Improving Competency and Metrics for PoLypectomy Skills Using Evaluation Tools and VidEo Feedback (COMPLETE) (COMPLETE)

November 4, 2020 updated by: Tonya Kaltenbach, San Francisco Veterans Affairs Medical Center

Training for COMPLETE Polyp Resection During Colonoscopy -Improving Competency and Metrics for PoLypectomy Skills Using Evaluation Tools and VidEo Feedback

I plan to investigate the value of video-based feedback in endoscopic training - specifically, the role of terminal video feedback as compared to usual concurrent feedback on cold snare polypectomy technique in trainees, using Direct Observation of Polypectomy Skills (DOPyS) competency score. I have focused the study on the competency of cold snare polypectomy for subcentimeter polyps. The majority (>75%) of colon polyps are smaller than one centimeter. Cold snare polypectomy has been shown, and recommended by the American Society for Gastrointestinal Endoscopy (ASGE), to be an effective removal technique. However, its widespread use and moreover, its teaching to trainees is lacking. It takes time and resources to learn and teach endoscopic techniques. Our study will hope to identify a mechanism through video-based feedback that could help to improve the translation of the training of polypectomy skills to its actual performance, and to accelerate the learning curve.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94121
        • San Francisco VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participants: Senior level UCSF gastroenterology trainees (2nd and 3rd year GI fellows) rotating at the San Francisco Veterans Affairs Medical Center (SFVAMC).
  • Patients undergoing elective routine colonoscopy procedure.

Exclusion Criteria:

  • Participants: Junior level University of California, San Francisco (UCSF) gastroenterology trainees (1st year GI fellows) rotating at the San Francisco Veterans Affairs Medical Center, and senior level trainees who are not rotating at the SFVAMC.
  • Patients: Patients undergoing undergoing emergency colonoscopy procedure.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Video-based terminal feedback
Behavioral: Video-based terminal feedback
Terminal feedback is given after skill performance using video-based coaching coupled with a validated polypectomy assessment tool
No Intervention: Conventional concurrent feedback

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of polypectomies for gastroenterology trainees to achieve competency
Time Frame: 2 years
Observing cold snare polypectomy of polyps <1cm as assessed by DOPyS (score greater or equal to 3)
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

San Francisco Veterans Affairs Medical Center

Collaborators

University of Colorado, Denver
University of Kansas Medical Center
Colorado Clinical & Translational Sciences Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2017

Primary Completion (Actual)

June 1, 2020

Study Completion (Actual)

August 30, 2020

Study Registration Dates

First Submitted

April 11, 2017

First Submitted That Met QC Criteria

April 11, 2017

First Posted (Actual)

April 14, 2017

Study Record Updates

Last Update Posted (Actual)

November 5, 2020

Last Update Submitted That Met QC Criteria

November 4, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COMPLETE 16-21096

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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