Online Education Module to Accurately Classify Polyp Size (ESTIMATE)

November 29, 2023 updated by: University of Colorado, Denver

Online Education Module (ESTIMATE: Estimating Polyp Size With Snare Tool to Improve Measurement Accuracy for Trainee Education) to Accurately Classify Polyp Size

Investigators developed an online educational module (ESTIMATE) to teach Gastroenterology (GI) trainees how to estimate polyp size using a snare. Key components include video instruction and real-time feedback incorporated over a 40-item polyp size assessment test. Trainees from GI fellowship programs will be randomized to one of four groups: control (no video, no feedback), video-only, feedback-only, and video + feedback. Participants will classify polyps into one of three size categories:- diminutive (1-5 mm), small (6-9 mm), and large (≥10 mm). Primary outcome is accuracy of polyp size classification [diminutive (1-5 mm), small (6-9 mm), and large (≥10 mm)]. Secondary outcomes include accuracy of exact polyp size (in mm), cumulative accuracy (to plot learning curves), confidence level of polyp size classification, and directionality of inaccuracy (polyp size overestimation vs underestimation).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Study Design This is a prospective, multicenter educational randomized controlled trial. Trainees from five Accreditation Council for Graduate Medical Education (ACGME)-accredited GI fellowship training programs in the US will be invited to participate.

Study Materials (ESTIMATE Online Educational Module) The Estimating Polyp Size with Snare Tool to Improve Measurement Accuracy for Trainee Education (ESTIMATE) online educational module was developed by the study team over an 11-month development phase from September 2020 - August 2021. ESTIMATE is a user-friendly, interactive, web-based teaching module consisting of two main educational components: (1) video instruction and (2) real-time feedback during a polyp size assessment test. Video instruction is provided in a five-minute didactic clip that narrates the importance of accurate polyp size classification and demonstrates proper technique for positioning the snare to estimate polyp size. Examples of both correct and incorrect technique are provided. Several case examples, with opportunity for trainee interaction and response, are also included.

The polyp size assessment test includes 40 polyp sizing questions. Each question contains a still image of a polyp with an adjacent snare and asks participants to correctly identify the polyp's size into one of the following clinically relevant size categories: diminutive (1-5 mm), small (6-9 mm), and large (≥10 mm), as well as the exact polyp size in mm. Participants are also asked to provide their confidence level (high or low) with each response. High confidence is defined as a sufficient level of certainty in polyp size to commit to a surveillance interval recommendation based on the response. Low confidence is defined as an insufficient level of certainty in polyp size to commit to a surveillance interval recommendation based on the response.

Real-time feedback on correct polyp size is provided immediately after a response is submitted in the form of a series of images with overlying graphics that demonstrate polyp size relative to the adjacent snare with a final image of the resected polyp affixed to a cork board and ruler. Investigators used measurement of the immediate post-resection, pre-formalin fixation polyp affixed to a cork board with an adjacent ruler to determine correct size. The feedback image deck will be provided in continuous fashion after each response as participants progress through the test.

Randomization In order to assess the impact of the key educational components of our module (video instruction and feedback), participants will be randomized in REDCap to one of four study groups: control, video-only, feedback-only, or video + feedback. The control group will complete the 40-item polyp size assessment test without receiving any video instruction or feedback. The video-only group will watch the video instructional clip and then completed the assessment, but will not receive any feedback after each question. The feedback-only group will receive feedback after each question, but will not watch the video. Lastly, the video + feedback group will receive both video instruction and feedback as they complete the assessment.

Data Collection and Reporting System All data will be collected and managed using Research Electronic Data capture (REDCap).

Statistical Analysis & Sample Size Considerations Bivariable analyses will be performed to identify potential differences between groups. Binomial regressions will be conducted to detect differences between the control and intervention groups in accuracy of polyp size by size classification and exact size in mm. Generalized linear mixed models will be used to assess differences in confidence while accounting for multiple responses within each participant. Models will be evaluated using a type I error rate of 0.05. Analyses will be conducted using R version 4.1.1. In order to achieve 80% power to detect a 20% difference between the three intervention groups and the control group, we will need to enroll twelve trainees within each group (48 total).

Study Type

Interventional

Enrollment (Estimated)

48

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
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Denver

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • GI trainees who have never received formal training in, nor had participated in a research study on, polyp sizing
  • Informed consent

Exclusion Criteria:

  • Those who do not complete the educational module during the allotted time

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: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
No video tutorial, no feedback
Active Comparator: Feedback
Feedback only
Other: ESTIMATE
An online educational module consisting of a video tutorial and feedback during a questionnaire
Active Comparator: Video
Video tutorial only
Other: ESTIMATE
An online educational module consisting of a video tutorial and feedback during a questionnaire
Experimental: Video + Feedback
VIdeo tutorial and feedback
Other: ESTIMATE
An online educational module consisting of a video tutorial and feedback during a questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participant entered rate of accurate polyp size classification into diminutive (1-5 mm), small (6-9 mm), or large (≥10 mm) category on 40 question polyp sizing test.
Time Frame: through study completion, estimated 1 year

The gold standard polyp size for the polyp images on the polyp sizing test was determined by affixing the polyp to a cork board post-procedure and measuring it with an adjacent ruler. The actual polyp size was determined by meauring it against the adjacent ruler. Polyps 1-5 mm were categorized as diminutive, polyps 6-9 mm were categorized as small and polyps ≥10 mm were categorized as large.

Participants completed a 40 item polyp sizing test where participants designated the polyp as either dimunitive (1-5mm), small (6-9mm) or large (≥10mm). The primary outcome was the rate that each participant correctly designated polyp size categories based on the gold standard.
through study completion, estimated 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participant entered rate of accurate polyp size by millimeter on 40 question polyp sizing test.
Time Frame: through study completion, estimated 1 year
Participant rate of accurate polyp size by millimeter (1mm, 2mm, 3mm, 4mm, 5mm, 6mm, 7mm, 8mm, 9mm, 10mm, 11mm, 12mm, 13mm, 14mm, 15mm, 16mm, 17mm, 18mm, 19mm, 20mm, etc) on 40 question polyp sizing test.
through study completion, estimated 1 year
Cumulative accuracy of polyp size category classification as participants progress through the 40 item polyp sizing test
Time Frame: through study completion, estimated 1 year
Cumulative accuracy of polyp size category classification as participants progress through the 40 item polyp sizing test
through study completion, estimated 1 year
Participant report of categorical high versus low confidence on each response of the 40 item polyp sizing test
Time Frame: through study completion, estimated 1 year
self-reported high vs low confidence of each polyp characterization. High confidence is defined as sufficient self-assessed confidence that participant can make a post-polypectomy surveillance interval recommendation based on their designation. This is categorical selection of "high" vs "low"
through study completion, estimated 1 year
Proportion of participant responses that underestimate actual polyp size category versus overestimate actual polyp size category on the 40-question polyp sizing test.
Time Frame: through study completion, estimated 1 year
Proportion of responses that underestimate actual polyp size category (a small or large polyp categorized as diminutive or a large polyp categorized as small) versus overestimate actual polyp size category (a diminutive or small polyp characterized as large or a diminutive polyp characterized as small).
through study completion, estimated 1 year

Collaborators and Investigators

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

Sponsor

University of Colorado, Denver

Collaborators

Northwestern University
University of California, San Francisco

Investigators

  • Principal Investigator: Swati G Patel, MD, University of Colorado Anschutz Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

November 1, 2021

Primary Completion (Actual)

November 30, 2021

Study Completion (Estimated)

December 28, 2024

Study Registration Dates

First Submitted

March 28, 2023

First Submitted That Met QC Criteria

April 26, 2023

First Posted (Actual)

May 6, 2023

Study Record Updates

Last Update Posted (Actual)

November 30, 2023

Last Update Submitted That Met QC Criteria

November 29, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-1413

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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