Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04310358 |
| Other study ID # |
19.360 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 20, 2023 |
| Est. completion date |
February 7, 2024 |
Study information
| Verified date |
March 2024 |
| Source |
Centre hospitalier de l'Université de Montréal (CHUM) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study is designed to:
1. Create 4 short PLMs aimed at improving visual estimation of LVEF on TTE images.
2. Design a study to determine if these online PLMs can be used to increase the ability of
medical students to estimate LVEF on TTE images and create long term retention of this
skill.
The hypothesis of the study is that several short PLM sessions over a period of approximately
1 month will improve the ability of third- and fourth-year novice medical students in
echocardiography to visually estimate LVEF using TTE images.
Description:
Echocardiography is increasingly used in the field of acute care for the diagnosis and
monitoring of patients. However, echocardiography is a difficult tool to master and the
recommendations for training in echocardiography require several tests to be performed and
interpreted. In a context of growing training needs, this long process of supervised
learning, even if it has been proven, presents difficulties, particularly the limited access
to patients and experts.
Perceptual learning modules (PLMs) represent an alternative modality to teach image
interpretation, and are already used in other fields where expertise is largely based on the
ability to recognize patterns. Placed on digital platforms, PLMs offer a series of images and
the learner must answer a question within a short time. Each response is followed by
immediate feedback (the correct answer). Thus, the learner can learn to quickly extract the
useful information, in this case, the left ventricle ejection fraction (LVEF) by viewing a
large number of exams in a short period of time, and by receiving quality feedback every
time.
Methods:
Perceptual learning modules (PLMs)
- PLMs will be assembled on the online platform using the image bank.
- Their objective is to improve visual estimation of LVEF.
- 96 TTE exams from the image bank will be used to build 4 distinct PLM modules of 24
images each.
- The answer key (LVEF) for each image set in the PLMs and performance tests will be
created by an echocardiography trained cardiologist using visual assessment of LVEF and
3D measurements of LVEF.
- For every exam within a PLM, the 3 standard echocardiographic views (apical 4-chamber,
apical 2-chamber, and apical long axis views) will be shown simultaneously and playing
in a continuous loop for a maximum of 20 seconds.
- The online platform will allow the participants to enter their visual estimation of the
LVEF (an integer between 0 and 100%).
- If no answer is entered after 20 seconds, the images will disappear, and the platform
will force the participants to enter an answer before providing feedback
- Feedback will be displayed following each participant answer for a maximum of
10-seconds. During the feedback phase, the same three views will be shown, but they will
be accompanied by the participants' answer and by the validated LVEF. Since LVEF by 3D
assessment is the most accurate, it will be used as the validated answer for the PLMs.
- Each module will be composed of
- 6 exams with a validated LVEF of less than 30%
- 6 exams with a validated LVEF of 30-39%
- 6 exams with a validated LVEF of 40-49%
- 6 exams with a validated LVEF of 50% or more
- The order of the exams within a module will be determined at random by the online
platform.
- The maximum duration of each module will be 12 minutes.
- Each exam will only be seen once. There will be no exam repetition within the modules or
performance test.
- It will be possible to pause the module between exams. During a pause, the images will
not be shown.
Performance tests 1 and 2
- Two performance tests of 20 exams each will be created using exams from the image banks
distinct from the 96 used for the PLMs.
- The objective of the tests is to measure the participants' ability to accurately
estimate LVEF (not to teach the skill),
- During testing, TTE exams will be presented like they are during the PLMs (same three
views looping continuously, maximum of 20 seconds per exam)
- As in the PLMs, the online platform will allow the participants to enter their
estimation of the LVEF as an integer between 0 and 100.
- However, after the participants' answer is entered, the platform will directly move on
to the next exam and no feedback will be given (the validated LVEF will not be given).
- The maximum duration of each test will be 6 minutes and 40 seconds.
Study chronology
Each participant will be issued a unique secured login into the online platform. After
providing informed consent and before beginning the study, each participant will complete a
short survey on their demographic characteristics and clinical experience, checking
specifically for exclusion criteria. After being given instructions on how the TTE exams are
displayed on the platform, how to enter their visual estimations, and the difference between
the testing and the learning portions of the project, all participants will take a 20-exam
performance pretest to measure their baseline ability to visually estimate LVEF. Which
version of the test they take will be determined at random by the platform (see below for
randomization strategy).
Immediately after the pretest, the first PLM will be done. Then, the platform will lock
itself for 5 days. Once this 5-day period has past, the platform will reopen, and the
participant will be able to complete the second PLM within the next 5 days. Access to the
platform will then again be blocked for another 5 days, after which the third PLM will become
available, again for 5 days. Finally, 5 days later, the participants will be able to complete
the fourth and final PLM. The exact PLM sequence each participant will complete will be
determined at random by the platform. Upon completing the fourth and last PLM, all
participants will take a 20-exam immediate post-test. Four weeks (28 days) after completing
the last PLM and the immediate post-test, the remote post-test will be available for a
one-week period. This test will contain the same test version taken as a pretest. Given the
43 to 65 day delay between both tests, and given the large number of TTE exams visualized by
each participant during the study, it is considered unlikely that participants would be able
to remember the exams from one test to another.
During the study, whenever a test or a PLM becomes available, the participants will
automatically be informed by email. Any participants who fails to complete one of these steps
within the allowed time will be excluded from the results analysis.
Randomization strategy
To minimize any bias in the eventuality that the level of difficulty of the two performance
tests were to be different, participants will be randomized by blocks of 2 to one of two
sequences of performance tests. These two sequences are:
- Test 1 (pre-test), Test 2 (immediate post-test), Test 1 (remote post-test)
- Test 2 (pre-test), Test 1 (immediate post-test), Test 2 (remote post-test)
Furthermore, participants will be randomly assigned a PLM sequence by the platform to avoid
biases in the eventuality that the difficulty of the modules differed from one another.
