Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05755724 |
| Other study ID # |
5424 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 11, 2023 |
| Est. completion date |
June 2024 |
Study information
| Verified date |
March 2023 |
| Source |
Sunnybrook Health Sciences Centre |
| Contact |
Ahtsham U Niazi, FRCPC |
| Phone |
416-480-4864 |
| Email |
ahtsham.niazi[@]sunnybrook.ca |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Patients in rural Canada face serious anesthesia care deficiencies relative to their
counterparts in urban centers. Despite 18% of Canadians living in rural settings only 3.1% of
medical specialists practice in rural areas. To provide equity in healthcare there is a need
to develop a network where specialists in urban centers can provide training, coaching, and
support to physicians in rural communities. Despite some work being done this is not possible
for all specialists due to cost and travel. One potential solution to this problem is
telesimulation, whereby telecommunication and simulation tools are used to provide training
remotely. Simple, 2D telesimulation setups using webcams and computers have been used to
teach remotely but problems with video displays and learner engagement have occurred leading
to a need for more sophisticated telesimulation tools. Recently, virtual reality (VR) systems
have been developed allowing the learner and teacher to immerse in a 3D computer-generated
environment where they feel as if they are in the same room. We propose to see whether
teaching ultrasound guided regional anesthesia (UGRA), a skill required by rural physicians,
using 3D VR is better than teaching by 2D tele simulation.
Description:
Introduction:
Ultrasound-guided regional anesthesia (UGRA) has many advantages over traditional regional
anesthesia approaches; however, it requires the acquisition of several new technical and
non-technical skills. Successful acquisition of these skills is relatively complex, and
generally not achievable through didactic teaching alone, thus the majority of UGRA training
takes place from expert-guided 'hands-on' teaching workshops. However, barriers such as
travel time and associated costs limit attendance at these workshops, especially for
physicians in remote and rural areas, increasing the inequality experienced by rural medicine
patients and practitioners.
One potential solution to this problem is telesimulation, whereby telecommunication and
simulation tools are used to provide training remotely. Indeed simple, 2D telesimulation
setups using webcams and computers have been used to successfully teach UGRA in remote areas.
More sophisticated telesimulation tools have recently been developed with elements of
immersive virtual reality (VR), i.e., a 3D computer-generated world including sensory
feedback that users can interact with. A simple and cost-effective immersive VR approach to
telesimulation includes a 360° camera and a VR headset/head mounted display (HMD), which has
the potential to immerse a teacher into the learner's environment, allowing the teacher to
see the learner's movements and actions in the first person.
Recent advancements in VR technology have reduced costs and increased accessibility, and 360°
VR video can benefit learning processes by boosting motivation and encouraging knowledge
retention. Thus, the investigators propose to compare remote teaching of UGRA using Remote
Immersive VR (RIVR) and 2D telesimulation teaching.
Purpose:
As highlighted in a recent report, patients, and healthcare practitioners in rural Canada
face serious deficiencies relative to their counterparts in urban centres. Despite 18% of
Canadians living in rural settings only 3.1% of medical specialists practice in rural areas.
Thus, there is a strong need for teaching and mentorship among anesthetists in Canada's
remote communities. This study will directly address two of the recommendations in this
report by assessing coaching tools which can guide improvements in the clinical practice of
rural physicians and by facilitating networks of care between urban specialists and rural
centers.
By directly comparing two training methods, the investigators will also increase knowledge of
telesimulation best practices and immersive VR as a training modality, potentially leading to
better educational outcomes for students and ultimately to better clinical outcomes for
patients. This is in alignment with the Sunnybrook Education Strategic Plan goal, to improve
learner, teacher and patient experiences and outcomes through education research and
scholarship.
Hypothesis:
The investigators hypothesize that telesimulation training through 3D RIVR will provide a
more effective method of teaching UGRA than the use of 2D teleconferencing (i.e., using
webcams and computer screens).
Study Objective:
To compare two telesimulation methods, 2D video and 3D RIVR, for remote teaching of UGRA.
Study Design:
The study will be designed as a single-centre, prospective, assessor blinded, randomized
(1:1) trial.
Recruitment:
Advertisements for eligible participants will be sent via electronic and hard copy formats.
These include emails via faculties/schools of medicine, hospital bulletin boards and student
common rooms. In all approaches, advertisements will ask for volunteers for the study and
will include details to contact a researcher via email or telephone.
Permission to access medical students will be sought via the faculties/schools of medicine,
with the advertisement sent on researcher's behalf. Researchers will not be seeking access or
retention of student email addresses.
A manual check of eligibility and exclusion criteria will be performed for all participants.
An informed consent form (ICF) will be provided. After consenting to participate, all
participants will be allocated a number and remain de-identified throughout the data
collection process.
Intervention and Randomization:
Following ethics approval, 24 medical students from the University of Toronto, with no prior
ultrasound experience, will be recruited to participate in this study. Students will be
randomized (1:1) to receive remote UGRA instruction using either 2D telesimulation technology
or 3D RIVR. Both groups will also use a simulation model on which needle insertion, needle
alignment, target acquisition and injection of local anesthetic will be taught.
2D Group: Telesimulation using standard teleconferencing software and equipment including 2D
computer monitors, webcams, and an ultrasound machine linked to a computer (enabling
ultrasound images to be transmitted).
3D RIVR Group: Telesimulation using immersive VR technology. Briefly, students will have a
360° camera mounted to their head, which will broadcast their first-person perspective to
their teachers. Teachers will be able to immerse themselves in the perspective of the trainee
using a virtual reality HMD (Oculus Quest 2), which allows the teacher to look around freely
and view equipment, hand movements, etc. and offer instruction accordingly.
Evaluation:
Prior to teaching, students in both groups will undergo a pretest using a validated, 22-item
procedural checklist and a 9-item Global Rating Scale (GRS). After the pretest, the students
will be provided with a PowerPoint presentation including basic knowledge of the ultrasound
machine, the simulation model, and the UGRA procedure. Students will then be invited back
after an hour and provided with a one-hour session of teaching on how to perform an
ultrasound-guided nerve block by an instructor in another room via telesimulation (either 2D
or 3D RIVR). After the session, students will be asked to undergo a posttest evaluation using
the same GRS and checklist. The pretest and posttest will be recorded and assessed by two
experts in UGRA who are blinded to the method of teaching. The two evaluators will score each
participant independently and the scores will be averaged.
Study Outcomes:
Primary Outcome: Difference in scores from before (pretest) to after training (posttest) as
assessed using a validated procedural checklist and Global Rating Scale (GRS) for assessment
of UGRA.
Expected Outcome: The investigators expect to see greater improvements in pretest to posttest
scores using 3D RIVR, relative to 2D telesimulation.
Secondary Outcomes: Time required to teach UGRA using each modality, qualitative assessment
of teacher and student satisfaction for each modality, quality of teaching using each method
(e.g., how well the teaching instructions were delivered and acted upon) as evaluated by two
blinded assessors.
Expected Outcome: The investigators will identify additional advantages and potential
barriers related to the use of 3D RIVR for remote telesimulation training of complex
technical and non-technical skills, relative to 2D telesimulation.
Statistical Analysis:
Sample size calculation was performed based on the conservative assumption that participants
will have an average percentage score of 60% (SD 20%) in the pretest, given their minimal
training in ultrasound and lack of familiarity with UGRA. The analysis of the primary outcome
(GRS and checklist) will be compared between groups using the paired sample t-test
(two-sided, where P < 0.05 will be considered statistically significant). A score of 80% on
the posttest will be chosen to represent a successful posttest score (i.e., significant
improvement), as previously described. Based on Type I error of 0.05 and beta = 0.1, 11
participants per group (22 total) are required. The investigators aim to recruit 24
participants to compensate for any attrition during the study.
Impact:
The goal of this project is to identify the most effective way to remotely teach the complex
skills required for UGRA procedures. This will allow specialist physicians working in large
urban centres to share their knowledge more widely, and directly benefit physicians working
in remote communities, by giving rural physicians access to expert teaching and mentorship.
This, in turn, will increase access to specialist care for patients living in remote and
rural communities, improving outcomes and allowing patients to access care where they live.
Furthermore, by providing evidence to support the use of 3D RIVR for teaching both technical
and non-technical skills, the investigators will increase their knowledge related to the use
of this novel technology and provide a proof-of-concept, which could be applied to other
techniques and medical specialties.
