Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02247115 |
| Other study ID # |
14-0604 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
September 15, 2014 |
| Last updated |
March 17, 2017 |
| Start date |
July 2014 |
| Est. completion date |
November 2016 |
Study information
| Verified date |
March 2017 |
| Source |
University of Colorado, Denver |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| 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 ACGME 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)
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 American Society of Gastrointestinal Endoscopy (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 tool: TEESAT, a tool designed for competency assessment, will be used
in a continuous fashion throughout the duration of training to grade technical and cognitive
skills in EUS and ERCP. The investigators have demonstrated he feasibility and validity of
this tool in previous studies.3-5 This tool uses a 4-point scoring system: 1-no assistance,
2-achieves with minimal verbal cues, 3-multiple verbal cues or hands on assistance needed,
4-unable to complete. Setting these anchors for specifics skills and behaviors for what is
expected to achieve each score will ensure that the data collected are reproducible from one
evaluator to the next. Technical aspects during EUS exams include grading of individual EUS
stations and technical success in EUS-FNA. Cognitive aspects include identification of
lesion of interest, appropriate classification of malignant tumors (TNM) staging
characterization of subepithelial lesions. Technical aspects during biliary/pancreatic ERCP
include endpoints such as intubation, achieving the short position, identification of the
papilla, cannulation of desired duct, sphincterotomy, stone removal and stent placement.
Cognitive aspects will include clear demonstration of indication of the procedure,
appropriate use of fluoroscopy and logical plan based on cholangiogram/pancreatogram
findings. This tool includes documentation of immediate and post-procedure complications.
Grading protocol: All AETs will be introduced to both the cognitive and technical aspects of
EUS and ERCP procedures at the onset of training. Although TEESAT is self-explanatory, the
program directors at each center will ensure that the AETs and trainers are familiar with
TEESAT's specific assessment parameters and score explanations. After completion of 25
hands-on EUS and ERCP exams, AETs will be graded on every ERCP and 3rd EUS exam by attending
endoscopists (trainers) at each center. This frequency of grading was chosen based on the
investigators pilot data. Grading of every 3rd EUS exam as opposed to every exam was chosen
given the fairly homogenous population undergoing EUS compared to ERCP. Procedures that the
AETs have no hands-on participation will be excluded for grading. If the exam eligible for
grading is an incomplete procedure for reasons such as medical instability, this exam will
not be used for grading. Trainers will complete the assessment immediately after the
procedure.
