Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT03826069 |
| Other study ID # |
18-389 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 17, 2019 |
| Est. completion date |
August 2023 |
Study information
| Verified date |
November 2022 |
| Source |
Unity Health Toronto |
| Contact |
Nikko Gimpaya, HBSc |
| Phone |
416-864-5628 |
| Email |
gimpayan[@]smh.ca |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Simulation-based training (SBT) is a safe and effective strategy for improving skills
development in gastrointestinal endoscopy. The use of curricula based on progressive
learning, as well as comprehensive structured curricula, have been demonstrated to be
effective in enhancing simulation-based training. With current advancements in technologies,
another possible enhancement to SBT is the use of augmented reality (AR). To date, no other
studies have examined the benefits of AR technology in endoscopy training. This study aims to
evaluate the effectiveness of a simulation-based AR curriculum in developing technical
skills, self-assessment accuracy, and clinical performance; as compared to a conventional
simulation curriculum.
Thirty six novice endoscopists will be recruited from the gastroenterology and general
surgery programs at the University of Toronto. Participants will be randomized and assigned
to two groups. The Conventional Simulation Training Curriculum group will receive 6 hours of
simulated training, with expert feedback, and four 1-hour didactic teaching sessions. The AR
Training Curriculum group will receive the same number of training hours and didactic
sessions as the control group. The main difference is the use of superimposed videos to guide
the intervention group through simulated polypectomy cases. During the didactic teaching
sessions, the intervention group will also receive a brief introduction to principles of AR
and its uses for endoscopy simulation. Participants will be trained to perform colonoscopies
on two validated simulator models: (1) a bench-top colonoscopy simulator; and (2) the EndoVR®
virtual reality simulator. Performance will be assessed before training (pre-test),
immediately after training (acquisition post-test) and 4-6 weeks after training (retention
test). On the same day as the retention test, the participants will perform two live
colonoscopies and use a mechanical polypectomy simulation test (transfer tests), assessed by
two blinded expert endoscopists.
The main hypothesis of this study is that novices trained under the AR-enhanced curriculum
will have better technical skill performance during simulated polypectomies and live
colonoscopies.
Description:
Simulation-based training (SBT) provides a safe and effective means to enhance skills
development. Simulation-based curricula have been developed for a number of minimally
invasive procedures, and more recently in gastrointestinal endoscopy. Previous studies have
demonstrated the effectiveness of comprehensive structured curricula and curricula based on
progressive learning in endoscopic simulation. However, as digital technologies evolve, other
educational strategies using the latest innovations may aid to further enhance procedural
skills training during simulation. One such strategy may lie in augmented reality (AR).
The use of AR involves the superimposition of a computer-generated image on a user's view of
the real world, which enhances the user's perception of reality. There has been a recent,
growing interest for the integration of AR in medical education, such as in the visualization
of anatomical structures, training for various medical procedures and telemedicine guidance
for remote procedural training. The real time interactive nature of AR provides immersion,
immediate learner support, and has the ability to lower the complexity of learning new tasks
by showing the content of the tasks using different perspectives, which is beneficial for
both engagement and the learning process.
To date, there are only a few studies which have investigated the application of AR for
medical education and procedural learning specifically. Some of the benefits demonstrated by
these studies include decreased amount of practice needed, reduced failure rate, improved
performance accuracy, accelerated learning, shortened learning curve and better understanding
of spatial relationships. However, the majority of studies on the application of AR have been
on training for laparoscopy, neurosurgical procedures, and echocardiography. There are
currently no studies showing the benefits of AR in endoscopy training.
Furthermore, several studies have shown the importance of self-assessment for suitable
lifelong learning of new techniques in minimally invasive surgery and gastrointestinal
endoscopy. A study by our group showed that experienced endoscopists had better
self-assessment accuracy compared to novice endoscopists, therefore, a targeted intervention
to help novice endoscopists is needed so that they may seek appropriate preceptorship during
their training. One such targeted intervention to improve self-assessment accuracy may be AR,
as it provides immediate and repeated visual support of the perfect approach to perform a
specific task, therefore, allowing the trainee to reflect on their performance.
In order to bridge the gap related to AR in endoscopy training, the investigators aim to
determine the impact of a simulation-based AR curriculum on areas such as knowledge
acquisition, technical performance during simulated polypectomies, non-technical skills
during integrated scenarios, and self-assessment accuracy. The investigators hypothesize that
AR is an instructional strategy with the potential to offer a highly realistic and meaningful
learning experience for novice endoscopists with transferable skills to clinical practice.
