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

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ClinicalTrials.gov Identifier: NCT02891304
Recruitment Status : Enrolling by invitation
First Posted : September 7, 2016
Last Update Posted : August 24, 2020
Sponsor:
Collaborators:
University of California, Los Angeles
University of California, Irvine
Drexel University College of Medicine
University of South Alabama
The University of Texas Health Science Center at San Antonio
Northwestern University
University Hospitals Cleveland Medical Center
Advocate Lutheran General Hospital
Washington University School of Medicine
Emory University
Rush University
Ochsner Health System
St. John Providence Health System
University of Wisconsin, Madison
State University of New York - Downstate Medical Center
University of North Carolina
University of Miami
New York Medical College
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:

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.


Condition or disease Intervention/treatment
Competency in General Endoscopic Surgical Procedures Other: Quarterly Feedback

Detailed Description:
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.

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Study Type : Observational
Estimated Enrollment : 220 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Multi-center Randomized Controlled Trial Evaluating Endoscopy Competence Among Gastroenterology Trainees in the Era of the Next Accreditation System.
Study Start Date : July 2016
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Group/Cohort Intervention/treatment
Quarterly Feedback
In addition to each center's traditional endoscopic feedback for trainees, centers/trainees will receive objective feedback every 3-months on trainee overall performance including learning curves on ACE tool performance, performance relative to de-identified anonymous peers on each of the individual skills (e.g. fine tip control), and the global assessment for technical and cognitive skill achievement. For those skills which are not advanced/superior - trainees will additionally receive links to online didactic videos which teach these skills.
Other: Quarterly Feedback
Learning curves received quarterly vs. annually

Annual Feedback
In addition to each center's traditional endoscopic feedback for trainees, centers/trainees will receive learning curves at the end of each training year. Learning curves, relative to de-identified anonymous peers will be provided to program directors annually (June).



Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Attendings and trainees in GI Fellowship Program
Criteria

Inclusion Criteria:

  • Attendings and trainees in GI Fellowship Program

Exclusion Criteria:

  • N/A

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02891304


Sponsors and Collaborators
University of Colorado, Denver
University of California, Los Angeles
University of California, Irvine
Drexel University College of Medicine
University of South Alabama
The University of Texas Health Science Center at San Antonio
Northwestern University
University Hospitals Cleveland Medical Center
Advocate Lutheran General Hospital
Washington University School of Medicine
Emory University
Rush University
Ochsner Health System
St. John Providence Health System
University of Wisconsin, Madison
State University of New York - Downstate Medical Center
University of North Carolina
University of Miami
New York Medical College
Investigators
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Principal Investigator: Sachin Wani, MD University of Colorado, Denver
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02891304    
Other Study ID Numbers: 16-0782
First Posted: September 7, 2016    Key Record Dates
Last Update Posted: August 24, 2020
Last Verified: August 2020
Keywords provided by University of Colorado, Denver:
esophagogastroduodenoscopy