West Philadelphia Asthma Care Implementation Plan
Phase: NA
Conditions: Childhood Asthma, Community Health Workers
Sponsor: Children's Hospital of Philadelphia

 
 
  
Title: 
West Philadelphia Asthma Care Implementation Plan 
Short Title: 
West Philadelphia Controls Asthma 
Regulatory Sponsor: 
NHLBI 
eIRB Number: 
17-013892 
NCT Number: 
NCT03514485 
Protocol Date: 
September 01, 2016 
Version #: 
9.0 
 
 
 
 
Amendment 1 Date: March 29 2017 
Amendment 8 Date: June 24, 2019 
Amendment 2 Date: April 14 2017 
Amendment 9 Date: August 15, 2019 
Amendment 3 Date: December 18, 2017 
Amendment 10 Date: November 15, 2019 
Amendment 4 Date: April 23, 2018 
Amendment 11 Date: March 19, 2020 
Amendment 5 Date: June 4, 2018 
Amendment 12 Date: November 13, 2020 
Amendment 6 Date: September 29, 2018 
Amendment 13 Date: April 19, 2021 
Amendment 7 Date: April 22, 2019 
 
 
 
Funding Sponsor 
NHLBI  
National Heart, Lung, and Blood Institute  
9000 Rockville Pike 
Bethesda, Maryland 20892 
United States 
Principal Investigator  
Tyra Bryant-Stephens, MD 
Children’s Hospital of Philadelphia 
2716 South Street, 9th Floor 
Philadelphia, PA 19146 
Phone 215-590-5020 
email: stephenst@chop.edu 
 

  
 
 
 
 
 
 
 
ii
TABLE OF CONTENTS 
Table of Contents ................................................................................................................... ii 
Abbreviations and Definitions of Terms............................................................................. iv 
Abstract .................................................................................................................................. v 
Protocol Synopsis .................................................................................................................. vi 
Table 1: Schedule of Study Procedures .............................................................................. ix 
Figure 1: WEPACC Model Study Design ........................................................................... x 
Figure 2: Logic Model for Study Design............................................................................. xi 
Figure 3: Risk Mapping ...................................................................................................... xii 
1 
BACKGROUND INFORMATION AND RATIONALE ....................................................................... 1 
1.1 
INTRODUCTION ..................................................................................................................................... 1 
1.2 
RELEVANT LITERATURE AND DATA ..................................................................................................... 4 
1.3 
COMPLIANCE STATEMENT .................................................................................................................... 5 
2 
STUDY OBJECTIVES .............................................................................................................................. 5 
2.1 
PRIMARY AIM ...................................................................................................................................... 5 
2.2 
SECONDARY AIMS ................................................................................................................................ 5 
3 
INVESTIGATIONAL PLAN .................................................................................................................... 6 
3.1 
GENERAL SCHEMA OF STUDY DESIGN ................................................................................................. 6 
3.1.1 
Screening Phase .............................................................................................................................. 7 
3.1.2 
Primary Care Based Intervention ................................................................................................... 7 
3.1.3 
School Based Intervention ............................................................................................................... 8 
3.2 
ALLOCATION TO TREATMENT GROUPS AND BLINDING ...................................................................... 10 
3.3 
STUDY DURATION, ENROLLMENT AND NUMBER OF SITES ................................................................... 9 
3.3.1 
Duration of Study Participation ...................................................................................................... 9 
3.3.2 
Total Number of Study Sites/Total Number of Subjects Projected ................................................ 10 
3.4 
STUDY POPULATION. .......................................................................................................................... 10 
3.4.1 
Inclusion Criteria .......................................................................................................................... 10 
3.4.2 
Exclusion Criteria ......................................................................................................................... 10 
4 
STUDY PROCEDURES .......................................................................................................................... 11 
4.1 
SCREENING VISIT ............................................................................................................................... 11 
4.2 
STUDY TREATMENT PHASE ................................................................................................................ 11 
4.2.1 
Visit 1 (All Participants) ............................................................................................................... 11 
4.3 
PRIMARY CARE BASED INTERVENTION: ............................................................................................. 11 
4.3.1 
Study Visit 1 (Enrollment) ............................................................................................................. 11 
4.3.2 
Study Visit 2 (Home Visit 1): ......................................................................................................... 13 
4.3.3 
Study Visit 3 (Home Visit 2) .......................................................................................................... 14 
4.3.4 
Study Visit 4 (Home Visit 3) .......................................................................................................... 13 
4.3.5 
Study Visits 5, 6, and 7 (Primary Care Office Visits 1-3).............................................................. 13 
4.3.6 
Study Visit 8 (12-Month Follow-Up) ............................................................................................. 15 
4.3.7 
Study Visit 9 (Post 12-Month Follow-Up) ..................................................................................... 14 
4.3.8 
Unscheduled Visits ........................................................................................................................ 15 
4.4 
SCHOOL INTERVENTION ..................................................................................................................... 15 
4.4.1 
Community Health Worker Coordination ..................................................................................... 15 
4.4.2 
School Nurse Coordination ........................................................................................................... 15 
4.4.3 
Classroom Environmental Assessments ........................................................................................ 15 
4.4.4 
Open Airways for Schools Curriculum.......................................................................................... 16 
4.4.5 
School Based Asthma Therapy ...................................................................................................... 16 
4.5 
RESCUE MEDICATION ADMINISTRATION ............................................................................................ 16 
4.6 
SUBJECT COMPLETION/WITHDRAWAL ............................................................................................... 16 

 
 
 
 
 
 
 
 
iii
4.6.1 
Early Termination Study Visit ....................................................................................................... 16 
5 
STUDY EVALUATIONS AND MEASUREMENTS ............................................................................ 17 
5.1 
INDIVIDUAL PARTICIPANT MEASURES ............................................................................................... 17 
5.2 
GROUP LEVEL PRIMARY CARE AND SCHOOL MEASURES ................................................................... 17 
5.3 
SCREENING AND MONITORING EVALUATIONS AND MEASUREMENTS ................................................ 18 
5.3.1 
Medical Record Review ................................................................................................................. 18 
5.3.2 
Physical Examination .................................................................................................................... 18 
5.3.3 
Vital Signs ..................................................................................................................................... 18 
5.4 
EFFICACY EVALUATIONS ................................................................................................................... 18 
5.4.1 
Diagnostic Tests, Scales, Measures, etc. ....................................................................................... 20 
5.5 
SAFETY EVALUATION ......................................................................................................................... 20 
6 
STATISTICAL CONSIDERATIONS .................................................................................................... 19 
6.1 
PRIMARY ENDPOINT ........................................................................................................................... 20 
6.2 
SECONDARY ENDPOINTS .................................................................................................................... 20 
6.3 
STATISTICAL METHODS...................................................................................................................... 20 
6.3.1 
Baseline Data ................................................................................................................................ 20 
6.3.2 
Efficacy Analysis ........................................................................................................................... 21 
6.3.3 
Subgroup Analysis: Mediator and Moderator Variables .............................................................. 21 
6.4 
SAMPLE SIZE AND POWER .................................................................................................................. 21 
6.5 
INTERIM ANALYSIS ............................................................................................................................ 22 
7 
STUDY MEDICATION (STUDY DEVICE OR OTHER STUDY INTERVENTION) .................... 23 
7.1 
DESCRIPTION ...................................................................................................................................... 23 
8 
SAFETY MANAGEMENT ..................................................................................................................... 23 
8.1 
CLINICAL ADVERSE EVENTS .............................................................................................................. 23 
8.2 
ADVERSE EVENT REPORTING ............................................................................................................. 23 
9. STUDY ADMINISTRATION ...................................................................................................................... 23 
9.1 
TREATMENT ASSIGNMENT METHODS................................................................................................. 23 
9.1.1 
Randomization............................................................................................................................... 23 
9.1.2 
Blinding ......................................................................................................................................... 24 
9.1.3 
Unblinding .................................................................................................................................... 24 
9.2 
DATA COLLECTION AND MANAGEMENT ............................................................................................ 24 
9.3 
CONFIDENTIALITY .............................................................................................................................. 24 
9.4 
REGULATORY AND ETHICAL CONSIDERATIONS.................................................................................. 25 
9.4.1 
Data and Safety Monitoring Plan ................................................................................................. 25 
9.4.2 
Risk Assessment ............................................................................................................................. 24 
9.4.3 
Potential Benefits of Trial Participation ....................................................................................... 25 
9.4.4 
Risk-Benefit Assessment ................................................................................................................ 25 
9.5 
RECRUITMENT STRATEGY .................................................................................................................. 26 
9.6 
INFORMED CONSENT/ASSENT AND HIPAA AUTHORIZATION ............................................................ 26 
9.7 
PAYMENT TO SUBJECTS/FAMILIES ..................................................................................................... 27 
9.7.1 
Payments to parent for time, effort and inconvenience (i.e. compensation).................................. 27 
9.7.2 
Gifts ............................................................................................................................................... 27 
10 
PUBLICATION ........................................................................................................................................ 27 
11 
REFERENCES ......................................................................................................................................... 27 
Appendix ............................................................................................................................... 31 
 

  
 
 
 
 
 
 
 
iv
ABBREVIATIONS AND DEFINITIONS OF TERMS 
CAPP 
 
Community Asthma Prevention Program 
ED 
 
Emergency Department (Admission) 
IP 
 
Inpatient Admission 
CHW 
 
Community Health Worker 
EHR 
 
Electronic Health Record 
SC 
 
Study Coordinator 
PCP 
 
Primary Care Provider 
RA 
 
Research Assistant 
SBAT 
 
School Based Asthma Therapy 
EBI 
 
Evidence Based Intervention 
CBM 
 
Center for Biomedical Informatics 
HV 
 
Home Visit 
REDCap 
 
Research Electronic Data Capture (Web-based Survey Platform) 
NHLBI 
 
The National Heart, Lung, and Blood Institute 
DSMB 
 
Data Safety Monitoring Board 
DSMP 
 
Data and Safety Monitoring Plan 
FQHC 
 
Federally Qualified Health Center 
NIH 
 
National Institutes of Health 
PAMCOP 
 
Pediatric and Adolescent Medicine Centers of Philadelphia 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

  
 
 
 
 
 
 
 
v
ABSTRACT 
Context:   
Childhood asthma is characterized by prominent, persistent and pervasive disparities. For 
instance, in addition to often cited disparities in specific health outcomes and global quality 
of life, students with asthma miss three times more school days than students without asthma 
with the highest proportion of missed days in low-income communities. To address asthma 
disparities in a patient-centered, sustainable manner, and consistent with a social ecological 
framework, one must intervene in all environmental contexts (i.e., home, school, healthcare 
system, community) of children with asthma. As a result of an assessment of local needs, 
resource mapping, and months of planning, an asthma care implementation program has 
been developed with the broad objective of integrating home, school, healthcare system, and 
community for school-aged asthmatic children in West Philadelphia. 
Objective: To determine if the utilization of CHWs in a comprehensive community-based 
intervention to connect home, school, healthcare system and community for low-income 
minority school-aged asthmatic children and their caregivers improves asthma control and 
thereby reduces asthma disparities for this community. 
Study Design: Randomized controlled trial 
Setting/Participants: 
640 asthmatic children (ages 5-13 years) will be recruited from CHOP Care Network sites 
(Cobbs Creek, Karabots, and South Philadelphia), CHOP ED, The Pediatric and Adolescent 
Medicine Centers of Philadelphia, Federally Qualified Health Centers and by community 
referral. 
Other sites of intervention include: All School District of Philadelphia public elementary 
schools located in West Philadelphia will be invited to participate. Several public charter 
elementary schools in West Philadelphia some of which are served by school-based health 
centers managed by Education Plus, Inc. d/b/a Education Plus Health will also be invited to 
participate for a total of no greater than 40 elementary schools. 
Study Interventions and Measures:  
Interventions taking place at school, home and in the primary care setting to improve asthma 
control and reduce symptom days evaluated using main and simple effects from the factorial 
design.  
 
 

  
 
 
 
 
 
 
 
vi
PROTOCOL SYNOPSIS 
Study Title 
West Philadelphia Asthma Care Implementation Plan 
Funder 
NIH 
Clinical Phase 
Implementation Phase 
Study Rationale 
The overall purpose of care coordination is to identify and engage 
families in development of a care plan that links clinical, 
psychosocial and other services in order to provide best care to the 
child with asthma.  It is essential that care coordination emphasizes 
the central role of the health of the child while recognizing family 
concerns and identifying strengths and gaps in care.  In care 
coordination, it is important to establish and support a continuous 
relationship with clinical caregivers as well as empower families to 
advocate for their needs and satisfaction.   
 
Through a combination of asthma management interventions for 
children including, Yes We Can™ Children’s Asthma Program, 
School Based Asthma Therapy, and the American Lung 
Association’s Open Airways For Schools®, utilizing CHWs as the 
connectors, families of children with asthma will receive services of 
a trained and knowledgeable liaison to proactively support the 
delivery of evidence based care and follow-up in the primary care 
office, school and at home. 
 
Study Objective(s) 
Primary  
To improve asthma control through the use of Community 
Health Workers that provide a network of education and care 
coordination support, and to facilitate communication for 
families of children with asthma in West Philadelphia by 
integrating home, school, healthcare system, and community for 
school-aged asthmatic children in West Philadelphia.   
 
Secondary 
To reduce asthma symptom days and school absences through 
the use of CHWs, evaluate cost-effectiveness of study 
interventions, and to investigate moderators of intervention 
effectiveness to identify subgroups of children that may be more 
likely to benefit from the study interventions.  
 
Test Article(s) 
(If Applicable) 
N/A 
Study Design 
 
Randomized controlled trial 

 
 
 
 
 
 
 
 
 
 
vii
Subject Population 
key criteria for 
Inclusion and 
Exclusion: 
Inclusion Criteria 
1. Parents (guardians) and their children ages 5-13 years 
2. Children with diagnosis of asthma 
3. Uncontrolled Asthma (as evidenced by one or more asthma 
exacerbations requiring oral steroids within the past year, 
two ED visits for asthma or one inpatient admission for 
asthma within the past year) 
4. Reside in one of the seven West Philadelphia zip codes: 
19104, 19131, 19139, 19142, 19143, 19151, 19153 
5. Enrolled in elementary school 
6. Receive primary care at CHOP Care Network sites (Cobbs 
Creek, Karabots, and South Philadelphia), The Pediatric and 
Adolescent Medicine Centers of Philadelphia (PAMCOP) or 
a Federally Qualified Health Center (FQHC) in West 
Philadelphia 
7. Parental/guardian permission (informed consent and if 
appropriate, child assent) 
8. English speaker 
 
Exclusion Criteria 
1. Children with other chronic respiratory illnesses such as 
cystic fibrosis 
2. Cyanotic congenital heart disease 
3. MRCP-Mental retardation and/or cerebral palsy 
4. Severe Neurological Disorder 
5. Parents/guardians or children who, in the opinion of the 
Investigator, is likely to be non-compliant with study 
schedules or procedures. 
6. Children who do not live in West Philadelphia (zip codes: 
19104, 19131, 19139, 19142, 19143, 19151, 19153) 
 
Number Of Subjects  
 
640 patients will be recruited from CHOP Care Network sites, a 
private pediatrician office, Federally Qualified Health Centers 
(FQHCs), CHOP ED and by community referral. 
 
Sites Include: 
• CHOP Care Network sites: Cobbs Creek, Karabots and 
South Philadelphia 
• CHOP Emergency Department  
• Federally Qualified Health Centers (FQHCs) serving West 
Philadelphia residents 
• The Pediatric and Adolescent Medicine Centers of 
Philadelphia (PAMCOP) serving West Philadelphia 
residents 

 
 
 
 
 
 
 
 
 
 
viii
• School District of Philadelphia Public Elementary Schools 
located in West Philadelphia (including Southwest 
Philadelphia) who agree to participate 
• Public Charter Schools located in West Philadelphia 
(including Southwest Philadelphia) who agree to participate 
 
Study Duration 
Active subject participation will last up to 24 months; Medical 
record review will continue for up to two years from the 12-month 
follow-up visit or until the data collection period for the study has 
ended, whichever occurs first. This study is expected to be 
conducted over six years. 
 
Study Phases 
  
Screening 
Study Intervention 
Study Follow-up 
 
Efficacy Evaluations 
Obtain baseline and follow-up measurements of asthma control, 
symptoms, patient and caregiver asthma knowledge, presence of 
environmental triggers, school and work day absenteeism, and 
healthcare utilization 
 
Safety Evaluations 
Adverse event reports will be collected at each visit. These reports 
will be reviewed at weekly meetings by the PI to determine if they 
are a result of the study. 
A DSMB has been appointed by the funding sponsor to oversee 
safety of the interventions. 
 
Statistical And 
Analytic Plan 
Analysis to be conducted by biostatisticians at the University of 
Pennsylvania and data managers at the Biostatistics and Data 
Management Core at CHOP 
 
DATA AND SAFETY 
MONITORING PLAN 
The PI will be responsible for the study’s Data and Safety 
Monitoring Plan with oversight provided by a DSMB appointed by 
the NIH. 
 

 
ix  
 
 
 
 
 
 
 
 
 
TABLE 1: SCHEDULE OF STUDY PROCEDURES 
Study Phase 
Screening 
Treatment/Intervention 
Follow-Up 
Visit Number 
0 
Baseline 
Home Visits 
Clinic Visits 
3, 6, and 9 Mo 
12 
Mo 
12 
Mo 
Post- 
12 Mo 
1 
HV1 
HV2 
HV3 
2 
3 
4 
HV4 
5 
6 
Informed Consent/Assent 
X 
 
 
 
 
 
 
 
 
 
 
Baseline Questionnaire with Asthma Symptom Recall 
 
X 
 
 
 
 
 
 
 
 
 
Photograph of child’s bedroom 
 
 
X 
 
X 
 
 
 
X 
 
 
Clinical Assessment – Vital Signs and BMI 
 
X 
 
 
 
X 
X 
X 
 
X 
 
Pulmonary Function Test 
 
X 
 
 
 
X 
X 
X 
 
X 
 
Metered Dose Inhaler (MDI) Checklist 
 
X 
 
X 
 
X 
X 
X 
 
X 
 
Paediatric Asthma Caregiver’s Quality of Life Questionnaire 
 
X 
 
 
 
 
 
 
 
X 
 
Asthma Control Questionnaire 
 
X 
 
 
 
X 
X 
X 
 
X 
X 
Child Asthma Risk Assessment Tool (CARAT) modified 
 
X 
 
 
 
 
 
 
 
X 
 
Initial Home Environmental Assessment 
 
 
X 
 
 
 
 
 
 
 
 
Asthma Knowledge Quiz 
 
 
X 
 
X 
 
 
 
X 
X 
 
Caregiver Needs Assessment 
 
X 
 
 
 
 
 
 
 
 
 
Community Health Worker Goal Tracking 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Asthma Management Education 
 
 
X 
X 
X 
X 
X 
X 
X 
 
 
Follow-Up Questionnaire with Asthma Symptom Recall 
 
 
 
 
 
X 
X 
X 
 
X 
X 
Follow-Up Home Environmental Assessment 
 
 
 
X 
X 
 
 
 
X 
 
 
School Nurse Checklist 
 
X 
 
 
 
 
 
 
 
X 
 
Initial Classroom Environmental Assessment 
 
X 
 
 
 
 
 
 
 
 
 
Follow-Up Classroom Environmental Assessment 
 
 
 
 
 
X 
 
 
 
 
 
School Based Asthma Therapy Intake Survey 
 
X 
 
 
 
 
 
 
 
 
 
CHW Caregiver Satisfaction Survey 
 
 
 
 
 
 
 
 
 
 
X 

 
x 
  
 
 
 
FIGURE 1: WEPACC MODEL STUDY DESIGN 
 
 
 
 
 
 
 
 
 
 

 
xi 
  
 
 
 
FIGURE 2: LOGIC MODEL FOR STUDY DESIGN 
 
 
 

 
xii 
  
 
 
 
FIGURE 3: RISK MAPPING 
 

 
  
 
 
 
1
1 
BACKGROUND INFORMATION AND RATIONALE 
1.1 Introduction 
Childhood asthma is characterized by prominent, persistent and pervasive disparities. For 
instance, in addition to often cited disparities in specific health outcomes and global quality 
of life1–4, students with asthma miss three times more school days than students without 
asthma, with the highest proportion of missed school days in low-income communities5. To 
address asthma disparities in a patient-centered, sustainable manner, and consistent with an 
ecological framework, one must intervene in all environmental contexts (i.e., home, school, 
healthcare system, community) of children with asthma. Previous studies demonstrate that 
community health workers (CHWs) can effectively deliver evidence-based care 
coordination, environmental mitigation, and asthma education interventions in specific 
settings6–8. However, this work has not been delivered in an integrative manner to connect 
settings. Utilization of CHWs in a comprehensive community-based intervention to connect 
home, school, healthcare system and community for school-aged asthmatic children and 
their caregivers may eliminate asthma disparities.   
The Community Asthma Prevention Program (CAPP) has a two decade history of utilizing 
CHWs to improve asthma outcomes of children in Philadelphia9,10. Over ten members of 
inner-city Philadelphia have been trained and employed as CHWs to effectively provide 
home asthma education and environmental mitigation for children who have asthma-related 
ED or hospital visits. Building on this foundation, we established a network of stakeholders, 
The West Philadelphia Asthma Care Collaborative (WEPACC), with representation from 
public housing, healthcare, community, and schools. As a result of local needs assessment, 
resource mapping, and months of planning, we designed an asthma care implementation 
program with the broad objective of integrating home, school, healthcare system, and 
community for school-aged asthmatic children in West Philadelphia. We will accomplish 
this goal using CHWs to deliver sustainable patient-centered evidence-based interventions. 
The evidence-based interventions include (1) a primary care-based Yes We Can™ 
Children’s Asthma Program with home visitation and (2) a comprehensive and rigorously 
evaluated school-based intervention, Open Airways For Schools® and (3) School Based 
Asthma Therapy11–13. CHWs will function as the hub of each intervention, serving either as 
primary care CHWs or school CHWs to provide a network of education, care coordination 
support, and to facilitate communication for families of children with asthma between the 
four sectors. If proven effective, this care coordination program will assist caregivers in 
assessing resources, improving self-management skills and ultimately reducing asthma-
related ED visits and hospitalizations.  
In the face of best asthma practices, quality of care is also affected by communication 
between patients and providers, particularly across cultures.  When people of color access 
routine care, physicians are often unknowingly biased in their care.  This may partially be 
explained by different styles of communicating between providers and patients, different 
belief systems and unfamiliarity with the patient/caregivers social stressors which affect 
their ability to be adherent with treatment.  Giving the caregiver a central health liaison who 
is also a resident in the community such as the CHW, will help to bridge communication 
gaps between caregiver and clinician, identify belief systems and enable caregivers to deal 
with social stressors.  

 
  
 
 
 
2
Another example of current system limitations is that of our own CAPP program.  Although 
many have benefited from these programs, high risk families need a higher intensity of 
service beyond the type of home visiting program CAPP provides which is focused on 
health education and environmental mitigation in the home without making a formal 
connection to health care and schools.  
Strunk and colleagues found that diverse ethnic and racial minorities experienced disparities 
in access to asthma care that lead to greater morbidity and mortality14. Absence of regular 
care for urban African American children results in increased morbidity for chronic diseases 
like asthma. Urban children have more difficulty with self-management of their asthma for 
various reasons, which include poverty, stresses related to living in an urban environment, 
lack of knowledge about asthma and lack of family and community support. Many studies 
reveal that asthma education is effective in reducing emergency department visits, 
hospitalizations and lost days of work. Improving access to care not only involves changing 
the structure of health care delivery, but also involves addressing educational needs, 
psychological issues, and cultural beliefs and practices in developing interventions to 
improve access to care. 
Community Needs Assessment. In order to understand the impact of asthma in West 
Philadelphia, our needs assessment included both qualitative inquiry (i.e., focus groups and 
interviews) as well as identification of key local, regional and national data sources for 
secondary data analysis conducted by Philadelphia Health Management Corporation 
(PHMC) under the guidance of WEPACC. Knowledge of the neighborhoods relevant to 
WEPACC informed our intervention planning and implementation.  
Results from secondary analysis of data. Population. West Philadelphia (zip codes 19104, 
19131, 19139, 19143, and 19151) has 233,000 residents, including 49,000 ages 0-17. 
Seventy-four percent of West Philadelphia residents identify as Black/African American. 
Thirty-two percent of children live below the federal poverty level, 98% of children have 
health insurance, and 100% of parents reported their child receives regular healthcare15. This 
high access to healthcare suggests that an intervention involving partnerships with 
healthcare providers has the potential to reduce the impact of asthma in West Philadelphia. 
Twenty-five percent of the children in these zip codes have asthma16. CHOP is the primary 
source of pediatric emergency and hospital care for West Philadelphia and provides primary 
care for over 40,000 children in West Philadelphia. 
Utilization. 1,353 children residing in West Philadelphia were hospitalized for asthma, and 
3,186 children were admitted to CHOP’s emergency room for asthma in 2014-201517. The 
concentration of hospitalizations and emergency room discharges is relatively consistent 
across West Philadelphia. Notably, the WEPACC pilot zone, outlined on both maps, is 
interior to the overall WEPACC ZIP codes, and contains census tracts with both high 
numbers of asthma hospitalizations and ED discharges.  
Community Resources. Community assets were mapped to inform the design of the 
intervention with input from WEPACC stakeholders.  
Risk Factors. Since poor housing conditions are associated with asthma morbidity, we 
mapped housing code violations and overlapped them with CHOP 

 
  
 
 
 
3
hospitalization/emergency room data to determine areas of highest risk. The resulting map 
revealed that the highest risk areas centered around three primary care centers which are the 
sites of enrollment for our study (Figure 3).  
Qualitative Assessment. Under the guidance of the West Philadelphia Asthma Care 
Collaborative (WEPACC), Philadelphia Health Management Corporation (PHMC) collected 
qualitative data from focus groups and key informant interviews in order to assess the needs 
of children with asthma in West Philadelphia.  A total of five focus groups were convened 
between November 2015 and April 2016. Three groups consisted of parents of children with 
asthma (n=24), one group with children with asthma (n=7), and one group with school 
nurses (n= 7). A total of seven key informant (KI) interviews were conducted between May 
2016 and July 2016. Participants included parents of children with asthma, health care 
providers, and an insurance company representative. Needs and concerns were identified 
from all environmental contexts, home, school, healthcare system, and community. Home 
concerns included landlord unresponsiveness, difficulty with controlling triggers such as 
second hand smoke exposure and mold, parental mental health issues, children living in 
multiple homes, and difficulty using medication. School nurse concerns included the lack of 
full time nurses, lack of asthma education, poor communication, indoor triggers in the 
school, missed school days due to asthma, and incomplete med-1 forms. Healthcare 
concerns were of lack of understanding about asthma, poor communication between parent 
and provider, missed appointments, medication use and controlling child’s asthma. Lastly, 
lack of awareness about asthma, uncontrollable outdoor triggers like air pollution and 
secondhand smoke were identified as major concerns in the community setting.  
Piloting the school intervention. As we conducted the needs assessment, we also began 
developing our plan for implementation strategies, or the “how” of implementation (i.e., the 
active methods to increase adoption, implementation and sustainment of evidence-based 
intervention)18. Intervention mapping is a systematic process for developing interventions to 
inform implementation strategies that comes out of a participatory design approach19. 
Mapping has been used to develop a number of effective health-related programs, including 
those addressing sex education, obesity, and cancer prevention20–22. We applied mapping to 
the development of the implementation strategies to be used to implement school-based 
asthma care. 
CHOP Care Network Cobbs Creek, Karabots and South Philadelphia locations each employ 
a CHW who conduct care coordination and home visits. However, these three CHWs are not 
able to serve all persistent asthmatics in the practice and do not connect directly with schools 
to coordinator care for children with asthma.  Since our needs assessment revealed caregiver 
and school nurse concerns regarding asthma management in schools, we focused our pilot 
on enhancing the connection of CHWs to a local elementary school in order to explore 
challenges and opportunities for CHWs in elementary school. Thus we piloted the feasibility 
of a CHW coordinating school asthma care for seven students receiving primary care 
through CHOP CN Cobbs Creek. After obtaining consent from the parents, the CHW 
worked directly with the school nurse, principal, and teacher in order to implement elements 
of the school intervention to improve communication between caregiver, clinical team and 
school. The CHW enrolled patients at CHOP CN Cobbs Creek and then coordinated with 
the primary care physician completion of all necessary forms and appropriate 

 
  
 
 
 
4
medication/device orders. Despite initial challenges, such as incomplete forms, poor 
communication between caregiver and nurse, no medications on site, our CHW was able to 
complete the initial intervention for all 7 children within three weeks of enrollment. 
Subsequent key informant interviews with the caregivers, school nurse and CHW were 
overall positive with caregivers and school nurses appreciative of the role of the CHW who 
coordinated with caregiver and school nurse to make sure that the school had forms, 
medication and devices needed to provide asthma care for enrolled students. With this 
success we believe our study design to put CHWs in each of the intervention schools is 
feasible and the best option for closing gaps and connecting asthma care for school-aged 
children. 
1.2 Relevant Literature and Data 
CHWs can improve outcomes for chronic diseases including asthma. Community Health 
Workers integrated into the health team is supported by the Affordable Care Act23. As 
community residents they are uniquely situated in the community and public health and can 
serve as the connectors between the two24. In the primary care setting, community health 
workers (CHWs) can enhance the three principles of the medical home: whole person 
orientation, care coordination, and quality and safety by (1) ensuring that the caregiver’s 
voice is heard regarding asthma, medications, and stressors,25–27 2) creating opportunities for 
the caregiver to “teach back” 3) facilitating communication between the caregiver and 
primary care provider/specialist, and 4) helping caregivers make and reach goals for asthma 
management28–30. Primary care-based CHWs can promote adherence to asthma guidelines 
for asthma control, care plan completion and spirometry. CHWs can also facilitate 
communications when caregivers encounter barriers to scheduling and obtaining 
medications and devices, or need advocacy for psychosocial issues31–33. In addition CHWs 
delivering multi-component trigger reduction interventions effectively improve asthma 
symptoms34. CHW delivered asthma classes in schools have resulted in improved asthma 
knowledge and self-management skills35,36. 
There is great potential for CHWs to connect the four sectors where children live. The 
potential synergistic strength of integrating interventions across multiple sectors (home, 
school, community, healthcare system) has not been fully leveraged despite knowledge that 
multi-level interventions are most effective34.  Currently asthma evidence-based 
interventions (EBI) are routinely implemented in either the home, school, or primary care 
setting. Even when caregivers of poor children are engaged in asthma interventions in one 
setting, they often have to navigate challenges in another setting, such as an under-resourced 
home, non-supportive school, or disengaged health care provider. In one study a 
comprehensive school management program to promote care coordination and better asthma 
management conducted by school nurses did not succeed because it placed additional 
responsibilities on the school nurse and there was no buy in from the primary care practice37. 
CHWs providing the connection between the home, school and primary care practice may 
reduce the burden on caregivers and facilitate asthma management for school-aged children. 
Further, CHWs, as community residents, are knowledgeable about the public school system 
and can help parents connect to local resources. CHWs potentially provide the missing link 
to coordinate between multiple sectors to optimize interventions36.  

 
  
 
 
 
5
Asthma-trained community health workers have the potential to ensure that caregivers make 
and keep follow-up appointments post ED visits by conducting periodic telephone 
assessments.  They are invariably equipped with asthma educational knowledge and 
resources that would be an invaluable asset to patients and their families. Not only are they 
trained in the nature of the disease, but they are often members of the same communities as 
patients and families, giving them an advantage on building bridges and establishing 
relationships between the family and primary care office.  
1.3 Compliance Statement 
This study will be conducted in full accordance all applicable Children’s Hospital of 
Philadelphia Research Policies and Procedures and all applicable Federal and state laws and 
regulations including 45 CFR 46. 
The investigators will perform the study in accordance with this protocol, will obtain 
consent and assent, and will report unanticipated problems involving risks to subjects or 
others in accordance with The Children’s Hospital of Philadelphia IRB Policies and 
Procedures and all federal requirements. Collection, recording, and reporting of data will be 
accurate and will ensure the privacy, health, and welfare of research subjects during and 
after the study. 
2 
STUDY OBJECTIVES 
2.1 Primary Aim 
The primary aim of this study is to compare effectiveness of the primary care and school 
interventions to improve asthma control using main and simple effects from the factorial 
design.  
• Specific Aim 1a.  Compare the main effects of primary care CHW and school CHW 
intervention to control group.  
• Specific Aim 1b. Compare the differences between children outcomes who receive 
both interventions (primary care AND school) to only one intervention (primary care 
OR school).  
• Specific Aim 1c. Compare each of the active interventions groups (primary care, 
school, combination) to control.  
2.2 Secondary Aims 
The secondary aim of this study is to explore moderators and mechanisms of effectiveness 
of the interventions.  
• Specific Aim 2a. Investigate moderators of intervention effectiveness outcomes to 
identify subgroups of children that may be more likely to benefit from the study 
interventions.     
• Specific Aim 2b. Investigate mechanisms of the effect of the intervention, i.e. linkage 
of communications between school and primary care CHWs and daily participation 
in school-based asthma therapy, on asthma control, reduced symptom days, and 
decreased school absences.  

 
  
 
 
 
6
3 
INVESTIGATIONAL PLAN 
3.1 General Schema of Study Design 
A factorial design will be used to understand the effectiveness of primary care and school 
CHWs in the implementation of Evidence Based Interventions (EBI) Yes We Can™ 
Children’s Asthma Program in the primary care setting, and Open Airways For Schools® 
and school-based asthma therapy in the school setting. West Philadelphia children with 
uncontrolled asthma will be recruited in the Emergency Department or primary care clinic 
and randomized to a primary care CHW (P+) or usual care (P-), and identified as being in a 
participating school that has been randomized to a CHW-led school intervention (S+) or 
none (S-). This study design demonstrates how each sector will be involved in this 
comprehensive implementation plan. The primary outcomes is asthma control. Secondary 
outcomes include symptom free days, school absences, hospital and emergency room 
utilization and cost savings. 
This will be a randomized controlled clinical trial of children diagnosed with asthma, ages 5-
13 years old randomized after consenting to primary care CHW (P+) or no primary care 
CHW (P).  In the Primary Care Based CHW arm (P+)  the CHW will provide one-on-one 
asthma education in the office and home, environmental trigger mitigation in the home, 
assistance in identifying care coordination goals with linkages to resources to address 
barriers and will facilitate communication between the health care provider and the family. 
The intervention group (P+) will have a total of four visits to the primary care office where 
they will receive asthma self-management education in the office, review of medications, 
asthma control assessment, pulmonary function assessment and care coordination. They will 
receive three intervention home visits where the CHW will reinforce asthma self-
management skills, assess the home environment for asthma triggers, provide supplies for 
environmental remediation and educate caregiver regarding asthma trigger avoidance 
techniques. This arm will also be eligible for school based direct observed asthma treatment 
called school-based asthma therapy (SBAT). At twelve months the intervention group will 
receive an end of study assessment in the primary care office and in the home. The control 
group will not receive any of the aforementioned services for one year after enrollment. 
They will be referred to community asthma classes administered by CAPP. After one year 
the control group will receive one home visit at which time they will receive an 
environmental home assessment and environmental remediation supplies.   
Children in both arms (P+ and P-) may attend an intervention school. Roughly 30 
elementary schools have been identified by the School District of Philadelphia to participate 
in this project. Several public charter schools including three public charter schools served 
by school-based health centers managed by Education Plus Health have been identified to 
participate in this study. One half of the schools (S+) will be randomized to receive Open 
Airways for Schools Plus designed by Clark, et. al., an EBI asthma education and care 
coordination model for schools, and School Based Asthma Therapy (directly observed 
controller medication use).11 The remaining half of the identified schools (S-) will be offered 
training on how to implement the two evidence-based programs in years 4 and 5 of the 
project. 

 
  
 
 
 
7
3.1.1 Screening Phase 
We will screen electronic health records to recruit 640 children ages 5-13 years old with 
uncontrolled asthma (evidenced by one or more asthma exacerbations requiring oral steroids 
within the past year -OR- two ED visits for asthma within the past year -OR- one 
hospitalization for asthma within the past year) from several primary care centers (CHOP 
Care Network – Cobbs Creek, CHOP Care Network - Karabots, CHOP Care Network – 
South Philadelphia, The Pediatric and Adolescent Medicine Centers of Philadelphia 
(PAMCOP) and Federally Qualified Health Centers) who live in seven West Philadelphia 
ZIP codes (19104, 19131, 19139, 19142, 19143, 19151, 19153). In addition, CHOP 
Emergency Department (ED) will screen and refer children for enrollment when they are 
seen in the ED. Community partners will also refer children at community events. All 
screening surveys will be faxed to a confidential fax line and caregivers of all referred 
patients will be asked if they would like to be screened for study eligibility and participation.  
Participants that both meet eligibility criteria and are interested in participation, will be 
consented/assented using a CHOP IRB reviewed consent form prior to participation in the 
study. The parent/guardian and the child will have 10 minutes or greater to review the 
consent form and ask any questions about participation. 
3.1.2 Primary Care Based Intervention 
Children who are randomized to the primary care arm will be assigned a primary care 
community health worker (CHW). We will implement the Yes We Can™ Children’s 
Asthma Program 12 intervention which is a medical-social model based on a chronic care 
approach, including risk stratification, clinical care management, social care coordination by 
a community health worker, and primary care asthma champions. This intervention includes 
asthma education and trigger reduction visits and care coordination. There will be five clinic 
visits and four home visits over 12 months implemented by the primary care CHW who is 
integrated into the practice.       
Study Visit 1 (primary care office): Once consented and randomized, the CHW will collect 
baseline data (study questionnaires, weight, height, spirometry), administer a caregiver 
needs assessment and assist caregiver in choosing 2-3 care coordination goals such as 
keeping appointments, reduce secondhand smoke exposure or using medications correctly. 
The CHW will conduct in-office asthma teaching (medications/devices/asthma care plan), 
coordinate specialist visits and assist caregivers in voicing questions/concerns about 
medications or treatment plans to the primary care provider. They will personally schedule 
patients for follow-up visits with the primary care provider. Home Visits 1, 2 and 3: The 
first three home visits will occur within 2, 4 and 6 weeks after enrollment. At the first visit 
the CHW will conduct an environmental assessment of the living area and bedroom for 
common asthma triggers. Based on those findings the CHW will educate regarding asthma 
trigger avoidance and give supplies to reduce those triggers (mattress and pillow covers, 
roach bait, mice traps, tiles for carpeted floors) at the second visit. The CHW will also 
review medications available for the child at home and whether forms/prescriptions have 
been completed for school. They will coordinate with the primary care team as needed. 
Video conferencing through a HIPAA-compliant application licensed by CHOP, 
including but not limited to Vidyo telehealth visits in MyCHOP, may be used for home 

 
  
 
 
 
8
visits that cannot be conducted in person due to health or safety concerns. For telehealth 
home visits, supplies will be provided to families via U.S. postal mail with caregivers 
providing confirmation of receipt. Study Visits 2, 3, and 4 (primary care) will occur at 3, 6, 
and 9 months post-randomization. At these visits, the participants will receive asthma 
maintenance care by the provider/clinician and pulmonary function testing (spirometry) in 
addition to the education and care coordination activities by the CHW as described in the 
first visit. A member of the research team other than the assigned CHW (Home Visitor) will 
administer study questionnaires at these visits. At Home Visit 4 at 12 months post-
randomization the CHW will conduct an environmental assessment to document trigger 
reduction techniques in the home and review medications. At Study Visit 5 at 12 months 
post-randomization, the asthma control questionnaire (ACQ)38, additional study 
questionnaires, pulmonary function testing (spirometry) and care coordination goals will be 
completed. Study staff will administer a CHW satisfaction survey via telephone between 13 
and 24 months post-randomization once all primary care and school interventions have been 
completed. 
3.1.3 School Based Intervention 
West Philadelphia elementary schools who have agreed to participate will be randomized to 
either receive the school intervention facilitated by a school CHW or usual school care (no 
intervention). Intervention schools will receive Open Airways for Schools Plus designed 
by Clark, et. al. to improve the disease management skills of children with asthma and 
enhance control of asthma in the school11. It contains four “essential components” of the 
recently published School-based Asthma Management Program (SAMPRO) summit 
guidelines and has been found to decrease both asthma symptom days and school 
absences39–41.  The school intervention includes: (1) Open Airways for Schools® 
curriculum for all children with asthma. One class series will be conducted by the school 
CHW each semester. (2) Orientation to asthma and control strategies for principals and 
school personnel at the start of each school year led by the study team along with the school 
CHW, (3) For School District of Philadelphia public schools, walk-throughs for custodial 
personnel to address potential environmental asthma triggers. This will be managed and 
conducted by school district personnel, and (4) Assistance with obtaining asthma care plans 
and medication administration forms from primary care provider offices facilitated by the 
school CHW. 
For participants assigned to both interventions, the school and primary care CHWs will 
collaborate to coordinate care across the school nurse and primary care offices. In addition 
to the primary care and school interventions above, this treatment group will receive 
enhanced coordination with School-Based Asthma Therapy for prescribed daily controller 
medication42.  The primary care CHW will obtain a copy of the current asthma care plan, 
school medication administration form, a rescue inhaler prescription for school, and an 
asthma controller medication prescription to conduct school based asthma therapy. 
Prescriptions for rescue inhalers and asthma controller medications will be dispensed before 
the child leaves the primary care office. Depending on the participant’s health insurance 
coverage the prescriptions may be filled using an automated medication dispensing system 
(mobile pharmacy) at Cobbs Creek, Karabots, and South Philadelphia CHOP primary care 
practices or through an internal pharmacy at a Federally Qualified Health Center. Primary 
care CHWs will deliver current asthma care plans, medication administration forms, rescue 

 
  
 
 
 
9
inhalers (if applicable), and asthma controller medications (if applicable) directly to School 
CHWs at weekly team meetings. School CHWs will deliver these items to the school nurse 
to file/store in a designated location in the school nurse’s office. The school nurse and/or 
School CHW will coordinate with teachers to schedule an intake appointment for children 
receiving school based asthma therapy at which the nurse will complete a metered dose 
inhaler (MDI) checklist with the child to assess ability to self-administer medications and to 
schedule a time for the child to return to the office for daily medication administration. 
Medication use (both rescue and controller) will be recorded by the school nurse or school 
CHW42. If nurse is not present, as per usual school protocol, the principal will be responsible 
for assigning this task. For this treatment group, asthma management skills will be 
reinforced at home, school and in the primary care office.  
 
Families of children who are not randomized to the primary care intervention will be offered 
Community Asthma Prevention Program (CAPP) asthma classes, conducted at community 
sites, which are available to the general public. Data will be collected from the control arm 
at 3, 6, 9 months by phone or in person. At 12 months an office visit will be scheduled, 
pulmonary function testing (spirometry) performed and end-of-study data collected. After 
completing the study these patients will receive one home visit from a primary care CHW to 
complete an asthma trigger assessment and distribute asthma trigger reduction supplies.  
 
Schools who are not randomized to intervention arm will be offered training after the study 
data collection period has ended and during the last year of grant funding in how to 
implement the school asthma interventions and will be provided with information on how to 
sustain these interventions by obtaining reimbursement from health insurance companies for 
school CHW services.  
 
During the COVID-19 pandemic, the study activities detailed above will be modified as 
follows to preserve the health and safety of participants, healthcare professionals, study staff 
and the West Philadelphia community. Data collection for study visits may take place 
remotely by telephone or video conference using a HIPAA-compliant application licensed 
by CHOP. In person clinic visits solely for study purposes will take place as permitted by 
CHOP Research Institute Policy and Guidelines. Study activities designed to take place in a 
school setting may take place remotely by telephone or video conference using a HIPPA-
compliant application licensed by CHOP.  
 
Asthma control is the primary outcome of this study. Symptom-free days, and school 
absences are secondary outcomes in this study. Asthma control has been cited by the 
NAEPP guidelines and asthma outcomes workshop as an important goal for prevention of 
asthma morbidity.  In several studies, poor asthma control, whether defined by the patient 
(using self-reported, validated instruments) or by national asthma guideline classifications, 
has been strongly associated with an increased risk of asthma exacerbations which may lead 
to emergency room visits, hospitalizations and even death43,44. Asthma control will be 
measured using Juniper’s Asthma Control Questionnaire, a validated instrument for children 
and adults38. Symptom-free days will be based on parental report recall of the last two 
weeks, consistent with previous studies45,46. School absences will be measured by school 
and parental report. Additional secondary outcomes will include asthma-related emergency 

 
  
 
 
 
10
visits and hospital visits (obtained from CHOP EHR), and cost-savings. Moderator variables 
will be measured using the CARAT survey which is a Child Asthma Risk Assessment Tool 
designed to help clinicians, asthma counselors and parents determine potential risks for 
children with asthma47,48. 
 
Data will be collected for all individually randomized participants at baseline, 3, 6, 9 and 12 
months by a member of the research team in person or by phone. Participants will be 
compensated $25 for each visit with data collection at baseline, 3, 6, and 9 months and $45 
for the end of study visit at 12 months.  
 
3.2 Allocation to Treatment Groups and Blinding 
The overall design will randomize participating schools to the school intervention (S+) or 
usual care (S-) based on predefined strata (defined by size, location, public school or public 
charter school status, etc.) to enhance balance. When children with uncontrolled asthma and 
their caregivers present in the primary care offices and provide consent to participate, these 
patients will be randomized either to a primary care CHW (child-level intervention) (P+) or 
usual care (P-), and this randomization will be stratified by the child’s current elementary 
school and clinic of recruitment to ensure balanced assignment in the factorial design.  
3.3 Study Duration, Enrollment and Number of Sites 
3.3.1 Duration of Study Participation 
The study duration per subject will be up to 24 months, if participant has not completed the 
assigned study interventions within the first 12 months of participation.  
3.3.2 Total Number of Study Sites/Total Number of Subjects Projected 
The study will be conducted at approximately six healthcare sites, including CHOP primary 
care sites (Cobbs Creek, Karabots and South Philadelphia), CHOP ED and approximately 
two Federally Qualified Health Centers serving West Philadelphia, and no greater than 40 
elementary schools according to the number of schools agreeing to participate. This includes 
as many as 30 public schools and as many as ten public charter schools located in the West 
Philadelphia area. 
Recruitment will stop when 640 subjects are enrolled. It is expected that at least 600 
children will be evaluable subjects.  
3.4 Study Population.   
3.4.1 Inclusion Criteria 
1) Parents (guardians) and their children ages 5-13 years 
- Children will include those who:  
a) Have a diagnosis of asthma 
b) Have uncontrolled Asthma (as evidenced by one or more asthma 
exacerbations requiring oral steroids within the past year -OR- 2 ED visits for 

 
  
 
 
 
11
asthma within the past year -OR- 1 inpatient admission for asthma within the 
past year). 
c) Reside in one of seven West Philadelphia zip codes:(19104, 19131, 19139, 
19142, 19143, 19151, 19153) 
d) Are enrolled in elementary school 
e) Are patients at primary care provider practices at CHOP CN Cobbs Creek, 
CHOP CN Karabots, CHOP CN South Philadelphia, PAMCOP or a 
Federally Qualified Health Center serving West Philadelphia residents. 
2) Parental/guardian permission (informed consent) and if appropriate, child assent. 
3) English Speaker 
3.4.2 Exclusion Criteria 
1) Subjects with other chronic respiratory illnesses such as cystic fibrosis 
2) Cyanotic congenital heart disease 
3) MRCP-Mental retardation and/or cerebral palsy 
4) Severe Neurological Disorder 
5) Cyanotic congenital heart disease 
6) Parents/guardians or subjects who, in the opinion of the Investigator, may be non-
compliant with study schedules or procedures. 
7) Those who do not live in West Philadelphia (zip codes: 19104, 19131, 19139, 19142, 
19143, 19151, 19153) 
Subjects that do not meet all of the enrollment criteria may not be enrolled. Any violations 
of these criteria must be reported in accordance with IRB Policies and Procedures.  
4 
STUDY PROCEDURES  
4.1 Screening Visit 
• Medical Record Review of the child 
• Verbal consent/complete eligibility screening 
• Identify child’s elementary school 
• Schedule first visit  
4.2 Study Treatment Phase 
4.2.1 Study Visit 1 (Enrollment) 
All study participants will complete the following: 

 
  
 
 
 
12
• Consent/Assent 
• Baseline Questionnaire  
• Clinical and vital sign measurements of child [weight, height, BMI, blood pressure, 
pulse, temperature, pulse oximetry (SpO2)] 
• Pulmonary function test (spirometry) with child if not obtained from medical record 
• 2-week parental recall of symptoms, school absences, and work days missed 
• Asthma Control Questionnaire  
• Child Asthma Risk Assessment Tool (CARAT)  
• Caregiver’s Quality of Life Questionnaire 
• Caregiver Needs Assessment 
• Cost Analysis Parent Questionnaire 
• Observe MDI technique and complete MDI Checklist 
• Assess possible adverse events from date of enrollment 
4.2.2 Study Visits 2, 3, and 4 (Primary Care Office Visits)  
Primary Care office visits will be scheduled for 3, 6 and 9 months post study enrollment. All 
study participants will complete the following: 
• Asthma Control Questionnaire 
• Clinical and vital sign measurements of child [weight, height, BMI, blood pressure, 
pulse, temperature, pulse oximetry (SpO2)] 
• Pulmonary function test (spirometry) with child if not obtained from medical record. 
• 2-week parental recall of symptoms, school absences, and work days missed 
• Cost Analysis Parent Questionnaire 
• Assess possible adverse events  
• Review child’s medical record for utilization of healthcare services 
• Review care coordination goals and direct to community resources 
4.2.3 Study Visit 5 (12-Month Follow-Up) 
All study participants will complete the following: 

 
  
 
 
 
13
• Pulmonary function test (spirometry) with child if not obtained from medical record. 
• Clinical and vital sign measurements of child [weight, height, BMI, blood pressure, 
pulse, temperature, pulse oximetry (SpO2)] 
• 2-week parental recall of symptoms, school absences, and work days missed 
• Asthma Control Questionnaire 
• Caregiver’s Quality of Life Questionnaire 
• Cost Analysis Parent Questionnaire 
• Child Asthma Risk Assessment Tool (CARAT) 
• Administer Asthma Knowledge Quiz 
• Observe MDI technique and complete MDI Checklist 
4.3 Primary Care Based Intervention: 
4.3.1 Study Visit 1 (Baseline) 
Additional components of Visit 1 will include:  
• Care coordination goals developed with the parent/caregiver 
• Coordinate school forms, medications and devices 
4.3.2 Home Visit 1 
Initial home visit scheduled within 2 weeks of enrollment. Primary care CHW will do the 
following with the child and parent/caregiver: 
• Administer home environmental assessment survey 
• Take photographs of child’s bedroom and home’s main living area (environmental 
remediation assessment) 
• Educate about asthma basics and asthma trigger avoidance  
• Review asthma medications and asthma care plan 
• Administer Asthma Knowledge Quiz 
• Observe MDI technique with either the child or the parent/caregiver 
• Give asthma supplies tailored to environment and show caregiver how to use  

 
  
 
 
 
14
• Assess possible adverse events  
• Review child’s medical record for utilization of healthcare services 
• Establish care coordination goals and refer to community resources as needed 
4.3.3 Home Visit 2 
Second home visit is scheduled within 4 weeks of enrollment. Primary care CHW will do 
the following with the child and caregiver/parent: 
• Complete follow-up home environmental assessment 
• Educate about types of asthma medications, how they work and how to use them 
properly 
• Review asthma medications and asthma care plan 
• Give asthma supplies tailored to environment and show caregiver how to use  
• Observe MDI technique with the child or the parent/caregiver 
• Assess possible adverse events  
• Review child’s medical record for utilization of healthcare services 
• Review care coordination goals and refer to community resources as needed 
4.3.4 Home Visit 3 
Third home visit is scheduled within 6 weeks of enrollment. Primary care CHW will do the 
following with the child and parent/caregiver: 
• Complete follow-up home environmental assessment 
• Take photographs of child’s bedroom and home’s main living area (environmental 
remediation assessment)  
• Educate about communicating with teachers and family members about asthma 
• Review asthma medications and asthma care plan 
• Observe MDI technique with the child or the parent/caregiver 
• Administer Asthma Knowledge Quiz  
• Assess possible adverse events  
• Review child’s medical record for utilization of healthcare services 

 
  
 
 
 
15
• Review care coordination goals and refer to community resources as needed 
4.3.5 Study Visits 2, 3, and 4 (Primary Care Office Visits)  
Additional components of Study Visits 2, 3, and 4 will include:  
• Coordinate school forms, medications and devices 
• Teach asthma care plan 
• Review care coordination goals and refer to community resources as needed 
4.3.6 Home Visit 4 (12-Month Follow-Up) 
• Follow-up environmental assessment 
• Take photographs of child’s bedroom and home’s main living area (environmental 
remediation assessment) 
• Administer Asthma Knowledge Quiz 
In between visits: 
• Primary care CHW will ensure that caregiver has all forms needed for rescue 
medication administration at school. Participants attending an intervention school 
may have rescue and controller medications hand delivered to school nurse through 
transfer from primary care CHW to school CHW at weekly meetings. 
4.3.7 Study Visit 6 (Post 12-Month Follow-Up) 
• Administer CHW Caregiver Satisfaction Survey 
• Administer Asthma Control Questionnaire 
• 2-week parental recall of symptoms, school absences, and work days missed  
4.3.8 Unscheduled Visits 
Usual care includes the caregivers’ ability to make clinical visits for their children whenever 
they feel that it is necessary. In addition, caregivers may contact the CHW for an 
unscheduled visit via cell phone for non-clinical issues to assist them in meeting their goals.  
CHW will assess goals on a case by case basis and make follow-up calls as needed. If the 
CHW is requested to accompany caregivers for unscheduled visits, the CHW will do their 
best to accommodate the caregivers’ needs.  CHWs are expected to contact families within 
48 hours after receiving phone messages from families or patients to assess whether a home 
visit or a primary care office follow-up appointment is needed.  

 
  
 
 
 
16
4.4 School Intervention 
4.4.1 Community Health Worker Coordination 
The primary care CHW will contact the school CHW to identify newly consented children 
present in each West Philadelphia elementary school participating in the study during 
weekly team meetings. The primary care CHW will then be responsible for contacting the 
child’s caregiver to arrange a visit for collection of appropriate forms and medications. 
4.4.2 School Nurse Coordination 
School CHW will: 
• Provide a portable locked filing cabinet that can be stored in the school nurse’s office 
for study participants 
• Help school nurse with filing medication administration forms (med1 forms) and 
attaining asthma medications for study participants. 
4.4.3 Classroom Environmental Assessments 
School CHW will:  
• Visit participant classrooms to do an environmental assessment for asthma triggers 
within the first 2 weeks of enrollment in the study.  
• Using environmental assessment findings, advise teacher of appropriate asthma 
trigger avoidance measures. 
• Provide teacher with supplies to assist in decreasing asthma triggers in the 
classroom. Supplies may include white vinegar and a spray bottle for cleaning, 
electrostatic dust cloths (dusters), and storage bins. School CHW will notify 
appropriate school personnel of any pest problems identified in the classroom. 
4.4.4 Open Airways for Schools Curriculum 
Implementation of the Open Airways for Schools Curriculum will occur over three to six 
asthma management education sessions. 
• The school CHW will conduct Open Airways for Schools classes at least once every 
semester for children with asthma facilitated by the school nurse or designated 
school staff by the principal. 
• Classes with be separated into sessions by grade. 
4.4.5 School Based Asthma Therapy 
School Based Asthma Therapy (SBAT) involves the administration of controller or 
preventive asthma medication at school in addition to rescue asthma medication as needed. 
School CHW will coordinate with teachers/school administers for all children that attend a 
school with the asthma intervention and have a primary CHW. To do this, school CHW will:  
• Schedule an initial intake for children receiving SBAT 
• Utilize an MDI checklist for school nurse or school CHW to assess child’s ability to 
self-administer his/her medication 

 
  
 
 
 
17
• Schedule a time for the child to return to the school nurse’s office for daily 
medication administration.  
• Utilize a tracking system for the child’s medication use (rescue and controller) 
4.5 Rescue Medication Administration 
Participants may use asthma rescue medication if there is an exacerbation in his/her asthma 
symptoms in the school, home and clinic as a part of their usual care. 
4.6 Subject Completion/Withdrawal 
Subjects may withdraw from the study at any time without prejudice to their care.  They 
may also be discontinued from the study at the discretion of the Investigator for lack of 
adherence to study procedures. It will be documented whether or not each subject completes 
the clinical study. If the Investigator becomes aware of any serious, related adverse events 
after the subject completes or withdraws from the study, they will be recorded in the source 
documents and on the CRF. 
Subjects who become a ward of the state during study participation will continue to have 
their medical records reviewed, but will no longer participate in study visits or the 
completion of questionnaires. The state agency assigned legal guardianship of the 
participant will be asked to provide consent for medical record review of the participant 
during the study follow-up period. If consent cannot be obtained the participant will be 
withdrawn. 
 
In the event that a parent or legal guardian regains custody and a participant is no longer a 
ward of the state, the legal guardian may be approached to provide consent for study 
participation. Once consent has been obtained, study visits can resume for the duration of 
the follow-up period.  
 
4.6.1 Early Termination Study Visit 
If participants withdraw prior to completing the study, all previously collected data will be 
stored and used for analysis.  
5 
STUDY EVALUATIONS AND MEASUREMENTS 
5.1 Individual Participant Measures 
• Children will be measured for height and weight (using standard scales and 
stadiometers), blood pressure, pulse, temperature, and pulse oximetry (SpO2) at 
baseline, 3, 6, 9, and 12 months following enrollment. This information may also be 
abstracted from the medical record. 
• Pulmonary function tests (spirometry) will be abstracted from the electronic 
health record if possible. If spirometry is not completed by the child’s healthcare 
team as a part of usual clinical care, it will be completed by a trained community 
health worker at baseline, 3, 6, 9 and 12 months post-enrollment. Each recording will 
be printed out to become a part of the child’s medical record. Pulmonary function 
testing completed for clinical purposes within one month before or after a baseline or 

 
  
 
 
 
18
follow-up study visit will be abstracted from the medical record if testing is unable to 
be completed at the time of a study visit. 
• Juniper’s Asthma Control Questionnaire is a validated survey and will be 
administered by a member of the research team to the parent/caregiver by reading 
out loud to avoid any literacy barriers. This will be administered at baseline, 3 
months, 6 months, 9 months and 12 months 
• A home environmental assessment will be conducted by a CHW in the living room 
and child sleeping area to note common triggers such as dust, pests, pets, mold and 
tobacco smoke measured at Home Visits 1, 2, 3, and 4.  
• CAPP’s asthma knowledge survey will be used to assess knowledge at home visits 
before, during and after the primary care intervention. This survey may be 
administered out loud to the parent/caregiver to avoid any literacy barriers. 
• CHW will ask parent/caregiver for a 2-week recall of daytime cough or wheeze, 
nighttime cough or wheeze, missed school days, missed parent workdays at the 
time of the visit. This will be recorded on a tracking form in REDCap. 
• The Caregiver Needs Assessment will be administered to the parent/caregiver at the 
baseline visit. The needs assessment is a validated instrument that focuses on the 
caregiver’s knowledge about asthma avoidance measures and their comfort level 
with managing their child’s asthma. For participants receiving the primary care 
intervention, this tool will assist the primary care community health worker with 
tailoring the educational component of the program to fit the needs of the individual 
family. 
• Adverse Event Forms will be completed as needed throughout study participation. 
5.2 Group Level Primary care and School Measures  
• A REDCap tracking form will be used for documentation of time, date and dose of 
medication dispensed in School Based Asthma Therapy. This information will be 
collected and recorded by the school CHW. 
• A classroom environmental assessment form will be completed by the school 
CHW at baseline and at end of semester for study participant classrooms. 
• As a part of the Open Airways for Schools Curriculum, an Open Airways Quiz will 
be administered at the beginning and end of a school asthma management class 
series. 
• Fidelity to the school EBI’s will be monitored via observation by study research staff 
utilizing yes/no completion checklists of core components of each intervention. 
These checklists include the MDI checklist, OAS lesson plan and classroom 
environmental survey once each semester. It is expected that 90% of the core 
components will be implemented for maintenance of fidelity to the intervention.  
5.3 Screening and Monitoring Evaluations and Measurements 
5.3.1 Medical Record Review 
The following variables will be abstracted from the medical chart. 
• Date of birth 

 
  
 
 
 
19
• Weight 
• Height 
• Blood pressure 
• Pulse 
• Temperature 
• SpO2 (Pulse Oximetry) 
• Zip code of residence 
• Gender 
• Race/Ethnicity 
• BMI 
• Pulmonary function test results  
• Asthma-related healthcare utilization (hospital, emergency, urgent care visits) 
5.3.2 Physical Examination 
No physical exam outside of usual care will be conducted in this study. 
5.3.3 Vital Signs 
Weight will be measured with a standardized scale. 
Height will be measured with a standardized stadiometer. 
Blood pressure, pulse, temperature and SpO2 will be measured by clinic staff using standard 
clinical procedures and equipment. This information will be abstracted from the medical 
record by study staff. 
Pulmonary function will be measured using a Morgan Scientific spirometer.  
5.4 
Efficacy Evaluations 
Primary Outcome: 
1. Asthma Control 
Secondary Outcomes: 
1. Asthma Symptom Days 
2. School Attendance 

 
  
 
 
 
20
3. Utilization of ED/Hospital for Asthma 
5.4.1 Diagnostic Tests, Scales, Measures, etc. 
Primary Outcome: 
• Asthma control will be measured with Juniper’s Asthma Control Questionnaire at 
baseline, 3 month, 6 month, 9 month and 12 month study visits. We will assess for 
changes in the ACQ scores from enrollment to completion of the study.  
Secondary Outcomes: 
• Asthma Symptoms will be measured using a 2 week recall diary at the baseline, 3 
month, 6 month, 9 month and 12 month study visits. 
• School Absences will be measured by school and parental report  
• ED visits and hospitalizations for an asthma-related cause (ICD-9 493.XX) in the 
12 months preceding the start of the study and the 12 months subsequent to study 
initiation, abstracted from the Epic medical record.  We will assess for changes in 
ED and hospitalization usage following study enrollment.   
5.5 Safety Evaluation 
Adverse event reports will be collected at each visit. These reports will be reviewed at 
weekly meetings by the PI to determine if they are a result of the study. 
The Funding agency will assemble a DSMB to oversee safety of the interventions. 
6 
STATISTICAL CONSIDERATIONS 
6.1 Primary Endpoint 
The primary endpoint is the difference in asthma control between the intervention and the 
control group. 
6.2 Secondary Endpoints 
Secondary endpoints will include the following: 
• The change in asthma symptom days between the intervention and the control group 
• The change in school absences between the intervention and the control group  
• The change in ED visits and inpatient hospitalizations for an asthma-related cause 
between the intervention and the control group. 
6.3 Statistical Methods 
6.3.1 Baseline Data  
Baseline and demographic characteristics will be summarized by standard descriptive 
summaries (e.g. means and standard deviations for continuous variables such as age and 
percentages for categorical variables such as gender). 

 
  
 
 
 
21
6.3.2 Efficacy Analysis 
The primary analysis will be based on an intention to treat approach and will include all 
subjects randomized at Study Visit 1.  The primary efficacy endpoint will be the change in 
asthma control between Study Visit 1 and Study Visit 5.  Secondary efficacy endpoints will 
include the change in asthma symptom days and school absences between Study Visit 1 and 
Study Visit 5.   
6.3.3 Subgroup Analysis: Mediator and Moderator Variables 
Baseline variables including asthma control, BMI, school type (public/charter) and 
demographic characteristics which may serve as moderators of intervention effectiveness 
will be evaluated through subgroup analyses. These variables will be used to identify 
subgroups of children that may be more likely to benefit from the study interventions. 
Mediator variables such as communication between school and primary care and level of 
participation in school-based asthma therapy will be evaluated to better understand the 
mechanism of effect of the intervention on the study’s primary outcomes. 
6.4 Sample Size and Power 
The factorial design has enhanced statistical power and can handle cluster randomization of 
schools. Our statistical methods will also estimate variation in the effect across schools over 
time. First, linear mixed effects models with random intercepts and slopes for school, and 
fixed effects for the school-level intervention, time, and time-by-intervention interaction (the 
estimate of interest) will be applied. Likewise, the main effect for the child-level 
intervention and a time*intervention interaction term will be included in the model, and 
variation across multiple measurements on a child within a school will be accounted for by 
child-level random effects. Second, marginal models using generalized estimating equations 
will produce robust estimates that adjust for clustering at the school level. Third, 
assumption-free, randomization-test-based (permutation test) methods do not rely on 
assumptions of parametric models. We will use conventional levels of statistical significance 
(p=0.05) for all pre-specified comparisons for these aims and shall report all results to 
confirm consistency of findings and their robustness to model specifications. Variability of 
the intervention effect across schools will reflect consistency of intervention effects and thus 
generalizability in new settings. Both mixed effects models and permutation-test methods 
will estimate variance components. All contrasts noted in specific Aims 1a through 1d are 
handled with the same modeling specifications. This approach will also be used to account 
for change over time across schools, and to assess sustainability of the proposed 
interventions.   
Missing data on covariates will be handled using formal multiple imputation as needed. The 
proposed mixed effects models make limited assumptions of “missing at random” (MAR). 
To the extent that children are lost to follow-up, we shall include in our models covariates 
that are associated with the probability of dropout to limit confounding by dropout. We 
anticipate no school withdrawals, but in case of loss, we will use all data collected until time 
of dropout. The primary analysis will be “as randomized” (also called intention to treat). 
Reporting will follow the CONSORT guidelines for randomized studies and cluster 
randomized designs.  

 
  
 
 
 
22
All power estimates are based on custom programmed simulations. The pre-specified 
contrasts from specific aims 1a, 1b, and 1c, appear in Table 2. All power estimates represent 
changes over time in the primary outcome (asthma control) in units of standard deviation of 
change. For translation into clinical terms, the minimally important difference (MID) for 
children on the Juniper’s Asthma Control Questionnaire is 0.5 standard deviation units, 
which equates to 0.4 units on the questionnaire scale (for children ages 6 to 17 years). 
Estimates assumed a modest degree of variation in outcomes across schools, which equates 
to clustering of children within schools. For an overall effect size of 0.5 standard deviation 
units, we assumed that individual schools would vary from no effect (0.0) to a large effect 
(1.0 sd units). This degree of variation corresponds to a random cluster (school) effect of 
0.025 sd units, and an intraclass correlation coefficient (ICC) of 0.06.  With an average of 28 
children per school, this variability equates to a design effect (variance inflation factor) of 
about 2.5.   As the table shows, the contrasts for the primary care intervention are powerful 
to show even small effects, because they are within-cluster comparisons and therefore are 
influenced if at all only slightly by clustering of children within schools. Across school 
contrasts, of the effects of the school intervention, remain powerful for MID changes. 
Table 2.  Power for Contrasts of Interest  
 
Specific 
Aim 
Contrast 
Contrast 
(Table cell) 
Stipulated 
Effect size(sd) 
Estimated 
Power 
 
 
 
P 
S 
P,S 
 
1a 
S+ v S- 
a,b vs c,d 
0.5 
0.5 
0.1 
0.90 
1a 
P+ v P- 
a,c vs b,d 
0.25 
0.25 
0.1 
0.95 
1b 
1b 
S+P+ v S-P+ 
S+P+ v S+P- 
a vs c 
a vs b 
0.5 
0.35 
0.5 
0.5 
0.1 
0.0 
0.95 
0.88 
1b 
S- P+ v S+P- 
b vs c 
0.75 
0.25 
0.0 
0.92 
1c 
S+P+ v S-P- 
a vs d 
0.25 
0.25 
0.1 
0.96 
1c 
S- P+ v S-P- 
c vs d 
0.35 
0.5 
0.0 
0.90 
1c 
S+P- v S-P- 
b vs d 
0.5 
0.5 
0.1 
0.90 
20% 
Subgroup 
 
 
 
 
 
2a 
S+ v S- 
a,b, vs c,d 
0.5 
0.6 
0.1 
0.83 
2a 
P+ v P- 
a,c vs b,d 
0.5 
0.6 
0.1 
0.88 
P=Primary care effect; S=School Effect; PS= interaction;  “+” = , “-“ = control 
Cells e, f are not included in this table for simplicity and to be conservative. 
6.5 Interim Analysis 
Interim efficacy or safety analyses not expected.  

 
  
 
 
 
23
7 
STUDY MEDICATION (STUDY DEVICE OR OTHER STUDY INTERVENTION) 
7.1 Description  
All medication taken by participating children will be prescribed by their primary care 
provider. 
8 
SAFETY MANAGEMENT 
8.1 Clinical Adverse Events 
Clinical adverse events (AEs) will be monitored throughout the study.  
8.2 Adverse Event Reporting 
Since the study procedures are not greater than minimal risk, SAEs are not expected. If any 
unanticipated problems related to the research involving risks to subjects or others happen 
during the course of this study (including SAEs) they will be reported to the IRB in 
accordance with CHOP IRB SOP 408: Unanticipated Problems Involving Risks to Subjects. 
AEs that are not serious but that are notable and could involve risks to subjects will be 
summarized in narrative or other format and submitted to the IRB at the time of continuing 
review.  
9 
STUDY ADMINISTRATION 
9.1 Treatment Assignment Methods 
9.1.1 Randomization 
Allocation concealment will be preserved by randomly permuted block.  This randomization 
will produce a 2-by-2 factorial design, partly clustered (by school). 
 
 
 
 
 
 
 
The proposed design results in 6 groups of children. Children who do not attend a 
participating school will be randomized to the primary care CHW (child-level) intervention 
or not (groups E and F) and will be followed for the duration of the study. The cells A,B,C 
will permit comparison of any of the 3 combinations of school and child intervention against 
the group that has neither (D), and will permit marginal analysis of the effect of the school 
intervention (A+B vs C+D), and the marginal effect of the primary care intervention 
TABLE 3 
Child-Level 
Intervention 
P+ 
P- 
School 
Level 
Intervention 
S+ 
A 
B 
S- 
C 
D 
none 
E 
F 

 
  
 
 
 
24
(A+C+E vs B+D+F).  We will collect baseline data on children and then follow schools and 
children over time. This design avoids contamination and interference through cluster 
randomization, but benefits from added power of a longitudinal analysis. It permits 
estimation (and testing) of interaction between the school and individual interventions. All 
randomization schemes will be prepared by the project statistical team and implemented 
using opaque sealed envelopes or a similar process electronically via REDCap.  
9.1.2 Blinding 
The PI will be blinded to the intervention/treatment group to the extent possible.  
9.1.3 Unblinding 
Unblinding will occur if there is an adverse event that warrants investigation or if the DSMB 
instructs the PI to become unblinded. 
9.2 Data Collection and Management 
For the study intervention, data will be collected, accessed and stored by the CHWs and 
study research team. Any paper forms will be stored in a locked cabinets in the Community 
Asthma Prevention Program’s (CAPP) badge-only accessible suite. Data collected using 
REDCap is accessible only by the CHWs and research study staff. Designated school 
administrators (i.e. principal), the school nurse and the child’s primary care provider will 
only have access to participant health care information necessary to conduct asthma 
management in the schools and primary care office, but none of the research data collected 
by the CHWs and study staff. Information will be kept confidential under HIPPA guidelines 
and Institutional policies. 
We will implement the following: 
• A master list containing PHI and subject ID number separate from data forms (paper 
and electronic) that have only a study ID number.  
• The master list and any other files with be password protected and kept on a secure 
CHOP computer to prevent double enrollments. 
CHOP’s Department of Biomedical and Health Informatics (DBHi) will work with the 
research team to extract variables from the EHR, and also provide support for the design and 
use of the REDCap database. 
9.3 Confidentiality 
All data and records generated during this study will be kept confidential in accordance with 
Institutional policies and HIPAA on subject privacy. The Investigator and other site 
personnel will not use such data and records for any purpose other than conducting the 
study. Hard data will be kept in locked file cabinets in the CAPP suite, and will be destroyed 
10 years after the end of the study unless subjects consent to contact regarding future 
research. Any soft data or electronic data will be password protected and kept on a secure 
CHOP computer.  

 
  
 
 
 
25
9.4 Regulatory and Ethical Considerations 
9.4.1 Data and Safety Monitoring Plan 
The study sponsor will appoint members to a Data and Safety Monitoring Board. Reporting 
on study conduct, safety measures, data collection and analysis will be provided to the 
DSMB. 
9.4.2 Risk Assessment 
Potential risks directly related to the study are minimal. Children may have difficulty with 
pulmonary function testing, which may be included as a part of their usual care depending 
on the child’s healthcare team, or collected by a trained CHW. Risks indirectly related to the 
study, particularly in a group of children where no evidence-based interventions are being 
conducted may include challenges with asthma management which may lead to ED visits or 
hospitalizations. 
Another risk is the potential breach of confidentiality for participant data. When possible, 
data will be coded by study personnel through the use of participant identification numbers. 
Any screening referrals from the community will be faxed to a confidential fax line. In 
addition, participants could potentially feel discomfort with engaging in any of 
interventions, as questions may be posed requiring personal information.  
9.4.3 Potential Benefits of Trial Participation 
Direct benefits: Community Health Workers providing the connection between the home, 
school and primary care practice may reduce the burden on caregivers and facilitate asthma 
management for school-aged children. Additionally, as community residents, CHWs are 
knowledgeable about the public school system and can help parents connect to local 
resources. Participants will also benefit from asthma management education. 
Indirect benefits: This project utilizes a pragmatic, integrated and sustainable design with 
evidence-based interventions to reduce asthma disparities in poor, minority children. We 
have engaged stakeholders with experience in the community, school district, health plans 
and health care systems to implement community and evidence-based interventions. These 
interventions, if proven successful, will reduce the disproportionate impact of asthma on 
minority children through the number of missed school days, ED visits and hospitalizations 
due to asthma exacerbations and also create a sustainable care-coordination model that can 
be replicated in other communities.  
9.4.4 Risk-Benefit Assessment 
There are minimal risks due to the possibility of loss of confidentiality and possible 
discomfort from answering questions.  There are significant benefits to be gained through 
participation in the primary care CHW program.  We will, to the best of our capabilities, 
ensure minimal risks by 1) assigning study identification numbers to patient records and for 
data collection purposes. Only these numbers will be shared with third parties. 2)  The 
caregiver will always have the option of refusing to answer or participate in any component 
of the study without change to usual care. 

 
  
 
 
 
26
9.5 Recruitment Strategy 
We will screen electronic health records to recruit 640 parent-child dyads with children ages 
5-13 years old with uncontrolled asthma (evidenced by one or more asthma exacerbations 
requiring oral steroids -OR- one hospitalization within the past year -OR- two ED visits 
within the past year) from up to five primary care centers (CHOP CN – Cobbs Creek, CHOP 
CN - Karabots, CHOP CN – South Philadelphia, The Pediatric and Adolescent Medicine 
Centers of Philadelphia (PAMCOP) and Federally Qualified Health Centers) who serve 
families who live in the seven West Philadelphia ZIP codes (19104, 19131, 19139, 19142, 
19143, 19151, 19153). In addition, CHOP Emergency Department (ED) will screen 
electronic health records and refer children for enrollment at the primary care sites when 
they are seen in the ED. The majority of eligible participants will be identified through 
medical record review and documented on the screening form completed by the CHW or 
research assistant in the primary care centers or CHOP ED. A waiver of consent will be used 
to facilitate this process. If additional information is needed to determine eligibility, the 
CHW will approach families to see if they are interested in being screened for any missing 
information on the screening form. The screening form will be reviewed by study staff (SC 
and PI) to confirm study eligibility.  
We will also post flyers in our CHOP primary care centers, CHOP ED, and also in 
partnering community centers. These flyers will contain the CAPP main phone number and 
email address for families interested in participating in the study. Community partners can 
also refer children at community events for study screening by research staff. 
The Recruitment Enhancement Core (REC) at CHOP provides assistance with recruitment 
plan development and may assist us in identifying and contacting potential participants 
using the Clinical Reporting Unit (CRU), the CHOP Recruitment Registry, social media and 
internal communication resources. The REC also engages community partners and 
facilitates outreach on behalf of the research Institute and CHOP research studies. 
9.6 Informed Consent/Assent and HIPAA Authorization 
For the screening process, a waiver of consent documentation and HIPAA will be used. For 
children and parents/caregivers interested in the study, they will be given explicit 
information regarding the purpose and procedures of the program, the family will then be 
asked if they have any questions.  The family will be given a consent form that will be read 
to them by a member of the study team describing the study procedures, the purpose of the 
study, that their consent to participate in the study is strictly voluntary, and that should they 
consent, they have the right to end study procedures at any time.  Parents who agree to 
participate will sign an IRB-approved combined informed consent form and HIPAA 
authorization on paper using a handwritten signature or on a tablet device using an 
electronic signature. Consent discussions may be held remotely by phone or through 
videoconference using a HIPAA-compliant application licensed by CHOP including but not 
limited to BlueJeans and Skype. For consent discussions held remotely, through video 
conferencing or by telephone, parents will be provided with a REDCap survey link to the 
informed consent and HIPAA authorization to review and sign electronically. Alternatively, 
parents with limited internet access can provide verbal consent for participation. Electronic 
informed consent forms will be stored and managed in the study’s REDCap database. Child 

 
  
 
 
 
27
assent will be handled in the same fashion. All participants will receive a copy of the signed 
informed consent form and HIPAA authorization. The electronic consent form will include 
the patient and caregiver’s typed names and written signatures using a stylus pen. 
Participants who provide an electronic signature will receive a copy of the signed document 
by email or a printed copy will be provided at the conclusion of the consent meeting. 
Participants providing verbal consent will receive a copy of the informed consent and 
HIPAA authorization and documentation of verbal consent via U.S. postal mail.  
9.7 Payment to Subjects/Families 
9.7.1 Payments to subject for time, effort and inconvenience (i.e. compensation) 
Data will be collected for all individually randomized participants at baseline, 3, 6, 9 and 12 
months by the research assistant or primary care CHW in person or by phone. Participants 
will be compensated $25 for each visit with data collection at baseline, 3, 6, and 9 months 
and $45 for the end of study visit at 12 months.  
9.7.2 Gifts 
During the study, birthday and holiday cards will be sent by mail to enrolled participants. 
Annually, a small holiday gift such as a jump rope, sports ball or a similar item valued at no 
more than $10 may be provided to each enrolled child. 
10 PUBLICATION 
Data may be used for scientific papers and presentations at medical conferences.  All data is 
reported in aggregate form and individuals are never identified.  
 
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31
APPENDIX 
A. Initial Home Environmental Assessment 
B. Follow-up Home Environmental Assessment 
C. Initial School Environmental Assessment 
D. Follow-up School Environmental Assessment 
E. Care Coordination Goals Form/Tracking Sheet 
F. Asthma Control Tool 
G. Asthma Knowledge Quiz (Pre/Post) 
H. Caregiver Needs Assessment survey 
I 
Caregiver Satisfaction Survey 
J. MDI checklist  
K. Paediatric Asthma Caregiver’s Quality of Life Questionnaire (PACQLQ) 
L. Pulmonary function test data collection form 
M. Intake Survey 
N. 3, 6, 9, 12 Month Follow-up Survey 
O. CARAT Survey 
P. You Can Control Asthma Curriculum