Medication ErrorsATOMNCT07504211
Augmenting the On-Scene Medic (ATOM): A Randomized, Controlled, Multicenter Study to Assess the Effectiveness of Augmented Reality Software on Prehospital Pediatric Medication Administration Accuracy
A study testing Augmented reality software for pediatric drug dosing in people with Medication Errors and Pediatric Medication Error, run by Western Michigan University School of Medicine at 1 site in United States.
Trial summary
The primary objective of this research study is to use simulated pediatric emergencies to test the effectiveness of a drug dosing safety system for EMS providers by comparing usual care to use of an augmented reality device. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medication Errors, Pediatric Medication Error
- What is being tested?
- Augmented reality software for pediatric drug dosing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2023to 31 Mar 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible participants were licensed EMTPs or EMTs authorized to practice within their agency.
Who cannot join
- strabismus
- severe astigmatism
- vertigo
- significant visual impairment
- motion sickness
- claustrophobia
- screen-induced nausea/headache
Trial locations and contacts
1 site in 1 country.
United States1 site
Western Michigan University School of Medicine
Kalamazoo, Michigan, 49008
About this study
The primary objective of this research study is to use simulated pediatric emergencies to test the effectiveness of a drug dosing safety system for EMS providers by comparing usual care to use of an augmented reality device.
Read the detailed description
The objective of this project is to develop a safe and effective dynamic cognitive aid application for use through a head-mounted display (HMD), to reduce error rates associated with pediatric medication administration (PMA) by emergency medical services (EMS). This objective will be achieved by examining characteristics associated with PMA, using a design thinking process to develop a prototype application, examining usability of the prototype, and testing the safety and efficacy in a randomized controlled trial.
Errors associated with PMA in EMS are alarmingly high. Numerous studies have shown that there is a 31% error rate across all drugs administered to children by EMS. Medications such as midazolam and fentanyl have even higher rates at 61% and 65%, respectfully, with many being 10-fold errors. Sadly, previous strategies have had little impact on reducing error rates below 31%. System changes have failed due to inconsistencies in EMS systems, and challenges associated with medication shortages. Previously developed cognitive aids have fallen short often due to the fact they generally act as simple reference tools and do not address all causes of error associated with PMA. As a result, we are proposing the most comprehensive design process ever taken to combat this issue, utilizing advanced technology, to implement a dynamic cognitive aid to help providers improve dosing accuracy during PMA.
We hypothesize that PMA errors in EMS will be significantly reduced by this application due to the comprehensive and rigorous design thinking process we will utilize followed by a randomized controlled trial to test safety and efficacy. Our interdisciplinary team will combine the fields of pediatric emergency medicine, EMS, engineering, computer science and user interface/user experience to address this issue with the support and effort of two medical schools in Michigan. In SA1 we will develop a prototype application. This will begin with identifying user and contextual information associated with PMA, and examine failure modes, root causes, and a task analysis of the procedure. We will then proceed into a comprehensive design thinking process to develop the application. During this process we will also create a desktop program that will allow EMS agency administrators to add new medications to the HMD application. In SA2, we will examine usability of the HMD application and associated desktop program in a simulation-based environment with a sample of end users, examining task duration, cognitive load and error rates and make any necessary refinements. In SA3, we will test the HMD application in a simulation-based randomized controlled trial to examine its safety and efficacy for use in EMS. This will result in a safe and effective tool to mitigate this alarming issue in the vulnerable EMS pediatric population.
- Conditions
- Medication Errors, Pediatric Medication Error
- Being tested
- Augmented reality software for pediatric drug dosing
- Keywords
- Simulated Pediatric Emergencies, Emergency Medical Services, Medication Errors, Patient Safety, Simulation, pediatrics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Augmented reality software for pediatric drug dosingOther
Augmented reality software, developed by the study team, will be utilized by the experimental arm. This software is specifically designed to decrease errors in the prehospital pediatric medication administration process.
| Study group | Role | What they receive |
|---|---|---|
| Augmented reality | Experimental | EMS crews who will utilize the augmented reality application Receives: Other: Augmented reality software for pediatric drug dosing |
| Usual care | No intervention | EMS crews who will provide usal care using their existing pediatric dosing references |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug dosing accuracy
Proportion of medication administration tasks performed accurately, with a target difference of >20% between control and experimental groups, assessed via structured observational methods over a [2] hour timeframe.
Measured: 2 hours
Secondary outcomes (1)
Tenfold dosing errors
Number of medication doses administered at ten times, one-tenth, or greater deviation from the correct dose, assessed over a 2-hour observation window.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study start1 Apr 2023
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (40)Papers the sponsor has linked to this study.
- Other trials for Medication ErrorsStudies 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
- Masking
- None (open label)
- Enrolment
- 312 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western Michigan University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan, Western Michigan University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07504211
- Sponsor's protocol ID
- Augmenting the On-Scene Medic
- Other IDs
- 5R18HS029283-03
- Acronym
- ATOM
- Status last verified
- Mar 2026
- First submitted
- 16 Mar 2026
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
R: The r project for statistical computing. Accessed May 20, 2022. https://www.r-project.org/
Python eda documentation. Accessed May 20, 2022. https://pyeda.readthedocs.io/en/latest/index.html
Ledalab software. Accessed May 20, 2022. http://www.ledalab.de/software.htm
Romine WL, Schroeder NL, Graft J, Yang F, Sadeghi R, Zabihimayvan M, Kadariya D, Banerjee T. Using Machine Learning to Train a Wearable Device for Measuring Students' Cognitive Load during Problem-Solving Activities Based on Electrodermal Activity, Body Temperature, and Heart Rate: Development of a Cognitive Load Tracker for Both Personal and Classroom Use. Sensors (Basel). 2020 Aug 27;20(17):4833. doi: 10.3390/s20174833.
PubMed 32867055Saitis C, Parvez MZ, Kalimeri K. Cognitive load assessment from EEG and peripheral biosignals for the design of visually impaired mobility aids. Wireless Communications and Mobile Computing. Published online 2018:1-9. doi:10.1155/2018/8971206
Wilson JC, Nair S, Scielzo S, Larson EC. Objective measures of cognitive load using deep multi-modal learning. Proceedings of the ACM on Interactive, Mobile, Wearable and Ubiquitous Technologies. 2021;5(1):1-35. doi:10.1145/3448111
Leuze C, Zoellner A, Schmidt AR, Cushing RE, Fischer MJ, Joltes K, Zientara GP. Augmented reality visualization tool for the future of tactical combat casualty care. J Trauma Acute Care Surg. 2021 Aug 1;91(2S Suppl 2):S40-S45. doi: 10.1097/TA.0000000000003263.
PubMed 33938509Mela CA, Papay FA, Liu Y. Intraoperative Fluorescence Imaging and Multimodal Surgical Navigation Using Goggle System. Methods Mol Biol. 2016;1444:85-95. doi: 10.1007/978-1-4939-3721-9_9.
PubMed 27283420Follmann A, Ohligs M, Hochhausen N, Beckers SK, Rossaint R, Czaplik M. Technical Support by Smart Glasses During a Mass Casualty Incident: A Randomized Controlled Simulation Trial on Technically Assisted Triage and Telemedical App Use in Disaster Medicine. J Med Internet Res. 2019 Jan 3;21(1):e11939. doi: 10.2196/11939.
PubMed 30609988Siebert JN, Ehrler F, Gervaix A, Haddad K, Lacroix L, Schrurs P, Sahin A, Lovis C, Manzano S. Adherence to AHA Guidelines When Adapted for Augmented Reality Glasses for Assisted Pediatric Cardiopulmonary Resuscitation: A Randomized Controlled Trial. J Med Internet Res. 2017 May 29;19(5):e183. doi: 10.2196/jmir.7379.
PubMed 28554878Scherl C, Stratemeier J, Rotter N, Hesser J, Schonberg SO, Servais JJ, Mannle D, Lammert A. Augmented Reality with HoloLens(R) in Parotid Tumor Surgery: A Prospective Feasibility Study. ORL J Otorhinolaryngol Relat Spec. 2021;83(6):439-448. doi: 10.1159/000514640. Epub 2021 Mar 30.
PubMed 33784686Frantz T, Jansen B, Duerinck J, Vandemeulebroucke J. Augmenting Microsoft's HoloLens with vuforia tracking for neuronavigation. Healthc Technol Lett. 2018 Oct 4;5(5):221-225. doi: 10.1049/htl.2018.5079. eCollection 2018 Oct.
PubMed 30464854Song T, Yang C, Dianat O, Azimi E. Endodontic guided treatment using augmented reality on a head-mounted display system. Healthcare Technology Letters. 2018;5(5):201-207. doi:10.1049/htl.2018.5062
Al Janabi HF, Aydin A, Palaneer S, Macchione N, Al-Jabir A, Khan MS, Dasgupta P, Ahmed K. Effectiveness of the HoloLens mixed-reality headset in minimally invasive surgery: a simulation-based feasibility study. Surg Endosc. 2020 Mar;34(3):1143-1149. doi: 10.1007/s00464-019-06862-3. Epub 2019 Jun 18.
PubMed 31214807Vorraber W, Gasser J, Webb H, Neubacher D, Url P. Assessing augmented reality in production: remote-assisted maintenance with HoloLens. Procedia CIRP. 2020;88:139-144. doi:10.1016/j.procir.2020.05.025
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmenting the On-Scene Medic (ATOM): A Randomized, Controlled, Multicenter Study to Assess the Effectiveness of Augmented Reality Software on Prehospital Pediatric Medication Administration Accuracy
- ClinicalTrials.gov ID
- NCT07504211
- Acronym / sponsor ID
- ATOM / Augmenting the On-Scene Medic
- Conditions
- Medication Errors, Pediatric Medication Error
- Keywords
- Simulated Pediatric Emergencies, Emergency Medical Services, Medication Errors, Patient Safety, Simulation, pediatrics
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 312 participants (estimated)
- Lead sponsor
- Western Michigan University School of MedicineUniversity, hospital or other
- Collaborators
- University of Michigan, Western Michigan University
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 31 Mar 2026 (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 primary objective of this research study is to use simulated pediatric emergencies to test the effectiveness of a drug dosing safety system for EMS providers by comparing usual care to use of an augmented reality device.
Detailed description
The objective of this project is to develop a safe and effective dynamic cognitive aid application for use through a head-mounted display (HMD), to reduce error rates associated with pediatric medication administration (PMA) by emergency medical services (EMS). This objective will be achieved by examining characteristics associated with PMA, using a design thinking process to develop a prototype application, examining usability of the prototype, and testing the safety and efficacy in a randomized controlled trial.
Errors associated with PMA in EMS are alarmingly high. Numerous studies have shown that there is a 31% error rate across all drugs administered to children by EMS. Medications such as midazolam and fentanyl have even higher rates at 61% and 65%, respectfully, with many being 10-fold errors. Sadly, previous strategies have had little impact on reducing error rates below 31%. System changes have failed due to inconsistencies in EMS systems, and challenges associated with medication shortages. Previously developed cognitive aids have fallen short often due to the fact they generally act as simple reference tools and do not address all causes of error associated with PMA. As a result, we are proposing the most comprehensive design process ever taken to combat this issue, utilizing advanced technology, to implement a dynamic cognitive aid to help providers improve dosing accuracy during PMA.
We hypothesize that PMA errors in EMS will be significantly reduced by this application due to the comprehensive and rigorous design thinking process we will utilize followed by a randomized controlled trial to test safety and efficacy. Our interdisciplinary team will combine the fields of pediatric emergency medicine, EMS, engineering, computer science and user interface/user experience to address this issue with the support and effort of two medical schools in Michigan. In SA1 we will develop a prototype application. This will begin with identifying user and contextual information associated with PMA, and examine failure modes, root causes, and a task analysis of the procedure. We will then proceed into a comprehensive design thinking process to develop the application. During this process we will also create a desktop program that will allow EMS agency administrators to add new medications to the HMD application. In SA2, we will examine usability of the HMD application and associated desktop program in a simulation-based environment with a sample of end users, examining task duration, cognitive load and error rates and make any necessary refinements. In SA3, we will test the HMD application in a simulation-based randomized controlled trial to examine its safety and efficacy for use in EMS. This will result in a safe and effective tool to mitigate this alarming issue in the vulnerable EMS pediatric population.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Augmented reality | Experimental | Other: Augmented reality software for pediatric drug dosingEMS crews who will utilize the augmented reality application |
| Usual care | No intervention | –EMS crews who will provide usal care using their existing pediatric dosing references |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Eligible participants were licensed EMTPs or EMTs authorized to practice within their agency.
Key exclusion criteria (7 listed)
- strabismus
- severe astigmatism
- vertigo
- significant visual impairment
- motion sickness
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 |
|---|---|---|
| Augmented reality software for pediatric drug dosingAugmented reality software, developed by the study team, will be utilized by the experimental arm. This software is specifically designed to decrease errors in the prehospital pediatric medication administration process. | Other | Augmented reality |
Primary outcome
Drug dosing accuracy
Time frame: 2 hours
Proportion of medication administration tasks performed accurately, with a target difference of >20% between control and experimental groups, assessed via structured observational methods over a [2] hour timeframe.
1 secondary outcome
Tenfold dosing errors
Time frame: 2 hours
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 31 Mar 2026.
- BackgroundR: The r project for statistical computing. Accessed May 20, 2022. https://www.r-project.org/
- BackgroundPython eda documentation. Accessed May 20, 2022. https://pyeda.readthedocs.io/en/latest/index.html
- BackgroundLedalab software. Accessed May 20, 2022. http://www.ledalab.de/software.htm
- Background: PubMed 32867055Romine WL, Schroeder NL, Graft J, Yang F, Sadeghi R, Zabihimayvan M, Kadariya D, Banerjee T. Using Machine Learning to Train a Wearable Device for Measuring Students' Cognitive Load during Problem-Solving Activities Based on Electrodermal Activity, Body Temperature, and Heart Rate: Development of a Cognitive Load Tracker for Both Personal and Classroom Use. Sensors (Basel). 2020 Aug 27;20(17):4833. doi: 10.3390/s20174833.
- BackgroundSaitis C, Parvez MZ, Kalimeri K. Cognitive load assessment from EEG and peripheral biosignals for the design of visually impaired mobility aids. Wireless Communications and Mobile Computing. Published online 2018:1-9. doi:10.1155/2018/8971206
- BackgroundWilson JC, Nair S, Scielzo S, Larson EC. Objective measures of cognitive load using deep multi-modal learning. Proceedings of the ACM on Interactive, Mobile, Wearable and Ubiquitous Technologies. 2021;5(1):1-35. doi:10.1145/3448111
- Background: PubMed 33938509Leuze C, Zoellner A, Schmidt AR, Cushing RE, Fischer MJ, Joltes K, Zientara GP. Augmented reality visualization tool for the future of tactical combat casualty care. J Trauma Acute Care Surg. 2021 Aug 1;91(2S Suppl 2):S40-S45. doi: 10.1097/TA.0000000000003263.
- Background: PubMed 27283420Mela CA, Papay FA, Liu Y. Intraoperative Fluorescence Imaging and Multimodal Surgical Navigation Using Goggle System. Methods Mol Biol. 2016;1444:85-95. doi: 10.1007/978-1-4939-3721-9_9.
- Background: PubMed 30609988Follmann A, Ohligs M, Hochhausen N, Beckers SK, Rossaint R, Czaplik M. Technical Support by Smart Glasses During a Mass Casualty Incident: A Randomized Controlled Simulation Trial on Technically Assisted Triage and Telemedical App Use in Disaster Medicine. J Med Internet Res. 2019 Jan 3;21(1):e11939. doi: 10.2196/11939.
- Background: PubMed 28554878Siebert JN, Ehrler F, Gervaix A, Haddad K, Lacroix L, Schrurs P, Sahin A, Lovis C, Manzano S. Adherence to AHA Guidelines When Adapted for Augmented Reality Glasses for Assisted Pediatric Cardiopulmonary Resuscitation: A Randomized Controlled Trial. J Med Internet Res. 2017 May 29;19(5):e183. doi: 10.2196/jmir.7379.
- Background: PubMed 33784686Scherl C, Stratemeier J, Rotter N, Hesser J, Schonberg SO, Servais JJ, Mannle D, Lammert A. Augmented Reality with HoloLens(R) in Parotid Tumor Surgery: A Prospective Feasibility Study. ORL J Otorhinolaryngol Relat Spec. 2021;83(6):439-448. doi: 10.1159/000514640. Epub 2021 Mar 30.
- Background: PubMed 30464854Frantz T, Jansen B, Duerinck J, Vandemeulebroucke J. Augmenting Microsoft's HoloLens with vuforia tracking for neuronavigation. Healthc Technol Lett. 2018 Oct 4;5(5):221-225. doi: 10.1049/htl.2018.5079. eCollection 2018 Oct.
- Individual participant dataSharing planned: No
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Healthy Volunteers
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?
A study testing Augmented reality software for pediatric drug dosing in people with Medication Errors and Pediatric Medication Error, run by Western Michigan University School of Medicine at 1 site in United States.
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 7 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: under way, not looking for participants, as of the sponsor's last update on 31 Mar 2026. 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 United States. 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?
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?
Drug dosing accuracy (time frame: 2 hours). 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 NCT07504211, which also lists 40 linked publications.
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 31 Mar 2026.