Respiratory Exacerbation Plans for Action and Care Transitions for Children With Severe Cerebral Palsy (CP)
Phase: NA
Conditions: Cerebral Palsy
Sponsor: University of Wisconsin, Madison

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RE-PACT: Respiratory Exacerbation Plans for Action and 
Care Transitions for Children with Severe CP 
Principal Investigator: Ryan Coller, MD, MPH 
 
Grant Number: 1R31HL153570-01A1 
Funded by: NHLBI 
15 November 2021 
NCT 05292365 
v. 2.24.23 
 
  
Investigator Contact Information: 
Name: 
Affiliation:  
Ryan Coller, MD, MPH 
UW-Madison School of Medicine, Department of Pediatrics 
Address:  
600 Highland Avenue, Madison, WI  53792 
Telephone:  608-263-9408 
Email:  
rcoller@pediatrics.wisc.edu 
 
Sub Investigator Contact Information: 
Name: 
Affiliation:  
Carlos Lerner, MD, MPhil 
University of California-Los Angeles, Department of Pediatrics 
Address:  
10833 Le Conte Avenue, Los Angeles, CA 90095 
Telephone:  310-825-0867 
Email:  
clerner@mednet.ucla.edu 
 
 

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1 PROTOCOL SUMMARY 
1.1 SYNOPSIS 
Title: 
Respiratory Exacerbation Plans for Action and Care Transitions 
for Children with Severe CP  
Grant Number: 
1R31HL153570-01A1  
Study Description: 
This study will pilot test a just-in-time adaptive intervention to re-
duce severe respiratory illness, for children with severe cerebral 
palsy (CP). Our intervention program, called RE-PACT, delivers 
timely, customized action planning and health coaching when mo-
bile text messaging with families predicts hospitalization risk is el-
evated. The study period will be divided into three waves: after 
each wave, feasibility, acceptability, and fidelity data will be re-
viewed against pre-defined measures of success to adjust the proto-
col and overcome implementation barriers. 
 
Objectives*: 
 
Primary Objective: To establish feasibility, acceptability, and  
fidelity of RE-PACT in 90 children with  
severe CP. 
Secondary Objec-
tives: 
To establish effect size of RE-PACT.  
 
Endpoints*: 
 
Primary Endpoint: The primary outcomes are pre-defined 
measures of feasibility, acceptability and  
fidelity of targeting RE-PACT and/or  
assessments to children with severe CP 
 
Secondary End-
points: 
The primary clinical outcome is severe res-
piratory illness, defined as respiratory diag-
nosis requiring hospitalization. 
  
Addition secondary clinical endpoints in-
clude: total hospital days during severe res-
piratory illness, numbers of systemic steroid 
courses, systemic antibiotic courses, respira-
tory ED visits, and death 
 
Study Population: 
This intervention will recruit primary caregivers of children with 
severe CP. A total of n=90 caregivers of children with severe 
(GMFCS level V) CP, ages 0-17 years and cared for by a respira-
tory specialist or receiving daily respiratory treatments will be en-
rolled. Caregivers will be at least 18 years of age and have a phone 
capable of sending/receiving text messages. Subjects will speak 
English or Spanish. There are no additional demographic enroll-
ment criteria. Participants will be recruited from pediatric complex 

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care programs at the University of Wisconsin-Madison (UW) and 
the University of California, Los Angeles (UCLA). 
 
Phase* or Stage: 
 
Behavioral Health Intervention Study 
Description of Sites/ 
Facilities Enrolling  
Participants: 
The two-site study takes place at clinical programs at US children's 
hospitals: the UW and UCLA Pediatric Complex Care Programs 
were each established to deliver care to children with medical 
complexity. Each program is comprised of primary care providers, 
care coordinators, and extended visit lengths, deliver comprehen-
sive care to children with cerebral palsy. These sites have existing 
collaborative relationships through their participation in the 
CYSHCNet national research network (http://cyshcnet.org) and 
other federally funded initiatives, and a track record of successful 
productive scientific collaboration. 
 
Description of Study Inter-
vention/Experimental Ma-
nipulation: 
 
The study period will be divided into three waves: after each wave, 
feasibility, acceptability, and fidelity data will be reviewed against 
pre-defined measures of success to adjust the protocol and over-
come implementation barriers. 
This study will be conducted through a six-month randomized pilot 
trial. Briefly, after recruitment and baseline assessments, eligible 
caregiver/child dyads are randomized to intervention (I) or active 
control (AC). Intervention subjects receive respiratory illness ac-
tion plans and weekly mobile health (mHealth) confidence surveil-
lance. At times of low confidence or hospitalization, just-in-time 
action planning and coaching activities are conducted. AC subjects 
will receive usual comprehensive medical care and coordination. 
Assessments of feasibility, acceptability and fidelity, as well as 
clinical outcomes, will be conducted at baseline and monthly inter-
vals for 6 months. Intervention outcomes will be evaluated at base-
line (i.e., randomization) and 6 months post-enrollment, and will 
also include the primary clinical outcome (i.e., hospitalization for 
respiratory diagnosis).  
 
Study Duration*: 
 
24 months 
 
Participant Duration: 
 
6 months 
 
 
 
 
 
 
 
 
 

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1.2 SCHEMA 
 
 
 
 
 
 
 
Enrollment Period 
(1-3 mon prior to T0)) 
 
 
 
 
 
 
 
Waves 1-3  
(6 months each) 
 
Enrollment 
Visit (T0) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Post-enrollment 
Evaluation 
(T0 + 6 mon) 
 
 
 
Protocol  
refinement 
between  
each wave 
 
 
Total N = 90 
Total by site: AFCH (45) UCLA (45) 
Total by arm: Intervention (45) Control (45) 
Wave 1 (10)  Wave 2 (20)  Wave (60) 
Administer 6-month study assessment 
Identify potential subjects via program rosters and chart review;  
mail families study invitation and information. 
Call families to assess interest and screen for inclusion/exclusion criteria; 
schedule enrollment visit if eligible and interested. 
Obtain informed consent (in-person at clinic visit or remotely via 
WebEx & REDCap survey); administer baseline study assessment 
Randomize 
Intervention Arm 
• Create respiratory illness action plan 
• Weekly mHealth text messages 
• Monthly study assessments 
• Action planning and JIT coaching 
• Usual comprehensive medical care 
and coordination via Complex Care 
Program 
Control Arm 
• Usual comprehensive medical care 
and coordination via Complex Care 
Program 
 
By wave, refine Re-PACT protocol based on feasibility, acceptability, and fidelity measures:  
     Wave 1 – focus on onboarding/training, recruitment, data collection 
     Wave 2 – focus on randomization and intervention activities 
     Wave 3 – focus on rapid enrollment and conducting all protocol activities with high-fidelity 

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1.3 SCHEDULE OF ACTIVITIES 
 
 
 
STUDY PERIOD 
 
Enroll-
ment 
Visit 
REPACT Intervention Period 
Final Visit 
Personnel involved 
Research 
Coordina-
tor  
Clinicians 
Research 
Coordina-
tor 
Month 
0 
1 
2 
3 
4 
5 
6 
End of 
Month 6 
Timepoint 
T0 
T1 
T2 
T3 
T4 
T5 
T6 
T7 
Confirm eligibility 
X 
 
 
 
 
 
 
 
Informed Consent 
X 
 
 
 
 
 
 
 
Baseline Assessment 
X 
 
 
 
 
 
 
 
6-month Assessment 
 
 
 
 
 
 
 
X 
Randomization 
X 
 
 
 
 
 
 
 
Subject Payment 
X 
 
 
 
 
 
 
X 
Usual comprehensive medical 
care and coordination via 
Complex Care Program 
 
X 
X 
X 
X 
X 
X 
 
Intervention Arm Only 
Text Msg Training 
X 
 
 
 
 
 
 
 
Weekly mHealth text mes-
sage and response 
 
X 
X 
X 
X 
X 
X 
 
Intervention overview 
 
X 
 
 
 
 
 
 
Create action plan 
 
X 
 
 
 
 
 
 
Action planning 
 
X 
X 
X 
X 
X 
X 
 
JIT coaching 
 
X 
X 
X 
X 
X 
X 
 
Monthly study 
assessments 
 
X 
X 
X 
X 
X 
X 
 
 
 
 

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2 INTRODUCTION 
2.1 STUDY RATIONALE 
Respiratory illnesses, including aspiration, pneumonia, and respiratory failure, are devastating to 
children with severe cerebral palsy (CP). Respiratory illness is the number one cause of hospitalization 
and death in children with severe cerebral palsy (CP). CP is the most common motor disability in US 
children, and children with CP have 26x higher medical costs than those without, averaging >$1.3M per 
child in lifetime care costs. We define severe CP as spastic quadriplegia, i.e., no independent mobility 
(gross motor function classification system level V). Little progress on respiratory outcomes in CP has 
occurred in the last 40 years. 
 
Severe respiratory illnesses, which we define as respiratory diagnoses requiring hospitalization, are 
considered potentially modifiable in CP. Families are first in line to manage these challenging events 
because the illness emerges at home. However, respiratory care routines are especially difficult for 
families in the setting of limited support to bolster knowledge, skills, and confidence. To bridge this gap, 
parents need clinical teams to provide the right support, at the right time, in the right context, i.e., just-
in-time and adaptive. 
 
Just-in-time adaptive interventions (JITAI) hold promise to help children with CP with respiratory illness. 
Our behavioral intervention, Plans for Action and Care Transitions (PACT) combined action planning with 
caregiver coaching and reduced all-cause hospitalizations for children with complex diseases including 
severe CP. Although PACT’s action plans gave families just-in-time options to manage crises, plans were 
pre-specified, static, and did not adjust to real-time issues. To prevent severe respiratory illness in CP, 
responses must be dynamic, and address the wide array of contexts and comorbidities that drive these 
episodes. Simultaneously, clinicians and families need very simple tools that signal when they need help. 
 
Mobile health (mHealth) approaches linked to clinical teams can easily indicate when families of children 
with CP experiencing respiratory illness need help. Meta-analysis of mHealth interventions suggests 
improved disease control in children, particularly when directed to caregivers. In early-stage studies of 
asthma and COPD, mHealth monitoring / response systems are associated with fewer exacerbations. We 
will integrate an mHealth texting solution with PACT to trigger our just-in-time adaptive intervention for 
severe CP. The objective of this study is to finalize a feasible, acceptable, and high-fidelity adaptive 
intervention, and to determine expected effect sizes for reducing severe respiratory illness for a fully 
powered trial. Completion of the study is necessary to subsequently conduct an adequately powered 
multisite efficacy trial. 
 
 
2.2 BACKGROUND 
Cerebral palsy (CP) is the leading cause of motor disability in childhood8,9 and has grave respiratory 
consequences.13 CP is caused by damage to the developing brain that permanently disrupts the ability to 

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control movement and maintain posture. Children with severe CP have spastic quadriplegia (i.e., all four 
extremities affected) and level V gross motor function classification system [GMFCS] (i.e., no 
independent mobility). Mechanisms of respiratory illness in severe CP parallel those of other 
neuromuscular diseases;27 examples include respiratory muscle weakness, recurrent infections and 
aspiration with inflammatory fibrosis, impaired airway clearance from altered tone, upper airway 
abnormalities and poor chest wall compliance.28,29 CDC estimates >$16B in lifetime cost for the children 
with CP born in 2000 alone.10 
  
Respiratory illness is consistently the #1 cause of death and hospitalization in severe CP.4,30 Only 33% 
of children with CP and four co‐occurring disabilities survive to age 30.31 Respiratory illness accounts for 
59% of deaths3,4 and 25% of hospitalizations1,7,8 in severe CP. Moreover, respiratory illness strongly 
predicts future episodes; respiratory hospitalization risk is 10-fold higher with a respiratory illness in the 
past year.14 In fact, over 20% of hospitalizations are followed by another within 30 days and nearly 70% 
in the next year.7 Hospitalizations for respiratory illness are 76% costlier8 and 2.5 times longer for 
children with severe CP than those without.14 Prevention of these events is a significant need, and a key 
to improving quality of life and mortality.6,13 Though the respiratory illness risk factors in severe CP are 
considered modifiable,14 and despite investments in respiratory care, little improvement in these 
outcomes has occurred in CP in 40 years.1,2,8  
  
The very high utilization and specialized needs of parents of children with severe CP demands unique 
solutions (Box 1). In a 2007-2014 population-based child cohort with severe CP, over 91% had ≥1 
hospitalization (median [IQR], 4 [2-8]).8 Unlike children with single system disease, such as asthma, 
those with severe CP are 100% dependent for every activity of daily living, cannot communicate, and 
have subtle illness signs. Families must monitor high-acuity comorbid conditions and administer 
elaborate care plans despite concerns that they lack preparation and tools to deliver this sophisticated 
care at home.6,13,15,32-35 Parents of children with CP articulate the need for interventions focused on crisis 
management and self-efficacy.7,15,36 
  
Preventing hospitalization requires the opportunity for families and clinical teams to connect early 
enough to change trajectory.15,16,37 Not knowing when just-in-time care is needed is a current barrier to 
effective action planning and health coaching in complex illnesses. Concerns may not reach clinical 
teams until an ED visit or hospitalization is inevitable. Families need their clinical teams to respond to 
early discomfort.38 In fact, a national expert panel to identify interventions to prevent hospitalization of 
children with complex diseases39 concluded that enhanced access, proactive crisis planning, and support 
for caregiver technical skill were key strategies to lower hospital use. Prior post-discharge research 
confirmed that when parents were not confident that their child with chronic conditions could avoid 
hospitalization or ED visit, admissions and ED visits within weeks were predicted better than by other 
clinical or demographic indicators.40,41 Preliminary work with a cohort including children with severe CP 
demonstrated that parent confidence, monitored prospectively and repeatedly by text message is 
feasible, acceptable and predicts hospitalization within 2 weeks. Being able to target rapid “just-in-
time”, customized, clinical response to periods of low parent confidence, before respiratory illness 
becomes crisis, is a key advance of this research. 

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Preventing Respiratory Illness in Severe CP Requires Broad, Adaptive, Timely Intervention. Action 
planning and health coaching are effective strategies in other populations. For example, from 2003 to 
2013, hospitalization rates for pediatric asthma dropped by half (from 9.6% to 4.7%), during which time 
asthma action plan use increased significantly.42 A family intervention linking home-based asthma 
coaching to action planning significantly reduced hospitalizations in poorly controlled asthma.43 
However, respiratory illness in severe CP has broad comorbid triggers, e.g., emesis, dysphagia, 
aspiration, seizures, among others. Simple action plans or coaching alone cannot address the breadth of 
respiratory illness triggers or potential responses. For example, if a parent of a child with severe CP 
follows an action plan directed towards bronchospasm, it would not effectively address an acute 
infectious lower respiratory infection. Parents of children with severe CP need action plans and 
coaching, but they also need an efficient direct extension to their clinical team for adaptive, just-in-time 
clinical response directed specifically to real-time acute problems. 
  
The Plans for Action and Care Transitions (PACT) intervention was developed by this team to prevent 
hospitalizations for children with complex chronic diseases including severe CP. After integrating 
systematic literature review,44 parent interviews,38 and a national expert panel,39 each focused on 
preventing hospitalization, PACT was designed to leverage evidence-based strategies from different 
populations: asthma action planning,45-47 health coaching,48-50 and feedback at our Parent Advisory 
Group’s monthly meetings. PACT delivered action planning and coaching activities to children with 
diverse complex diseases, including severe CP, and a PACT RCT found 40% lower hospitalization rates for 
intervention vs control patients.18 
  
The purpose of this study is to achieve protocol revisions and preliminary data to support a large 
multisite RCT to reduce respiratory illness in severe cerebral palsy. This study adapts the efficacious 
PACT intervention into “Respiratory Exacerbations-PACT” (RE-PACT) for children with severe CP. The 
proposed research is significant because the intervention targets the central, yet currently overlooked, 
cause of severe respiratory illness in severe CP – under-supported families managing emerging health 
crises at home. RE-PACT links an innovative just-in-time adaptive response to an effective intervention 
developed by this team. RE-PACT delivers the right care, at the right time, in the right context. The RE-
PACT intervention platform has direct potential to accelerate the translation of discovery into practice 
by embedding a research platform within ‘learning’ health systems, thereby engaging clinical care and 
patient communities; and creating an integrative interface between research and practice. This study 
will establish feasibility, acceptability, and fidelity, and determine likely effect sizes of the intervention 
to reduce respiratory illness in severe CP. Successful completion of these objectives, will build a strong 
scientific foundation and necessary data, infrastructure and protocols to conduct a full-scale efficacy 
trial. 
 
 

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2.3 RISK/BENEFIT ASSESSMENT 
2.3.1 KNOWN POTENTIAL RISKS 
The proposed research will pose minimal risks to human research subjects, comparable to the risks 
incurred through everyday conversations, routine visits with clinic providers, and basic psychological 
tests. The potential risks are immediate risks (not long-term) and include: 1) mild psychological 
discomfort in discussing parenting, personal and family matters, including challenges and demands 
about caring for a child with severe disabilities, and family socio-demographics, including parental 
education and household income; 2) social risk by participating in the study, if their participation were 
to become known to anyone outside the research team; and 3) loss of confidentiality.  
  
One potential long-term risk is that if families feel a false sense of security during an illness (e.g., from 
their coaching experience), they may seek care later and present with a more advanced or potentially 
severe acute illness. This risk is minimized however, by having clear protocols for coaches to follow to 
include clinical team members, and not restricting families from using their usual support channels 
when their child is ill (e.g., calling their provider, having an urgent visit in clinic, going to the emergency 
room, etc.).   
2.3.2 KNOWN POTENTIAL BENEFITS 
The potential benefits are immediate. All participants will receive information about their child’s health 
status (such as care recommendations and the results of clinical tests and procedures), which may 
benefit families with or without concerns, and in part ameliorate the psychological risk posed by the 
research. Clinical information will be exchanged by oral communication between the parent and the 
Peds Complex Care clinical team member. The clinical team member may also communicate (orally or by 
MyChart) with other members of the child’s clinical team (such as their pulmonologist and other 
specialists). Such communication is part of the standard care provided for families in the Pediatric 
Complex Care Program.  For families enrolled in the randomized clinical trial, study staff will also share 
information about parent confidence with clinical providers. For example, if a parent reports low 
confidence that their child will avoid hospitalization in the next month, the clinical team member will 
share this information with other members of the child’s care team to determine whether changes in 
care are recommended. As always, the clinical team member will discuss parental confidence, parental 
opinion of their child’s care plans, and/or parental opinion of their child’s providers with professionalism 
and sensitivity to patient-provider relationships. They will divulge the minimum amount of information 
needed to discuss the patient’s health status. 
 
The potential benefit of REPACT is that early communication will lead to early detection of crises 
(respiratory or otherwise) and opportunities for early intervention. It is unclear what the benefits of the 
RE-PACT intervention will be to study participants, but there is a potential benefit of preventing hospital 
and emergency department use, and improving experiences navigating the health system. There is also 
a potential benefit to providers in having RE-PACT help with care coordination (e.g., knowing who and 
when to call for respiratory health problems). 

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2.3.3 ASSESSMENT OF POTENTIAL RISKS AND BENEFITS 
Rationale for the necessity of exposing participants to risks: If proven effective for families and 
providers, the proposed RE-PACT intervention has the potential to help many families and clinical 
systems in the future. Developing more streamlined and effective processes for real-time identification 
of health crises and linking families with “just-in-time” clinical interventions has the potential to improve 
systems of care for vulnerable children and their families, ultimately with the potential to improve 
health outcomes. 
  
Summary of the ways that risks to participants were minimized in the study design: Participation in the 
study will be completely voluntary and participants may end their participation at any point. 
Participation in the study should not affect the routine medical care they receive. Clinical providers will 
be notified of screening results for all participants. Participants may decline to participate in any given 
component of the study and may decline to answer any particular question they do not wish to answer. 
Their participation in the study will remain confidential, with meetings between study staff and 
participants happening in private rooms. Written questionnaires will be labeled with a unique identifier 
and other identifying information will not be associated with written data. Any identifying information 
kept for the purposes of contacting participants will be kept secure, in REDCap, a locked filing cabinet or 
in a password-protected electronic file and will be destroyed when the study is complete. In the event of 
any adverse events, we will follow the protocols as described in the data safety monitoring plan, 
including notification of the PI and Co-I (UCLA site PI), clinical escalation as appropriate using the clinical 
staff in the respective clinic partner sites, and notification of authorities as required by law (Child 
Protective Services and/or law enforcement).   
  
Justification as to why the value of the information to be gained outweighs the risks of participation in 
the study: This platform may prove to be adaptable to other disease states which experience acute 
exacerbations managed (at least in part) by families at home. Many of these improved processes are yet 
to be developed and tested. This study would add to the knowledge about what is effective, possibly 
leading to important future research and implementation efforts. 
 
 

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3 OBJECTIVES AND ENDPOINTS 
OBJECTIVES ENDPOINTS 
JUSTIFICATION 
FOR ENDPOINTS 
PUTATIVE 
MECHANISMS 
OF ACTION 
Primary 
To establish 
feasibility, ac-
ceptability, 
and fidelity of 
RE-PACT in 
90 children 
with severe 
CP. 
MEASURES  
MEASURE 
DETAIL 
SUCCESS 
DEFINITION 
FEASIBILITY 
  
n=90 
Recruitment 
Days to enroll 
target, mean 
<14 
Intervention 
onset 
Days between 
randomization 
and “time zero” 
intervention 
activities, mean 
<7 
Intervention 
time 
Time logged 
(minutes) for 
action planning 
and for 
coaching 
activities, mean 
  
Intervention 
costs 
Mileage / travel 
costs; Personnel 
salary; Training; 
Other incurred 
costs, total 
  
Intervention 
triggers 
Number per 
patient 
(annualized); 
respiratory and 
non-respiratory 
focused 
  
Data 
infrastructure 
Data collection 
reliability; 
Coordination at 
UW, Data use 
agreements / 
IRBs 
  
ACCEPTABILITY   
  
Enrollment 
Enrollment rate 
(# of patients 
enrolled / # 
approached) 
>80% 
  
  

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OBJECTIVES ENDPOINTS 
JUSTIFICATION 
FOR ENDPOINTS 
PUTATIVE 
MECHANISMS 
OF ACTION 
Consent 
refusal 
Categorized 
reasons for 
refusal 
  
Loss, Drop out Rate of drop out 
(active or 
passive) before 
6 months (# 
drop out / # 
enrolled) 
<10% 
Action plan, 
Coaching, 
texting 
satisfaction 
Do caregivers 
use the action 
plan, coaching 
and texting 
(why / why not); 
How could it be 
improved; 
Would 
caregivers 
recommend this 
to another 
family? (why / 
why not) 
  
FIDELITY 
  
  
Enrollment 
duration 
Time (months) 
of participant 
enrollment in 
the study, mean 
6 
Action plan 
creation 
# respiratory 
and overall 
action plans per 
patient; Action 
plan focus areas 
≥1 
Coaching – 
home 
or virtual visit 
Success rate (# 
visits completed 
/ # expected); 
stratify by 
trigger 
(hospitalization 
vs confidence 
rating) 
>80% 

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OBJECTIVES ENDPOINTS 
JUSTIFICATION 
FOR ENDPOINTS 
PUTATIVE 
MECHANISMS 
OF ACTION 
Coaching – 
phone 
calls 
Success rate (# 
phone calls 
completed / # 
expected); 
stratify by 
trigger 
(hospitalization 
vs confidence 
rating); 
respiratory and 
non-respiratory 
>80% 
mHealth 
texting 
Response rates 
(# texts 
responded / # 
expected); 
respiratory and 
non-respiratory 
>90% 
Cross-over 
# Patient 
inappropriately 
receiving any 
intervention 
component 
0 
Data collection Complete entry 
and exit 
questionnaire, 
monthly 
questionnaire, 
chart review 
data (# data 
collection 
events 
complete / # of 
total data 
collection 
events) 
>95% 
Secondary 
To establish 
effect size of 
RE-PACT. 
Severe respiratory illness, defined as res-
piratory diagnoses requiring hospitaliza-
tion. Respiratory diagnoses includes dis-
charge diagnosis of any of the following: 
asthma, pneumonia (community or hospi-
tal acquired), bronchiolitis, influenza, up-
per or lower respiratory tract infection, 
  
  

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OBJECTIVES ENDPOINTS 
JUSTIFICATION 
FOR ENDPOINTS 
PUTATIVE 
MECHANISMS 
OF ACTION 
tracheitis, aspiration pneumonia/pneu-
monitis, chronic lung disease, respiratory 
failure. 
Tertiary/Exploratory 
To explore the 
mediating 
relationships 
between RE-
PACT and 
capability, 
opportunity, 
motivation 
(COM-B) 
measures. 
Capability: Family Caregiver Activation in 
Transition Measure (FCAT)117 – mean 
composite score 
Caregiver General Self-Efficacy Scale 
(GSES)118 – mean composite score. 
Opportunity: Family Experiences with Care 
Coordination (FECC)119 - % top-box score for 
selected items  
Motivation: Confidence Responses mHealth 
texting (weekly score 1 through 10) 
Blending our 
foundational research 
on preventing 
hospitalizations,38,39 
with behavioral 
intervention 
theory,113 our 
conceptual model 
suggests that 
decisions to seek care 
(behaviors) are 
influenced by 
capability (family 
capacity), opportunity 
(health system and 
susceptibility), and 
motivation 
(confidence). 
Confidence is a 
modifiable expression 
of self-efficacy to 
achieve an outcome, 
i.e., to avoid 
hospitalization and 
manage (respiratory) 
crisis at home. 
A theorized 
mechanism of RE-
PACT's effect is 
that the 
combination of 
action planning, 
mHealth 
surveillance, and 
coaching, will 
increase caregiver 
capability, 
opportunity, 
motivation to 
manage 
respiratory illness 
in severe CP. 
  

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4 STUDY DESIGN 
4.1 OVERALL DESIGN 
This is a pilot randomized, controlled clinical trial to establish the intervention protocol’s feasibility, 
acceptability, and fidelity, as well as preliminary effect size data. All study participants will undergo 
informed consent including authorization to view the child’s medical record and consent to participate 
in action planning, health coaching, and weekly text message surveillance. 
  
To participate in this study, a patient must be cared for at one of two sites (University of 
Wisconsin/American Family Children’s Hospital or UCLA/Mattel Children’s Hospital) in their complex 
care or cerebral palsy clinical programs, and meet study inclusion criteria, which include presence of 
severe cerebral palsy and respiratory care needs (see Section 5, Study Population for details).  
  
Following an intervention adaptation phase consisting of formative data from focus groups with primary 
caregivers, clinical teams and a group of national experts, this phase will employ the evidence-based 
Replicating Effective Program’s framework for intervention adaptation and the Patient-Centered 
Outcomes Research Institute's standards for improving research of complex health interventions. The 
previously efficacious PACT (Plans for Action and Care Transitions) intervention has been adapted to 
prevent severe respiratory illness in children with severe cerebral palsy, and to increased dose triggers 
from text messages indicating a family's low confidence for their child to avoid a hospitalization in real-
time. In addition, the Core Functions (standard components required for integrity) and Forms (the 
tailored activities to carry out the Core Functions) have been delineated. The adapted intervention is 
called RE-PACT, or Respiratory Exacerbation Plans for Action and Care Transitions.   
  
RE-PACT involves action planning and health coaching to prevent and manage respiratory illness, as well 
as weekly text messaging surveillance of caregiver confidence for their child to avoid a hospitalization. 
All intervention families will receive respiratory illness action plans at study entry. Action plan content  
will be consistent with standard clinical care guidelines and will not differ from the recommendations of 
the child’s clinical care team. Health coaching focuses on managing medications, understanding and 
responding to red flags, keeping patient-centered records, maintaining timely follow-up with primary or 
specialty care. Coaches focus on skill transfer to parent caregivers, achieved through structured face-to-
face or virtual telehealth coaching and phone follow-up over a 2-week period. Just-in-time action 
planning and coaching activities are triggered by caregiver text message responses indicating low 
confidence (rating ≤4 on 1-10 scale) to avoid a hospitalization. The usual care, active control group will 
continue to receive comprehensive care coordination and medical management. 
  
Study participants will be randomly assigned to receive usual care through the complex care clinical 
program, or the study intervention, RE-PACT. Random allocation will be concealed to research staff 
conducting recruitment and will use a 1:1 allocation with random block sizes of 2 and 4. Block 
randomization will be achieved with a computer-generated random number list prepared by the study 

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biostatistician having no clinical involvement in the trial. Randomization will be stratified by site to 
account for site-specific study characteristics. 
  
RE-PACT will be run through three successively larger 6-month trials (“waves”), allowing ongoing 
protocol refinement according to pre-specified definitions of success for measures of feasibility, 
acceptability and fidelity. Each wave has a specific protocol refinement focus: Wave 1 – 
onboarding/training, recruitment, data collection; Wave 2 – randomization and intervention activities; 
Wave 3 – rapid enrollment and conducting all protocol activities with high-fidelity. 
  
RCT participants in both groups will undergo assessments of demographic, clinical and caregiving 
measures reported through questionnaire and medical record review at baseline at 6 months after 
enrollment. Feasibility, acceptability and fidelity data will be collected through parent-report, medical 
record review, and research team logs monthly during the intervention, and, for control group 
participants, at 6 months after enrollment. 
  
Data about research participants (children and their families) will be collected by study research 
assistants through electronic self-administered questionnaires or structured interviews with parents 
either over the phone or in person, abstraction of child medical record data by the study RAs, and (for 
intervention group families) through phone interactions and direct observation with health coaches in 
RE-PACT. Content of these assessments include parent-report questions about child and parent health, 
parent perceptions of child health, family socio-demographic information, care utilization, and 
experiences of caregiving. 
  
Analyses will assess feasibility, acceptability, fidelity and effect size estimates (by comparing numbers of 
respiratory exacerbations between intervention and usual care groups). We will use pre-specified 
definitions of success for each of our feasibility, acceptability and fidelity measures. We anticipate being 
underpowered to assess the efficacy of the intervention in this pilot study, but to inform a future large 
RCT we will test differences between intervention and active groups in the primary and secondary 
clinical outcomes. For each of these measures, we will compare differences between intervention and 
active control group outcomes at 6 months controlling for their baselines. While we anticipate that the 
intervention and control groups will be similar due to random assignment, we will adjust for any 
variables in our analysis that are not equal between the groups given the small sample size. In addition, 
we will analyze for any effect of primary home language on the study outcomes, as this may affect 
families’ ability to navigate systems of care in the U.S. To explore theoretical intervention mechanisms, 
we will also test the mediating effect of caregiver capability, opportunity, and motivation measures on 
the relationship between intervention and respiratory illness outcomes. 
4.2 SCIENTIFIC RATIONALE FOR STUDY DESIGN 
Rational for the study design. Conducting this pilot study will provide a high degree of certainty that the 
final RE-PACT protocol is feasible, acceptable and can be delivered with fidelity. This is a critical 
approach to designing interventions that can be integrated in diverse, real-world, settings and sustained. 

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Using an RCT design (i.e., with a control group who do not receive intervention) is necessary to establish 
effect sizes needed to adequately power an efficacy trial. The findings from this study will allow precise 
estimation of effect sizes to conduct a fully powered, multisite hybrid Type 2 effectiveness-
implementation RCT.  
  
Rationale for the type and selection of control conditions. The control group will be randomly assigned, 
allowing the study team to conclude that endpoint differences between each group are most likely due 
to the intervention itself.  
  
Potential problems associated with the control group. The control group may have pre-existing 
respiratory action plans created during routine clinical care. In addition, the coach may have difficulty 
avoiding contaminating the control group by inadvertently conducting coaching activities to those not 
assigned to the intervention group. This risk will be minimized since action plans using the study 
protocol will only happen for intervention subjects, and coaching is triggered only through mHealth text 
responses and texting will only be set up for those assigned to the intervention. 
4.3 JUSTIFICATION FOR INTERVENTION 
Justification for the mode of intervention delivery. RE-PACT uses a dynamic Just-in-Time Adaptive 
Intervention (JITAI) design.17 Though causes of respiratory illness in severe CP are modifiable, they are 
also broad and require distinct responses, even for the same child over time. RE-PACT’s design 
addresses child and family changing needs. Managing crises with just-in-time action planning and 
bringing coaching directly to families breaks down barriers between home and clinical settings precisely 
when it matters most. This approach is innovative since we tailor the intensity of response (e.g., phone 
call, clinic visit, etc.) to family- and illness-specific needs. The adaptive nature of the intervention 
ensures it meets caregiver needs for that particular illness, whether requiring purely respiratory or a mix 
of respiratory and non-respiratory chronic disease management (e.g., seizures, feeding intolerance, 
etc.). The number and frequency of contacts is rooted in prior research using a related trial as well as 
feedback from families pilot-testing our texting tool. There is no minimum-acceptable participation in, 
or exposure to the intervention since the study is designed to assess feasibility, acceptability, and 
fidelity, i.e., varying rates of participation will be a relevant endpoint in itself.  
4.4 END-OF-STUDY DEFINITION 
A participant is considered to have completed the study if he or she has completed the baseline 
assessment, and the 6-month follow-up assessments, as shown in the Schedule of Activities (SoA), 
Section 1.3. 

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5 STUDY POPULATION 
5.1 INCLUSION CRITERIA 
The participant is the caregiver of a child with severe cerebral palsy. Individuals must meet all of the 
inclusion criteria in order to be eligible to participate in the study: 
  
Caregiver Criteria 
• 
Be at least 18 years of age 
• 
Primary caregiver to an eligible child (child criteria below) 
• 
Speak English or Spanish well enough to be interviewed 
• 
Have a phone capable of sending/receiving text messages 
Child Criteria 
• 
Ages 0-17 years 
• 
Have Gross Motor Function Classification System level IV or V Cerebral Palsy 
• 
Cared for by respiratory specialist or receive daily respiratory treatments (oxygen, ventilation, airway 
clearance device, medications) 
5.2 EXCLUSION CRITERIA 
An individual who meets any of the following criteria will be excluded from participation in this study: 
1. Lack of interest in text messaging or coaching interactions during the study 
5.3 LIFESTYLE CONSIDERATIONS 
During this study, participants are asked to: 
• 
Reply to text messages when received at random times during daytime hours.  
• 
Connect with an intervention coach either at home, in-person at a mutually agreeable location, by phone, 
or over the internet 
5.4 SCREEN FAILURES 
Screen failures are defined as participants who consent to participate in this study but are not 
subsequently assigned to the study intervention or entered in the study. Individuals who do not meet 
the criteria for participation in this trial (screen failure) because of meeting one or more exclusion 
criteria that are likely to change over time may be rescreened. Examples include child's development of 
needs for respiratory treatment, re-assignment to a GMFCS status that meets inclusion criteria, 

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acquisition of a phone capable to send/receive text messages. Rescreened participants will be assigned 
the same participant number as for the initial screening. 
5.5 STRATEGIES FOR RECRUITMENT AND RETENTION 
Recruitment 
We will recruit caregivers of children with severe CP between 0-17 years old. We will recruit a total of 
n=90 participants (n=45 at each site) divided across 3 waves. In each wave, there is a 1-2 month 
enrollment period. We anticipate approximately 80% of those screened will enroll, requiring 
approximately 110 individuals to be screened. 
  
Potential participants will be identified by reviewing the clinic registries and/or EHR data using 
diagnostic codes for CP (ICD-10 G80-83), which contain detailed information about children and their 
diagnoses. We will send an “opt-out” letter that alerts families that a research study is being conducted 
and their child may be eligible, with a contact number to call if they wish to opt out of the research or if 
they wish to receive additional information or have any questions. Potentially eligible caregivers will be 
contacted by phone to screen for eligibility and interest. 
  
If the research team is not notified that a family wishes to opt-out the research, the study research 
personnel will attempt to call the families (or meet them at an upcoming visit) to complete screening, 
informed consent, baseline questionnaires and random group assignment. Eligibility criteria for 
caregivers are detailed in Study Population, Section 5.1-5.2, and include being self-identified English- or 
Spanish-speaking caregivers of children with severe CP who have respiratory needs. CP status and 
additional eligibility criteria will be determined with a reliable and valid parent questionnaire and 
screener conducted at the beginning of initial phone contact. 
  
Retention and Incentives 
Study participants in this pilot RCT will be contacted at baseline (enrollment), monthly (for intervention 
subjects), and at 6 months (intervention and control groups). While we expect some degree of attrition 
will be inevitable, we will work to minimize attrition by sending regular follow-up post cards and phone 
calls requesting updates in contact information and also confirming or updating contact information 
when child medical records are reviewed. Moreover, participants will receive $100 on study entry and 
exit. 
  
Inclusion of Women and Minorities 
While we will not specifically recruit study participants based on gender, race or ethnicity, the 
demographics of our clinics are such that we expect parents to be predominantly women (mothers of 
young children brought to the clinic for care). At UCLA, families are predominantly Hispanic or Latino. 
Child participants will most likely be close to 50% male and 50% female. Together, we estimate 
approximately the demographic composition to be 35% Hispanic or Latino, 65% approximately 
distributed between white, non-Hispanic, African American (including a subset of Hispanic or Latino 
origin) and Asian, Pacific Islander, Native American, and multiracial groups combined. From the total 90 

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participants, we estimate 43 males and 47 females, 32 to identify as Hispanic and 58 non-Hispanic, and 
approximately 65 to identify as white, 9 as black, 5 as more than one race, and 11 as other (e.g., Asian, 
Pacific Islander, Native American, and unknown or not reported).  
  
We also know that the majority of the Hispanic or Latino families are Spanish-speaking and will ensure 
that study materials are linguistically appropriate. Due to limitation of study resources, we must exclude 
families unable to speak English or Spanish well enough to be interviewed and receive care materials 
written in either English or Spanish. 
  
We will collect demographic information about children and families as part of our data collection. 
While we anticipate that the intervention and control groups will be similar due to random assignment, 
we will adjust for any variables in our analysis that are not equal between the groups given the small 
sample size. In addition, we will analyze for any effect of primary home language on the study 
outcomes, as this may affect families’ ability to navigate systems of care in the U.S. 
  
Inclusion of Children/ Inclusion Across the Lifespan 
Research participants for this study will include children and their parents or legal guardians. We 
propose to enroll 90 children between ages 0-17 years into this study and follow their health and health 
care for 6 months. This sample size and timeframe will sufficiently meet the need to establish trial 
protocol feasibility, acceptability, and fidelity and collect preliminary data for power calculations (it is 
intentionally not designed to be large enough to prove efficacy of the intervention). Although the entire 
proposed study relates specifically to children, we expect actual participation of children themselves to 
be minimal. Child-level data will be collected primarily using parent report and medical record review, 
with no direct child responses. Parents will be asked to provide consent for themselves and permission 
for their children to participate, including for the collection of child-level data. Children with severe 
cerebral palsy typically have functional and/or development limitations of such severity that they are 
not considered able to provide assent, so only parental permission will be obtained for this study, which 
involves minimal risk. We have the expertise and facilities to work with children of all ages and 
developmental abilities. Our research team includes senior researchers with pediatric clinical trials 
experience. Our clinical team is located at two major tertiary children’s hospitals (American Family 
Children’s Hospital / University of Wisconsin and Mattel Children’s Hospital / UCLA) that specialize in 
delivering care to children and families facing this particular clinical condition. There is no upper age 
limit for parents or legal guardians to participate, and it is reasonable to expect that some older adults 
will be guardians for children in this study. 
  
Justification for Inclusion of Vulnerable Subjects 
Children of all ages with severe CP and see a respiratory specialist and/or use daily respiratory treatment 
will be included because those are the children with active disease who are most likely to have relevant 
fluctuations in health such that they will experience, and benefit from, intervention activities. Finally, we 
only have resources to recruit and interview families in English or Spanish. 

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6 STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) 
6.1 STUDY INTERVENTION(S) OR EXPERIMENTAL MANIPULATION(S) ADMINISTRATION 
6.1.1 STUDY INTERVENTION OR EXPERIMENTAL MANIPULATION DESCRIPTION 
The Respiratory Exacerbation Plans for Action and Care Transitions (RE-PACT) intervention has three 
primary activities: (1) mHealth surveillance of parent confidence to avoid hospitalization, (2) respiratory 
illness action planning, and (3) just-in-time adaptive coaching response triggered by low confidence or 
hospitalization. The theoretical basis of the intervention includes efficacy of the initial PACT trial, and 
prior research on preventing hospitalizations combined with behavioral intervention theory which 
suggests that decisions to seek care (behaviors) are influenced by capability (family capacity), 
opportunity (health system and susceptibility), and motivation (confidence). Confidence is a modifiable 
expression of self-efficacy to achieve an outcome, i.e., to avoid hospitalization and manage (respiratory) 
crisis at home. In our earlier work, low confidence predicted hospitalization. 
  
Participants randomized into the intervention will receive initial T0 intervention activities (mHealth 
monitoring and respiratory action plan) by phone, at clinic, or during a hospitalization within one month 
of enrollment. 
mHealth surveillance. Upon enrollment, families will begin receiving weekly text messages asking them 
to rate their confidence (1-10) for their child to avoid a hospitalization in the next month.  
Action Planning. The action and format are adapted from the original PACT study, and contents include 
(at minimum) recognizing, describing and managing the child’s known contributors to respiratory illness. 
In step 1, objective and subjective indicators of baseline (“green”), concerning (“yellow”), and severe 
(“red”) statuses are defined (e.g., >2 L/min of oxygen). In step 2, the specific actions caregivers should 
take to manage each status are defined (e.g., increase vest, albuterol, suction to q4, use oxygen up to 4 
L/min).  
Just-in-time Adaptive Coaching Intervention Response. Coaching is accomplished by adapting PACT, 
which was initially adapted from the Care Transitions Intervention® (CTI),50 to the pediatric population. 
The focus is: (1) medication self-management, (2) patient-centered records maintained by families, (3) 
timely follow-up, and (4) “red flags” and instructions how to identify/respond to them (i.e., action 
plans). Face-to-face visits are typically at the family’s home; however, a neutral or “virtual” (telephone) 
visit is an option. Coaches review the four components, elicit goals, and focus coaching activities on 
needs identified by families. Phone calls discuss progress toward goals. This coaching approach provides 
the structure for JITAI activities.  
  
Control Group. Those participants randomized to the control group will be provided usual care through 
the comprehensive clinical program at their children’s hospital. They will also complete pre- and post-
study assessments.  

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6.1.2 ADMINISTRATION AND/OR DOSING 
mHealth Surveillance. Text messages are programmed to be sent at random days / times to caregivers 
beginning the Monday after enrollment. Text messages average once weekly (Sun-Thurs) between 8AM 
and 9PM (local time). After 2 hours of non-response, a reminder is sent, and this is repeated up to 2 
times.   
Action Planning. All intervention families receive respiratory illness action plans within 1 month of study 
entry, and just-in-time plans are also created at times of low confidence. Plans are created in caregivers’ 
preferred language (English, Spanish) by physician or nurse practitioner using our protocol (see 
intervention manual). After plans are created, teach-back is used. Copies are given to families and 
included in medical records. Plans are discussed at weekly clinical meetings for clarity and accuracy.   
Just-in-time Adaptive Coaching Intervention Response. In the original design, coaches met families prior 
to a hospital discharge, conducted face-to-face visits within 72 hours and 3 phone calls within 30 days, 
post-discharge. Compared to the original PACT design, RE-PACT was adapted to trigger just-in-time 
adaptive intervention (JITAI) action planning and coaching doses when caregiver text message responses 
indicate low confidence. JITAI action planning and coaching doses occur within 24 hours of any text 
message ratings ≤4. This confidence threshold to trigger JITAI and the text prompt wording was vetted in 
preliminary qualitative research with families and clinicians and is based on our prospective pilot study 
at UW and UCLA whereby confidence ratings ≤4 predicted hospitalizations a median (IQR) 8 (2-10) days 
in advance. The protocol currently supports intervention coach credentials to include undergoing coach 
training (or equivalent, see intervention manual), and individuals can possess any university degree of 
higher. For example, a coach could be a care coordinator with a bachelor's degree, a physician, or other 
health professional. 
  
The study feasibility, acceptability and fidelity measures are designed to quantify intervention doses, 
dose intensity and frequency (e.g., # of coach visits, # of action plans), and include incomplete dose 
administration (e.g., poor text message response rates).   
6.2 FIDELITY 
6.2.1 INTERVENTIONIST TRAINING AND TRACKING 
Action plans are created by study physicians or nurse practitioners using our worksheet-based protocol 
(see intervention manual). Plans are discussed at weekly clinical meetings for clarity and accuracy. For 
each enrollee, the study team will log whether (1) an action plan was created (and how many were 
created), (2) when they were created, and (3) whether/when each plan was reviewed with the clinical 
team. Spanish-speaking Action Plans will be drafted in Spanish by native-speaking Spanish clinicians or 
designated clinical translators.  
  
Coaching interventionist training is based on the initial PACT protocol (see intervention manual), and 
includes an overview of coaching, scenarios and role-practice, mock sessions with feedback, supervisor 
observation with feedback, as well as weekly coaching peer discussions throughout the intervention 
period. The protocol currently supports intervention coach credentials to include any bachelor's degree 
of higher. For example, a coach could be a care coordinator with a bachelor's degree, a physician, or 

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other health professional. The study fidelity measures are designed to quantify coaching doses, dose 
intensity and frequency (e.g., # of coach visits), and include incomplete dose administration (e.g., missed 
coach visits / calls), etc. 
6.3 MEASURES TO MINIMIZE BIAS: RANDOMIZATION AND BLINDING 
Random allocation will be concealed to research staff conducting recruitment and will use a 1:1 
allocation with random block sizes of 2 and 4. Block randomization will be achieved with a computer-
generated random number list prepared by the study biostatistician having no clinical involvement in 
the trial. Randomization will be stratified by site (UW vs UCLA) to account for site-specific study 
characteristics. After the research team member obtains participant consent, they will telephone 
contact the study project manager who is independent from the recruitment process to receive the 
group assignment. Alternatively, it may be arranged that randomization will be built into the REDCap 
database by the study biostatistician. 
  
Since this study aim is feasibility, acceptability and fidelity, there is no plan for whether/when to break 
randomization codes. Study and clinical team members cannot practically be blinded to treatment 
because only those randomized to intervention will receive text messages, specific action plans, and 
coaching. The need for clinical team members to create action plans and interact with coaches will 
identify those randomized to intervention. Presumably, the need for admission to the hospital for a 
respiratory illness and secondary clinical endpoints (ED visits, need for antibiotics, steroids, hospital 
days, and death) are less prone to observer bias. The outcome evaluator (study biostatistician) will 
remain blinded during analyses. 
6.4 STUDY INTERVENTION/EXPERIMENTAL MANIPULATION ADHERENCE 
Given the nature of this pilot RCT, participant adherence measures are delineated within the primary 
acceptability and fidelity outcomes for the study. These include attrition, monthly self-reported action 
plan and coaching use, response rates to text messaging and response rates to coaching visits and 
follow-up phone calls.  
  
Loss to follow-up is defined in Section 7.3, Lost to follow-up. 
6.5 CONCOMITANT THERAPY 
For this protocol, participants may use existing action plans that have been created outside the study. 
Action plan existence/usage will be assessed at monthly study calls and documented in the relevant 
Case Report Form (CRF). 
6.5.1 RESCUE THERAPY 
The study site will not supply rescue medication. 
 
 

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7 STUDY INTERVENTION/EXPERIMENTAL MANIPULATION DISCONTINUATION AND 
PARTICIPANT DISCONTINUATION/WITHDRAWAL 
7.1 DISCONTINUATION OF STUDY INTERVENTION/EXPERIMENTAL MANIPULATION 
When a subject discontinues from any element of RE-PACT (action planning, texting, coaching), but not 
from the study, remaining study procedures will be completed as indicated by the study protocol. 
  
The data to be collected at the time of study intervention discontinuation will include the following: 
• 
The reason(s) for discontinuing the participant from the intervention, and methods for determining the 
need to discontinue 
• 
If the participant is due to complete assessments within 2 weeks of being discontinued from the study 
intervention, those assessments will be administered at the time of discontinuation; if the next scheduled 
assessments are more than 2 weeks from the discontinuation date, the discontinued participant will wait 
for the next scheduled assessment. Thereafter, the participant will be included in all future scheduled as-
sessments, even though not participating in the intervention. 
7.2 PARTICIPANT DISCONTINUATION/WITHDRAWAL FROM THE STUDY 
Participants are free to withdraw from participation in the study at any time upon request.  
An investigator may discontinue a participant from the study for the following reasons: 
• 
Significant study intervention non-compliance, unless varying compliance is an aspect of the study objec-
tives 
• 
Lost-to-follow up; unable to contact subject (see Section 7.3, Lost to Follow-Up) 
• 
The participant meets an exclusion criterion (either newly developed or not previously recognized) that 
precludes further study participation 
• 
If a subject is no longer a part of the complex care program at the UW or UCLA, their enrollment in the 
study will be discontinued. 
The reason for participant discontinuation or withdrawal from the study will be recorded on the 
Discontinuation/Withdrawal Case Report Form (CRF). Subjects who sign the informed consent form and 
are randomized but do not receive the study intervention may be replaced.  Subjects who sign the 
informed consent form, and are randomized and receive the study intervention, and subsequently 
withdraw, or are discontinued from the study, will not be replaced. 
7.3 LOST TO FOLLOW-UP 
A participant will be considered lost to follow-up if they are no longer a member of the clinical program, 
or if they fail to respond to 3 consecutive months of texting, or 3 monthly assessments in a row, and 
study staff are unable to contact the participant after at least 3 attempts. 
The following actions will be taken if a participant fails to respond: 

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• 
The site will attempt to contact the participant, counsel the participant on the importance of maintaining 
the assigned schedule and ascertain if the participant wishes to and/or should continue the study.  
• 
Before a participant is deemed lost to follow-up, the investigator or designee will make every effort to 
regain contact with the participant (where possible, 3 telephone calls and, if necessary, a certified letter 
to the participant’s last known mailing address or local equivalent methods). These contact attempts will 
be documented in the participant’s study file. 
• 
Should the participant continue to be unreachable, he or she will be considered to have withdrawn from 
the study with a primary reason of lost to follow-up. 

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8 STUDY ASSESSMENTS AND PROCEDURES 
8.1 ENDPOINT AND OTHER NON-SAFETY ASSESSMENTS 
Screening, Eligibility and Enrollment Procedures 
Using clinic registry or EHR data (see Section 5, Strategies for Recruitment and Retention), all children 
with known or suspected severe CP, up to age 17 years will be identified. After sharing introductions 
with these identified individuals by mail and telephone, trained research personnel will begin 
approaching potential participants using a standardized recruitment and screening script (for use in 
person, virtually or by telephone) to screen eligibility and interest. The eligible participant pool will be 
assembled up to 3 months prior to beginning wave 1 enrollment. Screening will be used during each trial 
wave's recruitment period until the recruitment target is reached. Randomization/enrollment will occur 
at the same time as screening but can be completed up to 1 month after screening if families need 
additional time.  
  
The screening questionnaires will confirm: 
• 
Caregivers: are at least 18 years of age, are the primary caregiver to candidate child (child criteria below), 
speak English or Spanish well enough to be interviewed, have a phone capable of sending/receiving text 
messages, and are willing to send/receive text messages on their device.  
o 
These measures are self-reported. 
• 
Children: are 0-17 years of age, have Gross Motor Function Classification System Level IV or V Cerebral 
Palsy, are cared for by respiratory specialist or receive daily respiratory treatments (oxygen, ventilation, 
airway clearance device, medications).   
o 
The Gross Motor Function Classification System (GMFCS) levels are determined by parent-report 
using a validated parent questionnaire.74 The family chooses the most accurate description of 
their child, and this corresponds directly to their GMFCS level based on their age.  
o 
Need for specialty respiratory care and/or respiratory treatments is self-reported 
Screening procedures continue until someone is deemed ineligible. Once deemed ineligible, the 
individual is thanked, and the interaction concludes. Screening results and reasons for ineligibility will be 
retained by study personnel.  
  
Study Endpoint Measures and Assessment Procedures 
Primary Study Endpoints - Feasibility, Acceptability, Fidelity: The specific measures and pre-specified 
definitions of success are listed in Section 3. These measures will be summarized between each of the 
three waves with protocol adjustments made for any measures below the definition of success.  
  
Clinical Endpoints: 
• 
Primary clinical outcome is severe respiratory illness, defined as respiratory diagnosis requiring hospitali-
zation. Respiratory diagnosis includes discharge diagnosis of any of the following: asthma, pneumonia 

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(community or hospital acquired), bronchiolitis, influenza, upper or lower respiratory tract infection, tra-
cheitis, aspiration pneumonia/pneumonitis, chronic lung disease, respiratory failure.120 Field-testing as-
sessment of this endpoint with trained research personnel at study sites demonstrated inter-rater reliabil-
ity (Kappa) > 0.9.  
• 
Secondary outcomes include: total hospital days during severe respiratory illness, numbers of systemic 
steroid courses, systemic antibiotic courses, respiratory ED visits, and death. Systemic corticosteroid 
course is defined by oral or parenteral corticosteroid prescribed for respiratory diagnosis, including hydro-
cortisone, prednisone, prednisolone, or methylprednisolone at least 1 mg/kg/day (or 30 mg/day) x mini-
mum 3 days, or dexamethasone at least 0.15 mg/kg/day (or 10 mg/day) x 1 or more days. Physiologic or 
stress replacement doses in adrenal insufficiency are excluded. Systemic antibiotic course is defined by 
oral or parenteral antibiotics prescribed for respiratory diagnosis x minimum 3 days. The specific antibiot-
ics are derived from IDSA pediatric pneumonia guidelines121 and published literature.122 Respiratory ED 
visits are any ED visits not resulting in admission and have a discharge respiratory diagnosis. 
  
Additional Assessment Measures: 
MEASURES 
SOURCE 
MEASURE DETAIL 
Covariates 
  
  
Child and Caregiver 
Demographics 
Survey 
Child: age, gender, primary language, race/ethnicity, payer,  
family structure 
Caregiver: relationship, age, gender, language, race/ethnicity, 
education, health literacy,114 income, rurality 
Confounders 
  
  
Child Clinical 
Characteristics 
Electronic health 
record 
Organ systems affected by chronic conditions, subspecialists in 
past year, medical technologies used (e.g., tracheostomy, 
gastrostomy, etc.), duration of enrollment clinical program, 
numbers of ED visits and hospitalizations in past year, and 
respiratory treatments at time of enrollment (medications and 
devices) 
Caregiver Strain 
Survey 
Caregiver Strain Questionnaire (CGSQ);115– mean global, objective, 
subjective scale scores 
Mental health (PHQ2)116 
Theory / 
Mechanism 
  
  
Capability 
Survey 
Family Caregiver Activation in Transition Measure (FCAT)117 – 
mean composite score 
Caregiver General Self-Efficacy Scale (GSES)118 – mean composite 
score 
Opportunity 
Survey 
Family Experiences with Care Coordination (FECC)119 - % top-box 
score for selected items 
Motivation 
Text logs 
Confidence Responses mHealth texting (weekly score 1 through 
10) 
  
Assessment Procedures. Feasibility, acceptability and fidelity endpoint data will be collected during each 
of the three waves by research personnel reviewing study logs, conducting monthly chart reviews, and 

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administering surveys (by telephone, in person, or sending electronic self-administered links) with 
caregivers randomized to intervention.  For active control groups participants, feasibility of assessments 
will be evaluated by completion rates at study exit. Caregiver and child measures above will be recorded 
at baseline, endpoints will be recorded at study exit (6 months after T0). Caregiving measures, which 
may change as a result of the intervention, will be collected at baseline and study exit. In addition, 
intervention and active control caregivers will be debriefed at study exit on their experiences in the 
study, and asked for feedback on the strengths, weaknesses and any concerns about the protocol. 
Between each wave and after the third wave, clinical teams at each site will be debriefed on strengths, 
weaknesses, and concerns about the protocol.  
  
Reliability of Assessment Measures. The CP GMFCS measures and all the caregiving measures have been 
well-documented as reliable in the literature.11,74,115-119 We have separately established the reliability of 
identifying respiratory illnesses in our preliminary research (Kappa > 0.9). We will ensure reliability in 
data collection through direct observation, data auditing, establishing clear data dictionaries / 
definitions, using uniform variable definitions, and a central data repository coordinated and maintained 
by UW. 
8.2 SAFETY ASSESSMENTS 
Safety assessments are not conducted as a part of this protocol.  
  
See Section 10.1 for Safety Oversight Details. 
8.3 ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS 
8.3.1 DEFINITION OF ADVERSE EVENTS 
This protocol uses the definition of adverse event from 21 CFR 312.32 (a): any untoward medi-
cal occurrence associated with the use of an intervention in humans, whether or not considered 
intervention related. Any medical or psychiatric condition that is present or within the expected tra-
jectory of the child's chronic condition at the time that the participant is screened will be considered 
as baseline and not reported as an AE. 
 
8.3.3.1 SEVERITY OF EVENT 
For adverse events (AEs) not included in the protocol defined grading system, the following guidelines 
will be used to describe severity. 
• 
Mild Events require minimal or no treatment and do not interfere with the participant's daily activities. 
• 
Moderate Events result in a low level of inconvenience or concern with the therapeutic measures. Moder-
ate events may cause some interference with functioning. 
• 
Severe Events interrupt a participant's usual daily activity and may require systemic drug therapy or other 
treatment. Severe events are usually potentially life-threatening or incapacitating. Of note, the term "se-
vere" does not necessarily equate to "serious". 

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8.3.3.2 RELATIONSHIP TO STUDY INTERVENTION/EXPERIMENTAL MANIPULATION 
All adverse events (AEs) will have their relationship to study procedures, including the intervention, 
assessed by an appropriately trained clinician based on temporal relationship and his/her clinical 
judgment. The degree of certainty about causality will be graded using the categories below. 
• 
Definitely Related There is clear evidence to suggest a causal relationship, and other possible contributing 
factors can be ruled out. The clinical event, including an abnormal laboratory test result, occurs in a plau-
sible time relationship to study procedures administration and cannot be explained by concurrent disease 
or other drugs or chemicals. The response to withdrawal of the study procedures should be clinically plau-
sible. The event must be pharmacologically or phenomenologically definitive. 
• 
Probably Related There is evidence to suggest a causal relationship, and the influence of other factors is 
unlikely. The clinical event, including an abnormal laboratory test result, occurs within a reasonable time 
after administration of the study procedures, is unlikely to be attributed to concurrent disease or other 
drugs or chemicals, and follows a clinically reasonable response on withdrawal. 
• 
Potentially Related There is some evidence to suggest a causal relationship (e.g., the event occurred 
within a reasonable time after administration of study procedures). However, other factors may have con-
tributed to the event (e.g., the participant's clinical condition, other concomitant events). Although an AE 
may rate only as "possibly related" soon after discovery, it can be flagged as requiring more information 
and later be upgraded to "probably related" or "definitely related", as appropriate. 
• 
Unlikely to be related A clinical event, including an abnormal laboratory test result, whose temporal rela-
tionship to study procedures administration makes a causal relationship improbable (e.g., the event did 
not occur within a reasonable time after administration of the study procedures) and in which other drugs 
or chemicals or underlying disease provides plausible explanations (e.g., the participant's clinical condi-
tion, other concomitant treatments). 
• 
Not Related The AE is completely independent of study procedures administration, and/or evidence exists 
that the event is definitely related to another etiology. There must be an alternative, definitive etiology 
documented by the clinician. 
8.3.3.3 EXPECTEDNESS 
A clinician with appropriate expertise will be responsible for determining whether an adverse event (AE) 
is expected or unexpected. An AE will be considered unexpected if the nature, severity, or frequency of 
the event is not consistent with the risk information previously described for the study procedures. 
8.3.4 TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND FOLLOW-UP 
The occurrence of an adverse event (AE) or serious adverse event (SAE) may come to the attention of 
study personnel during study visits and interviews of a study participant presenting for medical care, 
report from an involved clinician, or upon review by a study monitor. 
  

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All AEs, not otherwise precluded per the protocol, will be captured on the appropriate case report form 
(CRF). Information to be collected includes event description, time of onset, clinician's assessment of 
severity, relationship to study procedures (assessed only by those with the training and authority to 
make a diagnosis), and time of resolution/stabilization of the event. All AEs occurring while on study will 
be documented appropriately regardless of relationship. All AEs will be followed to adequate resolution. 
Any medical or psychiatric condition that is present or within the expected trajectory of the child's 
chronic condition at the time that the participant is screened will be considered as baseline and not 
reported as an AE. Changes in the severity of an AE will be documented to allow an assessment of the 
duration of the event at each level of severity to be performed. Documentation of onset and duration of 
each episode will be maintained for AEs characterized as intermittent. The project manager will record 
events with start dates occurring any time after informed consent is obtained until 7 (for non-serious 
AEs) or 30 days (for SAEs) after the last day of study participation. At each monthly assessment, the 
research staff or caregiver self-administered questionnaire will inquire about the occurrence of AE/SAEs 
since the last month. Events will be followed for outcome information until resolution or stabilization. 
  
In our consent materials, we will describe the specific procedures for handling each of the types of 
potential incident. These procedures will be based on those in previous projects and include: 
1. The staff member who suspect or learns of any adverse event will immediately begin the adverse event 
case report form in REDCap. 
2. The staff member who suspects or learns of any adverse event will immediately contact the project man-
ager and PI / site PI who in turn will make an immediate judgment as to whether to report it to the au-
thorities or whether additional action is warranted to protect the child’s or participant’s safety.  
3. The PI will decide on a course of action, consulting with an attorney and expert consultants as necessary. 
This course of action will usually follow the clinic’s existing guidelines and practices, with consideration of 
any pertinent legal or ethical issues related to it. For instance, a clinician would normally carry out child 
abuse reporting after it is deemed necessary. The course of action undertaken will be documented on the 
adverse CRF. 
4. Serious adverse events (e.g., suicidal intent, child abuse reporting) will be reported immediately to the IRB 
and Safety Monitoring Committee, per their reporting guidelines, whereas more mild adverse events (e.g., 
mild distress following survey administration or coaching) will be compiled on an annual basis and re-
ported to the IRB. 
5. The Data Monitoring Committee will review all adverse event reports and determine whether additional 
steps are necessary (See Section 10.1) 
6. As part of the informed consent process, study staff will provide subjects and their parent/guardian a spe-
cific name and phone number of a person to contact in case of an adverse event. 
8.3.6 SERIOUS ADVERSE EVENT REPORTING 
In consultation with the PI, a trained member of the study team will be responsible for conducting an 
evaluation of a serious adverse event.  Adverse events meeting the guidelines for required reporting to 

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the IRB will be reported according to UW IRB reporting guidelines 
(see https://irb.wisc.edu/manual/investigator-manual/post-approval-responsibilities/reportable-
events/?tab=reporting-requirements).  A copy of IRB-reportable events will be sent the ICTR DMC 
Protocol Review Manager within the same time frame as required for reporting to the IRB.  A report 
compiling all adverse events will be reviewed by the DMC on an annual basis. 
 
All serious adverse events will also be reported to the NICHD according to their policy. See 
https://www.nichd.nih.gov/grants-contracts/process-strategies/policies/data-safety.  
8.3.7 REPORTING EVENTS TO PARTICIPANTS 
N/A 
8.3.8 EVENTS OF SPECIAL INTEREST 
1. Detection of previously undisclosed dangerous or potentially dangerous situations or occurrences. It is 
possible that families may disclose information to our research staff that indicates they have been or may 
be subject to dangerous situations. Situations or occurrences that might be disclosed to or observed by 
the research staff and would require the staff to complete an incident report include but are not limited 
to child abuse, imminent threat to self, and imminent threat to others (even though our questionnaires 
will not specifically ask about these issues). General procedures we will take in these situations are out-
lined below. Specifically, any suspected child abuse must immediately be reported to the Wisconsin De-
partment of Child Protective Services (CPS) or Los Angeles Department of Child and Family Services (DCFS) 
and, if any immediate danger is possible to the child, family or other individual, to the local Police Depart-
ment. The social worker on call will be notified immediately if a participant discloses suicidal ideation or 
domestic violence. In any adverse situation possibly related to the research study, Dr. Coller, Dr. Lerner, 
and the IRB will also be notified. 
2. Accidental disclosure of confidential material. It is possible that despite careful procedures to protect pri-
vate information, there could be accidental disclosure of confidential information. To protect against acci-
dental disclosure, we will only use ID numbers on questionnaires and will keep any links to personal iden-
tifying information on REDCap. In the case of any breach of confidentiality we will notify the participant, 
PI and site-PI, and the IRB. 
3. Distress experienced during or after completing research survey. It is unlikely for parents to experience 
distress in typical clinical encounters or when given the survey questions, and if any distress does occur it 
would most likely be mild and transient. However, we are attentive to the possibility that answering per-
sonal questions may be upsetting for some individuals. To protect against this distress, participants will be 
made aware that participation in the research study is entirely optional, has no effect on their children’s 
medical care, that they may choose not to answer certain questions and that they may end their partici-
pation at any time. If a participant expresses distress, the research assistant will immediately notify PI / 
site-PI. Participants will also be given phone numbers (in the informed consent process) to contact the 
study PI and the IRB in case of distress during or after the study interview. In addition, on-call social work-
ers at our clinics will be notified to help with any distress that may arise. 
 

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8.4 UNANTICIPATED PROBLEMS 
8.4.1 DEFINITION OF UNANTICIPATED PROBLEMS 
This protocol uses the definition of Unanticipated Problems as defined by the Office for Human 
Research Protections (OHRP). OHRP considers unanticipated problems involving risks to participants or 
others to include, in general, any incident, experience, or outcome that meets all of the following 
criteria: 
• 
Unexpected in terms of nature, severity, or frequency given (a) the research procedures that are de-
scribed in the protocol-related documents, such as the Institutional Review Board (IRB)-approved re-
search protocol and informed consent document; and (b) the characteristics of the participant population 
being studied; 
• 
Related or possibly related to participation in the research ("possibly related" means there is a reasonable 
possibility that the incident, experience, or outcome may have been caused by the procedures involved in 
the research); and 
• 
Suggests that the research places participants or others at a greater risk of harm (including physical, psy-
chological, economic, or social harm) than was previously known or recognized. 
8.4.2 UNANTICIPATED PROBLEMS REPORTING 
The investigator will report unanticipated problems (UPs) to the reviewing IRB following reporting 
guidelines (see https://irb.wisc.edu/manual/investigator-manual/post-approval-
responsibilities/reportable-events/?tab=reporting-requirements).  A copy of such reports will be sent to 
the to the Data Coordinating Center (DCC).   
 
The UP report will include the following information: 
• 
Protocol identifying information: protocol title and number, PI's name, and the IRB project number 
• 
A detailed description of the event, incident, experience, or outcome 
• 
An explanation of the basis for determining that the event, incident, experience, or outcome represents 
an UP 
• 
A description of any changes to the protocol or other corrective actions that have been taken or are pro-
posed in response to the UP 
 
9 Statistical Considerations 
9.1 STATISTICAL HYPOTHESES 
• 
Primary Feasibility, Acceptability, Fidelity Endpoint(s): RE-PACT’s primary outcomes will be analyzed de-
scriptively, and evaluate feasibility, acceptability, fidelity using multiple approaches. Each outcome will be 

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assessed against our pre-specified measures of success, e.g., achieving at least 80% enrollment. By con-
ducting iterative refinements over three waves of implementation, we expect to achieve success in all 
measures. We will assess all participant feedback using both quantitative and qualitative data to deter-
mine what study design changes would enhance a large-scale RCT. We will use inductive content analysis 
of qualitative data. 
• 
Secondary Efficacy Endpoint(s): To inform a future large multisite RCT, we will test differences between 
treatment (I or AC) groups in the primary and secondary respiratory illness outcomes. Our goal with these 
analyses is to estimate effect sizes for the differences between groups. The primary clinical outcome is 
severe respiratory illness rate, defined as the total number of severe respiratory illnesses divided by the 
person-months over the 6 months period. The severe respiratory illness rate will be analyzed with nega-
tive binomial (NB) regression models to account for overdispersion in the count data. In the primary anal-
ysis, univariate NB regression analysis will be conducted with study arm as a predictor variable. Study site 
will be a stratification factor to account for stratified randomization. The observed effect size of the analy-
sis will be quantified in terms of relative risk (RR) and reported along with the corresponding 95% confi-
dence interval. A generalized linear mixed effects model with a logit link function and subject specific ran-
dom effects will evaluate longitudinal changes in the severe respiratory illnesses within and between 
study arms. An autoregressive (AR) correlation structure will account for within subject correlations. In 
this analysis, presence/absence of severe respiratory illness at the monthly assessments will be the de-
pendent variable; study arm will be included as a predictor variable, and study site as a stratification varia-
ble to account for the stratified randomization. To investigate theoretical mechanisms, we will test the 
mediating effect of caregiver capability, opportunity, and motivation (COM-B)113 measures on the rela-
tionship between intervention and respiratory exacerbations. 
9.2 SAMPLE SIZE DETERMINATION 
We will enroll a total of 90 participants. Wave 1 will contain 10 participants (5 UW, 5 UCLA); Wave 2 will 
contain 20 participants (10 UW, 10 UCLA); Wave 3 will contain 60 participants (30 UW, 30 UCLA).  Based 
on this team’s preliminary work, eligible children average one severe respiratory illness per year and we 
estimate 50% of participants will experience at least one respiratory illness during the period of 
enrollment. We expect to be able to maintain contact and collect data from ≥90% of the participants at 
the final follow-up, evenly divided between intervention and control groups. We assume this sample will 
not be powered to establish the efficacy of the intervention; however, it will provide a sufficient sample 
to determine feasibility and estimate effect sizes which will be used for power calculations in the future 
large RCT. The following table shows the attainable power levels for detecting various differences in 
severe respiratory illness rates (primary clinical outcome) between study arms at the two-sided 0.05 
significance level, based on a NB regression model with an overdispersion parameter of φ=1.0. 
  
Attainable power levels for detecting differences in severe respiratory illness rates between arms at the 
two-sided 0.05 significance level based on a NB regression model, assuming a sample size of 45 subjects 
per arm with a missing value rate of 10% or less. 
 
  
Number of severe respiratory illnesses in intervention arm over 6-month 
Follow-up period 
Relative Risk (RR) 
5 
10 
15 
20 
25 

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(Control vs. Intervention) (λ=0.02)* 
(λ=0.40)* 
(λ=0.06)* 
(λ=0.08)* 
(λ=0.10)* 
3.0 
19% 
29% 
38% 
45% 
52% 
4.0 
31% 
41% 
59% 
68% 
75% 
5.0 
42% 
62% 
74% 
83% 
88% 
*Severe respiratory illness rate per patient-month 
  
Hence, large effect sizes with RRs ranging between 3.0-5.0 for comparing the severe respiratory illness 
rates between study arms will be detected with 19-88% power at the two-sided 0.05 significance level. 
9.3 POPULATIONS FOR ANALYSES 
Given that the intervention being tested requires parent adherence to recommendations to achieve 
success, we will use an intention-to-treat analysis approach. 
  
While we anticipate that the intervention and control groups will be similar due to random assignment, 
we will adjust for any variables in our analysis that are not equal between the groups given the small 
sample size. In addition, we will analyze for any effect of primary home language on the study 
outcomes, as this may affect families’ ability to navigate systems of care in the U.S. 
9.4 STATISTICAL ANALYSES 
9.4.1 GENERAL APPROACH 
This section outlines the statistical analysis strategy and procedures for the study. We plan to use the 
primary outcome data to assess the RE-PACT intervention's feasibility, acceptability, and fidelity. We 
anticipate being underpowered to assess efficacy using the clinical endpoints of the intervention in this 
pilot study. The clinical outcome endpoints will be used to develop an estimate of effect size. Categorical 
variables will be displayed as percentages, and continuous variables as means with standard deviations 
(if normally distributed) or medians with IQR (if skewed).  For inferential statistics, two-sided p-values 
<0.05 will be considered statistically significant. A detailed Statistical Analysis Plan (SAP) describing all 
details of the analyses has been developed and will be finalized prior to the database lock and the 
analysis of the final study data.  
9.4.2 ANALYSIS OF THE PRIMARY ENDPOINT(S) 
RE-PACT’s primary outcomes will be analyzed descriptively, and will evaluate feasibility, acceptability, 
and fidelity. We will assess the outcomes against our pre-specified measures of success, e.g., achieving 
at least 80% enrollment. We will evaluate the actual vs expected performance of each intervention 
component (mHealth texting surveillance, action planning, just-in-time adaptive coaching intervention 
response) and completeness of each data collection element in intervention and active control groups. 
We will also determine overall positive, neutral, and negative reports of feasibility and acceptability 
using content analysis of qualitative data, similar to our previous intervention feedback research. We 
will explore any patterns if / when challenges emerge, e.g., enrollment refusal or drop out, low reported 
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9.4.3 ANALYSIS OF THE SECONDARY ENDPOINT(S) 
Clinical Outcomes. We will test differences between treatment (intervention or control) groups in the 
primary and secondary respiratory illness outcomes. Our goal with these analyses is to estimate effect 
sizes for the differences between groups which will allow precise sample size calculations for a future 
large-scale trial. 
  
Primary clinical outcome is the severe respiratory illness rate, defined as the total number of severe 
respiratory illnesses divided by the person-months over the 6-month follow-up period. The severe 
respiratory illness rate will be analyzed using a negative binomial (NB) regression model to account for 
overdispersion in the count data. For the primary analysis, univariate NB regression analysis will be 
conducted with study arm as a predictor variable. Study site will be included as a stratification factor in 
the primary analysis to account for stratified randomization. The observed effect size of the analysis will 
be quantified in terms of relative risk (RR) and reported along with the corresponding 95% confidence 
interval. 
  
As a secondary analysis, multivariate NB regression analysis will be performed to compare the severe 
respiratory illness rates between study arms. In this analysis, clinical and demographic characteristics 
will be included as covariates in an initial non-parsimonious model. The least absolute shrinkage and 
selection operator (lasso) and elastic net penalty methods for negative binomial regression models will 
be utilized to identify a parsimonious model with independent covariates. These methods are 
considered state-of-the art techniques for variable selection (Wang Z., et al. Stat Methods Med Res. 
2016). 
  
Longitudinal changes in the severe respiratory illnesses within and between study arms, will be 
evaluated with generalized linear mixed effects model with a logit link function and subject specific 
random effects. An autoregressive (AR) correlation structure will be utilized to account for within 
subject correlations. In this analysis, the presence/absence of severe respiratory illness at the monthly 
assessments will be the dependent variable, study arm will be included as a predictor variable and study 
site as a stratification variable to account for the stratified randomization. 
  
Secondary clinical outcomes include total hospital days during severe respiratory illness, numbers of 
systemic steroid courses, systemic antibiotic courses, respiratory ED visits and death. The numbers of 
systemic steroid courses, systemic antibiotic courses, and respiratory ED visits over the 6 months follow-
up period will be analyzed using NB regression analyses in in a similar fashion as described above the for 
primary outcome. Observed effect sizes will be reported along with the corresponding 95% confidence 
intervals. The presence/absence of systemic steroid courses, systemic antibiotic courses, and respiratory 
ED visits will be documented at the monthly assessments and longitudinal changes within and between 
study arms will be analyzed using generalized linear mixed effects modeling with a logit link function and 
patient specific random effects.  The total number of hospital days over the 6 months follow-up period 
will be analyzed using analysis of variance (ANOVA) with study site as stratification factor. In a secondary 
analysis, analysis of covariance (ANCOVA) will be performed where clinical and demographic baseline 
characteristic will be included as covariates and the lasso method will be used to identify a parsimonious 

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model. Longitudinal changes in the number of hospital days per hospitalization will be analyzed using a 
normal mixture linear mixed effects model with patient specific random effects. The normal mixture 
component will be in included in the model to capture the probabilities of a hospitalization at the 
monthly follow-up. Parameter estimation will be performed using the Expectation-Maximization 
algorithm which is the standard method for parameter estimation of mixture models. 
  
Missing values, e.g., due to loss of follow-up, missing monthly visits, will be evaluated by conducting a 
sensitivity analysis comparing the results obtained from the complete case analysis to the results 
obtained by imputation-based analyses. Specifically, multiple imputation (MI) will be used to impute 
missing values of primary and secondary clinical outcomes. For monotonic missing values data 
structures, we will use regression-based MI techniques. For non-monotonic missing value data 
structure, on the other hand, we will use Markov Chain Monte Carlo based imputation techniques. 
9.4.4 SAFETY ANALYSES 
N/A 
9.4.5 BASELINE DESCRIPTIVE STATISTICS 
Study confounders and covariates (see Section 8.1 for specific measures) will be summarized and 
compared at baseline. Given the small sample size, we will conduct adjusted and unadjusted analyses 
for variables that are statistically significantly different at baseline. 
9.4.6 PLANNED INTERIM ANALYSES 
Iterative refinements over three waves of implementation will be conducted by reviewing feasibility, 
acceptability, and fidelity measures from previous waves. 
9.4.7 SUB-GROUP ANALYSES 
There are not planned sub-group analyses aside from the secondary analyses described above.  
9.4.8 TABULATION OF INDIVIDUAL PARTICIPANT DATA 
N/A 
9.4.9 EXPLORATORY ANALYSES 
We will test the mediating effect of caregiver capability, opportunity, and motivation (COM-B) measures 
on the relationship between intervention and respiratory illness outcomes. The mediating effects will be 
evaluated by conducting a multi-step analysis approach. In the initial step, NB regression analyses will be 
conducted to examine whether there are differences in respiratory illness outcomes (number of severe 
respiratory illnesses, systemic steroid courses, systemic antibiotic courses, and respiratory ED visits) 
between the intervention and control arm, as described in the previous section. In the next step, we will 
conduct a sequence of univariate analyses, by regressing each potential mediator variable (caregiver 
capability, opportunity, and COM-B) on the binary study arm variable. If significant associations between 
the potential mediator variables and study arm are detected, we will regress the respiratory illness 
outcomes on both the mediator variables and study arm indicator variable using ANCOVA. The 

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mediation effect for each potential mediator variables will then be tested using the Sobel z-test based 
the slope parameter estimates from the corresponding regression models. 

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10 SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
10.1 REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS 
10.1.1 INFORMED CONSENT PROCESS 
10.1.1.1 CONSENT/ASSENT AND OTHER INFORMATIONAL DOCUMENTS PROVIDED TO 
PARTICIPANTS 
IRB-approved consent forms in English or Spanish (per participant preference) describing in detail the 
study intervention, study procedures, and risks are given to the participant and written documentation 
of informed consent is required prior to starting intervention/administering study intervention.  
10.1.1.2 CONSENT PROCEDURES AND DOCUMENTATION 
All study participants will undergo informed consent including consent to view the child’s medical 
record. In all informed consent materials, we will make clear to potential participants that their 
participation is voluntary, and they may choose to leave the study at any time. Potential participants 
identified from the clinic registry and, following an opportunity to opt-out of further contact, their 
interest and eligibility will be determined through a structured screening. If a family is interested in 
participation, they may contact the study team or a member of the study team will contact them for 
informed consent. Enrollment visits will be conducted either in person or remotely (via WebEx). All 
consent forms will be signed electronically using a REDCap form.  If a family enrolls in person, study staff 
will supply an iPad on which to sign the consent form.  If a family chooses to enroll remotely, study staff 
will send the family a REDCap survey link containing the consent form.  All subjects will also receive a 
hard copy of the consent form for their records.   Informed consent materials will be provided in private 
spaces in both written and verbal formats, will review in detail the study design, including random 
assignment to the intervention and control groups, potential risks of participation, protections against 
risk, and the rights of human research subjects. The informed consent process will also include review 
and signing of the HIPAA waiver, allowing researchers to review the child’s medical records. Parents will 
be able to decline parts of the study and still participate in other parts, and can revoke their consent at 
any point.  
  
Because this research involves children with severe cerebral, it is expected that all subjects will lack 
capacity to give meaningful assent. Assent will not be obtained. 
10.1.2 STUDY DISCONTINUATION AND CLOSURE 
This study may be temporarily suspended or prematurely terminated if there is sufficient reasonable 
cause. Written notification, documenting the reason for study suspension or termination, will be 
provided by the suspending or terminating party. If the study is prematurely terminated or suspended, 
the Principal Investigator (PI) will promptly inform study participants, the IRB, and sponsor and will 
provide the reason(s) for the termination or suspension. Study participants will be contacted, as 
applicable, and be informed of changes to study visit schedule. 

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Circumstances that may warrant termination or suspension include, but are not limited to: 
• 
Determination of unexpected, significant, or unacceptable risk to participants 
• 
Insufficient compliance of study staff to the protocol (i.e., significant protocol violations) 
• 
Data that are not sufficiently complete and/or evaluable 
The study may resume once concerns about safety, protocol compliance, and data quality are 
addressed, and satisfy the funding agency, sponsor, IRB, or other relevant regulatory or oversight bodies 
(OHRP, DSMB). 
10.1.3 CONFIDENTIALITY AND PRIVACY 
Participant confidentiality and privacy is strictly held in trust by the participating investigators, their 
staff, the safety and oversight monitor(s), and the sponsor(s) and funding agency. This confidentiality is 
extended to the data being collected as part of this study. Data that could be used to identify a specific 
study participant will be held in strict confidence within the research team. No personally identifiable 
information from the study will be released to any unauthorized third party without prior written 
approval of the sponsor/funding agency. 
  
All research activities will be conducted in as private a setting as possible. 
  
The study monitor, other authorized representatives of the sponsor, representatives of the Institutional 
Review Board (IRB), and regulatory agencies may inspect all documents and records required to be 
maintained by the investigator, including but not limited to, medical records for the participants in this 
study. The clinical study site will permit access to such records. 
  
The study participant’s contact information will be securely stored at each clinical site for internal use 
during the study. At the end of the study, all records will continue to be kept in a secure location for as 
long a period as dictated by the reviewing IRB, Institutional policies, or sponsor requirements. 
  
Study participant research data, which is for purposes of statistical analysis and scientific reporting, will 
be transmitted to and stored at the University of Wisconsin. This will not include the participant’s 
contact or identifying information. Rather, individual participants and their research data will be 
identified by a unique study identification number. The study data entry and study management 
systems used by clinical sites and by University of Wisconsin research staff will be secured and password 
protected. At the end of the study, all study databases will be de-identified and archived at 
the University of Wisconsin. 
  
Measures Taken to Ensure Confidentiality of Data Shared per the NIH Data Sharing Policies. It is NIH 
policy that the results and accomplishments of the activities that it funds should be made available to 
the public (see https://grants.nih.gov/policy/sharing.htm). The PI will ensure all mechanisms used to 
share data will include proper plans and safeguards for the protection of privacy, confidentiality, and 

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security for data dissemination and reuse (e.g., all data will be thoroughly de-identified and will not be 
traceable to a specific study participant). Plans for archiving and long-term preservation of the data will 
be implemented, as appropriate. 
 
 
Certificate of Confidentiality 
To further protect the privacy of study participants, the Secretary, Health and Human Services (HHS), 
has issued a Certificate of Confidentiality (CoC) to all researchers engaged in biomedical, behavioral, 
clinical or other human subjects research funded wholly or in part by the federal government. Recipients 
of NIH funding for human subjects research are required to protect identifiable research information 
from forced disclosure per the terms of the NIH Policy (see https://humansubjects.nih.gov/coc/index). 
As set forth in 45 CFR Part 75.303(a) and NIHGPS Chapter 8.3, recipients conducting NIH-supported 
research covered by this Policy are required to establish and maintain effective internal controls (e.g., 
policies and procedures) that provide reasonable assurance that the award is managed in compliance 
with Federal statutes, regulations, and the terms and conditions of award. It is the NIH policy that 
investigators and others who have access to research records will not disclose identifying information 
except when the participant consents or in certain instances when federal, state, or local law or 
regulation requires disclosure. NIH expects investigators to inform research participants of the 
protections and the limits to protections provided by a Certificate issued by this Policy. 
10.1.4 FUTURE USE OF STORED SPECIMENS AND DATA 
Data collected for this study will be analyzed and stored at the University of Wisconsin. After the study is 
completed, the de-identified, archived data will be stored at the University of Wisconsin, for use by 
other researchers including those outside of the study. Permission to transmit and to store data at 
the University of Wisconsin will be included in the informed consent. 
10.1.5 KEY ROLES AND STUDY GOVERNANCE 
Principal Investigator  
Medical Monitor or Independent 
Safety Monitor 
Ryan Coller, MD, MPH, Study PI 
UW ICTR DMC 
Gemma Warner, CCRC, MSSW, Project Manager 
  
Carlos Lerner, MD, MPhil, UCLA PI 
  
  
  
  
10.1.6 SAFETY OVERSIGHT 
This trial collects information that is typically collected during routine care, such as perceptions of child 
health, demographic and clinical information, caregiving experiences, and clinical plans for health 
concerns. Some of this information is potentially sensitive and could pose risk to subjects if involuntarily 
disclosed. Therefore, we will institute the following procedures to protect subject safety: 
  

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Data and Safety Monitoring Committee. Although we anticipate the nature of our questionnaires and 
study design to pose minimal risk, we will plan to create a Data Safety and Monitoring Board, 
independent from the investigator team and free of conflict of interest, or measures will be in place to 
minimize perceived conflict of interest. The UW Institute for Clinical and Translational Research (ICTR) 
has established a Data Monitoring Committee (DMC) to provide a key resource for UW-Madison 
investigators conducting clinical research. This DMC provides investigators services to ensure 
appropriate measures are in place to promote subject safety, research integrity and compliance with 
federal regulations and local policies for single site and multisite clinical research protocols in need of 
DMC review (as determined by the Principal Investigator (PI), the funding agency, the local Scientific 
Review Committee, or the local IRB, and for which no DMC exists). 
  
We plan to utilize the UW ICTR Data Monitoring Committee to oversee the study across both 
participating sites. The DMC is supported in its mission of safety and compliance by experienced ICTR 
staff to provide administrative assistance, experienced members representing a diversity of 
backgrounds, skills and knowledge, and the use of the Research Electronic Data Capture (REDCap) tool 
which provides data management functionality by allowing the development of eCRFs and surveys to 
support data capture. The UW ICTR DMC is comprised of experienced members (core plus ad hoc) with 
expertise required to oversee this study. 
  
The DMC members will review protocol-specific reports created by statisticians or delegates using data 
pulled from the REDCap data management tool. These standard reports will include an overview of 
study objectives, a review of actual and projected accrual rates, an evaluation of patient demographics 
for balance of randomization, and a summary of the number and seriousness of adverse events. An 
interim analysis of study results may be requested, and source documents may be reviewed to allow the 
DMC to independently judge whether the overall integrity and conduct of the protocol remain 
acceptable based on data provided and reported by the Principal Investigator. 
  
In providing oversight for the conduct of this study, the ICTR DMC will meet every year during the 2-year 
study to review all adverse events. Additional meetings may be scheduled as determined by the DMC or 
as requested by the PI. There are no predefined stopping points for this study. All reportable events will 
be submitted to the DMC and the Health Services IRB in accordance with their reporting guidelines. The 
DMC will make recommendations to the Principal Investigator that could include actions of 
continuation, modification, suspension, or termination. 
  
Adverse Event Protocol. The protocol for identifying and handling adverse events is outlined in Section 
8.3, Adverse Events and Serious Adverse Events and will be revised with the DMC and included in the 
IRB application. Prior to the initiation of any data collection, the UW-ICTR DMC will review and approve 
the adverse event protocol. 

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10.1.7 CLINICAL MONITORING 
Given the nature of the RE-PACT intervention (with plans to adapt the protocol to improve feasibility, 
acceptability and fidelity during 3 successive waves), the study team will monitor its own activities, as 
described in Section 10.1.8, Quality Assurance and Quality Control. 
• 
Independent audits will not be conducted as a part of this protocol 
10.1.8 QUALITY ASSURANCE AND QUALITY CONTROL 
Each clinical site will perform internal quality management of study conduct, data collection, 
documentation, and completion. All sites will follow a common quality management plan. 
Quality control (QC) procedures will be implemented as follows: 
 
Informed consent - Study staff will review both the documentation of the consenting process as well as 
a percentage of the completed consent documents. This review will evaluate compliance with GCP, 
accuracy, and completeness. Feedback will be provided to the study team to ensure proper consenting 
procedures are followed. 
 
Source documents and the electronic data - Data will be initially captured on source documents 
(see Section 10.1.9, Data Handling and Record Keeping) and will ultimately be entered into the study 
database. To ensure accuracy site staff will compare a representative sample of source data against the 
database, targeting key data points in that review. 
 
Intervention Fidelity - Consistent delivery of the study interventions will be monitored throughout the 
intervention phase of the study. Procedures for ensuring fidelity of intervention delivery are described 
in Section 6.2.1, Interventionist Training and Tracking. 
 
Protocol Deviations - The study team will review protocol deviations on an ongoing basis and will 
implement corrective actions when the quantity or nature of deviations are deemed to be at a level of 
concern. 
 
Should independent monitoring become necessary, the PI will provide direct access to all trial related 
sites, source data/documents, and reports for the purpose of monitoring and auditing by the 
sponsor/funding agency, and inspection by local and regulatory authorities. 
10.1.9 DATA HANDLING AND RECORD KEEPING 
10.1.9.1 DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES 
Data collection will be the responsibility of the clinical trial staff at the site under the supervision of the 
site investigator. The investigator will be responsible for ensuring the accuracy, completeness, legibility, 
and timeliness of the data reported. All source documents will be completed in a neat, legible manner to 
ensure accurate interpretation of data. Hardcopies of the study worksheets will be provided for use as 
source document worksheets for recording data for each participant consented/enrolled in the study. 

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Data recorded in the electronic case report form (eCRF) derived from source documents will be 
consistent with the data recorded on the source documents. 
  
Clinical data (including AEs) and clinical laboratory data will be entered into REDCap managed by the 
University of Wisconsin, a 21 CFR Part 11-compliant data capture system provided by the University of 
Wisconsin Institute for Clinical and Translational Research. The data system includes password 
protection and internal quality checks, such as automatic range checks, to identify data that appear 
inconsistent, incomplete, or inaccurate. Clinical data will be entered directly from the source documents 
or entered directly from a secure self-administered questionnaires (surveys) sent from REDCap to 
participants. 
10.1.9.2 STUDY RECORDS RETENTION 
Study documents will be retained for the duration required by the IRB and the sponsor, as required by 
local regulations. It is the responsibility of the sponsor/funding agency to inform the investigator when 
these documents no longer need to be retained. 
10.1.10 PROTOCOL DEVIATIONS 
This protocol defines a protocol deviation as any noncompliance with the clinical trial protocol, 
International Council on Harmonisation Good Clinical Practice (ICH GCP), or Manual of Procedures 
(MOP) requirements. The noncompliance may be either on the part of the participant, the investigator, 
or the study site staff. As a result of deviations, corrective actions will be developed by the site and 
implemented promptly. 
These practices are consistent with ICH GCP: 
• 
Section 4.5 Compliance with Protocol, subsections 4.5.1, 4.5.2, and 4.5.3 
• 
Section 5.1 Quality Assurance and Quality Control, subsection 5.1.1 
• 
Section 5.20 Noncompliance, subsections 5.20.1, and 5.20.2. 
It will be the responsibility of the site investigator to use continuous vigilance to identify and report 
deviations within 7 working days of identification of the protocol deviation, or within 7 working days of 
the scheduled protocol-required activity.  All deviations must be addressed in study source 
documents.  Protocol deviations must be sent to the reviewing IRB per their policies. The site 
investigator is responsible for knowing and adhering to the reviewing IRB requirements. Further details 
about the handling of protocol deviations will be included in the MOP. 
10.1.11 PUBLICATION AND DATA SHARING POLICY 
This study will be conducted in accordance with the following publication and data sharing policies and 
regulations: 
 
National Institutes of Health (NIH) Public Access Policy, which ensures that the public has access to the 
published results of NIH funded research. It requires scientists to submit final peer-reviewed journal 

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manuscripts that arise from NIH funds to the digital archive PubMed Central upon acceptance for 
publication. 
 
This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded 
Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule. As 
such, this trial will be registered at ClinicalTrials.gov, and results information from this trial will be 
submitted to ClinicalTrials.gov. In addition, every attempt will be made to publish results in peer-
reviewed journals. 
Data from this study may be requested from other researchers after the completion of the primary 
endpoint by contacting the study PI. Considerations for ensuring confidentiality of these shared data are 
described in Section 10.1.3. Even though the final dataset will be stripped of identifiers prior to the 
release for sharing, we believe that with the small sample size and relative uniqueness of these 
conditions, there remains the possibility of deductive disclosure of subjects with unusual characteristics. 
Thus, we will make the data and associated documentation available to users only under a data-sharing 
agreement that provides for: (1) a commitment to using the data only for research purposes and not to 
identify any individual participant; (2) a commitment to securing the data using appropriate computer 
technology; and (3) a commitment to destroying or returning the data after analyses are completed.  
 
Data prepared for distribution under a data-use agreement will be redacted to ensure privacy of study 
participant identity yet allow analyses to occur by other investigators. The data-use agreement will 
include requirements to protect participants' privacy and data confidentiality. It will prohibit the 
recipient from transferring the data to other users and require that the data’s security be protected by 
standard means and be used for research purposes only. Furthermore, we are required to honor the 
conditions under which we gained access to these data and will require that any applicants utilizing such 
data to perform data analyses per the data use agreement uphold these conditions. The method of 
distribution will be by request to the study PI.  After a requestor completes the data-sharing agreement, 
requestor will receive a limited dataset mailed by CD or emailed through UW-Madison secured email 
systems that require users to create an account and sign-in with a username and password in order to 
receive and download any type of sensitive data.  
10.1.12 CONFLICT OF INTEREST POLICY 
The independence of this study from any actual or perceived influence, such as by the pharmaceutical 
industry, is critical. Therefore, any actual conflict of interest of persons who have a role in the design, 
conduct, analysis, publication, or any aspect of this trial will be disclosed and managed. Furthermore, 
persons who have a perceived conflict of interest will be required to have such conflicts managed in a 
way that is appropriate to their participation in the design and conduct of this trial.  The study 
leadership, through the involved universities, have established policies and procedures for all study 
group members to disclose all conflicts of interest and will establish a mechanism for the management 
of all reported dualities of interest. 

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10.2 ABBREVIATIONS AND SPECIAL TERMS 
AE 
Adverse Event 
ANCOVA Analysis of Covariance 
CFR 
Code of Federal Regulations 
CLIA 
Clinical Laboratory Improvement Amendments 
CMP 
Clinical Monitoring Plan 
COC 
Certificate of Confidentiality 
CONSORT Consolidated Standards of Reporting Trials 
CRF 
Case Report Form 
DCC 
Data Coordinating Center 
DHHS 
Department of Health and Human Services 
DSMB 
Data Safety Monitoring Board 
DRE 
Disease-Related Event 
EC 
Ethics Committee 
eCRF 
Electronic Case Report Forms 
FDA 
Food and Drug Administration 
FDAAA 
Food and Drug Administration Amendments Act of 2007 
FFR 
Federal Financial Report 
GCP 
Good Clinical Practice 
GLP 
Good Laboratory Practices 
GMP 
Good Manufacturing Practices 
GWAS 
Genome-Wide Association Studies 
HIPAA 
Health Insurance Portability and Accountability Act 
IB 
Investigator's Brochure 
ICH 
International Council on Harmonisation 
ICMJE 
International Committee of Medical Journal Editors 
IDE 
Investigational Device Exemption 
IND 
Investigational New Drug Application 
IRB 
Institutional Review Board 
ISM 
Independent Safety Monitor 
ITT 
Intention-To-Treat 
LSMEANS Least-squares Means 
MedDRA Medical Dictionary for Regulatory Activities 
MOP 
Manual of Procedures 
NCT 
National Clinical Trial 
NIH 
National Institutes of Health 
NIH IC 
NIH Institute or Center 
OHRP 
Office for Human Research Protections 
PI 
Principal Investigator 
QA 
Quality Assurance 

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QC 
Quality Control 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SMC 
Safety Monitoring Committee 
SOA 
Schedule of Activities 
SOC 
System Organ Class 
SOP 
Standard Operating Procedure 
UP 
Unanticipated Problem 
US 
United States 
 

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