Asthma Link: A Real World Application of School Supervised Asthma Therapy
Phase: NA
Conditions: Childhood Asthma
Sponsor: University of Massachusetts, Worcester

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Sponsor name: 
NHLBI 
NCT number: 
NCT04942379 
Sponsor trial ID: 
K23HL150341 
Official Title of 
Study: 
Asthma Link: School Supervised Therapy to 
Improve Medication Adherence in Children 
with Poorly Controlled Asthma  
Document date: 
10.27.21 

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1. TITLE 
 
Examination of the Effectiveness and Implementation of Asthma Link™: A Real World 
Application of Supervised Asthma Therapy  
 
2. EXTERNAL IRB REVIEW HISTORY* 
N/A 
 
3. PRIOR APPROVALS: 
N/A 
 
4. OBJECTIVES* 
The objective of this pilot study is to evaluate the feasibility of an implementation study of 
Asthma Link as an effective method of evidenced-based practice of school-supervised asthma 
therapy in a real-world setting. If Asthma Link is found to be an acceptable practice with 
appropriate adoption and sustainability, it can serve as a scalable public health model for 
improving asthma medication adherence and combating the significant morbidity associated with 
pediatric asthma in the real world, rather than just research settings. 
 
Aim 1: We will analyze process outcomes (acceptability, adoption, costs, sustainability) of 
Asthma Link™ in two pediatric practices. 
 
Aim 2: Evaluate feasibility of a cluster RCT of Asthma Link™. The primary trial outcomes will 
be participant recruitment, retention, and intervention fidelity. The secondary trial outcomes will 
be differences in the frequency of asthma symptoms, emergency department visits, hospital 
admissions, courses of oral corticosteroids, spirometry values and school absences between 
Asthma LinkTM and Enhanced Usual Care sites. 
 
As each stage of Asthma Link™ evaluation builds upon the previous stage, we will submit 
separate IRB amendments and proposals for each stage of this project. The data collected from 
the proposed study will inform a large-scale cluster RCT to test the effectiveness and 
implementation of Asthma Link™. 
 
5. BACKGROUND* 
Countless pediatric asthma interventions have been successful in improving asthma outcomes in 
research settings, yet few are adopted into clinical practice to produce noticeable public health 
impact. Despite aggressive efforts to address remediable causes, childhood asthma still affects 
12-15% of children in the urban United States, causes over 14 million missed school days 
annually and costs billions of dollars in healthcare expenditures.1-3 Most of childhood asthma 
morbidity is attributable to non-adherence to a daily preventive medication, an inhaled 
corticosteroid (ICS).4-7 The highest asthma morbidity and the lowest ICS medication adherence 
rates occur in low income and minority children.8-10 These populations fall through the cracks as 
a result of failure to supervise and support adherence to preventive ICS medication. Recognizing 
this, the National Asthma Education and Prevention Program and the American Academy of 
Asthma, Allergy, and Immunology have urged that providers and researchers develop more 
effective adherence programs.11,12  
 

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School-supervised administration of asthma therapy has helped improve medication adherence 
and improves asthma symptoms among children enrolled in research studies. There have been 
multiple studies that have shown that school-supervised asthma therapy not only improves 
medication adherence in children with asthma but also that this practice is safe, with no adverse 
effects seen.13-15 School-supervised asthma therapy has been established as safe and efficacious, 
and therefore asthma experts (including the American Academy of Pediatrics, American 
Academy of Allergy Asthma and Immunology, and the National Association of School Nurses) 
endorse school-supervised asthma therapy as the evidenced-based standard of care.16 
 
However, despite the compelling evidence from studies and endorsement from experts, these 
tested school-supervised asthma interventions have not been widely adopted in practice. This is 
likely due to reliance on research staff for implementation and operations that are costly and 
highly resource intense, making them infeasible to adopt and sustain in the real world after 
research funding ends.  
 
In response to this critical public health issue, we propose to study Asthma Link, which is a low-
cost, low-intensity community-clinical based model of supervised asthma therapy in schools. 
Asthma Link is an established, ongoing clinical program that promotes the adoption of the 
evidenced-based practice of school-supervised asthma therapy in real world settings.  
 
Asthma Link connects the three groups that play vital roles in the health of school-aged children 
with asthma: pediatric practices, school nurses, and families. Pediatricians identify and enroll 
children with poorly controlled asthma and medication non-adherence as part of their routine 
practice. They send the school nurse an order for daily, supervised inhaled steroid administration 
at school. Families bring the prescribed inhaler to school. The school nurse supervises the child’s 
inhaler administration and provides adherence education, as part of her daily routine, to ensure 
adherence and proper inhaler/spacer technique. Ongoing communication occurs between the 
pediatric practice, the school nurse and families throughout the school year. Asthma Link is 
based on prior research studies that demonstrate the safety and efficacy of school-supervised 
asthma therapy. The goal of Asthma Link is for school-supervised asthma therapy to operate in a 
real-world setting, delivered by pediatricians, school nurses and families within their current 
routines and relying on minimal resources and no research staff.  
 
The goal of the proposed study is to examine the effectiveness and implementation of Asthma 
LinkTM in sustainable real-world practice.  
 
Preliminary Data: 
The current proposed study builds from our prior research, which has informed the proposed 
study. To initially test Asthma LinkTM, we performed a small pre/post study (SEE IRB DOCKET 
# H00010546_2) of 84 children enrolled in Asthma LinkTM (mean age 10 years, 95% Medicaid 
insurance, 67% Latino, 19% Black). We observed that children enrolled in Asthma LinkTM 
experienced a 54% decline in emergency room visits, a 95% decline in hospital admissions and a 
46% decline in rescue medication use over a one-year follow-up period (p<0.001),17 
demonstrating that Asthma LinkTM merits further rigorous evaluation. Additionally, in order to 
examine the barriers and facilitators to Asthma LinkTM real-world implementation, (SEE IRB 
DOCKET # H00012920_1), we are interviewing program stakeholders which include school 

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nurses, parent-child dyads, and medical providers who were participating in the program in 
addition to public health and insurance officials. Specifically, in our interviews with 12 school 
nurses, we found that they perceive Asthma LinkTM to be an acceptable program given the brief 
(<5min) time required and ease of incorporation into their existing routine.  
 
Despite our promising results, Asthma LinkTM needs to be tested against a comparison group, 
using a cluster randomized controlled trial (RCT). The first step is to perform a pilot cluster RCT 
to assess feasibility outcomes and health outcomes (Aim 2). Additionally, it is imperative to 
assess process outcomes (acceptability, adoption, costs, sustainability) of Asthma LinkTM in new 
pediatric practices to ensure that school-supervised asthma therapy can be successfully scaled up 
and utilized in real world practice (Aim 1). We propose to test Asthma LinkTM using a pilot 
cluster RCT of 4 pediatric primary care sites in Massachusetts. 
 
6. INCLUSION AND EXCLUSION CRITERIA* 
Child eligibility criteria for enrollment in Asthma LinkTM (established clinical program): 
(1) children aged 6-17 years (enrolled in grade 1-12)  
(2) prescribed daily inhaled corticosteroid (ICS) for asthma;  
(3) 1 or more courses of oral steroids in the past 2 years OR 1 or more hospitalizations or ED 
visits for asthma in the past 2 years OR Asthma Control Test (ACT) score <19 OR 1 or more 
sick or urgent care visits for asthma (including telehealth) in the last year 
(4) parent/child report of poor ICS adherence on adherence checklist- i.e. child or parent says 
“Yes” when provider asks if they have difficulty remembering to take their medication or if they 
regularly take medication holidays or breaks;  
(5) able and willing to assent;  
(6) parental permission  
(7) English or Spanish speaking. 
 
STUDY INCLUSION/EXCLUSION Criteria: 
Child Inclusion criteria:  
1) Meet the eligibility criteria for Asthma Link (as described above) with exception to (7) 
2) Enrolled in Asthma LinkTM (if randomized to the Asthma LinkTM Condition) 
3) Able and willing to provide informed assent 
4) Must be English or Spanish speaking 
 
Child Exclusion criteria:  
(1) Unable or unwilling to provide informed assent 
(2) Diagnosis of a serious co-morbid illness during the past 5 years 
(3) Developmental delay that would prevent study participation. 
(4) Planning on moving from primary residence or moving outside of the school district in the 
next 1 year 
 (5) A sibling to a child participating in this study 
 
Parent Inclusion criteria are:  
1) Parent/guardian to patient 
2) 18 years or older 
3) Able to understand and communicate in English or Spanish 

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4) Able and willing to provide informed consent. 
5) May or may not be or become pregnant 
 
Medical Provider Inclusion criteria are: 
1) Able and willing to provide informed consent 
 
Medical Provider Exclusion criteria are: 
1) Unable or unwilling to provide informed consent 
 
School Nurse Inclusion criteria are: 
1) Able and willing to provide informed consent 
 
School Nurse Exclusion criteria are: 
1) Unable or unwilling to provide informed consent 
 
Asthma Champion Inclusion criteria are: 
1) Able and willing to provide informed consent 
 
Asthma Champion Exclusion criteria are: 
1) Unable or unwilling to provide informed consent 
 
Adults lacking capacity and prisoners are also excluded 
 
7. STUDY-WIDE NUMBER OF SUBJECTS* 
N/A 
 
8. STUDY-WIDE RECRUITMENT METHODS* 
N/A 
 
9. STUDY TIMELINES* 
Describe: 
• The duration of an individual subject’s participation in the study: 6 months  
• The duration anticipated to enroll all study subjects: 1.5 years  
• The estimated date for the investigators to complete this study (complete primary 
analyses): 3 years  
 
10. STUDY ENDPOINTS* 
Please see below table describing the primary and secondary outcome measures 
SN=School Nurse 
MP=Medical Provider 
AC=Asthma Champion 
 
Study Assessments, Measures and Data Collection Timing 
Variable  
Measure/Instrument 
Designed for and Delivered to pediatric practice staff, school staff, and parent-child dyads 
Administered by Research coordinator 
AIM 1: Primary Feasibility Outcomes for Asthma LinkTM research protocol (cluster RCT) 

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Participation/Recruitment 
# of screened and eligible participants; # refusing to participate; reason(s) for 
refusal  
Retention  
# of dropouts; subjects lost to follow-up; reason(s) for dropping out 
Program usage/Intervention Fidelity 
(degree to which using program) 
• Checklist for pediatric practice staff to assess % of eligible children enrolled 
(see Pedi Practice checklist) 
• School nurse report of % enrolled students receiving supervised therapy (see 
SN checklist) 
• School nurse checklist of each enrolled child attending daily school nurse 
sessions and his/her family bringing medicine to school (see SN checklist) 
AIM 1: Secondary Asthma Health Outcomes 
Asthma symptoms 
• Asthma Control Test (see Parent surveys), validated 
• maximum symptom days, validated 
ED visits, Admissions, Oral steroids, 
Medication Adherence 
• Parent report (see Parent surveys) and electronic medical record review 
• Pharmacy refill data 
Spirometry 
• Portable Spirometer (PIKO), validated57 to assess Forced Expiratory Volume 
in 1sec 
School absences 
• Parent and school nurse report (see Parent surveys and SN checklist)  
AIM 2: Process Outcomes for Asthma LinkTM Intervention Protocol 
Acceptability  
• Acceptability rating scale (5 point Likert scale) to rate each component of the 
Asthma LinkTM intervention (see Parent, SN, MP, AC surveys) 
Adoption 
• Pedi practice log to track number of providers offering Asthma LinkTM (See 
Pedi Practice Intervention Fidelity Checklist) 
• School nurse log to track frequency of child coming to nurses office to receive 
med (see SN checklist) 
• School nurse log to track family bringing in medicine to school (see SN 
checklist) 
• Survey to family to assess ability to obtain 2 inhalers (one for home and one 
for school) and deliver medicine to school (see Parent 3 mo, 6mo survey) 
Costs 
• Survey to assess time and costs for: pediatric practice to train in and 
implement program, School nurse to deliver intervention, Family to pick up 
medicine and bring to school (transportation), above and beyond their daily 
routines (see MP, AC, SN, Parent surveys)  
Sustainability 
Brief Sustainability Rating (5 point Likert scale) to assess pediatric practice, 
School nurses, and Families perception that Asthma LinkTM could be continued 
over time (see MP, AC, SN, Parent surveys) 
 
 
11. PROCEDURES INVOLVED* 
Randomization. Two groups of two practices (4 practices in total) will be matched based on 
comparable size and percent of minority patients. Within each pair, practices will be randomly 
allocated to Asthma Link or the comparison condition, using a computerized function. This will 
result in two practices randomized to the Asthma Link condition and two practices randomized 
to the Enhanced Usual Care comparison condition.  
 
Recruitment will be performed from each practice site until the target n=72 parent-child dyads 
(18 per site) are recruited. (see section 13 on “Sample size calculation”) Recruitment will begin 
during the 2021-2022 academic school year.  
 
Procedure Steps: 
1. Research coordinator (RC) identifies potentially eligible patients (children aged 6-17 years 
(enrolled in grade 1-12) years and prescribed a daily inhaled corticosteroid per medical record 
from most recent visit scheduled for a clinic visit) through the practice’s office scheduling and 
medical record system (e.g., Epic). RC will also collect that patient’s name, DOB, mailing and 
email addresses, phone number, insurance type (as a proxy for socioeconomic status), list of 

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medications, number of emergency room visits, number of hospital admissions and number of 
oral steroid courses for asthma relief.  
2. RC creates a Lilac Form for any potentially eligible patients as described above. (Lilac form is 
an indicator to the medical provider seeing the patient that this patient is potentially eligible for 
study.) 
3. Asthma Link condition: As part of clinical practice, medical provider will determine if patient 
is struggling with taking daily asthma medicine. If YES, then will introduce Asthma Link by 
saying “There is a clinical program that allows for your child to receive their daily asthma 
medicine at school supervised by the school nurse.” Child can be enrolled in Asthma Link per 
the usual clinical steps (see Asthma Link steps).  
• After they are enrolled in Asthma Link, medical provider will give family one-page 
description of study (see Flyer) and state “Researchers at UMass are performing a study 
of children who are participating in Asthma Link, would you be interested in hearing 
more?”  
3a. Enhanced Usual Care comparison condition: Medical provider will determine if patient is 
struggling with taking daily asthma medicine, if YES, the provider will give family a one-page 
description of study (see Flyer) and state “Researchers at UMass are performing a study of 
children with asthma to learn about how to support them in taking their every day asthma 
medicine, would you be interested in hearing more?” 
• Attached to the “Flyer” will be the Authorization to Contact form. (see Authorization to 
Contact form)  
• If the parent agrees, the Lilac form with the family’s information is faxed to the Research 
Coordinator.  The pediatric office will fax this form with a confidential cover form.   
• The fact sheet will be mailed to the parent with a letter saying that the Research 
Coordinator will call or text them (see Fact Sheet).  
• The Research Coordinator will only call the parent five times. The first and third time a 
message will not be left, but a text message will be sent stating “This is X from Asthma 
Link, can I call you at TIME?” The second, fourth, and fifth time a message will be left 
saying “This is X from the University of Massachusetts Medical School. I am calling 
about the material on Asthma Link I sent you. Please call me back at X.”  
• A phone screen will be conducted to ensure study inclusion criteria (see phone script). 
• The Research Coordinator will obtain informed consent from eligible participants, 
including parental permission for their child to participate, child assent to participate, and 
parental consent to participate. (see sections 30, 31 on Consent) 
• After all questions are answered regarding the study by the parent, the Research 
Coordinator will send the baseline survey via email to the participant to be completed by 
the parent and child together or will complete the survey over the phone with the child 
and parent.  
• The Research Coordinator will then access the child’s medical record and obtain the 
discharge summaries, the emergency service records, the office/clinic notes, the problem 
list, the pulmonary studies, the child’s list of medications, and the child’s height and 
weight (to help interpret the spirometry data). 
• The Research Coordinator will then call the child’s pharmacy to obtain refill history for 
their daily ICS inhaler. 
 

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We anticipate that recruitment of n=72 dyads will take 18 months based on Dr. Pbert’s FITLINE 
study 18. We do not anticipate issues with this recruitment based on prior recruitment of families 
for Asthma LinkTM from the Worcester community in our pre/post study and based on prior 
recruitment from these same pediatric practices in the FITLINE study. (also see page 19 which 
describes estimated number of asthmatics in proposed Pediatric practices, demonstrating 
feasibility of recruitment). The Institutional Review Board will review all research procedures 
and protocols. All instruments will be submitted to the IRB for review and approval prior to use.  
 
We will not enroll any participants in the study prior to receiving IRB approval.  
 
SURVEY – PARENT AND CHILD – 20 MINUTES _See uploaded parent baseline, parent 3 
month, parent 6 month, and parent 12 month surveys. 
The 4 parent surveys will include the following constructs: Patient Health Outcome questions 
including the Asthma Control Test (ACT; measure of severity of asthma symptoms) and the 
Maximum Asthma Symptom Days (MSD), Emergency Department visits, hospital admissions, 
school absences, oral steroid usage and pharmacy refill data. The Baseline survey will include 
demographic questions that ask about the parent’s age, sex, race/ethnicity, relation to the child 
participating in the study, education, marital status, tobacco usage, health insurance, contact 
information, family functioning, comorbidities, income, and average monthly as a proxy for 
socioeconomic status. The 3 month, 6 month, and 12 month follow up surveys for the Asthma 
LinkTM condition will also include the following constructs: acceptability, cost, and 
sustainability. All surveys will be completed either on-line using RedCap (Please see data 
management) or over the phone with the Research Coordinator. We are using emails and/or 
phone calls to deliver/collect these surveys. As soon as the baseline survey has been completed, 
those completing the survey via email will be automatically sent out future surveys. 
 
SURVEY – SCHOOL NURSE – 10 MINUTES _See uploaded school nurse baseline and end-of 
-intervention surveys. 
The school nurse survey will include the following constructs: acceptability, cost, and 
sustainability. All surveys will be completed either on-line using RedCap (Please see data 
management section) or over the phone with the research coordinator. We are using emails 
and/or phone calls to deliver and collect these surveys. 
 
SURVEY – MEDICAL PROVIDER – 5 MINUTES _See uploaded medical provider baseline 
and end-of-intervention surveys. The medical provider survey will include the following 
constructs: acceptability, cost, and sustainability. All surveys will be completed either on-line 
using RedCap (please see data management section) or over the phone with the research 
coordinator. We are using emails and/or phone calls to deliver and collect these surveys. 
 
SURVEY- ASTHMA CHAMPION- 5 MINUTES_See uploaded asthma champion baseline and 
end-of-intervention surveys. This will include the same constructs of acceptability, cost and 
sustainability. Surveys will be completed either on-line using RedCap (please see data 
management section) or over the phone with the research coordinator. We are using emails 
and/or phone calls to deliver and collect these surveys.  
 

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We will be accessing the practice’s medical record system (same system as above, e.g., Epic) to 
obtain documentation of the child’s emergency room visits, hospital admissions, and oral steroid 
courses at the baseline time point (recording the number of events for the 6 months prior), 3 
month, 6 month, and 12 month time points (recording the number of each of these events for the 
3 or 6 months prior.). This data will also be collected 12 months following the completion of the 
12 month survey in order to observe for sustained impact on health outcomes and to see if 
engagement in Asthma Link continues beyond one year.  This data will be directly put into the 
RedCap database without any downloading of information. (please see data management section)   
 
We will be contacting the child’s pharmacy to obtain refill history of their daily ICS medication 
at baseline (obtaining the number of refills for the prior 6 months), 3, 6, and 12 months, and 12 
months following the completion of the 12 month survey to assess for medication adherence.  
This data will be entered directly into the REDCap database.   
 
Portable Spirometry: At baseline, 3, 6, and 12 months the child will perform spirometry in the 
school nurse’s office. The Research Coordinator will perform portable spirometry in the school 
at the time that the student normally reports to the nurse for their daily asthma medication so as 
not to disrupt the child’s school activities. Given that the spirometry test takes less than 3 
minutes to complete for each child, we are confident that it will not pose a disruption to the 
child’s school activities. The Research Coordinator will enter the spirometry data into RedCap 
for each participant without downloading any data.  
 
School absence data will be collected through school nurse report and will be recorded from the 
school nurse on the School Nurse checklist and faxed to the Research Coordinator. 
 
Asthma Link Condition: Those practices that are randomized to the Asthma Link group will 
receive pediatric pulmonologist delivered trainings for pediatric practices on behavioral 
strategies to help promote asthma medication adherence and a 1 hour training on the Asthma 
Link clinical program and how to enroll children in Asthma Link (reviewing the steps of this 
clinical program- see “Asthma Link Clinical Program Steps”) and carry out this evidenced- 
based program in the context of their clinical practice (reviewing the steps to Asthma Link and 
answering any questions they may have). 
 
Comparison Condition: Those practices that are randomized to the Enhanced Usual Care 
Comparison Group will receive pediatric pulmonologist delivered trainings for pediatric 
practices on behavioral strategies to help promote asthma medication adherence. These include 
training to counsel patients on the strategies such as the placement of cell phone alarms to 
remember to take their daily medicine and placement of an elastic band around the inhaler and 
the toothbrush so that a child always remembers to take their daily inhaler before brushing their 
teeth. We thought it ethically important to provide more than just usual care to the 2 pediatric 
practices assigned to the comparison condition. 
 
Families who agree to participate in the study from either the Asthma Link or Enhanced Usual 
Care practices will receive a mailed “Asthma Workbook” to aid in their understanding of 
asthma, support their asthma care and help with daily medicine adherence (See Asthma 
Workbook) 

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12. DATA AND SPECIMEN BANKING* 
N/A 
 
13. Data Analysis and Management* 
 
Sample size calculation 
 
In order to obtain a sample size of 72 parent-child dyads to complete the research, we will 
potentially enroll up to 100 parent-child dyads. Because pilot studies do not provide meaningful 
estimates of effect sizes for between-condition comparisons, due to the imprecision inherent in 
data from small samples 19,20 we base our proposed sample size of 72 parent-child dyads (36 per 
condition, 18 per practice) on pragmatics of recruitment, retention and the necessities for 
examining feasibility, providing important information for design and recruitment for the future 
R01 study to test the impact of Asthma LinkTM in a large cluster RCT.  We will identify 
refinements required to implement the large cluster RCT by obtaining data about several process 
outcomes as well as feasibility of recruitment, retention, engagement, fidelity and assessment 
procedures of Asthma LinkTM.  
 
Taking estimation of retention rate as an illustrative outcome, and applying an intra-class 
(pediatric practice) correlation of 0.01, similar to the value of 0.006 from Dr. Pbert’s prior 
studies of school-based teen smoking, the resulting design effect=1.19 = 1 + [1  + 0.01 × 9]21 
yields an effective sample size of 20/1.09 ≈18 dyads/condition.  For a conservatively low 
retention rate of 80%, lower than the 97% observed in Dr. Pbert’s previous FITLINE study,18 we 
can estimate a 95% confidence interval for retention percent of (51.9%, 95.7%) for each practice 
separately or (68.9%, 88.5%) combining all 4 practices. A sample of 18 dyads per practice (36 
per condition) yields 95% confidence intervals for practice ICC of (0.018, 0.094) for a 
conservatively large true ICC=0.05.22 Because estimates from pilot studies alone tend to be 
underpowered due to the variability in estimated standard errors,19,20 we will combine our results 
(including the ICC) with clinically meaningful effect and results of previous adequately powered 
interventions to calculate sample size requirements for our large cluster RCT. Data from the 
recruited pediatric practices show that 5-7 very poorly controlled asthmatics are seen per month.  
 
Statistical Analysis:  To assess feasibility outcomes in Aim 1, we will estimate parameters 
relevant for planning a larger study, including standard deviations of outcomes and ICC. We will 
also conduct preliminary analyses of the impact of Asthma LinkTM on asthma outcomes. We will 
compare participants in the two arms (Asthma LinkTM and comparison group), using methods 
such as parametric or nonparametric t-test or Poisson regression, depending on the observed 
outcome distribution. Some outcomes may have a Poisson distribution, such as hospital 
admissions, while spirometry values may be continuous. Intent-to-treat and completer analyses 
will be performed. The data collected in this proposal will provide estimates of trial retention, 
ICC, standard deviation, and effect size. We will use these and data published in the literature to 
estimate sample size for a larger trial. The secondary outcomes analyses of asthma health 
outcomes will be exploratory by necessity given the pilot nature of this study. 
 

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Data will be collected at baseline (study entry), and at 3-, 6-, and 12-month follow-up in the 
privacy of the parent/child’s home as the parent/child survey will be sent through email, in the 
pediatric practice staff’s office or home (for pediatric provider and asthma champion surveys 
which will be sent through email), in the school nurse office of home (for school nurse surveys 
which will be sent through email). Assessments will be pre-tested to ensure the time burden does 
not exceed 30 minutes. The parent/student survey and assessment tools for this study will be 
adapted from Dr. Pbert’s prior adolescent smoking cessation trials and our pre/post study 14,18. 
Data confidentiality will be emphasized on the surveys and verbally by Research Coordinator, 
and by the use of a unique study identification number. 
 
Data Management: The surveys will be conducted either over the phone or by using the 
REDCap™ system, a nationally used secure, web-based database application (http://project-
redcap.org) that provides: 1) an intuitive interface, 2) audit trails for tracking data manipulation 
and export, 3) procedures for importing data from external sources, 4) easy development of web 
survey tools and 5) automated export procedures to various statistical packages. 
 
14. PROVISIONS TO MONITOR THE DATA TO ENSURE THE SAFETY OF SUBJECTS* 
 
Potential Risks and Adequacy of Protection Against Risks. The interventions (both Asthma 
LinkTM and Enhanced Usual Care) in this proposal are state-of-the-art, developed by a Pediatric 
Pulmonologist and represent good standards of care as recommended by the National Asthma 
Education and Prevention Program and the American Academy of Pediatrics and the American 
Academy of Asthma, Allergy, and Immunology. Asthma LinkTM practices are evidenced-based 
and have not shown any adverse events in multiple prior studies.13,14 The potential risks of the 
evaluative research component of this project are minimal. Some participants may have concerns 
about the confidentiality of their surveys and study records. The Research Coordinator and 
Primary Investigator will emphasize the confidentiality of all data collected and reassure and 
address any participant with concerns. Participant confidentiality will be maintained through a 
number of strategies. Each participant will be assigned a unique study identification (ID) 
number. Any link between the unique study ID and participant identifiers such as demographics, 
asthma health data, and questionnaire data will only be accessible to the Primary Investigator and 
Research Coordinator responsible for data collection and will be maintained in a secure, 
encrypted, password-protected, HIPAA compliant research drive. Other UMMS personnel will 
not be privy to identifying information about the individual participants and the link between 
study ID and identifiers will otherwise be destroyed. Given the minimal risk nature of this study, 
a data monitoring committee would not be necessary. 
 
All data stored within computer files will be password protected behind a firewall to ensure that 
access is available only to those directly involved in the study analysis. Only data that has been 
stripped of all personal identifying information is made available to the data management (e.g. 
RedCap) systems;  
 
At study completion, the link between the identifying information and their data will be 
destroyed, as will be contact information.  
 
Finally, all study staff will complete the CITI Course in the Protection of Human Research 

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Subjects and Good Clinical Practices online training in research ethics to ensure that all staff are 
compliant with confidentiality training.  
 
Monitoring Adverse Events. 
 
The principal investigator and research coordinator will be responsible for monitoring adverse 
events during the study, with Dr Pbert assuming this responsibility if these individuals are 
unavailable. The role of the responsible person is 1) to identify the concern through assessing for 
health changes at each survey; 2) develop an appropriate response that involves consultation 
whenever possible to alleviate or minimize any adverse event (AE); and 3) to ensure that the 
adverse event is reported in a timely manner to the responsible authority. We will collect adverse 
events that are volunteered spontaneously during interactions with participants. Participants will 
be monitored for occurrence of events defined as any undesirable experience or unanticipated 
benefit. Events may occur during recruitment, intervention deployment, and follow-up 
assessments. Based upon previous research in school-supervised asthma therapy, we anticipate 
that adverse events or experiences will be rare. The Principal Investigator will assess whether an 
undesirable experience or unanticipated problem occurred (adverse event) and will record details 
of all adverse events on an adverse event case report form. 
 
Although our study poses minimal risk to subjects and no adverse events are expected due to 
the nature of the study, we will follow the adverse event procedure of the University of 
Massachusetts Medical School.  The current policy for reporting unanticipated problems and 
adverse events for the protection of human subjects in research at the University of 
Massachusetts Medical School is as follows: 
“All adverse events involving risk to subjects or others that are serious and unanticipated and 
related to the study procedures must be reported, using the applicable Prompt Reporting Form, 
within 48 hours of the investigator becoming aware of the event.  
All unanticipated problems which are unexpected and suggest that the research places subjects or 
others at a greater risk of harm and are related to the research must be reported, using the 
applicable Prompt Reporting Form, within 48 hours of the investigator becoming aware of the 
event.  
 
In certain situations, this requirement for prompt reporting may necessitate the submission of 
a report before all information has been collected.  In these situations, a preliminary report may 
be submitted with a follow-up report submitted at a later date when more information is 
available.     
 
Events/problems which are not serious, are anticipated and not related to the study procedures 
must be reported in summary format at the time of continuing review.” 
 
Adverse events that do not meet the requirements of prompt reporting will be provided at the 
time continuing review is submitted. The continuing review form in the UMMS eIRB will 
request this information. 
 
We do not anticipate that any serious adverse events (death, life threatening illness, new serious 
or permanent disability) will occur. However, should such an event occur, the Principal 
Investigator will report the event within 24 hours of initial receipt of information to the 
University of Massachusetts IRB and NHLBI program officer. Other serious and unexpected 
AEs related to the study will be reported to the Program Officer within 5 days. Unanticipated 

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problems (that are not serious AEs) will be reported to the UMass IRB and the NHLBI Program 
Officer within 14 days of becoming aware of the problem. Any reports sent to the funding 
agency about the event will be included in the report to the IRB. 
 
 The adverse event case report form will include a description of all undesirable experiences, 
required interventions, and an assessment of the subject after the event if possible. An estimate 
of the extent of injury, and prevention strategies will be reported. The Principal Investigator will 
classify the relationship of the study protocol to the event as follows: 
• Not related: The event is clearly related to factors such as the participant’s clinical state, not 
with the study protocol. 
• Remote: The event was most likely related to factors such as the participant’s clinical state, not 
with the study protocol. 
• Possible: The event follows a reasonable temporal sequence associated with participating in the 
study and/or is consistent with events related to receiving the intervention but is possibly related 
to factors such as the subject’s clinical state. 
• Probable: The event follows a reasonable temporal sequence associated with participating in 
the study and/or is consistent with receiving the intervention and cannot be reasonably explained 
by factors such as the subject’s clinical state. The severity of an adverse event in both groups is 
defined as a qualitative assessment of the degree or intensity of an adverse event as determined 
by the principal investigator as follows: 
• Mild: No impact (in anyway) on the participant. 
• Moderate: Impacts on the participant but is not life-threatening or incapacitating. 
• Severe: Fatal, life threatening, permanently disabling; severely incapacitating; requires 
immediate medical evaluation. 
All adverse events will simultaneously be reported to institutional officials. The report will 
summarize the facts of the case, including the date and a description of the participant; whether 
the event is related to the study’s protocols; the steps that have been taken to address the issue; 
whether the event provides emerging knowledge about the risks of the study that should be 
conveyed to respondents; and whether the consent form should be revised. 
 
Anticipated Adverse Events. 
Given that this is a minimal risk study, a data monitoring committee and/or a data safety 
monitoring board is not required for this study. An adverse events log is inappropriate for this 
type of study. Alternatively, the PI will periodically examine the data and should any research-
related unexpected events arise, the PI will evaluate the event per the procedure listed above and 
will adhere to the institution’s prompt reporting requirements. We do not anticipate any adverse 
events from this study as the primary procedures involve minimal risk surveys, checklists and 
routine clinical spirometry. 
 
In this research, the risks that result from study participation are considered minimal as the 
research is primarily evaluative with the use of surveys and performance of spirometry. The 
major risks are: 
• Risk of loss of confidentiality: The protections against confidentiality loss have been described 
The PI is principally responsible for ensuring that there is no loss of confidentiality during the 
course of the study. Any loss that occurs despite these protections will be evaluated on an 
individual basis. 

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• Risk of Spirometry: Spirometry is a routine, non-invasive clinical test that is commonly 
performed in children with asthma. This test has been used both clinically and in research 
without any adverse events.23,24 There are no risks associated with spirometry except for the 
potential for a slight dizzy feeling and/or temporary cough. These symptoms are not always 
present and are temporary. In order to minimize risks, the participant will be in a seated position 
with adult supervision and a trained technician will perform spirometry, with physician available 
by phone for concerns or questions. We will follow institutional policies for prevention of Covid 
transmission, which includes the technician wearing a surgical mask with eye protection and 
using a new disposable mouthpiece for each participant. For this study the test is performed 
without the intent of yielding direct health benefit. 
• Risk of discomfort while answering questions: Some subjects may feel uncomfortable 
answering certain survey questions (e.g., questions about family income) however subjects will 
be notified that they are welcome to skip questions or withdraw from the study at any time 
without penalty. 
 
Given that this is a minimal risk study, the only foreseeable risks to the subjects include the 
possible loss of confidentiality. To address this, all participants will be given information on 
ways to contact Dr. Trivedi and the University of Massachusetts Medical School IRB 
 
Data and Safety Monitoring Board (DSMB) 
Given that this is a minimal risk study (wherein participants agree to enroll in the study after they 
become part of the Asthma Link program if they are in the Asthma Link practices or after they fit 
study inclusion criteria if in the Enhanced Usual Care practices), participants will primarily be 
evaluated through surveys, interviews, and spirometry, and therefore a data monitoring 
committee and/or a data safety monitoring board is not appropriate for this study. Alternatively, 
the PI will periodically examine the data and should any research-related unexpected events 
arise, the PI will evaluate the event per the procedure listed above and will adhere to the 
institution’s prompt reporting requirements. We do not anticipate any adverse events from this 
study as the primary procedures involve minimal risk surveys, checklists and routine clinical 
spirometry.  
 
This research is not designed to discover incidental findings and therefore we do not plan to 
follow up on incidental findings 
 
15. WITHDRAWAL OF SUBJECTS WITHOUT THEIR CONSENT* 
Subjects will be withdrawn from the research if they appear to be unduly distressed 
 
16. RISKS TO SUBJECTS* 
In this research, the risks that result from study participation are considered minimal and 
primarily involve the risk of loss of confidentiality. 
 
• Risk of loss of confidentiality: Dr. Trivedi is principally responsible for ensuring that there is 
no loss of confidentiality during the course of the study. Any loss that occurs despite these 
protections will be evaluated on an individual basis. 
 

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• Risk of spirometry: Spirometry is a routine, non-invasive clinical test that is commonly 
performed in children with asthma. This test has been used both clinically and in research 
without any adverse events.23,24 There are no risks associated with spirometry except for the 
potential for a slight dizzy feeling and/or temporary cough. These symptoms are not always 
present and are temporary. For this study the test is performed without the intent of yielding 
direct health benefit. 
 
• Risk of feeling uncomfortable answering questions: Some subjects may feel uncomfortable 
answering certain questions (e.g., questions about family income) however subjects will be 
notified of this in the fact sheet (see fact sheet) and will be told that they are welcome to 
withdraw from the study at any time without penalty. 
 
Given that this is a minimal risk study, the only foreseeable risks to the subjects include the 
possible loss of confidentiality. To address this, all participants will be given information on 
ways to contact Dr. Trivedi and the University of Massachusetts Medical School IRB. 
 
17. POTENTIAL DIRECT BENEFITS TO SUBJECTS* 
The potential benefit gained by study participants is the improvement of their personal health 
status through the prevention of asthma-related health risks for those with improved adherence to 
their preventive medication. In addition, each individual participant is contributing to the 
evaluation of childhood asthma interventions for school-aged children. Potential benefits to 
society and the larger community include the implementation of effective evidenced- based 
asthma interventions for school-aged children and increased capability to deliver intervention 
programs to children and families. These benefits are substantial in comparison to the minimal 
risk possible. 
 
18. VULNERABLE POPULATIONS* 
This research will involve children. The description below explains the importance of including 
children to perform this research and the safeguards, which will protect their rights and welfare.  
 
Childhood asthma affects 12-15% of children in the urban United States with considerable 
morbidity and healthcare costs, despite aggressive efforts to address remediable causes. 
There exists extremely effective therapy for childhood asthma: inhaled corticosteroids (ICS). 
However, ICS are grossly underutilized with adherence rates at less than 20%, particularly in 
low-income, minority patients. Racial and socioeconomic disparities in childhood asthma are 
grave, with the highest rates of emergency room visits and hospitalizations for asthma occurring 
in low income and minority children. In spite of increasing recognition of the profound negative 
effects on children and families, which are mitigated by effective preventive therapy, including 
daily use of ICS, childhood asthma remains undertreated. Recognizing this gap, the NHLBI 
Expert Panel on Asthma emphasizes that asthma self-management is essential and there have 
been three successfully conducted trials of school-supervised ICS therapy in school-aged 
children.  
 
Despite their success at improving ICS adherence rates and asthma symptoms, these research-
tested interventions have not been adopted in real-world practice. This is due in part to high cost 
and high intensity approaches that are not feasible in the real world. This study seeks to 

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investigate a practical strategy (the Asthma LinkTM program) to promote the uptake of school-
supervised asthma therapy, which has been found to be safe and efficacious, into regular 
practice. This study will directly inform a large-scale cluster randomized controlled trial 
trial to test the effectiveness and implementation of Asthma Link with the goal of improving 
childhood asthma outcomes on a large public health scale. 
 
o The parent/legal guardian will provide verbal consent for both the child to 
participate in the study and for them to participate in the study.  
§ Research staff will mail interested families the fact sheet and contact them 
by phone to explain the study and describe the parent/legal guardian and 
child’s potential role.  The confidentiality of all collected information will 
be emphasized, and it will be explained that the child’s care in the 
pediatric practice will in no way be affected by whether or not they 
participate in the study.  The parent/legal guardian and child will be 
provided the opportunity to have questions answered by the research staff.  
If interested, parental/legal guardian consent and child assent will be 
requested and provided verbally during the call.   
§ All questions will be answered before a parent gives verbal consent and 
child gives verbal assent, which will serve as the overt agreement to 
participate.  
§ We will not enroll an individual if there is any sign of unwillingness to 
participate. 
§ If a person is not eligible for the study or not willing to participate, they 
will not be consented or assented.   
o Subjects will be withdrawn from the research if they appear to be unduly 
distressed.   
 
 
We will obtain permission from one parent/legal guardian who will be joining the study with the 
child given that this is a minimal risk study.  
 
Research staff will mail interested families the fact sheet and HIPAA authorization and contact 
them by phone to explain the study and describe the parent/legal guardian and child’s potential 
role using a standardized information sheet. The confidentiality of all collected information will 
be emphasized, and it will be explained that the child’s care in the pediatric practice will in no 
way be affected by whether or not they participate in the study.  The parent/legal guardian and 
child will be provided the opportunity to have questions answered by the research staff.  If 
interested, parental/legal guardian consent and child assent will be requested and provided 
verbally if the adult and child are both available at the time of the phone call.  
 
 
We will answer all questions the child and parent/legal guardian may have prior to the child 
giving verbal assent.  
• We will not enroll a child if there is any sign of unwillingness.   
• We will not obtain verbal consent or assent for anyone who is not eligible or not willing 
to participate.  

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This research may also involve women who are or may become pregnant. No inducements, 
monetary or otherwise will be given to any pregnant woman participating in this study to 
terminate her pregnancy. The PI and the RC will have no part in any decisions as to the timing, 
method, or procedures used to terminate a pregnancy. Also, the PI and the RC will have no part 
in determining the viability of a neonate in this study. Given that this is a minimal risk study, we 
believe that this study poses no risk to a pregnant woman or the fetus and does not require any 
additional safeguards.  
 
19. MULTI-SITE RESEARCH* 
We will be recruiting patients from 4 pediatric offices.  The physicians and staff in these 
practices will not: 
 
a. Obtain data about subjects through interaction for research purposes 
b. Obtain informed consent or assent of subjects to take part in the research 
c. Obtain identifiable private information about subjects for research purposes. 
 
The practices performed by the physicians and office staff for enrollment in Asthma Link are 
considered good clinical practice based on the evidence described previously for school-
supervised asthma therapy.13-15  
 
20. COMMUNITY-BASED PARTICIPATORY RESEARCH* 
N/A 
 
21. SHARING OF RESEARCH RESULTS WITH SUBJECTS* 
We will ask participants if they are interested in receiving a summary of the study findings.  If 
they are, they will be added to an email list (a mailing address will be obtained for anyone who 
prefers this to an email address). Once the study has been completed, we will send a lay 
summary of the results to participants who indicated interest 
 
22. SETTING 
This pilot feasibility study will take place in 4 Pediatric Primary Care practices in Worcester 
MA: Benedict Pediatrics, Worcester Pediatrics, Quality Kids and Harding Pediatrics. These 
particular sites were selected due to their high rates of asthma and matching for relevant 
demographics. We have worked with these sites in Dr. Pbert’s prior FITLINE study. If there are 
logistical issues with any of these practices after commencement of funding, we have identified 4 
alternative practices in Worcester as backups. 
 
23. RESOURCES AVAILABLE 
This study includes the PI, research coordinator, research assistants, statistician and 
senior mentor. Collectively the staff has over 40 years of clinical research experience at 
UMMS.  The roles of each research staff member is listed below: 
Principal Investigator (PI) (0.75 FTE): This position requires advanced training in 
Pediatric Pulmonology, research design and methods. The PI is responsible for ensuring 
that all team members have current CITI training, appropriate training for their respective 

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roles, including knowledge of the study protocol and procedures for maintaining 
confidentiality. This person will oversee all aspects of the study, data acquisition, and 
data analysis. 
Research Coordinator (0.6 FTE): This position is a specialized research professional 
working with and under the direction of the clinical Principal Investigator (PI).  The 
Research Coordinator supports, facilitate and coordinate the daily clinical trial activities 
and plays a critical role in the conduct of the study. The responsibilities include:  
maintaining records, handling IRB submissions, data management, and performing any 
other study related procedures that fall within their scope of practice only after receiving 
the appropriate training required to perform the procedures.   
Research Assistants (0.2 FTE): Responsibilities include support of study recruitment, data 
management, data analysis, and other study related activities deemed appropriate by the PI. 
 
Statistician (0.01 FTE): This position requires training in statistics.  The statistician will be 
responsible for data analysis and performing any other study related procedures that fall within 
their scope of practice only after receiving the appropriate training required to perform the 
procedures. 
 
Senior Mentor (0.01 FTE): A Ph.D, Senior level investigator who will dedicate her time in-
kind to oversight of this project 
 
All study staff will be supervised by the PI and will have completed CITI/GCP certification. All 
persons assisting with the research will be trained and monitored by either the PI or the Research 
Coordinator and will be given copies of the procedures for performing this research.   
 
 
24. LOCAL RECRUITMENT METHODS 
Justify the feasibility of recruiting the required number of suitable subjects within the given 
recruitment period. For example, how many potential subjects do you have access to? What 
percentage of them do you need to recruit?  
 
Feasibility of Recruitment: Rates of asthma approximately range from 15%-25% among the 
practices’ patients, with a mean of 18.5%.  Given this rate and number of patients, we are very 
confident that we will be able to recruit 13 families per practice over the course of the one and a 
half-year recruitment period.  
 
Describe when, where, and how potential subjects will be identified and recruited. If recruiting 
in a clinical setting, will clinical staff ask potential subjects if it’s ok for study staff to approach? 
If recruiting by mail, will letters come from the subject’s clinician or clinic head?  
 
For the sites that are randomized into the intervention arm of the study, a one page flyer for the 
clinical Asthma LinkTM program will be placed in each of the exam rooms in the clinics and will 
encourage families to ask their providers about Asthma LinkTM if they have a child who 
has asthma. The flyer will only advertise the clinical Asthma LinkTM program. Additionally, 
triage nurses at these sites may remind providers to screen potentially eligible patients for the 
clinical Asthma LinkTM program when scheduling sick visits related to Asthma or breathing 

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problems. During the clinic visit, the pediatric provider will give the family a one-page 
description of the study and, if interested, will send a referral to the study.  Research staff will 
mail the family the fact sheet and HIPAA authorization, contact them by phone to explain the 
study, and obtain verbal consent for those interested.  Research staff will send an email link to 
access the survey to families who provide verbal consent. The 4 pediatric practices participating 
in the trial estimate 7,462 children total in their practices between children in grades 1-6; with a 
conservative estimate of 15% with asthma symptoms, this provides approximately 1,119 children 
from which to recruit 40 children into the trial, making recruitment highly feasible.  
 
Describe how individuals will be screened for eligibility. Will any identifiers be recorded? If so, 
when will identifiers be de-linked from the data and when will identifiers be completely 
destroyed? Be sure to address individuals who enroll and individuals who turn out to be 
ineligible or who decline to participate. 
 
The fact sheets and the HIPAA authorization form will be mailed to the potential participants 
with a letter saying that the Research Coordinator will call them. The Research Coordinator will 
contact the parent by phone to explain the study and describe the parent/legal guardian and 
child’s potential role using a standardized information sheet. The Research Coordinator will 
answer any questions about the study and obtain verbal consent. Once the parent provides 
consent, the Research Coordinator will obtain verbal assent from the child. The Research 
Coordinator will then email the link to sign the HIPAA authorization. Once the HIPAA 
authorization is signed, the Research Coordinator will then email the link to complete the survey 
via REDCap. The Research Coordinator will only call the family five times.  The first time a 
message will not be left.  The second, fourth and fifth time a message will be left saying “This is 
X from the University of Massachusetts Medical School. I am calling about the material I sent 
you. Please call me back at X. (please see uploaded flyer and phone script). Enrollment will not 
begin until IRB has approved these materials. Individuals who decline to be contacted or who 
decline to participate in the study will not be contacted. 
 
Describe the amount, method, and timing of any payments to subjects. 
To compensate participants for their time, and to incentivize participation in the completion of 
all assessments, we will provide compensation to each parent-child dyad in the form of gift cards 
to a local retailer (i.e., Target or Wal-Mart). Compensation will be divided through the study 
period (a $30 gift card for each parent-child dyad on enrollment and completion of baseline 
assessment, another $30 gift card at 3-month assessment, a $30 gift card at 6-month assessment, 
and a $40 gift card at the 12 month assessment). We will also be mailing families with a short 
hand-written thank you note and ‘prize’ after the 3 month survey (stickers), 6 month survey 
(small toy prize), at the 9 month time point (magnet or postcard with reminder for 12 mo 
survey), and after the completion of the 12 month survey (completion certificate). All mailings 
will be in a sealed envelope to protect confidentiality.  Pediatric practice sites will be provided 
lunch during their information session for the research study which will be funded by the NIH 
KL2TR001454 award and will be considered separate from the subject compensation. 
 
School nurses participating in the study will receive a $35 honorarium for their help with 
completing the School Nurse checklist and for completing the brief surveys. 
 

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Asthma Champions will receive $15 for completing the baseline survey and $20 for completing 
the follow-up AC survey for a total honorarium of $35. 
 
We will provide coffee and donuts to the medical provider’s practice if all participating providers 
complete both the baseline and follow-up surveys. 
 
Upload copies of recruitment materials, including flyers, emails, letters, phone scripts, etc., to 
eIRB. For advertisements, upload the final copy of printed advertisements. When advertisements 
are taped for broadcast, provide a link to the final production of the audio/video tape. You may 
submit the wording of the advertisement prior to taping to preclude re-taping because of 
inappropriate wording; however, the IRB must review and approve the final audio/video tape. 
 
See flyer and phone screen 
 
25. LOCAL NUMBER OF SUBJECTS 
 
200 parents and children in grades 1-12 (aged 6-17 years) (i.e. 100 parent-child dyads total) with 
asthma will be recruited from the practices (25 parent-child dyads/practice) to achieve a retention 
of N=144 parents and children (i.e. 72 parent-child dyads) at the end of the study (from the 4 
practices) at 12 month follow-up. 
 
If two siblings are eligible for Asthma Link and this study, both children may participate in 
Asthma Link clinical program but only one child per family may be allowed to participate in the 
research study. We will grant the parent/guardian permission to choose which child they would 
like to participate in the research arm of the study. 
 
Up to 16 Pediatric providers participating in Asthma LinkTM will be recruited from the 
participating practices to participate in this study. 
 
Up to 50 School nurses participating in Asthma LinkTM will be recruited from the schools that 
the children participating in the study attend to participate in this study. 
 
Up to 4 Asthma Champions participating in Asthma LinkTM will be recruited from the 
participating practices to participate in this study. 
 
26. CONFIDENTIALITY  
 
Protection of study data will be assured by the use of locked files and password-protected 
computer databases with access available only to the principal study personnel. The data files 
will also be encrypted.  Besides UMMS IRB, the NIH, research, and compliance offices, the only 
individuals to have access to these identifiers are the PI and the Research Coordinator. The data 
will be stored for at least seven years unless directed otherwise by the research organization.  
 
Study participants will be provided with a unique de-identified research ID code. We will create 
a database with ONLY the de-identified separate research ID for each subject and then 

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associated collected survey data. The Name and DOB will be hidden and protected through 
REDCap database privacy settings. (see Data Management section) 
 
Any link between the de-identified research ID code and the patient’s protected information 
(such as name, dob) will be only accessible to Principal Investigator, study staff for this project 
and will be maintained in a secure, HIPAA compliant research drive. The link between the two 
will otherwise be destroyed. 
 
We will not download any information. The Research Assistant or Research Coordinator will 
place all data collected directly into the secure protected REDCap database and the survey 
information is performed directly within REDCap through REDCap surveys. 
 
Data for analysis will be completely de-identified. 
 
 
27. PROVISIONS TO PROTECT THE PRIVACY INTERESTS OF SUBJECTS 
Potential subjects will have ample time to read the consent and assent and ask any questions.  It 
will be explained that the family’s overall care at the clinic will in no way be affected by whether 
or not the child participates in the study and that confidentiality will be maintained. Children and 
parents/legal guardians will be informed that they can stop participating at any time without 
reason, if they so request. 
 
We are accessing records before they enter the study and we are requesting a HIPPA waiver in 
order to identify potential subjects for this. We will obtain HIPAA authorization via electronic 
signature for the PHI that will be collected during the study. (see HIPAA waiver and HIPAA 
Authorization). 
After the family interacts with the medical provider and consents to be contacted, they will 
provide their name, address, phone number, and email to be contacted.  
The fact sheet (which will be mailed to the house and then reviewed over the phone in addition 
to the HIPAA authorization) will describe that we will be accessing the child’s medical record 
and communicating with their school nurse and pharmacist to obtain information about 
emergency room visits, hospital admissions, oral steroid bursts, spirometry results, and pharmacy 
refill data. 
 
28. COMPENSATION FOR RESEARCH-RELATED INJURY 
Given that this is a minimal risk study no funds have been set aside. 
 
29. ECONOMIC BURDEN TO SUBJECTS 
Based on prior research experience, this study will not generate economic burden as a result of 
participating in this study to the families of the participating children with asthma, the 
participating pediatric practices, the practices’ providers, the schools, or the schools’ 
participating nurses. 
 
30. CONSENT PROCESS 
We are following SOP: Informed Consent Process for Research.  Potential participants will be 
provided a mailed fact sheet prior to receiving a phone call from the Research Coordinator.    

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The study will be described in full detail and all of the potential subject’s questions will be 
answered. Subjects will be informed about all of the risks described above and all aspects of the 
study. The consent/assent process is expected to take 20-30 min. We will minimize the 
possibility of coercion or influence by providing subjects the opportunity to call back. They will 
have the opportunity to opt out at the initial phone contact or at any point including while the 
study is underway. The Research Coordinator conducting the process will determine that the 
subject understands the information provided and is capable of making and communicating an 
informed consent or assent and will document this.  After the informed consent and assent are 
obtained subjects will be emailed the baseline survey assessment. 
 
31. PROCESS TO DOCUMENT CONSENT IN WRITING 
We are asking for a waiver of written consent for the provider survey as this poses 
minimal risk and the research involves no procedures for which written consent is 
normally required outside of the research context.  
We are asking for a waiver of written consent for the parent and written assent for the 
child as this poses minimal risk and the research involves no procedures for which 
written consent is normally required outside of the research context. 
 
32. DRUGS OR DEVICES 
N/A 
 
eIRB Section 7.0 Attachments Upload Checklist 
Follow How to Manage Files in eIRB and upload the following items as applicable to your 
submission. This checklist is provided for your convenience and is not a requirement for review. 
 
 
Investigator Study Plan 
 
Sponsor protocol 
 
Research portion of the grant 
 
Human subjects portion of the grant 
 
Written approvals from ancillary reviews (Clinical Engineering, COI, IBC, PRC, RSC, 
Students as Subjects, etc.) 
 
Recruitment materials such as flyers, brochures, posters, scripts of radio ads, etc. 
 
Data collection sheets, case report forms, etc. 
 
Surveys, measures, instruments, etc. 
 
Measures to assess capacity to consent 
 
DMC or DSMB charter 
 
Data safety monitoring plan 
 
Adverse event log 
 
Investigator brochure or package insert for drugs  
 
Instructions for use or approved FDA labeling for devices 
 
Sponsor justification or FDA documentation for non-significant risk device study  
 
IND or IDE documentation 
 
Patient information sheet for Humanitarian Use Device 

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Approval order for Humanitarian Use Device 
 
Product labeling for Humanitarian Use Device 
 
HIPAA waiver 
 
HIPAA authorization 
 
Authorization to contact form 
 
Consent form(s) 
 
Assent forms(s) 
 
Fact sheet(s) 
 
Multi-site communication plan 
 
Study staff training plan 
 
SOPs or Manuals of Operations 
 
Screening log 
 
Compensation log 
 
Certificates of translation or translator attestations 
 
Data use agreements, memoranda of understanding,  
 
Documentation of data/specimen anonymity (i.e., provider will never break the code) 
 
 
 
 
1. 
Akinbami LJ, Simon AE, Rossen LM. Changing Trends in Asthma Prevalence Among 
Children. Pediatrics 2016;137. 
2. 
Centers for Disease C, Prevention. Vital signs: asthma prevalence, disease characteristics, 
and self-management education: United States, 2001--2009. MMWR Morb Mortal Wkly Rep 
2011;60:547-52. 
3. 
Akinbami LJ, Moorman JE, Garbe PL, Sondik EJ. Status of childhood asthma in the 
United States, 1980-2007. Pediatrics 2009;123 Suppl 3:S131-45. 
4. 
Sumino K, Cabana MD. Medication adherence in asthma patients. Current opinion in 
pulmonary medicine 2013;19:49-53. 
5. 
Williams L, Peterson E, Wells K, et al. Quanitfying the proportion of severe asthma 
exacerbations attributable to inhaled corticosteroid nonadherence. J Allergy Clin Immunol 
2011;128:1185-91. 
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