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Medical EducationMAP-ETTNCT04310358

Online Perceptual Modules and Spaced Learning, a Modern Approach to Teaching LVEF Assessment to Medical Students.

A study testing 4 short PLMs group 1 and 4 short PLMs group 2 in people with Medical Education, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Medical Education
What is being tested?
4 short PLMs group 1 and 4 short PLMs group 2
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteCanada
Study dates
20 Feb 2023to 7 Feb 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Third- or fourth-year medical students
  • Access to a computer with high speed internet (no smartphone or tablet since the images would be too small)

Who cannot join

  • Previous formal echocardiographic training (transthoracic, transesophageal or FOCUS echocardiography)

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Centre Hospitalier de l'Université de Montréal (CHUM)

    Montreal, Quebec, H2X 3E4

Other trials in Canada

About this study

Official title: Online Perceptual Modules and Spaced Learning, a Modern Approach to Teaching Left Ventricular Systolic Assessment to Medical Students.

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.

Read the detailed 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.

Being tested
4 short PLMs group 1, 4 short PLMs group 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 4 short PLMs group 1Other

    Participants will take the 4 short PLMs on the visual estimation of LVEF. They will also take a pretest, an immediate post-test and a remote post-test at 1 month. Test 1 (pre-test), Test 2 (immediate post-test), Test 1 (remote post-test)

  • 4 short PLMs group 2Other

    Participants will take the 4 short PLMs on the visual estimation of LVEF. They will also take a pretest, an immediate post-test and a remote post-test at 1 month. Test 2 (pre-test), Test 1 (immediate post-test), Test 2 (remote post-test)

Study groups in NCT04310358
Study groupRoleWhat they receive
PLM group 1ExperimentalParticipants will do a pretest (Test 1), the 4 short PLMs, an immediate post-test (Test 2) and a remote post-test (Test 1).
Receives: Other: 4 short PLMs group 1
PLM group 2ExperimentalParticipants will do a pretest (Test 2), the 4 short PLMs, an immediate post-test (Test 1) and a remote post-test (Test 2).
Receives: Other: 4 short PLMs group 2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Impact of the spaced online 4 short PLMs on the ability to correctly visually estimate LVEF during a remote post-test (1 month).

    The mean absolute deviation of the participants' visual estimations from the validated answer (expert estimate) will be used as a measure of the precision of the estimations.

    Measured: Change between baseline (pre-test) and remote post-test (1 month)

Secondary outcomes (3)
  1. Impact of the online perceptual modules on the ability to correctly estimate LVEF during an immediate post-test (module validation).

    The mean absolute deviation of the participants' visual estimations from the validated answer (expert estimate) will be used as a measure of the precision of the estimations.

    Measured: Change between baseline (pre-test) and immediately after the fourth PLM online session.

  2. The progression (improvement of performance) of the participants' ability to correctly assess LVEF throughout the completion of the 4 modules.

    The evolution of the participants' accuracy in LVEF estimation during the PLMs could allow us to estimate a learning curve for our study group.

    Measured: At the end of the fourth online session, on an average of 15 to up to 30 days.

  3. The fluency (time to answer) of each participant as they progress through the study protocol.

    The mean response time in seconds to the different tests.

    Measured: At baseline (pretest), immediately after the fourth PLM online session and on remote post-test (1 month).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2020
  2. Study start20 Feb 2023
  3. Primary completion7 Feb 2024
  4. Study completion7 Feb 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective, randomized, open label study.
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04310358
Sponsor's protocol ID
19.360
Acronym
MAP-ETT
Status last verified
Mar 2024
First submitted
10 Mar 2020
Last updated
20 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing 4 short PLMs group 1 and 4 short PLMs group 2 in people with Medical Education, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Impact of the spaced online 4 short PLMs on the ability to correctly visually estimate LVEF during a remote post-test (1 month). (time frame: Change between baseline (pre-test) and remote post-test (1 month)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2024.

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