Feasibility and Acceptability of a Low-cost, Mobile Telemedicine Platform for Remote Assessment of Children Transported by Ambulance
Phase: NA
Conditions: Respiratory Distress Syndrome
Sponsor: Boston Medical Center

Prehospital telemedicine feasibility pilot 
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Feasibility and Acceptability of a low-cost, mobile telemedicine platform for remote 
assessment of children transported by ambulance 
 
Protocol Version Number: 2.1 
Protocol Version Date: 25, September, 2024 
ClinicalTrials.gov number: NCT05967624 
Funding Mechanism:  NHLBI 1K23HL145126 
Principal Investigator: Tehnaz Boyle 
 
Phone: 617-414-3682 
 
E-mail: Tehnaz.Boyle@bmc.org 
 
 
 
Statistical Analysis Plan- pages 17-19 
 
 
 
 
 
 
 
CONFIDENTIAL 
 
This document is confidential and the property of Boston Medical Center. No part of it may be 
transmitted, reproduced, published, or used by other persons without prior written authorization 
from the institution. 2023, Boston Medical Center Corporation. All rights reserved.  
 
 

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1 
List of Abbreviations 
 
Abbreviation 
Abbreviation definition 
EMS 
Emergency Medical Services 
BCH 
Boston Children’s Hospital 
BMC 
Boston Medical Center 
 
2 
Protocol Summary 
 
Title: 
Feasibility and Acceptability of a low-cost, mobile telemedicine 
platform for remote assessment of children transported by 
ambulance 
Population: 
1) Clinically stable children aged <18 years (n=20) being transferred 
by ambulance from acute care facilities in Massachusetts and 
adjacent New England states by the BCH Critical Care Transport 
Team for acute respiratory illness from any cause. 
2) Up to 6      total providers who will participate in the study 
assessments. 
Intervention: 
Prehospital teleconsultation (intervention) – Transport team 
personnel in moving ambulances will use Zoom Pro video-
conferencing software on tablet computers as a low-cost mobile 
telemedicine platform (prototype platform) for synchronous video 
communication with remote physicians for the purpose of medical 
direction. 
Objectives: 
The primary objective is to test if it is feasible for a remote physician 
to assess the presence of respiratory distress in a child in a moving 
ambulance using the prototype platform. 
Design/Methodology: 
We will conduct an open-label, nonrandomized, pilot feasibility trial 
of children with respiratory distress transported by the BCH Critical 
Care Transport Team that also serves BMC. Transport providers will 
initiate a video-call from the ambulance to one of two medical 
control physicians who will be at a geographically distant location. 
The remote medical control physician will assess each child subject 
using streaming video from the prototype platform to test video 
quality, an important feasibility measure. The remote medical 
control physician and the transport team member at the patient 
bedside in the ambulance will score a brief checklist to measure the 
presence of visible signs of respiratory distress simultaneously. It 
takes approximately 15 seconds to score the checklist.  
We will measure feasibility (primary outcomes) by assessing 
agreement in assessments of respiratory distress by providers in the 
ambulance (transport team personnel) with those in the hospital 
(remote medical control physicians).  We will measure acceptability, 
video quality, audio quality, video-call connection success, success of 
tablet mount strategies, various transport time intervals, and 

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potential adverse events (secondary outcomes) on two brief 
questionnaires administered to users after each call. In this pilot 
study, we will not test efficacy; all decision making will occur 
according to usual care protocols. 
Total Study Duration: 
12 months 
Subject Participation 
Duration: 
5 minutes or less 
 
3 
Background/Rationale & Purpose 
 
3.1 
Background Information 
In the United States, Emergency Medical Services (EMS) transport approximately 8 million children to 
hospitals per year, of which 10-14% require life-saving care outside hospitals.1,2 EMS encounters with 
critically ill and injured children are prone to errors and preventable harm with life-threatening 
consequences.3-7 Improving the safety of prehospital emergency care for children remains an unmet 
national priority.  
Teleconsultation, or the use of video telecommunications technology to deliver expert recommendations 
for care remotely, has been used to improve the safety and quality of emergency care for children in 
hospital-based acute care settings by providing real-time access to remote pediatric physician experts 
experienced in the care of seriously ill children.8-11 Whether this intervention can benefit sick and injured 
children in the prehospital setting is unknown. The EMS 2050 Agenda for Future Systems has proposed 
integrating digital health technologies to improve the safety and quality of prehospital care.12 Despite 
advances in mobile technology, few U.S. EMS systems use video for any application, even for adults.13,14 
The paucity of prehospital efficacy trials involving children has limited adoption and use of this 
intervention by the EMS community.  
In prior simulation studies, we found high intervention acceptance among key stakeholder groups 
(pediatric emergency physicians and paramedics) and demonstrated that it was feasible to integrate video 
communication into prehospital clinical workflows involving critical care delivery in high-risk pediatric 
scenarios (preliminary data). These initial simulation studies were conducted in a controlled prehospital 
setting in static ambulances using infant simulator manikins to minimize risk to children and providers. 
Demonstrating feasibility and acceptability with real children in moving ambulances is the next step to 
build the necessary evidence base to support future planned prehospital efficacy trials with children.  
 
This study will be conducted in compliance with the protocol, applicable regulatory requirements, and 
policies and procedures of the Boston Medical Center and BU Medical Campus Human Research 
Protection Program. 
 
3.2 
Rationale and Purpose  
In the United States today, most EMS systems use standardized care protocols with standing orders 
followed by physician consultation via radio or telephone if needed. These physician-provider interactions 
rely on audio-only technologies and occur after most care events are completed. Adding video would 
allow the remote physician to view the patient, scene, and care events, which could enhance their ability 
to assess a child and guide care remotely. Thus, teleconsultation could improve outcomes by improving 
clinical decision-making and intervention timeliness, and reducing prehospital medical errors related to 

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medication administration and performance of critical procedures in sick children. This study is part of an 
NIH-funded phased research plan to develop teleconsultation as an efficacious prehospital patient safety 
intervention for children. 
Teleconsultation with low-cost, commercially available mobile platforms (e.g., video-conferencing 
applications on mobile and tablet devices) has been used to assess and treat adults with stroke and 
myocardial infarction as examples of time-sensitive critical illnesses in the prehospital setting. Severe 
respiratory illness is a leading cause of EMS activation and transportation for children. Whether it is 
feasible or acceptable to use similar technology to assess critically ill children with respiratory distress 
remotely in moving ambulances is unknown. Children, particularly infants, are physically smaller so clinical 
signs and pertinent exam findings (e.g., use of accessory respiratory muscles) may be more difficult to see 
by tablet device cameras when patients are secured for safe transportation. Broadband connections may 
be harder to maintain to stream video, and environment noise and limited lighting may be additional 
confounders.  
The objective of this study is to test whether it is feasible to use low-cost mobile technology to assess the 
presence of acute respiratory distress in children in moving ambulances. We will conduct an open-label, 
non-randomized pilot feasibility trial of children with respiratory distress transported by the BCH Critical 
Care transport team to sample an enriched population of eligible children (because EMS pediatric 
transports are infrequent), and leverage specialty teams experienced in the care of sick children in the 
prehospital setting to minimize risks to children and providers when introducing new technology in high-
stakes clinical settings. We hypothesize that remote respiratory assessment of children by medical control 
physicians (expert physicians) using the prototype teleconsultation platform is technically feasible during 
ambulance transports and acceptable to physicians and transport providers. We will use the results of this 
trial and a fully powered simulation trial to assess intervention efficacy (R01 proposal pending NIH 
scientific review) to prepare for a future real-world prehospital efficacy trial testing the 
efficacy/effectiveness of teleconsultation as a prehospital patient safety intervention for children. 
 
4 
Objectives 
 
4.1 
Study Objectives 
 
The primary objective is to test the feasibility of using low-cost mobile technology to assess the presence 
of acute respiratory distress in a child in a moving ambulance. 
 
The secondary objectives are to assess the acceptability of using the prototype platform to conduct 
remote patient assessment; the adequacy of audio and video quality during teleconsultation encounters; 
the success of establishing video-call connections within a maximum of 2 attempts; the success of tablet 
mount strategies; and the impact on transport time intervals as time delay is a potential adverse effect. 
 
4.2 
Study Outcome Measures 
 
4.2.1 Primary Outcome Measures 
 
Agreement in global assessment of respiratory distress: Each child subject will be assessed concurrently 
by a remote medical control physician from a geographically separate location (e.g., in the hospital) and 
a transport provider in the ambulance. The medical control physician will assess the child via real-time 

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streaming video using the HIPAA-compliant Zoom Pro web application pre-loaded on a tablet device 
(prototype teleconsultation platform). The transport provider will assess the child in-person at the patient 
bedside in the ambulance. The remote medical control physician and the transport provider will score 
digital versions of the validated Respiratory Observation Checklist independently while assessing the child. 
The checklist measures 9 observable signs and 1 global measure of acute respiratory distress and has been 
validated for use in hospital-based emergency settings. The primary outcome, agreement in global 
assessment of respiratory distress, will range from 0 to 1.0, where 0 is no agreement and 1.0 is perfect 
agreement between remote physicians performing video assessment and transport providers performing 
in-person assessment. We will use the following scale to categorize agreement: 0.01-0.20=none to slight, 
0.21-0.40=fair, 0.41-0.60=moderate, 0.61-0.80=substantial, and 0.81-1.0=almost perfect agreement.  
Time Frame: Checklist data will be collected for each enrolled child during the 6-month study period. 
 
4.2.2 Secondary Outcome Measures 
 
1. Total Usability Score: This will be measured by the Telehealth Usability Questionnaire (TUQ). The 21-item 
TUQ is a validated measure of key usability characteristics of telehealth platforms. Users (physicians and 
transport providers) rate each item on a 7-point Likert-scale (1=disagree to 7=agree) in 6 domains 
(usefulness, ease of use and learnability, interface quality, interaction quality, reliability, and satisfaction 
and future use). The investigators modified this questionnaire to specifically address usability in the 
prehospital setting. The total usability score is the total mean score for all 21 questions (maximum possible 
score=7). Higher scores indicate greater usability. We will report the mean total usability score and 
standard deviation for all transports. 
Time Frame: 6 months 
2. Video quality: This will be measured by TUQ items #11 and #14 within the “Interaction Quality” domain. 
Users rate each item on a 7-point Likert-scale (1=disagree to 7=agree), so scores will range from 1 to 7. 
We will report the mean score and standard deviation for each item.  
Time Frame: 6 months 
3. Audio quality: This will be measured by TUQ items #12 and #13 within the “Interaction Quality” domain. 
Users rate each item on a 7-point Likert-scale (1=disagree to 7=agree), so scores will range from 1 to 7. 
We will report the mean score and standard deviation for each item. 
Time Frame: 6 months 
4. Success of video-call connection: This is the number of attempts transport team providers make to 
successfully connect with the medical control physician via video-call. We define success of video-call 
connection as ≤2 attempts to achieve a video-call connection. 
Time Frame: 6 months 
5. Success of tablet mount strategy: Study investigators will note any problems with tablet mounts in the 
ambulance cabin (e.g., location makes call activation difficult), as well as specific qualitative comments 

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from participants regarding tablet mount strategy. This outcome will be reported as the proportion of 
calls without any problem related to the tablet mount strategy. 
Time Frame: 6 months 
6. Proportion of calls with adequate video quality for assessment: This will be measured as the proportion 
of video-calls where clinicians are able to observe all 10 items on the Respiratory Observation Checklist. 
Time Frame: 6 months 
7. Time to arrival at referring facility: This is the time interval (minutes) from when BCH receives the patient 
transport request from the referring facility to the time the transport team arrives at the referring facility. 
This will be abstracted from transport records. 
Time Frame: 6 months 
8. Scene time: This is the time interval (minutes) from when the BCH transport team arrives at the referring 
facility to when the transport team leaves the referring facility. This will be abstracted from transport 
records. 
Time Frame: 6 months 
9. Time to arrival at destination facility: This is the time interval (minutes) from when the BCH transport team 
leaves the referring facility to the time of arrival at BCH/BMC (the destination facility). This will be 
abstracted from transport records. 
Time Frame: 6 months 
10. Total transport time: This time interval encompasses the time from when the transport team is dispatched 
to the referring facility to when they arrive at the destination (receiving facility). This will be abstracted 
from transport records. 
Time Frame: 6 months 
 
4.2.3 Exploratory Outcome Measures 
 
There are no exploratory outcome measures. 
 
 
5 
Study Design 
 
This is an open-label, nonrandomized, pilot feasibility trial to field test the feasibility and acceptability of 
using low-cost mobile technology to assess children remotely in moving ambulances. The study 
population will include clinically stable children (aged <18 years) from the New England region who are 
being transported by the BCH critical care team between hospitals for treatment of severe respiratory 
illness from any cause. We will mount tablet devices with Zoom Pro software in the cabin of both BCH 
ambulances. The tablet devices will utilize the secure wireless network used by BCH. Transport providers 
will initiate a video-call from the ambulance to the remote medical control physician. The physician will 
view streamed video to assess the child remotely. The physician and transport provider will each complete 

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a brief checklist to independently score the presence or absence of observable signs of respiratory 
distress. We will assess agreement in assessments of respiratory distress between transport providers in 
the ambulance and remote physicians in the hospital (primary outcome). We will also measure 
acceptability (total usability score) and various feasibility measures (secondary outcomes: video-call 
connection success; ease of making/receiving video-calls; adequate audio and video quality; and transport 
and treatment time intervals) on brief questionnaires administered to users (transport nurses and 
physicians) after each call. All data will be entered directly into web versions of each questionnaire and 
checklist tool using REDCap, a secure web platform for data collection and management hosted by Boston 
University. 
 
6 
Potential Risks and Benefits 
 
6.1 
Risks 
 
The primary risk to participants is loss of confidentiality. We do not anticipate any reasonably foreseeable 
physical, psychological, legal, social, or financial risks as no treatment decisions will be made based on the 
intervention, participation in the study is anticipated to last <5 minutes, no video data will be recorded, 
and we will only recruit patients with stable illness who do not require immediate life-saving interventions 
during transportation. Therefore, there is minimal risk to subjects because of their participation in this 
research. 
 
We will minimize risks because: 
• 
Prior to child subject enrollment, we will first test the feasibility of using the teleconsultation 
equipment and completing video calls using infant manikins with study team members in moving 
ambulances. This will allow us to modify technology or equipment as necessary to ensure video-calls can 
be made successfully before involving child subjects. This will minimize the risk of equipment failure. 
• 
We will only enroll children whose respiratory illness is not immediately life-threatening (i.e. 
requiring active bag-valve-mask ventilation, tracheal intubation, or cardiopulmonary resuscitation by the 
team in the ambulance during transportation). Only transported children who require supplemental 
oxygen, non-invasive ventilation, respiratory medications (e.g., albuterol), or are stabilized on invasive 
mechanical ventilation prior to initiating ambulance transportation will be eligible. This is to minimize any 
risks to subjects related to intervention feasibility testing. We will first confirm that the platform is 
efficient and provides clearly visible and accurate clinical data to the medical control physician and can be 
used in diverse geographic locations in Massachusetts and New England. Although prehospital 
teleconsultation with a pediatric expert may ultimately be most effective for critically ill children, it is 
important to initially study the intervention in sick children who are clinically stable for transportation. 
This is to minimize problems with connectivity or data transmission and ensure that system function is 
optimal and physician use of the scoring tool does not detract from care delivery. 
• 
All data collection will be conducted using HIPAA compliant and encrypted technology. We will 
not record or store the actual clinical encounter. Although there could be a potential risk to confidentiality 
if the teleconsultation connection security was compromised, we will use a secure connection and devices 
that are used in current clinical practice that should minimize this risk. 
• 
Only ID coded data will be provided to study investigators. This will minimize risks to loss of 
confidentiality. 
 

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6.2 
Potential Benefits 
The potential long-term benefits of knowledge gained by this study outweigh its risks. All children enrolled 
in this study will receive prehospital care consistent with the current standard. The prototype 
teleconsultation platform, which will be available to all participants, could potentially provide a direct 
benefit to the child subjects because a video connection could assist the medical control physician in more 
accurate remote assessment of a child, and ultimately provide better and earlier access to diagnosis and 
treatment, and enhance transitions of care between prehospital and hospital settings. There is also 
potential to gain generalizable knowledge as this intervention could be particularly important in areas 
with limited access to pediatric expertise, such as rural or otherwise underserved communities. 
 
6.3 
Analysis of Risks in Relation to Benefits 
Adding streaming video to the usual mode of radio or telephone-based communication does not increase 
the probability or magnitude of harm within the communication mode itself for several reasons. First, in 
simulated prehospital settings, we found that prehospital providers in stationary ambulances could 
establish a video call with a remote physician at a geographically distant location on the first attempt in 
<30 seconds. Second, each video call is anticipated to last 1-3 minutes to allow the medical control 
physician and transport provider adequate time to score a brief checklist. Third, we will only enroll 
patients that do not require active care during transportation. Thus, study participation and intervention 
use are not anticipated to cause harms such as delayed transportation or alter care delivery. Last, while 
the study physicians are the Medical Directors for the BCH transport team, they will not be the medical 
control physicians on-call who are responsible for providing actual patient care. Transport providers will 
be instructed to use their usual modes and procedures for communicating with on-call medical control 
physicians for clinical care delivery. 
 
The main risk to subjects is loss of confidentiality of patient data. All study data forms will be identified 
with a unique study ID number which will be linked to a master-code list that contains all study ID numbers 
and direct subject identifiers (medical record number). The BCH nursing supervisor who conducts daily 
review of BCH transport record for the purpose of quality assurance will maintain this secure, password-
protected crosswalk separately from study files and will be the sole study team member with access to 
this information. This individual will abstract limited patient demographic data (age, sex, race/ethnicity, 
comorbid medical conditions), physical exam findings (initial vital signs), reason for transportation 
(primary diagnosis), and transport encounter details (referring facility, destination facility, date, transport 
time intervals) from electronic transport medical records of enrolled child subjects directly into a REDCap 
database that will be shared with study investigators. Further, we do not anticipate psychological, legal, 
social, financial, or physical risks even in the unlikely event that loss of confidentiality were to occur. Thus, 
the potential societal benefits from the knowledge gained by conducting this study outweigh the potential 
minimal risks to subject related to loss of confidentiality. 
 
7 
Study Subject Selection 
 
7.1 
Subject Inclusion Criteria 
 
To be eligible to participate in this study, a child subject must meet all the following criteria: 
•  Children, aged <18 years, from the New England region who are transported by the Boston Children 
Hospital for respiratory illness from any cause AND 

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•  Clinically stable for transportation [e.g., need supplemental oxygen, medications, or are stable on 
mechanical ventilation] AND 
● Have English speaking parents/guardians to participate in the verbal consent process. 
Medical providers and transport personnel (n=4) are also human subjects but also have volunteered for 
this role as study personnel. 
7.2 
Subject Exclusion Criteria 
 
A child who meets any of the following criteria will be excluded from participation in this study: 
● Children with non-respiratory complaints 
● Children whose illness is anticipated by transport providers to be acutely life-threatening during 
transportation [e.g., requiring emergency resuscitation procedures in the ambulance] 
● Children with non-English speaking parents or guardians who cannot participate in the verbal 
consent process required for this study. 
● Minors who are wards of the state, as verbal consent cannot be obtained in a timely manner. 
 
8 
Study Intervention 
 
In this study, teleconsultation is a behavioral intervention to enhance interdisciplinary communication in 
the prehospital setting using commercially available mobile technology. Transport providers will use Zoom 
Pro© video-conferencing software (Zoom Video Communications, Inc.), on iPad Pro© tablet devices 
(Apple Inc.) as a scalable, low-cost teleconsultation platform (prototype platform) for synchronous 
communication with remote physicians using on-demand, real-time, streaming video interactions to 
enhance patient assessment and medical direction. One tablet device will be mounted and stored in the 
ambulance cabin, while the second device will be hand-held by the physician. Zoom Pro is a HIPAA-
compliant software used by BCH and BMC in clinical and non-clinical settings. BMC will provide the tablet 
devices and mounting equipment, and the institutional Zoom Pro license for installation and use in two 
BCH critical care ambulances.  
 
Each child subject will be exposed to the intervention only once during the transport encounter to 
complete scoring of the primary outcome measure (Respiratory Observation Checklist) which is 
anticipated to take <5 minutes. 
 
 
9 
Recruitment and Retention Procedures 
 
9.1.1 Recruitment Procedures 
 
The critical care transport team on a typical interfacility ambulance transport consists of two nurses and 
one paramedic. We have identified two transport nurses who have volunteered to serve as BCH study 
team members.  
Child subjects who meet eligibility criteria will be identified by one of the two transport nurses. The 
transport nurse will screen the child for eligibility for participation after they have completed their initial 

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field assessment and patient care is transferred to the BCH team by the referring facility. In most 
interfacility transports, the parent or guardian accompanies the child (patient) and the transport nurse in 
the ambulance cabin for the duration of the transport from the referring facility to the receiving facility 
(BCH or BMC). Recruitment will occur in the ambulance only if a parent/guardian is present, and after the 
transport team has secured the patient within the ambulance cabin and completed all necessary patient 
care. As the provider of the transport service, BCH will be the sole recruiting site. 
 
9.1.2 Retention Procedures 
 
 
Retention strategies are not required as the participants will only be retained in the study for the duration 
of the interfacility ambulance transport to the receiving hospital. As the BCH Critical Care Transport Team 
serves the New England region, the duration of a given transport can range from minutes to hours based 
on the geographic distance between facilities.  
 
10 Screening Procedures 
 
There are no screening procedures beyond what is described above in Section 9.1.1. 
 
11 Consent Procedures  
 
Child subjects 
For child subjects, we will use a verbal Consent Script and a printed Parent Permission Form 
that has been abbreviated for an Alteration of Consent. The consent script will be read by 
one of the two transport nurses indicating that they will be contacting a study physician 
using a video-conference platform and that the video of their child will not be recorded.  
The parent/guardian will have the opportunity to ask questions prior to providing consent. 
The transport nurse will document the parent/guardian’s response to this consent 
discussion (Yes/No) in a REDCap consent data form. After the verbal consent discussion, 
the transport nurse will provide the parent/guardian a printed paper copy of the Parent 
Permission Form which includes the consent script, confidentiality risks and protections, 
and contact information for the study investigators and the IRB of record. 
We anticipate that most minor subjects will be infants or young children who are not 
developmentally capable of providing assent, or minors who are cognitively impaired due 
to underlying chronic conditions. Nevertheless, the transport nurse conducting the 
consent discussion with the parent/guardian will obtain and document assent from all 
minor subjects who can understand what participation in the study involves unless 
otherwise prohibited by the severity of the child's clinical condition. 
While the transport nurse will only attempt to recruit the patient once, the parent/guardian 
will have the opportunity to consider participation for the duration of the transportation 
prior to arrival at the receiving facility assuming the patient's clinical condition (eligibility) 
is unchanged. 

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Parents/guardians can decline to participate and elect to remove their child's data at any 
point.  
 
Transport nurses and physicians 
For transport nurses and physicians, we will present a brief Exempt Information Sheet prior 
to filling out the post-call questionnaires. This brief paragraph will be presented 
electronically via REDCap.  They will provide their opinions on the technology and report 
any problems with the video call. If they agree, they will proceed to complete an 
electronic version of the post-call questionnaire. Because there are only four people 
involved, and they are all voluntary study team members or volunteered to work on this 
project, it is not feasible or necessary for them to be anonymous. We will keep their 
name and date of the study encounter so that we can pair data measuring agreement in 
assessment between providers (primary outcome) with the presence or absence of any 
technology failures. 
 
12 Study Procedures 
 
Event 
Study team member(s) responsible 
Data form 
Time 
Screening 
Transport nurse screens for 
eligibility 
 
 
Based on dispatch call 
information, after initial 
clinical assessment of 
patient prior to initiating 
transport to receiving 
facility (beginning of 
clinical encounter) 
Transport nursing supervisor 
maintains log 
Screening log (Excel) 
After transport 
completed (end of clinical 
encounter) 
Recruitment, 
consent 
Transport nurse recruits, consents 
 
Parent Permission Form 
(REDCap) 
During transport in 
ambulance 
Enrollment 
Transport nurse enrolls consented 
child 
 
Parent Permission Form 
(REDCap) 
During transport in 
ambulance 
Transport nursing supervisor 
maintains log 
Recruitment/Enrollment 
log (Excel) 
After transport 
completed 
Study encounter 
Transport nurse assesses patient at 
bedside, scores checklist 
Respiratory Observation 
Checklist (REDCap) 
During video-call in 
ambulance (study 
encounter) 
Remote physician assesses patient 
remotely via video, scores checklist 
Respiratory Observation 
Checklist (REDCap) 
Post-call user 
ratings, call 
characteristics 
Transport nurse rates platform, 
reports any technical issues with call  
 
Post-call questionnaire 
(REDCap) 
After transport 
completed (within 24 
hours after end of clinical 
encounter) 
Remote physician rates platform, 
reports any technical issues with call  
Post-call questionnaire 
(REDCap) 
After video-call 
completed (end of study 
encounter) 
Patient, transport 
characteristics 
Transport nursing supervisor 
abstracts patient, transport clinical 
Patient, transport 
questionnaire (REDCap) 
After transport 
completed (within 1 

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encounter data from electronic 
medical record 
week after end of clinical 
encounter) 
 
We will use the following study procedures for each enrolled subject (see Table above):  
 
1. Establish video-call connection: After obtaining consent, the transport nurse will initiate a two-way 
video-call from the ambulance to the remote study physician using the prototype teleconsultation 
platform on a tablet device mounted in the ambulance cabin. This marks the beginning of the study 
encounter. The remote physician will answer the call on a separate handheld tablet device to establish 
the video call connection.  
2. Confirm study ID: The transport nurse will confirm the study ID number with the remote physician to 
ensure outcome data are paired correctly. 
3. Optimize video-call conditions: If requested by the remote physician, the transport nurse will adjust 
the position of the tablet device to optimize view of the child. We will mount the tablet device within 
arm distance of the transport nurse so it can be safely adjusted in a moving ambulance without 
removing safety restraints. 
4. Blinded outcome assessment: The remote physician will use streaming video to assess the child 
remotely while the transport nurse will use direct observation to assess the child at the bedside in the 
ambulance. The remote physician and the transport nurse will then score digital versions of the 
Respiratory Observation Checklist independently in REDCap data forms using their smart phones. The 
remote physician and transport nurse will be blinded to all outcome assessment. The transport nurse 
will then end the two-way video-call. This marks the end of the study encounter. The total duration 
of the study encounter is anticipated to last <5 minutes.  
In the event of call failure (inadequate video quality to conduct remote assessment) or call 
disconnection, the transport nurse will make up to 2 additional attempts to complete a video-call 
successfully for a total of 3 attempts. The transport nurse will determine the timing of each additional 
attempt based on patient care needs and expected duration of the transport. 
5. Post-call questionnaires: After each study encounter, the remote physician and transport nurse will 
complete a brief post-call questionnaire to rate the usability of the prototype platform (Telehealth 
Usability Questionnaire) and input video-call feasibility data (frequency of attempts; problems with 
the platform, call quality, tablet mounting strategy; and any perceived adverse events). This 
questionnaire takes 5-10 minutes to complete. Whenever feasible, remote physicians will complete 
the questionnaire immediately after the study encounter ends, and transport nurses immediately 
after clinical encounter ends (to minimize interference with patient care). If this is not feasible, 
providers will be encouraged to complete the questionnaire within 24 hours. 
6. Screening, recruitment, and enrollment logs: After the end of the clinical transport encounter, the 
transport nurse will provide the transport nursing supervisor with the patient medical record number 
for screened patients who were eligible for inclusion and approached for recruitment and consent; 
and study ID number for enrolled patients. The transport nursing supervisor will record and maintain 
the crosswalk of master codes linking patient medical record numbers and study ID numbers in a 
secure, password-protected electronic database with limited access. 
7. Electronic medical record data abstraction: The transport nursing supervisor reviews all clinical 
transport encounters daily for quality assurance as part of routine care. The transport nursing 
supervisor will review the electronic medical record for each enrolled patient to abstract limited 
patient demographic information, vital signs, illness severity data, the primary diagnosis, reason for 
transportation, comorbid conditions, facility names, and transport time intervals. They will enter this 

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data directly into a REDCap data form without any identifying patient information other than the study 
ID number. This data form is anticipated to take 15 minutes to complete. 
 
Subjects will participate in the study for 5 minutes or less during with study activities will occur (patient 
assessment and scoring of respiratory distress). The total study duration will be 1 year, with 6 months to 
complete recruitment and enrollment and 6 months to complete data analysis and reporting. 
 
Early termination: Any patient that has a change in clinical status that alters their eligibility for study 
participation after consent procedures are completed but prior to initiation of the study encounter will 
be terminated from the study. 
 
Blinding:  This is an open-label, nonrandomized study as the intervention cannot be masked or blinded. 
However, remote physicians and transport nurses will be blinded to each other’s assessment as they will 
not communicate verbally while they assess a given patient and will score respiratory distress 
independently on separate electronic data forms. We do not require unblinding procedures, as no clinical 
decision-making will occur using remote video assessment. All clinical decision-making will occur using 
usual care processes and communication modes to contact the medical control physician on call (non-
study physicians). 
 
13 Assessment of Safety and Data Safety Monitoring Plan (DSMP) 
 
13.1 Definitions for Safety Assessment 
 
The following definitions will be used in the assessment of safety: 
 
Adverse Event (AE) is any untoward or unfavorable medical occurrence in a human subject, including any 
abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, 
temporally associated with the subject’s participation in the research, whether or not considered related 
to the subject’s participation in the research. 
 
Serious Adverse Event (SAE) is any adverse event that  
(1) results in death; 
(2) is life-threatening; 
(3) results in inpatient hospitalization or prolongation of existing hospitalization; 
(4) results in a persistent or significant disability/incapacity; 
(5) results in a congenital anomaly/birth defect; or 
(6) based upon appropriate medical judgment, may jeopardize the subject's health and may require 
medical or surgical intervention to prevent one of the other outcomes listed in this definition 
(examples of such events include allergic bronchospasm requiring intensive treatment in the 
emergency room or at home, blood dyscrasias or convulsions that do not result in inpatient 
hospitalization, or the development of drug dependency or drug abuse).  
 
Life-threatening means that the event places the subject at immediate risk of death from the event as it 
occurred.  
 
Unanticipated Problem is defined as an event, experience or outcome that meets all three of the following 
criteria:  

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● 
is unexpected; AND 
● 
is related or possibly related to participation in the research; AND 
● 
suggests that the research places subjects or others at a greater risk of harm (including physical, 
psychological, economic, or social harm) than was previously known or recognized.  
 
Possibly related means there is a reasonable possibility that the incident, experience, or outcome may 
have been caused by the procedures involved in the research 
 
Unexpected means the nature, severity, or frequency of the event is not consistent with either: 
● the known or foreseeable risk of adverse events associated with the procedures involved in the 
research that are described in (a) the protocol–related documents, such as the IRB-approved 
research protocol, any applicable investigator brochure, and the current IRB-approved informed 
consent document, and (b) other relevant sources of information, such as product labeling and 
package inserts; or 
● the expected natural progression of any underlying disease, disorder, or condition of the subject(s) 
experiencing the adverse event and the subject’s predisposing risk factor profile for the adverse 
event. 
 
13.2 Safety Review 
 
Both the risks listed in Section 4.1 and unknown risks will be monitored as follows:  
• 
Risk classification and recommended level of monitoring: This is a minimal risk study because the 
probability and magnitude of harm or discomfort anticipated for children participating in this research 
involving remote physical examination do not exceed those encountered during routine physical 
examination, and confidentiality is protected. Thus, the study can be monitored by the PI and does not 
require independent monitoring per NHLBI and BUMC IRB policy on minimal risk studies. We will use 3 
mechanisms for PI notification. (1) BCH Transport Nurses providing clinical care in the ambulance and 
recruiting/enrolling children will notify the BCH Transport Nursing Supervisor and the BMC study PI within 
48 hours if an AE occurs or is perceived to have occurred. (2) If either the transport nurse or the remote 
physician participating in the study indicates that an AE could have or did occur while entering data in the 
post-call questionnaire in REDCap, the REDCap database will send an automatic email alerting the study 
PI. (3) Finally, if the BCH Transport Nursing Supervisor identifies an AE during data abstraction from the 
medical record, they will notify the PI within 72 hours.  
 
• 
Internal data monitoring: The PI will be responsible for internal monitoring of AE and UP in the 
study overall. The PI will delegate monitoring responsibility to the BCH Nursing Supervisor as this study 
team member has the appropriate qualifications, privileges, and access to patient data to serve as the 
medical monitor. The BCH Nursing Supervisor is uniquely situated to distinguish research-related events 
from non-research related events as they review all transport clinical encounters as part of routine care 
quality assurance and can consult the Medical Director when necessary. The BCH Nursing Supervisor and 
the study PI will meet at least monthly with flexibility based on recruitment and enrollment progress. 
 
• 
UP, AE, and significant AE (SAE) definitions, classification and grading, and attribution: We will 
utilize all BUMC accepted definitions for UP, AE, and SAEs. UPs will be any incident, experience, or 
outcome that is unexpected, related/possibly related to intervention use, and places child subjects at a 
greater risk of harm than previously known or recognized. In clinical trials involving ill participants, events 
considered related to the natural history of the disease process (acute respiratory distress) are not 

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considered “unexpected”. Events that would typically not be reported as AEs include abnormal physical 
findings or vital signs expected in a child with acute respiratory distress (e.g., abnormal respiratory rate 
for age), fluctuations that are consistent with the natural course of illness (e.g., worsening respiratory 
distress during ambulance transportation), and hospitalization. Events that we will monitor include if 
intervention use impedes or delays patient care delivery, and if use of video causes unexpected emotional 
distress in a child subject or parent/guardian. AEs will be graded as “mild” if treatment is not required, 
“moderate” if resolved with treatment, or “severe” if professional medical attention is required to 
continue or return to normal activity. The BCH Transport Nursing Supervisor will assess each AE to assign 
grading. If needed, the Medical Director will assist the Transport Nursing Supervisor with AE classification. 
Attribution of AEs will utilize the BUMC IRB scale relating AE as definite, probable, possible, unlikely, or 
unrelated to the study intervention. 
 
• 
Reporting Responsibilities: All UP, AE, and SAEs will be reported by the PI to the IRB per BUMC 
policy. 
 
• 
Emergency Actions: This trial cannot be blinded due to the nature of the intervention. However, 
we will deliberately exclude children when the transport team deems intervention use is not practical due 
to the child’s clinical condition (e.g., receiving cardiopulmonary resuscitation, requiring extensive 
monitoring or active therapeutic interventions during transportation) for the initial feasibility trial. Finally, 
in the rare and unlikely event that use of the study intervention results in a life-threatening delay in 
delivery of the standard of care for a child, the study will be suspended pending further review. 
 
13.2.1 Multi-Site Safety Monitoring 
 
This is a collaborative study with study team members located at two different sites. BCH study team 
members will perform data collection and outcome assessment, and BMC study team members will 
perform data analysis. This is not a multi-site study because the clinical protocol will be implemented at a 
single site (BCH) where participants will receive the intervention and be assessed for outcomes.  
 
13.3 Reporting Plans 
   
The Principal Investigator at BMC/BU Medical Campus will report Unanticipated Problems, safety 
monitors’ reports, and Adverse Events to the BMC/BU Medical Center IRB in accordance with IRB policies: 
 
● Unanticipated Problems occurring the BCH site will be reported to the BMC/BU Medical Campus 
IRB within 7 days of the principal investigator learning of the event. 
● Adverse Events (including Serious Adverse Events) will be reported in summary at the time of 
continuing review, along with a statement that the pattern of adverse events, in total, does not 
suggest that the research places subjects or others at a greater risk of harm than was previously 
known. 
 
13.4 Stopping Rules 
 
If a subject’s condition worsens during any point in the study encounter between recruitment and 
conduce of remote patient assessment by video, the subject will be withdrawn from active participation 
in the study. The BCH critical care transport team will immediately provide appropriate care using all usual 
protocols and procedures, including those for obtaining online medical direction. The study will be 

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stopped if rules are met for stopping, such difficulties interfacing with the intervention platform impedes 
or delays the standard of care during transportation. 
 
14 Data Handling and Record Keeping 
 
14.1 Confidentiality 
● BCH study team members will perform all data collection. Only BCH transport nurses and the BCH 
transport nursing supervisor who provide routine care to the child subject will have access to 
identifiable patient data. BMC study team members will create all data collection and 
management tools using study record numbers (without identifiable patient information) and 
conduct all data analysis. 
● All participants will be assigned a unique study code using REDCap. We will create a secure 
REDCap data form that includes the script for the verbal consent process. This data form can be 
accessed on by any mobile device with internet access, such as a smart phone. The transport 
nurse will read this script and select whether the parent/guardian consented to or declined study 
participation. When consent is obtained, a data form containing the respiratory observation 
checklist with a unique study ID number will be automatically generated. The transport nurse will 
provide the study ID number and the patient medical record number directly to the nursing 
supervisor at the end of the transport encounter via direct verbal communication or secure email. 
● The master crosswalk that links study codes to participant medical record numbers will be held 
by the BCH transport team nursing supervisor as this individual reviews every transport record as 
part of routine care. The master crosswalk will be stored on a password protected computer in 
the nursing supervisor office at BCH for the duration of the study and then destroyed. The study 
PI will be responsible for ensuring that it is shredded or otherwise destroyed. 
● Medical control physicians and transport team members will enter their independent 
assessments of respiratory distress directly into a secure, online REDCap database held at BMC 
(hosted by Boston University). 
● The BCH Transport Team Nursing Supervisor will abstract patient and transport encounter data 
from the electronic medical record directly into a secure REDCap database held at BMC (hosted 
by Boston University). 
 
● All REDCap data will be stored on a HIPAA compliant, password protected, secure cloud server 
maintained by BU/BMC with access limited to BMC study team members only. We will use data 
collection and management tools that meet HIPAA security rules to protect confidentiality and 
security of protected health information. All data will be kept for seven years after data analysis 
is complete and then destroyed. 
 
● This trial has been registered on ClinicalTrials.gov and will be updated at least every 12 months or 
within 30 calendar days of change to protocol information, including recruitment status and 
primary completion date. 
 
14.2 Study Documentation, Source Data, and Case Report Forms (CRFs) 
 

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We will not collect biological specimens. We will gather two types of data as detailed above in Section 
14.1: 
Participant data: We will collect data on the success of child subject recruitment and enrollment on the 
consent form. We will use transport medical records to abstract patient demographic information (age, 
sex, race/ethnicity), clinical encounter data (vital signs, illness severity, primary clinical diagnosis, and 
clinically relevant comorbid conditions), and transport data (referring facility location, time of video-call 
initiation to the physician, duration of the video-call, and all key transport and treatment time intervals). 
This data will be entered direction into REDCap. We will not record names, date of birth, social security 
numbers, or home address.  
User ratings: Transport providers and medical control physicians (BCH study team members) will enter 
platform ratings and provide written qualitative comments directly into REDCap data forms. 
 
See Section 18 Appendix for the following data collection forms:  
● Patient and transport records_DATA FORM 
● Videocall_DATA FORM 
● Transport personnel TUQ 
● Physician TUQ 
 
14.3 Study Records Retention 
 
As per Boston Medical Center and Boston University policy, we will retain study records for at least 
seven years after study completion.   
 
 
15 Statistical Plan 
 
15.1 Study Hypotheses 
 
We hypothesize that we will have adequate agreement (Kappa >= 0.8) between providers assessing the 
presence of acute respiratory distress in children using direct observation at the bedside (transport 
nurses) and video observation (remote medical control physicians). 
 
15.2 Sample Size Determination 
 
This study involves two populations: 
(1) Child subjects (n=20) with respiratory distress who require ambulance transportation for 
hospitalization  
(2) Transport nurses (n=2) and physicians (n=2) – These study personnel meet the definition of "human 
subjects" as they will provide their opinions and preferences in the TUQ. 
 
CHILD SUBJECTS 
After review of 12 months of BCH transport records, 400 (36%) of 1,121 children met eligibility criteria. 
We plan a 6-month study from October to March to maximize subject recruitment with respiratory illness 
and reasonably enroll at least 20 (10%) expected eligible subjects.  

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 We will assess the agreement in assessments of 
respiratory 
distress 
by 
providers 
in 
the 
ambulance (transport nurses) with those in the 
hospital (remote medical control physicians).  
This is measured by the question “Patient in 
respiratory distress? Yes/No” on the 10-item 
Respiratory Observation Checklist. In a sample of 
20 children being transported, assuming a 
prevalence of assessed respiratory distress of 90% for raters in each location, the lower bound of a 95% 
confidence interval (CI) for a clinically relevant minimal kappa statistic of 0.8 is 0.54 with an upper bound 
of 1.0.  In comparison, in a sample of 40 children, again assuming a prevalence of assessed respiratory 
distress of 90% for raters in each location, the lower bound of a 95% CI for a kappa statistic of 0.8 is 0.61 
with an upper bound of 1.0.  Thus, in samples of the size that we anticipate being able to evaluate for this 
trial, the widths of these confidence intervals for a clinically meaningful kappa of 0.80 are acceptably 
narrow (Table 1).  
 
TRANSPORT NURSES & PHYSICIANS 
The BCH Critical Care Transport Program has approximately 30 employees. We have identified 2 transport 
nurses, and 2 medical control physicians in the BCH Critical Care Transport Program who have volunteered 
to participate in this research. We anticipate on identifying up to 2 more. The physicians are the prior 
Medical Director (Dr. Monica Kleinman) and the current Medical Director (Dr. Jordan Rettig) of the 
Transport Program. Their specific clinical experience and expertise will support the validity of the 
outcomes. 
 
We will sample two individuals within each group so we can assess interrater reliability from more than 
one pair of providers. 
 
15.3 Statistical Methods 
 
We will report descriptive statistics including means with SD for continuous variables (selected quantiles, 
if non-Gaussian), counts with proportions for categorical variables, and 95% CI for both. 
We define the agreement threshold as Kappa ≥0.8 as this represents a clinically meaningful threshold of 
agreement between raters. We will refine the intervention for agreement ratings below this threshold, 
guided by low-scoring TUQ items that measure specific telehealth system attributes, and qualitative 
results. We will proceed to a future efficacy trial with children (non-simulated) if we demonstrate that 
children can be adequately assessed remotely to determine the presence or absence of acute respiratory 
distress via the low-cost mobile teleconsultation platform. 
We will summarize the number of subjects approached and screened, number and reason ineligible, 
number declining participation, number enrolled, and estimated recruitment rate. 
We will also summarize patient (age, sex, race/ethnicity, vital signs, illness severity, physical exam) and 
transport encounter characteristics (referral source, transport time intervals). 
We will analyze written qualitative comments using the Technology Acceptance Model framework and 
grounded theory to identify themes. We will start with a set of conceptual categories using the Constant 
Comparative Method, apply these to data, and revise categories to reflect new concepts. This process will 
Number 
of 
children 
 
Kappa (95% CI) 
20 
0.80 (0.54, 1.00) 
40 
0.80 (0.61, 1.00) 
Table 1. Precision of estimates in interrater agreement 
in assessment of respiratory distress between bedside 
and remote providers assuming a 90% prevalence of 
assessed respiratory distress for raters in each location. 

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generate the subsequent theory of intervention acceptance. To ensure coding validity, we will use two 
study team members for all coding. We will use critical review and team consensus to resolve coding 
discrepancies. 
 
16 Ethics/Protection of Human Subjects 
 
This study is to be conducted according to applicable US federal regulations and institutional policies 
(which are based in federal regulations, guidance, and ICH Good Clinical Practice guidelines). 
 
This protocol and any amendments will be submitted to the Boston Medical Center and Boston University 
Medical Campus IRB for formal approval of the study conduct. The decision of the IRB concerning the 
conduct of the study will be made in writing to the investigator. A copy of the initial IRB approval letter 
will be provided to the sponsor before commencement of this study.  
 
All subjects for this study will be provided a Parent Permission Form with Alteration of Consent describing 
this study and providing sufficient information for subjects to make an informed decision about their 
participation in this study. The consent form will be submitted with the protocol for review and approval 
by the IRB. The consent of a subject, using the IRB-approved consent form, must be obtained before that 
subject is submitted to any study procedure. Consent will be documented as required by the IRB.   
 
17 Literature References 
 
1. 
Diggs LA, Sheth-Chandra M, De Leo G. Epidemiology of Pediatric Prehospital Basic Life Support 
Care in the United States. Prehosp Emerg Care 2016;20:230-8. 
2. 
Shah MN, Cushman JT, Davis CO, Bazarian JJ, Auinger P, Friedman B. The epidemiology of 
emergency medical services use by children: an analysis of the National Hospital Ambulatory Medical 
Care Survey. Prehosp Emerg Care 2008;12:269-76. 
3. 
Hoyle JD, Jr., Ekblad G, Woodwyk A, Brandt R, Fales B, Lammers RL. Methods Used to Obtain 
Pediatric Patient Weights, Their Accuracy and Associated Drug Dosing Errors in 142 Simulated 
Prehospital Pediatric Patient Encounters. Prehosp Emerg Care 2022;26:511-8. 
4. 
Meckler G, Hansen M, Lambert W, et al. Out-of-Hospital Pediatric Patient Safety Events: Results 
of the CSI Chart Review. Prehosp Emerg Care 2018;22:290-9. 
5. 
Hansen M, Eriksson C, Skarica B, Meckler G, Guise JM. Safety events in pediatric out-of-hospital 
cardiac arrest. Am J Emerg Med 2018;36:380-3. 
6. 
Hoyle JD, Jr., Crowe RP, Bentley MA, Beltran G, Fales W. Pediatric Prehospital Medication Dosing 
Errors: A National Survey of Paramedics. Prehosp Emerg Care 2017;21:185-91. 
7. 
Hansen M, Meckler G, Lambert W, et al. Patient safety events in out-of-hospital paediatric 
airway management: a medical record review by the CSI-EMS. BMJ open 2016;6:e012259. 
8. 
Marcin JP, Sauers-Ford HS, Mouzoon JL, et al. Impact of Tele-Emergency Consultations on 
Pediatric Interfacility Transfers: A Cluster-Randomized Crossover Trial. JAMA network open 
2023;6:e2255770. 
9. 
Curfman AL, Hackell JM, Herendeen NE, et al. Telehealth: Improving Access to and Quality of 
Pediatric Health Care. Pediatrics 2021;148. 
10. 
Donohue LT, Hoffman KR, Marcin JP. Use of telemedicine to improve neonatal resuscitation. 
Children 2019;6. 

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11. 
Dharmar M, Kuppermann N, Romano PS, et al. Telemedicine consultations and medication 
errors in rural emergency departments. Pediatrics 2013;132:1090-7. 
12. 
EMS Agenda 2050 Technical Expert Panel. EMS Agenda 2050: A People-Centered Vision for the 
Future of Emergency Medical Services. Washington, DC2019. Report No.: DOT HS 812 664. 
13. 
Kim Y, Groombridge C, Romero L, Clare S, Fitzgerald MC. Decision support capabilities of 
telemedicine in emergency prehospital care: systematic review. Journal of medical Internet research 
2020;22:e18959. 
14. 
Winburn AS, Brixey JJ, Langabeer J, 2nd, Champagne-Langabeer T. A systematic review of 
prehospital telehealth utilization. J Telemed Telecare 2018;24:473-81. 
 
 
 

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18 Appendix 
 
18.1 Schedule of Events 
 
 
Transport encounter 
 
 
Event 
Dispatch 
Arrival at 
receiving 
facility 
Patient 
preparation 
for transport 
Transport in 
ambulance 
Arrival at 
destination 
facility 
24 hours  
post-transport 
1 week  
post-transport 
Screening 
x 
 
x 
 
 
 
 
Recruitment, consent 
 
 
 
x 
 
 
 
Enrollment 
 
 
 
x 
 
 
 
Remote and bedside 
respiratory assessment 
of child subject 
(study encounter) 
 
 
 
x 
 
 
 
Post-call user ratings, 
call characteristics 
 
 
 
 
 
x 
 
Patient, transport 
characteristics 
 
 
 
 
 
 
x