely and effectively. Another study found that involving trainees in colonoscopies did not negatively affect most outcomes, suggesting that the training process is usually well-tolerated. However, limited information exists on how training with simulations affects skills and safety in endoscopy. Overall, supervised training is a common and accepted practice that helps ensure procedures are done safely. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the impact of supervision and coaching in endoscopy training, a critical area for improving medical procedures. Unlike traditional methods where trainees often learn through unsupervised practice, this trial evaluates how structured guidance can enhance skill acquisition and confidence. By comparing unsupervised and supervised training sessions, the study aims to identify the most effective approach for developing proficient endoscopists, potentially improving patient outcomes and safety in endoscopic procedures.

What evidence suggests that supervision/coaching is effective for endoscopy training?

Research shows that guidance and coaching during endoscopy training can greatly enhance skills. In this trial, participants will experience both supervised and unsupervised training sessions. One study found that trainees who received coaching improved their efficiency in removing polyps, increasing from 10.5% to 13.0% over three years. Another study found that 59.4% of practitioners felt early training had a significant impact on their work. Learning through simulations with coaching helps trainees effectively gain important endoscopy skills. Overall, supervised training boosts performance and confidence in endoscopy procedures. ^{3 6 7 8 9}

Who Is on the Research Team?

William Tierney, MD

Principal Investigator

University of Oklahoma

Are You a Good Fit for This Trial?

This trial is for trainees in adult and pediatric gastroenterology fellowships, as well as general surgery residencies at the University of Oklahoma Health Sciences Center. Participants must consent to join and will provide demographic information.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training

Participants undergo randomized training sessions with both unassisted and supervised/coached colonoscopy modules

1 session

1 visit (in-person)

Follow-up

Participants are monitored for satisfaction and effectiveness of training through surveys and simulator metrics

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Supervision/Coaching

Trial Overview The study tests if supervision during endoscopy simulation training affects learning outcomes. Trainees are randomly assigned to start with either supervised or unsupervised colonoscopy modules before switching to the other type.

How Is the Trial Designed?

Group I: Unsupervised Active Control 1 Intervention

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).

Group II: Supervised Active Control 1 Intervention

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).

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials

484

Recruited

95,900+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11470744/

Impact of advanced endoscopy training on colonoscopy ... Polypectomy efficiency was 10.5%, 11.2%, and 13.0%, with significant improvements from the first to third year (p < 0.01) and from the second to ...

2. turkishjcrd.com turkishjcrd.com/articles/effect-of-a-surgical-endoscopy-training-program-on-postgraduate-daily-practice-results-from-a-single-center/tjcd.galenos.2021.2021-5-4

Effect of a Surgical Endoscopy Training Program on ... Of the respondents, 19 (59.4%) were of the opinion that earlier training had a significant impact on their practice while 12 (37.5%) felt it had ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2590030722000198

Ensuring Quality in Endoscopic Training: Tools for the ... We review tools that the educator can employ such as effective feedback, clinical coaching, and mastery learning.

4. gastrojournal.org gastrojournal.org/article/S0016-5085(20)35011-3/fulltext

Simulation-Based Mastery Learning With Virtual Coaching We aim to describe the applications of ML in training novice endoscopists and demonstrate that trainees can acquire the necessary skills for standardized upper ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/jgh.16794

Prospective study on comparison of simulation‐based ... The simulation-based mastery learning (SBML) method holds promise for improving the efficiency and effectiveness of endoscopy training. However, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2931191/

Assessing Colonoscopy Training Outcomes Using Quality ... Conclusions. Quality indicators for colonoscopy were met after 101 supervised procedures. Postgraduate tracking of nationally recognized colonoscopy quality ...

7. gastrojournal.org gastrojournal.org/article/S0016-5085(24)05119-9/fulltext

Training in Advanced Endoscopy: Current Status and ... Data on the impact of simulation-based training on advanced endoscopy skills acquisition, clinical safety, and outcomes are particularly sparse.

8. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2795794

Association of Trainee Participation in Colonoscopy ... This study suggests that trainee involvement during colonoscopy was associated with reduced ssPDR but not other colonoscopy outcome measures.

9. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/jgh3.13004

Needs assessment of basic gastrointestinal endoscopy ... From our survey, we found that all of the surveyed participants had received supervision during their endoscopy training. However, the degree or ...