NCT02891304

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
157

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2016

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, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 7, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2018

Completed
Last Updated

August 17, 2021

Status Verified

August 1, 2021

Enrollment Period

2 years

First QC Date

August 29, 2016

Last Update Submit

August 13, 2021

Conditions

Keywords

esophagogastroduodenoscopy

Outcome Measures

Primary Outcomes (1)

  • ACE Tool Validation

    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.

    3 years

Secondary Outcomes (1)

  • Development of Centralized Performance Database

    3 years

Study Arms (2)

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

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).

Interventions

Learning curves received quarterly vs. annually

Quarterly Feedback

Eligibility Criteria

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

Attendings and trainees in GI Fellowship Program

You may qualify if:

  • Attendings and trainees in GI Fellowship Program

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

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

August 29, 2016

First Posted

September 7, 2016

Study Start

July 1, 2016

Primary Completion

June 15, 2018

Study Completion

June 15, 2018

Last Updated

August 17, 2021

Record last verified: 2021-08