Coaching Language to Improve Endoscopy Training Quality (CLIEnT)

August 24, 2023 updated by: Roopa Vemulapalli, University of Texas Southwestern Medical Center

A Prospective Study of Standardized Coaching Language to Improve Endoscopy Training Quality

The goal of this randomized control study is to determine if the use of standardized coaching language by faculty trainers for teaching colonoscopy is associated with improved colonoscopy performance. The main questions it aims to answer are:

  • If the use of standardized coaching language is effective in improving colonoscopy training?
  • If the use of standardized coaching language influences the clarity of instructions by the faculty trainers during colonoscopy teaching Participants will take part in simulated colonoscopy teaching encounter using a virtual reality simulator for 1 hour in 2 different sessions 2 weeks apart.

Researchers will compare 2 groups of faculty trainers to to see if the standardized coaching language effects the colonoscopy training quality.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

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

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Faculty members who are endoscopy trainers in either pediatric or adult gastroenterology division at University of Texas Southwestern Medical Center or Children's Medical Center, Dallas
  • Fellow trainees in pediatric or adult gastroenterology division at University of Texas Southwestern Medical Center or Children's Medical Center, Dallas

Exclusion Criteria:

  • Advanced endoscopy fellows
  • Fellows beyond Post-Graduate Year-6 (PGY-6)

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Training Group

Faculty participants will participate in educational training designed to teach them standardized coaching language for endoscopy instruction and strategies to promote effective communication during an endoscopy teaching. It will be comprised of:

  1. A 15-minute-long training video demonstrating the use of recommended coaching language for endoscopy instruction (e.g., recommended 14 standard terms, need to refer to the screen when directing a trainee as opposed to their hands, use of a clockface analogy) and communication best practices (e.g., checking to ensure understanding, avoidance of cognitive overload, task deconstruction)
  2. The faculty will be given a small (10x10 cm) flash card with the recommended 14 standard terms which they can access during the second simulated encounter. To control for any potential effect of the presence of the card on the trainee during teaching, each faculty be given an identical card with 14 random words on it to hold during the first encounter
Other: Educational Training on standardized coaching language
The faculty trainer participants in training groups will watch a 15-min long video between the two simulated endoscopy teaching encounters. The video link will be emailed to them 1 week before the second simulated encounter, and they can watch it in their own time. The training video will demonstrate the use of recommended coaching language for endoscopy instruction (e.g., recommended 14 standard terms, need to refer to the screen when directing a trainee as opposed to their hands, use of a clockface analogy) and communication best practices (e.g., checking to ensure understanding, avoidance of cognitive overload, task deconstruction).
Active Comparator: Control Group

Faculty participants will take part in 'dummy' educational training comprised of:

  1. A 15-minute-long 'dummy' colonoscopy training video which outlines how to set goals ahead of an endoscopy training session. The video will not discuss standardized coaching language and/or communication best practices
  2. This group will also be provided a small (10x10cm) flash card but with random words on it (identical to the first simulated colonoscopy teaching encounter).
Other: Educational Training on goal setting
The faculty trainer participants in the control groups will watch a 15-min long video between the two simulated endoscopy teaching encounters. The video link will be emailed to them 1 week before the second simulated encounter, and they can watch it in their own time. The video will be a 'dummy' colonoscopy training video which outlines how to set goals ahead of an endoscopy training session. The video will not discuss standardized coaching language and/or communication best practices.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in colonoscopy performance
Time Frame: Change from Baseline colonoscopy performance at 2 weeks

The de-identified video-recording of the simulated colonoscopy will be assessed by blinded external rater.

This will be done using the Gastrointestinal Endoscopy Competency Assessment Tool (GiECAT) which is a colonoscopy assessment tool with strong validity evidence. For the GiECAT, 6 global rating items on supervision scale (measuring from 1 to 5) and 5 checklist items which are applicable to simulated procedures (i.e., no patients involved) will be used. Since it is a competency based tool with a checklist, there is no maximum score, but instead is a rating scale.

To ensure blinding, only the trainee's gloved hands will be seen, and the videos used for assessment of colonoscopy performance will not have sound to control for any effects the faculty instruction may have on the ratings of performance.
Change from Baseline colonoscopy performance at 2 weeks
Change in colonoscopy performance
Time Frame: Change from Baseline colonoscopy performance at 2 weeks

The de-identified video-recording of the simulated colonoscopy will be assessed by blinded external rater.

This will be done using another colonoscopy assessment form with strong validity evidence - 8 'Procedure' items from the Joint Advisory Group on GI Endoscopy (JAG) Colonoscopy Direct Observation of Procedural Skills (DOPS) form. This is a supervision-based scale (measuring from 1 to 4). Since this is also a competency based tool with a checklist, it has a rating scale with no maximum score.

To ensure blinding, only the trainee's gloved hands will be seen, and the videos used for assessment of colonoscopy performance will not have sound to control for any effects the faculty instruction may have on the ratings of performance.
Change from Baseline colonoscopy performance at 2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in 'Red-out' time
Time Frame: Change from baseline time in red-out at 2 weeks
The percentage of procedure time during which the endoscope tip (camera) was against the mucosa of the virtual bowel (i.e., there was no proper visualization of the bowel mucosa - appears as 'reddened out screen', aka 'red-out'), as auto-generated automatically by the colonoscopy simulator. The percentage ranges from 0 to 100.
Change from baseline time in red-out at 2 weeks
Change in time to cecum
Time Frame: Change from baseline time to cecum at 2 weeks
The time it took the trainee to reach the cecum, as auto-generated automatically by the colonoscopy simulator. This is reported in minutes and seconds (min:sec). The range from 0 to 20 minutes
Change from baseline time to cecum at 2 weeks
Change in Cognitive load
Time Frame: Change from Baseline cognitive load at 2 weeks
Printed forms will be given to all participants immediately after the pre-and post-sessions to measure the cognitive load. It will be measured by 3 measurement tools (Outcome 5-7) Overall cognitive load: A single item rating tool asking participants to rate the amount of mental effort they required to complete the simulated endoscopy on a 9-point scale (1 = very, very small effort and 9 = very, very high effort).
Change from Baseline cognitive load at 2 weeks
Change in Cognitive load
Time Frame: Change from Baseline cognitive load at 2 weeks

Printed forms will be given to all participants immediately after the pre-and post-sessions to measure the cognitive load.

NASA Task Load Index (NASA-TLX): A 6-item rating scale with strong validity evidence that assesses perceived demand, effort and frustration in performing the task, with higher scores indicating an increased cognitive load (Ranges from 0 to 20).
Change from Baseline cognitive load at 2 weeks
Change in Cognitive load
Time Frame: Change from Baseline cognitive load at 2 weeks

Printed forms will be given to all participants immediately after the pre-and post-sessions to measure the cognitive load.

Cognitive Load Index for Colonoscopy (for trainees ONLY): A measure of intrinsic, extraneous, and germane cognitive load related to performing colonoscopy. Fifteen items that are applicable to the simulation will be rated. Given the nature of this scale, it will be administered to trainees only. Scale ranges from 1 (strongly disagree) to 10 (strongly agree).
Change from Baseline cognitive load at 2 weeks
Change in the Clarity of instruction (trainee's perception)
Time Frame: Change from Baseline trainer's language assessment at 2 weeks

The clarity of instruction will be rated by the trainee on a Likert scale, using linguistics specific metrics developed an expert in linguistics. Description-based scale with following categories- Excellent, Satisfactory, Needs Improvement and Not Acceptable.

This form will be provided to the trainees only to assess their perception of the instructions provided by the faculty instructor.
Change from Baseline trainer's language assessment at 2 weeks
Change in the trainer's language (assessed by linguistics expert)
Time Frame: Change from Baseline trainer's language assessment at 2 weeks

Based on the de-identified video recordings, the trainer's clarity of instructions and use of recommended language will be rated using specialized linguistic-designed assessment rubric by a blinded external linguistics expert.

Name of Measurement- Clarity of language and use of standardized terminology Measurement Tool- Linguistics rubric (descriptive rating scale, with following categories- Excellent, Satisfactory, Needs Improvement and Not Acceptable)
Change from Baseline trainer's language assessment at 2 weeks
Semi-structured interview of the trainees
Time Frame: At 2 weeks
In order to complement and enhance the data from above mentioned assessment tools (i.e., clarity of instruction, cognitive load), trainees will be asked to participate in a short 10-15 minute interview with the PI and/or Co-PI after the they have completed all 4 simulated cases, to explore their perceptions of instruction provided. The interview guide has been adapted from a study examining gastroenterology trainees' perception of endoscopy training activities. Interviews will be transcribed (removing any identifiers) and coded qualitatively using a constant comparison approach to compare differences in trainee's perceptions between groups
At 2 weeks
Semi-structured interview of the faculty instructor
Time Frame: At 2 weeks
In order to explore faculty's perceptions of the training modality being tested, faculty participants will also be asked to participate in a separate 10-15 minute long semi-structured interview with the PI and/or co-PI, after completing the 2 simulation sessions with a trainee fellow. The interview guide has been adapted from a study exploring endoscopy trainers' experience in teaching endoscopy. Interview will be transcribed and coded qualitatively using a constant comparison approach to explore the faculty's perception of the instructional strategies.
At 2 weeks

Collaborators and Investigators

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

Sponsor

University of Texas Southwestern Medical Center

Collaborators

The Hospital for Sick Children

Investigators

  • Principal Investigator: Aayush Gabrani, MD, University of Texas

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

Helpful Links

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)

March 23, 2022

Primary Completion (Actual)

May 30, 2023

Study Completion (Actual)

June 30, 2023

Study Registration Dates

First Submitted

December 9, 2022

First Submitted That Met QC Criteria

December 30, 2022

First Posted (Actual)

January 6, 2023

Study Record Updates

Last Update Posted (Actual)

August 29, 2023

Last Update Submitted That Met QC Criteria

August 24, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • STU-2021-0829

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual Participant Data (IPD) will not be shared because this was not included in the consent form at the time of study design. Most of the participants have already been consented and recruited to participate and IPD was not included in that discussion.

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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