Medical EducationMAP-ISNCT03767010
Implementation and Evaluation of a Perceptual Learning Module on the Identification of the Brachial Plexus
A study testing PLM in people with Medical Education, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
Purpose: This study is designed to: 1. Implement a website hosting perceptual learning modules (PLMs) 2. Implement and assess a PLM designed to improve the capacity of fourth-year medical students and first-year residents (novices) to locate the brachial plexus (BP) at the level of the interscalene groove on surface… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Medical Education
- What is being tested?
- PLM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteCanada
- Study dates
- 12 Feb 2019to 19 Feb 2021
- 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
- Fourth-year medical students and first-year residents having access to a computer with a high speed internet connection
- Fourth-year medical students and first-year residents with no significant experience in ultrasound-guided regional anesthesia
Who cannot join
- Smart phones and tablets will not be accepted due to their smaller screens.
- Significant experience with ultrasound-guided regional anesthesia
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2X 3E4
About this study
Official title: Implementation and Evaluation of a Perceptual Learning Module Aimed at Improving the Identification of the Brachial Plexus in the Interscalene Groove With Ultrasound
Purpose:
This study is designed to:
- Implement a website hosting perceptual learning modules (PLMs)
- Implement and assess a PLM designed to improve the capacity of fourth-year medical students and first-year residents (novices) to locate the brachial plexus (BP) at the level of the interscalene groove on surface ultrasound images.
Hypothesis: The hypothesis of the study is that the PLM will improve the ability of novices to correctly locate the BP at the level of the interscalene groove on surface ultrasound images, compared to a control group.
Read the detailed description
Introduction:
Regional anesthesia has greatly benefited in recent years from the use of ultrasound to facilitate the location of nerves and of their surrounding structures. Allowing real-time visualization of anatomical structures, ultrasound has been shown to improve the success rate of blocks, to decrease procedure times and to improve patient safety by reducing accidental injections into vessels and nerves.
Ultrasound-guided regional anesthesia training, however, remains a long process. The conventional way to develop expertise is to practice on patients. The learner does the techniques under the supervision of an expert, who gives him feedback. While well established, this approach has several limitations: In addition to being time-consuming, it is limited by the number of available cases and access to supervising experts.
Perceptual learning modules (PLMs) represent an alternative modality to teach image interpretation in regional anesthesia and are already used in other fields. PLMs are online tools created to enhance the development of pattern recognition, a skill required to efficiently interpret ultrasound-guided images. With PLMs, learners observe a series of images or videoclips and must answer a question about each image in a short period of time. Each answer is followed immediately by feedback (the correct answer). By observing a large number of images online and by receiving systematic and expert feedback, the trainee quickly learns to extract efficiently the required information from the image.
PLMs developed with real ultrasound images could complement current training methods in regional anesthesia. A PLM could be especially useful for learning the interscalene block. Identification of the BP in the interscalene groove is often difficult in the absence of a reliable vascular marker. Furthermore, the presence of important surrounding structures to be avoided, like the vertebral artery and the pleura, make accurate image interpretation crucial to avoid complications.
The aim of this study is to set up a PLM focusing on the location of the BP in the interscalene groove using ultrasound imaging. As a first step, ultrasound images of the neck of healthy volunteers will be collected. Subsequently, these images will be uploaded on a secured website and interpreted by experts. Finally, a study will be undertaken to test whether the PLM improves the ability of medical students and junior residents (novices) to correctly locate the brachial plexus in the interscalene groove using ultrasound images.
Methods:
Development of a website to host the new PLM from an already existing model
Two professional programmers collaborating with our team have already developed a website to host and evaluate another PLM. Using this site as a template, the same programmers will be responsible for creating a similar website for this project.
Acquisition of images in healthy volunteers
Each volunteer will correspond to a case and each case will consist of three elements:
- A video of approximately thirty seconds of ultrasound images of the neck;
- A video taken simultaneously showing the position of the operator's hand and of the ultrasound probe on the volunteer's neck as the ultrasound images shown in the first video are being acquired;
- A static image corresponding to one of the last frames of the first clip.
Validation of cases by experts and construction of a case bank
- Prior to inclusion in the study, the selected cases will be anonymized and uploaded to the website and then validated independently by 3 anesthesiologists who are experts in regional anesthesia;
- For each case, each expert will have to circle the BP on the static image after viewing the simultaneous videos without time limitation;
- For each case, in addition to identifying and locating the BP, the experts will have to rate the difficulty of identifying and locating the BP on a 4 point Likert scale.
Recruitment of volunteers will continue until a sufficient number of validated cases is available to build the PLM and two tests.
Development of the PLM (20 cases)
The PLM will be developed with validated cases distinct from those of the performance tests and will have the following characteristics:
- For each case, both videos will play simultaneously and loop for up to 90 seconds;
- A static image including the BP will also be displayed;
- Participants will need to move a pointer over the static image and place it anywhere over what they think is the BP;
- The website will then provide feedback to the participants: the BP will be highlighted on the static image for up to 30 seconds;
- After the feedback, the following case will be presented.
Two blocks of 10 cases will be formed. These blocks will contain the same proportion of "easy" "moderate" and "hard" cases. Cases within a block will be shown in a random order, but participants will always see the two blocks in the same order.
Development and validation of two tests to assess the performance of learners (10 cases each)
The objective of the tests is different from that of the PLM since their purpose is to assess the ability of participants to correctly identify the BP at different points during the study. These tests will have the same format as the PLM, except that no expert feedback will be provided after each case.
Two test version will be created with different cases. The order of the cases within a test will be random.
Pilot study of the effect of PLM on learner performance
Fourth-year medical students and first-year residents in anesthesiology will be invited to participate via email. Consent will be given online. In the first session, participants will complete a short online questionnaire about their demographics and clinical experience with ultrasound-guided regional anesthesia. They will also be shown a short tutorial to familiarize them with the platform, with basic sonoanatomy of the neck, and with the ultrasound scanning technique.
Subsequently, they will be randomly assigned to one of two groups: Control Group or PLM Group. Both groups will participate in two on-line sessions. The project will proceed as follows according to the participant assignment group:
- Control Group (tests only)
- First 30-minute session, immediately after agreeing to participate in the study
- pre-test (10 cases)
- post-test (10 cases)
- Second session lasting 15 minutes, 6 months after the first session
- 6 months post-test (10 cases)
- PLM Group (tests and PLM)
- First session of 1h10, immediately after agreeing to participate in the study
- pre-test (10 cases)
- PLM (20 cases with feedback)
- post-test (10 cases)
- Second session lasting 15 minutes, 6 months after the first session
- 6 months post-test (10 cases)
At the end of the study, participants of the Control group will be allowed to complete the PLM if they wish to.
- Conditions
- Medical Education
- Being tested
- Control (no PLM), PLM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control (no PLM)Other
Pre, post, delayed test Participants will perform a pretest, a posttest and a delayed test at 6 months.
PLMOther
PLM Participants will take the PLM on the location of the brachial plexus at the level of the interscalene groove on surface ultrasound images. They will also take a pretest, a post-test and a delayed test at 6 months. Pre, post, delayed test Participants will perform a pretest, a posttest and a delayed test at 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Control (no PLM) | Experimental | Control: Pre, post, delayed test Participants will not do the PLM, but will perform a pretest, a posttest and a delayed test at 6 months Receives: Other: Control (no PLM) |
| Experimental (PLM) | Experimental | Experimental: PLM group (pre, post, delayed test, PLM) Participants will do a pretest, the PLM, a posttest and a delayed test at 6 months Receives: Other: PLM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in correct locations of the BP between the pretest and the immediate post-test, for the Control group vs the PLM group.
The BP for a case will be considered correctly located if the participant has placed a pointer inside a predefined "target zone", determined as representing the BP by three independent regional anesthesia experts.
Measured: At baseline (pretest) and on the immediate post-test
Secondary outcomes (4)
Difference in the average distance of BP location
Difference in the average distance of the participant's pointer relative to the target zone between the pretest and the immediate post-test, for the Control group vs the PLM group.
Measured: At baseline (pretest) and on the immediate post-test
Difference in correct locations of the BP
Difference in correct locations of the BP between the pretest and the delayed post-test, for the Control group vs the PLM group.
Measured: At baseline (pretest) and on the delayed test at 6 months
Average response times during the various tests
This measure represents the fluency or automaticity with which images are interpreted, and can be used to evaluate the cognitive effort deployed to make a reading. Training not only allows the expert to make an accurate location. It also allows the expert to do it quickly, and therefore with little cognitive effort, an essential attribute in clinical practice.
Measured: At baseline (pretest), on an immediate post-test, and on the delayed test at 6 months
For the PLM group only, the evolution of the participants' accuracy during the PLM
The change in the participants' rate of correct answers as they progress through the PLM; indeed, since learners will evaluate all case blocks in the same order, we can estimate an average learning curve for our population (pretest vs block 1 vs block 2 vs post-test)
Measured: During the PLM, at the end of the first on-line session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2018
- Study start12 Feb 2019
- Primary completion19 Feb 2021
- Study completion19 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medical EducationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
- Sponsor type
- University, hospital or other
- Collaborators
- Université de Montréal
- Responsible party
- Sponsor
- Investigators
- Arnaud Robitaille, MD, FRCPC, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03767010
- Sponsor's protocol ID
- 18.275
- Acronym
- MAP-IS
- Status last verified
- May 2022
- First submitted
- 5 Dec 2018
- Last updated
- 27 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation and Evaluation of a Perceptual Learning Module Aimed at Improving the Identification of the Brachial Plexus in the Interscalene Groove With Ultrasound
- ClinicalTrials.gov ID
- NCT03767010
- Acronym / sponsor ID
- MAP-IS / 18.275
- Conditions
- Medical Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Collaborators
- Université de Montréal
- Study start
- 12 Feb 2019 (actual)
- Primary completion
- 19 Feb 2021 (actual)
- Study completion
- 19 Feb 2021 (actual)
- First posted
- 6 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose:
This study is designed to:
- Implement a website hosting perceptual learning modules (PLMs)
- Implement and assess a PLM designed to improve the capacity of fourth-year medical students and first-year residents (novices) to locate the brachial plexus (BP) at the level of the interscalene groove on surface ultrasound images.
Hypothesis: The hypothesis of the study is that the PLM will improve the ability of novices to correctly locate the BP at the level of the interscalene groove on surface ultrasound images, compared to a control group.
Detailed description
Introduction:
Regional anesthesia has greatly benefited in recent years from the use of ultrasound to facilitate the location of nerves and of their surrounding structures. Allowing real-time visualization of anatomical structures, ultrasound has been shown to improve the success rate of blocks, to decrease procedure times and to improve patient safety by reducing accidental injections into vessels and nerves.
Ultrasound-guided regional anesthesia training, however, remains a long process. The conventional way to develop expertise is to practice on patients. The learner does the techniques under the supervision of an expert, who gives him feedback. While well established, this approach has several limitations: In addition to being time-consuming, it is limited by the number of available cases and access to supervising experts.
Perceptual learning modules (PLMs) represent an alternative modality to teach image interpretation in regional anesthesia and are already used in other fields. PLMs are online tools created to enhance the development of pattern recognition, a skill required to efficiently interpret ultrasound-guided images. With PLMs, learners observe a series of images or videoclips and must answer a question about each image in a short period of time. Each answer is followed immediately by feedback (the correct answer). By observing a large number of images online and by receiving systematic and expert feedback, the trainee quickly learns to extract efficiently the required information from the image.
PLMs developed with real ultrasound images could complement current training methods in regional anesthesia. A PLM could be especially useful for learning the interscalene block. Identification of the BP in the interscalene groove is often difficult in the absence of a reliable vascular marker. Furthermore, the presence of important surrounding structures to be avoided, like the vertebral artery and the pleura, make accurate image interpretation crucial to avoid complications.
The aim of this study is to set up a PLM focusing on the location of the BP in the interscalene groove using ultrasound imaging. As a first step, ultrasound images of the neck of healthy volunteers will be collected. Subsequently, these images will be uploaded on a secured website and interpreted by experts. Finally, a study will be undertaken to test whether the PLM improves the ability of medical students and junior residents (novices) to correctly locate the brachial plexus in the interscalene groove using ultrasound images.
Methods:
Development of a website to host the new PLM from an already existing model
Two professional programmers collaborating with our team have already developed a website to host and evaluate another PLM. Using this site as a template, the same programmers will be responsible for creating a similar website for this project.
Acquisition of images in healthy volunteers
Each volunteer will correspond to a case and each case will consist of three elements:
- A video of approximately thirty seconds of ultrasound images of the neck;
- A video taken simultaneously showing the position of the operator's hand and of the ultrasound probe on the volunteer's neck as the ultrasound images shown in the first video are being acquired;
- A static image corresponding to one of the last frames of the first clip.
Validation of cases by experts and construction of a case bank
- Prior to inclusion in the study, the selected cases will be anonymized and uploaded to the website and then validated independently by 3 anesthesiologists who are experts in regional anesthesia;
- For each case, each expert will have to circle the BP on the static image after viewing the simultaneous videos without time limitation;
- For each case, in addition to identifying and locating the BP, the experts will have to rate the difficulty of identifying and locating the BP on a 4 point Likert scale.
Recruitment of volunteers will continue until a sufficient number of validated cases is available to build the PLM and two tests.
Development of the PLM (20 cases)
The PLM will be developed with validated cases distinct from those of the performance tests and will have the following characteristics:
- For each case, both videos will play simultaneously and loop for up to 90 seconds;
- A static image including the BP will also be displayed;
- Participants will need to move a pointer over the static image and place it anywhere over what they think is the BP;
- The website will then provide feedback to the participants: the BP will be highlighted on the static image for up to 30 seconds;
- After the feedback, the following case will be presented.
Two blocks of 10 cases will be formed. These blocks will contain the same proportion of "easy" "moderate" and "hard" cases. Cases within a block will be shown in a random order, but participants will always see the two blocks in the same order.
Development and validation of two tests to assess the performance of learners (10 cases each)
The objective of the tests is different from that of the PLM since their purpose is to assess the ability of participants to correctly identify the BP at different points during the study. These tests will have the same format as the PLM, except that no expert feedback will be provided after each case.
Two test version will be created with different cases. The order of the cases within a test will be random.
Pilot study of the effect of PLM on learner performance
Fourth-year medical students and first-year residents in anesthesiology will be invited to participate via email. Consent will be given online. In the first session, participants will complete a short online questionnaire about their demographics and clinical experience with ultrasound-guided regional anesthesia. They will also be shown a short tutorial to familiarize them with the platform, with basic sonoanatomy of the neck, and with the ultrasound scanning technique.
Subsequently, they will be randomly assigned to one of two groups: Control Group or PLM Group. Both groups will participate in two on-line sessions. The project will proceed as follows according to the participant assignment group:
- Control Group (tests only)
- First 30-minute session, immediately after agreeing to participate in the study
- pre-test (10 cases)
- post-test (10 cases)
- Second session lasting 15 minutes, 6 months after the first session
- 6 months post-test (10 cases)
- PLM Group (tests and PLM)
- First session of 1h10, immediately after agreeing to participate in the study
- pre-test (10 cases)
- PLM (20 cases with feedback)
- post-test (10 cases)
- Second session lasting 15 minutes, 6 months after the first session
- 6 months post-test (10 cases)
At the end of the study, participants of the Control group will be allowed to complete the PLM if they wish to.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, randomized, open-label study
| Arm | Type | Receives |
|---|---|---|
| Control (no PLM) | Experimental | Other: Control (no PLM)Control: Pre, post, delayed test Participants will not do the PLM, but will perform a pretest, a posttest and a delayed test at 6 months |
| Experimental (PLM) | Experimental | Other: PLMExperimental: PLM group (pre, post, delayed test, PLM) Participants will do a pretest, the PLM, a posttest and a delayed test at 6 months |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Fourth-year medical students and first-year residents having access to a computer with a high speed internet connection
- Fourth-year medical students and first-year residents with no significant experience in ultrasound-guided regional anesthesia
Key exclusion criteria (2 listed)
- Smart phones and tablets will not be accepted due to their smaller screens.
- Significant experience with ultrasound-guided regional anesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control (no PLM)Pre, post, delayed test Participants will perform a pretest, a posttest and a delayed test at 6 months. | Other | Control (no PLM) |
| PLMPLM Participants will take the PLM on the location of the brachial plexus at the level of the interscalene groove on surface ultrasound images. They will also take a pretest, a post-test and a delayed test at 6 months. Pre, post, delayed test Participants will perform a pretest, a posttest and a delayed test at 6 months. | Other | Experimental (PLM) |
Primary outcome
Difference in correct locations of the BP between the pretest and the immediate post-test, for the Control group vs the PLM group.
Time frame: At baseline (pretest) and on the immediate post-test
The BP for a case will be considered correctly located if the participant has placed a pointer inside a predefined "target zone", determined as representing the BP by three independent regional anesthesia experts.
4 secondary outcomes
Difference in the average distance of BP location
Time frame: At baseline (pretest) and on the immediate post-test
Difference in correct locations of the BP
Time frame: At baseline (pretest) and on the delayed test at 6 months
Average response times during the various tests
Time frame: At baseline (pretest), on an immediate post-test, and on the delayed test at 6 months
For the PLM group only, the evolution of the participants' accuracy during the PLM
Time frame: During the PLM, at the end of the first on-line session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arnaud Robitaille, MD, FRCPC principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PLM 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 2 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 27 May 2022. 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?
Difference in correct locations of the BP between the pretest and the immediate post-test, for the Control group vs the PLM group. (time frame: At baseline (pretest) and on the immediate post-test). 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 27 May 2022; AzTrials last refreshed its copy on 30 Oct 2026.