BE Smokefree: Behavioral Economics Incentives to Engage Adolescents in Smoking Cessation
Phase: NA
Conditions: Smoking Cessation
Sponsor: Children's Hospital of Philadelphia

 
Template version: May 28, 2014 
  
Title: 
BE Smokefree: Behavioral Economics Incentives to Engage 
Adolescents in Smoking Cessation   
Short Title 
BE Smokefree  
Protocol Date: 
 
NCT Number:  
9/18/2020 
 
NCT03670264 
 
 
 
 
 
 

  
 
 
 
 
 
 
 
ii 
TABLE OF CONTENTS 
Table of Contents ................................................................................................................... ii 
Abbreviations and Definitions of Terms ............................................................................. iv 
Abstract ................................................................................................................................... v 
Figure 1: Study Diagram ...................................................................................................... vi 
1 
BACKGROUND INFORMATION AND RATIONALE ........................................................................ 1 
1.1 
INTRODUCTION ..................................................................................................................................... 1 
1.2 
NAME AND DESCRIPTION OF INTERVENTION ........................................................................................ 1 
2 
STUDY OBJECTIVES ............................................................................................................................... 2 
2.1 
PRIMARY OBJECTIVE (OR AIM) ............................................................................................................. 2 
2.2 
SECONDARY OBJECTIVES (OR AIM) ...................................................................................................... 2 
3 
INVESTIGATIONAL PLAN ..................................................................................................................... 2 
3.1 
GENERAL SCHEMA OF STUDY DESIGN .................................................................................................. 2 
3.1.1 
Screening Phase ............................................................................................................................... 2 
3.1.2 
Study Treatment Phase .................................................................................................................... 3 
3.1.3 
Follow-up Phase .............................................................................................................................. 3 
3.2 
ALLOCATION TO TREATMENT GROUPS AND BLINDING ........................................................................ 3 
3.3 
STUDY DURATION, ENROLLMENT AND NUMBER OF SITES ................................................................... 3 
3.3.1 
Duration of Study Participation ...................................................................................................... 3 
3.3.2 
Total Number of Study Sites/Total Number of Subjects Projected .................................................. 3 
3.4 
STUDY POPULATION ............................................................................................................................. 4 
3.4.1 
Inclusion Criteria ............................................................................................................................. 4 
3.4.2 
Exclusion Criteria ............................................................................................................................ 4 
4 
STUDY PROCEDURES ............................................................................................................................. 4 
4.1 
SCREENING PHASE ................................................................................................................................. 4 
4.2 
STUDY TREATMENT PHASE ................................................................................................................... 5 
4.3 
FOLLOW-UP PHASE ............................................................................................................................... 5 
4.4 
SUBJECT COMPLETION/WITHDRAWAL .................................................................................................. 6 
5 
STUDY EVALUATIONS AND MEASUREMENTS .............................................................................. 7 
5.1 
SCREENING AND MONITORING EVALUATIONS AND MEASUREMENTS .................................................. 7 
5.1.1 
Medical Record Review ................................................................................................................... 7 
5.1.2 
Laboratory Evaluations ................................................................................................................... 7 
5.2 
EFFICACY EVALUATIONS ...................................................................................................................... 8 
5.3 
SAFETY EVALUATION ........................................................................................................................... 8 
6 
STATISTICAL CONSIDERATIONS ...................................................................................................... 9 
6.1 
PRIMARY ENDPOINT .............................................................................................................................. 9 
6.2 
SECONDARY ENDPOINTS ....................................................................................................................... 9 
6.3 
STATISTICAL METHODS ........................................................................................................................ 9 
6.3.1 
Baseline Data ................................................................................................................................... 9 
6.3.2 
Efficacy Analysis .............................................................................................................................. 9 
6.3.3 
Safety Analysis ................................................................................................................................. 9 
6.4 
SAMPLE SIZE AND POWER ..................................................................................................................... 9 
7 
STUDY INTERVENTION ....................................................................................................................... 10 
7.1 
DESCRIPTION ....................................................................................................................................... 10 
8 
SAFETY MANAGEMENT ...................................................................................................................... 12 

 
 
 
 
 
 
 
 
iii 
8.1 
CLINICAL ADVERSE EVENTS ............................................................................................................... 12 
8.2 
ADVERSE EVENT REPORTING ............................................................................................................. 12 
9 
STUDY ADMINISTRATION .................................................................................................................. 13 
9.1 
TREATMENT ASSIGNMENT METHODS ................................................................................................. 13 
9.1.1 
Randomization ............................................................................................................................... 13 
9.1.2 
Blinding .......................................................................................................................................... 13 
9.2 
DATA COLLECTION AND MANAGEMENT ............................................................................................. 13 
9.3 
CONFIDENTIALITY ............................................................................................................................... 14 
9.4 
REGULATORY AND ETHICAL CONSIDERATIONS .................................................................................. 14 
9.4.1 
Data and Safety Monitoring Plan .................................................................................................. 14 
9.4.2 
Risk Assessment ............................................................................................................................. 14 
9.4.3 
Potential Benefits of Trial Participation ....................................................................................... 14 
9.4.4 
Risk-Benefit Assessment ................................................................................................................. 15 
9.5 
RECRUITMENT STRATEGY ................................................................................................................... 15 
9.6 
INFORMED CONSENT AND HIPAA AUTHORIZATION .......................................................................... 15 
9.6.1 
Waiver of Parental Permission ...................................................................................................... 16 
9.6.2 
Re-consent of Subjects Turning 18 ................................................................................................ 16 
9.7 
PAYMENT TO SUBJECTS/FAMILIES ...................................................................................................... 16 
10 
PUBLICATION ................................................................................................................................ 16 
11 
REFERENCES ................................................................................................................................. 17 
 

  
 
 
 
 
 
 
 
iv 
ABBREVIATIONS AND DEFINITIONS OF TERMS 
NCI 
 
National Cancer Institute 
PeRC 
 
Pediatric Research Consortium  
WTH 
 
Way to Health Platform 
EHR 
 
Electronic Health Record 
DBHi 
 
Department of Biomedical and Health Informatics  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
page v 
  
 
 
 
ABSTRACT 
Context: 
Cigarette smoking remains a leading preventable cause of death in the US with substantial 
morbidity, mortality, and financial costs each year. More than 90% of adult smokers initiate 
tobacco use before age 18, making prevention and treatment of adolescent smoking a critical 
health priority. Behavioral economic interventions utilizing financial incentives can promote 
smoking cessation in adult populations. No studies have evaluated financial incentives among 
adolescents to promote engagement in effective smoking cessation programs through primary 
care settings.  
 Objectives: 
Primary Objective: To compare, through a pilot, randomized controlled trial, an intervention 
incentivizing contact with the Quitline, an intervention incentivizing quitting, or no financial 
incentive intervention on adolescent smoker enrollment and depth of engagement in a smoking 
cessation program (Free Smoker Quitline).  
Secondary Objective: To compare cotinine-confirmed 2-month quit rates across the 3 groups, 
among users who report abstinence.  
 Study Design:  
This is a randomized controlled trial of a quitline incentive vs smoking cessation incentive vs no 
financial incentive on adolescent engagement with a smoking cessation program.  
Setting/Participants: 
Setting: Primary care sites within CHOP’s Pediatric Research Consortium along with other non-
clinical community settings.  
60 adolescent smokers will be recruited. Eligibility criteria include adolescents (aged 14-21 
years), who speak English, live in Pennsylvania, screen positive for tobacco use, are interested in 
quitting, and have a smart phone.  
Study Interventions and Measures:  
Adolescents will be randomized to 1 of 3 financial incentive groups: (1) Quitline Incentive: the 
payment structure emphasizes engaging with the quitline, with an additional smaller payment for 
smoking cessation; (2) Smoking Cessation Incentive: the payment structure emphasizes quitting 
regardless of engagement with the quitline (though the quitline will be presented as a helpful 
tool); and (3) no financial incentive. The Quitline is funded by the Pennsylvania Department of 
Health and staffed by trained cessation counselors available 24 hours a day, 7 days a week.  
Outcomes Measures: Objective 1: The main outcome of interest is adolescent smoker 
completion of the smoking cessation program, defined as the proportion of smokers identified in 
the clinic that enroll, use, and complete the Quitline program compared across the 3 groups. 
Objective 2: The secondary outcome is to confirm abstinence, via salivary cotinine concentration 
of <30 ng per milliliter at 10 weeks after the start of the study. 

 
page vi 
  
 
 
 
FIGURE 1: STUDY DIAGRAM 
 
 

 
  
 
 
 
1 
1 
BACKGROUND INFORMATION AND RATIONALE 
1.1 Introduction 
Cigarette smoking remains a leading preventable cause of death in the US with substantial 
morbidity, mortality, and financial costs each year.1 Nearly 20% of US adolescents smoke 
cigarettes or use other tobacco products like e-cigarettes,2 80% of youth who initiate 
smoking transition to regular use by young adulthood,3,4 and more than 90% of adult 
smokers initiate tobacco use before age 18, making prevention and treatment of adolescent 
smoking a critical health priority.1 Further, e-cigarettes are now the most common tobacco 
product used by teenagers, and adolescent use of e-cigarettes is strongly associated with 
transition to cigarette use.5 Pediatricians see the majority of the US child and adolescent 
population,6 and adolescents view pediatricians as trusted sources for credible health 
information.7 Consequently, pediatricians are uniquely positioned to screen for tobacco use 
in their patients, initiate treatment, and connect adolescents to smoking cessation services.8,9  
While evidence-based smoking cessation programs for adolescent tobacco use are available, 
including the quitline, text messaging, mobile phone apps and web-based programs, they are 
underutilized by teenagers.10-14 Although most youth smokers want and attempt to quit, few 
seek assistance to do so.8,15 Consensus guidelines and the US Preventive Service Task force 
emphasize that clinician counseling can initiate behavior change in adolescent tobacco users 
and effectively educate them about available smoking cessation resources.16,17 A critical 
knowledge gap is how to best to translate screening into effective service receipt and 
quitting.8,17 
Behavioral economics applies economic, marketing and psychological principles, such as 
framing, present bias, and loss aversion, to overcome barriers to behavior change. 
Behavioral economic interventions utilizing financial incentives have been used to promote 
smoking cessation in adult populations.18,20,22,23,24 Among adolescents, a systematic review 
of financial incentives for smoking cessation suggests potential for promoting abstinence.22 
To our knowledge, no studies have evaluated use of financial incentives among adolescents 
to promote engagement in effective smoking cessation programs through pediatric 
healthcare settings.25 
1.2 Name and Description of Intervention 
Way to Health (WTH) Platform: Way to Health is a web-based platform that automates 
many of the research functions necessary for conducting randomized controlled trials of 
healthy behavior interventions. This was designed by faculty and staff at the LDI Center for 
Health Incentives and Behavioral Economics (CHIBE) at the University of Pennsylvania to 
create an efficient, scalable, and low-cost way to test behavioral interventions using a 
platform that can be deployed anywhere in the United States. The WTH platform uses 
secure, high-performance servers that have the necessary security protections to permit 
storage and analysis of data containing protected health information. Further, the WTH 
platform has secure financial tracking and processing systems to manage participant 
payments, including the ability to track earnings and pay participants via a non-integrated 
payment system (ClinCard) ideally suited for adolescent subjects.  
 

 
  
 
 
 
2 
2 
STUDY OBJECTIVES 
The purpose of the study is to determine if financial incentives for adolescent smokers 
compared to no financial incentive increases engagement in a smoking cessation program. 
2.1 Primary Objective (or Aim) 
The primary objective of this study is to compare, through a pilot, randomized controlled 
trial, an incentive for Quitline engagement, an incentive for smoking cessation, or no 
financial incentive intervention on adolescent smoker enrollment and depth of engagement 
in a smoking cessation program (Free Smoker Quitline, hereafter referred to as the Quitline).   
2.2 Secondary Objectives (or Aim) 
The secondary objective is to compare cotinine-confirmed 2-month quit rates across the 3 
groups, among users who report abstinence at the 10-week follow-up call. 
 
3 
INVESTIGATIONAL PLAN 
3.1 General Schema of Study Design 
This is a randomized controlled trial of financial incentives on adolescent engagement with a 
smoking cessation program (Quitline).  
3.1.1 Screening Phase 
Potential adolescent subjects will be screened using the protocol inclusion and exclusion 
criteria. Adolescent smokers may be identified at their primary care visit through standard 
screening approaches embedded within the electronic health record (EHR) (Epic®) at PeRC 
study sites. Adolescent smokers may also be identified through outreach facilitated by the 
CHOP Research Enhancement Core (REC).  
Adolescents will be recruited in one of three ways: 
1. Adolescents who screen positive for tobacco use at their primary care visit (defined 
as having smoked cigarette(s) and/or used an e-cigarette on at least 1 day during the 
30 days before the clinical encounter) and are interested in treatment will be 
approached over the phone (with a potential introductory text message) by the study 
team to gauge interest in participating and obtain consent either electronically or 
over the phone and confirm participant eligibility. 
2. Adolescents who contact the study team as a result of outreach facilitated by the 
REC will be screened by the study team. The team will describe the study, inform 
prospective participants of the eligibility requirements, and ask the prospective 
participants if they are still interested in participating. If interested, the study team 
will obtain consent either electronically or over the phone and confirm participant 
eligibility.  
3. Facilitated by REC, advertisements with study information, including eligibility 
requirements and an embedded REDCap link, will be distributed at schools, CHOP 

 
  
 
 
 
3 
primary care clinics, and other non-clinical community settings (for example, a 
commercial entity like convenience stores). Adolescents who are interested in 
learning more can go to the REDCap link where they will provide consent 
electronically and then be screened for eligibility. Permission will be obtained from 
the school principle or non-clinical community setting building owner/proprietor 
before any recruitment materials are distributed. The research presents minimal risk 
to participants and involves no procedures for which written consent is normally 
required outside of the research context.  
3.1.2 Study Treatment Phase  
Following adolescent consent, subject information (name and smart phone number) will be 
sent to the intervention delivery platform, called the Way to Health (WTH) platform, using 
secure, HIPAA-compliant methods for the transmission of protected health information.  
The WTH platform will help with management of the financial incentive interventions. 
Adolescent subjects will enroll in the smoking cessation program – the Quitline. 
Adolescents will continue in the program for 10 weeks, depending upon their individual 
needs. See Section 7 description for full details on Quitline delivered treatment.  
3.1.3 Follow-up Phase 
To be eligible for the follow-up phase, adolescents must self-report tobacco cessation. All 
study subjects will be contacted by the study team 10 weeks after study enrollment to 
inquire about smoking cessation (defined as no tobacco use in the last 30 days). For subjects 
that report quitting, to confirm cessation, subjects will complete a salivary cotinine 
specimen. The result will either be collected at the clinic or collected remotely, in the latter 
case performed in front of a live video-conference with a study staff member to confirm 
adherence. The result can be reported immediately.  
3.2 Allocation to Treatment Groups and Blinding 
Randomization to the 3 groups will be based on an automatically generated randomization 
sequence (block randomization stratified by cigarette or e-cigarette use), managed through 
the Way to Health (WTH) Platform.  
3.3 Study Duration, Enrollment and Number of Sites 
3.3.1 Duration of Study Participation 
The study duration per subject will be up to 12 weeks, with 1 day for screening, up to 10 
weeks for the treatment phase, and 1 day for follow-up. 2 additional weeks are allotted to 
coordinate both initial enrollment in the quitline and remote follow-up with the adolescent. 
3.3.2 Total Number of Study Sites/Total Number of Subjects Projected 
The study will be conducted at primary care sites within CHOP’s Pediatric Research 
Consortium (PeRC). Subjects may also be recruited through study materials distributed at up 
to 2 schools and posted in up to 10 other non-clinical community settings (for example, a 
commercial entity like convenience stores). Permission will be obtained from the school 

 
  
 
 
 
4 
principle or non-clinical community setting building owner/proprietor before any 
recruitment materials are distributed. 
Recruitment will stop when approximately 60 subjects are enrolled. It is expected that 
approximately 70 subjects will be enrolled to produce 60 evaluable subjects.  
3.4 Study Population 
3.4.1 Inclusion Criteria 
Inclusion criteria include adolescents (aged 14-21 years), male or female, who speak 
English, live in Pennsylvania, screen positive for tobacco use (defined as having smoked 
cigarette(s) and/or used an e-cigarette on at least 1 day during the past 30 days), are 
interested in quitting smoking, have a smart phone, and provide consent to participate.  
3.4.2 Exclusion Criteria 
Subjects that do not meet all of the inclusion criteria will not be enrolled.  
4 
STUDY PROCEDURES 
4.1 Screening Phase 
4.1.1 Screening at Primary Care Visit 
Adolescent cigarette or e-cigarette users may be identified at their primary care visit through 
standard screening approaches embedded within the electronic health record (EHR) (Epic®) 
at PeRC study sites. The screening procedure will also include an option to receive text 
messages about the study (with notice that standard text messaging charges may apply). 
Adolescents who screen positive for tobacco use and are interested in treatment will be 
approached by the study team (after the clinic visit via phone call or via text message if the 
individual opted in to receiving text messages about the study) to gauge interest in 
participating and obtain consent. Adolescents who have given permission to receive a text 
may be sent the following introductory message:  
 “Hi this is [NAME] from CHOP contacting you about a paid research study you might be 
eligible for. Click here to learn more: [insert REDCap link] 
REDCap will be used to track attempts to contact prospective participants in an organized, 
secure way. The information abstracted from the EHR will be entered into REDCap. The 
study team will use this information to contact eligible adolescents and to document the 
date, time, and outcome of all contact attempts. This database will be separate from the main 
study database and will not be used for any purposes other than managing contact attempts. 
• Primary Care Visit: Screening for Tobacco Use (using standard approaches) 
• Medical Record Review  
• Adolescent Consent (either electronically or over the phone) 
4.1.2 Screening by the Study Team 

 
  
 
 
 
5 
Adolescent smokers may also be identified through outreach facilitated by the CHOP 
Research Enhancement Core (REC). REC communications will contain information about 
the study, an embedded link to electronic consent and screening questions, and the study 
team contact information (name, e-mail, phone number). This provides the option for those 
interested in the study to reach out to the study team directly or complete consent and study 
screening electronically.  
Adolescents who contact the study team as a result of outreach facilitated by the REC will 
be screened in one of two ways: 
1) Screening by the study team: the team will describe the study, inform prospective 
participants of the eligibility requirements (listed in section 3.4.1), and ask the 
prospective participants if they are still interested in participating. If interested, 
the study team will obtain verbal consent. After providing verbal consent, they 
will be asked to verbally answer screening questions to ascertain eligibility.   
2) Screening electronically: the adolescents will receive an electronic consent form, 
which will inform the prospective participants of the eligibility requirements 
(listed in section 3.4.1), and ask the prospective participants if they are still 
interested in participating. If interested, they will provide electronic consent. 
After providing electronic consent, they will be asked to answer electronic 
screening questions to ascertain eligibility.  
REDCap will also be used to track contacts by the study team with this group of adolescents. 
This database will be separate from the main study database and will not be used for any 
purpose other than managing contact attempts.  
4.2 Study Treatment Phase 
Adolescents who screen positive for tobacco use and are interested in treatment will be 
referred to the WTH platform. Following consent, subject information (name and mobile 
phone number) will be sent to WTH using secure, HIPAA- compliant methods to transmit 
protected health information.  
• Connect to WTH Platform, randomized to 1 of 3 groups (incentive for Quitline 
engagement, incentive for smoking cessation, or no financial incentive)  
• Enroll in smoking cessation program (the Quitline) 
• Participate in the Quitline program (up to 5 coaching calls with the Quitline, every 1-
2 weeks, depending upon individual subject needs) 
4.3 Follow-up Phase 
To confirm cessation, adolescents will complete a salivary cotinine specimen either 
collected in the clinic with a study team member or collected remotely. In the latter case, 
performed in front of study team member via a live-video conference. 

 
  
 
 
 
6 
4.4 Subject Completion/Withdrawal 
Subjects may withdraw from the study at any time without prejudice to their care. It will be 
documented whether or not each subject completes the clinical study.  

 
  
 
 
 
7 
5 
STUDY EVALUATIONS AND MEASUREMENTS 
5.1 Screening and Monitoring Evaluations and Measurements 
5.1.1 Medical Record Review 
Adolescent smokers will be identified through standard screening approaches embedded 
within the electronic health record (EHR) (Epic®) at PeRC study sites or through outreach 
facilitated by the REC. Variables abstracted from the EHR may include the following, some 
of which will be used solely for contact/recruitment purposes and some of which may also 
be stored in the main study data base (as noted below):  
• Patient name (stored in main study data base) 
• Patient date of birth and age (stored in main study data base) 
• Patient MRN (contact/recruitment only) 
• Patient sex (stored in main study data base) 
• Patient insurance status (as a proxy for Socioeconomic Status) (contact/recruitment 
only) 
• Patient race/ethnicity (stored in main study data base) 
• Patient tobacco use (stored in main study data base) 
• Patient email address (stored in main study data base) 
• Adolescent mobile/smart phone number (stored in main study data base) 
• Parent name (contact/recruitment only) 
• Parent mailing address (contact/recruitment only) 
• Parent email address (contact/recruitment only) 
• Parent phone number (contact/recruitment only) 
If non-CHOP patients are enrolled in this study, their medical records will not be accessed. 
Any participant information needed for the study will be collected by directly asking the 
participant.  
5.1.2 Laboratory Evaluations 
• Salivary cotinine measurement 
o Smoking cessation abstinence will be biologically confirmed by a salivary 
cotinine measurement at 10 weeks after study initiation, with a concentration 
of <30 ng per milliliter as a threshold.26,27  

 
  
 
 
 
8 
o Subjects will use a salivary swab measurement that they are able to perform 
on their own that immediately reports the measurement.  
o This will be performed either in front of a study team member at the primary 
care clinic or in front of a study team member via a video-conferencing 
session. 
o No videos will be recorded. The specimen will be thrown away by the subject 
immediately after the result is noted.  
5.2 Efficacy Evaluations 
The main outcome of interest is adolescent smoker completion of the smoking cessation 
program, defined as the proportion of smokers identified in the clinic that enroll, use, and 
complete the Quitline program compared across the 3 groups.  
The secondary outcome is to confirm abstinence, via salivary cotinine concentration of <30 
ng per milliliter at 10 weeks after study initiation.  
5.3 Safety Evaluation 
This study presents no more than minimal risk to study participants, as this is a study aimed 
to improve adolescent cigarette or e-cigarette user engagement in a smoking cessation 
program. Adolescents smokers can already access the particular program – the Quitline – 
free-of-charge.  

 
  
 
 
 
9 
6 
STATISTICAL CONSIDERATIONS 
6.1 Primary Endpoint 
The main outcome of interest is adolescent cigarette or e-cigarette user completion of the 
smoking cessation program, defined as the proportion of smokers identified in the clinic that 
enroll, use, and complete the Quitline program compared across the 3 study arms.  
6.2 Secondary Endpoints 
The secondary outcome is to confirm abstinence, via salivary cotinine concentration of <30 
ng per milliliter at 10 weeks after study initiation.  
6.3 Statistical Methods 
6.3.1 Baseline Data  
Characteristics of subjects in all 3 groups of the study will be described with proportions for 
categorical variables and means and standard deviations for continuous variables.  
6.3.2 Efficacy Analysis 
We will calculate proportions for the clinical outcomes (enrollment, use, and completion of 
the Quitline program) and evaluate the magnitude and statistical significance of differences 
between the 3 groups. Intention-to-treat analysis will be used so that subjects will be 
analyzed according to the group to which they were initially randomized. Secondary 
analyses will describe results for participants as-treated. Categorical variables will be 
compared between groups using chi-square tests. Multivariable logistic regression models 
(that potentially include confounding variables) will be used to compare quit rate between 
groups. These models will include indicator variables for each of the financial incentive 
groups; the no financial incentive group will be the reference. The treatment groups will 
differ significantly from usual care if its indicator variable differs significantly from zero (p-
value < 0.05 as criterion for statistical significance in a likelihood ratio or Wald’s test). A 
Wald’s test of the hypothesis that the two indicator variables are equal will also be 
performed (hypothesis that the probability of a subject quitting is the same for both financial 
incentive groups). We will explore for potential confounding by referral bonuses in the 
models and adjust if necessary. 
6.3.3 Safety Analysis 
As this study presents no more than minimal risk to study participants, a safety analysis will 
not be performed. If any safety risks are realized, see section 8.2 for adverse event reporting.  
6.4 Sample Size and Power 
The goals of this pilot project are feasibility and estimation of effect size and, therefore, no 
formal sample size calculations are performed. We anticipate 20 participants per group (60 
total) will provide sufficient data to determine effect sizes to power a future larger grant.  
 

 
  
 
 
 
10 
7 
STUDY INTERVENTION 
7.1 Description 
Intervention: Subjects will be randomized within the WTH platform to 1 of 3 financial 
incentive groups:  
1) Quitline Incentive: the payment structure emphasizes engaging with the quitline, 
with an additional smaller payment for smoking cessation. Each adolescent can 
receive $15 payments for enrolling in the quitline, for maintaining involvement in 
the quitline program ($15 per call for up to 5 calls), and, for those reporting 
abstinence, $20 for submitting the cotinine swab and $25 for confirmed quitting 
(negative cotinine swab); 
2) Smoking Cessation Incentive: the payment structure emphasizes quitting regardless 
of engagement with the quitline (though the quitline will be presented as a helpful 
tool). Each adolescent will receive $15 for enrolling in the quitline and, for those 
reporting abstinence, $20 for submitting the cotinine swab and $100 for confirmed 
quitting (negative cotinine swab); and  
3) No financial incentive.  
The WTH platform has secure financial tracking and processing systems to manage 
participant payments, including the ability to track earnings and pay participants via a non-
integrated payment system (ClinCard) ideally suited for adolescent subjects. ClinCards are 
reloadable, prepaid cards managed by Greenphire. Subjects will be able to access the 
payments during the study duration. Payments are based off the following:   
- 
Enrolling in the Quitline Program, defined as the subject connecting with a 
Quitline counselor, providing basic information about smoking history, and 
discussing program details (see “Quitline Delivered Treatment” section below). To 
receive this payment, subjects must enroll in the Quitline within 2 weeks of start of 
the study; 
- 
Maintaining involvement in the program, defined as the subject engaging in 5 
proactive counseling calls with the Quitline counselors. Calls are scheduled every 1-
2 weeks, depending upon the needs of the subject, and the Quitline counselor reaches 
out to the subject to initiate the call. Subjects eligible to receive payments for quitline 
calls must complete each call within a 2-week designated window;     
- 
Submitting the Cotinine Swab, defined as, for those subjects who self-report 
quitting smoking (defined as no tobacco use in past 30 days) at the 10-week follow-
up call, successfully completing the cotinine-specimen within 2 weeks of the call. 
- 
Quit Confirmed, defined as a salivary cotinine measurement concentration of  <30 
ng per milliliter. 
Subject engagement with the Quitline will be reported back to the WTH platform in real 
time using secure, password-protected methods. This allows subjects, through their 
interactions with the WTH platform, to see regular progress reports of their payments. See 
Table 1 for payment structure. 

 
  
 
 
 
11 
All subjects across the 3 groups, regardless of their level of engagement with the Quitline, 
will be contacted by the study team at 10 weeks after study enrollment to assess their 
smoking status. For those reporting quitting smoking, they will be asked to complete the 
salivary cotinine measurement. 
Table 1: Payment Structure   
 
Connect to 
Way to Health 
Quitline 
Enrollment 
Quitline 
Counseling Calls 
Submit 
Cotinine 
Swab* 
Quit 
Confirmed^ 
Incentive, Quitline 
 
$15 
$15 
$15 $15 $15 $15 $15 
$20 
$25 
Incentive, Smoking 
Cessation 
$15 
$15 
0 
0 
0 
0 
0 
$20 
$100 
No Incentive 
$15 
0 
0 
0 
0 
0 
0 
$20 
0 
*For subjects that report quitting smoking (defined as no tobacco use in past 30 days) at the 10-week follow-
up call. All subjects will receive $20 for submitting the salivary cotinine swab, regardless of the result. 
^Payment received for negative result, meaning cotinine level <30 ng per milliliter  
 
Quitline Delivered Treatment  
The PA Free quitline is funded by the Pennsylvania Department of Health and staffed by 
trained cessation counselors available 24 hours a day, 7 days a week, and most holidays. 
Counseling is available in English, Spanish, Arabic and can be provided in more than 15 
additional languages through a third party. All cigarette or e-cigarette users who enroll in 
smoking cessation treatment will receive counseling and support consistent with accepted 
clinical practice guidelines.28 This treatment includes 5 proactive counseling calls, each 
designed to help develop problem-solving and coping skills, secure social support, and plan 
for long-term abstinence. Participants can also call an 800 telephone number as needed for 
additional support between proactive calls. The timing of counseling calls will be relapse 
sensitive and include a call 1 or 2 days after the quit date, another telephone call a week after 
the first call, and additional calls generally occurring at 1- to 2-week intervals thereafter. 
The call timing will be flexible and adjusted as needed. Completing the program involves 
completing at least of the 5 proactive counseling calls and reporting no tobacco use in the 
last 30 days.   
 

 
  
 
 
 
12 
8 
SAFETY MANAGEMENT 
8.1 Clinical Adverse Events 
Clinical adverse events (AEs) will be monitored throughout the study.  
8.2 Adverse Event Reporting 
Since the study procedures are not greater than minimal risk, SAEs are not expected. If any 
unanticipated problems related to the research involving risks to subjects or others happen 
during the course of this study (including SAEs) they will be reported to the IRB in 
accordance with CHOP IRB SOP 408: Unanticipated Problems Involving Risks to Subjects. 
AEs that are not serious but that are notable and could involve risks to subjects will be 
summarized in narrative or other format and submitted to the IRB at the time of continuing 
review.  

 
  
 
 
 
13 
9 
STUDY ADMINISTRATION 
9.1 Treatment Assignment Methods 
9.1.1 Randomization 
Randomization to the 3 groups will be performed via a random number generator used by 
the Way to Health platform and employ block randomization. Block randomization with 
stratification by cigarette and/or e-cigarette use will be used over simple randomization to 
ensure an equal number of participants among groups, considering the relatively small 
sample size.  
9.1.2 Blinding 
Subjects will not be blinded to their study treatment group. The statistician will be blinded to 
individual subject group allocation. The WTH platform team, not part of the study team, will 
not be blinded to group allocation.   
9.2 Data Collection and Management 
To minimize the risk of loss of confidentiality, adolescent subjects will have a unique study 
ID number. The generated report that contains adolescent name and contact information will 
be stored within PeRC databases managed by DBHi. Data from this generated report will be 
sent, via secure-password protected methods, to the WTH platform and the Quitline team to 
facilitate interactions with individual adolescent subjects, via their mobile phone. Data will 
also be sent to Greenphire ClinCard via secure password-protected methods so that subjects 
can receive payments. The WTH platform, Quitline, and Greenphire ClinCard use secure, 
high-performance servers that have the necessary security protections to permit storage and 
analysis of data containing protected health information. Interactions with the WTH 
platform and the Quitline – to assess benchmark complete and trouble-shoot any potential 
issues in these interactions – will be reported back to the study team via these same secure 
methods.  
Further, the study team will use additional procedures to minimize risk to confidentiality, 
including unintentional disclosure by the adolescent to their parent/guardian regarding their 
tobacco use. In telephone-based interactions, the study team will begin any phone 
discussions with questions that assess level of privacy (e.g. “Can anyone overhear our 
conversation?”). To obtain the salivary cotinine measurement, subjects will be given the 
choice to either return to the clinic to perform the specimen in front of a study team member 
at a mutually agreed upon time or have the salivary swab mailed to their home, with the 
specimen collection performed remotely. If needed, the research team may also meet 
subjects at a mutually agreed upon location. 
After data cleaning and quality assurance procedures are completed, the de-identified data 
will be converted into SAS format or Stata format (or equivalent software) for analysis.   
We will keep a master list containing PHI and subject study ID numbers separate from data 
forms that will only have the study ID number. All files will be stored on one of the 
Hospital’s password-protected secure servers, specifically REDCap. All consent documents 
will either be obtained via REDCap or obtained via paper then scanned and stored within 

 
  
 
 
 
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REDCap, with the original paper versions destroyed. These servers are secure with planned 
redundancies in place to prevent the loss of data.  
PHI data will be stored on password-protected, secure systems until 6 years after study 
closure. After those 6 years, all PHI identifiers will be deleted from the stored data. 
 
9.3 Confidentiality 
All data and records generated during this study will be kept confidential in accordance with 
Institutional policies and HIPAA on subject privacy and that the Investigator and other site 
personnel will not use such data and records for any purpose other than conducting the 
study. No PHI, managed by DBHi, will be retained for future research, as it will be 
destroyed after data collection.  
9.4 Regulatory and Ethical Considerations 
9.4.1 Data and Safety Monitoring Plan 
The study PI will monitor and review the study progress, the accuracy and security of the 
emerging data, and will maintain oversight over data integrity. Identifying information 
collected for study or recruitment purposes will be stored securely. No PHI will be retained 
for future research, as it will be destroyed upon closure of the study protocol. No other PHI 
identifiers will be collected at any time, and no other PHI identifiers will be stored.  
9.4.2 Risk Assessment 
Risks are not greater than minimal. Current national guidelines recommend that 
pediatricians and pediatric clinicians screen adolescents for tobacco use (both at routine 
preventive visits and at visits for diseases that may be caused or exacerbated by tobacco use) 
and offer tobacco dependence treatment and/or referral to adolescents who want to stop 
smoking.9 For adolescent subjects, because the procedures herein involve discussion and 
connect to a smoking cessation program that they could already access as part of routine 
clinical care, we foresee no special risks. The main risk, therefore, to subjects is breach of 
confidentiality. 
While this study involves treatment for tobacco use, there is the potential for adolescent 
subjects to report additional substance use to the study team. In those rare situations, the 
study team will review and consult with site clinicians about the case and determine if 
further evaluation or treatment is necessary. 
9.4.3 Potential Benefits of Trial Participation 
Although the proposed research poses minimal risks to participants, there are both potential 
direct benefits to study participants and contributions to scientific knowledge. The 
objectives of the study involve increasing adolescent engagement in an evidence-based 
program that helps smokers quit. Helping adolescent smokers quit provides direct benefit. 
Further, this trial may contribute to scientific knowledge by examining how to best translate 
routine tobacco use screening into effective service receipt and quitting.  

 
  
 
 
 
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9.4.4 Risk-Benefit Assessment 
From a risk-benefit assessment perspective, the potential benefits outweigh the minimal risk 
posed by the study, justifying proceeding with the trial.  
9.5 Recruitment Strategy 
Identification of adolescent smokers will be achieved through the clinical care encounter, as 
described in protocol section 4.1.1, or through outreach facilitated by the CHOP Research 
Enhancement Core (REC), or through a referral program. The REC aids with recruitment 
plan development and may assist in identifying and contacting potential participants using 
the CRU, the CHOP Recruitment Registry, social media and internal communication 
resources. For social media postings, the study team will use the main CHOP social media 
pages and will work in conjunction with the REC and CHOP Social Media group. The REC 
also engages community partners and facilitates outreach on behalf of the research Institute 
and CHOP research studies. REC-facilitated recruitment strategies may include deploying 
recruitment emails and paper letters, tear pad and flyer advertising around CHOP’s campus, 
schools, and commercial entities, public facing short ads posted on CHOP’s public website, 
and This Week at CHOP and Clinical Trial Finder advertisement. All recruitment materials 
circulated by the REC will be first be submitted for review and approval by the IRB before 
use. In addition, permission will be obtained from the school principle or non-clinical 
community setting building owner/proprietor before any recruitment materials are 
distributed.  
Subjects who are enrolled in the study after AM13 will also have the opportunity to receive 
a referral bonus, with a cap of 5 referrals per enrolled individual. The investigators will track 
referrals through a REDCap contact tracking database. This database will be separate from 
the main study database and will not be used for any purposes other than managing contact 
attempts. 
9.6 Informed Consent and HIPAA Authorization 
Prior to the completion of any study materials, verbal or electronic informed consent from 
all subjects, including minors who can consent for themselves, will be obtained. Consent 
will be obtained over the phone or electronically, either after the clinic visit or after the 
REC-facilitated recruitment. Subjects will be emailed (from a CHOP study email account) 
an electronic version of the consent form for their records. In current clinical practice, 
adolescent tobacco use is screened for by pediatric practitioners at confidential adolescent 
visits. Parents are not present in the exam room during this part of the visit, though they may 
be present with the adolescent at the clinic for other portions of the visit. Thus, to project 
privacy of subjects, adolescent consent will be obtained after the visit, over the phone or 
electronically. Adolescents who screen positive for tobacco use and are interested in further 
treatment will be asked, by the pediatric practitioner, if they can be contacted by a member 
of the study team. After verbal or electronic consent is obtained, current tobacco use will be 
confirmed electronically or by a study team member. 

 
  
 
 
 
16 
9.6.1 Waiver of Parental Permission 
This study is minimal risk, and conducting the research involves treatment for adolescent 
tobacco use. Studies of adolescent tobacco and substance use identify systematic biases, 
including lower responses rates overall and lower enrollment rates of males, African-
Americans, and self-reported tobacco use, when parental permission is required.29 In this 
situation, parental permission may be a barrier to identification and treatment for adolescent 
tobacco use. Further, all subjects who enroll in this study are either adults or minors who can 
consent for themselves (14-17 years) under the alcohol or drug abuse provision, since they 
want to quit smoking. Minors who can consent for themselves will be providing consent 
rather than assent and we will not need to request a waiver of parental permission. 
9.6.2 Re-consent of Subjects Turning 18 
Per IRB protocols, documentation of verbal or electronic consent will be obtained at time on 
enrollment into the study. Participants turning 18-years-old during the follow-up period will 
not be asked to re-consent before continuing with the study because they are minors who can 
consent for themselves, and thus are providing consent at their time of enrollment into the 
study.  
9.7 Payment to Subjects/Families 
Subjects will receive $15 for their participation in the study. The intervention involves 
comparing 3 financial incentive structures on adolescent engagement in a smoking cessation 
program, with participants eligible for payments depending on completion of certain 
requirements. All study subjects will receive $20 for completing the confirmatory saliva 
specimen. All payments will be distributed through the virtual accounts, managed through 
the WTH platform.  
Subjects who are enrolled in the study after AM13 will also have the opportunity to receive 
an additional $5 per potentially eligible person they refer, with a cap of 5 referrals per 
enrolled individual. Referral fees will be paid independent of whether or not the referred 
individual enrolls in the study. 
10 PUBLICATION 
Results from this study will be submitted for publication in peer-reviewed journals.  Results 
may also be used for presentation at relevant professional seminars and meetings.  No 
identifiable information will be disclosed in any publication. 
 
 

 
  
 
 
 
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