Skip to content

Evaluating Learning Curves and Competence in Colorectal Endoscopic Mucosal Resection Among Advanced Endoscopy Trainees

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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06376006
Acronym
EMR-STAT
Enrollment
42
Registered
2024-04-19
Start date
2022-05-11
Completion date
2026-11-01
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Assessment, Self, Competence

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 participant's 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 resection/ablative 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 validated6,11,12 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

Interventions

BEHAVIORALEMR STAT - Survey

Surveys are completed before and after Advanced Fellow Training.

Sponsors

AdventHealth
Lead SponsorOTHER
Duke University
CollaboratorOTHER
University of South Florida
CollaboratorOTHER
Stony Brook University
CollaboratorOTHER
Atrium Medical Center
CollaboratorOTHER
Hofstra University
CollaboratorOTHER
Long Island Jewish Medical Center
CollaboratorOTHER
Vanderbilt University
CollaboratorOTHER
Yale University
CollaboratorOTHER
Columbia University
CollaboratorOTHER
Geisinger Clinic
CollaboratorOTHER
University of Virginia
CollaboratorOTHER
Baylor University
CollaboratorOTHER
University of Kentucky
CollaboratorOTHER
Cedars-Sinai Medical Center
CollaboratorOTHER
University of Chicago
CollaboratorOTHER
University of California, Irvine
CollaboratorOTHER
University of Alabama at Birmingham
CollaboratorOTHER
Beth Israel Deaconess Medical Center
CollaboratorOTHER
Unity Health Toronto
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* 1\. All AETs from the participating centers starting their advanced endoscopy fellowship training in the academic year of 2022 (regardless of prior experience with colorectal EMR) * 2\. Patients 18 years of age or older undergoing colonoscopy with EMR by the AET being evaluated for this study

Exclusion criteria

* 1\. AETs in Advanced endoscopy programs that do not train AETs in colorectal EMR or AETs who do not intend to train in colorectal EMR during their fellowship will be excluded

Design outcomes

Primary

MeasureTime frameDescription
Primary Endpoint12 monthsThe primary endpoint will be the establishment of minimum thresholds in colorectal EMR training, including benchmarks for pre-defined cognitive and technical core skills based on the survey responses from study participants.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORDennis Yang, MD

AdventHealth

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 28, 2026