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
Phase: NA
Conditions: Medication Errors, Pediatric Medication Error
Sponsor: Western Michigan University School of Medicine

Page 1 of 38 
 
A Simulation-Based Randomized, Controlled, Multicenter Trial to Test the Efficacy of 
Augmented Reality Software on Prehospital Pediatric Medication Administration Accuracy. 
The Augmenting the On-Scene Medic (ATOM) study 
 
 
Study Protocol 
 
Clinical Trial Registry Number: XXX 
Registration date: XXX Principal Investigator: John D. Hoyle, Jr. MD (john.hoyle@wmed.edu) 
Funded by: Agency for Healthcare Research and Quality 
Grant number: 1R18HS029283-01 
Version Number 1 
December 16, 2025 
 
 
 
This protocol version has been provided by the study team to provide additional information on 
the study to the reader. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Table of Contents 
 
1. Protocol…………………………………………………………………………………………  4 
2. Principal Investigator and Funding Source……………………………………………………. 
4 
3. Version Date…………………………………………………………………………………… 
4 
4. Objectives……………………………………………………………………………………… 
4 
5. Background and Rationale……………………………………………………………………... 
4 
6. Setting…………………………………………………………………………………………... 6 
7. Resources Available……………………………………………………………………………. 
6 
8. Study Design…………………………………………………………………………………… 
6 
              a) Number of EMS agencies…………………………………………………………………... 
6 
              b) Number of Subjects………………………………………………………………………… 
6 
              c) Estimated study duration……………………………………………………………………. 
6 
              d) Subject eligibility…………………………………………………………………………… 
6 
              e) Randomization……………………………………………………………………………… 
7 
              f) Inclusions and Exclusion Criteria…………………………………………………………… 
7 
              g) Screen Failures……………………………………………………………………………… 
8 
              h) Subject Enrollment………………………………………………………………………….. 8 
9. Study Procedures……………………………………………………………………………….. 
8 
              a) Informed Consent…………………………………………………………………………… 
8 
              b) Demographic survey, non-disclosure agreement (NDA), and continuing education credits.. 8 
              c) Simulation instructions……………………………………………………………………… 9 
              d) Simulation trailer………………………………………………………………………….... 
10 
              e) Drug box stocking…………………………………………………………………………... 
10 
              f) HoloLens training and training scenario……………………………………………………. 
10 
              g) Control group training……………………………………………………………………… 
11 
              h) Sample size…………………………………………………………………………………. 
11 
                i) Compliance………………………………………………………………………………….  12 
              j) Simulation scenarios………………………………………………………………………… 
12 
              k) Cognitive Load Analysis……………………………………………………………………. 18 
              l) Debriefing…………………………………………………………………………………… 
18 
              m) Video review……………………………………………………………………………….. 
19 
              n) Data entry…………………………………………………………………………………… 
19 
              o) Data review…………………………………………………………………………………. 
19 
 p) Study endpoints……………………………………………………………………………. 
19 
 q) Data management………………………………………………………………………….. 
20 
 r) Withdrawal of Subjects…………………………………………………………………….. 
20 
10. Statistical Plan………………………………………………………………………………….. 
20 
a) Sample size determination………………………………………………………………… 
20 
b) Statistical methods………………………………………………………………………… 
20 
1) Primary analyses……………………………………………………………………... 
20 
2) Secondary analyses…………………………………………………………………... 
21 
3) Supplementary analyses……………………………………………………………… 
21 
11. Risks to Subjects……………………………………………………………………………….. 
22 
12. Potential Benefits to Subjects…………………………………………………………………... 22 
13. Provisions to Protect the Privacy of Subjects…………………………………………………... 22 
14. Provisions to Maintain the Confidentiality of Data……………………………………………. 
22 
15. Costs to Subjects……………………………………………………………………………….. 
22 
16. Sharing of results with subjects………………………………………………………………… 23 

Page 3 of 38 
 
17. References……………………………………………………………………………………… 
23 
       Appendix A…………………………………………………………………………………………   25 
       Appendix B………………………………………………………………………………………… 
29 
       Appendix C………………………………………………………………………………………… 
32 
       Appendix D………………………………………………………………………………………… 
35 
       Glossary……………………………………………………………………………………………. 
38 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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1. Protocol Title: A Simulation-Based, Randomized, Controlled, Multicenter Trial to Test the 
Efficacy of Augmented Reality Software on Prehospital Pediatric Medication Administration 
Accuracy. The Augmenting the On-Scene Medic Study (ATOM) 
 
Short Title: Augmenting the On-Scene Medic (ATOM) 
 
2. Principal Investigator: John D. Hoyle, Jr. MD, Western Michigan University Homer 
Stryker M.D. School of Medicine, john.hoyle@wmed.edu 
 
Funding Source: Agency for Healthcare Research and Quality (AHRQ) 
 
3. Version Date: January 8, 2026 
 
4. Objectives 
 
Primary: To assess the effect of augmented reality software delivered via a head mounted 
display (HMD) for prehospital pediatric medication administration (PMA) dosing accuracy. 
 
Secondary: To assess the effect of augmented reality software on errors of omission and 
commission 
 
Hypothesis: Use of augmented reality software, developed via human-centered design 
thinking, will reduce PMA errors made by EMS paramedics compared to usual practice with 
existing cognitive aids. 
 
5. Background and Rationale 
Research examining the quality of care provided by Emergency Medical Services (EMS) has 
shown that errors with serious consequences occur at high rates.1 Numerous studies have 
shown that pediatric patients are at significantly higher risk to experience medical errors in 
EMS.2–6 One aspect of pediatric care shown to have extraordinarily high rates of error is 
pediatric medication administration (PMA). Studies have shown an overall medication error 
rate of 31% during EMS pediatric care3,4,7,8 with some medications having error rates over 
60%.7 In 2021, 1,263,959 children aged 12 and younger were treated by EMS and received 
one or more drugs.9  Based on a 31% medication error rate, an estimated 391,827 (31%) of 
those children received an incorrect drug dose with many possibly suffering an adverse drug 
event.7  This number of pediatric patients receiving an incorrect dose in EMS is enough to fill 
the University of Michigan Stadium, the largest football stadium in the United States, over 
3.5 times. This alarming data has led to strategies aimed at reducing these errors which have 
had limited success. 
 
In comparison to the hospital setting, little effort has been made to decrease errors in EMS. A 
California EMS quality improvement initiative targeting pediatric epinephrine dosing errors 
reduced error rates from 60% to 35%.8  This study’s interventions were an EMS pediatric 
drug reference with doses in milligrams, encouragement of use of the Broselow-Luten Tape, 
a length-based pediatric weight estimation tool, and the requirement that the paramedic 
consult a physician via radio after the first dose was delivered for dose confirmation. This 
rigorous study demonstrated significant improvement. However, even with the interventions, 

Page 5 of 38 
 
an error rate of 35% still occurred. Some weaknesses of this study were: it only focused on a 
single drug and excluded the many other drugs that EMS providers administer to children, it 
did not describe a needs assessment of the paramedics, root cause analysis (RCA) of errors, 
failure modes and effects analysis (FMEA) of the drug administration process or testing that 
includes direct observation or simulation of the interventions for efficacy and unintended 
consequences prior to implementation. By not evaluating the systems for error causes and 
failure modes prior to implementation, the causes of the remaining 35% of errors were never 
discovered. 
 
A recent study describes the results of 142 pediatric patient simulations with 16 EMS 
agencies in Michigan.7 These took place after implementation of an EMS-specific pediatric 
drug dosing reference (PDR) with doses listed in milliliters. PDR use by all paramedics is 
mandated in Michigan, including psychomotor biennial training on PDR use and PMA. After 
implementation, 31.2% of all drug doses were still incorrect. The changes in incorrect dosing 
pre and post PDR implementation were epinephrine in cardiac arrest: Pre-75%, Post-27% 
(32% of post errors were ten-fold overdoses), benzodiazepine doses for seizures: Pre-76%, 
Post-34%. Prior to PDR implementation, based on the aforementioned database study 94.6% 
of opioid doses were incorrect, with 89% being under doses.10 After PDR implementation, 
the opioid error rate decreased to 35% incorrect, but 80% of incorrect doses were overdoses, 
with the median overdose being 5 times the correct dose.7  While previously studied 
interventions have reduced the error rates for prehospital medication administration, there 
remains an overall error rate of 31-35%.3,7,8  Studies that demonstrate reduced errors have 
several significant limitations including focus on a single drug, lack of direct observation, 
lack of paramedic needs assessment, lack of FMEA analysis of drug administration 
procedures, and lack of testing of interventions to determine efficacy and unintended 
consequences prior to implementation. Additionally, many of the error types discovered in 
observational studies are not addressed through the current design of cognitive aids. This has 
resulted in this abnormally high error rate continuing unchecked. 
 
The errors that occur during PMA call out for cognitive support aids that are more dynamic. 
Dynamic cognitive aids are usually electronic and can offer step-by-step support through 
changing interactive display options.13 This combines features of multiple cognitive aid 
designs, such as reference lists, calculation devices, and procedural checklists. Furthermore, 
dynamic cognitive aids can read objects in the environment, such as medication labels.12 This 
allows for an interactive experience for the user that supports their performance in multiple 
ways.  
 
One evolving technology for implementing dynamic cognitive aids are head-mounted 
displays (HMD). These devices project an interactive display into the user’s field of view 
while allowing continuous visibility of the surrounding environment. Outside of healthcare, 
research from numerous disciplines, including aviation and manufacturing, have shown 
significant improvement in efficiency and reduction in errors using applications with 
HMDs.14-19 Although there is limited research regarding their use in EMS, other disciplines in 
healthcare have shown dramatic improvement in accuracy and lower error rates with use of 
HMD applications.20-23 These studies have seen error reductions of 34% to as high as 
66%.21,24-28 One of the most widely utilized HMDs is the Microsoft HoloLens. Currently on 
its second edition (HoloLens 2), the device can read objects in the user’s field of view and 
use that information to display crucial instructions the user needs to perform a certain task. 

Page 6 of 38 
 
The headset can remain in a shelf in kiosk mode, which allows a user to put it on and quickly 
launch an application in seconds with the tap of a button. Depending on the application being 
used, the user can interact with the displays through hand gestures, a hand-held clicker, or 
even voice commands.29  
 
6. Setting: 
The setting for this research will be the Western Michigan Homer Stryker M.D. School of 
Medicine and the Western Michigan University. Simulation scenarios will be conducted in 
our mobile pediatric simulation trailer, with high-fidelity pediatric simulators.  The trailer 
will be taken to seven different EMS agencies in Michigan and Indiana. 
 
7. Resources Available 
Personnel: Research coordinator, investigators, data analysts, simulation 
technician/specialists. 
 
Equipment: simulation trailer with 4 camera audio/video recording system using Avigilon AV 
Software, four HoloLens 2s, sham medications, syringes (1, 3, 5, 10 ml), three-way 
stopcocks, IV catheters (22 and 24 gauge), EZ IO drill with all three sizes of needles, 
anchoring devices and extension tubing, 1L and 500mL bags of NS, IV tubing. 
 
Human patient simulators: Gaumard Super Tory with Microsoft Surface computer to run the 
simulator and a separate Microsoft Surface computer to project vital signs.  Gaumard Hal Jr. 
with Microsoft Surface computer to run the simulator and a separate Microsoft Surface 
computer to project vital signs.   
 
8. Study Design 
This is a block-randomized, controlled, parallel group, unblinded, simulation-based, 
multicenter trial involving Emergency Medical Services (EMS) crews in Michigan and 
Indiana.  Subject EMS crews will be randomized within each agency to have an equal 
number of experimental and control crews in each agency thereby accounting for inter-
agency variation.  Experimental group crews will use the augmented reality software and 
control group crews will use their usual references and do their usual practice for PMA. 
 
a) Number of EMS agencies 
This study will be a multicenter study performed with seven EMS agencies, six in 
Michigan and one in Indiana. 
 
b) Number of subjects 
Eighty-four EMS crews, twelve at each agency, are planned to be randomized. We expect 
a 20% decline rate leaving a total of 33 crews in each arm. Rationale for sample size is 
included in the section labeled Sample size. 
 
c) Estimated study duration 
Enrollment for this study will take place over sixteen weeks, April through July 2025. 
 
d) Subject eligibility 

Page 7 of 38 
 
Investigators will maintain a log that includes demographic information about each 
identified subject, as well as outcome of the screening process (enrolled, reason for 
ineligibility, refusal to consent). 
 
e) Randomization 
This RCT will employ block randomization by agency to ensure balance between the 
control (usual practice) and experimental (augmented reality) arms, thereby accounting 
for potential between-agency and intra-agency variations. Specifically, within each 
agency, crews will be randomized in a 1:1 ratio to yield 6 control crews and 6 
experimental crews per agency.  Study team members will not know crew randomization 
assignment until the evening before the simulation session.  Study team will not know 
crew scenario order until the morning of the simulation session.  Crews will not be told of 
their assignment until after they are consented. 
 
The order of the three simulation scenarios will also be randomized, resulting in six 
possible permutations of their sequence (e.g., cardiac arrest first, followed by burn, then 
seizure). To counterbalance the design and further control for between-agency and 
between-crew variations while ensuring balanced exposure to scenario sequences, each of 
the six permutations will be assigned exactly once to the control arm and once to the 
experimental arm within each agency. Crews will not be told which scenario they will be 
participating in until they are given dispatch information just prior to the case starting. 
 
Randomization to treatment arm (control vs. experimental) and scenario sequence 
permutation will be performed using a random number generator, specifically the 
Mersenne Twister (MT19937). To accommodate logistical constraints, restricted 
randomization will be applied such that no more than two experimental groups are 
scheduled per simulation day to ensure enough time to reset scenarios and to fully charge 
patient simulators and the HMDs. 
 
The paramedic in the experimental crew will use the HMD application. For crews 
consisting of two paramedics, simple randomization using a mobile application 
(Roundom: Decision Maker, version 2.0.4) will be used to assign one paramedic to 
operate the HMD, which will take place after consent. Similarly, for control crews with 
two paramedics, using the same randomization method, one will be designated as the lead 
paramedic for the simulations after consent has been obtained.  The randomization 
scheme will be concealed from the two study scenario observers until the start of each 
agency's simulation day. 
 
Crews will either be temporarily removed from service by the agency, or will come in on 
their non-working day, at the discretion of the agency. Agencies will be compensated for 
the personnel time for the simulations. Four crews will go through the simulation 
scenarios each day. Each of the four crew slots will be randomized for each day. If a crew 
is not available for a given time slot, that crew slot will be dropped and recorded as 
excluded. 
 
f) Inclusion and Exclusion Criteria 
Inclusion criteria 

Page 8 of 38 
 
Eligible participants will be licensed paramedics or EMTs authorized to practice within 
their agency.   
 
Exclusion criteria 
 Do not agree to participate (consent not given) 
 Strabismus 
 Severe astigmatism 
 Vertigo 
 Significant visual impairment 
 Motion sickness 
 Claustrophobia  
 Screen-induced nausea/headache 
 
g) Screen Failures 
Subjects who fail exclusion screening will be tracked with the reason for failing 
screening and which group they are assigned to. 
 
h) Subject Enrollment 
Agencies will have crews consisting of paramedic/paramedic, paramedic/EMTA and 
paramedic/EMT. Both paramedic and EMT subjects will undergo written informed 
consent prior to any screening procedures. The paramedic of the crew will use the 
augmented reality software.  For crews consisting of two paramedics, one will be 
randomly assigned to the augmented reality software.  Crews and agencies participating 
in the trial will not have participated in preliminary simulations or usability testing during 
development of the application software.  This will eliminate any possibility of 
contamination by communication about the project between members of the agency.  
Agencies who participate in preliminary simulations and usability testing will not be told 
identities of agencies participating in the RCT.  This will also decrease the possibility of 
contamination by communication between members of agencies.  In addition, all 
participants will sign a non-disclosure agreement and receive instruction on not 
discussing information about the study with other members of their agency or members 
of other agencies to decrease the possibility of contaminating the trial.   
 
9. Study Procedures 
a) Informed consent 
Before participation in the trial, members of each crew will undergo informed consent by 
having the consent form (Appendix A) read to them by a member of the study team.  The 
consent form will include information about the Federal Certificate of Confidentiality 
that covers the study and its protections and limitations. The crew members will be 
allowed to ask questions regarding the consent form and the study.  If both members of 
the crew consent, they will be asked to sign a consent form and then will be given a copy 
of the consent form to retain for their personal records.  If one or both members of the 
crew do not consent, they will be recorded as failing to consent and they will be excluded 
and logged as an excluded crew for the arm to which they were assigned. 
 
b) Demographic Survey, non-disclosure agreement (NDA), and continuing 
education credit 

Page 9 of 38 
 
Following consent, crew members will complete a demographic survey on an electronic 
tablet with internet connection directly linked to a Research Electronic Data Capture 
(REDCap) database, followed by an NDA form.  The NDA form is used to discourage 
discussion of the trial between personnel of the same or different agencies and therefore 
prevent participant contamination.  The demographic form will ask basic demographic 
information along with years of experience and pediatric experience. Crew members with 
an EMTA or Paramedic certification in Michigan are eligible for one continuing 
education credit for pediatric medication administration. Crew members eligible for this 
credit will be asked to sign an attendance form for the State of Michigan. 
 
c) Simulation Instructions 
Once each crew has completed their demographic survey, they will be read standardized 
instructions on how to participate in the simulation scenarios that includes: they will be 
using their usual equipment they would take into a pediatric call (monitor/defibrillator, 
first in bag, airway kit, IV start kit) including their drug box.  Teams will be told that they 
will use a training drug box supplied by their agency instead of their duty drug box, but it 
will look, function and be stocked identically to their duty drug box. They are to draw up 
any medications they plan to give to the patient and hand the syringe off to one of the 
study team members in the simulation space.  They will be given an orientation to how 
the simulation trailer is set up.  The rear represents a small room in a house, and the 
middle represents an ambulance.  If they desire to move the patient to the ambulance, 
they can pick the patient simulator up and move to the ambulance stretcher.  They will be 
told that study team member (who will identify themselves) will play the role of the 
patient’s parent who can answer questions about the patient.  EMS crews will be 
instructed to take whatever equipment they would normally take to a patient’s side into 
the simulation trailer. 
 
Crews will be told that they are to do everything they would normally do in caring for a 
patient.  This includes placing monitoring devices, obtaining IV or IO access, as 
indicated, and administering medications.  They will be instructed on the procedures they 
can perform on the simulators.  They can place oral airways and endotracheal tubes if 
desired (none of the agencies have supraglottic airways for pediatric patients in their 
scope of practice).  They can place intraosseous access in designated areas of the 
simulators if desired.  If they desire to place an IV, they can locate their target area and 
not poke the mannequin with the IV catheter.  Instead, they should pull the needle from 
the IV catheter and tape the plastic catheter to the mannequin.  When they administer a 
medication, they are to draw it up as they normally do, but instead of pushing the fluid 
through their IV or IO access, or administering it intramuscularly or intranasally, they are 
to hand the syringe off to a study team member. 
 
They will be told that they can hook up whatever monitoring devices they desire for the 
simulated patient.  However, the vital signs will not be displayed on their monitor but 
instead will be displayed on a monitor in the simulation space that will be shown to them 
by a study team member once the vital sign monitoring device(s) are connected to the 
simulated patient. 
 
If a crew has a third member, such as an EMT in training or a paramedic in training, that 
team member will sign an NDA and be allowed to observe the simulations in the control 

Page 10 of 38 
 
room, behind a closed door, of the simulation trailer and will not participate in the 
simulations. This person will not be able to communicate with the persons participating 
in the simulation. 
 
d) Simulation Trailer 
We will utilize a simulation trailer.  It is approximately 22 feet in length and six feet wide 
divided into three sections. The rear represents a small room in a house.  This section also 
has an entry door from which the crew will enter the simulation space, as well as a fold 
down ramp.  There is fold-down section on the left rear wall that serves as a changing 
table/crib with a box underneath that serves as a chair.  The middle section represents an 
ambulance and contains a stretcher, bench seat, airway seat (at the head of the stretcher), 
a set of upper cabinets and lower cabinets.  The front-most section is the control room.  
This is separated from the rest of the trailer by a door and a wall with a large one-way 
mirror allowing visualization into the simulation space.  There is a desk area that faces 
the simulation space and shelves that run along the left wall and the front wall.  A 
computer and screen for the AV system and the computer for running the simulators are 
placed on the shelf facing the simulation space.    
 
The trailer is climate controlled. It will be parked in the agency’s apparatus bay during 
the simulations.  It will be leveled with jacks that will prevent any swaying motion, so it 
is a stable platform.   
 
e) Drug box stocking 
We will utilize a training drug box or bag that matches the drug box or bag carried on an 
agency’s ambulances.  This will be stocked as it is found on an ambulance with the 
following changes:  the study team will replace existing stock with study-supplied real 
epinephrine pre-filled syringes and sham fentanyl and midazolam vials. These will be the 
same size, color and concentration as those that are used by each agency.  Experimental 
crews will have their pediatric length-based tape replaced with the study length-based 
tape that only has colored blocks with a unique barcode for each block.  Their existing 
hard-copy pediatric drug dosing references will be removed.  For experimental crews that 
use a phone app-based PMA reference, they will be told not to use that during the 
simulations and instead use the ATOM application on the HoloLens.  Control groups will 
continue to have access to their usual PMA references and length-based tapes. 
 
f)  HoloLens training and training scenario 
After receiving standardized participation instructions, experimental group EMS crews 
will undergo a standardized orientation to the HoloLens and study application conducted 
by two study team members. Prior to each training session, each HoloLens will be reset 
(e.g., previous holograms removed, recharged). Training will proceed in two phases. 
 
Phase 1: Crews will observe a complete demonstration of the HoloLens application from 
start to finish, including the delivery of two doses of 1mg/ml epinephrine, with one study 
team member role-playing the primary medic and another role-playing the partner. This 
demonstration will model correct use of the HoloLens, including eye-tracking calibration 
and fitting, activation of hologram buttons, navigation of the application interface, use of 
the study length-based tape, operation of the integrated barcode scanner, and progression 
through the application workflow. The demonstration will also include instruction on 

Page 11 of 38 
 
recentering holograms, adjusting the visor, and understanding spatial positioning during 
movement. During the demonstration, study team members will also model expected 
partner-check behaviors, including talk-aloud and closed-loop communication, consistent 
with standard EMS communication practices and with the communication prompts 
embedded in the application. 
 
Phase 2: Participating EMS crews will complete a supervised, hands-on orientation to the 
HoloLens and study application. During this phase, each crew member will calibrate and 
fit the HoloLens and perform a training scenario. This training scenario will allow the 
crew to practice interacting with hologram buttons, familiarize themselves with the 
application layout and capabilities, and rehearse partner-check interactions using talk-
aloud and closed-loop communication. Crews will also verify that the HoloLens audio 
output is functioning properly and is audible in the training environment. This training 
will be limited to system orientation and communication practices and will not include 
instruction, guidance, or feedback regarding specific medical decision-making or 
treatment. 
 
The practice scenario will be a 10-year-old child that weighs 70 pounds, per parent report 
if asked, and measures in the green color zone on the length-based tape, who is 
experiencing anaphylaxis and requires a dose of 1 mg/ml epinephrine intramuscularly.  
Crews will be allowed to determine weight by asking the parent, using the length-based 
tape or using age at their discretion.  Experimental crews will use the HoloLens 
application to navigate through obtaining the patient’s weight, drawing up the medication 
and administering it. Crews will be provided with a study length-based tape, vial of sham 
epinephrine, 1 milliliter syringe, and needles. 
 
g)   Control group training 
After receiving standardized simulation instructions, control group crews will participate 
in the same practice scenario as the experimental group without using the HoloLens.  The 
practice scenario will be a 10-year-old child that weighs 70 pounds, per parent report if 
asked, and measures in the green color zone on the length-based tape, who is 
experiencing anaphylaxis and requires a dose of 1mg/ml epinephrine intramuscularly.  
Crews will be allowed to determine weight by asking the parent, using the length-based 
tape or using age at their discretion.  They will be able to use their usual pediatric drug 
reference(s) and length-based tape. Crews will be provided with a vial of epinephrine, 1 
milliliter syringe and needle and asked to draw up and deliver the correct dose of 
epinephrine for the simulated patient.  This approach ensures that both groups receive 
equivalent recent PMA exposure, controlling for any potential training effects unrelated 
to the assistive technology itself. 
 
h)    Sample size  
To show superiority of the augmented reality software versus usual care, the study plan 
calls for 84 crews, 42 per study arm. Each crew administers six total drug doses over the 
three simulation scenarios, totaling 252 dose administrations in each arm. This sample 
size equates to a two-proportion superiority test with a 25% baseline pediatric medication 
administration error rate and an estimated 35% reduction using the HMD application, 
with alpha = 0.1, Power = 80%, and a participant/crew ineligible rate of 25%. The four 

Page 12 of 38 
 
EMS agencies involved in application design and usability testing will be excluded from 
the RCT. 
 
 
            i)     Compliance 
Institutional Review Board 
This study is approved as exempt by the Western Michigan University, Homer Stryker, 
MD School of Medicine Institutional Review Board (IRB).  All study team members 
have completed Collaborative Institutional Training Initiative (CITI) modules on human 
subject research required by the IRB and will maintain these certifications throughout the 
study period.  
 
Subject Confidentiality 
All study team members are responsible for maintaining the confidentiality of study 
subjects. 
 Confidentiality is covered by a Federal Certificate of Confidentiality. (See 
informed consent form provided in appendix A.) 
 No identifiable data will be shared with subject’s employer, management, 
supervisors or other employees. 
 No supervisory, management or executive personnel of any of the agencies 
will be allowed to observe any of the simulations.  No crew members will be 
allowed to observe another crew’s simulations.   
 
 
             j)     Simulation scenarios 
Three pediatric scenarios will be presented to the crews using high-fidelity mannequins. 
The order of the scenario presentation will be randomized for each crew.  The scenarios 
will be recorded with four, high resolution, zoom capable cameras (Avigilon, Inc) in the 
simulation trailer and audio recorded. Video recordings will be captured via four cameras, 
each with zoom capability, and one microphone on a password protected computer using 
Avigilon software which also has zoom capability.  Each scenario will be scored with a 
case report form specific to the scenario. (Appendix B-D)   
 
A large digital clock will be placed at the rear of the simulation trailer in view of one 
of the video cameras and will serve as the time reference for all crew activities.  
 
Patient simulators will be wirelessly operated by a simulation specialist via a 
computer in the control room of the simulation trailer.  The simulation specialist will 
be able to hear all conversation in the simulation space and will follow a script for 
changes in mannequin vital signs, cardiac rhythms, seizure activity, etc. for each 
simulation scenario. 
 
Two study team members will observe crews in the simulation space and record 
actions using a scenario specific CRF.  Study team members will not be blinded to 
whether a crew is in the control or experimental group due to the experimental group 
wearing the HoloLens and the control group not wearing the HoloLens.  Study team 
member A will deliver the dispatch information to the crew outside the simulation 
trailer rear door and play the role of the parent. Study team member B will be inside 

Page 13 of 38 
 
the simulation trailer prior to the simulation starting.  During the simulation, study 
team member A will record actions taken by crews in the simulation space using the 
scenario specific CRF.  Study team member B will observe in the study simulation 
space and record actions taken by crews in the simulation space using the scenario 
specific CRF. 
 
Due to the cost of certain supplies and to reduce the financial impact of the study on 
the participating agencies, the study will supply certain items.  These include an 
intraosseous drill and needles, bags of normal saline and IV extension tubing as well 
as 20- and 22-gauge IV catheters.  All supplies supplied by the study team will be 
standardized (same brand and model) throughout the entire study.  If a crew decides 
to obtain IO access, once they have located their own IO kit in their own equipment 
bag, a team member will state to them “We have an IO kit for you to use”. They will 
then be handed the study IO kit that contains an IO drill, IO needles (infant, pediatric 
and adult) connection tubing and an anchoring device.  If they decide to “hang a bag 
of fluids”, once they locate their IV bag and extension tubing a study team member 
will state “We have an IV bag and tubing for you to use”. They will then be handed 
the IV bag, with extension tubing connected, by a team member.    
 
Teams will use their own IV catheters from their own equipment bags if they want to 
start IV access.  IV access attempts will be deemed successful, on the first attempt, 
with that information communicated to the crew, on the first attempt. 
 
Crew Time Management 
A simulation session will include three separate sessions: prebrief, simulations 
(cardiac arrest, seizure, burn) and debrief.  The prebrief and debrief will take place in 
a location separate from the simulations, such as a classroom at the agency and will 
be visually and sound separated from each other and the simulations.   Crews will be 
scheduled at two-hour intervals.  A crew can be undergoing prebrief and/or 
simulations while another crew is undergoing debrief.   
 
Study Team members A and B will be responsible for prebrief, control group training 
scenario and simulations.  Study Team members C and D will be responsible for 
HoloLens and application training for the experimental group.  Study team members 
C, E, F and G will be responsible for debrief. Study team members B and H will be 
responsible for placing Empatica watches on participants and baseline data collection 
on cognitive load.  A simulation specialist will be responsible for running the human 
patient simulators.   
 
Upon completion of each scenario, all equipment will be repacked and expended 
equipment such as IV catheters and medication vials or syringes will be replaced.  
Correct repackaging of equipment and supplies will be confirmed by Team member A 
including that the existing PMA reference and length-based tape are available to the 
next group if they are a control group and removed if they are an experimental group.  
All crew equipment will be staged outside the rear door of the simulation trailer prior 
to each simulation scenario. 
 

Page 14 of 38 
 
Syringe review and dose determination:  Once a crew has a medication drawn up 
into a syringe and is ready to administer it intramuscularly or intranasally (midazolam 
or fentanyl) or via IV or IO access (epinephrine, midazolam or fentanyl), they will be 
directed to hand the syringe to study team member A or B prior to any attempt to 
administer it or attach it to IV or IO access.  The study team member will then grasp 
the syringe by the barrel with the administration tip held toward the ceiling and then 
gently place the syringe on the counter of the control room on a labeled surface with 
“Dose A” for the first dose and “Dose B” for the second dose.  This process will be 
carried out for both doses in each scenario.  If, for the cardiac arrest scenario, a crew 
decides to push medication directly out of the prefilled epinephrine syringe, they will 
be asked to gently squirt the medication into a cup made of low surface tension 
plastic.  The first dose cup will be labeled “A” and the second dose cup will be 
labeled “B”.   These cups will be within easy reach of the study team members but 
hidden from the simulation participants. 
 
Upon conclusion of the scenarios, team members A and B will go into the control 
room to evaluate the syringes and/or cups for the correct volume.  This will be done 
out of sight and out of hearing range of the simulation participants. Because of the 
difficulty in differentiating air versus fluid, and the importance of documenting the 
exact volume of liquid and air in the syringe, this process will be carried out by 
consensus with team member A and B.  Team member A will examine the syringes 
first and Team member B will examine the syringes second.  This will not be done 
with each blinded to the other’s interpretation and interrater reliability will not be 
calculated.   
 
For syringes, team members will handle them carefully and avoid touching the 
plunger during examination. Each team member will examine the syringe 
individually using a bright light source and magnification via reading glasses. If there 
are air bubbles located at the bottom of the syringe or along the sides of the syringe, 
team member A will gently agitate the syringe, being careful to not force any fluid out 
of the syringe, by using a single finger to direct enough force to the syringe barrel to 
loosen the air bubble and allow it to float to the top of the syringe without causing 
any loss of fluid through the end of the syringe.  After this, the graduations on the 
syringe will be used to determine the portion of fluid and any air in the syringe.  This 
will be confirmed between team member A and B by consensus and then recorded by 
both on their case report forms. This method of dealing with the syringes from the 
hand off through to the examination of syringe volume has been practiced in the 
simulations used for research team education and usability testing (176 doses) before 
the RCT. 
 
For doses pushed out of the prefilled syringe into a cup, team member A will ensure 
all the fluid is in a single drop in the bottom of the cup and that no fluid is on the 
sides of the cup. The fluid will then be drawn up into a 1 mL syringe (Exel brand 
Luer Lock) for volumes of 1 mL or less and a 5 mL syringe (Exel 5cc Luer lock)  
using a 20 mL needle until the meniscus is at the base of the injection port of the 
syringe (at the distal end of the graduated portion of the syringe prior to the injection 
barrel or needle tip of the syringe).  Once all the fluid is collected, the graduations on 
the side of syringe will be used to determine the volume of fluid in the syringe.  If the 

Page 15 of 38 
 
dose is more than 5 ml, the remaining fluid will be drawn up in a 1mL syringe.  This 
will be confirmed between team member A and B by consensus and then recorded by 
both on their case report forms. 
 
Scenario One: Infant Cardiopulmonary Arrest 
The crew will receive dispatch information outside of the simulation trailer prior to 
entering, from the study team member playing the role of the parent, of “You are 
responding to 100 Fremont Street for an infant that is not breathing.”  The study team 
member will then open the door to the simulation trailer and step inside with the crew 
following. 
 
A Gaumard Super Tory simulator (Gaumard, Miami, FL) will be used.  The patient 
will be found in a diaper only laying supine on a crib with a large stuffed animal and 
fluffy blanket with the mannequin’s face turned toward and in contact with the stuffed 
animal mimicking a suffocation scenario.  Upon entering the “patient’s room”, the 
study team member playing the parent will state “I put her down for her nap with her 
blanket and stuffed animal like I always do and I don’t think she is breathing.”  If the 
crew asks if the parent knows the weight, they will respond, “They weighed 9 pounds 
at their checkup two weeks ago.”  The mannequin measures in the gray color zone for 
the study tape, Broselow-Luten Tape and Pedia Tape which may be used by crews to 
obtain weight.  The parent will respond, if asked, that there is no past medical history, 
normal birth history, no recent fever, and no medications. 
 
The mannequin represents a 1-month-old infant.  The crew finds the infant to be 
cyanotic, with no limb motion, no respiratory activity and no pulse. The initial cardiac 
rhythm is asystole.  After the first dose of epinephrine, the rhythm changes to a 
pulseless electrical activity (sinus bradycardia with a rate of ~50), BP will not be 
measurable, pulse ox will be 53% and end tidal CO2 will be 16mmHg.  Vital signs 
will be displayed, if monitoring device(s) or defibrillator pads are attached to the 
mannequin, on a monitor in the simulation space that will be pointed out by the study 
member A playing the role of parent.  After the crew starts compressions and 
ventilations, a study team member B will identify themselves as an EMT that has 
arrived on scene.  They will state that they can help with compressions and 
ventilation.  The study team member will then perform compressions, ventilations or 
both at the direction of the crew and will continue to do so until told to stop or switch 
role(s).   
 
Crews can obtain intraosseous (IO) or IV access for medication administration.  If the 
crew decides to obtain IO access, once they have pulled their IO device out of their 
equipment bag, they will be handed a study IO device (EZ-IO, Teleflex Morrisville, 
NC) that contains the drill and all three sizes of IO needles along with connection 
tubing and anchoring device.  At this time, a study team member will point to the area 
on each leg where IO access can be obtained. 
 
If epinephrine is drawn into a syringe, that syringe is to be handed off to a study team 
member instead of connected to the IV or IO access.  If the crew wants to administer 
epinephrine directly from the manufacturers prefilled syringe, they will be provided a 

Page 16 of 38 
 
plastic cup, with low surface tension plastic, to push their dose into.  This cup will 
then be handed into the control room. 
 
After a second dose of epinephrine, on the subsequent pulse check the study team 
member playing the role of parent will announce that there is a pulse and the scenario 
has concluded.  At this time the HoloLens wearing paramedic (experimental group) or 
drug administering paramedic (control group) will be given a piece of paper with 
“Dose 1 _____mg” and “_____ml” and “Dose 2 _____mg” and “_____ml” on it and 
be instructed to write down the doses they delivered.  Control crews can consult their 
PDR prior to writing down the doses.  The study team will then replace all used items 
from the crew’s equipment and medication bags (epinephrine preloaded syringes, IV 
tubing and fluids, IV catheters, IV start kits, syringes and any other expendable 
supplies) used during the scenario.   
 
Scenario Two: Infant Seizure  
The crew will receive dispatch information outside of the simulation trailer prior to 
entering, from the study team member playing the role of the parent, of “You are 
responding to 151 Sweet Street for an infant that is seizing.”  The study team member 
will then open the door to the simulation trailer and step inside with the crew 
following. 
 
A Gaumard Super Tory mannequin (Gaumard, Miami, FL) will be used.  The patient 
will be found in a diaper only laying supine on a crib with active seizure activity of 
the arms and legs by placing the mannequin settings to “jittery”.  Upon entering the 
“patient’s room”, the study team member playing the parent will state “She just 
started doing that five minutes ago.”  If the crew asks if the parent knows the weight, 
they will respond, “I don’t know.”  If the crew asks for the patient’s age, they will 
respond “6 months”.  If the crew measures the patient with a length-based tape, the 
study team member playing the parent will state “for the purposes of the simulation, 
the patient measures in the pink zone.”  The parent will respond, if asked, that there is 
no past medical history, normal birth history, no recent fever, and no medications.  If 
the crew asks about the possibility of a poisoning or ingestion, the parent will state 
that that there is no concern.   
 
Crews can obtain intraosseous (IO) or IV access for medication administration.  If the 
crew decides to obtain IO access, once they have pulled their IO device out of their 
equipment bag, they will be handed a study IO device (EZ-IO Teleflex, Morrisville, 
NC) that contains the drill and all three sizes of IO needles (adult, child and infant) 
along with connection tubing and anchoring device.  At this time, a study team 
member will point to the area on each leg where IO access can be obtained. 
 
Vital signs will be displayed, if a monitoring device(s) is/are attached to the simulator, 
on a monitor in the simulation space that will be pointed out by the study member 
playing the role of parent.  Initial vital signs will be heart rate 180, respiratory rate 40, 
oxygen saturation 94% on room air, blood pressure 90/60. If a point of care blood 
sugar is obtained, the study team member playing the parent will state that “the blood 
sugar is 80”.  If oxygen via mask or nasal canula is placed on the patient, the oxygen 
saturation will improve to 98%.  

Page 17 of 38 
 
 
The patient will require two doses of midazolam for seizure cessation.  Sixty seconds 
after the second dose of midazolam is administered, the seizure activity will stop, and 
the study team will announce that the scenario has concluded.  At this time the 
HoloLens wearing paramedic (experimental group) or drug administering paramedic 
(control group) will be given a piece of paper with “Dose 1 _____mg” and “____ml” 
and “Dose 2 _____mg” and “_____ml” on it and be instructed to write down the 
doses they delivered.  Control crews can consult their PDR prior to writing down the 
doses.  The study team will then replace all used items from the crew’s equipment and 
medication bags (midazolam vial(s), IV tubing and fluids, IV catheters, IV start kits, 
syringes and any other expendable supplies used during the scenario.   
 
Scenario Three: Toddler Burn/Pain Management 
The crew will receive dispatch information outside of the simulation trailer prior to 
entering, from the study team member playing the role of the parent, of “You are 
responding to 131 North Street for an eighteen-month-old with a burn.”  The study 
team member will then open the door to the simulation trailer and step inside with the 
crew following. 
 
A Gaumard Pediatric HAL simulator (Gaumard, Miami, FL) will be used.  The 
patient will be found sitting on a low chair wearing shorts but no shirt.  The 
mannequin will have moulage on the chest demonstrating first and second degree 
burns with blisters.  There will be a similar moulage to burn to the right lower leg and 
right upper arm.  The burns cover approximately 5% total body surface area.    Upon 
entering the “patient’s room”, the study team member playing the parent will state “I 
was boiling water for mac and cheese and turned away for a minute, and his older 
brother grabbed the pot handle and pulled the boiling water over on him.”  If the crew 
asks if the parent knows the weight, they will respond, “He weighed 24 pounds at his 
doctor’s appointment last week.”  If the crew asks for the patient’s age, they will 
respond “18 months”.  The mannequin measures in the purple zone on length-based 
tapes.  The parent will respond, if asked, that there is no past medical history, normal 
birth history, no recent fever, and no medications.   
 
Crews can obtain intraosseous (IO) or IV access for medication administration.  If the 
crew decides to obtain IO access, once they have pulled their IO device out of their 
equipment bag, they will be handed a study IO device (EZ-IO Teleflex, Morrisville, 
NC) that contains the drill and all three sizes of IO needles (adult, child and infant) 
along with connection tubing and anchoring device.  At this time, a study team 
member will point to the area on each leg where IO access can be obtained. 
 
Vital signs will be displayed, if a monitoring device(s) is/are attached to the 
mannequin, on a monitor in the simulation space that will be pointed out by the study 
member playing the role of parent.  Initial vital signs will be heart rate 160, 
respiratory rate 40, oxygen saturation 100% on room air, blood pressure 110/70. 
 
The toddler is conscious, represented by eyes that are actively blinking and loud 
crying via a small portable Bluetooth speaker placed in the mannequin’s pants pocket 

Page 18 of 38 
 
linked to a looped recording of a toddler crying.  The crying volume will be 
maintained until the patient receives a second dose of fentanyl.   
 
The patient will require two doses of fentanyl for adequate pain management 
(indicated by crying cessation).  If three minutes elapses after the first dose of 
fentanyl and there is no indication that a second dose will be given, the parent will 
state “I think his burn still really hurts, can you give him some more medicine?”   If 
the crew decides not to give a second dose, the parent will not say anything further.  
Sixty seconds after the second dose of fentanyl is administered, the volume on the 
crying will be turned down to zero over 25 seconds.  At that time the parent will state 
“I think he feels much better now” and announce that the scenario has concluded.  At 
this time the HoloLens wearing paramedic (experimental group) or drug 
administering paramedic (control group) will be given a piece of paper with “Dose 1 
_____mcg” and “_____ml” and “Dose 2 _____mcg” and “_____ml” on it and be 
instructed to write down the doses they delivered.  Control crews can consult their 
PDR prior to writing down the doses.  The study team will then replace all used items 
from the crew’s equipment and medication bags (fentanyl vial(s), IV tubing and 
fluids, IV catheters, IV start kits, syringes and any other expendable supplies used 
during the scenario.   
 
      k)      Cognitive Load Analysis 
Both the control and experimental groups will be evaluated for cognitive load during 
scenarios using the Empatica 4 wristband. Crew members will wear the Empatica 4 
wristband to collect biometric data, including heart rate variability and electrodermal 
activity/galvanic skin response (EDA). Baseline data will be measured while subjects 
take an operational span task test (Stroop Effect test) to examine working memory 
capacity and again during 5 minutes of relaxation to obtain baseline EDA 
measurements.  During relaxation they will sit in a quiet area with soft, gentle music 
playing.  The same music will be used for all participants.  EDA data analysis will 
focus on critical decision-making points in both experimental and control groups and 
evaluate the increase or decrease of cognitive load of while using the HoloLens. 
Critical decision-making points include start of scenario, calculation of drug 
dosage(s), preparation of drug dosage(s), delivery of drug dosage(s), and end of 
scenario. Post simulations, participants will complete the Cognitive Load Assessment 
Scales in Simulation (CLAS) scale for a subjective measurement of cognitive load. 
Observer XT program (Noldus Observer XT, Noldus Media Recorder) will be used to 
synchronize the EDA data with simulation video recordings. The skin conductance 
response (SCR) component of EDA occurs as a peak in the EDA signal, between one 
to four seconds after stimulus presentation. Peak SCR amplitude will be used as the 
indicator of cognitive load. We will extract EDA data for the first five seconds after 
the start of each critical decision-making point. The EDA signal will be decomposed 
into SCR by performing continuous decomposition analysis using Ledalab software 
(Ledalab version 3 4.9). SCR amplitudes will be computed using PyEDA (PyEDA 
version 0.27.5).  R (R version 4.2.0) will be used for statistical analysis with a p-value 
of less than 0.05 considered statistically significant. A linear mixed model will be 
used to compare the participants’ cognitive load between subjective and objective 
measures. 
 

Page 19 of 38 
 
      l)      Debriefing 
Once a crew has completed all three scenarios, they will proceed to the debriefing 
area where they will first complete the System Usability Scale (SUS), User 
Experience Questionnaire (UEQ) and Cognitive Load Assessment Scales in 
Simulation.   These will be administered via a tablet computer connected to Wi-Fi 
with a direct link to the study REDCap form.   Each member of the crew for both the 
experimental and control group will complete each of the surveys.   
 
Following completion of the three surveys, participants in both groups will be 
informed of any errors that occurred by Team member A or B and will be given a 
brief time to discuss them with the investigators.   
 
As part of the debrief, participants will also be asked a small number of open-ended 
questions. These questions will invite participants to describe their overall experience 
with the system used in the scenario (HoloLens or usual PMA reference), to identify 
perceived strengths and weaknesses of that system, and to reflect on their confidence 
in having prepared and administered the correct medication dose in each scenario.  
 
      m)     Video Review 
Team members A and B, together, will review video of all three scenarios for each 
crew in their entirety.  This will be done to confirm findings recorded in real time, 
except for drug doses, and times in which they occurred.  This will be done from the 
same day the simulations occurred up to two weeks after.  Team members will be able 
to zoom individual cameras as needed and reverse and replay sections of video as 
needed.   
 
      n)      Data entry 
Case report form data entry will be done by study team member I.  Data will be 
directly entered from the master CRF into a REDCap form.  Each scenario has its 
own CRF.  Each crew will have a record generated for each scenario.  All data 
regarding drug dosing (“drug” dose in ml, air dose in ml, and dose in mg) will require 
double data entry-each value will be entered twice.  The REDCap form will 
automatically check to make sure both values are identical.  If not, the form will 
generate a flag and not allow the data enterer to proceed any further until the 
difference between the two values is resolved.   
 
            o)     Data review 
Once all the data is entered, an excel spreadsheet will be generated from REDCap and 
these values will be compared to those on the master CRF for each scenario for each 
crew.  If discrepancies are found between the REDCap data and the CRF, the 
REDCap data will be corrected to reflect the data on the master CRF.  This will be 
carried out by three separate individuals reviewing the records.  Once all three 
individuals have completed their review, a discussion will be held amongst them to 
ensure that the data is correct in REDCap and that all data entry errors or REDCap 
discrepancies have been found and corrected.   
 
       p)     Study endpoints 
The study will conclude with the final simulation of the final EMS agency. 

Page 20 of 38 
 
 
             q)     Data management 
                   A Research Electronic Data Capture (REDCap) database will be used for data    
collection and storage of survey data. Data will be entered by study subjects and 
collected in web-accessible REDCap surveys. Data exported from Research 
Electronic Data Capture will be de-identified and stored in the Western Michigan 
University School of Medicine Virtual Data Warehouse SharePoint Hub. 
 
              Only investigators and research staff are granted access to the secured data. Access 
control to data export for the study will be the responsibility of the investigators 
and/or data manager.   Only study team members listed as key personnel in the IRB 
application will have access to the study-specific SharePoint folder. Data will not be 
moved from or stored outside of the SharePoint folder without notifying the VDW 
Data Manager.  
 
        r)    Withdrawal of subjects 
              Subjects who fail screening will be tracked with the reason for failing screening and 
which group they are assigned to. Each of the four crew slots will be randomized for 
each day.  If a crew is not available for a given time slot, that crew slot will be 
dropped and recorded as excluded. 
 
10. Statistical Plan 
a)     Sample size determination 
The study plan calls for 84 crews, 42 per study arm. Each crew administers six total 
drug doses over the three simulation scenarios, totaling 252 dose administrations in 
each arm. This sample size equates to a two-proportion superiority test with a 25% 
baseline PMA error rate and a 35% reduction using the HMD application, with 
alpha = 0.1, Power = 80%, and a participant/crew ineligibility rate of 25%. The four 
EMS agencies involved in application design and usability testing were excluded 
from the RCT. 
 
b.     Statistical Methods 
      For this study, data for all eligible study subjects will be considered. Missing value 
management is scrutinized at the variable (not case) level. Consequently, missing 
variable data will be excluded from analysis.  Spurious measurements will be 
considered for possible verifiable correction and inclusion; failing satisfactory 
resolution, erroneous data will be excluded from statistical analyses. 
 
1.       Primary Analyses: 
      Demographics of all participants will be assessed via an electronic survey and will   
      include:  
 
Age 
 
Race (self-reported)  
 
Ethnicity (self-reported)  
 
Sex 
 
Crew configuration 
 
Years of experience working in EMS  

Page 21 of 38 
 
 
Time since last pediatric course 
 
Number of pediatric calls in the last year  
 
Level of confidence in caring for high acuity pediatrics patients 
 
Comfort with technology 
 
EMS instructor status  
 
       These will be expressed as means (with Interquartile range for age), and   
       percentages.  
 
       Drug dosing accuracy data will also be collected and expressed as means and  
       percentages with 95% confidence intervals. To compare the proportion of  
       medication errors between the HMD application (experimental group) and standard  
       practice (control group), chi-square tests will be employed; if sample sizes are   
       small Fisher's exact tests will be used. Additionally, relative risk of errors between  
       the two groups will be assessed. Specific areas of analysis for both experimental  
       and control groups include:  
 
 
 
Accuracy (defined as a >20% deviation from correct dose according to the 
 
reference used by the agency) of doses, per drug and overall  
 
Frequency of any overdose, per drug and overall  
 
Frequency of 10 times overdose, per drug and overall  
 
Frequency of underdose, per drug and overall 
 
Frequency of 10 times underdose, per drug and overall 
 
Median overdoses and underdoses per drug and overall, with IQR 
    Errors of omission (e.g. omitting a drug dose, omitting a blood sugar  
   check) 
    Errors of commission (e.g. intubating a patient, giving the wrong     
   concentration of drug) 
 
2.       Secondary Analyses: 
Surveys will be used to assess cognitive load associated with the simulation and  
usability of the ATOM software and HMD.   The following surveys will be utilized: 
 (CLAS) Cognitive Load Assessment Scale in Simulation  
 (SUS) System Usability Scale 
    (UEQ) User-Experience Questionnaire 
      
These surveys will be scored per their respective scoring instructions. 
 
3.        Supplementary Analyses: 
Appropriate descriptive/summary statistics will be generated for additional 
variables of interest.  Quantitative data will be represented as means or medians. 
Additional measures for numeric variables include location, spread, and shape of 
the underlying population distribution. Nominal and ordinal data will be reported as 
frequencies and percentages.  
 
Descriptive/summary statistics will be illustrated via tabular formatting, as well as 
suitable charts and/or graphs. Confidence intervals will be reported at a 95% level 
of confidence, unless otherwise indicated. Significance / Inference testing will 

Page 22 of 38 
 
employ a significance threshold of α ≤ .05, unless otherwise indicated. Additionally, 
suitable corrections for multiple testing will be applied when appropriate. All data 
will be cleaned, organized, and analyzed using SAS Proprietary Software Version 
9.4 (SAS Institute, Cary, NC). 
 
11. Risks to Subjects: 
Real needles and medications are used during the simulation. Subjects have the same risk of 
injuring themselves with a needle as during a real case. However, there would be no exposure 
to infectious materials from patients. 
 
Some people feel uncomfortable or stressed during patient simulations. Some are reluctant to 
analyze their own performance or critique the system in which they work. The research team 
will do its best to make subjects comfortable with the simulation and debriefing experience. 
A subject’s responses will remain confidential.  A subject’s performance in the simulations 
will not be included in their work evaluations, nor will it affect their employment. All 
information will be kept confidential. 
 
12. Potential Benefits to Subjects 
By participating in this study, subjects will provide information to the investigators about the 
effectiveness of the augmented reality application in managing prehospital pediatric 
emergencies, system problems that limit their ability to perform your job, pitfalls that result 
in errors in the care of children, and ways to avoid errors in the future.  
 
13. Provisions to Protect the Privacy Interests of Subjects 
We will do everything possible to keep a subject’s performance and answers confidential. 
Scoring forms and questionnaires will be locked up. Once they are assigned a code and 
combined with those of other participants, they will be destroyed. We will video record the 
simulations to improve the accuracy of our scoring and record participant responses. These 
recordings are not available to anyone except the investigators. They will be locked up and 
eventually erased to maintain subject confidentiality. Subjects will not be identified in any 
publication. We will not compare individual performances of paramedics with field data; 
only combined data will be used. 
 
14. Provisions to Maintain the Confidentiality of Data 
This research is covered by a Certificate of Confidentiality from the National Institutes of 
Health. This means that the researchers cannot release or use information, documents, or 
samples that may identify a subject in any action or suit unless the subject consents to it. The 
researchers also cannot provide them as evidence unless the subject agrees. This protection 
includes federal, state, or local civil, criminal, administrative, legislative, or other 
proceedings. An example would be a court subpoena. 
 
15. Costs to Subjects 
There are no costs for participating in this study. Because subjects are participating in this 
study during their shift, they will be paid their usual, hourly income per and by the EMS 
agency. However, they will not receive any additional compensation for their time.  The 
investigators will not provide compensation for injuries that may occur during the session.  
This will be covered by the workers compensation coverage provided by each agency.   
 

Page 23 of 38 
 
16. Sharing of Results with Subjects 
The EMS crew will be provided with the drug dosage accuracy information during their 
debrief.  Each agency administration will receive a deidentified composite of the error rate in 
their experimental and control group.  Individuals will not be able to be identified from this 
data.  Agencies do not have any information that identifies who was in the control versus 
experimental group. 
 
 
17. References 
 
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Hoyle JD, Ekblad G, Hover T, et al. Dosing Errors Made by Paramedics During Pediatric 
Patient Simulations After Implementation of a State-Wide Pediatric Drug Dosing Reference. 
Prehospital Emergency Care. 2020;24(2). doi:10.1080/10903127.2019.1619002  
3. 
Hoyle Jr. JD, Davis AT, Fales WD, Trytko JA, Putman KK. Medication Dosing Errors in 
Pediatric Patients Treated by Emergency Medical Services. Prehospital Emergency Care. 
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4. 
Lammers R, Willoughby-Byrwa M, Fales WD. Medication errors in prehospital 
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Lammers R, Willoughby-Byrwa M, Fales WD. Errors and error-producing conditions 
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6. 
Kaji AH, Gausche-Hill M, Conrad H, et al. Emergency medical services system changes 
reduce pediatric epinephrine dosing errors in the prehospital setting. Pediatrics. 
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7. 
Bosson N, Kaji AH, Gausche-Hill M. A Standardized Formulary to Reduce Pediatric 
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2022;26(4):492-502. doi:10.1080/10903127.2021.1955058  
8. 
Chassee T, Reischman D, Mancera M, Hoyle Jr. JD. A novel approach utilizing 
emergency medical dispatchers to obtain weights on pediatric patients. Prehospital Emergency 
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9. 
Hansen M, Eriksson C, Skarica B, Meckler G, Guise JM. Safety events in pediatric out-
of-hospital cardiac arrest. Am J Emerg Med. 2018;36(3):380-383. 
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10. 
Eriksson CO, Bahr N, Meckler G, et al. Adverse Safety Events in Emergency Medical 
Services Care of Children with Out-of-Hospital Cardiac Arrest. JAMA Netw Open. 
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RL L, MJ B, WD F. Root causes of errors in a simulated prehospital pediatric emergency. 
Academic Emergency Medicine. 2012;19(1):37-47.  
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Hansen ML, Walker-Stevenson G, Bahr N, et al. EMS Agency Characteristics and 
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Chmielewski M, Sapiejewski K, Sobolewski M. Application of augmented reality, mobile 
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Alarcon R, Wild F, Perey C, et al. Augmented reality for the enhancement of space 
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Hoover M, Miller J, Gilbert S, Winer E. Measuring the performance impact of using the 
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Park S, Bokijonov S, Choi Y. Review of Microsoft Hololens applications over the past 
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Hololens 2 overview, features, and specs. Microsoft HoloLens. Accessed April 2, 2022. 
https://www.microsoft.com/en-us/hololens/hardware 
 
 
 
 
 
 
Appendix A:  
Consent Form for Research 
 
Title:   Augmenting the On-Scene Medic (ATOM) 
 
Final Phase SA 3: A Simulation Based Randomized Controlled Trial 
 
Principal Investigator:  John Hoyle, MD 
 
Western Michigan University Homer Stryker M.D. School of 
Medicine 
 
Funding by:  Agency for Healthcare Research and Quality (AHRQ) 
 
Introduction 
 
We invite you to take part in a research study involving paramedics and EMTs.  Your 
participation is entirely voluntary.  Please ask one of the investigators to explain any part of the 
study you do not understand. 
  
Purpose 
 
The primary objective of this research study is to use simulated pediatric emergencies to 1) 
identify the pitfalls and problems in pediatric prehospital care that result in errors and 2) assess 
the effectiveness of a drug dosing safety system for EMS. 
 
As part of the research, we may not tell you everything about the research procedures.  At the 
conclusion of the study, we will provide you with that information.   
 
Procedure 
 
How do I qualify for this study? 
You are eligible for this study if you meet the following criteria: 
1. You are a licensed paramedic or EMT in one of the participating agencies. 
2. You are currently authorized by the local medical control authority to practice within the 
local EMS system. 
3. You have not attended one of the previous research simulation events offered by Dr. 
Hoyle and his team. 
 
Approximately 312 paramedic/EMT and paramedic/paramedic teams are expected to participate 
in this simulation session across several agencies.     
 

Page 26 of 38 
 
What do I have to do? 
You will be participating in a simulation session today. 
 
This session will last about 2-2 1/2 hours.  
 
You will complete the following activities during this session: 
 
1) You will complete a questionnaire that provides some basic information about you, such as 
your training, experience level, and your confidence with pediatric emergencies.   
 
2) You will receive general information about the project and detailed instructions about this 
session, such as the capabilities of the simulators and how to use them, what to do during the 
simulation, and how to interact with actors who will play the roles of parents.   
 
3) You and your team member(s) will manage different simulated pediatric emergencies. Each 
simulation will last about 10 minutes. The session will be video recorded. 
 
4) You and your partner will share your general impression of the simulation with the 
investigators. 
 
5) You will undergo a “facilitated debriefing.” This interactive exercise consists of answering 
written questions and discussing your opinions and self-analysis with the investigator. You will 
a) help identify problems and pitfalls (including errors and “close-calls”) that you encountered 
during the simulation; b) determine if the problems had any adverse consequences; c) look for 
contributory factors, such as equipment failure, equipment design limitations, excessive 
workload, communication failures, inadequate training or experience, and system factors and d) 
suggest solutions that would prevent problems in the future. The session will be audio recorded 
so that the investigators conducting the debriefing can play back the interview later. This method 
improves the accuracy of the debriefing.   
 
Potential Benefits 
 
By participating in this study, you will provide information to the investigators about effective 
and innovative methods of managing prehospital pediatric emergencies, system problems that 
limit your ability to perform your job, pitfalls that result in errors in the care of children, and 
ways to avoid errors in the future.     
 
Potential Risks and Discomfort 
 
The amount of time required to complete a session is about 2-2 ½ hours.  
 
Real needles and medications are used during the simulation. You have the same risk of injuring 
yourself with a needle as you would during a real case. However, there would be no exposure to 
infectious materials from patients. 
 
Some people feel uncomfortable or stressed during patient simulations.  Some are reluctant to 
analyse their own performance or critique the system in which they work.  We will do our best to 

Page 27 of 38 
 
make you comfortable with the simulation and debriefing experience.  Your responses will 
remain confidential. 
 
Your performance in the simulations will not be included in your work evaluations, nor will it 
affect your employment. All information will be kept confidential. 
 
Costs, Compensation, and Physical Injuries 
 
There are no costs to you for participating in this study. Because you are participating in this 
study during your shift, you will be paid your usual, hourly income. However, you will not 
receive any additional compensation for your time.  The investigators will not provide 
compensation if you injure yourself during the session.   
 
Confidentiality 
 
To encourage you to provide honest and forthright opinions about your own performance and 
about problems with your work environment and the system, you must keep everything that was 
said and done during this session completely confidential. Do not discuss the simulation with 
anyone once the session is over.   
 
We will do everything possible to keep your performance and answers confidential.  Scoring 
forms and questionnaires will be locked up. Once they are assigned a code and combined with 
those of other participants, they will be destroyed. We will video record the simulations to 
improve the accuracy of our scoring and record your responses.  These recordings are not 
available to anyone except the investigators.  They will be locked up and eventually erased to 
maintain your confidentiality.  You will not be identified in any publication.  We will not 
compare individual performances of paramedics with field data; only combined data will be 
used.  
This research is covered by a Certificate of Confidentiality from the National Institutes of 
Health. This means that the researchers cannot release or use information, documents, or samples 
that may identify you in any action or suit unless you say it is okay. They also cannot provide 
them as evidence unless you have agreed.  This protection includes federal, state, or local civil, 
criminal, administrative, legislative, or other proceedings. An example would be a court 
subpoena. 
 
There are some important things that you need to know.  The Certificate DOES NOT stop 
reporting that federal, state or local laws require. Some examples are laws that require reporting 
of child or elder abuse, some communicable diseases, and threats to harm yourself or 
others.  The Certificate CANNOT BE USED to stop a sponsoring United States federal or state 
government agency from checking records or evaluating programs. The Certificate DOES NOT 
stop disclosures required by the federal Food and Drug Administration (FDA).  The Certificate 
also DOES NOT prevent your information from being used for other research if allowed by 
federal regulations. 
 
Researchers may release information about you when you say it is okay. For example, you may 
give them permission to release information to insurers, medical providers or any other persons 
not connected with the research.  The Certificate of Confidentiality does not stop you from 

Page 28 of 38 
 
willingly releasing information about your involvement in this research. It also does not prevent 
you from having access to your own information. 
 
Additional Information 
 
Your participation is voluntary.  You are free to withdraw at any time without affecting your 
employment status.  The investigators have the right to withdraw you from the study without 
your consent.   
 
This study was approved by the WMed Institutional Review Board (IRB).  If you have any 
questions about the research, you may contact Dr. John Hoyle at 269-337-6600.  If you have 
questions about your rights as a research subject, you may contact the representative of the IRB 
at 269-337-4345 or irb@med.wmich.edu.  
 
Agreement to Participate 
 
I have read the information above, have had the study fully explained to me, and have had all 
questions answered fully by an investigator before participating in the study.  I voluntarily give 
my consent to participate in this study.  By signing this form, I have not waived any of the legal 
rights that I would otherwise have as a participant in a research study. 
 
Subject Name (print) ________________________________   Date __________ 
 
Subject signature   ________________________________ 
 
Signature of investigator explaining the study    
                               _______________________________    Date __________ 
 
 

Page 29 of 38 
 
Appendix B: 
 
Infant Cardiac Arrest Score Sheet 
 
Start Time:  
Skill Set 
Skill Components Scoring Sheet 
Evaluator Guide 
Phase 1: 
Airway & 
Breathing 
Assessment 
 
 
 
 
 
 
 
 
 
 
__ Initial assessment performed (pulse, breathing) 
 
Instructor will play role of parent 
 
Instructor script (as EMS comes through door): “I 
put my baby down for a nap about 20 minutes ago 
with his pillows and blankets.  I came to check on 
him about 5 minutes ago and I don’t think he’s 
breathing” 
 
If EMS checks breathing: “there is no breathing” 
If EMS checks pulse: “there is no pulse” 
 
PMH: none, the child was born term with no 
complications. 
 
After EMS crew starts CPR and resuscitation, IF 
they call for additional crew people, one instructor 
can serve as an EMT/MFR who can do BVM 
and/or compressions. 
 
 
Actor: ‘My baby’s not 
breathing’ 
 
Starting rhythm: 
asystole 
 
Instructor: at the start 
of the scenario that 
“the infant’s 
extremities and face 
are cyanotic.” 
 
Parent will answer that 
they know the weight 
is 9 pounds  
 
 
Provide information 
about physical exam 
only if requested.  
 
*(Paramedic can ask 
EMT partner or MFR 
to perform this step.) 
Circulation 
Assessment 
 
 
Circulation 
Management 
__ Attach cardiac monitor electrodes  
     to chest. * 
__ Begin compressions. * Time: __________ 
__ Perform compressions at 100-120/min., 
__ Compressions 15:2 breaths 
__ Use two thumb technique or two fingers if 
doing BVM and CPR alone   
__ Call for additional help. 
 
 
 
 
 
 
 

Page 30 of 38 
 
IV/IO access 
 
 
 
 
 
 
__ Insert IV/IO   Time: _________________  
      Location: _________________________ 
__ Attach IV line to IV/IO needle. * 
IV line is successful.  If 
IO attempted, it is 
immediately successful. 
Instructor will state:  
“You got blood return 
immediately.” 
 
Phase 2: 
Initial  
Drug Therapy 
 
 
 
 
 
 
 
 
Card used: 
 Gray 
Other 
__________ 
 
 
 
 
 
 
 
 
Epi correct 
dose 0.5 ml of 
1:10,000 IO or 
IV 
 
__ Obtain patient weight (4 kg or GREY) 
 Method Used:     Time: __________ 
     __ Asked parent 
     __ Broselow Tape    
     __ Patient age 
     __ Guess 
     __ Other: _____________ 
 
Method to obtain epi dose.   Time: ________  
       ___ MI-MEDIC Cards 
       ___ ATOM software 
       ___ Broselow Tape 
       ___ Memory of dose 
       ___ Other Reference 
       ___ Other ______________________ 
 
__Obtain allergies 
 
Give epinephrine 1:10,000 concentration  
Time Given: __________________ 
Dose Given: ML_______________ 
                     AIR (ML) __________ 
                      MG______________ 
            Scale Wt: _____________ 
Concentration(circle)  
 1:1000      1:10,000 
Route Given (circle):  IV   IO    IM 
Diluted?   Y   N  
ML Drug: _____________ 
ML Diluent: ___________  
Drawn up into 1ml syringe from preloaded 
syringe using stopcock?  Y N 
     Syringe size: 1, 3, 5, 10 ml 
     Syringe brand & type: 
____________________________________     
__ Check cardiac rhythm on monitor  
     after epinephrine. 
__ Check pulse after epinephrine. (absent) 
 
 Cross check 
 
Weight 
 
Card 
 
Error using tape?  Y   N 
 Not at top of head  
 Leg not straight  
 Didn’t measure at 
heel  
 Tape not pulled tight 
 Tape Upside down  
 Tape folded over  
__other 
____________________ 
 
 
 
 Cross Check 
 Weight 
 
Card 
 
Drug 
 Concentration 
 Expiration  
 Calculation 
 Dose in ml 
 Volume in 
Syringe 
 Air bubble  
Volume: ____________ 
 Allergies 
 Closed loop 
communication 
 Speaking milliliters etc. 
vs ml 
 Any errors caught with 
comms/cross check?       
List:_______________  
__________________ 
 
 

Page 31 of 38 
 
When epinephrine is first given, change 
rhythm to pulseless electrical activity; rhythm 
= sinus bradycardia; rate ~ 50/min (pre-set) 
 
 
Repeat Drug 
Therapy 
 
 
 
 
Card used: 
 Gray 
Other 
__________ 
 
 
 
 
 
 
 
 
 
Epi correct 
dose 0.5 ml of 
1:10,000 IO or 
IV 
 
 
 
 
 
 
 
End Scenario 
     Repeat initial dose of epinephrine 
     within 3-5 minutes of first dose: 
 
Method to obtain epi dose Time:________ 
       ___ MI-MEDIC Cards 
       ___ HoloLens 
       ___ Broselow Tape 
       ___ Memory of dose 
       ___ Other Reference 
       ___ Other ________________________ 
 
 
Give epinephrine 1:10,000 concentration 
Time Given: ____________________ 
Dose Given: ML_________________ 
                     AIR (ML) ___________ 
                     MG_________________ 
            Scale Wt: _____________ 
Concentration(circle)  
 1:1000      1:10,000 
Route Given (circle):  IV   IO    IM 
Diluted?   Y   N    
ML Drug: _____________ 
ML Diluent: ___________  
Drawn up into 1ml syringe from preloaded 
syringe using stopcock?  Y   N 
     Syringe size: 1, 3, 5, 10 ml 
     Syringe brand & type: 
____________________________________ 
 
__ Atropine given (incorrect action) 
__ Patient electrically paced (incorrect action)  
__ Patient intubated (incorrect action) 
 
 
 
 
End Time: ________________ 
 
 Cross Check 
 Weight 
 
Card 
 
Drug 
 Concentration 
 Expiration  
 Calculation 
 Dose in ml 
 Volume in 
Syringe 
 Air bubble  
Volume: ___________ 
 Allergies 
 Closed loop 
communication 
 Speaking milliliters etc. 
vs ml 
 Any errors caught with 
comms/cross check?       
List: ______________   
__________________ 
 
 
 
 
 
 
 
 
 
Scenario ends after 
second dose of 
epinephrine is 
administered 
 
 
 

Page 32 of 38 
 
Appendix C: 
 
Pain Management/Burn Score Sheet 
 
Start Time:   
Skill Set 
Skill Components (Scoring Sheet) 
Evaluator Guide 
Phase 1 
History 
 
 
 
 
 
 
 
 
__Obtain weight (24 pounds per parent, 
Purple on Broselow tape)   
Time: ________ 
How weight was obtained:  
       __ Asked Parent 
       __ Broselow Tape 
       __ Age 
       __ Guess 
       __ Other 
 
__Obtain vital signs Time: ____________ 
__Obtain pain score (10) Time: ________ 
__Assess burn and look for burns 
elsewhere (burn covers approx. 4.5% of 
body surface area) 
 Cross Check 
 Weight 
 Card 
 
Error using tape?  Y   N 
 Not at top of head  
 Leg not straight  
 Didn’t measure at heel  
 Tape not pulled tight 
 Tape Upside down  
 Tape folded over  
__other 
____________________ 
 
 
Initial pain score is 10 
Phase 2 
Medication  
 
Card used: 
 Purpl
e 
 None 
 Other 
__________
_ 
 
 
 
 
Correct 
doses: 
Fent 
IN/IV/IO 0.2 
ml undiluted 
(10mcg) 
MS IV/IM/ 
1ml diluted 
(1mg) 
 
Method used to obtain opioid dose 
 Time: __________ 
      ___ MI-MEDIC Cards 
      ___ ATOM Software 
      ___ Broselow Tape 
      ___ Memory of dose 
      ___ Other Reference 
      ___ Other________________ 
 
__Obtain allergies 
 
__Obtain IV access   Time: _____ 
Give dose of opioid  
Time Given: ____________________ 
Drug Given: ____________________ 
Dose Given: mL ______________ 
                    AIR (mL)___________     
                    Mcg_______________ 
            Scale Wt: _____________ 
Route Given (circle):  IV   IN    IM   IO 
Diluted   Y   N   Dilution Correct?  Y   N 
ML Drug: _____________ 
ML Diluent: __________  
 
Syringe size: 1, 3, 5, 10 ml 
 Cross Check 
 Weight 
 
Card 
 
Drug 
 Concentration 
 Expiration  
 Calculation 
 Dose in ml 
 Volume in Syringe 
 Air bubble  
Air Volume: _____________ 
 Allergies 
 Closed loop communication 
 Speaking milliliters etc. vs ml 
 Any errors caught with 
comms/cross check?             
List: _______________           
___________________ 
 
If EMT-P does nothing to 
address pain, document and 
parent will state “Aren’t you 
going to do anything about his 
pain?” 
Vitals will remain unchanged 

Page 33 of 38 
 
If diluted: 
Fent; 2ml 
drug & 8ml 
of NS = 
10mcg/ml 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Card used: 
 Purpl
e 
 Other 
__________
_ 
 
 
 
 
 
Dilution: 
Fent; 2ml 
drug & 8ml 
of NS = 
10mcg/ml 
MS: 1ml 
drug & 9ml 
NS = 1mg/ml 
 
Correct 
doses: 
Syringe brand & type: 
_______________________________ 
 
 
__Reassess pain 2-5 minutes after giving 
medication Time: ___________ 
 
__Reassess VS Time:  ____________ 
__Prompted by Parent to give pain 
medicine?  Y    N 
 
Second Dose of opioid 
 
Method used to obtain dose  
 Time: ______ 
       ___ MI-MEDIC Cards 
       ___ ATOM Software 
       ___ Broselow Tape 
       ___ Memory of dose 
       ___ Other Reference 
       ___ Other ________________ 
 
Time Given: ____________________ 
Drug Given: ____________________ 
Dose Given: mL _______________ 
                    AIR (mL) ___________ 
                    Mcg______________ 
            Scale Wt: _____________ 
Route Given (circle):  IV   IN    IM   IO 
Diluted   Y   N   Dilution Correct?  Y   N 
ML Drug: _____________ 
ML Diluent: __________  
 
Syringe size: 1, 3, 5, 10 ml 
Syringe brand & type: 
__________________________________
__ 
 
_________________________ 
__Reassess pain 2-5 minutes after giving 
medication (<=3)    
Time: _________ 
 
__Reassess VS Time:  _________ 
 
 
 
 
After first dose of pain med, 
child is still crying. 
 
If no reassessment of pain or no 
second dose of pain medicine, 
parent states “I think his burn 
still really hurts, can you give 
him some more medicine?” 
 
 
 
 
 
 
 
 Cross Check 
 Weight 
 
Card 
 
Drug 
 Concentration 
 Expiration  
 Calculation 
 Dose in ml 
 Volume in Syringe 
 Air bubble  
Volume: _____________ 
 Allergies 
 Closed loop communication 
 Speaking milliliters etc. mL 
 Any errors caught with 
comms/cross check?             
List: _______________           
__________________ 
 
After second dose of pain 
medicine, child has stopped 
crying and is content. 
 
Repeat VS 
HR 120, BP 90/60, RR 14 
Sat 98% 
 

Page 34 of 38 
 
Fent IN 0.2 
ml undiluted 
(10mcg) 
Fent IV 1.0 
ml diluted 
(10 mcg) 
MS IV/IM 
1ml diluted 
(1mg) 
 
If diluted: 
Fent; 2ml 
drug & 8ml 
of NS = 
10mcg/ml 
 
Scenario 
Ends 
Scenario ends Time:  _________ 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Page 35 of 38 
 
Appendix D: 
 
Infant Seizure Score Sheet 
 
Start Time:   
Skill Set 
Skill Components Scoring Sheet 
Evaluator Guide 
Phase 1: 
 
Initial 
Assessment: 
Appearance 
Breathing 
Circulation 
 
 
 
 
 
__ Recognize presence of seizure activity  
     within 60 seconds.  Time: ________ 
__ Check pulse (present; rate =180/min) 
__ Check for respiratory rate (40).  
     (present) 
__ Check O2 Sat (94%) 
     (Capillary refill normal; skin normal;  
      skin turgor normal; eyes deviated left) 
Provide information about 
physical exam only if requested.  
 
If asked, father will not know 
the patient’s weight.   
 
IF BROSELOW TAPE IS 
USED, TELL MEDICS PT 
MEASURES PINK 
 
Airway & 
Oxygen 
 
 
 
 
 
 
Vascular 
access 
Deliver oxygen 
     NC.   NRB 
     Liters: _____________________ 
          Time: _________ 
 
Obtain access 
 
__ IV-line Time: __________ 
 
__ IO line. Time: ___________ 
 
Record on computer when 
oxygen is applied.  (O2 sat 
changes automatically.) 
 
 
 
 
If an IO line is attempted, there 
is immediate blood return and 
normal flow.  EMT provides 
cues. 
 

Page 36 of 38 
 
Phase 2: 
Anticonvulsant 
Therapy 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Card used: 
 Pink 
 Other 
___________ 
 
 
 
Dilution 1 ml 
of drug added 
to 4 ml saline 
 
 
Correct Dose:   
Midazolam 
IM:  0.2 ml  
(UNDILUTE
D) 
Midazolam 
IV/IO: 0.4 ml 
(DILUTED) 
 
 
 
 
 
 
 
 
 
__ How was weight estimated? Time: 
____ 
      __ Asked Parent 
      __ Broselow tape 
      __ Age 
      __ Guess 
      __ Other 
__________________________ 
 
 
 
 
 
 
 
Administer benzodiazepine: 
 
Method used to obtain dose Time: 
_______ 
       ___ MI-MEDIC Cards 
       ___ ATOM Software 
       ___ Broselow Tape 
       ___ Memory of dose 
       ___ Other Reference 
       ___ Other ____________________ 
 
__Obtain allergies 
 
Time Given: ____________________ 
Drug Given: ____________________ 
Dose Given: ML_________________ 
                      AIR (ML) ____________ 
                      MG: ________________ 
            Scale Wt: ________________ 
Route Given (circle):  IV   IN    IM    IO 
Diluted   Y   N   Dilution Correct?  Y   
N 
ML Drug: _____________ 
ML Diluent: __________  
Syringe size: 1, 3, 5, 10 ml 
Syringe brand & type: 
__________________________________
__ 
 
Test Glucose 
 
Test glucose with dipstick. * Time: 
______   
 Cross Check 
 Weight 
 Card 
 
Error using tape?  Y   N 
•  Not at top of 
head  
•  Leg not straight  
•  Didn’t measure 
at heel  
•  Tape not pulled 
tight 
•  Tape Upside 
down  
•  Tape folded over  
Other 
____________________ 
 
 
 Cross Check 
 Weight 
 Card 
 Drug 
 Concentration 
 Expiration  
 Calculation 
 Dose in ml 
 Volume in Syringe 
 Air bubble  
Air Volume: _________ 
 Allergies 
 Closed loop 
communication 
 Speaking milliliters 
etc vs ml 
 Any errors caught 
with comms/cross 
check?             
List:_____________
__           
_________________
_ 
 
 
 
Seizure will stop 60 seconds 
after second dose of midazolam 

Page 37 of 38 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
END Scenario 
 
 
     (80 mg%) 
 
 
2nd dose?               
Time Given: ____________ 
Drug Given: ____________________ 
Dose Given: ML__________________ 
                      AIR (ML) _____________ 
                      MG: __________________ 
            Scale Wt: __________________ 
Route Given (circle):  IV   IN    IM    IO 
Diluted   Y   N   Dilution Correct?  Y   
N 
ML Drug: _____________ 
ML Diluent: __________ 
 
Syringe size: 1, 3, 5, 10 ml 
Syringe brand & type: 
__________________________________
__ 
 
 
 
 
 
 
 
 
 
END TIME: _____________ 
 
 
 
 
 Cross Check 
 Weight 
 Card 
 Drug 
 Concentration 
 Expiration  
 Calculation 
 Dose in ml 
 Volume in Syringe 
 Air bubble  
Air Volume:_________ 
 Allergies 
 Closed loop 
communication 
 Speaking milliliters 
etc. vs ml 
 Any errors caught 
with comms/cross 
check?             List: 
______________         
_________________
_ 
  
 
 
 
Seizure will end 60 seconds 
after second dose of midazolam 
whether it is correct or not. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Page 38 of 38 
 
Glossary 
 
ABC Airway, Breathing, Circulation 
ACLS Advanced Cardiac Life Support 
CLAS Cognitive Load Assessment Scale in simulations 
CPR 
Cardiopulmonary Resuscitation 
CRF 
Case Report Form 
EDA Electrodermal activity 
EHR Electronic Health Record 
EMS Emergency Medical Services 
EMT Emergency Medical Technician 
EMTA Emergency Medical Technician-Advanced 
FMEA Failure Modes & Effects Analysis 
HMD Head Mounted Display 
MFR Medical First Responder 
PARAMEDIC Emergency Medical Technician-Paramedic 
PDR 
Pediatric Drug Dosing Reference 
PMA Pediatric Medication Administration 
SCR 
Skin Conductive Response 
SUS 
System Usability Scale 
UEQ User Experience Questionnaire 
VDW Virtual Data Warehouse