Clinical trial NCT02891304: Trial Evaluating Endoscopy Competence Among Gastroenterology Trainees in the Era of the Next Accreditation System.
Official title: A Prospective Multi-center Randomized Controlled Trial Evaluating Endoscopy Competence Among Gastroenterology Trainees in the Era of the Next Accreditation System.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Competency in General Endoscopic Surgical Procedures
Keywords: esophagogastroduodenoscopy
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: University of California, Los Angeles
name: University of California, Irvine
name: Drexel University College of Medicine
name: University of South Alabama
name: The University of Texas Health Science Center at San Antonio
name: Northwestern University
name: University Hospitals Cleveland Medical Center
name: Advocate Lutheran General Hospital
name: Washington University School of Medicine
name: Emory University
name: Rush University
name: Ochsner Health System
name: St. John Providence Health System
name: University of Wisconsin, Madison
name: State University of New York - Downstate Medical Center
name: University of North Carolina
name: University of Miami
name: New York Medical College
First posted: 2016-09-07
Enrollment: 157
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Attendings and trainees in GI Fellowship Program

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.

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.

Eligibility criteria: Inclusion Criteria:

* Attendings and trainees in GI Fellowship Program

Exclusion Criteria:

* N/A

Primary outcomes:
measure: ACE Tool Validation
timeFrame: 3 years
Secondary outcomes:
measure: Development of Centralized Performance Database
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
affiliation: University of Colorado, Denver
name: Sachin Wani, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.