Phase 4: Improving Asthma Outcomes By Facilitating Patient-Centered Care At School (Asthma-Free School)
Phase: NA
Conditions: Asthma
Sponsor: Children's Hospital Medical Center, Cincinnati

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Title of Study: Phase 4: Improving Asthma Outcomes By Facilitating Patient-
Centered Care At School (Asthma-Free School)  
 
Study ID: 2015-6747 
 
Principal Investigator:  
Theresa Guilbert 
Co-Investigators:  
 
Suzanna Hicks, RC 
 
 
 
 
Sandy Durrani, MD 
 
 
 
 
Carolyn Kercsmar, MD 
 
 
 
 
Karen McDowell, MD 
 
 
 
 
Marilyn Crumpton, MD 
 
 
 
 
Barb Wiley-Kroner, RN 
 
 
 
 
Kevin Hommel, PhD 
 
 
 
 
Rachelle Ramsey, PhD (Adherence/Health psychology 
 Fellow) 
 
 
 
 
Nanhua Zhang, PhD 
 
 
 
 
Susan Webb, MSN RN 
 
Funding: 
 
 
Luther Foundation Gift 
 
 
 
 
Verizon Foundation Gift 
 
 
 
 
1. ABSTRACT 
This is a pilot study based on the community stakeholder-derived data from three previous 
Quality Improvement projects to improve the partnership between Cincinnati Children’s 
Medical Center (CCHMC), Cincinnati Public Schools (CPS), and Cincinnati Health 
Department (CHD) to reduce the morbidity of childhood asthma in the inner city schools 
of Cincinnati and CCHMC. Through this work, we developed a preliminary understanding 
of school-based asthma care by defining barriers and identifying outcomes important to 
key stakeholders. These data were used to adapt and improve the 2008 to current Asthma 
Improvement Collaborative between CCHMC and CPS through the school health program 
of the CHD in order to test asthma outcomes in this pilot study. The CCHMC Asthma 
Center has an established working relationship with the CPS-CHD through the Asthma 
Improvement Collaborative. To address the concerning incidence of asthma in Greater 
Cincinnati, we are embarking on an innovative pilot to develop “asthma-free schools” in 
neighborhoods where the incidence of asthma is especially high. In partnership with CPS 
(Oyler, Roberts, Withrow, and School of Creative and Performing Arts schools), we intend 
to achieve asthma-free schools through school-based asthma care programs. High-risk 
asthmatic participants will be identified to participate. “High-risk” will be defined as poorly 
controlled asthma, frequent school absences, and/or need for daily controller asthma 
medications. A number of interventions will be incorporated into the pilot study of 30 
participants including use of a commercially available inhaler cap monitoring sensor, a 
mobile software management platform that tracks adherence of all asthma medications, 
mobile based telehealth medical visits to assess asthma control, and mobile based 
telehealth adherence problem-solving interventions. 
 
 
 
 

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2. PURPOSE OF STUDY: 
The purpose of this project is to adapt an existing CCHMC- CPS- CHD asthma 
infrastructure in order to address school-based asthma care barriers and then to test the 
efficacy of this program in a pilot study to improve asthma outcomes in 30 urban core 
youth.  
 
The stakeholder feedback from Stages 1-3 (IRB 2014-6757, 2015-3056, 2015-4754) of 
our quality improvement (QI) project on barriers and outcomes for school-based asthma 
care was collected in order to determine the feasibility of a school-based asthma 
intervention.  This work involved following stakeholder groups: school staff, school nurses, 
and primary care providers and the pooled anonymous data from these focus group has 
been used to design this asthma intervention.  This project is a cross-over QI-research 
project which extends our current school-based QI work by the Pulmonary Medicine 
Asthma Center but tests the outcomes in a pilot study which will be used as part of a 
journal article submission and used as preliminary data for a NIH U01 grant application in 
2016. A number of interventions will be incorporated into the pilot study of 30 participants 
including use of a commercially available inhaler cap monitoring sensor, a mobile software 
management platform that tracks adherence of all asthma medications, mobile based 
telehealth medical visits to assess asthma control, and mobile based telehealth adherence 
problem-solving interventions. 
 
 
3. BACKGROUND: 
Asthma is a common, complex and costly chronic condition in the U.S., resulting in nearly 
2 million acute care visits and $56 billion in overall costs each year (Akinbami 2012). Of 
these patients, 5-20% have poorly controlled asthma accounting for nearly 50% of all 
asthma-related expenditures (Pakhale 2011).   
 
Previous work done in this area:  Greater Cincinnati’s geography places it at the 
environmentally tricky confluence of low-lying smog-trapping hills, three heavily traveled 
interstate highways, and high rate of allergen exposure. This makes it an area ripe for 
asthma. The overall rate of pediatric asthma in Greater Cincinnati is more than twice the 
national average and, in some urban-core neighborhoods, as high as 10 times the national 
rate. At Cincinnati Children’s, we see daily evidence of this in our Emergency Department, 
where as kids often arrive in asthma distress and in a high-rate of re-hospitalization in our 
Medicaid population. Poor asthma control across the nation and locally in Cincinnati is 
associated with an overrepresentation of children from minority groups, low-income 
families, and single parent households who have higher rates of financial hardship and 
familial strain compared those with well-controlled asthma (Moorman 2012, Beck 2014). 
Many of these high-risk children attend local Cincinnati Public Schools (CPS) and are 
cared for at Cincinnati Children’s Hospital Medical Center (CCHMC).  Barriers to asthma 
care in our population have previously been described (Mansour 2000) and ongoing 
quality improvement (QI) work at CCHMC which includes asthma education, written 
asthma action plans, post-hospitalization follow-up appointments, and medications in 
hand at discharge have reduced hospital readmissions. Yet, data from previous 
investigations and our internal data show that no more than 50% of patients keep 
appointments or fill prescriptions, leading to continued poor asthma control and risk for 
future exacerbation (Lozano 2003). A CCHMC-CPS-Cincinnati Health Department (CHD) 
asthma infrastructure has been developed (Mansour 2008) in order to address some of 
these barriers. However, many of these children still have poor asthma control and missed 
school days. 

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Successful management of a lifelong chronic medical condition is usually complex. 
Patients with persistent asthma typically require multiple medications, taken several times 
a day via different routes and use of complicated devices. Many of these children do not 
access preventative medical care for asthma and/or do not have adequate self-
management skills to avoid or manage asthma exacerbations. These highest-risk asthma 
patients may need more intensive intervention rather than just traditional medical office 
clinic visits than those with intermittent or well-controlled asthma. 
 
Previous studies indicate that a school-based asthma intervention with direct 
administration of asthma controller medication by a school nurse (Halterman 2011 and 
2012) can improve asthma outcomes in children.  Furthermore, the use of an innovative 
software sensor and interactive management platform, Propeller Health, in a community 
setting has also been shown to improve asthma outcomes in adults (Van Sickle 2013). 
However, the propeller platform has not been extensively tested in children or in the school 
setting. Up to 75% of adolescents 12-17 years and 85% of African-American children have 
access to a smartphone and over 80% of middle-schoolers have their own cell phone. 
Over 
90 
% 
of 
middle-schoolers 
and 
adolescents 
go 
online 
(ref: 
http://www.pewinternet.org/2015/04/09/teens-social-media-technology-2015/; 
http://cdn.theatlantic.com/static/mt/assets/science/Research%20Findings_%20MARC%2
02011%20Survey%20Grades%203-12.pdf).  71% of adolescents use at least one social 
media web-site with Facebook, Instagram, Snapchat, Twitter, Google+, Vine, and Tumblr 
being the most popular (ref: http://www.pewinternet.org/2015/04/09/teens-social-media-
technology-2015/).  
 
Current infrastructure for implementing this project:  The CCHMC Asthma Center in 
partnership with the CCHMC Anderson Center for Community Health, the CHD and CPS 
have an in-school asthma improvement initiative in place called the Asthma Control Test 
(ACT) screening program. This program provides asthma screening in the fall to CPS 
participants in the school setting by CHD school nurses and consultation support through 
the CCHMC Asthma Center. This program is driven and has oversight through the 
CCHMC Population Health Community Committee, a multidisciplinary group representing 
the various stakeholders. For this project, we would identify potential focus group 
participants through the ACT screening program and through participant sick visits to the 
school nurses for asthma related problems. To address the concern of high rate of 
pediatric asthma hospitalizations in Greater Cincinnati, we are embarking on an innovative 
QI-research pilot to develop “asthma-free schools” in neighborhoods where the incidence 
of asthma is especially high. 
 
 
4. STUDY DESIGN  
This is an interventional pilot study based on the community stakeholder-derived data from 
three previous Quality Improvement projects to improve the partnership between CCHMC, 
CPS, and CHD to reduce the morbidity of childhood asthma in the inner city schools of 
Cincinnati and CCHMC. About 30 high-risk asthmatic participants will be identified to 
participate and a number of interventions will be incorporated including asthma specific 
questionnaires, use of a commercially available inhaler cap monitoring sensor, a mobile 
software management platform that tracks adherence of all asthma medications, mobile 
based telehealth medical visits to assess asthma control, and mobile based telehealth 
adherence problem-solving interventions. 
 

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This proposal is funded through a Luther Foundation and Verizon Foundation 
philanthropic gifts. 
 
 
5. DURATION:  
Duration for the participants will be 6 months. Participants will be enrolled in the study 
during the first year of the project. If necessary to complete enrollment the enrollment 
period will extend into the second school year. Data analysis will be performed 3 months 
after the last participant completes the project. 
 
 
6. SELECTION & RECRUITMENT OF PARTICIPANTS:  
A. Number of participants 
Patient Population: 30 middle-schoolers/adolescents that attend a participating CPS 
(Oyler, Roberts, Withrow, and School of Creative and Performing Arts schools) will be 
recruited for a 6 month pilot study of testing the feasibility of a novel, school-based 
care delivery system to improve asthma outcomes. Given the relationship of the 
CCHMC Asthma Center with CPS and the CHD in our ongoing quality improvement 
work, the study investigators have contacts with the school staff, school nurses, and 
primary care providers associated with the following CPS (Oyler, Roberts, Withrow, 
and School of Creative and Performing arts).  As part of this work, our team also helps 
the school nurses screen children with asthma to identify those with uncontrolled 
asthma and help the nurse’s contact families to encourage them to establish or 
connect with an existing medical home to schedule an asthma visit and to obtain 
asthma medication.  
 
B. Inclusion/Exclusion criteria 
Inclusion 
 
age 10-17 years; history of provider-diagnosed asthma;  
 
history of uncontrolled asthma in the past 12 months (two ACT scores <20;  
> 1 UC/ED visit or hospitalization for asthma, >2 prednisone bursts) with 
current persistent asthma as defined by NAEPP guidelines,  
 
and attendance at a participating school.   
 
Age 10 years is the minimum age to engage the children in an adherence 
intervention based on CCHMC Adherence Center experience (Hommel, CCHMC 
Adherence Center, personal communication).  
 
Exclusion 
 
active chronic disease apart from asthma or allergic disease  
 
plans to change schools during the school year 
 
C. Recruitment 
We have access to eligible middle-schoolers/adolescents from several sources: over 
1000 middle-schoolers/adolescents that attend the participating CPS or middle-
schoolers/adolescents cared for at the CCHMC ED or hospital units (~4000 per year) 
that attend a participating CPS.  We anticipate that participants will have similar 
demographic characteristics as our current CPS population (18% Caucasians, 73% 

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Black, 5% More Than One Race) is comprised of over 70% of participants from low-
income families.  
 
The middle-schoolers/adolescents will be recruited by one of the following methods: 
1) During the asthma screening process at the school as part of our QI work, 2) a 
school flyer, 3) CPS-CHD school nurse, 4) CCHMC provider, or 5) the child’s primary 
care provider. Once a child is identified, the study team and school nurse will contact 
the family and screen for eligibility using a phone script.   
 
We will utilize several successful strategies employed in our past research to retain 
families.  We will implement the following; (1) stress confidentiality, (2) gather detailed 
information regarding names, addresses, and phone numbers of people who might 
know where the family is living in case they lose contact with the study, (3) adequate 
incentives, (4) provide email, phone and/or text reminders of upcoming study visits, 
(5) frequent mailings of birthday cards, holiday cards, and quarterly newsletters, (8) 
address tracing software via Accurint®, a subsidiary of NexisLexis, to search for 
families whose phone numbers become obsolete, (6) home-visits to confirm that the 
family continues to reside at the available address for those who lack telephone 
service, and (7) searching publically available resources including social-media 
websites. The study consent form contains information that we plan to contact them 
by phone call, text, email or Facebook. 
 
Because this is a long‐term study, with extended periods of time between research‐
related interactions, maintaining the cohort will be a challenging element of completing 
the research. In order to facilitate the retention of the cohort, specific information will 
be obtained during the first research encounter (and updated at all subsequent 
encounters). Although critically important to the successful completion of the research, 
if a participant expresses concern and or refuses to provide this information they will 
not be excluded from the research. 
 
The information collected on data collection form, AFS contact form, will be used for 
this purpose. 
 
Once collected this contact information will be stored in a separate secure database 
separate from the participants research‐related information and will not be shared 
with additional participating sites, external research coordinating centers or as a part 
of the main study database. 
 
In the event that a research participant becomes lost to follow‐up and traditional re‐
contact methods (i.e. telephone, email, traditional mail, etc.) are unsuccessful, the use 
of a nationwide electronic search strategy will be employed. This will include general 
use of public web‐based search functionality, and as a last resort, the use of a 3rd 
party service (Accurint). The use of Accurint to identify current contact information for 
a lost to follow-up research participant will be administered through a centralized 
standard process managed by the CCHMC Center for Clinical and Translational 
Science and Training (CCTST). Only the demographic/contact information identified 
above will be utilized for the purpose of facilitating the Accurint search function. 
Specific individual request will be submitted to a designated member of the CCTST 
staff that will perform the search using the Accurint functionality. CCTST staff will 
provide a report back to the research team that includes the most current available 

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contact information for the requested research participant(s). Records of each search 
will be maintained and be available for IRB review if needed. 
 
The research team will attempt to re‐contact the lost to follow‐up participant. Once 
contact is re‐established, the participants will be reminded of the research study and 
that they voluntarily agreed to participate, interest in continued participation will be 
verbally confirmed and documented and the participant will return to active study 
participation as appropriate based on their status/time point in the research. 
 
Social Media Plan: This plan has been submitted for approval by the CCHMC Social 
Media Committee and is in compliance with the CCHMC Social Media Policy. 
Executing searches on online social networking sites to look for individual middle-
schoolers/adolescents and/or parent/guardians would aid our efforts in keeping in 
contact with these eligible and willing families. Searches on online social networking 
sites are only to recruit/retain individual middle-schoolers/adolescents, not to send out 
blanket recruitment messages on the web.  Nor are they performed to harass or trouble 
middle-schoolers/adolescents that are not interested in participating. When searching 
online for a participant, we will be using the study-specific Facebook (or other social 
networking profile) page. General news on the wall must be limited to Cincinnati 
Children's updates and research news. We will ask participants and parent/guardians 
to “like” our study page and “friend” our study profiles. We will use state of the art 
confidentiality and privacy settings when “friending” occurs by setting our profile 
preferences commensurate with keeping all names and identities of all other “friends” 
hidden. Those who have “liked” the study page will not be allowed to view the names 
or profiles of others in the study.  
 
For recruitment, the following is the type of message that will be sent to eligible 
participants identified by recruitment methods.  This language is also consistent with 
what is proposed for the recruitment flyer. 
 
Hi Anne, This is Jackie from Children’s Hospital and the Asthma Free School study.  
You could be eligible for a study where we are trying to see if providing asthma care 
at school could make your asthma easier to control. We have been trying to reach you 
and your caregiver about this project but have been unable to reach you via the phone 
or through the mail. Visit our Facebook page (www.Facebook.AsthmaFreeSchool) or 
call us at XXX-XXXX. If enrolled, you will get paid up to $550 for all of your time and 
effort (12 visits at school) and, you will receive a smart phone for your own use.  
 
For retention, there are two broad categories of communication that will be launched 
through our Facebook page.  First, we will send out study updates and general 
communication to participants who have “liked” the study page.  For example,  
 
Have you moved or gotten new phone numbers?  Please call AsthmaFreeSchool 
(XXX-XXX-XXXX or Toll free at XXX XXX-XXX) or message us your new information 
through our Facebook page. 
 
You are due for your asthma visit.  Please call or text us (XXX-XXX-XXXX or Toll free 
at XXX XXX-XXX). 
 

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We will also utilize Facebook to reach out to participants that are challenging to make 
phone contact with after a referral and an introductory letter has been sent. Using a 
study account, study staff will conduct a Facebook search for the participant using their 
first and last name. The participant’s identity will be verified by their date of birth and/or 
place of residence, if listed on Facebook. If the participant’s identity cannot be verified, 
no message will be sent. If the participant is located and verified on Facebook, a 
private message will be sent to them from the study account informing them that that 
they are eligible for a research study at Children’s Hospital and the study line phone 
number will be provided if they are interested in contacting the study staff or have 
questions. We will only utilize these methods to contact participants once an 
introductory letter has been sent to their current address.  
 
Since 
social 
networking 
is 
one 
of 
the 
most 
common 
ways 
middle-
schoolers/adolescents communicate we will use social networking to communicate 
directly with participants about scheduling their study visits.  These individual 
communications will be sent securely though individual private messaging through 
social networking sites and will not be visible to anyone outside the study team. Hence, 
these communications will NOT appear in “news feeds” and are akin to email 
communications like those that are routinely used in studies of this kind. 
 
It is possible that unintentionally these communications will appear in participants’ 
“news feeds”, but we will refrain from revealing any PHI in these communications and 
these updates will be benign in nature. These communications are designed to stay in 
contact with participants and remind them that they can contact us at any time. Our 
consent indicates that privacy cannot be guaranteed given that setting could be 
changed by Facebook without warning.  We will not allow comments on the main page 
and participants will not be able to see each other. 
 
In the consent/assent form, participants and parent/guardians will be told that, we will 
obtain information that will help us find them in case they move. This information 
includes several demographic details, various phone numbers, social networking 
screen names (if different than their name), and the names and addresses of close 
relatives or friends who will know of their whereabouts. Participants will be informed 
that we will use this information to locate them and that their information will be secured 
and will not be shared with anyone outside the study team. However, we will also 
inform them that social networking sites occasionally use personal information for 
targeted advertising and we do not have control over this. During the consent/assent, 
when participants are supplying the “demographic information” we will reiterate the 
fact that we will use this information to find them in case we lose track of their 
whereabouts. They will be reminded that we will not share this information with anyone 
outside the study team. Finally, participants will be informed that they may be eligible 
for follow-up assessments after the study has been completed and we will use this 
information to locate them in order to let them know of their eligibility for future 
research.  
 
D. Vulnerable Populations 
For participants under 18 years of age, additional efforts will be made to protect this 
vulnerable population. Assent will be obtained after age appropriate explanation of the 
study.  The participant is informed that participation in research is voluntary and that 
they may decline or withdraw at any time for any reason independent of their 

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parent/guardian.  Assent will be reaffirmed before study procedures are performed. 
They will be informed that participation in the research even though it may be on school 
property, will not affect their school grades, nor will it affect their clinical care in the 
school clinic and CCHMC. 
 
E. FERPA and PPRA 
In compliance with Statute:  20 U.S.C. § 1232h.  Regulations:  34 CFR Part 98 to make 
provisions for  
 The right of parents to inspect, upon request, a survey created by a third party 
before the survey is administered or distributed by a school to students and the 
procedure for granting a request by a parent for such access. 
 
The survey/questionnaire materials and handouts used in this study will be handed to 
the parent for review prior to the child receiving them or filling them out. This will occur 
at the initial visit (Visit 1) when parental informed consent will be obtained and where 
parental participation at the visit is required by the study protocol.  These documents 
are listed in the attached document AFS Study Visit Table. 
 
 
7. PROCESS OF OBTAINING CONSENT:  
If the parent and child/adolescent state they are interested in the study on the screening 
phone call, the team will schedule a visit in one of the following locations: the home, 
CCHMC, school nurse office or school-based health clinic, whichever location is more 
convenient for the family to consent the parent/legal guardian(s) and obtain assent from 
the child/adolescent.  The consent form includes a modified language from the CCHMC 
standard consent used to obtain participant consent for a CCHMC clinical telehealth visit.  
 
We are requesting a waiver of written consent for the screening phone call that will include 
review of medical history information and inclusion/exclusion criteria. An IRB approved 
phone script will be used. We are asking for a waiver of written HIPAA authorization to 
identify potential participants by review of school clinic health data records for 
inclusion/exclusion criteria and contact information/phone number. Signed HIPAA 
authorization will be obtained at the time of written informed consent. 
 
The subject or the subject and his or her parent will be given the consent for the study and 
it will be reviewed and time given for questions.  The subject will sign the assent or consent 
after all questions are answered and a signed copy of the consent form will be given to 
the subject to keep.  The subject will be informed that this research is voluntary and that 
they are able to withdraw at any time.  No study related procedures will be done prior to 
consent being signed. 
 
For participants under age 18, age of assent will be determined by the IRB and those 
assenting will sign after all questions are answered.   
 
For non-English speaking participants 
Because this is a small pilot and heavily dependent on English fluency for teleconference 
interviews and questionnaires, only participants who are fluent in English will be enrolled. 
If a parent is non-English speaking, the PI will determine if the subject can be enrolled 
based on subject’s fluency. If a non-English speaking parent will be giving Parental 

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Permission, the research team will use a short form consent process as per CCHMC SOP 
41-1.8. The approved long consent form will serve as the summary of the research.  
 
 
8. STUDY PROCEDURES:  
 
 
 
 
The study length is 6 months. 30 participants will be enrolled over 3 months during the 
2015-2016 school year.  Propeller, TreatSmart program and ACT screenshots are located 
in the Appendix. 
 
There will be Post-Visit Surveys for subjects, parents and nurses that will be done 
periodically throughout the study. Survey participants will receive e-mails from the study 
team through RedCap for the surveys to be completed online directly into RedCap. The 
purpose of the surveys is feedback for effectiveness/satisfaction with the telehealth and 
propeller device. All participants who complete their response to the Post-Visit Surveys 
(subject, parent, school nurses) will receive $10 added to their ClinCard. Nurses may be 
approached and asked follow-up questions regarding their perceptions of the study (see 
appendix X). 
 
Visit 1- Baseline Medical Visit: This visit will be conducted in one of the following 
locations: the home, CCHMC, school nurse office or school-based health clinic, whichever 
location is more convenient for the family.    
 
The coordinator will consent the parent/legal guardian(s) and obtain assent from the 
child/adolescent. Baseline questionnaires will be completed by a parent/guardian and 
participant and the study visits and procedures will be explained. A smart phone prepared 
by the CCHMC IT team with a data plan will be provided to the participant.  
 

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Basic asthma education will be provided.  The study coordinator will conduct this visit.  
The participant will complete an Asthma Control Test (ACT) and the study coordinator will 
assist the participant to complete the TreatSmart program on a CCHMC secured laptop. 
The TreatSmart software web-based program, developed at CCHMC and hosted on a 
CCHMC secure server, will be used to determine the participant’s symptom burden, health 
care utilization, systemic corticosteroid use, and current medication use to determine the 
level of asthma severity/control the participant has.  The program also makes an initial 
treatment recommendation based on the National Asthma Education and Prevention 
Program (NAEPP asthma guidelines) if the participant’s asthma meets the definition of 
persistent asthma and if their treatment dose should remain the same or be changed 
based on their level of control. This program will also produce a visit summary and asthma 
action plan. The TreatSmart program takes approximately 10 minutes to complete. 
 
After the TreatSmart program is completed, the study coordinator would connect with a 
CCHMC Asthma Center asthma pulmonary or allergy specialist investigator (Guilbert, 
Kercsmar, McDowell, Durrani) to conduct a telehealth visit using CCHMC-provider Jabber 
software on the laptop (similar to Skype but HIPAA compliant) to perform a physical exam, 
review the TreatSmart program visit summary and treatment recommendations and make 
a final decision of the level of asthma control and asthma medication needed.  The laptop-
based Jabber software has been implemented successfully in other clinical visits through 
the CCHMC Telehealth Program. The visit summary, asthma medication recommendation 
and asthma action plan from the medical visit will be documented in the CCHMC medical 
record as a telehealth visit and physically given, mailed or faxed to the participant, family, 
school nurse and primary care provider by the study team. Through our QI work, the 
school nurses and community primary care providers have read-only access of EPIC and 
can access these medical records after this visit.  
 
If no change in current asthma medication required: The study coordinator will place 
the Propeller Health monitoring caps on the participant’s current inhalers, register the 
Propeller Health inhaler monitoring caps with Propeller Health, and review how to take the 
medication with the participant.  Prescriptions for asthma medications and inhaler spacers 
will be written by the study physician and sent to a delivery pharmacy as required.  
 
If new asthma medication required: Prescriptions for asthma medications and inhaler 
spacers will be written by the study physician and sent to a delivery pharmacy if required.  
The medications will be delivered to a central location; either the school nurse office, 
school-based clinic or CCHMC depending on the school and family’s preference.  The 
study coordinator will place the Propeller Health monitoring caps on the inhalers and 
arrange a time for the participant to pick up their medications at school or deliver them to 
their house, sync the inhaler caps with their smartphone app, and review how to take the 
medication with the participant. Prescriptions for asthma medications and inhaler spacers 
will be written by the study physician and sent to a delivery pharmacy as required.    
 
Visit 2 - Visit 7: These visits will be conducted in one of the following locations: school 
nurse office, school conference room or school-based health clinic.  These visits will occur 
at school or CCHMC over the lunch hour, during a study hall or non-core class, or 
afterschool. The study visits may be combined with school clinic visits with routine clinic 
care including vital signs and asthma assessments delivered by the school nurse or their 
assigned nursing students. Parent/guardian participation is not required for these visits.  
At visit 2, the coordinator will sync the Propeller app on the participant’s cell phone and 

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the Propeller Health web platform with the inhaler caps so they and their family can see 
their inhaler use data for the rest of the study. 
 
Each visit, the participants will be encouraged to use only the inhalers with the caps on 
them and given instructions to call the study team for replacements if they lose their 
medications. 
 
After the baseline visit, 6 monthly medical Study Visits will be scheduled to assess the 
participant’s level of asthma control and adjust the asthma medications as needed by the 
TreatSmart program using the same procedures as outlined above in the baseline medical 
visit.  
 
Procedures done at these visits include: 
 
Questionnaires, ACT, TreatSmart 
 
Review of adherence from Propeller cap data 
 
Telehealth visit and medical evaluation 
 
Review of prescriptions and adjustment as needed 
 
Post-visit REDCap survey link will be emailed to the parent after medical visits 1 
and 6 to solicit feedback on the telehealth visit to elicit feedback on participating in 
the study and use of the Propeller and telehealth technology. 
 
Post-visit REDCap survey link will be emailed to the child after the V2 and V6 
medical visits and the first adherence visit to solicit feedback on the telehealth visit 
to elicit feedback on participating in the study and use of the Propeller and 
telehealth technology. The content of the survey is similar to the parent survey, 
The parent will be informed at the time they take the survey that a similar survey 
will be sent to their child and to contact the study team if they have questions or 
concerns about the survey content. 
 
Post-visit REDCap survey link will be emailed to participating school nurses, nurse 
practitioners, and primary care physicians after medical visit 6 to elicit feedback on 
participating in the study and use of the Propeller and telehealth technology. 
School nurses or nurse practitioners may be approached and asked follow-up 
questions regarding their perceptions of the study (see appendix X). 
 
Adherence/Self-Management Visits.  These visits will occur at school or CCHMC over 
the lunch hour, during a study hall or non-core class, or afterschool in a private conference 
room, school nurse office or school-based health clinic as available. To minimize lost 
classroom time, these visits will be scheduled separately from the medical Study Visits. 
An adherence visit summary will be documented in the CCHMC medical record as a 
telehealth visit. Through our QI work, the school nurses and community primary care 
providers have read-only access of EPIC and can access these medical records after this 
visit. Parent/guardian participation is not required for these visits. 
 
Starting at 6 weeks into the study, every 2 weeks the participant will receive self-
management visits (total of 5) with the goal to improve inhaler adherence. The participant 
will meet with the CCHMC Adherence Health Psychology team investigators. Adherence 
data from the Propeller Health monitoring system will also be reviewed with the participant 
by the adherence specialist during adherence visits and the study coordinator during 

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medical visits. The study coordinator will help the participant connect to the Adherence 
team using the secure Telehealth Jabber software on the CCHMC laptop. The adherence 
specialist will also provide customized supportive text messages originating from the 
CCHMC email system to the participant’s study phone. Text messages will not include 
personal health information, but instead will provide support and reminders related to 
adherence (e.g., Hello, remember to use your inhaler today!, Don’t forget to put a reminder 
in your locker, Have you been using your monitoring log?).   
 
A meal or snack will be provided to the participant.    
 
Other: 
PCP communication:  
Based on the community primary care provider (PCP) focus group feedback, the primary 
care providers will have 2 business days to communicate back to the study team with any 
concerns about the proposed medication plan and the study physicians will reach out and 
come to a consensus regarding the asthma medication and new prescriptions will be 
provided based on the consensus plan.   
 
If the participant does not have a primary care provider, we will follow the current standard 
of practice at school where the school nurse provides the family a list of practices close to 
the school.  If contact is made with a primary care physician, we will include them in the 
study as outlined above.  
 
Propeller Health Inhaler monitoring and Web-based Platform During the Study Visit 1:   
Propeller Health, a web-based inhaler cap monitoring sensor and mobile software 
management platform will be used to monitor how frequently the participant uses their 
inhaled asthma medication (Appendix A).  The monitoring cap will be placed on both the 
controller and rescue inhalers by the study team and they will be registered with Propeller 
Health.  The inhaler use will be recorded on the web platform. Starting at Study Visit 2, a 
mobile-based app program will be available for both android and IOS platforms and will 
allows the participant and family to interact directly with the platform. This is a FDA 
approved, HIPAA compliant device that has been demonstrated to improve asthma 
outcomes and adherence measures. This equipment has been approved by the CCHMC 
Equipment committee pending approval by the IRB.  A contract and data use agreement 
is currently being reviewed by the CCHMC legal and business offices. 
 
During the first month of the study, we will establish the participant’s baseline adherence 
to daily asthma controller medication and need for rescue short-acting beta-agonist.  Thus, 
the study team, school nurse, participant and family will be blinded to this baseline data 
collection.   
 
Propeller Health Inhaler monitoring and Web-based Platform during Study Visits 2-6:  
At the second study visit, the Propeller Health platform will be turned on and data on the 
participant’s baseline adherence to daily asthma controller medication and need for rescue 
short-acting beta-agonist shared with the study team, participant, family, school nurse, 
and primary care physician. Starting at the second medical visit, the participant and 
parent/guardian will receive access to the Propeller Health online interface either through 
their smartphones displaying maps and charts of the participant’s inhaler usage (Appendix 
A). The participant and family will receive a weekly summary of the time and location for 
each controller and rescue inhaler use and summarized use for the preceding week 
(Appendix B).  They will also receive cell phone alerts from the Propeller Health app when 

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the use rescue medication prompting them to select their symptoms and triggers based 
on a pre-populated list.   
 
Based on stakeholder feedback, the school nurse and community primary care physician 
stakeholders will also receive monthly summary e-mail or faxed reports with the time and 
location for each controller and rescue inhaler use and summarized use for the preceding 
month. The study team will be able to see each patient’s adherence data through the 
Propeller Health web portal and receive alerts when a patient changes asthma control 
status or uses more albuterol than baseline. Access to the Propeller Health portal for a 
specific participant cared for by the school nurse or primary care physician will also be 
offered. This data will also be summarized in the participant’s CCHMC EPIC medical 
record. 
 
Asthma Exacerbations:  
The current standard of care for middle-schoolers/adolescents who have an acute 
exacerbation of asthma symptoms is for them to go to the school nurse or health-aide for 
evaluation and management.  The child’s asthma action plan also contains advice for 
handling increased or severe asthma exacerbations.  A recommendation is made to the 
family to take the child for evaluation to their PCP or urgent care. This visit will be 
documented in the CHD medical record and will be collected at the monthly study visits. 
The school nurse will also be encouraged to contact the study team if additional advice on 
asthma treatment of a study participant is desired.   
 
In addition, the CCHMC study team will receive a Propeller Health daily report of 
participants that have not taken their daily controller medication in the last 7 days, have 
changed their asthma symptoms control level, or have experienced a 200% increase in 
their rescue medication use in the past 24 hrs. The study team will communicate with both 
the school nurse and the participant to gather more information on the severity of their 
asthma symptoms using the Phone Call Exacerbation Form.  If the participant is 
experiencing severe symptoms, they will be encouraged to be urgently evaluated by the 
school nurse, school-based health clinic, community primary care provider, or a local 
urgent care or emergency department.  
 
Study Termination.  During each medical visit, the number of severe asthma 
exacerbations [treated with > 4 days of systemic steroids; > 2 hospitalizations for asthma; 
>1 PICU admission, intubation or hypoxic seizure due to asthma] since the start of the 
study will be determined.  If the participant has > 4 severe asthma exacerbations, study 
participation will be ended. The procedures for the end of study will also be followed with 
the recommendation of referral to the CCHMC Difficult-to-Treat Asthma Clinic. 
 
End of study. At the end of the study, the participant and their parents/legal guardians will 
be given a letter which summarizes which medication the participant was prescribed at 
the last month of the study.  The study team will make sure that the participant has 2 
additional refills at the end of the study. The letter will encourage them to make an 
appointment and visit their primary care physician within 2 months of the study end. 
Information on how to make an appointment at CCHMC Asthma Center will also be 
provided. 
 
 
 
 

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9. DATA ANALYSIS/METHODS:  
Study Outcomes: 
The adolescent’s asthma outcomes and adherence will be measured at baseline and 
during the monthly medical visits for a total of 6 months. Outcomes will be measured 
during the monthly medical visits using a computerized TreatSmart program based on the 
NAEPP asthma guidelines which was adapted by the CCHMC Asthma Center database 
team from the Inner City Asthma Coalition (Appendix B), ACT scores (Appendix C), and 
Propeller Health web-based inhaler cap monitoring sensor and mobile software 
management platform (Appendix A). 
 
Primary Outcome: 
Two-week histories of asthma symptoms measured per month (daytime symptoms, 
nighttime symptoms, or activity limitations) during the intervention period (from completion 
of the first month to study exit).  The symptoms will be measured by a two-week recall of 
adolescent captured by the TreatSmart program. 
 
Secondary Outcomes: 
ACT score over past 4 weeks; rescue medication use (Propeller Health monitoring), oral-
steroid requiring exacerbations questionnaires (2-week recall TreatSmart program); 
school absences (parent and subject report), adherence of controller medication 
(Propeller Health monitoring).  
 
The asthma symptom burden, ACT score, exacerbation, healthcare utilization outcomes 
are commonly reported in both the adult and pediatric asthma literature, are endorsed by 
national asthma guidelines and the National Institutes of Health (NIH) asthma-outcome 
conference, and will also be measured.  
 
Data Analysis 
We will use descriptive statistics to characterize the sample demographics. A descriptive 
analysis with calculation of means, medians, and standard deviations will be performed 
for each continuous measure; categorical measures will be examined with percentages. 
We used paired t-tests to evaluate the null hypothesis that there was no change in the 
primary outcomes (two-week histories of daytime symptoms, nighttime symptoms, or 
activity limitations) while participants are blinded to data collected by the Propeller 
medication sensor in the first month of participation. Nonparametric methods will be used 
if the assumptions for paired t-tests are violated. The primary analyses will test whether 
the school-based interventional program improves two-week histories of asthma 
symptoms measured per month (daytime symptoms, nighttime symptoms, or activity 
limitations) during the intervention period (from completion of the first month to study exit). 
Linear mixed effects models with a random effect for subject assessed changes in primary 
asthma endpoints across the five subsequent months of enrollment (at the completion of 
the first month, the second month, the third month, the fourth month and the fifth month 
upon exit) when participants will be able to access their usage data online. Participants 
with one or more observations will be included in the analysis. All statistical analyses will 
be implemented in SAS 9.3 (SAS Institute, Cary, NC) and use a significance level of 0.05. 
Potential confounders identified from the literature, such as age, gender, season of 
enrollment, severity of asthma at baseline, smoke exposure, history of allergic disease, 
will be adjusted in the analyses. The REML model used for these analyses requires that 
any missing data are “missing at random” (MAR) to yield valid estimates. In order to 
account for the presence of possible non-ignorable missing data, pattern-mixture modeling 
will be applied for these analyses.  

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The secondary analyses will look at the health system utilization, rescue medication use, 
adherence and lost school days. Linear mixed-effect models will be used to compare the 
continuous outcomes such as lost school days. Generalized linear mixed effect models 
will be used to compare the discrete outcomes such as health system utilization, both 
accounting for repeated measurement over time while adjusting for confounders.  
 
Future use 
The de-identified data may be used for future research, analysis or recruitment. All 
reidentification codes will be destroyed. 
 
 
10. FACILITIES and PERFORMANCE SITES:  
External sites will be at Cincinnati Public Schools or home of the participant or the 
Cincinnati Children’s Hospital and Medical Center CCHMC Pulmonary Division and 
CTRC. 
 
 
11. POTENTIAL BENEFITS:  
Participants will have direct benefit of being closely monitoring for their asthma and clinical 
care. The future benefit is to strive to develop “asthma-free schools” in neighborhoods 
where the incidence of asthma is especially high. 
 
 
12. POTENTIAL RISKS, DISCOMFORTS, INCONVENIENCES AND PRECAUTIONS:  
The risks to participants are minimal and include: 
 
Missed school classroom time to participate in the school study visits:  Efforts will 
be made to minimize testing during class time such as conducting them over the 
lunch hour, during study halls or non-core classes, or afterschool. 
 
Asthma Questionnaires: There is a slight inconvenience to the family in the time 
required to answer questionnaires.  
 
Confidentiality: There is a slight risk of unintentional release of PHI.  
 
Concerns about Access Adult Websites and Apps on Cell Phones: 
Participants will be provided with a cellular phone for use over a 6 month period.  During 
the consenting and assenting process, participants will be asked to use the cellphone “as 
they normally would use any smartphone that has internet access”. We have gone to great 
lengths to make the cell phones provided easy to use and compelling in terms of incentives 
and features so that participant will use the cell phone provided as opposed to other cell 
phones they likely have.  However, for this endeavor to be successful, participants must 
feel confident that their phone activity--how they normally use the phone--will not be met 
with repercussion or reprimand.  
 
We considered only installing the Propeller Health software apps and severely restricting 
the internet website allowed to be accessed on the study cell phones.  However, this would 
create an “unnatural” cell phone use environment for those participants that had not 
previously been exposed to filtering and would cause them to not use the study cell phone 
as their main device they carry with them.  Therefore, we have consulted closely with 
CCHMC’s IT and Office of Research Compliance to adequately design the following 

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procedures for informing parent/guardians of their options, and adhering to 
parent/guardians’ wishes, while not compromising the integrity of the study. Hence, the 
smart phones will be loaded with a security software program Air Watch and include a 
basic package of social media apps that middle-schoolers and adolescents frequently use. 
We will list out for the parent/guardians that apps are installed on the phone and brief 
descriptions of the risks and benefits and they will be told this is similar to their teen’s 
current cell phone. After being informed, parent/guardians and participants will then be 
given an instruction sheet (See Appendix B) on how to use the cell phone.  Within this 
instruction sheet there will be instructions on how to add apps by using the family’s apple 
ID account or removing apps from the cell phone if the participants or parent/guardian 
desire. However, CCHMC IT will be alerted if the Propeller Health app is removed from 
the phone. The Air Watch security software enforces specific security measures, such as 
passcode and encryption. The study team working with the CCHMC IT department will be 
able to erase all content in the event of a lost/stolen device. The Air Watch security 
software does not monitor the participants’ usage or personal information.  Internet access 
on the smartphone is being restricted with Apple’s built in Adult Content Filter for the Safari 
web browser. This content filter does its best to block websites with inappropriate content. 
The Internet content filter can identify, with a high degree of accuracy, whether a Web 
page is safe or not by examining various properties of the website including text and 
structure. The content filter is being managed by the Air Watch security software and 
cannot be removed. 
 
 
13. RISK/BENEFIT ANALYSIS:  
This study is minimal risk with direct benefit to the participants.  It builds on the CCHMC-
CPS-CHD existing asthma QI program to improve asthma care and it provides more 
comprehensive asthma management and monitoring than many of these participants 
currently receive.   
 
 
14. DATA SAFETY & MONITORING:  
DSMP: 
The Data Safety and Monitoring Plan (DSMP) will consist of a Steering Committee made 
up of Dr. Guilbert and key study personnel.  The committee will meet a annually to review 
adverse events and to provide oversight and coordination of project management, 
research administration, publications and data sharing, and integration of all resources 
needed for the project.  
 
Adverse Events: 
Events that are unexpected and related to the conduct of medical or adherence visits or 
asthma symptoms will be reported promptly to the IRB according to IRB policy. Serious, 
life threatening events that are related to study related procedures will be reported to the 
IRB within 48 business hours. All other adverse events that happen in the course of study 
procedures as well as minor deviations from protocol will be reported in table form at the 
next continuing review.  
 
Any untoward or unfavorable medical occurrence associated with the subject’s 
participation in the research, whether or not considered related to the subject’s 
participation in the research (modified from the definition of adverse events in the 1996 
International Conference on Harmonization E-6 Guidelines for Good Clinical Practice) 
(from OHRP "Guidance on Reviewing and Reporting Unanticipated Problems Involving 

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Risks 
to 
Subjects 
or 
Others 
and 
Adverse 
Events 
(1/15/07)" 
http://www.hhs.gov/ohrp/policy/advevntguid.html#Q2 ).  
 
For this study, the occurrence of wheezing episodes and the development of allergic 
rhinitis are anticipated events and will be recorded as expected AEs. This information will 
also be collected on other study forms.  Fluctuations in the status of pre-existing atopic 
dermatitis, a process that is expected to wax and wane in severity, will not be recorded as 
an AE unless, in the opinion of the site investigator, the degree of deterioration is 
unexpected for the participant.  
  
An adverse event or suspected adverse reaction is considered “unexpected” if it is not 
listed is not consistent with the risk information described in the general investigational 
plan.  
 
An adverse event or suspected adverse reaction is considered “serious” if, in the view of 
either the investigator, it results in any of the following outcomes (21 CFR 312.32(a)): 
1. 
Death. 
2. 
A life-threatening event: An AE or SAR is considered “life-threatening” if, in the 
view of either the investigator its occurrence places the subject at immediate risk of death. 
It does not include an AE or SAR that, had it occurred in a more severe form, might have 
caused death.  
3. 
Inpatient hospitalization or prolongation of existing hospitalization. 
4. 
Persistent or significant incapacity or substantial disruption of the ability to conduct 
normal life functions. 
5. 
Congenital anomaly or birth defect.  
6. 
Important medical events that may not result in death, be life threatening, or require 
hospitalization may be considered serious when, based upon appropriate medical 
judgment, they may jeopardize the subject and may require medical or surgical 
intervention to prevent one of the outcomes listed above. 
 
Wheezing episodes and exacerbations of asthma are anticipated events in the population 
under study even when receiving standard of care therapy.  A hospitalization for wheezing 
or asthma will not be recorded as an SAE unless it is considered a serious and unexpected 
suspected adverse reaction SUSAR (9.3.2).  All other hospitalizations will be recorded in 
the case reporting forms.   
 
Review with family of possible adverse events will be done at medical visits and follow-up 
phone calls by the research coordinator if adverse events occur, will be documented. 
Adverse events will be recorded on an Adverse Event Reporting Form and will be reviewed 
at the meeting of the Steering committee.  
 
If a parent/guardian response or complaint is not an expected adverse event (see section 
4) or if the adverse event presents with greater than expected severity, the adverse event 
will be brought to the Investigator’s attention in a timely manner for evaluation. The 
reviewing investigator will determine if the event is a Reportable Event as defined below. 
 
Definition of Reportable Events 
Reportable events must fall into one of the categories below: 
1. Adverse event that is BOTH unexpected AND related or possibly related to 
participation in the research. This is regardless of whether internal or 
external site or seriousness. 

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2. An event that requires a change to the protocol or informed consent. 
3. Information that indicates a change to the risks or potential benefits of the 
research. 
4. Breach of confidentiality. 
5. Change in labeling or withdrawal from marketing for safety reasons of a 
device used in research protocol. 
6. Change to protocol made without prior IRB review to eliminate an apparent 
immediate hazard to a research participant. 
7. Protocol violation that harmed a participant or others or indicates that 
participants or others are at increased risk of harm. 
8. Incarceration of a participant in a protocol not approved to enroll prisoners. 
9. Complaint of a participant that indicates unexpected risks or cannot be 
resolved by the research team. 
10. Other unanticipated problem posing potential risk to participants or others 
comparable 
to 
the 
events 
listed 
above 
that 
are 
BOTH 
unexpected/unanticipated AND have a reasonable possibility of 
relatedness to the research. 
11. INVESTIGATIONAL DEVICES: Unanticipated adverse device effect, 
deviation from the protocol to protect the life of a subject in an emergency, 
or any use of the without obtaining informed consent. 
 
 
15. PRIVACY and CONFIDENTIALITY:  
Confidentiality of Participant Data: 
Precautions to protect the privacy of participant data include: 
 
Participants will be given a study ID that does not include any personal 
identifiers for study records and questionnaire data stored outside of CCHMC 
EPIC.  
 
A study ID not related to any PHI will be used in the study database. 
 
All electronic research data will be reviewed by the statisticians without PHI. 
 
The ID code and the research records will be maintained in a secured location 
and/or in password protected databases. 
 
Summary of the school-based medical and adherence visits will be 
documented in the CCHMC EPIC medical record which can be accessed by 
school nurses and community primary care physicians who have been granted 
read-only access by CCHMC. 
 
Propeller Health data is stored on a HIPPA compliant server and has been 
approved by CCHMC IT and equipment committee. 
 
TreatSmart program and data are located on a CCHMC secure server. 
 
To minimize risk, the source document will be kept in the research record and stored in a 
secure location. Data will be entered into password protected databases with participants 
identified with a study number that contains no PHI.  To minimize the inconvenience, we 
are limiting administration of the baseline questionnaires to the baseline visit.  The 
adherence questionnaire will be given at the first and last medical visit.  The TreatSmart 
program will take 10 minutes to complete. 
 
 
16. COST OF PARTICIPATION:  

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There is no cost to participants for the phone, data plan, Propeller caps or for medical care 
received as part of the study visits. 
 
The cost of prescriptions and sick visits will be the responsibility of the subject and their 
insurance. 
 
 
17. PAYMENT FOR PARTICIPATION: *  
This compensation is for reimbursement of time for the parent/guardians and participants 
for time spent in visit and as an honorarium for their ongoing participation. 
 
All compensation given to participants will be in the form of ClinCard. A ClinCard is a 
reloadable debit card. Incentives will be loaded onto the card after each visit according to 
the payment schedule. Participants will receive a handout to explain the use of the card.  
Participants will receive a graduated amount to facilitate retention.  
 
Parent/guardians will receive $20 for completing questionnaires at the baseline visit.   
 
We will provide the participants with payment as they progress through the study visits.  
 
 
For the Study Visit 2-7: We will also provide the participant with a meal or snack valued 
at approximately $10 from a local restaurant such as Subway, Chipotle or Chick-Fil-A.  An 
additional $10 or an item valued at approximately $10 will be given if Propeller caps are 
returned each month to place on new inhalers. 
 
For the Adherence Only visits: We will also provide the participant with a meal or snack 
valued at approximately $10 from a local restaurant such as Subway, Chipotle or Chick-
Fil-A. 
 
For Study Visit 7: The participant will be given the cell phone used in the study to keep 
but the data plan will be stopped and reset to factory settings.  
 
For Post-Visit Surveys:  
All participants who complete their response to the Post-Visit Surveys (subject, parent, 
school nurses) will receive $10 added to their ClinCard. Nurses may be approached and 
asked follow-up questions regarding their perceptions of the study (see appendix X). 
 
 
 

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Appendix A. Propeller Health System. 
 
 
 
 
 

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Appendix B. TreatSmart Program screen shots. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Appendix C. Asthma Control Tests. (ACT will only be used for ages 12 and up)