Medical EmergenciesNCT05729802
The Holographic Standardized Patient
A study testing HoloSIM Software via Hololens 2 and Training by Mannequin Based Simulation in people with Medical Emergencies and Educational Problems, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
The current pandemic has revealed in-person simulation training and evaluation is vulnerable to disruption, and alternatives are needed which allow remote evaluation. The recently developed Microsoft Hololens headset device allows interactable holograms to be inserted into a user's workspace (mixed reality) … Read more about this study
- Who is it for?
- Ages 20 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Medical Emergencies, Educational Problems, Simulation of Physical Illness
- What is being tested?
- HoloSIM Software via Hololens 2 and Training by Mannequin Based Simulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2023to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Resident or fellow level volunteers from acute care postgraduate training programs (Internal Medicine, Emergency Medicine, Anesthesiology, Critical Care Medicine at Sunnybrook Health Sciences Centre
Who cannot join
- Unwilling to enter the study
- Previous experience with simulator based teaching on anaphylaxis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4E 3M4
Julian R Wiegelmann, MD, 416-480-4864, julian.wiegelmann@sunnybrook.ca
About this study
Official title: The Holographic Standardized Patient: Using Mixed Reality to Reduce Barriers to Crisis
The current pandemic has revealed in-person simulation training and evaluation is vulnerable to disruption, and alternatives are needed which allow remote evaluation. The recently developed Microsoft Hololens headset device allows interactable holograms to be inserted into a user's workspace (mixed reality) - permitting the augmentation of existing clinical and training spaces with holographic (i.e. virtual) patients via the prototype HoloSIM software. This study is the first known research initiative aiming to demonstrate the feasibility and effectiveness of mixed reality for acute medicine training and assessment at a distance.
Space, time, personnel, pandemic, and cost constraints limit opportunities for high-fidelity simulation exercises for post-graduate trainees at Sunnybrook. By developing and demonstrating the effectiveness of this new training modality, increased simulation exercises will lead to a higher quality education experience, better functioning teams, and better patient outcomes.
Read the detailed description
The study is the first known research initiative aiming to demonstrate that a mixed reality simulation training and assessment modality can be implemented in different clinical contexts and can improve decision making skills and management in a complex crisis scenario.
The investigators hypothesize that a mixed reality simulation training solution is usable, feasible, and can improve decision making skills and management.
It is a two stage study: 1) iteratively develop and usability test the HoloSIM software with acute care medicine specialties at Sunnybrook, and 2) determine if the HoloSIM platform is non-inferior to the current teaching and assessment standard of high-fidelity mannequin-based crisis simulation.
The understanding is that this will be a first-of-its-kind study that will generate an accessible, easy to administer tool to educate residents and fellows. The presented HoloSIM software will allow teams to practice and assess their responses to a variety of scenarios in clinical environments such as the trauma bay and ICU. This has the potential to improve team function and enhance quality of care across the healthcare system.
Healthcare facilities without expensive simulation centres are unable to participate in high-fidelity medical simulation. Inequities in access to high quality training and professional development have been repeatedly cited as a barrier to retention of rural health care providers. The SHSC simulation centre will adapt this approach and offer training at a distance and medical crisis coaching to rural health care providers utilizing the this mentioned platform. Lastly, all simulation resources developed during the project will be made freely available via the project website. Other institutions internationally may use them to improve their team performance, patient safety, and postgraduate education programs.
- Being tested
- HoloSIM Software via Hololens 2, Training by Mannequin Based Simulation
- Keywords
- Mixed Reality, Augmented Reality, Medical Simulation, Hololens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HoloSIM Software via Hololens 2Device
Participants will train via a mixed reality simulated crisis scenario using the HoloSIM software on the Microsoft Hololens 2
Training by Mannequin Based SimulationOther
Participants will train a via traditional mannequin based medical crisis scenario
| Study group | Role | What they receive |
|---|---|---|
| Group A: HoloSIM (intervention) | Experimental | Training by Mixed Reality Simulation Receives: Device: HoloSIM Software via Hololens 2 |
| Group B: Mannequin (control) | Active comparator | Training by Mannequin Based Simulation Receives: Other: Training by Mannequin Based Simulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anaphylaxis Checklist of Core Decision Making Steps
Expert consensus based checklists of critical scenario actions on a mannequin based crisis scenario. Student scenario performance graded from 0 to 45, with higher scores representing a better performance.
Measured: 30 days post exposure
Secondary outcomes (4)
System Usability Scale (SUS)
Likert scale (5 point) based assessment of software usability. Higher scores on a scale of 1 to 5 represent a better software system usability.
Measured: Immediately after exposure
Modified Simulation Effectiveness Tool (SET-M)
likert scale (3 point) validated assessment of learning satisfaction tool
Measured: Immediately after exposure
Time required to complete critical crisis related tasks
Measured time until critical scenario management events occur
Measured: 30 days post exposure
anaphylaxis knowledge test
validated multiple choice quiz of anaphylaxis knowledge developed by allergists for use with the same curriculum included in our study
Measured: 30 days post exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start1 Mar 2023
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medical EmergenciesStudies 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
- It is a two stage study that will: 1) iteratively develop and usability test the HoloSIM software with acute care medicine specialties at Sunnybrook, and 2) determine if the HoloSIM platform is non-inferior to the current teaching and assessment standard of high-fidelity mannequin-based crisis simulation.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julian Wiegelmann, Dr., Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05729802
- Sponsor's protocol ID
- 3777
- Status last verified
- Jan 2025
- First submitted
- 6 Jan 2023
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: For confidentiality purpose, Participants personal information will not be shared, and any study data that will be sent outside of the research institution will be encrypted by an ID code for each participant.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Holographic Standardized Patient: Using Mixed Reality to Reduce Barriers to Crisis
- ClinicalTrials.gov ID
- NCT05729802
- Acronym / sponsor ID
- 3777
- Keywords
- Mixed Reality, Augmented Reality, Medical Simulation, Hololens
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 15 Feb 2023 (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 current pandemic has revealed in-person simulation training and evaluation is vulnerable to disruption, and alternatives are needed which allow remote evaluation. The recently developed Microsoft Hololens headset device allows interactable holograms to be inserted into a user's workspace (mixed reality) - permitting the augmentation of existing clinical and training spaces with holographic (i.e. virtual) patients via the prototype HoloSIM software. This study is the first known research initiative aiming to demonstrate the feasibility and effectiveness of mixed reality for acute medicine training and assessment at a distance.
Space, time, personnel, pandemic, and cost constraints limit opportunities for high-fidelity simulation exercises for post-graduate trainees at Sunnybrook. By developing and demonstrating the effectiveness of this new training modality, increased simulation exercises will lead to a higher quality education experience, better functioning teams, and better patient outcomes.
Detailed description
The study is the first known research initiative aiming to demonstrate that a mixed reality simulation training and assessment modality can be implemented in different clinical contexts and can improve decision making skills and management in a complex crisis scenario.
The investigators hypothesize that a mixed reality simulation training solution is usable, feasible, and can improve decision making skills and management.
It is a two stage study: 1) iteratively develop and usability test the HoloSIM software with acute care medicine specialties at Sunnybrook, and 2) determine if the HoloSIM platform is non-inferior to the current teaching and assessment standard of high-fidelity mannequin-based crisis simulation.
The understanding is that this will be a first-of-its-kind study that will generate an accessible, easy to administer tool to educate residents and fellows. The presented HoloSIM software will allow teams to practice and assess their responses to a variety of scenarios in clinical environments such as the trauma bay and ICU. This has the potential to improve team function and enhance quality of care across the healthcare system.
Healthcare facilities without expensive simulation centres are unable to participate in high-fidelity medical simulation. Inequities in access to high quality training and professional development have been repeatedly cited as a barrier to retention of rural health care providers. The SHSC simulation centre will adapt this approach and offer training at a distance and medical crisis coaching to rural health care providers utilizing the this mentioned platform. Lastly, all simulation resources developed during the project will be made freely available via the project website. Other institutions internationally may use them to improve their team performance, patient safety, and postgraduate education programs.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- It is a two stage study that will: 1) iteratively develop and usability test the HoloSIM software with acute care medicine specialties at Sunnybrook, and 2) determine if the HoloSIM platform is non-inferior to the current teaching and assessment standard of high-fidelity mannequin-based crisis simulation.
| Arm | Type | Receives |
|---|---|---|
| Group A: HoloSIM (intervention) | Experimental | Device: HoloSIM Software via Hololens 2Training by Mixed Reality Simulation |
| Group B: Mannequin (control) | Active comparator | Other: Training by Mannequin Based SimulationTraining by Mannequin Based Simulation |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Resident or fellow level volunteers from acute care postgraduate training programs (Internal Medicine, Emergency Medicine, Anesthesiology, Critical Care Medicine at Sunnybrook Health Sciences Centre
Key exclusion criteria (2 listed)
- Unwilling to enter the study
- Previous experience with simulator based teaching on anaphylaxis
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 |
|---|---|---|
| HoloSIM Software via Hololens 2Participants will train via a mixed reality simulated crisis scenario using the HoloSIM software on the Microsoft Hololens 2 | Device | Group A: HoloSIM (intervention) |
| Training by Mannequin Based SimulationParticipants will train a via traditional mannequin based medical crisis scenario | Other | Group B: Mannequin (control) |
Primary outcome
Anaphylaxis Checklist of Core Decision Making Steps
Time frame: 30 days post exposure
Expert consensus based checklists of critical scenario actions on a mannequin based crisis scenario. Student scenario performance graded from 0 to 45, with higher scores representing a better performance.
4 secondary outcomes
System Usability Scale (SUS)
Time frame: Immediately after exposure
Modified Simulation Effectiveness Tool (SET-M)
Time frame: Immediately after exposure
Time required to complete critical crisis related tasks
Time frame: 30 days post exposure
anaphylaxis knowledge test
Time frame: 30 days post exposure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- Individual participant dataSharing planned: Yes. For confidentiality purpose, Participants personal information will not be shared, and any study data that will be sent outside of the research institution will be encrypted by an ID code for each participant.
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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.
Julian Wiegelmann, Dr. principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HoloSIM Software via Hololens 2 and Training by Mannequin Based Simulation in people with Medical Emergencies and Educational Problems, run by Sunnybrook Health Sciences Centre 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 1 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: looking for participants now, as of the sponsor's last update on 29 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anaphylaxis Checklist of Core Decision Making Steps (time frame: 30 days post exposure). 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 29 Jan 2025.