DiagnosisNCT06470269
Examining Clinical Reasoning With Eye-tracking
An observational study of Diagnosis and Educational Problems, run by University of Alberta at 1 site in Canada.
Trial summary
The process of medical information intake, interpretation and diagnosis, commonly referred to as clinical reasoning, involves a complex interaction between visual perception and multiple cognitive processes. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Diagnosis, Educational Problems
- What is being tested?
- Eye tracking
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 42 participants
- Where
- 1 siteCanada
- Study dates
- 1 May 2023to 30 May 2024
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Physicians in neurology department and medical students registered in medical school.
Who may be able to join
- Adult
- Has normal or corrected to normal vision
- Healthcare provider
Who cannot join
- -Non healthcare provider
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Examining Clinical Reasoning With Eye Tracking
The process of medical information intake, interpretation and diagnosis, commonly referred to as clinical reasoning, involves a complex interaction between visual perception and multiple cognitive processes. Assessing students' clinical reasoning skills is a challenging but critical task in developing an optimal teaching curriculum. In this project, the investigators plan to apply the eye-tracking technology to medical education with a specific goal of examining cognitive processing during reading medical chart and x-ray films. Data collected by eye tracking technology will help investigate the perceptual and cognitive underpinnings of clinical reasoning (CR), misinterpretation and misdiagnosis among three participant groups with different levels of clinical experience. Knowledge gained from this project will help to decode the intricate cognitive loop involved in medical interpretation. Further, this study will help to develop alternative methods of assessing student's clinical reasoning skills and promote medical education with novel eye tracking technology.
Read the detailed description
Objective:
In this project, the investigators plan to apply the eye-tracking technology to medical education with a specific goal of examining cognitive processing during clinical reasoning (CR). The investigators expect that by checking the eye movements of medical trainees during case and image reading, a list of valid behavioral markers could be created, to quantitatively classify the expertise, identify the moment of decision-making difficulty, and decode the source of the judgement errors. To examine differences in CR processes across varying levels of expertise, three categories of participants (novice, intermediate, and expert) will be recruited. While participants' eye motions are tracked, participants will read a trauma case, provide a diagnosis and propose a suitable treatment plan. The investigators postulate that 1) different participant groups will produce significantly different CR outcomes, measured by their score on diagnostic judgement and treatment plan; 2) participants will display different gaze fixation patterns; and 3) combining evidence from clinical judgement and eye behavior analysis will provide useful information regarding the source of judgment errors.
Research Method/Procedures:
Staff and students in the SSRL (Surgical Simulation Research Lab) with a difficulty level of health training background will be enrolled as participants in the study. A trauma case with complex life-threatening situations will be presented. The case is a trauma cases with multiple internal injuries. The case will be summarized into a one-page description and 3 x-ray films. Our participants will need to make a diagnosis and give a treatment plan based on case information displayed on a screen. The total reading time will be 4 minutes. During the case reading, the Tobii X2-60, a high-resolution remote eye-tracker, will be used to capture the participant's eye movements. In addition, the investigators will develop a 15-20 quiz regarding the patient's condition and the participant's final diagnosis. The total score and errors in the quiz will be used to describe participants' overall quality of their clinical reasoning.
The investigators will carefully examine participants' eye motions and report their scanning patterns during case reading. Specifically, the investigators will look for moments when participants rapidly move their eyes (saccade) over a sentence before fixating on a particular word (fixation). These eye behavior parameters have previous associations with mental workload and reasoning processing methods, which can be used to further analyze results.
Plan for Data Analysis:
The investigators will firstly compare quiz scores and eye behaviors variables across the three participant groups with different clinical experience levels. The investigators will then analyze eye-scanning patterns on case readings across the three different groups. Specifically, The investigators predict that experts will achieve the highest score in quiz. The investigators therefore will examine the expert's short and long fixation locations over the case reading. The assumption is that experts know where to find key information in the case description and mentally connect separate information together to generate an correct judgement in the short period of time. Fixation spots recorded from the novice and intermediate groups will be compared with experts'. Differences will help us identify different visual searching strategies over different stages in the development of clinical reasoning skills. Lastly, the investigators will examine clinical judgement errors and check the root cause by connecting quiz errors with eye behaviors. If a participant failed to give a long fixation to key case features in the case description, the clinical decision error may be due to a checking problem. If a participant performs a long fixation to key case features, the clinical decision error may due to recognition or decision-making problems.
- Conditions
- Diagnosis, Educational Problems
- Being tested
- Eye tracking
- Keywords
- Eye tracking, Clinical Reasoning, Cognitive Development
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye trackingBehavioural
Recording the eye movement of participants while they read medical cases.
| Study group | Role | What they receive |
|---|---|---|
| Expert | Physicians Receives: Behavioral: Eye tracking | |
| Novice | Medical Students Receives: Behavioral: Eye tracking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eye Fixation
Eye fixation over key reading area
Measured: During case reading (about 5 minutes)
Secondary outcomes (1)
Eye Saccade
Rapid eye shift between key reading areas
Measured: During case reading (about 5 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start1 May 2023
- Primary completion30 Jan 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiagnosisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06470269
- Sponsor's protocol ID
- Pro00102074
- Status last verified
- Jul 2024
- First submitted
- 17 Jun 2024
- Last updated
- 2 Aug 2024
- 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 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining Clinical Reasoning With Eye Tracking
- ClinicalTrials.gov ID
- NCT06470269
- Acronym / sponsor ID
- Pro00102074
- Conditions
- Diagnosis, Educational Problems
- Keywords
- Eye tracking, Clinical Reasoning, Cognitive Development
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 24 Jun 2024 (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.
The process of medical information intake, interpretation and diagnosis, commonly referred to as clinical reasoning, involves a complex interaction between visual perception and multiple cognitive processes. Assessing students' clinical reasoning skills is a challenging but critical task in developing an optimal teaching curriculum. In this project, the investigators plan to apply the eye-tracking technology to medical education with a specific goal of examining cognitive processing during reading medical chart and x-ray films. Data collected by eye tracking technology will help investigate the perceptual and cognitive underpinnings of clinical reasoning (CR), misinterpretation and misdiagnosis among three participant groups with different levels of clinical experience. Knowledge gained from this project will help to decode the intricate cognitive loop involved in medical interpretation. Further, this study will help to develop alternative methods of assessing student's clinical reasoning skills and promote medical education with novel eye tracking technology.
Detailed description
Objective:
In this project, the investigators plan to apply the eye-tracking technology to medical education with a specific goal of examining cognitive processing during clinical reasoning (CR). The investigators expect that by checking the eye movements of medical trainees during case and image reading, a list of valid behavioral markers could be created, to quantitatively classify the expertise, identify the moment of decision-making difficulty, and decode the source of the judgement errors. To examine differences in CR processes across varying levels of expertise, three categories of participants (novice, intermediate, and expert) will be recruited. While participants' eye motions are tracked, participants will read a trauma case, provide a diagnosis and propose a suitable treatment plan. The investigators postulate that 1) different participant groups will produce significantly different CR outcomes, measured by their score on diagnostic judgement and treatment plan; 2) participants will display different gaze fixation patterns; and 3) combining evidence from clinical judgement and eye behavior analysis will provide useful information regarding the source of judgment errors.
Research Method/Procedures:
Staff and students in the SSRL (Surgical Simulation Research Lab) with a difficulty level of health training background will be enrolled as participants in the study. A trauma case with complex life-threatening situations will be presented. The case is a trauma cases with multiple internal injuries. The case will be summarized into a one-page description and 3 x-ray films. Our participants will need to make a diagnosis and give a treatment plan based on case information displayed on a screen. The total reading time will be 4 minutes. During the case reading, the Tobii X2-60, a high-resolution remote eye-tracker, will be used to capture the participant's eye movements. In addition, the investigators will develop a 15-20 quiz regarding the patient's condition and the participant's final diagnosis. The total score and errors in the quiz will be used to describe participants' overall quality of their clinical reasoning.
The investigators will carefully examine participants' eye motions and report their scanning patterns during case reading. Specifically, the investigators will look for moments when participants rapidly move their eyes (saccade) over a sentence before fixating on a particular word (fixation). These eye behavior parameters have previous associations with mental workload and reasoning processing methods, which can be used to further analyze results.
Plan for Data Analysis:
The investigators will firstly compare quiz scores and eye behaviors variables across the three participant groups with different clinical experience levels. The investigators will then analyze eye-scanning patterns on case readings across the three different groups. Specifically, The investigators predict that experts will achieve the highest score in quiz. The investigators therefore will examine the expert's short and long fixation locations over the case reading. The assumption is that experts know where to find key information in the case description and mentally connect separate information together to generate an correct judgement in the short period of time. Fixation spots recorded from the novice and intermediate groups will be compared with experts'. Differences will help us identify different visual searching strategies over different stages in the development of clinical reasoning skills. Lastly, the investigators will examine clinical judgement errors and check the root cause by connecting quiz errors with eye behaviors. If a participant failed to give a long fixation to key case features in the case description, the clinical decision error may be due to a checking problem. If a participant performs a long fixation to key case features, the clinical decision error may due to recognition or decision-making problems.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Expert | – | Behavioral: Eye trackingPhysicians |
| Novice | – | Behavioral: Eye trackingMedical Students |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Physicians in neurology department and medical students registered in medical school.
Key inclusion criteria (3 listed)
- Adult
- Has normal or corrected to normal vision
- Healthcare provider
Key exclusion criteria (1 listed)
- -Non healthcare provider
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 |
|---|---|---|
| Eye trackingRecording the eye movement of participants while they read medical cases. | Behavioural | Expert, Novice |
Primary outcome
Eye Fixation
Time frame: During case reading (about 5 minutes)
Eye fixation over key reading area
1 secondary outcome
Eye Saccade
Time frame: During case reading (about 5 minutes)
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 2 Aug 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diagnosis and Educational Problems, run by University of Alberta 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 3 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 2 Aug 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?
Eye Fixation (time frame: During case reading (about 5 minutes)). 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 2 Aug 2024.