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

NCT ID: NCT02891304

Last Updated: 2021-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

157 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-07-31

Study Completion Date

2018-06-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Competency in General Endoscopic Surgical Procedures

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Quarterly Feedback

Intervention Type OTHER

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).

No interventions assigned to this group

Interventions

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Quarterly Feedback

Learning curves received quarterly vs. annually

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Attendings and trainees in GI Fellowship Program

Exclusion Criteria

* N/A
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, Los Angeles

OTHER

Sponsor Role collaborator

University of California, Irvine

OTHER

Sponsor Role collaborator

Drexel University College of Medicine

OTHER

Sponsor Role collaborator

University of South Alabama

OTHER

Sponsor Role collaborator

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role collaborator

University Hospitals Cleveland Medical Center

OTHER

Sponsor Role collaborator

Advocate Lutheran General Hospital

OTHER

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role collaborator

Emory University

OTHER

Sponsor Role collaborator

Rush University

OTHER

Sponsor Role collaborator

Ochsner Health System

OTHER

Sponsor Role collaborator

St. John Providence Health System

OTHER

Sponsor Role collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role collaborator

State University of New York - Downstate Medical Center

OTHER

Sponsor Role collaborator

University of North Carolina

OTHER

Sponsor Role collaborator

University of Miami

OTHER

Sponsor Role collaborator

New York Medical College

OTHER

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sachin Wani, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

References

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Han S, Obuch JC, Keswani RN, Hall M, Patel SG, Menard-Katcher P, Simon V, Ezekwe E, Aagaard E, Ahmad A, Alghamdi S, Austin K, Brimhall B, Broy C, Carlin L, Cooley M, Di Palma JA, Duloy AM, Early DS, Ellert S, Gaumnitz EA, Goyal J, Kathpalia P, Day L, El-Nachef N, Kerman D, Lee RH, Lunsford T, Mittal M, Morigeau K, Pietrak S, Piper M, Shah AS, Shapiro AB, Shergill A, Sonnier W, Sorrell C, Vignesh S, Wani S. Effect of individualized feedback on learning curves in EGD and colonoscopy: a cluster randomized controlled trial. Gastrointest Endosc. 2020 Apr;91(4):882-893.e4. doi: 10.1016/j.gie.2019.10.032. Epub 2019 Nov 9.

Reference Type DERIVED
PMID: 31715173 (View on PubMed)

Other Identifiers

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16-0782

Identifier Type: -

Identifier Source: org_study_id

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