Parent eReferral to Tobacco Quitline in Primary Care
Phase: NA
Conditions: Secondhand Smoke
Sponsor: Children's Hospital of Philadelphia

 
Template version: May 28, 2014 
  
Title: 
Parent eReferral to Tobacco Quitline in Primary Care 
Short Title 
Parent eReferral to Tobacco Quitline 
Drug or Device 
Name(s): 
n/a 
FDA IND 
n/a 
Regulatory Sponsor: 
 
eIRB Number 
IRB 16-012868   
Protocol Date: 
5/11/2017  
 
Amendment 1 Date: 6/22/2016 
Amendment 3 Date: 5/11/2017 
Amendment 2 Date: 10/5/2016 
Amendment 4 Date:  
 
 
Site Principal Investigator 
Brian Jenssen, MD, MSHP 
The Children’s Hospital of Philadelphia 
2716 South Street, 10th Floor  
Philadelphia, PA 19146 
Phone 215-554-4390 
email: jenssenb@email.chop.edu 
 
 

 
 
 
 
 
 
 
 
 
 
ii 
TABLE OF CONTENTS 
Table of Contents ........................................................................................................................ ii 
Abbreviations and Definitions of Terms ................................................................................ iv 
Abstract ........................................................................................................................................ v 
1 
BACKGROUND INFORMATION AND RATIONALE .............................................................................1 
1.1 
INTRODUCTION.................................................................................................................................. 1 
1.2 
NAME AND DESCRIPTION OF INVESTIGATIONAL PRODUCT OR INTERVENTION ...................................... 2 
2 
STUDY OBJECTIVES.......................................................................................................................................3 
2.1 
PRIMARY OBJECTIVE (OR AIM) .......................................................................................................... 3 
2.2 
SECONDARY OBJECTIVES (OR AIM) .................................................................................................... 3 
3 
INVESTIGATIONAL PLAN ............................................................................................................................3 
3.1 
GENERAL SCHEMA OF STUDY DESIGN ................................................................................................ 3 
3.1.1 
Screening Phase ........................................................................................................................ 3 
3.1.2 
Study Treatment Phase (start of the study intervention)............................................................... 3 
3.2 
ALLOCATION TO TREATMENT GROUPS AND BLINDING ........................................................................ 3 
3.3 
STUDY DURATION, ENROLLMENT AND NUMBER OF SITES ................................................................... 4 
3.3.1 
Duration of Study Participation ................................................................................................. 4 
3.3.2 
Total Number of Study Sites/Total Number of Subjects Projected ................................................ 4 
3.4 
STUDY POPULATION .......................................................................................................................... 4 
3.4.1 
Inclusion Criteria ...................................................................................................................... 4 
3.4.2 
Exclusion Criteria ...................................................................................................................... 4 
4 
STUDY PROCEDURES ....................................................................................................................................4 
4.1 
STUDY TREATMENT PHASE ................................................................................................................ 4 
4.2 
SUBJECT COMPLETION/WITHDRAWAL ................................................................................................ 4 
5 
STUDY EVALUATIONS AND MEASUREMENTS ....................................................................................6 
5.1 
SCREENING AND MONITORING EVALUATIONS AND MEASUREMENTS ................................................... 6 
5.1.1 
Medical Record Review.............................................................................................................. 6 
5.2 
EFFICACY EVALUATIONS ................................................................................................................... 6 
5.3 
SAFETY EVALUATION ........................................................................................................................ 7 
6 
STATISTICAL CONSIDERATIONS .............................................................................................................8 
6.1 
PRIMARY ENDPOINT .......................................................................................................................... 8 
6.2 
SECONDARY ENDPOINTS .................................................................................................................... 8 
6.3 
STATISTICAL METHODS ..................................................................................................................... 8 
6.3.1 
Baseline Data ............................................................................................................................ 8 
6.3.2 
Efficacy Analysis........................................................................................................................ 8 
6.3.3 
Safety Analysis ........................................................................................................................... 8 
6.4 
SAMPLE SIZE AND POWER .................................................................................................................. 8 
7 
STUDY MEDICATION (STUDY DEVICE OR OTHER STUDY INTERVENTION)..........................9 
7.1 
DESCRIPTION .................................................................................................................................... 9 
8 
SAFETY MANAGEMENT ............................................................................................................................ 10 
8.1 
CLINICAL ADVERSE EVENTS ............................................................................................................ 10 
8.2 
ADVERSE EVENT REPORTING ........................................................................................................... 10 
9 
STUDY ADMINISTRATION ........................................................................................................................ 11 
9.1 
TREATMENT ASSIGNMENT METHODS ............................................................................................... 11 
9.1.1 
Randomization ......................................................................................................................... 11 

 
 
 
 
 
 
 
 
 
 
iii 
9.2 
DATA COLLECTION AND MANAGEMENT ........................................................................................... 11 
9.3 
CONFIDENTIALITY ........................................................................................................................... 11 
9.4 
REGULATORY AND ETHICAL CONSIDERATIONS ................................................................................. 11 
9.4.1 
Data and Safety Monitoring Plan ............................................................................................. 11 
9.4.2 
Risk Assessment ....................................................................................................................... 12 
9.4.3 
Potential Benefits of Trial Participation ................................................................................... 12 
9.4.4 
Risk-Benefit Assessment ........................................................................................................... 12 
9.5 
RECRUITMENT STRATEGY ................................................................................................................ 12 
9.6 
INFORMED CONSENT/ASSENT AND HIPAA AUTHORIZATION............................................................. 12 
9.6.1 
Waiver of HIPAA Authorization ............................................................................................... 13 
9.7 
PAYMENT TO SUBJECTS/FAMILIES .................................................................................................... 13 
10 
PUBLICATION .............................................................................................................................................. 13 
11 
REFERENCES ............................................................................................................................................... 14 
Appendix .................................................................................................................................... 16 
  

 
 
 
 
 
 
 
 
 
 
iv 
ABBREVIATIONS AND DEFINITIONS OF TERMS 
AE 
 
Adverse event 
SHS 
EHR 
CDS 
NRT 
 
Secondhand Smoke 
Electronic Health Record 
Clinical Decision Support 
Nicotine Replacement Therapy 
DBHi  
 
 
Department of Biomedical and Health Informatics  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
v 
ABSTRACT 
Context:  (Background) 
Secondhand smoke (SHS) exposure is a significant public health problem in that it both 
harms children and is widely prevalent, affecting more than 40% of US children. Tobacco 
cessation quitlines are effective in helping smokers quit, but few smokers make use of their 
services. Electronic health record-based systems that automate referral of interested parents 
to quitlines through pediatric settings may increase the proportion of smokers who 
successfully enroll in treatment. 
Objectives: (primary and important secondary objectives) 
Primary Objective: To compare through a randomized clinical trial parent smoker 
enrollment in the tobacco quitline using an electronic referral process (parent information 
sent to quitline with quitline calling the parent) to the current standard manual process 
(giving the parent the quitline phone number).  
Secondary Objective: To explore certain parent and child factors associated with successful 
enrollment in and willingness to receive services from the tobacco quitline in order to 
inform future interventions that maximize impact. 
Study Design:  
We propose a randomized controlled study of electronic quitline referral compared to 
standard practice. Parent enrollment in the quitline will be reported to the study team by the 
state tobacco quitline, managed by the Pennsylvania Department of Health. 
Setting/Participants: 
This is a single site study at one large outpatient pediatric practice (Karabots). Eligible study 
participants are parents/caregivers (hereafter referred to as “parents”), 18 years of age or 
older, who are present for the child’s healthcare (both well-child and acute) visit, who 
smoke, and who are interested in receiving treatment through the tobacco quitline. 
Study Interventions and Measures:  
The intervention is electronic referral to the tobacco quitline for parent smokers. The referral 
process will be embedded in a tobacco treatment clinical decision support (CDS) tool, 
created to help pediatricians provide counseling and treatment to parent smokers. The 
primary outcome of interest is smoker enrollment in the quitline, defined as the proportion 
of parent smokers identified in the clinic that enroll in quitline treatment compared across 
the intervention (electronic referral) and control (standard practice) approaches. Secondary 
outcomes include patient and parent demographic and behavioral factors associated with 
successful enrollment. 

 
 
 
 
 
 
1 
1 
BACKGROUND INFORMATION AND RATIONALE 
1.1 Introduction 
Secondhand smoke (SHS) exposure is a significant public health problem in that it 
both harms children, increasing their risk of acute respiratory infections, asthma 
exacerbations, sudden infant death syndrome, and premature death,(1) and is widely 
prevalent, affecting more than 40% of US children.(2) When a parent quits smoking, they 
eliminate the majority of their children’s SHS exposure,(1)(3)(4) decrease the risk of their 
children becoming smokers when they grow up,(5) and increase their own life expectancy 
by an average of 10 years.(6) Pediatricians are uniquely positioned to educate and motivate 
parents towards protecting their children from SHS.(7) Parents who smoke are often 
underserved medically, but see their child’s doctor an average of 4 times each year, 
significantly more than they themselves see a clinician.(8) Parents expect their pediatrician 
to ask about their smoking status and are interested in their pediatrician providing smoking 
cessation medication and connecting them to additional resources,(9) such as tobacco 
counseling quitlines.(10) Despite this opportunity to intervene, pediatricians rarely provide 
such treatments.(11) Nationally, of parents who smoke who had accompanied their child to 
the pediatric clinician in the past year, only 38% were advised to quit and 15% had treatment 
options recommended to them.(9) 
Tobacco cessation quitlines are effective in helping smokers quit,(12)(13) but few 
smokers make use of their services. Less than 3% of smokers who saw their healthcare 
provider in the last year report being connected to them, (14) and only 8% of smokers who 
are trying to quit, and who are aware of quitlines, actually use them. (15) Quitlines provide 
free (to the user) population-based treatment to tobacco users available through a nationwide 
consortium (1-800-QUIT-NOW). Telephone counseling can be proactive or reactive. In a 
proactive approach the counselor initiates one or more calls to provide support in making a 
quit attempt or avoiding relapse. Reactive counseling in contrast is available on demand for 
people who smoke, or their friends and family.(13)(16) 
Electronic health records (EHRs) and clinical decision support (CDS) systems may 
improve the quality and standardization of clinical interventions for tobacco 
use.(17)(18)(19) Additionally, the EHR may reduce the costs and burden of delivering 
tobacco dependence interventions by efficiently referring smokers to state tobacco 
quitlines.(19) In adult settings, CDS systems that automate referral of interested patients to 
quitlines significantly increase the proportion of smokers who successfully enroll in 
treatment.(20)(21) Use of CDS tools help pediatric clinicians provide counseling and 
prescribe nicotine replacement therapy (NRT) to parents who smoke in pediatric primary 
care and hospital settings.(22)(23) For pediatric developmental evaluation, automated 
referrals to early intervention (EI), compared to the standard practice of handing the parent a 
phone number and asking him or her to make the connection, are strongly associated with 
completion of multidisciplinary evaluation by EI.(24) No pediatric-based studies have 
evaluated automated electronic referral to quitlines with proactive counseling compared to 
standard practice (giving the parent the quitline phone number) for parent smoker 
enrollment in the quitline program. We hypothesize that automated electronic referral will 
increase enrollment into the quitline program compared to standard practices of providing 
the number quitline number to the parent.  

 
 
 
 
 
 
2 
1.2 Name and Description of Investigational Product or Intervention 
The electronic quitline referral will be embedded within the Tobacco Treatment CDS tool, 
CDS system previously developed to help pediatricians provide smoking cessation 
counseling and treatment to parents who smoke,(22) modeled off the CEASE intervention, 
an evidence-based approach for implementing smoking cessation treatment of parents in the 
pediatric setting.(25) The parental tobacco treatment CDS tool, which interfaces seamlessly 
within the EHR (EpicCare®, Epic Sytems, Inc, Verona, WI, USA), prompts the pediatric 
clinician to ask the parent about smoking status and assess interest in quitting (at all well-
child and acute visits), links to an electronic nicotine replacement therapy prescription for 
parents interested in quitting, and guides appropriate documentation. Electronic referral to 
the quitline will be made by clicking an automated link embedded in the tool that will send 
the parent smokers’ names and telephone numbers (entered by the clinician) directly to the 
Pennsylvania (PA) Free Quitline. This approach matches an existing workflow for CDS for 
other aspects of pediatric care already successfully in use by the practice.(26)(27)(28)(29) 
Parent information will be sent using secure, HIPAA-compliant methods to transmit 
protected health information, coordinated by the Department of Biomedical and Health 
Informatics (DBHi). (See Figure for Study Flow Diagram.)  
Figure: Study Flow Diagram 
 
 

 
 
 
 
 
 
3 
2 
STUDY OBJECTIVES 
The purpose of the study is to determine if electronic referral to the state tobacco quitline for 
parent smokers increases program enrollment compared to standard referral practice.  
2.1 Primary Objective (or Aim) 
To compare through a randomized clinical trial parent smoker enrollment in the tobacco 
quitline using an electronic referral process (parent information sent to quitline with quitline 
calling the parent) to the current standard manual process (giving the parent the quitline 
phone number).  
2.2 Secondary Objectives (or Aim) 
To explore certain parent and child factors associated with successful enrollment in and 
willingness to receive services from the tobacco quitline in order to inform future 
interventions that maximize impact. 
3 
INVESTIGATIONAL PLAN 
3.1 General Schema of Study Design 
We propose a randomized controlled study of electronic quitline referral compared to 
standard practice. Parent smokers will be randomized based on patient medical record 
number. Parent enrollment in the quitline will be reported to the study team by the state 
tobacco quitline, managed by the Pennsylvania Department of Health. 
3.1.1 Screening Phase 
Potential parent subjects will be screened using the protocol inclusion and exclusion criteria. 
Parent subjects will be recruited at their child’s medical visit by their pediatric clinician. If 
parents are interested in using the tobacco quitline, they will be referred either via the 
standard method or through the electronic referral process.   
3.1.2 Study Treatment Phase (start of the study intervention) 
Parent subjects will be referred to the tobacco quitline, either through electronic referral 
(intervention) or the standard manual process (control).  
3.2 Allocation to Treatment Groups and Blinding 
Randomization to the intervention and control approaches will be based on an automatically 
generated randomization sequence, managed by an honest broker as part of the Department 
of Biomedical and Health Informatics (DBHi). This will allow for blinding of the clinicians 
to the allocation.  

 
 
 
 
 
 
4 
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 6 days, with 1 day of screening, up to 5 days of 
interactions with the tobacco quitline. Both the parent and the child are considered subjects. 
The parent receives the intervention but the child's data will also be collected. 
3.3.2 Total Number of Study Sites/Total Number of Subjects Projected 
The study will be conducted at 1 investigative site in the United States at the Karabots 
Pediatric Care Center, within the CHOP care network at The Children’s Hospital of 
Philadelphia.   
Recruitment will stop when approximately 601 parent subjects are enrolled (referred to the 
quitline via either approach). It is expected that approximately 601 parent subjects will be 
enrolled to produce 500 evaluable parent subjects. While the parent receives the 
intervention, the patient child is also considered as a subject as their data will be collected as 
well. Each of the 601 parent subjects will have a corresponding child subject. Thus, a total 
of 1202 subjects (601 parents plus 601 related children) will be enrolled.  
3.4 Study Population 
3.4.1 Inclusion Criteria 
Eligible subjects will include parents, 18 years of age or older, present for the child’s 
healthcare (both well-child and acute) visit, who smoke, and who are interested in being 
referred to the tobacco quitline.  
3.4.2 Exclusion Criteria 
Exclusion criteria will include parents who smoke but are not present during the visit, who 
are less than 18 years of age, or who are not interested in referral to the tobacco quitline. 
Non-English language speakers will not specifically be excluded. Counseling available 
through the tobacco quitline is available in English and Spanish and can be provided in at 
least 15 additional languages through a third party. 
Subjects that do not meet all of the enrollment criteria will not be enrolled.  
4 
STUDY PROCEDURES 
4.1 Study Treatment Phase 
Potential parent subjects will be screened for smoking in the context of their child’s medical 
visit. If a parent smoker is identified and they are interested in treatment, the pediatric 
clinician will obtain their permission to refer the parent to the tobacco quitline. 
4.2 Tobacco Quitline Phase 
The PA Free Quitline will reach out to interested parent subjects and provide telephone 
based counseling (see Section 7.1 for intervention description). The Quitline will collect 
information regarding parent smoker subject counseling. This information will be 

 
 
 
 
 
 
5 
aggregated in monthly reports and will then be sent back to the DBHi team via a secure, 
HIPAA compliant data exchange system. DBHi will act as an honest broker and provide this 
information to the study team in de-identified reports. 
4.3 Review of Medical Record Phase 
DBHi, who will act as an honest broker, will abstract information from the child patient’s 
electronic medical chart and present that information to the study team as a de-identified 
data set (see section 5.1.1 for variable description).  
 

 
 
 
 
 
 
6 
5 
STUDY EVALUATIONS AND MEASUREMENTS 
5.1 Screening and Monitoring Evaluations and Measurements 
During this study, an honest broker – DBHi – will be providing all data between CHOP and 
from the PA Free Quitline, presenting information to the study team in de-identified reports. 
5.1.1 Information collected from Medical Record Review 
DBHi, who will act as an honest broker, will abstract information from the child patient’s 
electronic medical chart and present that information to the study team as a de-identified 
data set. This data will be merged by DBHi, the honest broker, with data from the Quitline. 
The following variables will be abstracted: 
- 
Patient age 
- 
Patient race/ethnicity 
- 
Patient insurance status 
- 
Presence of chronic condition (e.g. Asthma) 
- 
Parent baseline smoking characteristics, including: 
o Number of cigarettes smoked per day 
o Stage of change assessed by asking if they were planning to quit in the next 
30 days or 6 months 
In addition to data abstracted from the patients’ medical charts, parent smokers who are 
interested in treatment will have their name and phone contact information entered by the 
clinician, to be electronically sent to the tobacco quitline. 
5.1.2 Information collected from tobacco quitline - Pennsylvania (PA) Free Quitline 
The PA Free Quitline will collect the following information from/about parent smoker 
subjects: 
- 
Parent baseline smoking characteristics, including: 
o Number of cigarettes smoked per day 
o Stage of change assessed by asking if they were planning to quit in the next 
30 days or 6 months 
- 
Parent smokers who talk with the quitline 
- 
Parent smokers unreachable by the quitline 
- 
Parent smokers who enroll in treatment 
o Including number of successful calls once enrolled 
- 
Parent smokers who decline to enroll in treatment 
This information will be aggregated in monthly reports and will then be sent back to the 
DBHi team via a secure, HIPAA compliant data exchange system. DBHi will act as an 
honest broker and provide this information to the study team in de-identified reports. 
5.2 Efficacy Evaluations 
The primary outcome of interest is smoker enrollment in the quitline, defined as the 
proportion of parent smokers identified in the clinic that enroll in quitline treatment 

 
 
 
 
 
 
7 
compared across the intervention (electronic referral) and control (standard practice) 
approaches.  
Secondary outcomes include patient and parent demographic and behavioral factors 
associated with successful enrollment. Multivariable logistic regression models will be used 
to assess the adjusted association of independent variables with dependent variables. 
Additionally, the RE-AIM conceptual framework – a systematic way to evaluate the impact 
of public health interventions (30), used in a variety of healthcare settings and for varied 
conditions (31) – will help contextualize parent enrollment in the quitline and improve 
understanding of system implementation. The RE-AIM model includes the 5 criteria of 
reach, efficacy, adoption, implementation, and maintenance. This study will measure reach, 
efficacy, adoption, and impact. Reach will be calculated as the number of parent smokers 
who visited the clinic who subsequently talked with the quitline divided by the total number 
of parent smokers visiting the clinic. Efficacy will be calculated as the total number of 
parent smokers who visited the clinic who enrolled in treatment with the quitline divided by 
the total number of parent smokers who visited the clinic who talked with the quitline. 
Adoption will be measured as the proportion of clinicians who refer parent smokers to the 
quitline (that is, the proportion of clinicians who use the tool who received the tool prompt). 
We hypothesize that the efficacy of the standard practice approach will exceed that of the 
electronic referral approach because parent smokers who followed up with referrals on their 
own (using the number provided by the pediatric clinician to call the quitline) would be 
more motivated to enroll in cessation treatment. Thus, we will multiply reach by efficacy to 
yield a composite measure of overall impact.(21) 
 
 
5.3 Safety Evaluation 
This study presents no more than minimal risk to study participants, as this is a study aimed 
to improve parent smoker enrollment in the state tobacco quitline. The quitline offers 
evidence-based tobacco cessation counseling, and referral to this resource is already part of 
standard practice. The only identifying information that will be collected for the parent 
subjects will be participants’ name and telephone number. Once data collection is 
completed, the master list containing only the names of the study participants will be 
deleted. No other PHI identifiers will be collected at any time, and no other PHI identifiers 
will be stored for parent subjects. 

 
 
 
 
 
 
8 
6 
STATISTICAL CONSIDERATIONS 
6.1 Primary Endpoint 
The primary endpoint of interest is smoker enrollment in the quitline, defined as the 
proportion of parent smokers identified in the clinic that enroll in quitline treatment 
compared across the intervention (electronic referral) and control (standard practice) 
approaches.  
6.2 Secondary Endpoints 
Secondary endpoints will include the reach, efficacy, adoption, and impact of the 
intervention and control approaches, as described above.  
6.3 Statistical Methods 
6.3.1 Baseline Data  
Baseline and demographic characteristics for subjects will be summarized by standard 
descriptive summaries (e.g. means and standard deviations for continuous variables such as 
age and percentages for categorical variables such as gender). 
6.3.2 Efficacy Analysis 
The primary analysis will be based on an intention to treat approach and will include all 
subjects randomized at their referral visit.    
The primary efficacy endpoint will be the difference in the proportion of quitline enrollment 
between intervention and control approaches.    
Secondary endpoints will include the difference in reach, efficacy, adoption, and impact of 
the intervention and control approaches. 
6.3.3 Safety Analysis 
As this study presents no more than minimal risk to study participants, a safety analysis will 
not be performed. 
6.4 Sample Size and Power 
We estimate that enrolling at least 500 parents subjects, 250 in each arm, would provide 
greater than 80% power to detect an absolute difference of at least 6% in enrollment 
between the intervention and control groups, an effect difference identified in comparable 
adult studies.(21)(20) 
 

 
 
 
 
 
 
9 
7 
 STUDY INTERVENTION 
7.1 Description 
Intervention – electronic referral to quitline  
The electronic quitline referral will be embedded within the Tobacco Treatment CDS 
tool, a CDS system previously developed to help pediatricians provide smoking cessation 
counseling and treatment to parents who smoke,(22) modeled off the CEASE intervention, 
an evidence-based approach for implementing smoking cessation treatment of parents in the 
pediatric setting.(25) The parental tobacco treatment CDS tool, which interfaces seamlessly 
within the EHR (EpicCare®, Epic Sytems, Inc, Verona, WI, USA), prompts the pediatric 
clinician to ask the parent about smoking status and assess interest in quitting (at all well-
child and acute visits), links to an electronic nicotine replacement therapy prescription for 
parents interested in quitting, and guides appropriate documentation. Electronic referral to 
the quitline will be made by clicking an automated link embedded in the tool that will send 
the parent smokers’ names and telephone numbers (entered by the clinician) directly to the 
Pennsylvania (PA) Free Quitline. This approach matches an existing workflow for CDS for 
other aspects of pediatric care already successfully in use by the practice.(26)(27)(28)(29) 
Parent information will be sent using secure, HIPAA–compliant method to transmit 
protected health information.  
Control 
All procedures implemented in the standard referral approach will be identical to 
those in the electronic referral approach with the exception of providing the telephone 
number for the Quitline to the parent (rather than electronic referral). The clinician 
workflow will be nearly the same, in that the clinician will use the link embedded in the 
tobacco treatment CDS tool to add the quitline to the patient’s discharge paperwork (rather 
than automatically refer to the quitline).  
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 and Spanish and can be provided in at least 15 
additional languages through a third party. All smokers who enroll in smoking cessation 
treatment will receive counseling and support consistent with accepted clinical practice 
guidelines.(32) This treatment includes as many as 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 2- to 3-week intervals thereafter. 
The call timing will be flexible and adjusted as needed. 

 
 
 
 
 
 
10 
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.  

 
 
 
 
 
 
11 
9 
STUDY ADMINISTRATION 
9.1 Treatment Assignment Methods 
9.1.1 Randomization 
Randomization to the intervention and control approaches will be based on an automatically 
generated randomization sequence, managed by an honest broker as part of the Department 
of Biomedical and Health Informatics. 
9.2 Data Collection and Management 
To minimize the risk of loss of confidentiality, parent subjects will have a unique study 
number. The generated report that contains parent name and contact information, used to 
facilitate the clinical referral process, will be stored within PeRC databases managed by 
DBHi. The Tobacco Quitline will add information about parent smokers who talk with the 
quitline, are unreachable by the quitline, and enroll or do not enroll in treatment to that 
report. That report will then be sent back to the DBHi team, who will act as an honest broker 
and provide this information to the study team in de-identified reports. The study team will 
have access to the unique study numbers mentioned above but will not be able to link 
identifiable information with those numbers. Only the Project Director and other senior 
research staff listed on the protocol will be able to access these de-identified reports. These 
reports will be password protected and will not be stored on portable media devices (e.g., 
flash drives).  
 
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 
This study presents no more than minimal risk to study participants, as this is a study aimed 
to improve parent smoker enrollment in the state tobacco quitline. The quitline offers 
evidence-based tobacco cessation counseling, and referral to this resource is already part of 
standard practice. The only identifying information that will be collected for parent subjects 
will be parent participants’ name and telephone number. That information, entered during 
the clinical care encounter by the pediatric clinician, will be collected by an honest broker 
(within the Department of Biomedical and Health Informatics), and information about 
parent enrollment in the quitline will be presented back to the study team in de-identified 
reports. Once data collection is completed, the master list containing the names of the study 
participants will be deleted by the Department of Biomedical and Health Informatics 
(DBHi). The Department of Biomedical and Health Informatics will also build the final 

 
 
 
 
 
 
12 
analytic data set for the study team. No other PHI identifiers will be collected at any time, 
and no other PHI identifiers will be stored. The study PI will maintain oversight over data 
integrity.  
 
9.4.2 Risk Assessment 
Risks are not greater than minimal. For parent subjects, because the procedures herein 
involve accepted forms of treatment interventions and referral to those interventions, we 
foresee no special risks. The main risk, therefore, to parent subjects is breach of 
confidentiality. The alternative to participation is parent subject to decide not to be referred 
to the quitline program.  
9.4.3 Potential Benefits of Trial Participation 
Although the proposed research poses minimal risks to participants, the benefits to scientific 
knowledge are numerous. The objectives of the study involve increasing parent smoker 
enrollment in evidence-based programs that help smokers quit. Helping parent smokers quit 
not only helps improve their individual health outcomes but also protects their children from 
the harms of secondhand smoke exposure.  
Additionally, the study is novel in two ways. First, it makes use of clinical decision support 
to guide referral to the smoker quitline by pediatricians for parents who smoke. Second, this 
study is unique in its attempt to create a systematic bridge between pediatric healthcare 
setting and adult treatment programs, decreasing logistical barriers to parents receiving 
services. This study will test if the automated referral improves delivery of care for pediatric 
patients exposed to SHS and will improve understanding of the technical issues involved in 
implementing an intervention focused on parents, individuals that are not in the direct care 
of pediatricians. 
9.4.4 Risk-Benefit Assessment 
From a risk-benefit assessment perspective, the potential large benefits outweigh the 
minimal risk posed by the study, justifying proceeding with the trial.  
9.5 Recruitment Strategy 
Identification of parent smokers will be achieved through the clinical care encounter.  
9.6 Informed Consent/Assent and HIPAA Authorization 
We request a waiver of obtain informed consent as the research meets the criteria of 45 CFR 
46.116(d), in that:  
1) the research involves no more than minimal risk to the subjects as this is a study 
aimed to improve parent smoker enrollment in the state tobacco quitline. The quitline 
offers evidence-based tobacco cessation counseling, and referral to this resource is 
already part of standard practice.; 

 
 
 
 
 
 
13 
2) the waiver or alteration will not adversely affect the rights and welfare of the 
subjects as parent smokers are being connected with evidence-based resources that 
they could already use or not use at their discretion; 
3) the research could not practicably be carried out without the waiver as obtaining 
consent would introduce significant bias into the study. Parents referred to the 
quitline could potentially change their behavior if they knew they were being 
studied, decreasing the likelihood that they would be willing to be referred (either 
electronically or the standard approach) to an evidence-based tobacco treatment 
quitline service. We would not be able to practicably achieve the first objective of 
the study to determine if electronic referral to the state tobacco quitline for parent 
smokers increases program enrollment compared to standard referral practice; and, 
4) after their study participation, the parent subjects will be provided with additional 
pertinent information about their participation in study aimed at helping parent 
smokers quit through increased enrollment in the tobacco quitline. This information 
will be posted throughout the clinic.  
9.6.1 Waiver of HIPAA Authorization 
We request a waiver of HIPAA authorization as the use of protected health information 
(parent name and contact information) involves no more than minimal risk to the privacy of 
the parent subjects based on the presence of the following elements: 
 
1) there is an adequate plan to protect the identifiers from improper use and disclosure;  
2) there is an adequate plan to destroy the identifiers at the earliest opportunity 
consistent with conduct of the research; and  
3) the protected health information will not be reused or disclosed to any other person 
or entity, except as required by law, for authorized oversight of the research project, 
or for other research for which the use or disclosure of protected health information 
would be permitted by this subpart;  
a. The research could not practicably be conducted without the waiver or 
alteration (for the reasons detailed above); and  
b. The research could not practicably be conducted without access to and use of 
the protected health information (we would not be able to connect parents to 
the tobacco quitline if their name and contact information was not available). 
  
9.7 Payment to Subjects/Families 
No payments will be made to the subjects for participation in the study.  
 
10 PUBLICATION 
After completion of the study, a manuscript will be prepared for publication.  
 

 
 
 
 
 
 
14 
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APPENDIX 
Append relevant information.