Clinical trial NCT03826069: Impact of Augmented Reality in Polypectomy Skills Acquisition in Simulation-based Endoscopy Training
Official title: Impact of Augmented Reality on Procedural Skills Acquisition in a Simulation-based Training Curriculum for Polypectomy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colonic Polyp
Keywords: Augmented reality
Endoscopy
Polypectomy
Simulation training
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2019-02-01
Enrollment: 36
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel group, single-blinded, randomized controlled trial
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Postgraduate trainees in the gastroenterology, general surgery, or internal medicine residency programs
* Performed 25 or less live or simulated endoscopic procedures

Exclusion Criteria:

* Performed more than 25 live or simulated endoscopic procedures

Primary outcomes:
measure: Technical performance during simulated polypectomies
timeFrame: The change in DOPyS score will be assessed between pre-test and post-test done 6 weeks after the intervention.
Secondary outcomes:
measure: Technical performance during simulated and live colonoscopies
timeFrame: The change in technical performance will be measured between a pre-test and post-test 6 weeks after the intervention.
measure: Self-assessment of colonoscopy performance
timeFrame: The self-assessment will be at the time of the Integrated Scenario Tests 6 weeks after the intervention.
measure: Non-technical skill performance during the Integrated Scenario Test
timeFrame: Participant non-technical skill performance will be measured during the integrated scenario six weeks after the intervention.
measure: Patient Comfort during live colonoscopies
timeFrame: This will be measured during colonoscopies performed 6 weeks after the intervention.
measure: Self-Efficacy
timeFrame: This will be measured at time of post-tests done 6 weeks after the intervention.
measure: Cognitive Load
timeFrame: This will be measured at time of post-tests done 6 weeks after the intervention.
measure: Knowledge acquisition
timeFrame: This will be measured as the difference in score between pre-test and post-test, administered 6 weeks after the intervention.
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
affiliation: Unity Health Toronto
name: Samir Grover, MD, MEd, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: