Telemedicine Enhanced Asthma Management Through the Emergency Department
Phase: NA
Conditions: Asthma
Sponsor: University of Rochester

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Telemedicine Enhanced Asthma Management through the Emergency Department 
 (TEAM-ED) 
 
Investigators: 
Jill S. Halterman, MD, MPH;  
Arlene Butz, ScD, MSN, CPNP;  
Kenneth M. McConnochie, MD, MPH;  
Ekaterina I. Noyes, Ph.D., MPH;  
Tamara T. Perry, MD 
 
 
Background: 
Asthma is one of the most common chronic illnesses of childhood, affecting nearly 10% of children in 
the US.1,2,3 Asthma causes morbidity from recurrent symptoms, impairment of quality of life, limitation 
of activity, school absenteeism, and missed days of work for caretakers.  In addition, asthma is the most 
common reason for a pediatric emergency department (ED) visit, contributing to substantial health care 
costs.  In 2007, direct health care costs from asthma exceeded $14 billion.4 In the US, children from 
impoverished and minority ethnic and racial backgrounds suffer disproportionately from asthma. In fact, 
Black children are approximately 2.5 times more likely to have an ED visit or hospitalization for asthma 
than White children, and ED recidivism is common.5 The US has made a commitment to eliminate health 
disparities, yet numerous studies document disparities in medication use, health care utilization, and 
asthma outcomes in minority patients.6-12 
 
It is increasingly recognized that asthma is a chronic disease characterized by inflammation of the 
airways, and that preventive anti-inflammatory medications are paramount for the management of the 
disease and prevention of morbidity.  Inhaled corticosteroids are the most effective long-term therapy 
for patients with persistent asthma and the NHLBI Expert Panel guidelines recommend that all patients 
with persistent asthma receive daily preventive anti-inflammatory medications.13 These medications 
reduce asthma symptoms, improve pulmonary function, and prevent exacerbations leading to 
emergency visits and hospitalizations when used as recommended.14 In addition, once medications are 
prescribed, the guidelines recommend follow-up assessments in 4-6 weeks, with adjustments in therapy 
as needed, to assure the goals of therapy are met.  
 
Unfortunately, inadequate therapy with preventive medications is common, and many children suffer 
from morbidity that is potentially preventable.15-18  Strikingly, among children presenting to the ED for 
asthma, as many as 75% are not using any preventive asthma medication.19  Missed opportunities for 
the delivery of preventive asthma care are common, in part due to very poor follow-up rates in primary 
care.20-25,26,27  Further, while an office visit provides an opportunity for the clinician to apply asthma 
guidelines to clinical care, written action plans and asthma education are not provided consistently,28, 29 
and opportunities to prescribe preventive medications are often missed.29,30  In addition, many children 
who are prescribed a preventive medication do not achieve optimal control, at least in part due to lack 
of appropriate follow-up care.31 Asthma symptoms, ED visits, and even hospitalizations may occur 
without a primary care provider’s knowledge.32,33Importantly, the greatest under-use of preventive 
medications occurs among poor inner-city children. 11,34,35  
 
To overcome several of these barriers, we developed the PAIR-UP (Prompting Asthma Intervention in 
Rochester – Uniting Parents and Providers) intervention which included 638 children from 12 diverse 

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urban primary care practices.36 The primary intervention included a simple prompt that was created at 
the time of a healthcare visit and given to the provider with information regarding the child’s symptom 
severity or level of control, preventive medication use, exposure to tobacco smoke, and specifically 
tailored recommendations for guideline-based preventive care.  Results from this study demonstrated 
improved preventive care delivery at the time of the visit, as well as reduced asthma morbidity (see 
progress report).  However, for PAIR-UP we only targeted children who presented for care in the 
primary care office, thus potentially missing a large population of high-risk children with very limited 
access to health care for whom the ED is the primary source of asthma care.34,37,38  Thus we now aim to 
expand our successful intervention to high-risk children presenting for asthma care in the ED, to 
promote optimal preventive care treatments and reduce morbidity. 
 
Preventive asthma care is rarely addressed in the ED setting, which has a focus primarily on acute, 
episodic care.39 Thus, in order to provide optimal preventive care and prevent repeat episodes following 
an ED visit, the asthma guidelines recommend that all children follow up with a primary care provider 
within 1-4 wks.40 During this follow-up visit the primary care provider has the opportunity to prescribe 
effective preventive asthma medications, step-up medications for children who demonstrate poor 
control, promote medication adherence, and provide education on asthma self-management and trigger 
control to ultimately reduce morbidity and prevent subsequent ED visits.  However, studies show that 
only 6-46% of children attend ED follow-up visits,20-25,26,27 and those rates are particularly low for high 
risk children living in urban areas. In one of Rochester’s largest urban primary care clinics, only 6% of 
patients followed up in the office within 4 weeks of an ED visit.41 Thus opportunities to optimize 
preventive care after an ED visit are frequently missed. 
 
A significant amount of asthma morbidity could be prevented if a sustainable intervention improved the 
delivery of guideline-based care after an emergency visit.  Other programs have attempted to facilitate 
primary care follow-up after an ED visit,20-23,26,27 or even provide specialized follow-up for patients right 
in the ED setting.19 These programs have had varied effectiveness and none have been disseminated 
broadly.  We have developed the Telemedicine Enhanced Asthma Management through the Emergency 
Department (TEAM-ED) program, which utilizes telemedicine technology to link children from acute to 
primary care and provide point-of-care prompting to assure that children receive the guideline-based 
treatments that can effectively reduce morbidity.  This study will allow us to build upon our successful 
office-based preventive care intervention, optimize its effectiveness, and facilitate access to treatment 
for high risk children seen in the ED.   
 
The University of Rochester’s existing telemedicine model includes mobile units that enable clinicians to 
provide assessments based on a full complement of clinically-important information.  Equally important, 
it enables providers to engage parents in counseling through remote audiovisual technology. A Clinical 
Telehealth Assistant (CTA) collects medical data and images from the child at their school, daycare, or 
home.  These data are then stored for the child’s primary care provider (PCP) in a secure internet 
system.  The PCP can complete the visit at their convenience, and communicate with the caregiver by 
telephone to collect additional information and discuss the treatment plan.   Visits can also be done in 
‘real-time’; connecting all parties via teleconference. It enables children to be seen by a PCP without 
making a trip to the office, thus eliminating a significant barrier to care.42,43 Well designed telemedicine 
models allow patients to be cared for appropriately for acute and chronic problems while the child 
remains at home or school, the parent remains at work and the PCP remains at their usual work place 
(or home). There is reimbursement for telemedicine visits by all local payers, including Medicaid 
Managed Care (which covers 75% of Rochester’s urban children), making it a sustainable system of care.  
Telemedicine is an efficient, cost-effective, and safe way to facilitate access to care for patients.44-46 

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The overall goal of TEAM-ED is to extend our prior work with a novel telemedicine based program to 
promote appropriate primary care follow-up and optimal guideline-based preventive treatment for 
high-risk children presenting to the ED for an asthma exacerbation.  
 
Over the past 15 years, we have established a strong partnership with local PCPs and the Rochester 
community, which has allowed us to implement several programs for urban children with asthma, 
including the PAIR-UP study36 that informed this study.  Similar to PAIR-UP, this current intervention 
uses a system change to improve the delivery of optimal, guideline-based asthma care with a focus on 
promoting prescribing of effective preventive medications.  However, it is unique because it focuses on 
a new, particularly high-risk population (urban children in the ED) and uses telemedicine technology to 
provide facilitated access to optimal primary care services.  The telemedicine template includes point-of-
care prompting, which parallels the PAIR-UP prompt and includes information regarding the child’s 
asthma symptom severity or level of control, preventive medication use, exposure to tobacco smoke, 
and specific tailored recommendations to promote the delivery of consistent, guideline-based asthma 
care.  This current study represents an innovative extension of our work to improve preventive care for 
these high-risk children through the ED.  We aim to establish whether:  
• 
Telemedicine will successfully link children from acute to primary care, assuring timely primary 
care follow-up after an asthma-related emergency visit,  
• 
The telemedicine visits, performed by a primary care provider and supported by templates with 
‘point-of-care’ prompting for guideline-based care, will enhance the provision of preventive 
asthma treatment,  
• 
Asthma morbidity and repeat unscheduled asthma visits are reduced for these high-risk 
children.     
 
Study Objectives: 
This study has the following objectives: 
• 
To identify and recruit an urban sample of young children, aged 3-12 years, with mild persistent 
to severe persistent asthma from the ED setting at Strong Memorial Hospital (SMH) and 
Rochester General Hospital (RGH). 
• 
To collect baseline morbidity data to characterize this group of children with asthma and 
determine risk factors for the frequency and severity of recurrent symptoms. 
• 
To randomly allocate subjects into either: 1) TEAM-ED Intervention Group (facilitation of 
preventive asthma management through telemedicine assessment and follow-ups in addition to 
guideline-based provider prompting) or 2) a control condition including enhanced usual care 
(eUC) (report of symptoms to PCP). 
• 
To follow subjects prospectively throughout the year for endpoints defined by clinical outcomes 
(symptom severity, asthma control, health care use), functional outcomes (absenteeism, quality 
of life), and airway inflammation (FeNO). 
• 
To assess the effectiveness of TEAM-ED in reducing asthma morbidity and preventing repeat 
unscheduled asthma visits. 
• 
To assess the effectiveness of the intervention in improving preventive asthma care. 
• 
To establish the financial sustainability of the intervention with a specific focus on ultimate 
dissemination. 
 
Study Overview: 
This project aims to improve the delivery of optimal primary care services for high-risk children who 
present to the ED, using telemedicine to directly link from acute to primary care. This intervention is 

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designed to overcome key barriers to guideline-based preventive asthma care among minority, poor 
children in Rochester, NY. Screening will take place in the ED to identify children who present for an 
acute asthma exacerbation and have persistent or poorly controlled asthma. Children in the TEAM-ED 
group will receive a telemedicine asthma assessment in school (or other convenient location for family 
and telemedicine staff). Follow-up telemedicine visits will be completed to make treatment revisions to 
optimize guideline-based treatment. The overall aim of this study is to evaluate the use of the TEAM-ED 
intervention for improving guideline-based care, preventing repeat unscheduled asthma visits, and 
reducing morbidity among young urban children with asthma. 
 
Study Design: 
This is a randomized trial of the TEAM-ED intervention versus an enhanced usual care (eUC) comparison 
group with 430 urban children (and their caregivers) aged 3-12 who present to the emergency 
department for an asthma exacerbation.  Children presenting to the ED will be systematically screened, 
and eligible children will be randomly assigned to either the TEAM-ED intervention (telemedicine 
asthma assessment and follow-up visits using a pre-developed template with guideline-based 
prompting) or the eUC comparison condition (asthma screening with symptom reports and guideline-
based recommendations for preventive medications sent to the PCP, and systematic feedback to the 
PCP and caregiver to promote appropriate follow-up care). Randomization will be stratified by 
enrollment site and use of a preventive asthma medication at baseline.  A permutated block design will 
be used to assure an equal balance of children in each group over time.  Following randomization, 
children will be followed prospectively and systematically for a year.  
 
Subjects and Setting: 
There are 2 EDs (Strong Memorial Hospital (SMH), Rochester General Hospital (RGH)) that provide 
pediatric emergency care for children in Rochester and the surrounding areas.  Children 4-12 years of 
age presenting to the ED at either site will be screened for eligibility.  A total of 430 children and 430 
caregivers will be recruited into the study over 4 consecutive years. 
 
Inclusion Criteria (all 4 criteria must be met): 
• 
Prior doctor report stating that the child has asthma or reactive airway disease (RAD).  
• 
Current emergency visit for an acute asthma exacerbation. 
• 
Age >3 and <12 years, and living in the city of Rochester (primary residence within the following zip 
codes: 14428, 14445, 14467, 14513, 14514, 14515, 14586, 14604, 14605, 14606, 14607, 14608, 
14609, 14610, 14611, 14612, 14613, 14614, 14615, 14616, 14617, 14618, 14619, 14620, 14621, 
14622, 14623, 14624, 14625, 14626).  
• 
Persistent asthma or poor asthma control, defined by NHLBI guidelines40 as any 1 of the following: 
• 
>2 days/wk with asthma symptoms in the past month, 
• 
>2 days/wk with rescue medication use in the past month, 
• 
>2 days/month with nighttime symptoms in the past month or 
• 
>2 episodes of asthma during past year that required systemic corticosteroids (including the 
current emergency visit). 
 
Exclusion Criteria: 
 
• 
Inability to speak and understand either English or Spanish. 
• 
No access to a phone for follow-up surveys (either at the subject’s home or an easily accessible 
location). 
• 
Participation in another asthma study at the time of enrollment, or a sibling currently participating 
in this or another study. 

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• 
Other significant medical conditions, including congenital heart disease, cystic fibrosis, or other 
chronic lung disease, that could interfere with the assessment of asthma-related measures. 
• 
Children in foster care or other situations in which consent cannot be obtained from a legal 
guardian. 
(Parents unable to read will be eligible and all self-administered instruments will be given verbally.) 
 
Based on our prior studies, we anticipate <10% of subjects to be excluded based on these criteria. 
 
After the amendment for Spanish documents has been approved, all Spanish speaking families will be 
recruited by Spanish speaking research associates and follow-up surveys will be completed by Spanish-
speaking research assistants. All research documents will be provided in Spanish for families to review.  
If Spanish speaking researchers are not available at the time of enrollment, the family will not be 
enrolled at that time, but may be eligible for enrollment at a future date.  If a Spanish-speaking 
Telemedicine provider is not available to conduct the visit, then the Telemedicine providers will use 
translation services, as they normally would, in conducting telemedicine care visits.  
 
The recruitment goal for this study is to enroll 430 children using the Inclusion/Exclusion criteria stated 
above.   For the purposes of the University of Rochester’s Research Subject’s Review Board, we will also 
consider each child’s caregiver as a subject of this study (430 subjects).  Therefore, we anticipate 
approximately 860 ‘subjects’ will be included in this study. 
 
Study Procedures: 
 
• 
Flagging and Screening Procedures 
Screening and enrollment will occur prior to ED discharge.  The study team will review medical charts to 
flag children with an asthma or reactive airway disease diagnosis who present with an acute asthma 
exacerbation. A study team member will then approach parents of identified children in the emergency 
department and complete a brief screening survey to assess eligibility (see inclusion/exclusion criteria 
above). Trained and experienced recruiters are already stationed at the SMH ED (RSRB #33814).  Once 
this study is approved at RGH, we will also station trained recruitment staff at the RGH ED who will use 
identical screening and enrollment processes.  We have experience enrolling at both sites. 
 
• 
Baseline Assessment 
At the time of the ED visit, informed consent will be obtained from the parent and assent from children 
≥8 years.  The baseline survey will include an assessment of asthma symptoms, standard family and 
health history variables, exposure to secondhand smoke, and an environmental checklist.  The interview 
survey includes questions adapted from several validated scales.  An asthma symptom diary will be 
given to the caregiver for tracking asthma symptoms throughout the year and to assist with recall during 
the telephone follow-up assessments. All families will receive an educational packet including basic 
asthma information, smoking cessation resources, and information about the local asthma coalition.  
We also will obtain saliva samples from each child to objectively measure smoke exposure using the 
biomarker cotinine.  Lastly, we will obtain exhaled nitric oxide measurements from each child using a 
portable NIOX VERO machine, in order to objectively measure airway inflammation.  All surveys will be 
available in English and Spanish, and questions will be read aloud. 
 
In instances when the caregiver who provided consent is unavailable for follow-up, if a different legal 
caregiver would prefer to respond to the follow-up assessments, the study will be described in detail 
and verbal consent will be obtained over the telephone from the new caregiver for completion of the 

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follow-up survey. In rare instances where the child’s legal caregiver changes written consent will be 
obtained from the new caregiver. 
 
Participants will be given the option to allow for future contact for other research studies at the time of 
consent.  All participants who provided permission will be added to a future contact database dedicated 
to childhood asthma research (RSRB #31010).   A voluntary photo/image consent form will be signed at 
the 12 month final home visit and images will be used only for study related purpose of publications, 
conferences, handouts, pamphlets, and presentations/posters. 
 
• 
Randomization 
Following completion of the baseline assessment in the ED, each child will be randomly assigned to 
either the TEAM-ED or eUC group.  Randomization will be stratified by enrollment site and use of a 
preventive asthma medication at baseline.  A permutated block design will be used to assure an equal 
balance of children in each group over time.  The randomization scheme will be independently 
developed by the Biostatistics Center, and will be implemented electronically via REDCapTM. 
 
• 
TEAM-ED  Group: 
Once randomized, we will send a symptom report and notification of enrollment in the study to 
each child’s PCP.   This report will include an explanation of the processes of the TEAM-ED program 
and will advise them to continue to care for the child’s healthcare needs as usual. We will also 
provide caregivers with a copy of the symptom report and a prompt for guideline-based care for 
their child.  In collaboration with the existing UR Telemedicine Program, a telemedicine follow-up 
appointment will be scheduled within a week of discharge from the ED.  As per the Telemedicine 
program’s usual process, the visit will be prepared by a clinical telehealth assistant (CTA) and the 
CTA will bring the mobile telemedicine unit to the child’s school where he/she will meet with the 
child.  The CTA will compile clinical history and physical examination data (including medical images, 
height/weight, and breath sounds), which will either be securely stored in the telemedicine system’s 
“virtual waiting room”, or will be viewed by the PCP in real time, using videoconferencing to link the 
child and PCP (the caregiver is also invited to meet the child at school for the visit).  We have 
experience with both ‘store and forward’ and ‘real time’ telemedicine assessments. In the event 
that the child is not expected to return to school within one week of the ED discharge or during 
school breaks, the telemedicine visit will be prepared in the child’s home (or other agreed upon 
location) at a time that is convenient for the caregiver. We anticipate the majority of enrollment to 
occur during ‘asthma season’, which coincides with the school year.  
 
The visit will be scheduled with the telemedicine provider in real time when possible, or will be 
performed within 48 hours using the ‘store and forward’ mechanism.  The telemedicine provider will 
log into the telemedicine system from their office or home, review the recorded symptom 
information, view the child’s images, and listen to the breath sounds.  The telemedicine provider will 
then complete the assessment using a pre-developed template with guideline-based prompting 
based on our prior PAIR-UP study, with checklists of guideline-based actions for preventive care.  
They will communicate with the child’s caregiver via teleconference (or telephone for ‘store and 
forward’ visits) to further discuss the child’s asthma and develop a treatment plan.  During this 
contact, the telemedicine provider will deliver asthma education (e.g. trigger avoidance, symptom 
monitoring) and provide referrals to community resources as needed.  All of the children in the 
study will have persistent or poorly controlled asthma (per enrollment criteria), warranting the use 
of a daily preventive asthma medication per NHLBI guidelines.  When the telemedicine provider 
writes a preventive medication prescription, the prescription may be sent electronically to a local 

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pharmacy that offers delivery services.  As part of the telemedicine system,  a summary of the visit 
assessment and plan will be sent to the parent and faxed to the child’s PCP for inclusion in the 
medical record (if it is not automatically included in their EMR). The telemedicine visit will model 
care that would be delivered at an outpatient asthma follow-up visit.  We view the post-ED time 
period as an ideal ‘teachable moment’ for education and self-management promotion, since the 
stress and inconvenience of an ED experience is likely to heighten the caregiver’s attention towards 
preventive asthma care.  Visits take approximately 20 minutes for the provider to complete.  Similar 
to a standard asthma visit, reimbursement will be submitted to the child’s health insurance. 
 
Several PCPs perform telemedicine visits as part of the current telemedicine system, including at 
least 3 different practices that serve >60% of the children living in the city of Rochester.  We will 
schedule asthma telemedicine visits with the child’s primary care practice whenever possible.  If 
there is no telemedicine provider at the child’s practice or if the PCP is unavailable for the visit (or if 
the child does not have a PCP), several providers at Strong’s Pediatric Clinic and Rochester General 
Pediatric Associates are routinely available to perform visits; this scheduling system is currently 
used, is well received, and works very efficiently. For children without a PCP, the study team will also 
assist the family in connecting with a PCP. While the telemedicine providers are well versed in the 
asthma guidelines and endorse the use of inhaled corticosteroids for all children with persistent 
asthma, they will receive refresher training from Dr. Perry prior to the start of the intervention.  A 1-
hour lunchtime session will be held at the beginning of each intervention year and will include an 
overview of asthma, the newest guideline recommendations (e.g.; distinction between severity and 
control, impairment vs. risk), recommendation for inhaled corticosteroids, adherence tips, 
resources, and a review of the telemedicine template for asthma care. 
 
Follow-Up Telemedicine Asthma Control Assessments and Medication Adjustments: 
In addition to the initial telemedicine assessment, each TEAM-ED subject will receive two additional 
telemedicine-assisted follow-up assessments during the study period.  By including these additional 
follow-up visits, we will assure ample opportunity for the provider to tailor each child’s asthma 
therapy to their specific needs, supporting maximum control and promoting long-term benefits.  
The second telemedicine assessment will occur 4-6 weeks after the initial assessment.  The third 
assessment will occur 4-6 weeks after the second.  Just as for the initial assessment, the CTA will 
meet with the child at school to prepare the visit for the provider, who will complete the visit either 
in real time or within 48 hours.  These assessments will focus on level of control, ongoing triggers or 
co-morbid conditions that might interfere with an optimal response to treatment, and brief asthma 
education.  The telemedicine provider will make guideline-based medication adjustments (or 
specialist referral, if appropriate) for children who continue to have persistent symptoms, and 
referrals to community-based resources will be made as needed.  After the final telemedicine-
facilitated follow-up assessment we will ask both providers and families to schedule the next follow-
up in the primary care office.  Providers will be given a summary of the guidelines for asthma 
management and will be directed to provide ongoing asthma management as needed.  Additional 
telemedicine visits will be prepared only if specifically requested by the family or the provider.     
 
Referrals to Additional Resources: 
In the TEAM-ED group, the telemedicine provider may also provide referrals to an asthma specialist, 
American Lung Association of Western New York, and New York State Smokers’ Quitline, as 
appropriate. 
 
• 
Enhanced Usual Care (eUC) Group: 

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Similar to children in the TEAM-ED group, children in the eUC group will receive a symptom 
assessment using NHLBI guidelines, a recommendation for appropriate treatment, and asthma 
education materials given at the time of the ED visit.  After baseline and randomization we will send 
the child’s PCP a symptom report with guideline-based recommendations for preventive care and 
recommend a follow-up visit with the PCP.  We also will give all providers a summary of the current 
national guidelines.  We will provide systematic feedback to the family and child’s PCP at intervals 
that parallel the TEAM-ED group’s telemedicine assessments (1st feedback: 4-6 weeks after ED, 2nd 
feedback: 4-6 weeks after 1st feedback letter).  This feedback will include prompting caregivers to 
schedule a recommended asthma follow-up appointment with the PCP and encouraging providers 
to adhere to the NHLBI asthma care guidelines.  While participants will not be blinded to their group 
allocation, they will be told that they are randomly assigned to two different ways of approaching 
asthma management.  In all of our prior studies, children in the eUC group improved over time, 
creating a conservative bias. 
 
• 
Follow-Up Assessments 
We will follow subjects prospectively for 12 months. The effectiveness of the study will be assessed by 
interviews with caregivers, measures, and medical record review.  Research assistants blinded to the 
subject’s group allocation will collect follow-up data by telephone at 3, 6, and 9 months after the 
baseline assessment. We may also send reminders and schedule appointments through text messages 
and emails.  Text messages will be formatted in a manner that provides research relevance in the 
absence of personal health information (PHI).  We may use a limited data set when sending text 
messages that can include dates and times for visits or telephone call reminders. The final follow-up at 
12 months will be conducted with a home visit. While the intervention will only last 12 months, we may 
follow subjects for up to 18 months post their enrollment into the study if there is difficulty contacting 
with participants. These measures may include medical chart review or additional survey assessments 
with the primary caregiver.  If additional surveys are conducted with the caregiver, we will request 
verbal permission from the caregiver prior to collecting survey data.  
 
• 
Measures 
The table below summarizes the outcome measures and covariates that will be collected for this study.  
The table includes how the data will be collected, validated scales/instruments used, and times of 
administration. 
 
Clinical Outcomes 
Measurement Strategy 
Time of Administration 
Symptom Severity 
 
Caregiver report of symptom free 
days (SFDs), NHLBI guideline-based 
items47 
 
Baseline, each follow-up 
(3, 6, 9 mo.), final survey 
(12 mo.) 
Health Care Utilization, Nights 
with asthma symptoms, Days 
needing rescue meds, Days 
with limited activity, and 
Asthma control 
Health care utilization survey 
Asthma Control Test (ACT)48,49 
Review of medical chart 
Baseline, each follow-up, 
final survey (12 mo.) 
Airway Inflammation 
Objective measurement:  FeNO50 
Baseline, final 
assessment 
Functional Outcomes 
 
 
School Absenteeism & 
Caregiver missed days of work 
due to asthma 
Caregiver interview 
 
Baseline, each follow-up, 
final survey (12 mo.) 

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Quality of Life 
Juniper Quality of Life Instrument 
(PACQLQ)51 
Baseline, each follow-up, 
final survey (12 mo.) 
Potential Mediators 
 
 
Adherence, Preventive Meds, 
Action Plans & Spacers, 
Preventive asthma education, 
Asthma Visits 
Horne Adherence Scale52, NHLBI 
guideline-based items, healthcare 
utilization survey 
Baseline, each follow-up, 
final survey (12 mo.) 
 
Communication with Providers 
Perceived efficacy in Patient-physician 
interactions (PEPPI)53 
Baseline, final 
Satisfaction with Medical Care 
Patient Satisfaction Questionnaire, 
Short-Form (PSQ-18)54 
Baseline, final  
Independent Variables 
 
 
Demographic, Medical 
Variables 
Caregiver interview 
Baseline 
Caregiver Depression 
CES-D55 
Baseline, final  
Environmental Allergens 
Environmental survey  
Baseline 
Secondhand Smoke 
Caregiver interview 
Objective measurement: Salivary 
Cotinine56,57 
Baseline,  final 
Process Evaluation 
 
 
Training of CTAs, Providers, 
and System support needs 
Time to train CTAs and providers for 
asthma assessments, and providers 
for reinforcement of guideline-based 
asthma care 
Tracking logs for entire 
study period 
Telemedicine Visits 
Track telemedicine visit completion, 
resources needed to carry out 
intervention 
Baseline, each follow-up 
(3,6, 9), final survey (12 
mo.) 
 
 
 
 
*All Families will be provided a list of local mental health resources at the beginning of this study.  
 
Fraction of Exhaled Nitric Oxide (FeNO): 
Fraction of Exhaled Nitric Oxide (FeNO) measurement is a non-invasive measure of lung inflammation.  
This inflammation could be caused by many factors including colds, pollutant exposures, and asthma. 
FeNO will be measured using the NIOX VERO® Airway Inflammation Monitor, an easy-to-use 
electrochemical hand-held device that instantly analyzes exhaled air for NO concentration. The NIOX 
VERO® is regularly used in clinical practice to measure FeNO, and requires little training to use. Children 
will be asked to first fully exhale and then to take a fast and deep inhalation through a disposable 
mouthpiece attached to the device. Then, we will ask children to exhale slowly and steadily through the 
mouthpiece.  If done correctly, a reading will appear on the screen which will be recorded manually. 
FeNO will be measured 2 times, once at the baseline visit and then again at the 12-month home visit. 
Some children may have difficulty with this procedure; we will only include data for children who are 
able to perform the procedure accurately. The NIOX VERO® assessment only requires children to simply 
breathe into the machine, thus risks with this procedure are minimal. 
 
Secondary Smoke Exposure: Saliva Sample Collection for Measurement of Cotinine: 
Exposure to secondhand smoke will be assessed by both interview survey and cotinine measurements.  
At the baseline interview and the final home visit a member of the research team will collect salivary 
fluid samples from each child using the SalivaBio Children’s Swab, a thin (8mm diameter) polymer swab.  

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Collection will be made according to a standard protocol developed for use with children.  Salivary 
samples will be stored frozen and shipped via courier to Salimetrics, LLC in State College, PA for analysis.  
The cotinine results will be recorded as an outcome measure, and will be available to families only by 
request.  However, all families will receive resources on how to stop smoking and prevent smoke 
exposure.   
 
 
• 
Compensation 
Each participating caregiver will be paid $25 after completion of the baseline assessment.  Subjects will 
also be mailed $20 after each of the telephone follow-up surveys and $50 after the final follow-up 
survey.  Total payment will be no more than $130. Payment to participants will be in the form of a gift 
certificate.  
 
There may be some cost to participate in this study. Participants in the TEAM- ED group will be 
responsible to purchase medications and spacers that may be prescribed by the telemedicine provider 
as well as any fees associated with telemedicine visits (e.g., co-pays etc.) completed through the study 
(these are medical processes that should occur according to the national guidelines regardless of the 
child’s participation in the study). Based on our prior work with this population, we anticipate that most 
of the children will have some form of health insurance to cover the cost of visits and the medications 
with minimal or no co-pay fee.  In our prior studies we found that approximately 70% of families in the 
City of Rochester were insured with Medicaid which often eliminates co-pay fees for medications and 
care.  If a child does not have insurance, the study team will help the family secure health insurance.  If a 
child is unable to obtain health insurance or if a family or provider expresses a financial concern, the 
study team will pay for the participant’s asthma medication and spacer prescribed by the telemedicine 
provider.  If there is no insurance reimbursement for the telemedicine visit, subjects will not be asked to 
pay any additional costs (e.g., co-pay). Participants and their insurance company will be responsible for 
the cost of all standard of care office visits and additional medications prescribed by their PCP.  
  
• 
Data Storage and Confidentiality 
To maintain the integrity, security, and confidentially of study data, the data will be maintained in a 
secure and encrypted web-based database and/or a password protected database on a secure 
university network drive.  The majority of data will be entered through REDCapTM, a secure password-
protected website supported by the University of Rochester.  Subject tracking information will also be 
entered into a secure password-protected database created with Microsoft Access, that is only 
accessible on a secure university network drive and research personnel must use their University NetID 
and password to access the databases No subject data will be stored on the internal hard drives of any 
computers. After data validation and analysis, subject information will be de-identified.  All consent 
forms, paper surveys and additional correspondence will be stored in a locked filing cabinet in a locked 
hallway or locked office, and will only be accessible by the study staff.  
 
• 
Safety 
Potential risks related to participation in this study are minimal.  No medications, investigational 
treatments, or devices are being tested as part of this study.  The study is designed to improve 
guideline-based asthma care following an emergency visit.  The pediatric telemedicine provider may 
prescribe a daily controller medication, as part of the treatment regimen, which is standard of care for 
children with the degree of asthma symptom severity required for enrollment into the program.  The 
most frequently reported side effects of these types of medicines are sore throat, hoarseness, a fungal 
infection of the throat and mouth, and dry mouth.  Rinsing the mouth after using this medicine and 

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always using a spacer/holding chamber (if applicable) decreases the risk of these side effects.  The follow-
up research assistants will routinely assess common side-effects of asthma treatments, and any 
significant adverse events will be flagged by the follow-up team and relayed promptly to the study 
coordinator, the principal investigator, and the Institutional Review Board within 24-hours, and to the 
NIH as per protocol.  Any child (in either group) experiencing an exacerbation or persistent symptoms at 
the time of an assessment will be referred to their primary care provider.  In addition, an asthma 
coordinator will review the treatment plans to help ensure guideline-based care is followed 
appropriately and will be available to families to answer questions about the treatment plan. 
 
There is a risk that the study team may discover an unknown medical condition.  If this is to occur, we 
will refer the family to their PCP or another appropriate health care professional for evaluation and 
treatment.  There is also a risk that the study team may discover child abuse or neglect during a home 
visit, and will be required to report these concerns to authorities. 
 
The study team has conducted over 1,500 home visits for families of children with asthma, and 
implements extensive training each study year about home visit guidelines, safety, mandatory reporting, 
and cultural competency. The study team also meets weekly to review concerns.  
 
All records will be kept strictly confidential as required by the policies and procedures of the University 
of Rochester where data are collected, processed, or reported. We plan to hold bi-weekly research 
meetings with the study team to provide monitoring to ensure subject safety as well as treatment 
integrity. The family can discontinue their participation at any time during the study. 
Data Safety Monitoring Plan (DSMP):   
This study also includes a Data Safety Monitoring Plan as submitted to and approved by the study 
sponsor: National Institutes of Health and National Heart, Lung, and Blood Institute.   The plan for safety 
and monitoring is as follows: 
 
• 
Data and Safety Monitoring 
Data Quality Monitoring 
The research associates will be responsible for all data collected during the assessments.  They will 
receive training from key study personnel regarding asthma terminology, symptoms, medication 
understanding, and environmental assessment.  They also will be trained by the project coordinator on 
the use of equipment for cotinine measurements and the NIOX VERO® instrument for collection of 
exhaled nitric oxide. 
The project coordinators are all experienced in asthma terminology, symptoms and other aspects of 
the illness and have extensive training in research methods.  They will oversee the data collection 
methods and all data will be reviewed by the study coordinators.  Data forms will be completed at each 
study visit or telephone interview and will be returned with a cover sheet and other source 
documentation support materials (informed consent, contact information, etc.).  Pre-intervention 
training of study staff will be conducted to increase knowledge about asthma, asthma medications, and 
other important information in order to reduce the number of “real-time” data collection errors.  
Through this training, staff will note any inconsistencies in parent reported data and will discuss them 
with the parent at the time of the interview. 
  Key study personnel will perform all follow-up interviews and follow-up data management.  These 
data will be collected by the follow-up research associates who are independent from the research 
associate recruiters, and thus we will be able to perform blinded assessments of outcomes.  Our team, 
including the principal investigator, senior project coordinator, and recruitment and follow-up project 

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coordinators, has a prior record of high-quality data collection and management.  We have tracked 
hundreds of children in our randomized trials, and completed follow-ups with over 90% of subjects.  
Treatment group assignment will not be included with any follow-up materials in order to ensure 
blinding of the outcome assessment. 
Once surveys have been administered, errors that can be corrected over the telephone (legibility, 
incorrect dates, etc.) will be done using telephone interviews.  Simple range checks as well as cross-form 
validation checks will be performed to ensure the accuracy and completeness of the data.  Any errors 
detected will be noted on the form (including initials and date of change).  In addition, data forms, valid 
informed consent documents for each enrolled patient, and supporting source documentation materials 
will be reviewed by the research associates for accuracy.  Required regulatory documents (IRB approval, 
updates to the protocol, data monitoring documents) will be maintained by the senior study 
coordinator.  All events during the course of the trial including study enrollments, adverse events and 
study terminations will be reported to the senior study coordinator.   
 
Safety Monitoring Plan 
Potential risks related to participation in this study are minimal since the goal of this study is to ensure 
follow-up after an emergency visit and improve guideline-based asthma care for children with persistent 
asthma. In our prior school-based and office-based asthma programs, which have included hundreds of 
children, there have been no reports of significant adverse events related to study participation. The 
frequency and severity of all reported adverse events will be systematically recorded at each follow-up 
interview.  Telephone interviewers will inquire about any adverse events, and specifically ask about 
hospitalizations, emergency visits and common side-effects from medications (yeast infections of the 
mouth, facial rash).  Any significant adverse events will be flagged by the follow-up research associates 
and relayed promptly to the senior study coordinator, the principal investigator, the child’s primary care 
provider, the Institutional Review Board, and the NIH.  We will hold bi-weekly research review meetings 
with the study team to provide an additional layer of monitoring to ensure subject safety as well as 
treatment integrity.  The NIH does not require a formal Data Safety Monitoring Board (DSMB) for this 
study 
 
All records will be kept strictly confidential as required by the policies and procedures of the University 
of Rochester where data are collected, processed, or reported.   
 
• 
Potential Benefits 
Potential benefits for participants of the randomized trial exist for both groups of children (TEAM-ED 
and eUC).  The goal is for children in the TEAM-ED group to have improved symptom assessment, 
adherence to preventive medications, and appropriate tailoring of therapy, thus they may experience 
less morbidity from asthma.  Although children in the eUC group will not be receiving follow-up 
telemedicine assessments, we will prompt their PCP to provide guideline-based asthma care including 
prescription of the appropriate preventive medications and will provide regular reminders to PCPs and 
caregivers to care for the child’s asthma.  Improved asthma management should result in reduced 
morbidity for these children.   
 
• 
Analysis 
Sample Size: 
Based on our experience with prior studies and the number of unique asthma visits to the ED, we expect 
to be able to enroll 430 child participants in 4 years.  There are more than 950 individual patients -12 
years of age with a primary diagnosis of asthma presenting to the 2 EDs each year, (450 at Strong 
Memorial, >500 at Rochester General), and >45% of these children live in the city of Rochester (>430). 

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Conservatively assuming enrollment of 1/4 of eligible subjects, we will have no difficulty enrolling 108 
subjects/year.  We anticipate a maximum of 15% attrition, based on an attrition rate of <5% in our prior 
studies. We therefore expect complete data on at least 365 children, randomized into 2 groups (182 
subjects per group).  We now consider power calculations based on this sample size. 
 
The primary hypothesis is that children in TEAM-ED will have more symptom-free days at 3, 6, 9, and 12-
months compared to eUC.  Previous asthma interventions have demonstrated that improvements of 
0.85-0.95 SFD/2 weeks are feasible and clinically meaningful.59,60  Based on our prior data, we estimate a 
pooled standard deviation (SD) of SFD to be 3.5 and within-subject correlation (ICC) of 0.3. We 
calculated power for the intervention effect on SFD while justifying repeated assessments for outcomes 
(3, 6, 9, 12 months).61,62  A sample size of 182 subjects per group will provide >90% power to detect a 
difference of 0.85 in SFD at a 2-sided 5% significance level.63  We also calculated the smallest detectable 
differences in secondary outcomes with 80% power based on prior data.  
          
We also aim to test whether children in TEAM-ED will have fewer unscheduled asthma visits over 12 
months compared to eUC. Based on our preliminary data and data for similar populations, we estimate 
the baseline unscheduled asthma visit rate ranges 0.7-1.5 per person year.  A sample size of 365 subjects 
will provide 80% power to detect a rate ratio of 0.7 if the control group has rate of 0.7 per person year.  
For preventive measures such as preventive medication use, in our prior study, 59% of children used a 
preventive medication at baseline. With 182 subjects in each group, we will have 90% power to detect 
an increase of 16% in using a two-sided Z test at a significance of 5%.  
 
Primary Analysis:  
Assess the effectiveness of TEAM-ED in reducing asthma morbidity and preventing repeat unscheduled 
asthma visits; Assess the effectiveness of the intervention in improving preventive asthma care. We will 
follow subjects prospectively throughout the year for clinical outcomes (symptoms, asthma control, 
health care use), functional outcomes (absenteeism, quality of life), and airway inflammation (FeNO). 
We will use graphs and descriptive statistics to summarize the primary and secondary outcomes by 
intervention group at each assessment point (baseline, 3, 6, 9 and 12 months).  We will assess for 
differences between groups at baseline despite randomization in key characteristics (i.e.; age, race, 
ethnicity, insurance, caregiver education, caregiver depression, smoke exposure (determined by 
cotinine)).  These comparisons will enable the identification of covariates to be controlled when 
evaluating the treatment effect.  If distributional assumptions associated with a particular statistical 
procedure are violated, appropriate transformations will be made or non-parametric alternatives will be 
used.  In accordance with the intention-to-treat principle,64 all randomized subjects will be analyzed 
within the group to which they were assigned.  Minimal crossover is expected.  Hypothesis-driven 
comparisons will be made to control the family-wise type I error rate at 0.05 (two-sided) for the primary 
hypothesis. 
 
For the primary outcome analysis, the time-course of treatment effect on SFD during the follow-up 
period will be evaluated using a linear mixed model (LMM) accounting for repeated measures within 
each subject to test the intervention effect of TEAM-ED over time, with SFD as the dependent variable, 
and intervention group and group by time interaction as independent variables.65  The treatment effect 
will be regarded as fixed and the subjects as the random effect, with appropriate variance covariance 
structure specified.  Interaction effects between intervention and follow-up period are included to catch 
possible differences in how SFD changes over time between intervention groups.  Post treatment effects 
and maintenance gain from short to long term will be assessed by specifying appropriate linear 
contrasts. To adjust for potential confounding, baseline SFD and factors that differentiate between 

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groups will be included in the model as covariates.  Model fitting statistics such as Information Criteria 
and difference in log likelihood will be used for model selection.  Standard measures such as residual 
plots will check goodness-of-fit of the regression model assumptions and identify outliers.  We will 
calculate intraclass coefficient (ICC) within providers; if autocorrelation is significant, provider will be 
included as another level of random effect in the mixed model to account for the nested data structure.  
If the outcome measure violates the normal assumption required by LMM, we will evaluate the 
intervention effect using Generalized Estimating Equations (GEE).66  By specifying marginal mean effects 
of independent variables on the outcome variable, the GEE method offers consistent and robust 
estimates but does not require specification of a fully parametric distribution.  Other continuous 
outcomes (quality of life, FeNO, absenteeism) will be analyzed similarly.  
 
Categorical outcomes such as unscheduled asthma-related healthcare utilization will be analyzed by 
fitting Poisson regression models (with number of visits as the dependent variable).  Estimation of the 
regression coefficients and standard errors will be obtained using the GEE method with a log link 
function and Poisson error.  Baseline rate and factors imbalanced between groups will be controlled in 
this analysis.  Other discrete outcomes (such as preventive medication use and availability of written 
asthma action plans) will be analyzed in a similar manner with appropriate link functions and response 
probability distributions specified.   
 
The primary analyses will be performed according to the intention-to-treat principle and will include all 
randomized subjects.  Substantial attention will be invested in participant retention; reasons for any 
subject withdrawals that may occur will be carefully documented.  Missing data patterns will be 
examined by comparing subjects who discontinued with those who remained in the study.  Inference 
based on the proposed methods GEE and/or LMM is valid provided that missing data follows the missing 
completely at random (MCAR) assumption.  However, if the occurrence of missing data depends on the 
observed response but is independent of unobserved data (MAR), weight GEE (WGEE) will be used.  
Sensitivity analysis to the MAR assumption will also be carried out by modeling the between-group 
difference using WGEE.67,68 Separate secondary per protocol analyses will be performed, however, 
results of these analyses are potentially subject to bias and will be interpreted with appropriate caution. 
 
Cost Effectiveness Analysis:  Establish the financial sustainability of the intervention with a specific focus 
on ultimate dissemination.  We will assess the health and economic benefits of TEAM-ED from both the 
societal and the Medicaid perspectives.  We also will use Diffusion of Innovations Theory to help 
understand how this innovative model can be maintained in the current system of care. 
 
We will use cost-effectiveness (CE) methodology69,70 to assess the health and economic benefits of 
TEAM-ED versus eUC over 12 months.  The basecase analysis will be conducted from the societal 
perspective which includes all identifiable costs and benefits, regardless of whom they impact.  Since the 
majority of subjects are eligible for Medicaid (73% based on prior work59), a second analysis will take the 
Medicaid perspective.  The intervention benefits will be assessed using the primary outcome (mean 
symptom-free days over 12 mos.).71,72   
 
Three main categories of costs to be considered include programmatic costs, productivity costs, and 
medical costs estimated at the individual child level.  Programmatic costs include costs of initiating and 
running the program, hiring and training staff, purchasing or leasing equipment, staff travel, and 
information system costs. Programmatic costs will be tracked by the UR General Pediatric Division 
Administrator and the UR Telemedicine Program Administrator. Research-related costs that are not 
associated with the intervention and would not exist beyond the duration of the study will not be 

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included.  Per person programmatic costs will be calculated by dividing the total costs of the program by 
the total number of children with persistent asthma in the EDs.  We will determine productivity costs 
based on the amount of time parents take from work to care for sick children or take them to a doctor.  
Time from work will be valued at the median of the Bureau of Labor Statistics pay scale estimates based 
on age, race and gender.  We will assess the impact of the intervention on medical costs using both 
parent-reported health care utilization data and medical record review.  We will ask parents at each 
follow-up about their child’s visits to the ED, urgent care facility, or primary care office, as well as 
hospitalizations.  Health care use will be converted to costs using the NYS Medicaid fee schedule and 
other sources.  Money spent out-of-pocket by caregivers to cover the cost of medical procedures, 
medications, or equipment will also be included in the medical costs.  Annual medical costs per person 
will be analyzed using a 2-part model to adjust for zero expenses in a given year.73  All costs will be 
adjusted to the last year of the intervention using the appropriate component of the Consumer Price 
Index (CPI).  
We will consider the total cost of initiating and maintaining the program as well as the incremental cost-
effectiveness ratio (ICER) of TEAM-ED versus eUC.  The ICER is the difference in cost between the 2 study 
groups relative to the difference in the number of symptom-free days (SFD) gained between the 2 
groups.  The main outcome for the analysis from the societal perspective will be the ICER, defined as:  
(∆Medical+∆Productivity+$Program)/∆SFD, where ∆=(TEAM-ED)-(eUC). We will bootstrap74 the ICER to 
estimate standard error and to evaluate the uncertainty around the point estimate. The ICER will be 
compared to similar estimates from the literature.71,72  An acceptability curve, linking various values of 1 
SFD to the probability of TEAM-ED being cost-effective, will be plotted.75  The study from the Medicaid 
perspective will use the cost-benefit approach to economic evaluation.  Benefits will be described as the 
net difference in medical and productivity costs between children in the TEAM-ED and eUC groups and 
accounts for a potential reduction in unplanned visits as well as an increase in number of preventive 
visits.  The cost is equivalent to the cost of the program (Net Monetary Benefit=∆Medical-$Program). 
 
COVID-19 
In response to the COVID-19 crisis, we will follow the Human Subjects Research guidelines outlined by 
the University of Rochester to continue enrollment for this study.  Please find the following link for these 
guidelines:  https://www.urmc.rochester.edu/coronavirus/coronavirus-research/guidance-for-
researchers/human-subjects-research.aspx.  We will minimize in-person contacts to only those tasks 
necessary to conduct the research (e.g., obtaining consent, collecting breathing measurements if 
needed).  We will ensure that team members are appropriately trained in safety measures, maintain 
social distancing when possible, use personal protective equipment for themselves and research 
subjects (and family members), and will ensure proper cleaning/sanitizing of hands, equipment and 
workstations.  We will continue to monitor and follow the updated guidelines put forth by the UofR in 
the link above.  
We’ve included a brief, optional survey to assess how the COVID-19 Crisis is affecting children with 
asthma and their families.  We will ask the caregivers if they would be willing to answer these questions 
at the end of follow-up surveys that we are already conducting.  
 
 

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