NCT05674500

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 23, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 9, 2022

Completed
28 days until next milestone

First Posted

Study publicly available on registry

January 6, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

August 29, 2023

Status Verified

August 1, 2023

Enrollment Period

1.2 years

First QC Date

December 9, 2022

Last Update Submit

August 24, 2023

Conditions

Keywords

FacultyFellowsSimulation

Outcome Measures

Primary Outcomes (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 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

    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 Outcomes (9)

  • Change in 'Red-out' time

    Change from baseline time in red-out at 2 weeks

  • Change in time to cecum

    Change from baseline time to cecum at 2 weeks

  • Change in Cognitive load

    Change from Baseline cognitive load at 2 weeks

  • Change in Cognitive load

    Change from Baseline cognitive load at 2 weeks

  • Change in Cognitive load

    Change from Baseline cognitive load at 2 weeks

  • +4 more secondary outcomes

Study Arms (2)

Training Group

EXPERIMENTAL

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

Control Group

ACTIVE COMPARATOR

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

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).

Training Group

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.

Control Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UTSW

Dallas, Texas, 75390, United States

Location

Related Publications (20)

  • 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.

    PMID: 27345645BACKGROUND
  • 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.

    PMID: 27345649BACKGROUND
  • 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.

    PMID: 31210174BACKGROUND
  • 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.

    PMID: 21165376BACKGROUND
  • 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.

    PMID: 27846065BACKGROUND
  • 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.

    PMID: 22661458BACKGROUND
  • 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.

    PMID: 31799965BACKGROUND
  • 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.

    PMID: 28757268BACKGROUND
  • 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.

    PMID: 32790087BACKGROUND
  • 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.

    PMID: 31891790BACKGROUND
  • 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.

    PMID: 33440438BACKGROUND
  • 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.

    PMID: 22227035BACKGROUND
  • 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.

    PMID: 29614526BACKGROUND
  • 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.

    PMID: 31738285BACKGROUND
  • 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.

    PMID: 25753836BACKGROUND
  • 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.

    PMID: 25564819BACKGROUND
  • 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.

    PMID: 27170086BACKGROUND
  • 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.

    PMID: 31179594BACKGROUND
  • 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.

    PMID: 31425188BACKGROUND
  • 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.

    PMID: 16451236BACKGROUND

Related Links

Study Officials

  • Aayush Gabrani, MD

    University of Texas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 9, 2022

First Posted

January 6, 2023

Study Start

March 23, 2022

Primary Completion

May 30, 2023

Study Completion

June 30, 2023

Last Updated

August 29, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

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.

Locations