Rapid Assessment of Trainee Endoscopy Skills (RATES) Study Two

Competency Based Education Clinical Trial

— RATES 2  

Official title:

Rapid Assessment of Trainee Endoscopy Skills (RATES) Study Two: A Prospective Multicenter Study Evaluating Competence in Endoscopic Ultrasound and Endoscopic Retrograde Cholangiopancreatogram Among Advanced Endoscopy Trainees

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02509416
• Other study ID #: 14-0604-2
• Status: Completed
• Start date: July 2015
• Est. completion date: June 15, 2017

Study information

• Verified date: August 2021
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The establishment of a number of training programs in therapeutic endoscopy, standardization of the performance of endoscopic ultrasound (EUS) and endoscopy retrograde cholangiopancreatography (ERCP) and definition of competence is of paramount importance. The length of training and minimum number of procedures, requisite theoretical learning and methodology to define competence in EUS and ERCP are not well defined. The investigators research has demonstrated that individuals in training acquire skills at different rates and the number of procedures completed alone is a suboptimal marker for competency in a given procedure. Hence, emphasis needs to be shifted away from the number of procedures performed to performance metrics with well-defined and validated thresholds of performance. Multicenter prospective data are needed to help guide development of competency based medical education that define learning curves in EUS and ERCP and set evidence-based benchmarks required to achieve competence using a validated competency assessment tool.

Hypothesis: The central hypothesis is that a validated EUS and ERCP competency assessment tool will allow for reliable and generalizable standardized learning curves, competency benchmarks and creation of a centralized national database that compares a trainee's performance amongst peers.

Description:

Competency-based medical education and milestones: Given the increasing emphasis on quality metrics and competency in health care, the Accreditation Council for Graduate Medical Education (ACGME) recently announced plans to replace their current reporting system in 2014 with the Next Accreditation System (NAS). This reporting system focused on: 1) ensuring that milestones are reached at various points in training, 2) ensuring that competence is achieved by all trainees, and 3) making certain that these assessments are documented by their programs.

Learning curves and competence in EUS: EUS is a vital tool in the diagnosis and staging of gastrointestinal and certain non-gastrointestinal malignancies and diseases. EUS is operator dependent and training in EUS requires the development of technical and cognitive skills beyond that required for standard endoscopic procedures. It is intuitive that the quality of EUS in provision of patient care is directly proportional to the training, skill and experience of the endosonographer. Unfortunately, the intensity and length of training and minimum number of procedures required, requisite curriculum and extent of theoretical learning, and methodology to define competence are not well defined. There are limited data on learning curves in EUS imaging.Based on expert opinion, the American Society of Gastrointestinal Endoscopy (ASGE) recommends a minimum of 150 total supervised procedures, 75 of which have a pancreatobiliary indication and 50 cases of fine needle aspiration (FNA) (25 of which are pancreatic FNA) before competency can be determined.

Similar guidelines were recently proposed by the British Society of Gastroenterology (BSG)13 and the European Society of Gastrointestinal Endoscopy. However, these guidelines have not been validated. This does not account for the different rates at which people learn and in fact, many experts believe that the majority of trainees will require double the number of proposed procedures to achieve competency in EUS.

Learning curves and competence in ERCP: ERCP is an effective modality in the evaluation and management of pancreatobiliary diseases. This procedure can be technically demanding and associated with a wide range of adverse events. Technically failed ERCP may result in complications, need for additional procedures and their associated costs. Similar to EUS, ERCP is operator dependent and requires acquisition of certain technical and cognitive skills. There are limited data on learning curves and competence in ERCP, a cannulation rate of >80% (with some suggesting >90%) has been considered a surrogate for trainee competency. The ASGE recommends a minimum of 180 total procedures, the majority of which are therapeutic before competency can be achieved. However, this threshold is based predominantly on biliary cannulation success rate and does not take into account procedure complexity and the different rates at which people learn. It is also important to note that none of the previous studies have evaluated learning curves and competency in other quality indicators such as successful stone extraction, traversing and dilating a stricture, stent placement to name a few.

Competency assessment tools: Previous competency assessment tools have focused primarily on a limited number of motor skills involved in EUS and ERCP with no procedure-related cognitive skill assessment. The investigators have designed a prospective comprehensive competency assessment tool using validated benchmarks to define competency thresholds. The EUS and ERCP Skills Assessment Tool (TEESAT) can be used in a continuous fashion throughout the duration of training to grade technical and cognitive skills in EUS and ERCP in a balanced manner.

Significance, Innovation and Impact on Training and Education with the launch of the ACGME's NAS, advanced endoscopy training programs should utilize competency based medical education and demonstrate that advanced endoscopy trainees (AETs) have attained the technical and cognitive skills required for safe and effective unsupervised practice in advanced endoscopy. Based on the investigators research, the investigators can draw two conclusions: a) individuals in training in any technical procedure acquire skills at different rates and emphasis needs to be shifted away from the number of procedures performed to performance metrics with defined and validated competency thresholds of performance and b) current guidelines of performing 150 EUS and 180 ERCPs are inadequate to achieve competence in EUS and ERCP, respectively. With the expanding indications and applications of EUS and ERCP and establishment of a number of "third tier" training programs in advanced endoscopy, standardization of the performance of EUS and ERCP and definition of competence and training among AETs is of paramount importance. The potential impacts of this study's results are multifold: i) facilitate the ability of training programs to evolve with the new ACGME/NAS reporting requirements, (ii) help program directors/trainers and trainees identify specific skill deficiencies in training and allowing for tailored, individualized remediation, (iii) create a centralized national database that would allow generation of "on-demand" detailed reports on how individual trainees are progressing compared with their peers across the nation, (iv) establish reliable and generalizable standardized learning curves (milestones) and competency benchmarks that national GI societies and training programs can use to develop credentialing guidelines.

APPROACH AND RESEARCH STRATEGY Setting and Subject Recruitment: Program directors and AETs at all advanced endoscopy programs registered with the ASGE will be invited to participate in this study and will be considered as study participants. AETs will complete a questionnaire to determine baseline characteristics and prior experience with EUS and ERCP. AETs' prior experience with EUS and ERCP will not be an exclusion criterion for this study.

Competency assessment tools: Previous competency assessment tools have focused primarily on a limited number of motor skills involved in EUS and ERCP with no procedure-related cognitive skill assessment. The investigators have designed a prospective comprehensive competency assessment tool using validated benchmarks to define competency thresholds. The EUS and ERCP Skills Assessment Tool (TEESAT) can be used in a continuous fashion throughout the duration of training to grade technical and cognitive skills in EUS and ERCP in a balanced manner.

Learning curves during independent practice and Quality Indicators in EUS and ERCP: The ASGE and ACG Task Force on Quality in Endoscopy recently published documents highlighting quality indicators in EUS and ERCP. Impact of structured feedback on learning curves, specifically related to quality metrics, during the first year of independent practice for AETs has not been evaluated. This is an important component of construct validity for the proposed assessment tool and novel web-based comprehensive data collection and reporting, was identified as a priority research question by the Task Force. The defined performance targets and quality metrics will serve as benchmarks for analysis during training and first year of independent practice.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: June 15, 2017
• Est. primary completion date: June 15, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Program directors and AETs at all advanced endoscopy programs registered with the ASGE will be invited to participate in this study and will be considered as study participants.

Exclusion Criteria:

• N/A

Related Conditions & MeSH terms

• Competency Based Education

Locations

Country	Name	City	State
n/a

Sponsors (38)

Lead Sponsor

Collaborator

University of Colorado, Denver

Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Carolinas Medical Center, Columbia University, Dartmouth-Hitchcock Medical Center, Duke University, Emory University, Feinberg School of Medicine, Northwestern University, Geisinger Clinic, H. Lee Moffitt Cancer Center and Research Institute, Henry Ford Hospital, Icahn School of Medicine at Mount Sinai, Indiana University, Johns Hopkins University, Mayo Clinic, St. Luke's Medical Center, Stanford University, Stony Brook University, The Cleveland Clinic, The University of Texas Health Science Center at San Antonio, University Hospitals Cleveland Medical Center, University of Alberta, University of California, Davis, University of California, Los Angeles, University of Florida, University of Kansas, University of Massachusetts, Worcester, University of Michigan, University of North Carolina, University of Pennsylvania, University of Texas, University of Virginia, University of Wisconsin, Madison, Vanderbilt University Medical Center, Virginia Mason Hospital/Medical Center, Washington University School of Medicine, Weill Medical College of Cornell University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall competency	The proportion of advanced endoscopy trainees (AETs) that achieve overall competency in EUS and ERCP using a standardized competency assessment tool with a comprehensive data collection and reporting system.	Up to 12 months
Secondary	Number of advanced endoscopy fellows that reach competency	Creation of a nationalized database utilizing the comprehensive assessment tool as to have advanced endoscopy fellows compare themselves to the national average in EUS and ERCP exams.	Up to 12 months