Development and Implementation of a Tobacco and ENDS Use Intervention for Adolescents and Young Adults in the Pediatric Hospital
Phase: NA
Conditions: Vaping, Smoking
Sponsor: Children's Mercy Hospital Kansas City

IRB # 00002116 
22FEB2024 
PROTOCOL TITLE:  
Development and Implementation of a Tobacco and ENDS Use Intervention for Adolescents and Young 
Adults in the Pediatric Hospital  
 
PRINCIPAL INVESTIGATOR: 
Name Abbey Masonbrink, MD MPH 
Department Pediatric Hospital Medicine 
Telephone Number (816) 802-1493 
Email Address armasonbrink@cmh.edu 
 
IND/IDE NUMBER: N/A 
 
VERSION NUMBER/DATE: 
Version 1.0 November 19, 2021 
 
REVISION HISTORY 
 
This Revision History table is provided for the benefit of study team version control.  If this table will not 
be useful please delete it. 
 
Revision 
# 
Version Date 
Summary of Changes 
Consent 
Change? 
1 
4.24.23 
Addition of Twilio to send secure text 
messages through REDCap 
yes 
2 
6.9.23 
Addition of exploratory aim of genetic 
variation and collection of voluntary salivary 
samples from all participants 
yes 
3 
6.21.23 
Clarification of reconsenting process for 
participants who turn 18 years old during 
study 
 
4 
7.12.23 
Clarification of eligibility criteria, must be an 
ENDS user (cannot be solely a traditional 
cigarette user, can be co-user) 
 
5 
7.28.23 
Addition of hospital staff as participants and 
information about the interviews for them 
 
6 
7.28.23 
Inclusion of vulnerable population, wards of 
the state 
 
7 
2.21.24 
Addition of another salivary testing option for 
participants.  
yes 
8 
5.24.24 
Addition of option for blood salvage samples 
for genomic sequencing. 
yes 
9 
8.30.24 
Adding additional study site, Children’s 
Hospital of Los Angeles (CHLA). The current 
Yes 

IRB # 00002116 
22FEB2024 
study PI (Masonbrink) will be starting a 
position there on November 1, 2024. At the 
time of her departure we will change the CMH 
study PI to Dr. Melissa Miller (currently a Co-
Investigator). CHLA will be added as a study 
site but will complete external reliance on the 
CMH IRB and no data collection will occur at 
CHLA. 
 
 
 

IRB # 00002116 
22FEB2024 
Table of Contents 
STUDY INFORMATION 
1.0 Study Summary 
2.0 Objectives 
3.0 Background 
4.0 Study Design 
5.0 Research Interventions 
SUBJECT MANAGEMENT 
6.0 Inclusion and Exclusion Criteria 
7.0 Local Number of Subjects 
8.0 Screening and Recruitment Methods 
9.0 Surveys and Psychometric Testing 
10.0 Additional Study Activities 
11.0 Follow-Up 
12.0 Genetic Analysis Information 
13.0 Sharing of Results with Subjects 
14.0 Risks to Subjects 
15.0 Potential Benefits 
16.0 Investigator Assessment of Risk/Benefits Ratio 
17.0 Payment, Reimbursement and Tangible Property Provided to Subjects 
18.0 Compensation for Research-Related Injury 
19.0 Economic Burden to Subjects 
20.0 Parental Permission and Adult Consent Process 
21.0 Assent of Pediatric Subjects 
22.0 HIPAA and Confidentiality 
23.0 Provisions to Protect the Privacy Interests of Subjects 
24.0 Withdrawal of Subjects 
DATA MANAGEMENT 
25.0 Data Collection 
26.0 Adverse Events and Unanticipated Problems 
27.0 Data Analysis 
28.0 Data and Specimen Management 
29.0 Storage/Banking of Data and Specimens for Future Research 
30.0 Provisions to Monitor the Data to Ensure the Safety of Subjects 
DATA MANAGEMENT 

IRB # 00002116 
22FEB2024 
31.0 Settings and Locations 
32.0 Multi-Site Research 
33.0 International Research 
ADDENDUMS 
Addendum A: Waiver of Documentation of Permission/Consent 
Addendum B: Waiver/Alteration of Permission/Assent/Consent 
Addendum C: Non-English Speaking Subjects 
Addendum D: Surrogate Decision Maker Consent 
Addendum E: Waiver/Alteration of HIPAA Authorization 
 
 
 

IRB # 00002116 
22FEB2024 
STUDY INFORMATION 
1.0 
Study Summary* 
1.1  Synopsis 
 
Study Title 
Development and Implementation of a Tobacco and ENDS Use 
Intervention for Adolescents and Young Adults in the Pediatric 
Hospital  
Study Design 
Randomized controlled pilot study with 3-month follow up to 
evaluate preliminary efficacy as well as implementation 
outcomes (i.e., acceptability, feasibility, fidelity) of a tobacco use 
and vaping cessation program. All data collection will occur at 
Children’s Mercy Hospital (CMH) but we will have a second study 
stie (CHLA; added due to change in position of PI Masonbrink) 
where no data collection will occur, but data containing PHI may 
be shared. 
Primary Objective 
We will evaluate preliminary efficacy (i.e., 30-day self-reported 
abstinence with biochemical verification) as the primary 
outcome. 
Secondary Objective(s) 
We will assess self-reported motivation and confidence to quit 
and implementation outcomes (i.e. acceptability, feasibility, and 
fidelity) immediately post-intervention and at 3-month follow up. 
Study Population 
Adolescents and young adults (AYAs; 14-21 years old) admitted to 
the hospital 
Sample Size 
144 AYA, up to 144 parents, up to 10 hospital staff 
Study Duration for 
Individual Participants 
3 months 
Study Specific 
Abbreviations/ 
Definitions  
Adolescents and young adults (AYAs) 
electronic nicotine delivery system (ENDS) 
American Academy of Pediatrics (AAP) 
United States (US) 
United States Preventive Service Task Force (USPSTF) 
Motivational interviewing (MI) 
SBIRT (Screening, Brief Intervention, Referral to Treatment) 
clinical decision support (CDS) 
Emergency department (ED) 
Nicotine replacement therapy (NRT) 
Electronic health record (EHR) 
Consolidated Framework for Implementation Research (CFIR) 
Randomized controlled trial (RCT) 
 
2.0 
Objectives* 
2.1 
Purpose, specific aims or objectives:   
Design and iteratively refine a tobacco and ENDS use intervention for AYAs. We will draw on 
promising primary care and hospital-based approaches to develop and iteratively refine, based 
on survey and interviews of key stakeholders, a novel intervention to screen for and treat 
current tobacco and ENDS use in hospitalized AYAs. 

IRB # 00002116 
22FEB2024 
Evaluate preliminary efficacy and implementation outcomes of the tobacco and ENDS use 
intervention. We will conduct a randomized pilot trial with 3-month follow up to assess 
preliminary efficacy and implementation of the intervention in hospitalized AYAs with current 
tobacco and ENDS use. Self-reported 30-day abstinence with biochemical verification at 3 
months will be the primary outcome and secondary outcomes will include implementation 
measures (e.g., acceptability, feasibility, fidelity). 
Exploratory secondary aim: We will explore the impact of individual-level factors (e.g., CYP2A6 
genotype, nicotine metabolite ratio, sex) at baseline with our primary outcome (past 30 day ENDS use 
abstinence).  
 
 
2.2 
Hypothesis to be tested/Exploratory study design:  
We hypothesize the intervention arm will have higher rates of biochemically confirmed self-
reported tobacco use abstinence (preliminary efficacy; primary outcome) compared to the 
control arm at 3 month follow up. 
3.0 
Background* 
Tobacco use is the single leading cause of preventable death, disability and disease in the United States 
(US). Adolescence is a critical developmental period for intervention because 90% of adult tobacco 
users initiate during this period.1 Although tobacco control efforts have led to declining rates of 
combustible cigarette use, electronic nicotine delivery system (ENDS) use among youth has risen 
dramatically in the past decade. ENDS, which include electronic or “e”-cigarettes, pod-based or 
disposable vaping devices, and vape pens, are now the most common tobacco product used by 
adolescents and young adults (AYAs).2,3 Between 2011-20, current (past 30-day) ENDS use increased 
from 1.5% to 20% among high school students and from 0.6% to 5% among middle school students.2–4 
ENDS use is linked with increased use of cigarettes, alcohol and other illicit substances, as well as 
adverse health outcomes among AYAs.5–9 Recently there was an outbreak of hospitalizations for e-
cigarette and vaping-associated lung injury including among youth (£ 18 years).10,11  
 
The American Academy of Pediatrics (AAP) and the US Preventive Service Task Force (USPSTF) 
recommend counseling using the 5 A’s Framework (Ask, Advise, Assess, Assist, Arrange) and 
motivational interviewing (MI) techniques to address tobacco use at every adolescent clinical visit.12–14 
This recommendation is based largely on research from the primary care setting, although many 
adolescents do not routinely attend primary care visits. With more than 1.5 million AYA 
hospitalizations annually, the hospital setting offers an untapped venue for identifying and treating 
AYA cigarette and ENDs use.15–18 Many hospitalized AYAs are at increased risk for tobacco use as well 
as tobacco-related poor health outcomes due to underlying comorbidities (e.g., mental health 
disorders, diabetes, asthma).5,6,16 In addition, the rising prevalence of ENDS use may be linked with 
increased risk for hospitalizations for respiratory illnesses as well as an increased risk for unrecognized 
and untreated nicotine withdrawal among hospitalized AYAs.1,17–19 Although research on tobacco and 
ENDS use among hospitalized AYAs is sparse, our preliminary data indicate that 28% report any 
tobacco use, and 15% report current ENDS use.20  
 
While there is strong evidence supporting the feasibility and effectiveness of treating tobacco use 
during adult hospitalizations and promising evidence for substance use treatment (e.g., alcohol) during 

IRB # 00002116 
22FEB2024 
hospitalization among AYAs,21–26 no interventions for tobacco and ENDS use have been developed or 
tested in the pediatric hospital setting. In primary care-based tobacco treatment for AYAs there are 
limited ENDs use treatment interventions.27 In this proposal, we aim to address these limitations by 
initiating a line of research focused on treating tobacco and ENDS use among AYAs in the hospital.  
 
Drawing on related work in the hospital and primary care settings, we will adapt components of the 
most efficacious tobacco and ENDS use interventions (e.g., 5 A’s Framework, MI) to design an 
intervention that accounts for important hospital-specific contextual factors. We will use the Proctor 
and CFIR (Consolidated Framework for Implementation Research) frameworks to evaluate 
implementation such as determining the optimal process for tobacco and ENDS use screening and 
treatment while managing acute illness; coordinating care with the medical team; and using 
confidential computerized decision support (CDS) systems to achieve systematic and high-quality 
implementation.28,29 We will also identify and utilize feasible post-discharge follow-up strategies. 
 
4.0 
Study Design* 
 
Health Services/Programmatic Activities 
Design and iteratively refine a tobacco and ENDS use intervention based in clinical practice 
guidelines for AYAs  
Research Activities 
• 
Conduct a pilot RCT to assess implementation of the evidence-based intervention in the 
pediatric hospital setting with 3-month follow up to assess preliminary efficacy and 
implementation outcomes. We will evaluate preliminary efficacy (i.e., 30-day self-
reported abstinence with biochemical verification) as the primary outcome. We will also 
assess self-reported motivation and confidence to quit and implementation outcomes 
(i.e. acceptability, feasibility, and fidelity) immediately post-intervention and at 3-month 
follow up.  We will conduct 4 follow up phone sessions with AYA post hospitalization.  
These phone calls will consist of counseling provided by the health educator and will last 
approximately 30 minutes.  Parents of AYA will complete a post intervention survey. 
Hospital staff will be asked to complete a post intervention survey and interview. 
 
All data collection will occur at Children’s Mercy Hospital (CMH)  however we will have a second study 
stie (CHLA; added due to change in position of PI Masonbrink November 1, 2024) where no data 
collection will occur, but data containing PHI may be shared for analysis.
 
 
 
5.0 
Research Interventions* 
5.1 
Description: We will conduct a prospective, pilot trial with 3-month 
follow up to assess preliminary efficacy and implementation outcomes.  
Hospitalized AYAs with current (past 30-day) ENDS use (including those with co-
use of cigarettes) will be randomized 2:1 to receive either novel intervention or 
control intervention that will consist of brief advice and printed quit line referral 
as part of their clinical care. We will evaluate preliminary efficacy (i.e., 30-day 

SHORT TITLE: Tobacco Inpatient Intervention 
Page 2 of 33 
 
self-reported abstinence with biochemical verification) as the primary outcome. 
We will also assess self-reported motivation and confidence to quit and 
implementation outcomes (i.e. acceptability, feasibility, and fidelity) immediately 
post-intervention and at 3-month follow up.  
We will screen the EMR to identify potential eligible participants and send a text 
page to the medical team to notify them that we will approach the potential 
participant. The text page will state “Your patient is potentially eligible to 
participate in Dr. Masonbrink’s research study about vaping and tobacco use. 
Please call us if you have concerns about our team approaching the patient.” The 
study team will then approach the eligible participant and give brief information 
about the study (e.g., “We are doing a research project to learn how we can help 
adolescents and young adults stop vaping and using tobacco products. Are you 
interested in hearing more about this?”). The study team will then review and 
consent the eligible participants. Randomization of consented participants will 
be stratified on sex and age using a 2:1 ratio within strata via computer 
generated assignment sequence placed in sequentially numbered sealed 
envelopes. Control participants will receive brief advice from the health educator 
regarding tobacco and ENDS use cessation and printed referral to a quit line. 
Intervention participants will receive our vaping and tobacco use cessation  
intervention based in clinical practice guidelines and administered by a health 
educator. Intervention participants will be eligible to receive a prescription for 
nicotine replacement therapy based on current clinical practice guidelines if they 
demonstrate risk for nicotine withdrawal. All participants will complete a post-
intervention survey and a 3-month survey sent via email, text message via Twilio, 
and/or mailed paper survey so the research team is not directly involved in 
outcome data collection.  Four phone calls will be conducted on the intervention 
group post hospitalization to provide smoking cessation counseling.  These calls 
will take approximately 30 minutes.  Parents/guardians of AYAs will be asked to 
complete a post-intervention survey which will be administered by the health 
educator and will take approximately 15 minutes.   
Hospital Staff will be asked to complete a post-intervention survey and interview 
conducted by the health educator to assess acceptability and disruption of the 
intervention, it will take approximately 10 minutes, the only PHI that will be 
collected is to compensate them and will include no sensitive data.  
 
Participant demographics and clinical characteristics (e.g., age of initiation, nicotine 
dependence) will be assessed at baseline. Preliminary efficacy will be assessed via self-
reported 30-day point prevalence tobacco/ENDS abstinence using the timeline follow-
back method at 3-month follow-up. To obtain a biochemically verified outcome and to 
encourage accurate self-reporting we will assess salivary cotinine via mailed samples 
from all participants (not currently on NRT) who report abstinence. We will assess this 
by either mailing a saliva specimen home collection kit to then be return mailed (pre 

SHORT TITLE: Tobacco Inpatient Intervention 
Page 3 of 33 
 
addressed and paid) to our study team or we will also offer the option of completing a 
home saliva cotinine test which do not require return mailing. For this option home 
saliva cotinine tests will be mailed to the participant. The study team will then schedule 
a secure Microsoft Teams video call to witness saliva test completion and results or 
photos of the test results can be emailed at a convenient time to 
phmteenresearch@cmh.edu . Although accurate verification will not be possible with 
participants who are occasional users or those on NRT, this will also allow us to evaluate 
the feasibility of confirming abstinence by collecting saliva specimens by mail or 
completing witnessed (via Microsoft Teams secure video or securely emailed photos) 
home saliva cotinine tests in this population which will be informative for future studies 
with daily ENDS users. Secondary efficacy outcomes will include self-reported 
motivation and confidence to quit immediately post-intervention and at 3-month follow 
up. We will assess acceptability with the overall intervention and intervention 
components via survey immediately post intervention (AYAs and parents) and at 3 
month follow-up (AYAs). We will also explore our secondary objective by obtaining a 
voluntary saliva or salvage leftover blood samples at baseline from all participants to 
assess genotyping the impact of individual-level factors (e.g., CYP2A6 genotype, nicotine 
metabolite ratio, sex) at baseline with our primary outcome (past 30 day ENDS use 
abstinence). 
Acceptability will also be evaluated via participant enrollment and session completion 
rates. Study Procedures: Data from AYAs and parents/guardians will be collected using 
confidential electronic survey collection via REDCap.. AYAs who decline to participate 
will be asked to provide age, sex, race and ethnicity to facilitate identification of 
participation bias.  
 
 
SUBJECT MANAGEMENT 
6.0 
Inclusion and Exclusion Criteria* 
6.1 
Eligibility Criteria:  
AYA patients  
Inclusion: 14-21 years, current or past 
30-day ENDS use, hospitalized, English 
speaking 
Exclusion: severe illness, severe 
psychiatric illness or cognitive 
impairment 
Parents/Guardians 
Inclusion: AYA agrees to 
parent/guardian surveys 

SHORT TITLE: Tobacco Inpatient Intervention 
Page 4 of 33 
 
 
6.2 
Equitable Selection:  There are no exclusions based on sex or 
race/ethnicity. We will plan to enroll a balanced study sample by reviewing the 
EHR and approaching a study population that is representative of the 
hospitalized AYAs at our hospital. As a majority of patients are English speaking 
we will plan to enroll English speaking participants, we will provide a parent 
information sheet in Spanish for participants whose parents speak Spanish but 
the enrolled participant must be English speaking. 
 
6.3 
Vulnerable Populations: Check any vulnerable populations that are being 
targeted for enrollment into the study: (Members of the following populations 
may not be included as participants in the research unless selected here.) 
☐ Children/Minors (under 7 years of age) 
☒ Children/Minors (7-17 years of age) 
☐ Neonates (infants less than 30 days old) 
☐ Neonates of Uncertain Viability (infants 
less than 30 days old) 
☐ Non-Viable Neonates (infants less than 
30 days old) 
☒ Wards of the State 
☐ Fetuses 
☐ Pregnant Women  
☐ Adults with impaired decision-making 
capacity         
☒ CM Employees 
☐ CM Students/Residents/ Fellows 
☐ Economically or Educationally 
Disadvantaged Persons 
☐ Prisoners 
 
 
Adolescents aged 14-17 years: 
Adolescent assent procedures will follow practices accepted by the Society for 
Adolescent Health and Medicine and current regulatory guidelines and align with those 
previously used for CM studies involving adolescents 
All adolescents will be encouraged to ask questions, provided necessary time to 
consider participation, and able to stop participation at any time, should they choose to 
do so. 
All adolescents will be assured that their decision to participate or not will have no 
impact on their relationship with and care received at CM. 
 
Wards of the State: 
Another population that requires close attention are those who are wards of the state.  
This population is extremely important to capture, as they are known to have higher risk 
Hospital Staff 
Inclusion: Staff of enrolled AYA agrees 
to participate  

SHORT TITLE: 
Page 5 of 33 
 
for all of the factors being studied here and likely benefit from prevention at every 
medical encounter.   
 
Hospital staff as participants: We will enroll CMH employees (hospital staff) in the study. 
We will minimize the potential for employees to feel coerced or unduly influenced to 
participate in the study by ensuring that employee will not be recruited or enrolled by 
their direct supervisor. Participation in the study is completely voluntary and does not 
impact the AYA patient’s participation.  
7.0 
Local Number of Subjects 
144 AYA and up to 144 parents of AYA, up to 10 hospital staff members 
will be recruited at CMH (the lead study site). 
 
 
8.0 
Identification and Recruitment of Potential Participants* 
8.1 
Identification of Potential Participants:   
How will participants be identified? (Check all that apply) 
 
☐ Chart reviews  
 
☐ By their treating physician who will then provide the study team’s contact 
information to the potential subject/family 
☐ By their treating physician who will obtain patient/family permission to share 
contact information with the study team 
☐ By a partnering community-based organization who will then provide the 
study team’s contact information to the potential subject/family 
☐ By a partnering community-based organization who will obtain patient/family 
permission to share contact information with the study team 
☐ Self-refer in response to IRB approved advertisements or websites  
☒ Through Cerner or other CM sources (e.g. databases, billing records, 
pathology reports, admission logs, etc.) May involve access of records by 
individuals not involved in the patient’s care. 
☐ List of candidates provided through the Data Report Request Form  
☐ Registry of individuals interested in research opportunities   
☐ Past subject list 

SHORT TITLE: 
Page 6 of 33 
 
☐ Participants will roll-over from another research study: Study 
#___________________ 
☒ Other: Hospital staff of enrolled AYA will be identified at bedside.  
 
8.2 
Pre-Screening prior to HIPAA Authorization 
Will any of the identification methods checked above involve 
access to Protected Health Information (PHI) prior to obtaining 
HIPAA Authorization? 
☒ Yes 
 
☐ No 
• If yes, a “Partial Waiver of HIPAA Authorization” is required.  Be sure to 
make this selection in the “HIPAA & Confidentiality” section below and 
complete Addendum E: Waiver/Alteration of HIPAA Authorization 
 
8.3 
Recruitment of Potential Subjects:   
All data collection will occur at CMH, the lead study site. The research 
team will use the EHR to identify and recruit a heterogeneous sample of 
eligible AYAs for the pilot RCT. The health educator will monitor the EHR 
to identify, notify the medical team and then enroll and consent eligible 
AYA participants. Recruitment will occur at flexible times to minimize 
hospital care disruptions. Hospitalized AYAs with current (past 30-day) 
ENDS use (including those with co-use of cigarettes) will be randomized 
2:1 to receive our novel intervention or control intervention that will 
consist of brief advice and printed quit line referral. Data from AYAs and 
parents/guardians will be collected using confidential electronic survey 
collection via REDCap. The health educator will recruit, screen, consent, 
and randomize eligible participants. AYAs who decline to participate will 
be asked to provide age, sex, race and ethnicity to facilitate identification 
of participation bias. 
Randomization of consented participants will be stratified on sex and age 
using a 2:1 ratio within strata via computer generated assignment 
sequence placed in sequentially numbered sealed envelopes.  
Parents of enrolled AYA will be identified at the bedside or given a phone 
call to ask about interest in the study.  The health educator obtain verbal 
consent from parents in person or by phone. 
Hospital staff of enrolled AYA will be identified at bedside. The health 
educator will obtain verbal consent from hospital staff in person.  

SHORT TITLE: 
Page 7 of 33 
 
 
9.0 
Surveys and Psychometric Testing: 
• Data Collection:  
All participants will complete a post-intervention survey and a 3-month 
survey sent via email, text message via Twilio, and/or mailed paper survey so 
the research team is not directly involved in outcome data collection. 
Parents/guardians of AYAs will be asked to complete a post-intervention 
survey. Hospital staff of AYAs will be asked to complete a post-intervention 
survey and interview (n=up to 10). A member of the study team, the health 
educator will complete brief survey items and field notes after each session.  
Measures: Participant demographics and clinical characteristics (e.g., age of 
initiation, nicotine dependence) will be assessed at baseline. The outcome 
measures, method of assessment, relevant stakeholders and detailed description 
are depicted in Table 3 and sample survey items in Table 4. Preliminary efficacy will 
be assessed via self-reported 30-day point prevalence tobacco/ENDS abstinence 
using the timeline follow-back method at 3-month follow-up.73 To obtain a 
biochemically verified outcome and to encourage accurate self-reporting we will 
assess salivary cotinine from all participants (not currently on NRT) who report 
abstinence. We will assess this by either mailing a saliva specimen home collection 
kit to then be return mailed (pre addressed and paid) to our study team or we will 
also offer the option of completing a home saliva cotinine test which do not require 
return mailing. For this option home saliva cotinine tests will be mailed to the 
participant. The study team will then schedule a secure Microsoft Teams video call 
to witness saliva test completion and results or photos of the test results can be 
emailed at a convenient time to phmteenresearch@cmh.edu.  If video call is 
performed the Microsoft Teams video call will not be recorded. If photos are 
emailed, the photos will be uploaded to REDCap and then deleted from the email.  
Secondary efficacy outcomes will include self-reported motivation and confidence to 
quit immediately post-intervention and at 3-month follow up.65, 74,75 We will assess 
acceptability with the overall intervention and intervention components via survey 
immediately post intervention (AYAs and parents) and at 3 month follow-up (AYAs). 
Acceptability will also be evaluated via participant enrollment and session 
completion rates. Feasibility will be assessed via intervention duration in minutes 
from audio recordings and Dr. Masonbrink and the health educator will complete a 
brief survey and record field notes to assess feasibility (e.g., impact on workflow, 
disruption, suitability). To assess fidelity we will review audio recordings and rate 
health educator intervention and control sessions based on a previously developed 
fidelity rating scales.76  
 
10.0 Additional Research Activities 

SHORT TITLE: 
Page 8 of 33 
 
10.1 
Data collection from the medical record: The research team will 
use a REDCap instrument to collect some demographic information (eg, 
age, insurance type) from the medical record for each participant. 
Additionally, upon completion of enrollment, we will collect additional 
medical record data based on Cerner orders and/or prescription 
information (to assess for prescription of NRT).  
10.2 
Refusal Log: The study team will maintain a refusal log to assess 
potential differences between AYAs that participate and those that do 
not. AYAs who decline to participate will be asked if they will provide 
information anonymously. If they agree to do this, they will complete an 
anonymous survey to assess age, sex, gender, race/ethnicity, primary 
language, and reason for not participating. This survey will be 
administered via REDCap/tablet computer. If the adolescent declines to 
complete the refusal survey, the study team member will complete 
survey items on age and sex (available via EHR) and reason for study 
declination, if provided.  
10.3 
Blood and Other Specimen Collection: 
• To explore the impact of genetic variation on electronic cigarette use, 
nicotine dependence and cessation outcomes, DNA will be isolated from 
each participant and genotyping/sequencing will be completed by CMRI 
Genomics core or a similar service. This will allow for detection of known 
SNPs of interest and creation of an exploratory dataset for future inquiry as 
new questions arise. To evaluate this exploratory outcome we will collect a 
salivary or salvage leftover blood (collected during hospital stay) samples 
from all participants at baseline. 
• A saliva sample kit will be mailed to the participant’s home with a pre-paid 
label for their return of the sample or participants will have the option of 
completing a salivary cotinine test at home that will be witnessed by a study 
team member through secured Microsoft Teams video calling or photos will 
be securely emailed to a research specific email address.  If using the return 
mailing option participants will collect saliva according to included 
instructions and send the sample back in the package we provide them. 
• No extra samples will be collected during this time. 
 
11.0 Follow-up 
• All AYA participants (both control and intervention arms) will be 
asked to complete a follow-up Survey at 12 weeks (completion 
window 10-14 weeks). 
• AYA participants will receive an email and/or text via Twilio inviting 
them to complete the follow-up survey using a weblink provided. We 
will send up to 2 emails and/or 2 text reminders, as needed. If by 

SHORT TITLE: 
Page 9 of 33 
 
week 13 the participant has not completed the follow-up survey, a 
study team member will call them using the phone number(s) 
provided to remind them about the survey (maximum number of 
phone calls = 3). If needed at the time of the call, the follow-up survey 
weblink will be sent via email and/or text via Twilio.  
12.0 Genetic Analysis Information 
Single nucleotide polymorphism (SNPs) analysis and genomic sequencing may occur as 
part of this study for research purposes only to explore the impact of genetic variation 
on pharmacokinetics, pharmacodynamics and/or disease.  
 
 
 
13.0 Sharing of Results with Subjects 
13.1 
Results from genetic analysis will not be shared individually with 
participants. We will not share results of research procedures with 
participants.  
 
14.0 Risks to Subjects* 
14.1 
Breach of confidentiality: As with any study, there is potential for 
breach of confidentiality. Strict measures will be taken to ensure 
participant privacy and confidentiality. All data will be managed in 
accordance with hospital institutional review board and HIPPA 
requirements to ensure confidentiality and protection of research 
participants. Participants will provide assent/consent and complete data 
collection privately to maintain confidentiality. Study personnel will not 
use study data and records for any purpose other than conducting the 
study. Only researchers involved in this study will have access to the 
collected data. All data will be de-identified then stored in the secure 
REDCap database, and all participants will be assigned a unique 
identification number. The contact information needed to facilitate the 3-
month Follow-up will not be linked to survey data. All personally 
identifiable information will be kept strictly confidential and stored in 
REDCap and only accessible by Dr. Masonbrink and the necessary, 
designated study staff at both study sites, including CMH and CHLA. At 
the completion of data collection and gift card provision, personally 
identifiable information will be destroyed. 
14.2 
Mandatory reporting: During the consent process, we will inform 
participants that we are unable to maintain confidentiality if they verbally 
disclose abuse that requires a mandated report by state law or 

SHORT TITLE: 
Page 10 of 33 
 
relationship behaviors that raise significant concern for safety of a minor 
(i.e., < 18 years of age) adolescent participant. 
14.3 
Emotional distress: Participants may experience distress triggered 
by the study topic. However, our prior experience with similar studies 
and available published evidence suggests this risk is minimal. We include 
information in the assent/consent process that reminds participants that 
they are not required to answer questions that make them feel 
uncomfortable and may choose to terminate study participation at any 
time. CMH social workers are available 24 hours daily for patients and 
families; participants will be informed of this availability during the 
informed consent process, as well as upon interview completion. 
Additionally, each participant will receive a list of teen community 
resources (e.g., teen resource center, mental health resources, substance 
use disorder treatment resources, national suicide hotline), such that 
they may contact needed resources at any time without disclosure of 
need to the study team. 
14.4 
Study risks are not greater than minimal for all participants. 
 
15.0 Potential Benefits* 
15.1 Participants may benefit directly from the teen resource list that will be 
provided to each participant. Information provided in the teen resource list and 
the intervention may enable participants to reduce or quit smoking and/or 
vaping, to provide support for peers who use tobacco and/or ENDS use, and to 
access CM and community resources for common issues, including substance use 
disorders. Intervention participants may benefit directly from the knowledge and 
resources gained through the intervention itself by receipt of MI-based 
counseling with the health educator and Dr. Masonbrink, possible prescription of 
nicotine replacement therapy if indicated and follow up through booster 
sessions and/or text messaging program. Control participants may benefit from 
receipt of brief advice to quit tobacco use by a health professional and referral to 
a quit line. Indirect benefit from this study may include potentially decreasing 
prevalence of AYA tobacco and/or ENDS use and adverse health outcomes.  
15.2 
Benefits to society/science may include 1) improved care of AYAs 
treated receiving care in the pediatric hospital in the future, and 2) better 
understanding of effective interventions to promote tobacco and ENDS 
use cessation among youth. In the long term, the findings of this study 
could contribute to a reduction in tobacco and ENDS use among AYAs 
and associated negative outcomes, which include cancer, 
cardiorespiratory illnesses and death. The minimal risks of participation 
are reasonable in relation to these generalizable benefits. 

SHORT TITLE: 
Page 11 of 33 
 
 
16.0 Investigator Assessment of Risk/Benefits Ratio*  
16.1 
 
 
Select as applicable: 
Pediatric Risk Category: 
☒ 
Category 1  Research not involving greater than minimal risk  
(45 CFR §46.404 and 21 CFR §50.51)   
☐ 
Category 2 
Research involving greater than minimal risk but 
presenting the prospect of direct benefit to the 
individual subjects. (45 CFR §46.405 and 21 CFR 
§50.52) 
☐ 
Category 3 
Research involving greater than minimal risk and no 
prospect of direct benefit to individual subjects, but 
likely to yield generalizable knowledge about the 
subject's disorder or condition.  
(45 CFR §46.406 and 21 CFR §50.53) 
☐ 
Category 4 
Research not otherwise approvable which presents 
an opportunity to understand, prevent, or alleviate a 
serious problem affecting the health or welfare of 
children. (45 CFR §46.407 and 21 CFR §50.54) 
Select if applicable: 
Adult Risk Category: 
☒ 
Not Greater than Minimal Risk 
☐ 
Greater than Minimal Risk 
 
 
17.0 Payment, Reimbursement and Tangible Property provided to 
subjects*  
Is payment, reimbursement, or tangible property part of the study?  
☒  Yes                 ☐  No (If No, delete the following subsections) 
 
17.1 
Payment to Subjects: If providing payment for participation (e.g. 
cash equivalent for participation, payment for time off work), select the 
form of payment: 
 
☐  Greenphire/ClinCard 
☐  Gift Card: (Merchant:_____________) 
☒  Other: ___Clinical Conductor (CCpay)_______ 
 
Note: “Gift Card” and “Other” options require approval by Research Administration. Upon 
submission in myIRB, ORI staff will initiate the Research Administration approval process. 
 

SHORT TITLE: 
Page 12 of 33 
 
Payment Schedule:  
Formative stage: Parents of AYA will receive $20 for participation. 
Hospital staff of AYAs will receive $10 for participation. 
 
Research stage: Pilot RCT: AYAs will receive $15 for study enrollment and 
$20 for 3-month follow up survey completion. For eligible participants who 
agree to complete a saliva sample at the 3 month follow up they will 
receive $25 once the sample is completed/received. Total potential 
payment for one AYA participant is $60. We will also provide NRT 
prescription free of charge for AYA participants assigned to the 
intervention group and for which this is clinically indicated. 
 
 
 
17.2 
 Reimbursement:  N/A 
17.3 
Tangible Property:  N/A 
18.0 Compensation for Research-Related Injury 
18.1 
Being in this study involves no more than minimal risk, therefore 
we do not require compensation for research-related injury. 
 
19.0 Economic Burden to Subjects 
Participants may incur costs related to text messaging and data charges 
for surveys completed on their cellular phone. Participants may incur 
costs related to follow up after the hospital visit during which they 
enrolled in the study (e.g., if they follow up in the CM adolescent clinic). 
 
20.0  Parental Permission and Adult Consent Process* 
 
Waiver of Documentation of Permission/Consent 
Permission/Consent form provided but signature will NOT be obtained (e.g. verbal consent) 
Must complete Addendum A: Waiver of Documentation of Permission/Consent 
 
☒ Waiver of written documentation of permission of parent/LAR for pediatric 
participants  
Study group(s) to which this method applies: Parents of Adolescent participants 
(14-17 years old).  An information sheet will be left in the room/given to parents of 
adolescents who decide to participate in the study.  
☒ Waiver of written documentation of consent of adult participants  

SHORT TITLE: 
Page 13 of 33 
 
 
Study group(s) to which this method applies: Parents as Participants; Parents will 
give verbal consent to participate in the study and complete a survey. 
☐ Waiver of written documentation of consent of participants turning 18  
 
Study group(s) to which this method applies:  
 
Waiver or Alteration of Permission/Consent 
Adult consent will NOT be obtained, or you propose to alter a required element of consent. 
Must complete Addendum B: Waiver of Permission/Assent/Consent 
 
☒ Waiver/Alteration of permission of parent/LAR for pediatric participants We 
request a waiver of parent/LAR permission for adolescent participants 14-17 years 
of age admitted to the hospital without a parent/LAR present. 
We will enroll wards of the state and children in foster care, consistent with the 
above process legal guardians will be given brief information about the study but 
we will waive consent from a legal guardian.  We feel this is appropriate, as there is 
very low risk for harm to the participants. 
☐ Waiver/Alteration of consent of adult participants 
 
Study group(s) to which this method applies: 
☐ Waiver of consent of participants turning 18 
 
Study group(s) to which this method applies: 
 
Written Informed Permission/Consent 
☐ Written informed permission of parent/LAR for pediatric participants 
 
Study group(s) to which this method applies: 
☒ Written informed consent of adult participants 
Study group(s) to which this method applies: AYA participants age 18-21 years of 
age will provide written consent using eConsent. 
☒ Written informed consent of participants turning 18 
This includes the continued access to and use of their PHI by the study team. 

SHORT TITLE: 
Page 14 of 33 
 
 
Study group(s) to which this method applies: If a participant turns 18 during the 
course of the study they will be asked to reconsent at a subsequent study interaction 
which will provide written consent using eConsent. 
Additional Methods 
☒ Obtaining permission/assent/consent of non-English speaking parents or 
participants 
Must compete Addendum C: Non-English Speaking Subjects 
 
 
☐ Surrogate decision maker consent form adults not capable of consenting for 
themselves 
Must complete Addendum D: Surrogate Decision Maker Consent 
 
Study group(s) to which this method applies: N/A 
 
20.2  Permission/Consent/Consent at 18 Discussion: The 3-month follow-up 
survey will include a question asking the patient if they have turned 18 since 
they enrolled in the study. For those that answer “yes,” we will use branching 
logic to ensure that they consent to participate at this point.   
 
20.3  Documentation of Permission/Consent/Consent at 18:  For those who 
turn 18 while enrolled in the study we will review the consent form with the 
adult participant and obtain eConsent for continued study participation. 
 
 
21.0 Assent of Pediatric Subjects 
 
21.1 
Select the option(s) that apply to the study: 
 
☐ Obtaining assent of pediatric participants is NOT POSSIBLE due to: 
☐  The capability of the participants (considering the ages, maturity, physical 
and/or psychological state) is so limited that they cannot reasonably be 
consulted. 
☐  The intervention or procedure involved in the research holds out a prospect 
of direct benefit that is important to the health or well-being of the 
participants and is available only in the context of the research. 
 

SHORT TITLE: 
Page 15 of 33 
 
☐ Obtaining assent of pediatric participants is NOT PRACTICLE given the 
context of this study (e.g., minimal risk, no direct contact with subjects). 
Must complete Addendum B: Waiver/Alteration of 
Permission/Assent/Consent 
 
☒ Assent of pediatric participants WILL BE SOUGHT following assessment of 
ability to assent. 
 
 
21.2  Assessment of Ability to Assent: Research team members will verify with 
the clinical care team that the patient has the capacity to assent.   
 
21.3  Assent Discussion: Informed assent will occur during the hospital visit in a 
private setting (i.e., parent/LAR will not be present during the assent process). 
The study team will:  
1) Provide ample opportunity for potential participants to ask questions and to 
consider participation, including coming back later during the visit to allow the 
participant time for consideration.  
2) Use teach-back to confirm comprehension of study procedures.  
3) Communicate that current and future care at CM will not be impacted by the 
decision to participate in the study or not.  
 
21.4  Documentation of Assent or Inability to Assent: We will use eConsent to 
document participant assent 
 
 
22.0 HIPAA and Confidentiality 
HIPAA regulations apply to this study if the data used or accessed relates to: 
• The past, present or future physical or mental health or condition of an 
individual; 
• The provision of health care to an individual; OR 
• The payment for the provision of health care. 
 
22.1 
HIPAA Authorization  
☒  Full Written HIPAA Authorization will be obtained (within the p/a/c form or 
standalone form) 
 
☒ Partial Waiver of HIPAA Authorization (e.g. waiver for recruitment and 
pre-screening purposes only) We request a partial waiver of HIPAA 
Authorization for: 
• Use of Cerner to facilitate recruitment and pre-screening. 
 
 

SHORT TITLE: 
Page 16 of 33 
 
☒ Alteration of HIPAA Authorization (some but not all required elements of an 
Authorization are present, e.g. signature will not be obtained) 
 
Adolescent participants (14-17 years old): An information sheet will be provided  
to parents, parent signature will not be obtained 
 
Parent as Participant (survey): A brief verbal consent will be obtained, 
participant signature will not be obtained 
 
Hospital staff as participants: A brief verbal consent will be obtained, participant 
signature will not be obtained. 
 
 
☒ Waiver of HIPAA Authorization (authorization will NOT be obtained) 
For participants under 18 years old without a parent or guardian present we request a 
waiver of HIPAA authorization to enroll without parental/guardian permission or 
consent 
 
☐ If Other, explain: 
22.2 
Data confidentiality:  
• PHI will be stored in a secure CM REDCap file, accessible only to 
members of the study team members at both study sites, including 
CMH and CHLA.  
• We will destroy PHI at the earliest opportunity. We will maintain PHI 
through completion of enrollment and data analysis. PHI will then be 
deleted.  
• PHI will only be accessed by members of the study team as necessary 
for study procedures. Good Clinical Practice guidelines will be 
followed in order to ensure that study data is not disclosed to 
unauthorized persons.  
• Study team training will include the importance of data confidentiality 
and mechanisms to protect confidentiality.  
22.3 
As this is an NIH-funded study, a Certificate of Confidentiality will 
be issued for this study.  
 
 
23.0 Provisions to Protect the Privacy Interests of Subjects* 
23.1 
The study team will take great care to protect participant privacy.  
Recruitment and enrollment will occur privately.  

SHORT TITLE: 
Page 17 of 33 
 
Participants will be assigned a study number. Surveys will be completed 
confidentially and will not contain identifying information. We will use a unique, 
participant-created code to link study surveys over time, such that participant 
identity is not linked to the study survey data.  Contact information used to 
facilitate follow-up survey completion will be stored in a separate REDCap tool 
and thus not linked to study data. Identifying information necessary for gift card 
provision will be obtained upon survey completion via a separate REDCap tool 
and thus this information will not be linked to an individual participant’s survey 
data.  
All data will be managed in accordance with the CM Institutional Review Board 
and HIPAA requirements to ensure confidentiality and protection of research 
participants. Study team members will not use study data and records for any 
purpose other than for conducting the study.  PHI will be kept in a password 
protected database that is separate from the study survey database. PHI will be 
deleted at the earliest opportunity. There are no patient identifiers recorded in 
the permanent research record. Clinical information will not be released without 
written permission of the participant, except as necessary for monitoring by IRB, 
the FDA, the OHRP, the Sponsor, or the Sponsor’s designee. 
23.2 
To ensure participants feel at ease with study procedures, we will 
thoroughly explain study procedures, ensure ample opportunity for questions at 
any point during the study, provide assurance that participation is voluntary and 
can be terminated at any point, and provide assurance that the decision to 
participate or not will not impact the participant’s relationship with CMH. If 
eligible participants do not want to participate in the research but are interested 
in learning more about how to quit smoking or vaping we will inform them that 
they can ask their medical team for more information. 
23.3 
Study team members will only have access to data required to complete 
their designated study duties. Study team member training will include necessity 
of and mechanisms to protect privacy and confidentiality. 
 
24.0 Withdrawal of Subjects* 
24.1 
All participants may withdraw from the study at any time by 
notifying the research team. If a participant withdraws from the study, 
any data collected up to that point will be kept and deidentified for 
analysis purposes. 
 
DATA MANAGEMENT 
25.0 Data Collection* 

SHORT TITLE: 
Page 18 of 33 
 
25.1 
Sources of data include surveys and medical records of AYA 
participants, parent surveys and Health Educator field notes.  
25.2 
Sensitive Data: Study data includes report of substance use and 
receipt of NRT prescription during hospital visit. 
25.3 
Identifiable Data:  PHI sufficient to enable delivery of the study 
follow-up survey will be recorded.  
25.4 
.   
 
1. Name/Initials 
☐ Accessed only 
☒ Recorded 
2. All elements of date (except year) directly 
related to an individual (e.g. date of birth, 
admission date, discharge date, date of 
death) 
☐ Accessed only 
☒ Recorded 
3. Medical record number 
☐ Accessed only 
☒ Recorded 
4. Account number 
☐ Accessed only 
☒ Recorded 
5. Health plan identification number 
☐ Accessed only 
☐ Recorded 
6. Social Security Number 
☐ Accessed only 
☐ Recorded 
7. Device identifiers and serial number 
☐ Accessed only 
☐ Recorded 
8. Certificate/License number 
☐ Accessed only 
☐ Recorded 
9. Telephone number 
☐ Accessed only 
☒ Recorded 
10. Fax number 
☐ Accessed only 
☐ Recorded 
11. Email addresses 
☐ Accessed only 
☒ Recorded 
12. Web addresses (URLs); Internet IP addresses 
☐ Accessed only 
☐ Recorded 
13. Street address, city, county, precinct, zip 
code or equivalent geographical codes 
☐ Accessed only 
☒ Recorded 
14. Full face photographic images and any 
comparable images 
☐ Accessed only 
☐ Recorded 
15. Biometric identifiers, including finger and 
voice print 
☐ Accessed only 
☒ Recorded 
16. Vehicle identifiers and serial numbers, 
including license plate number 
☐ Accessed only 
☐ Recorded 
17. Any other unique identifying number, 
characteristic or code that may help identify 
individual participants including their initials 
(e.g. student or employee ID number) 
☐ Accessed only 
☒ Recorded 
18. Elements of date, including year, for persons 
90 years or older 
☐ Accessed only 
☐ Recorded 
19. Other: 
☐ Accessed only 
☐ Recorded 
 

SHORT TITLE: 
Page 19 of 33 
 
 
26.0 Adverse Events and Unanticipated Problems* 
26.1 
Monitoring:  The PI and study team will meet weekly during enrollment 
and the 3-month follow-up period to identify and discuss adverse events and 
unanticipated problems. Study team members will promptly notify the PI if an 
adverse event or unanticipated problem is identified.  
 
26.2 
Reporting:  We will follow Policy 5.11 Reportable Events of the CM 
Research Program Policies and Procedures in regards to reporting adverse 
events and other unanticipated problems to the CM IRB.  
 
26.3 
Plans for Assuring Compliance with Requirements Regarding Reporting 
of Adverse Events  
Serious adverse events will be monitored and handled as described below: 
Definition: Consistent with the definition by the US Food and Drug 
Administration (FDA), a serious adverse event includes any event experienced by 
a participant while in the study that: 
• Is fatal 
• Is life-threatening (participant was at risk of death from the event as it 
occurred) 
• Is disabling or incapacitating 
• Requires inpatient hospitalization or prolongs a current hospitalization 
• Is a congenital anomaly in the offspring of a subject who received the study 
medication 
• Requires intervention to prevent permanent impairment or damage 
 
Monitoring: Information about serious adverse events experienced by study 
participants will be monitored by the following means: 
• Report given by study participant to study staff either in person or by 
telephone  
 
 
 
 
  
• Report given to study staff by study participant’s family or friends either in 
person or by telephone 
• Report by the participant’s physician or other health care provider involved in 
their care 
• Report from a hospital or other facility where the study participant(s) is being 
treated for the serious adverse event 
• Other persons who may have knowledge of the serious adverse event 
Procedure: Upon receiving report of a serious adverse event: 
• The study staff will page Dr. Masonbrink as soon as possible 
• The study staff will give the necessary information to Dr. Masonbrink 
• Dr. Masonbrink will obtain other necessary information and complete the FDA 
“MED WATCH” form for each serious adverse event 
• Dr. Masonbrink will make a decision whether to stop the study temporarily or 

SHORT TITLE: 
Page 20 of 33 
 
permanently and inform study staff of this decision 
• Dr. Masonbrink will submit the serious adverse event to the Institutional 
Review Board at the Children’s Mercy Hospital within 7 days of learning of the 
event and will work with the IRB to determine the need for changes to study 
procedures and the study protocol 
• Dr. Masonbrink will provide a completed copy of the FDA “MED WATCH” form 
to the Data Safety and Monitoring Board within 7 days of learning of the event 
• Dr. Masonbrink will submit the serious adverse event to the NIDA program 
officer within 7 days of learning of the event 
• A copy of the completed “MED WATCH” form will be kept in the study file  
 
 
27.0 Data Analysis* 
27.1  
Measures: Participant demographics and clinical characteristics (e.g., age of initiation, 
nicotine dependence) will be assessed at baseline. The outcome measures, method of 
assessment, relevant stakeholders and detailed description are depicted in Table 3 and 
sample survey items in Table 4. Preliminary efficacy will be assessed via self-reported 
30-day point prevalence tobacco/ENDS abstinence using the timeline follow-back 
method at 3-month follow-up.73 To obtain a biochemically verified outcome and to 
encourage accurate self-reporting we will assess salivary cotinine from all participants 
(not currently on NRT) who report abstinence. We will assess this by either mailing a 
saliva specimen home collection kit to then be return mailed (pre addressed and paid) 
Table 3: Assessment of Proctor Outcome Measures  
Outcome 
Measure  
Definition 
How/What Assessed  
Team member/ 
Stakeholder(s) 
Description 
Preliminary 
Efficacy  
Impact on 
treatment 
outcomes of the 
intervention vs. 
control 
Survey  
AYA participant 
Self-reported and biochemically verified 
(salivary cotinine) 30-day tobacco/ENDS use 
abstinence at 3-mo follow up survey (primary 
outcome) 
Self-reported motivation & confidence 
immediately after intervention and at 3-mo 
follow up survey 
Acceptability 
Participant 
satisfaction with 
the intervention 
components 
Survey 
 
 
 
Study process data 
AYA participant, 
Parent/Guardian 
 
 
AYA participant 
Likert-scale AYA and parent/guardian survey 
items on intervention satisfaction after the 
session (AYAs and parent/guardians) and at 
3-mo survey (AYAs only)* 
Proportion of eligible patients who enroll, 
complete the intervention & booster 
sessions 
Feasibility 
Intervention fit 
within the context; 
suitability for 
everyday use; 
practicality 
 
Field notes, session 
length, & survey items 
Health Educator, 
Dr. Masonbrink 
Mean score of Likert-scale items on 
intervention feasibility (immediately post 
intervention*; Session duration (minutes) 
from audio-recordings; Health educator field 
notes of interruptions to workflow and 
modifications to care 
Fidelity 
Extent to which the 
intervention is 
delivered as 
intended? 
Audio-recordings of 
Health Educator and 
Dr. Masonbrink’s 
sessions 
Health Educator, 
Dr. Masonbrink  
Drs. Masonbrink and Catley will review 
audio-recordings and perform fidelity scoring 
of intervention sessions utilizing adapted 
fidelity rating scales 
*For outcomes assessed by 5-point Likert-scale survey items, we will calculate mean scores of survey items by categories (e.g., mean 
AYA satisfaction/acceptability for each intervention component and for the overall intervention).  Mean scores ³ 4 will be 
considered satisfactory. 

SHORT TITLE: 
Page 21 of 33 
 
to our study team or we will also offer the option of completing a home saliva cotinine 
test which do not require return mailing. For this option home saliva cotinine tests will 
be mailed to the participant. The study team will then schedule a secure Microsoft 
Teams video call to witness saliva test completion and results or photos of the test 
results can be emailed at a convenient time to phmteenresearch@cmh.edu, a secure 
email address created specifically for this research study. Although accurate verification 
will not be possible with participants who are occasional users or those on NRT, this will 
also allow us to evaluate the feasibility of collecting saliva by mail or completing secure 
video or photos witnessed home saliva cotinine tests in this population which will be 
informative for future studies with daily ENDS users. Secondary efficacy outcomes will 
include self-reported motivation and confidence to quit immediately post-intervention 
and at 3-month follow up.65, 74,75 We will assess acceptability with the overall 
intervention and intervention components via survey immediately post intervention 
(AYAs and parents) and at 3 month follow-up (AYAs). Acceptability will also be evaluated 
via participant enrollment and session completion rates. Feasibility will be assessed via 
intervention duration in minutes from audio recordings and Dr. Masonbrink and the 
health educator will complete a brief survey and record field notes to assess feasibility 
(e.g., impact on workflow, disruption, suitability). To assess fidelity we will review audio 
recordings and rate health educator intervention and control sessions based on a 
previously developed fidelity rating scales To assess preliminary efficacy, differences in 
self-reported and biochemically verified 30-day tobacco/ENDS use abstinence at 3-
month follow up (primary outcome) will be analyzed using a generalized linear model 
assuming an underlying binomial distribution and logit link function to compare 
between study arms. Motivation and Confidence to quit will be analyzed using a 
repeated measures analysis of variance. Potential differential outcomes based on sex 
and demographic factors will be explored. Chi-square (categorical variables) and 
Wilcoxon Rank Sum (continuous variables) tests will be used to assess participation bias. 
For acceptability, we will calculate the proportion of AYA participants and 
parents/guardians in the intervention arm with mean ratings of satisfaction and 
acceptability of ³ 4 on the 5-point Likert scale. In addition, frequencies and percentages 
will be used to describe the enrollment and session completion rate. For feasibility we 
will conduct thematic analysis of field notes and conduct simple descriptive analyses 
(means, frequencies, percentages) of the brief survey items completed by Dr. 
Masonbrink and the health educator and session length data. Fidelity will be 
summarized utilizing similar descriptive analyses of the fidelity ratings (e.g., percentage 
of intervention steps completed; mean rating of key MI skill adherence). 
 
CYP2A6 genotype-predicted phenotype (slow, intermediate, extensive) and other 
genetic variants of interest may be explored as co-variants in the analysis. Given the 
exploratory nature of the genetic analysis, we are likely underpowered to find 
significant association across numerous genetic co-variants, but these data may inform 
future studies designed to evaluate the relationship. 
 

SHORT TITLE: 
Page 22 of 33 
 
27.2 
Our proposed sample size [n=144 (96 treatment, 48 control)] is well 
within the recommendations for behavioral intervention development pilot trials 
based on what is feasible to recruit in our hospital and judged to be sufficient to 
evaluate efficacy (i.e., self-reported/biochemically verified abstinence) in a 
preliminary behavioral design trial.63,64 With respect to percentage reporting 
self-reported and/or biochemically confirmed abstinence at 3-mo follow up the 
margin of error (ME) around our observed outcomes depends on the observed 
proportion with the largest ME occurring when the proportion is 50%. Our 
sample size is sufficient to provide a ME of 10% (if the proportion is 50%) or less. 
 
28.0 Data and Specimen Management* 
Data Management:  Data will include that obtained from the study 
surveys and medical record, as described above. 
Data will be collected via REDCap or paper survey or EHR review. Data 
from the surveys and EHR will be stored in REDCap. Paper surveys, if used 
in the event of a REDCap or other IT issue, will be stored in a locked office 
of the investigators. 
Deidentified data will be exported from REDCap to statistical programs 
for analysis (e.g., SAS, SPSS, Excel). All data will be securely stored on 
password-protected CM servers.  
Strict measures will be taken to ensure participant privacy and 
confidentiality. Participants will be assigned a unique study identification 
number. Additionally, survey data will be collected using a unique, 
participant-created code such that a link between participant survey 
number and participant identity do not need to be linked.39 The study 
REDCap project will be set up such that the study team will not be able to 
link survey data to individual participant identity. All personally 
identifiable information needed to facilitate data collection and 
intervention fidelity review will be kept strictly confidential, stored on 
REDCap, and accessible only to designated study team members.  Only 
study team members needing access to data to fulfill their study 
responsibilities will have access to the data. Non-study team members 
will not have access to the data.  
Data will be stored per CM records retention policy.  
28.1 
Specimen Management: Describe how specimens will be handled, 
including: 

SHORT TITLE: 
Page 23 of 33 
 
Genetic data and biospecimens will be stored up to 5 years for this study (IRB 
STUDY00002116); biospecimen storage will occur in the existing Adolescent 
Medicine Pharmacogenetic Repository. 
If this study involves storing of data or banking of leftover specimens for future 
research, indicate how the use will be managed: 
☐  Contributing data and/or leftover specimens to an existing CM 
repository protocol (myIRB#___________________________) 
☐  Contributing data and/or leftover specimens to an existing non-CM 
repository (Institution/Repository Name: _________________________) 
☒  Not contributing to an existing repository for the management of 
data/specimens for future research use.   
☒  Other: Samples will be stored in the Adolescent Medicine 
Pharmacogenomic Repository (AMP) (IRB#13020033).  
Saliva or salvaged blood samples will be stored in the AMP freezer space 
until time of analysis. The samples will be accessed by study team 
members and lab members needed to analyze the samples. All personnel 
are CM researchers. All samples will be deidentified and marked in with a 
systematic record number including no individual identifying information.  
For participants who begin the study as a minor and turn 18 they will be 
asked to reconsent at a subsequent study interaction which will provide 
written consent using eConsent. 
 
30.0 Provisions to Monitor the Data to Ensure the Safety of Subjects 
Although this study represents no more than minimal risk to participants, 
we will exercise the following provisions to ensure participant safety. Dr. 
Masonbrink will have overall responsibility for monitoring the safety of 
participants and data. The data and safety monitoring plan will be 
developed in accordance with NIH guidelines and code of federal 
regulations established by the Department of Health and Human Services 
(45 CFR 46; the Common Rule). Dr. Masonbrink will share reports of 
preliminary data with Dr. Catley (primary mentor) monthly through the 
duration of participant enrollment and data collection. In the unlikely 
event of an adverse outcome associated with the study protocol, the 
outcome will be documented and, as appropriate, reported to the 
Institutional Review Board, FDA and NIH.  
Regulatory Requirements & Site Performance 

SHORT TITLE: 
Page 24 of 33 
 
This multi-site collaborative research study (see below under Multi-Site 
Research) is approved by the CMKC Institutional Review Board (IRB) and 
will comply with all applicable regulatory requirements. The committee 
will monitor subject accrual and retention and ensure that the study 
cohort is balanced for age, gender, race/ethnicity.  
 
Monitoring Committee A Data Safety Monitoring Board (DSMB) will be 
established, to periodically review and evaluate accumulated study data for 
participant safety, study conduct and progress, and efficacy. Based on these 
assessments, the DMSB will make recommendations regarding the 
continuation, modification, or early termination of the study. The committee 
will meet twice yearly (via teleconference) to review the studies associated with 
this application and to monitor any adverse events. Documentation of the 
meetings will be recorded and stored in the Division of Pediatric Hospital 
Medicine at CMKC. The DMSB membership will include experts in adolescent 
health and tobacco use and investigators with expertise in the conduct and 
methodology of trials for behavioral interventions. Members of the DSMB will 
review the written protocols, informed consent procedures, and plans for data 
and safety monitoring. The DSMB reporting guidelines will then be 
individualized for the study, taking into consideration the population under 
study, the known or anticipated adverse outcomes or risks of the study 
procedures, and any other data monitoring or oversight required. The DSMB will 
review data quality and timeliness, adherence to the study protocol, participant 
recruitment and consenting procedures, accrual and retention figures, and all 
adverse and other events and outcomes. For the purposes of DSMB review, 
adverse and other events will be defined broadly to include any negative 
occurrence experienced by a participant during the course of their participation 
in the study regardless of any investigator-determined attribution to the study 
protocol or procedure. This allows the DSMB to independently evaluate 
attribution for the event. Through these reviews the DSMB determines whether 
cumulative data indicate the need to change the research design, to modify 
information presented to participants, or to terminate the project. New 
scientific developments outside the study that may impact participant safety or 
the ethics of the study are considered in making these determinations. Pre-
specified stopping rules are established in consultation with the investigator and 
are employed if significant benefits or risks have developed, if trial management 
issues prevent successful completion, or if compelling ethical concerns arise. 
Again, should it be deemed necessary to have a DSMB, we will elucidate the 
plan in greater detail in accordance with institutional guidelines. 
 
30.1 
In addition to the Principal Investigator, which individual or group 
will be responsible for monitoring the data and safety for this study? 
 
☐ Sponsor or Sponsor Designee (including the Sponsor CRO) 

SHORT TITLE: 
Page 25 of 33 
 
☒ Data and Safety Monitoring Board (DSMB) or Data Safety Monitoring 
Committee (DSMC)  
☐ Independent Monitor (s) 
☐ Internal Committee at CM 
☐ Other: ____________ 
 
30.2 
Data Safety Monitoring Plan: Please see Data Safety and 
Monitoring plan in IRB documents for details. 
 
STUDY MANAGEMENT 
31.0 Setting & Locations* 
31.1 
Describe the sites or locations where the research will be 
conducted. 
• Identify where research procedures will be performed including any 
non-CM affiliated locations.  For any non-CM affiliated locations, upload 
a letter of support in myIRB which states that the site is aware that 
research will be conducted on their premises. 
• Describe the composition and involvement of any community advisory 
board. 
• For research conducted outside of CM and its affiliates describe: 
o Regulations or customs affecting the research  
o The local scientific and ethical review structure 
• Describe the availability of medical or psychological resources that 
subjects might need as a result of taking part in the study. 
 
32.0 Multi-Site Research 
Is this a multi-site or collaborative research study? 
☐    No 
If no, you do not need to complete this section. 
☒    Yes 
If yes, continue below: 
☐    Multi-Site Research: Multiple sites will be engaged in this human research 
project. Sites will use the same protocol to conduct the same human research 
activities (except for minor variations due to local context considerations).   
☒    Collaborative Research: Multiple sites will be engaged in this human 
research project. Sites will not be performing the same research activities. The 
Site submission will specify the specific research activities each site will perform.  
REQUIRED: Enter summary of site-specific activities that differ from the 
overall protocol: The study P.I. Abbey Masonbrink, MD MPH, will start a 

SHORT TITLE: 
Page 26 of 33 
 
new position at Children’s Hospital of Los Angeles (CHLA) on November 
1, 2024. At that time we will assign a new CMH site PI (Dr. Miller, 
currently co-Investigator) and Dr. Masonbrink will be added as an external 
collaborator at CHLA with a external reliance on CMH IRB. No study 
participants will be enrolled at CHLA but data containing PHI will be 
shared with Dr. Masonbrink and necessary study team members at CHLA 
for data analysis and dissemination (manuscript and future grant 
preparation. 
☐    Student(s):  Student(s) will help with this project and will be engaging their 
home institution.  
☐    Visiting Resident(s) / Visiting Fellow(s):  Visiting Resident(s) / Visiting 
Fellow(s) will help with this project and will be engaging their home institution.  
 
Is Children’s Mercy (CM) acting as the single IRB of Record (sIRB)? 
☐    No, each site is getting their own IRB approval.  
☒    Yes, some or all sites will rely on the CM as the sIRB.  
• Reliance is required for non-Exempt NIH or other Federally 
Funded research where: 
o The institution's employees or agents intervene or 
interact with human subjects for research purposes;     
o The institution's employees or agents obtain 
individually identifiable private information or 
identifiable biospecimens about human subjects for 
research purposes; or     
o The institution receives a direct HHS award to conduct 
human subjects research, even where all activities 
involving human subjects are carried out by a 
subcontractor or collaborator.  
If CM is sIRB for another site, complete the chart for that site(s) (Add a new row 
for each site relying on the CM IRB, delete chart if not acting as sIRB): 
Site Name 
Enrollment Goal for 
Site(s) 
Choose One 
Relying on CM IRB?  
CHLA 
☐  Site Enrollment 
Goal: N/A  
 
☒  Site will not 
enroll: No study 
subjects will be 
☒  External Site will rely on the CM IRB as 
the IRB of Record using a reliance 
agreement.  
☐  Not Applicable. Site will not interact or 
intervene with human participants or their 
identifiable data / identifiable biospecimens. 

SHORT TITLE: 
Page 27 of 33 
 
enrolled, however 
data containing PHI 
will be shared with 
this study site for 
analysis. 
Site is also not a primary NIH or federal 
grant recipient.   
 
 
 
 
 
32.1 
Multi-Site Research:  
All study procedures will occur at CMH. However, some co-investigators are from 
non-CM institutions: Karen Wilson MD MPH (University of Rochester Medical 
Center, Rochester NY), Kimber Richter, PhD (University of Kansas Medical 
Center). These study members are categorized as not participating in human 
participants research as they will at no time interact with study participants or 
have access to identifiable data. The study P.I. Abbey Masonbrink, MD MPH, will 
start a new position at Children’s Hospital of Los Angeles (CHLA) on November 1, 
2024. At that time we will assign a new CMH site PI (Dr. Miller, currently co-
Investigator) and Dr. Masonbrink will be added as an external collaborator at 
CHLA with a external reliance on CMH IRB. No study participants will be enrolled 
at CHLA but data containing PHI will be shared with Dr. Masonbrink and 
necessary study team members at CHLA for data analysis and dissemination 
(manuscript and future grant preparation.