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

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: Colorectal Cancer
• Intervention / Treatment: Behavioral: Video-based terminal feedback

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	Observing cold snare polypectomy of polyps <1cm as assessed by DOPyS (score greater or equal to 3)	2 years

Collaborators and Investigators

• 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

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: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• 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