CClinicalTrials.gg
CompletedNCT05674500CLIEnTUpdated Aug 29, 2023

Coaching Language to Improve Endoscopy Training Quality

An interventional study of Educational Training on standardized coaching language and Educational Training on goal setting in Education, Medical and Colonoscopy, sponsored by University of Texas Southwestern Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-29.

Sponsored by University of Texas Southwestern Medical Center · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Mar 2022, registered Dec 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Education, Medical
  • Colonoscopy

Keywords

  • Faculty
  • Fellows
  • Simulation
03

In context

Lead sponsor

University of Texas Southwestern Medical Center is the lead sponsor of 990 studies on the registry; 201 are open to participants now.

Of its 135 completed or terminated interventional studies of FDA-regulated products, 100 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Advanced endoscopy fellows
  • Fellows beyond Post-Graduate Year-6 (PGY-6)
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
25 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • OtherEducational 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).

  • OtherEducational 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.

06

What researchers measure

Primary outcomes

  1. Change in colonoscopy performance

    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.

    Time frame: Change from Baseline colonoscopy performance at 2 weeks

  2. Change in colonoscopy performance

    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.

    Time frame: Change from Baseline colonoscopy performance at 2 weeks

Secondary outcomes

  1. Change in 'Red-out' time

    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.

    Time frame: Change from baseline time in red-out at 2 weeks

  2. Change in time to cecum

    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

    Time frame: Change from baseline time to cecum at 2 weeks

  3. Change in Cognitive load

    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).

    Time frame: Change from Baseline cognitive load at 2 weeks

  4. Change in Cognitive load

    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).

    Time frame: Change from Baseline cognitive load at 2 weeks

  5. Change in Cognitive load

    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).

    Time frame: Change from Baseline cognitive load at 2 weeks

  6. Change in the Clarity of instruction (trainee's perception)

    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.

    Time frame: Change from Baseline trainer's language assessment at 2 weeks

  7. Change in the trainer's language (assessed by linguistics expert)

    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)

    Time frame: Change from Baseline trainer's language assessment at 2 weeks

  8. Semi-structured interview of the trainees

    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

    Time frame: At 2 weeks

  9. Semi-structured interview of the faculty instructor

    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.

    Time frame: At 2 weeks

07

Study locations

1 site
  • UTSW
    Dallas, Texas 75390, United States
08

References and documents

Publications

  • Walsh CM. In-training gastrointestinal endoscopy competency assessment tools: Types of tools, validation and impact. Best Pract Res Clin Gastroenterol. 2016 Jun;30(3):357-74. doi: 10.1016/j.bpg.2016.04.001. Epub 2016 Apr 16. PubMed 27345645 ↗
  • Waschke KA, Anderson J, Macintosh D, Valori RM. Training the gastrointestinal endoscopy trainer. Best Pract Res Clin Gastroenterol. 2016 Jun;30(3):409-19. doi: 10.1016/j.bpg.2016.05.001. Epub 2016 May 14. PubMed 27345649 ↗
  • Siau K, Green JT, Hawkes ND, Broughton R, Feeney M, Dunckley P, Barton JR, Stebbing J, Thomas-Gibson S. Impact of the Joint Advisory Group on Gastrointestinal Endoscopy (JAG) on endoscopy services in the UK and beyond. Frontline Gastroenterol. 2019 Apr;10(2):93-106. doi: 10.1136/flgastro-2018-100969. Epub 2018 Nov 13. PubMed 31210174 ↗
  • Coderre S, Anderson J, Rostom A, McLaughlin K. Training the endoscopy trainer: from general principles to specific concepts. Can J Gastroenterol. 2010 Dec;24(12):700-4. doi: 10.1155/2010/493578. PubMed 21165376 ↗
  • Walsh CM, Anderson JT, Fishman DS. Evidence-based Approach to Training Pediatric Gastrointestinal Endoscopy Trainers. J Pediatr Gastroenterol Nutr. 2017 Apr;64(4):501-504. doi: 10.1097/MPG.0000000000001473. PubMed 27846065 ↗
  • Gavin DR, Valori RM, Anderson JT, Donnelly MT, Williams JG, Swarbrick ET. The national colonoscopy audit: a nationwide assessment of the quality and safety of colonoscopy in the UK. Gut. 2013 Feb;62(2):242-9. doi: 10.1136/gutjnl-2011-301848. Epub 2012 Jun 1. Erratum In: Gut. 2013 Feb;62(2):249. PubMed 22661458 ↗
  • Broekaert I, Tzivinikos C, Narula P, Antunes H, Dias JA, van der Doef H, Isoldi S, Norsa L, Romano C, Scheers I, Silbermintz A, Tavares M, Torroni F, Urs A, Thomson M. European Society for Paediatric Gastroenterology, Hepatology and Nutrition Position Paper on Training in Paediatric Endoscopy. J Pediatr Gastroenterol Nutr. 2020 Jan;70(1):127-140. doi: 10.1097/MPG.0000000000002496. No abstract available. PubMed 31799965 ↗
  • Dilly CK, Sewell JL. How to Give Feedback During Endoscopy Training. Gastroenterology. 2017 Sep;153(3):632-636. doi: 10.1053/j.gastro.2017.07.023. Epub 2017 Jul 27. No abstract available. PubMed 28757268 ↗
  • Zawadzki M, Gomez Ruiz M, Tou S, Jeffels A, Matzel KE. A proposed system for standardized terminology in minimally invasive surgery - a video vignette. Colorectal Dis. 2020 Dec;22(12):2346-2347. doi: 10.1111/codi.15309. Epub 2020 Sep 16. No abstract available. PubMed 32790087 ↗
  • Lauridsen KG, Watanabe I, Lofgren B, Cheng A, Duval-Arnould J, Hunt EA, Good GL, Niles D, Berg RA, Nishisaki A, Nadkarni VM. Standardising communication to improve in-hospital cardiopulmonary resuscitation. Resuscitation. 2020 Feb 1;147:73-80. doi: 10.1016/j.resuscitation.2019.12.013. Epub 2019 Dec 28. PubMed 31891790 ↗
  • Khan R, Zheng E, Wani SB, Scaffidi MA, Jeyalingam T, Gimpaya N, Anderson JT, Grover SC, McCreath G, Walsh CM. Colonoscopy competence assessment tools: a systematic review of validity evidence. Endoscopy. 2021 Dec;53(12):1235-1245. doi: 10.1055/a-1352-7293. Epub 2021 Mar 16. PubMed 33440438 ↗
  • Barton JR, Corbett S, van der Vleuten CP; English Bowel Cancer Screening Programme; UK Joint Advisory Group for Gastrointestinal Endoscopy. The validity and reliability of a Direct Observation of Procedural Skills assessment tool: assessing colonoscopic skills of senior endoscopists. Gastrointest Endosc. 2012 Mar;75(3):591-7. doi: 10.1016/j.gie.2011.09.053. Epub 2012 Jan 9. PubMed 22227035 ↗
  • Siau K, Dunckley P, Valori R, Feeney M, Hawkes ND, Anderson JT, Beales ILP, Wells C, Thomas-Gibson S, Johnson G; Joint Advisory Group on Gastrointestinal Endoscopy (JAG). Changes in scoring of Direct Observation of Procedural Skills (DOPS) forms and the impact on competence assessment. Endoscopy. 2018 Aug;50(8):770-778. doi: 10.1055/a-0576-6667. Epub 2018 Apr 3. Erratum In: Endoscopy. 2018 Aug;50(8):C9. doi: 10.1055/a-0658-2732. PubMed 29614526 ↗
  • Siau K, Crossley J, Dunckley P, Johnson G, Feeney M, Iacucci M, Anderson JT; Joint Advisory Group on Gastrointestinal Endoscopy (JAG). Colonoscopy Direct Observation of Procedural Skills Assessment Tool for Evaluating Competency Development During Training. Am J Gastroenterol. 2020 Feb;115(2):234-243. doi: 10.14309/ajg.0000000000000426. PubMed 31738285 ↗
  • Walsh CM, Ling SC, Khanna N, Grover SC, Yu JJ, Cooper MA, Yong E, Nguyen GC, May G, Walters TD, Reznick R, Rabeneck L, Carnahan H. Gastrointestinal Endoscopy Competency Assessment Tool: reliability and validity evidence. Gastrointest Endosc. 2015;81(6):1417-1424.e2. doi: 10.1016/j.gie.2014.11.030. Epub 2015 Mar 7. PubMed 25753836 ↗
  • Walsh CM, Ling SC, Mamula P, Lightdale JR, Walters TD, Yu JJ, Carnahan H. The gastrointestinal endoscopy competency assessment tool for pediatric colonoscopy. J Pediatr Gastroenterol Nutr. 2015 Apr;60(4):474-80. doi: 10.1097/MPG.0000000000000686. PubMed 25564819 ↗
  • Sewell JL, Boscardin CK, Young JQ, Ten Cate O, O'Sullivan PS. Measuring cognitive load during procedural skills training with colonoscopy as an exemplar. Med Educ. 2016 Jun;50(6):682-92. doi: 10.1111/medu.12965. PubMed 27170086 ↗
  • Sewell JL, Young JQ, Boscardin CK, Ten Cate O, O'Sullivan PS. Trainee perception of cognitive load during observed faculty staff teaching of procedural skills. Med Educ. 2019 Sep;53(9):925-940. doi: 10.1111/medu.13914. Epub 2019 Jun 9. PubMed 31179594 ↗
  • Sewell JL, Bowen JL, Cate OT, O'Sullivan PS, Shah B, Boscardin CK. Learning Challenges, Teaching Strategies, and Cognitive Load: Insights From the Experience of Seasoned Endoscopy Teachers. Acad Med. 2020 May;95(5):794-802. doi: 10.1097/ACM.0000000000002946. PubMed 31425188 ↗
  • Kennedy TJ, Lingard LA. Making sense of grounded theory in medical education. Med Educ. 2006 Feb;40(2):101-8. doi: 10.1111/j.1365-2929.2005.02378.x. PubMed 16451236 ↗

Individual participant data

Plan to share: No — 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.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 29, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05674500
Lead sponsor
University of Texas Southwestern Medical Center
Collaborators
The Hospital for Sick Children
Responsible party
Roopa Vemulapalli (Associate Professor, University of Texas Southwestern Medical Center) — Principal investigator
First posted
Jan 6, 2023
Start date
Mar 23, 2022
Primary completion
May 30, 2023
Completion
Jun 30, 2023
Last update
Aug 29, 2023

Study contacts

Aayush Gabrani, MD
principal investigator · University of Texas

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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