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

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Video-based terminal feedback
Sponsored by
San Francisco Veterans Affairs Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Colorectal Cancer

Eligibility Criteria

25 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • San Francisco VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Video-based terminal feedback

Conventional concurrent feedback

Arm Description

Outcomes

Primary Outcome Measures

Number of polypectomies for gastroenterology trainees to achieve competency
Observing cold snare polypectomy of polyps <1cm as assessed by DOPyS (score greater or equal to 3)

Secondary Outcome Measures

Full Information

First Posted
April 11, 2017
Last Updated
November 4, 2020
Sponsor
San Francisco Veterans Affairs Medical Center
Collaborators
University of Colorado, Denver, Colorado Clinical & Translational Sciences Institute, University of Kansas Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03115008
Brief Title
Improving Competency and Metrics for PoLypectomy Skills Using Evaluation Tools and VidEo Feedback (COMPLETE)
Acronym
COMPLETE
Official Title
Training for COMPLETE Polyp Resection During Colonoscopy -Improving Competency and Metrics for PoLypectomy Skills Using Evaluation Tools and VidEo Feedback
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
June 1, 2020 (Actual)
Study Completion Date
August 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
San Francisco Veterans Affairs Medical Center
Collaborators
University of Colorado, Denver, Colorado Clinical & Translational Sciences Institute, University of Kansas Medical Center

4. Oversight

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

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Video-based terminal feedback
Arm Type
Experimental
Arm Title
Conventional concurrent feedback
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Video-based terminal feedback
Intervention Description
Terminal feedback is given after skill performance using video-based coaching coupled with a validated polypectomy assessment tool
Primary Outcome Measure Information:
Title
Number of polypectomies for gastroenterology trainees to achieve competency
Description
Observing cold snare polypectomy of polyps <1cm as assessed by DOPyS (score greater or equal to 3)
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
San Francisco VA Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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