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 (ATOM)

March 26, 2026 updated by: Western Michigan University School of Medicine
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

312

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Kalamazoo, Michigan, United States, 49008
        • Western Michigan University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Eligible participants were licensed EMTPs or EMTs authorized to practice within their agency.

Exclusion Criteria:

  • strabismus
  • severe astigmatism
  • vertigo
  • significant visual impairment
  • motion sickness
  • claustrophobia
  • screen-induced nausea/headache

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Augmented reality
EMS crews who will utilize the augmented reality application
Other: Augmented reality software for pediatric drug dosing
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.
No Intervention: Usual care
EMS crews who will provide usal care using their existing pediatric dosing references

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tenfold dosing errors
Time Frame: 2 hours
Number of medication doses administered at ten times, one-tenth, or greater deviation from the correct dose, assessed over a 2-hour observation window.
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Western Michigan University School of Medicine

Collaborators

University of Michigan
Western Michigan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Estimated)

March 31, 2026

Study Completion (Estimated)

March 31, 2026

Study Registration Dates

First Submitted

March 16, 2026

First Submitted That Met QC Criteria

March 26, 2026

First Posted (Actual)

March 31, 2026

Study Record Updates

Last Update Posted (Actual)

March 31, 2026

Last Update Submitted That Met QC Criteria

March 26, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Augmenting the On-Scene Medic
  • 5R18HS029283-03 (U.S. AHRQ Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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