Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06376006
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-24
First Post:
2024-04-17
Brief Title:
Evaluating Learning Curves and Competence in Colorectal Endoscopic Mucosal Resection Among Advanced Endoscopy Trainees
Sponsor:
AdventHealth
Organization:
AdventHealth
Study Overview
Official Title:
Prospective Multicenter Study Evaluating Learning Curves and Competence in Colorectal Endoscopic Mucosal Resection Among Advanced Endoscopy Trainees Using A Standardized Assessment Tool A Quality Improvement Initiative
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EMR-STAT
Brief Summary:
Quality improvement project with the aim to use a standardized assessment tool EMR-STAT to establish learning curves and competence thresholds for key cognitive and technical colorectal EMR core skills among advanced endoscopy trainees AETs
Detailed Description:
Baseline and Post-Training Questionnaires The EMR-STAT Baseline Questionnaire is to better understand the participants level of comfort with the C-EMR procedure At the end of their training the participant will complete the EMR-STAT Post-Training Questionnaire to evaluate their training experience
Standardized Assessment tool EMR-STAT and Grading Protocol Phase 1 The EMR-STAT is a tool designed for competence assessment The tool will be used in a continuous fashion during the AETs training in colorectal EMR The aim of the tool is to evaluate key concepts and core skills necessary for high-quality colorectal EMR as recently outlined by the US Multi-Society Task Force on Colorectal Cancer10 We have previously demonstrated the feasibility of this tool in a prior study9 The instrument evaluates for key cognitive and technical steps including scope positioning lesion assessment submucosal lifting endoscopic resection adjunct resectionablative techniques management of adverse events and elective defect closure A 4-point scoring system was developed to grade each endpoint 4 superior achieves task without instruction 3 advanced achieves with minimal verbal cues 2 intermediate achieves with multiple verbal cues or hands-on assistance 1 novice unable to complete and requires trainer to take over Setting these pre-defined anchors for specific individual cognitive and technical skills during grading ensures that the data collected are reproducible from one evaluator to the next In addition a 10-point overall assessment score 1-3 below average 4-6 intermediate 7-9 advanced 10 superior will be provided for each case This grading format for endoscopic performance has been previously validated61112
The trainees will be evaluated during live cases as part of the training experience There will patient data that will be collected on the EMR_STAT but no patient identifiers will be documented This data collection is integral to the study because these factors may play a role in the complexity of the procedure and impact trainees EMR performance ex a cancerous lesion is more difficult to dissect than a non-cancerous lesion This data will be analyzed as part of the learning curve for the trainees
Standardized Assessment tool EMR-STAT and Grading Protocol Phase 1 The EMR-STAT is a tool designed for competence assessment The tool will be used in a continuous fashion during the AETs training in colorectal EMR The aim of the tool is to evaluate key concepts and core skills necessary for high-quality colorectal EMR as recently outlined by the US Multi-Society Task Force on Colorectal Cancer10 We have previously demonstrated the feasibility of this tool in a prior study9 The instrument evaluates for key cognitive and technical steps including scope positioning lesion assessment submucosal lifting endoscopic resection adjunct resectionablative techniques management of adverse events and elective defect closure A 4-point scoring system was developed to grade each endpoint 4 superior achieves task without instruction 3 advanced achieves with minimal verbal cues 2 intermediate achieves with multiple verbal cues or hands-on assistance 1 novice unable to complete and requires trainer to take over Setting these pre-defined anchors for specific individual cognitive and technical skills during grading ensures that the data collected are reproducible from one evaluator to the next In addition a 10-point overall assessment score 1-3 below average 4-6 intermediate 7-9 advanced 10 superior will be provided for each case This grading format for endoscopic performance has been previously validated61112
The trainees will be evaluated during live cases as part of the training experience There will patient data that will be collected on the EMR_STAT but no patient identifiers will be documented This data collection is integral to the study because these factors may play a role in the complexity of the procedure and impact trainees EMR performance ex a cancerous lesion is more difficult to dissect than a non-cancerous lesion This data will be analyzed as part of the learning curve for the trainees
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None