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OpenTrials
Completed

NCT Number: NCT02891304

Trial Evaluating Endoscopy Competence Among Gastroenterology Trainees in the Era of the Next Accreditation System.

Hypothesis: ACE (The Assessment in Competency in Endoscopy Tool) tool for colonoscopy and EGD (Esophagogastroduodenoscopy) allows for reliable standardized learning curves, competency benchmarks, and creation of a centralized database that compares trainee performance amongst peers. Trainees receiving quarterly learning curves achieve competence in endoscopic procedures at a faster rate (ie less procedures) compared to trainees receiving usual feedback on endoscopic performance as established by their respective GI (gastrointestinal) fellowship program.

Aims: To compare the number of procedures necessary to achieve competence in EGD and colonoscopy between trainees receiving learning curve performance feedback every three months in addition to standard feedback versus trainees receiving annual learning curve performance feedback in addition to standard feedback for these endoscopic procedures. To demonstrate the feasibility of development and adoption of a centralized database that would allow program directors and general GI trainees to generate performance reports in relation to national peers to provide real-time targeted performance feedback during training and evaluate trainee and GI fellowship program directors predictors of competence.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

About this study

There has been an increasing emphasis on standardizing competency assessment and demonstrating readiness for independent practice as medical training transitions from an apprenticeship model to competency based medical education (CBME). The Accreditation Council for Graduate Medical Education (ACGME) replaced their long-standing reporting system in 2014 with the Next Accreditation System (NAS). For Gastroenterology (GI) fellowship programs (GIFPs), this includes assessing and documenting competence in basic endoscopic procedures [esophagogastroduodenoscopy (EGD)] in a continuous fashion. For colonoscopy, the prior minimum threshold of 140 procedures after which competence can be assessed was based on surrogates of competence such as cecal intubation rate, with limited assessment of technical and cognitive skills required to perform high-quality endoscopic examination. Recent data has demonstrated wide variability in trainee learning curves, hence emphasis needs to be shifted away from the volume of procedures performed to independent performance of well-defined metrics. Tools with comprehensive assessment of motor and cognitive abilities have been developed. The American Society for Gastrointestinal Endoscopy (ASGE) endorsed the assessment of competence in endoscopy tool (ACE) designed to help GIFPs facilitate implementation of the NAS requirements. While the ACE tool for EGD has yet to be validated, Sedlack and colleagues recently validated the ACE tool in colonoscopy. Multicenter prospective data are needed to help guide development of CBME that define learning curves in colonoscopy and EGD and generate a centralized database which will allow programs to provide individualized feedback and follow trainee performance longitudinally throughout training.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Attendings and trainees in GI Fellowship Program

Exclusion criteria

  • N/A

Treatment and study plan

Quarterly Feedback

Other

Learning curves received quarterly vs. annually

Primary outcomes

  1. ACE Tool Validation

    Time frame: 3 years

    Primary Aim: Using the ACE tool with a comprehensive electronic data collection and reporting system, the primary aim of this study is to compare the number of procedures necessary to achieve competence in EGD and colonoscopy between trainees receiving learning curve performance feedback every three months in addition to standard feedback as provided by supervising attendings at a given institution versus trainees receiving annual learning curve performance feedback in addition to standard feedback for these endoscopic procedures as provided by supervising attendings at a given institution.

Secondary outcomes

  1. Development of Centralized Performance Database

    Time frame: 3 years

    To demonstrate the feasibility of development and adoption of a centralized database that would allow program directors and general GI trainees to generate performance reports in relation to national peers to provide real-time targeted performance feedback during training and evaluate trainee and GIFP predictors of competence.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Advocate Lutheran General Hospital
  • Drexel University College of Medicine
  • Emory University
  • New York Medical College
  • Northwestern University
  • Ochsner Health System
  • Rush University
  • St. John Providence Health System
  • State University of New York - Downstate Medical Center
  • The University of Texas Health Science Center at San Antonio
  • University Hospitals Cleveland Medical Center
  • University of California, Irvine
  • University of California, Los Angeles
  • University of Miami
  • University of North Carolina
  • University of South Alabama
  • University of Wisconsin, Madison
  • Washington University School of Medicine

Registry information

Official study title

A Prospective Multi-center Randomized Controlled Trial Evaluating Endoscopy Competence Among Gastroenterology Trainees in the Era of the Next Accreditation System.

Acronym: EnCompAS

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 7, 2016
Registry last updated
Aug 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.