Colonoscopy Clinical Trial
— CLIEnTOfficial title:
A Prospective Study of Standardized Coaching Language to Improve Endoscopy Training Quality
Verified date | August 2023 |
Source | University of Texas Southwestern Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 25 |
Est. completion date | June 30, 2023 |
Est. primary completion date | May 30, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | UTSW | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
University of Texas Southwestern Medical Center | The Hospital for Sick Children |
United States,
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* Note: There are 20 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | 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. | Change from baseline time in red-out at 2 weeks | |
Secondary | 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 | Change from baseline time to cecum at 2 weeks | |
Secondary | 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). | Change from Baseline cognitive load at 2 weeks | |
Secondary | 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). |
Change from Baseline cognitive load at 2 weeks | |
Secondary | 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). |
Change from Baseline cognitive load at 2 weeks | |
Secondary | 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. |
Change from Baseline trainer's language assessment at 2 weeks | |
Secondary | 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) |
Change from Baseline trainer's language assessment at 2 weeks | |
Secondary | 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 | At 2 weeks | |
Secondary | 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. | At 2 weeks |
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