Competency in General Endoscopic Surgical ProceduresEnCompASNCT02891304
Trial Evaluating Endoscopy Competence Among Gastroenterology Trainees in the Era of the Next Accreditation System.
An observational study of Competency in General Endoscopic Surgical Procedures, run by University of Colorado, Denver.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Competency in General Endoscopic Surgical Procedures
- What is being tested?
- Quarterly Feedback
- How many people
- 157 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to 15 Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Attendings and trainees in GI Fellowship Program
Who may be able to join
- Attendings and trainees in GI Fellowship Program
Who cannot join
- N/A
About this study
Official title: A Prospective Multi-center Randomized Controlled Trial Evaluating Endoscopy Competence Among Gastroenterology Trainees in the Era of the Next Accreditation System.
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.
Read the 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.
- Being tested
- Quarterly Feedback
- Keywords
- esophagogastroduodenoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quarterly FeedbackOther
Learning curves received quarterly vs. annually
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Secondary outcomes (1)
Development of Centralized Performance Database
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 GIFP predictors of competence.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study startJul 2016
- Primary completion15 Jun 2018
- Study completion15 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Competency in General Endoscopic Surgical ProceduresStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles, University of California, Irvine, Drexel University College of Medicine, University of South Alabama, The University of Texas Health Science Center at San Antonio, Northwestern University, University Hospitals Cleveland Medical Center, Advocate Lutheran General Hospital, Washington University School of Medicine, Emory University, Rush University, Ochsner Health System, St. John Providence Health System, University of Wisconsin, Madison, State University of New York - Downstate Medical Center, University of North Carolina, University of Miami, New York Medical College
- Responsible party
- Sponsor
- Investigators
- Sachin Wani, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02891304
- Sponsor's protocol ID
- 16-0782
- Acronym
- EnCompAS
- Status last verified
- Aug 2021
- First submitted
- 29 Aug 2016
- Last updated
- 17 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31715173
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multi-center Randomized Controlled Trial Evaluating Endoscopy Competence Among Gastroenterology Trainees in the Era of the Next Accreditation System.
- ClinicalTrials.gov ID
- NCT02891304
- Acronym / sponsor ID
- EnCompAS / 16-0782
- Keywords
- esophagogastroduodenoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- University of California, Los Angeles, University of California, Irvine, Drexel University College of Medicine, University of South Alabama, The University of Texas Health Science Center at San Antonio, Northwestern University, University Hospitals Cleveland Medical Center, Advocate Lutheran General Hospital, Washington University School of Medicine, Emory University, Rush University, Ochsner Health System, St. John Providence Health System, University of Wisconsin, Madison, State University of New York - Downstate Medical Center, University of North Carolina, University of Miami, New York Medical College
- Study start
- Jul 2016
- Primary completion
- 15 Jun 2018 (actual)
- Study completion
- 15 Jun 2018 (actual)
- First posted
- 7 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quarterly Feedback | – | Other: Quarterly FeedbackIn 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. |
| 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). |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Attendings and trainees in GI Fellowship Program
Key inclusion criteria (1 listed)
- Attendings and trainees in GI Fellowship Program
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quarterly FeedbackLearning curves received quarterly vs. annually | Other | Quarterly Feedback |
Primary outcome
ACE Tool Validation
Time frame: 3 years
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.
1 secondary outcome
Development of Centralized Performance Database
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2021.
- Derived from this study: PubMed 31715173Han 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sachin Wani, MD principal investigator
University of Colorado, Denver
Questions about this trial
What is this clinical trial studying?
An observational study of Competency in General Endoscopic Surgical Procedures, run by University of Colorado, Denver.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ACE Tool Validation (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02891304, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2021.