Change in Sustained AttentionACCPNCT02928796
Attentional Capacity and Clinician Performance
An observational study of Change in Sustained Attention, run by University College Cork at 1 site in Ireland.
Trial summary
Uncovering the distinct measurements and features that potentially exist in different levels of expertise when performing cardiology-based procedures. There is a belief that tracking the visual attention and other psychophysiological measures during performance of these procedures may assist in uncovering the… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Change in Sustained Attention
- What is being tested?
- Cognitive Stimulus
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 14 participants
- Where
- 1 siteIreland
- Study dates
- Sep 2016to Oct 2017
- 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: Qualified medical professionals, trainees/registrars or trainers/consultants, working within the cathlab environment and discipline of interventional cardiology.
Who may be able to join
- They must be qualified medical doctor with specific interest in cardiology (e.g. consultant cardiologist). Consultant group must contain consultants only and registrar group must have enrolled registrars only.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Anthony G. Gallagher, DSc, PhD contact
Ireland1 site, 1 recruiting
- Recruiting
ASSERT Centre, University College Cork
Cork, Cork
David Power, +353 (0)21 420 5604, d.power@ucc.ie
About this study
Official title: Attentional Capacity and Clinician Performance: Eye-Tracking Participants When Using a High-Fidelity Surgical Simulator That Emulates Cardiology Procedures
Uncovering the distinct measurements and features that potentially exist in different levels of expertise when performing cardiology-based procedures. There is a belief that tracking the visual attention and other psychophysiological measures during performance of these procedures may assist in uncovering the attentional capacity of participants and how it links with overall performance.
Read the detailed description
Attentional capacity is the number of items a person can hold in their temporal memory whilst undertaking a task (researchers equivocate this to Random Access Memory in computing hardware). Therefore, attentional capacity is thought to play a role in task performance and if a person's attentional capacity is measured 'in-vivo' then one can predict that person's ability and aptitude (classifying if they are an expert or novice since an expert will not require the full capacity of their temporal capacity, as many of the routine steps are stored in their permanent memory). The measurement of performance is of interest in medical training and competency testing research. Eye-tracking and other novel methods could offer new and effective components for measuring performance during complex procedures. These novel methods have increasingly been spotted in new healthcare research studies which aim to use them for a multitude of purposes, mostly to uncover valuable insights between different participant performance levels. One form of medical training is high-fidelity virtual reality simulators that can provide an almost life-like training environment for the trainee and one common use of these simulators is for surgical training . Some work with eye-tracking has already been done with surgical tasks that indicates visual attention does discriminate between novice and expert level performance. There is scope for using eye-tracking technology to capture visual attention during complex surgical procedures to uncover the discriminatory measurements between participants at different levels of expertise.
Aims The first aim of the study is to investigate the relationship between attentional capacity and performance during cardiology-based procedures. The hypothesise is that a significant relationship will be found and that attentional capacity will be a statistically significant predictor for discriminating between experts and novices.
The second aim of the study is to investigate the relationship between visual attention (recorded via eye tracking) and the precisely recorded actions taken by the participant during the procedure.
A third aim of the study is to investigate the relationship between physiological metrics (Heart rate, GSR recorded via E4 wristband) and the precisely recorded actions taken by the participant during the procedure.
This will be facilitated by the capture of the participant's visual attention, through worn eye-tracking glasses, level of arousal, through worn GSR/EDA wristband and their verbalisation (thinking-aloud during task performance), recorded through video/microphone, during two simulated cardiology-based procedures. The simulator will provide its own metrics (duration etc.) to represent the participants' performance during the procedure. The simulation will be provided by a state of the art of surgical simulator in the ASSERT Centre, University College Cork. An extra display monitor will also be included to provide the extra stimulus to assess attentional capacity. The monitor will display a specific playing card at certain times during the proceedings. The participant will have to acknowledge what the card was. This and the visual attention capture will provide insight to the participants' attentional capacity.
- Conditions
- Change in Sustained Attention
- Being tested
- Cognitive Stimulus
- Keywords
- Attentional capacity, Working memory, Simulation-based training, Eye-tracking, Visual attention, Psychophysiological measurement, Surgical simulation, Computer-based simulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive StimulusBehavioural
Participants to pay attention to a supplementary display monitor and respond to specified stimulus images, all while performing the simulated cardiology-based procedure.
| Study group | Role | What they receive |
|---|---|---|
| Trainees | Registrar Cardiologists Receives: Behavioral: Cognitive Stimulus | |
| Trainers | Consultant Cardiologists Receives: Behavioral: Cognitive Stimulus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean attentional capacity
The hypothesis is that a significant statistical relationship will be found between measured attentional capacity (via a card reading task) and overall surgical task performance grading. Attentional capacity, we hypothesise, will be a statistically significant predictor for discriminating between performance level.
Measured: Up to 12 Months.
Visual attention characteristics for stimulus reading 'card' task
The hypothesis is that a significant statistical relationship will be found with characteristics of participant's visual attention (e.g. mean fixation duration, mean saccade latency, overall visual latency before card acknowledgement) and the measured attentional capacity.
Measured: Up to 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2016 (estimated)
- Study startSep 2016
- Primary completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Change in Sustained AttentionStudies 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
- Prospective
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College Cork
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ulster
- Responsible party
- Principal investigator, Prof Anthony G. Gallagher, University College Cork
- Investigators
- Anthony G. Gallagher, DSc, PhD, Principal investigator, University College Cork
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02928796
- Sponsor's protocol ID
- ACCP - 1
- Acronym
- ACCP
- Status last verified
- Oct 2016
- First submitted
- 30 Sep 2016
- Last updated
- 10 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Currie J, Bond RR, McCullagh P, Black P, Finlay DD, Gallagher S, Kearney P, Peace A, Stoyanov D, Bicknell CD, Leslie S, Gallagher AG. Wearable technology-based metrics for predicting operator performance during cardiac catheterisation. Int J Comput Assist Radiol Surg. 2019 Apr;14(4):645-657. doi: 10.1007/s11548-019-01918-0. Epub 2019 Feb 7.
PubMed 30730031
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attentional Capacity and Clinician Performance: Eye-Tracking Participants When Using a High-Fidelity Surgical Simulator That Emulates Cardiology Procedures
- ClinicalTrials.gov ID
- NCT02928796
- Acronym / sponsor ID
- ACCP / ACCP - 1
- Conditions
- Change in Sustained Attention
- Keywords
- Attentional capacity, Working memory, Simulation-based training, Eye-tracking, Visual attention, Psychophysiological measurement, Surgical simulation, Computer-based simulation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- University College CorkUniversity, hospital or other
- Collaborators
- University of Ulster
- Study start
- Sep 2016
- Primary completion
- Oct 2017 (estimated)
- First posted
- 10 Oct 2016 (estimated)
- 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.
Uncovering the distinct measurements and features that potentially exist in different levels of expertise when performing cardiology-based procedures. There is a belief that tracking the visual attention and other psychophysiological measures during performance of these procedures may assist in uncovering the attentional capacity of participants and how it links with overall performance.
Detailed description
Attentional capacity is the number of items a person can hold in their temporal memory whilst undertaking a task (researchers equivocate this to Random Access Memory in computing hardware). Therefore, attentional capacity is thought to play a role in task performance and if a person's attentional capacity is measured 'in-vivo' then one can predict that person's ability and aptitude (classifying if they are an expert or novice since an expert will not require the full capacity of their temporal capacity, as many of the routine steps are stored in their permanent memory). The measurement of performance is of interest in medical training and competency testing research. Eye-tracking and other novel methods could offer new and effective components for measuring performance during complex procedures. These novel methods have increasingly been spotted in new healthcare research studies which aim to use them for a multitude of purposes, mostly to uncover valuable insights between different participant performance levels. One form of medical training is high-fidelity virtual reality simulators that can provide an almost life-like training environment for the trainee and one common use of these simulators is for surgical training . Some work with eye-tracking has already been done with surgical tasks that indicates visual attention does discriminate between novice and expert level performance. There is scope for using eye-tracking technology to capture visual attention during complex surgical procedures to uncover the discriminatory measurements between participants at different levels of expertise.
Aims The first aim of the study is to investigate the relationship between attentional capacity and performance during cardiology-based procedures. The hypothesise is that a significant relationship will be found and that attentional capacity will be a statistically significant predictor for discriminating between experts and novices.
The second aim of the study is to investigate the relationship between visual attention (recorded via eye tracking) and the precisely recorded actions taken by the participant during the procedure.
A third aim of the study is to investigate the relationship between physiological metrics (Heart rate, GSR recorded via E4 wristband) and the precisely recorded actions taken by the participant during the procedure.
This will be facilitated by the capture of the participant's visual attention, through worn eye-tracking glasses, level of arousal, through worn GSR/EDA wristband and their verbalisation (thinking-aloud during task performance), recorded through video/microphone, during two simulated cardiology-based procedures. The simulator will provide its own metrics (duration etc.) to represent the participants' performance during the procedure. The simulation will be provided by a state of the art of surgical simulator in the ASSERT Centre, University College Cork. An extra display monitor will also be included to provide the extra stimulus to assess attentional capacity. The monitor will display a specific playing card at certain times during the proceedings. The participant will have to acknowledge what the card was. This and the visual attention capture will provide insight to the participants' attentional capacity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trainees | – | Behavioral: Cognitive StimulusRegistrar Cardiologists |
| Trainers | – | Behavioral: Cognitive StimulusConsultant Cardiologists |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Qualified medical professionals, trainees/registrars or trainers/consultants, working within the cathlab environment and discipline of interventional cardiology.
Key inclusion criteria (1 listed)
- They must be qualified medical doctor with specific interest in cardiology (e.g. consultant cardiologist). Consultant group must contain consultants only and registrar group must have enrolled registrars only.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Cognitive StimulusParticipants to pay attention to a supplementary display monitor and respond to specified stimulus images, all while performing the simulated cardiology-based procedure. | Behavioural | Trainees, Trainers |
Primary outcome
Mean attentional capacity
Time frame: Up to 12 Months.
The hypothesis is that a significant statistical relationship will be found between measured attentional capacity (via a card reading task) and overall surgical task performance grading. Attentional capacity, we hypothesise, will be a statistically significant predictor for discriminating between performance level.
Visual attention characteristics for stimulus reading 'card' task
Time frame: Up to 12 months.
The hypothesis is that a significant statistical relationship will be found with characteristics of participant's visual attention (e.g. mean fixation duration, mean saccade latency, overall visual latency before card acknowledgement) and the measured attentional capacity.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2016.
- Derived from this study: PubMed 30730031Currie J, Bond RR, McCullagh P, Black P, Finlay DD, Gallagher S, Kearney P, Peace A, Stoyanov D, Bicknell CD, Leslie S, Gallagher AG. Wearable technology-based metrics for predicting operator performance during cardiac catheterisation. Int J Comput Assist Radiol Surg. 2019 Apr;14(4):645-657. doi: 10.1007/s11548-019-01918-0. Epub 2019 Feb 7.
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.
Anthony G. Gallagher, DSc, PhD contact
Anthony G. Gallagher, DSc, PhD principal investigator
University College Cork
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 Change in Sustained Attention, run by University College Cork at 1 site in Ireland.
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 1 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: status not confirmed, as of the sponsor's last update on 10 Oct 2016. 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 Ireland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jonathan Currie, BSc (+447525778242, currie-j@email.ulster.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean attentional capacity (time frame: Up to 12 Months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02928796, which also lists 1 linked publication.
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 10 Oct 2016.