Education, MedicalCLIEnTNCT05674500
Coaching Language to Improve Endoscopy Training Quality
A study testing Educational Training on standardized coaching language and Educational Training on goal setting in people with Education, Medical and Colonoscopy, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Education, Medical, Colonoscopy
- What is being tested?
- Educational Training on standardized coaching language and Educational Training on goal setting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Mar 2022to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Advanced endoscopy fellows
- Fellows beyond Post-Graduate Year-6 (PGY-6)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Education, Medical, Colonoscopy
- Being tested
- Educational Training on standardized coaching language, Educational Training on goal setting
- Keywords
- Faculty, Fellows, Simulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational Training on standardized coaching languageOther
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).
Educational Training on goal settingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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). Receives: Other: Educational Training on goal setting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Change from Baseline colonoscopy performance at 2 weeks
Secondary outcomes (9)
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.
Measured: Change from baseline time in red-out at 2 weeks
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
Measured: Change from baseline time to cecum at 2 weeks
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).
Measured: Change from Baseline cognitive load at 2 weeks
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).
Measured: Change from Baseline cognitive load at 2 weeks
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).
Measured: Change from Baseline cognitive load at 2 weeks
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.
Measured: Change from Baseline trainer's language assessment at 2 weeks
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)
Measured: Change from Baseline trainer's language assessment at 2 weeks
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
Measured: At 2 weeks
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.
Measured: At 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2023
- Study start23 Mar 2022
- Primary completion30 May 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Education, MedicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- The Hospital for Sick Children
- Responsible party
- Principal investigator, Roopa Vemulapalli, University of Texas Southwestern Medical Center
- Investigators
- Aayush Gabrani, MD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05674500
- Sponsor's protocol ID
- STU-2021-0829
- Acronym
- CLIEnT
- Status last verified
- Aug 2023
- First submitted
- 9 Dec 2022
- Last updated
- 29 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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 27345645Waschke 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 27345649Siau 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 31210174Coderre 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 21165376Walsh 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 27846065Gavin 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.
PubMed 22661458Broekaert 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 31799965Dilly 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 28757268Zawadzki 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 32790087Lauridsen 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 31891790Khan 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 33440438Barton 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 22227035Siau 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.
PubMed 29614526Siau 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 31738285Walsh 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
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Standardized Coaching Language to Improve Endoscopy Training Quality
- ClinicalTrials.gov ID
- NCT05674500
- Acronym / sponsor ID
- CLIEnT / STU-2021-0829
- Conditions
- Education, Medical, Colonoscopy
- Keywords
- Faculty, Fellows, Simulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- The Hospital for Sick Children
- Study start
- 23 Mar 2022 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 6 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training Group | Experimental | Other: Educational Training on standardized coaching languageFaculty 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 |
| Control Group | Active comparator | Other: Educational Training on goal settingFaculty 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Advanced endoscopy fellows
- Fellows beyond Post-Graduate Year-6 (PGY-6)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational Training on standardized coaching languageThe 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). | Other | Training Group |
| Educational Training on goal settingThe 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. | Other | Control Group |
Primary outcome
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 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.
9 secondary outcomes
Change in 'Red-out' time
Time frame: 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
Change in Cognitive load
Time frame: Change from Baseline cognitive load at 2 weeks
Change in Cognitive load
Time frame: Change from Baseline cognitive load at 2 weeks
Change in Cognitive load
Time frame: 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
Change in the trainer's language (assessed by linguistics expert)
Time frame: Change from Baseline trainer's language assessment at 2 weeks
Semi-structured interview of the trainees
Time frame: At 2 weeks
Semi-structured interview of the faculty instructor
Time frame: At 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2023.
- Background: PubMed 27345645Walsh 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.
- Background: PubMed 27345649Waschke 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.
- Background: PubMed 31210174Siau 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.
- Background: PubMed 21165376Coderre 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.
- Background: PubMed 27846065Walsh 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.
- Background: PubMed 22661458Gavin 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.
- Background: PubMed 31799965Broekaert 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.
- Background: PubMed 28757268Dilly 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.
- Background: PubMed 32790087Zawadzki 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.
- Background: PubMed 31891790Lauridsen 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.
- Background: PubMed 33440438Khan 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.
- Background: PubMed 22227035Barton 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.
- NASA-Task Load Index (TLX) scaleLink provided by the sponsor.
- Joint Advisory Group on GI Endoscopy. Course Finder, JAG Endoscopy Training SystemLink provided by the sponsor.
- Canadian Association of Gastroenterology. Skills Enhancement for Endoscopy ProgramLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aayush Gabrani, MD principal investigator
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Training on standardized coaching language and Educational Training on goal setting in people with Education, Medical and Colonoscopy, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in colonoscopy performance (time frame: Change from Baseline colonoscopy performance at 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05674500, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2023.