NCT02247115

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2014

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 23, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

March 20, 2017

Status Verified

March 1, 2017

Enrollment Period

1.3 years

First QC Date

September 15, 2014

Last Update Submit

March 17, 2017

Conditions

Keywords

endoscopic ultrasoundendoscopic retrograde cholangiopancreatographycompetency

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Competency in EUS

    Up to 12 months

  • Competency in ERCP

    Up to 12 months

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

  • 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.

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Sachin Wani, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2014

First Posted

September 23, 2014

Study Start

July 1, 2014

Primary Completion

November 1, 2015

Study Completion

November 1, 2016

Last Updated

March 20, 2017

Record last verified: 2017-03