Electronic Pediatric Office Systems to Support Treatment for Parental Tobacco Use
Phase: NA
Conditions: Tobacco Smoking, Second Hand Tobacco Smoke, Smoking Cessation
Sponsor: Massachusetts General Hospital

 
Version Date: 04.01.2025 
 
 
Title: 
Electronic Pediatric Office Systems to Support Treatment for 
Parental Tobacco Use 
Short Title 
eCEASE 
Drug or Device Name(s): 
N/A 
NCT Number: 
NCT04974736 
Sponsor:  
NIH 
eIRB Number:  
IRB 20-018146 
Protocol Date: 04/01/2025 
 
Amendment 1 Date: 06/21/2021                               Amendment 2 Date (Staff Change): 07/07/2021 
 
Amendment 3 Date (Staff Change): 07/14/2021      Amendment 4 Date (Staff Change): 07/23/2021 
Amendment 5 Date: 9/29/2021                                 Amendment 6 Date (Staff change): 10/04/2021 
Amendment 7 Date (Staff change): 12/16/2021       Amendment 8 Date (Staff change): 1/14/2022 
Amendment 9 Date: 1/19/2022.                                Amendment 10 (Staff change) Date: 2/1/2022 
Amendment 11 Date: 2/16/2022                               Amendment 12 (Staff change) Date: 2/25/2022 
Amendment 13 (staff change) Date: 3/15/2022        Amendment 14 Date: 6/2/2022 
Amendment 15 (staff change) Date: 6/4/2022          Amendment 16 (staff change): 06/13/2022 
Amendment 17 Date: 6/13/2022                               Amendment 18 (staff change): 06/23/2022 
Amendment 19 (staff removal) Date: 07/05/2022    Amendment 20: 08/16/2022 
Amendment 21 (staff change) Date: 10/06/2022      Amendment 22 (staff change): 12/05/2022     
Amendment 23 (staff removal) Date: 01/12/2023    Amendment 24 (staff change): 02/03/2023 
Amendment 25 Date: 2/24/2023                               Amendment 26 (staff change): 04/03/2023 
Amendment 27: Date: 05/02/2023                            Amendment 28: (staff removal): 06/07/2023 
Amendment 29: (staff removal) 04/05/2024             Amendment 30: (staff removal): 03/20/2025 
Amendment 31: 04/01/2025 
 
Sponsor: National Institutes of Health, NCI 
6701 Rockledge Drive MSC 7768 
Bethesda MD 20892-7768 
 

 
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TABLE OF CONTENTS  
TABLE OF CONTENTS .................................................................................................................................... 2 
ABBREVIATIONS AND DEFINITIONS OF TERMS ................................................................................... 5 
ABSTRACT ......................................................................................................................................................... 6 
PROTOCOL SYNOPSIS .................................................................................................................................... 8 
TABLE 1: SCHEDULE OF STUDY PROCEDURES ................................................................................... 12 
1 
BACKGROUND INFORMATION AND RATIONALE ..................................................................... 14 
 INTRODUCTION .................................................................................................................................... 14 
 NAME AND DESCRIPTION OF INVESTIGATIONAL PRODUCT OR INTERVENTION ........ 15 
 RELEVANT LITERATURE AND DATA ............................................................................................. 15 
 COMPLIANCE STATEMENT ............................................................................................................... 17 
2 
STUDY OBJECTIVES ............................................................................................................................. 17 
 PRIMARY OBJECTIVE ......................................................................................................................... 17 
 SECONDARY OBJECTIVES. ................................................................................................................ 17 
3 
INVESTIGATIONAL PLAN .................................................................................................................. 19 
 GENERAL SCHEMA OF STUDY DESIGN ......................................................................................... 19 
3.1.1 PRACTICE SELECTION AND RANDOMIZATION ......................................................................... 19 
3.1.2 PARENT SCREENING & ENROLLMENT ......................................................................................... 19 
3.1.3 INTERVENTION ..................................................................................................................................... 20 
3.1.4 FOLLOW-UP ............................................................................................................................................ 20 
 PRACTICE SELECTION, RANDOMIZATION AND BLINDING ................................................... 21 
 STUDY DURATION, ENROLLMENT AND NUMBER OF SITES .................................................. 21 
3.3.1 DURATION OF STUDY PARTICIPATION ........................................................................................ 21 
3.3.2 TOTAL NUMBER OF STUDY SITES/TOTAL NUMBER OF SUBJECTS PROJECTED ........... 22 
 STUDY POPULATION ........................................................................................................................... 22 
3.4.1 INCLUSION CRITERIA ......................................................................................................................... 22 
3.4.2 EXCLUSION CRITERIA ........................................................................................................................ 23 
4 
STUDY PROCEDURES .......................................................................................................................... 23 
 SCREENING & ENROLLMENT .......................................................................................................... 23 
 INTERVENTION ..................................................................................................................................... 27 
4.2.1 IEHR .......................................................................................................................................................... 27 
4.2.2 COMMUNITY HEALTH NAVIGATORS (CHNS) ............................................................................. 28 
 FOLLOW-UP ............................................................................................................................................ 29 
4.3.1 PARENT FOLLOW-UP .......................................................................................................................... 29 
4.3.2 ONGOING EHR DOCUMENTATION & EVALUATION ................................................................. 31 
4.3.3 PRACTICE CLINICIANS AND STAFF QUALITATIVE INTERVIEWS ....................................... 31 

 
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 SUBJECT COMPLETION/WITHDRAWAL ....................................................................................... 32 
4.4.1 EARLY TERMINATION STUDY VISIT ............................................................................................. 32 
5 
STUDY EVALUATIONS AND MEASUREMENTS ............................................................................ 32 
 SCREENING AND MONITORING EVALUATIONS AND MEASUREMENTS ........................... 32 
5.1.1 MEDICAL RECORD REVIEW ............................................................................................................. 32 
5.1.2 LABORATORY EVALUATIONS ......................................................................................................... 33 
 EFFICACY EVALUATIONS ................................................................................................................. 35 
5.2.1 DIAGNOSTIC TESTS, SCALES, MEASURES, ETC. ........................................................................ 37 
 SAFETY EVALUATION ......................................................................................................................... 37 
6 
STATISTICAL CONSIDERATIONS .................................................................................................... 37 
 PRIMARY ENDPOINT ........................................................................................................................... 37 
 SECONDARY ENDPOINTS ................................................................................................................... 37 
 STATISTICAL METHODS .................................................................................................................... 37 
6.3.1 BASELINE DATA .................................................................................................................................... 38 
6.3.2 SAFETY ANALYSIS ............................................................................................................................... 38 
 SAMPLE SIZE AND POWER ................................................................................................................ 38 
7 
STUDY INTERVENTION ....................................................................................................................... 39 
 DESCRIPTION ......................................................................................................................................... 39 
7.1.1 TREATMENT COMPLIANCE AND ADHERENCE .......................................................................... 39 
8 
SAFETY MANAGEMENT ..................................................................................................................... 39 
 CLINICAL ADVERSE EVENTS ........................................................................................................... 39 
 ADVERSE EVENT REPORTING ......................................................................................................... 39 
9 
STUDY ADMINISTRATION ................................................................................................................. 39 
 TREATMENT ASSIGNMENT METHODS ......................................................................................... 39 
9.1.1 RANDOMIZATION ................................................................................................................................. 40 
9.1.2 BLINDING ................................................................................................................................................ 40 
9.1.3 UNBLINDING .......................................................................................................................................... 40 
 DATA COLLECTION AND MANAGEMENT .................................................................................... 40 
9.2.1 BASELINE SURVEY AND 12-MONTHS FOLLOW-UP DATA ....................................................... 41 
9.2.2 DATA SHARING WITH THE QUITLINE ........................................................................................... 41 
9.2.3 DATA SHARING WITH THE SMOKEFREETXT ............................................................................. 42 
9.2.4 DATA SHARING WITH THE BRIGHTMEDICAL ........................................................................... 42 
9.2.5 DATA TRANSFER OF THE EHR EXTRACTIONS BETWEEN CHOP AND MGH .................... 42 
9.2.6 DATA SHARING WITH THE ADA TRANSCRIPTION ................................................................... 43 
9.2.7 CONFIDENTIALITY .............................................................................................................................. 43 
9.2.8 SECURITY. ............................................................................................................................................... 46 
9.2.9 ANONYMIZATION, DE-IDENTIFICATION OR DESTRUCTION. ............................................... 46 

 
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 CONFIDENTIALITY .............................................................................................................................. 47 
 REGULATORY AND ETHICAL CONSIDERATIONS ..................................................................... 47 
9.4.1 DATA AND SAFETY MONITORING PLAN ...................................................................................... 47 
9.4.2 RISK ASSESSMENT ............................................................................................................................... 48 
9.4.3 POTENTIAL BENEFITS OF TRIAL PARTICIPATION .................................................................. 50 
9.4.4 RISK-BENEFIT ASSESSMENT ............................................................................................................ 50 
 RECRUITMENT STRATEGY ............................................................................................................... 51 
 INFORMED CONSENT/ASSENT AND HIPAA AUTHORIZATION .............................................. 52 
9.6.1 WAIVER OF CONSENT ......................................................................................................................... 53 
9.6.2 WAIVER OF HIPAA AUTHORIZATION ........................................................................................... 53 
 PAYMENT TO SUBJECTS/FAMILIES ............................................................................................... 53 
9.7.1 PAYMENTS TO PARENT FOR TIME AND INCONVENIENCE (I.E., COMPENSATION) ....... 53 
9.7.2 PAYMENTS TO PRACTICES FOR TIME, EFFORT AND INCONVENIENCE (I.E., 
COMPENSATION) ........................................................................................................................................... 54 
9.7.3 PAYMENTS TO CLINICIANS AND STAFF FOR TIME, EFFORT AND INCONVENIENCE 
(I.E., COMPENSATION) ................................................................................................................................. 54 
10 
PUBLICATION ........................................................................................................................................ 54 
11 
REFERENCES .......................................................................................................................................... 54 
APPENDIX ......................................................................................................................................................... 59 
 

 
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ABBREVIATIONS AND DEFINITIONS OF TERMS 
 
 
 
CEASE 
 
Clinical Effort Against Secondhand Smoke Exposure 
AAP 
 
American Academy of Pediatrics 
CHN 
 
Community Health Navigators 
EHR 
 
Electronic Health Record 
iEHR 
 
Innovative Electronic Health Record 
TSE 
 
Tobacco Smoke Exposure 
SHS 
 
Secondhand Smoke 
NRT 
 
Nicotine Replacement Treatment 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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ABSTRACT 
Context:  When parents quit smoking, their life expectancy is increased, their children have 
lower odds of becoming adult smokers, and their children may no longer be exposed to high 
levels of tobacco smoke, decreasing the odds of tobacco smoke exposure related health 
problems. Parents who smoke are often medically underserved and visit their child’s 
healthcare clinician more often than they see their own clinician if they even have one. 
Routinely delivered tobacco control to parents in child healthcare settings would benefit the 
overall health of the nation.  
Objectives: To compare parents’ combusted tobacco quit rates, and adoption of tobacco free 
behaviors between the two arms (iEHR + Navigator vs. usual care control)  
Study Design: Cluster randomized controlled trial of child healthcare practices with at least 
4 practices each randomized to iEHR + Navigator or usual care control arms. 
Setting/Participants: We will recruit at least 8 primary care pediatric practices in a large 
primary care practice network, The Pediatrics Research Consortium (PeRC), at CHOP.  
In each arm to collect data related to the primary outcome, we will enroll in the longitudinal 
cohort approximately 400 parents or legal guardians who smoke, who are present at the 
visit, and whose child is seen by a child healthcare clinician in a participating practice. We 
may also add additional practices to maximize the likelihood of meeting the recruitment goal 
of 400 parents enrolled in each arm. 
Study Interventions and Measures: The iEHR + Navigator intervention includes an 
innovative EHR platform (iEHR) with the addition of community health navigators (CHNs). 
iEHR consists of an electronic platform for smoking screening and automated smoking 
cessation support for parents who smoke. iEHR will include automated EHR-generated 
Nicotine replacement treatment (NRT) prescriptions, automated enrollment in the free state 
tobacco Quitline, and EHR prompts for the clinician to deliver a brief motivational message.  
CHN’s will work with offices to provide customized cessation support to household tobacco 
users through phone follow-up, ensuring access to medications and services, and/or home 
visits, depending on the needs of each family and as study resources allow. 
Primary outcome: Parental combusted tobacco quit rate at 1 year, as assessed by validated 
surveys, biochemically-confirmed at 12-months compared between iEHR + Navigator vs. 
usual care control. 
Secondary Outcomes: 
1. To compare parents’ self-reported adoption of tobacco free behaviors (quit attempts, 
use of pharmacotherapy, use of Quitlines and institution of smoking and vaping bans in 
their homes and cars) between the iEHR + Navigator and usual care arms 
2. To establish the incremental cost per quit of the iEHR + Navigator vs. usual care arms  
3. To assess the implementation and sustainability of the intervention in the iEHR + 
Navigator arm (NRT prescription and Quitline referrals as assessed by the parental report 
around 12-months, the screening survey conducted at check-in, and EHR documentation 

 
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of screening and services delivery fidelity, before and immediately following 
implementation, 6, 12, 18, 24, 30, and 36 months).

 
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PROTOCOL SYNOPSIS 
Study Title 
Electronic Pediatric Office Systems to Support Treatment for 
Parental Tobacco Use 
Funder 
NIH 
Study Rationale 
Rationale for iEHR + Navigator. The Clinical Effort Against 
Secondhand Smoke Exposure (CEASE) intervention has been successfully 
developed and implemented to train child healthcare clinicians to address 
household smoking behavior and promote smoke-free and e-cigarette free 
home and car rules in a routine and effective manner.1,2 A recent trial by 
the present research team used a tablet screener to replace the previously 
used paper screening system and created a registry of smokers, yielding 
dramatic increases in NRT and Quitline enrollment rates for parents 
compared to control practices (NRT 38% vs. <1%; Quitline 32% vs. <1% 
P<.01 for each).2 Despite such strong and effective results, sustainability 
of the intervention and impact on parental quit rates have been limited due 
to the lack of fidelity, systems-level integration, and methods to facilitate 
connection to external resources. To address the weaknesses of the 
previous strategy and to best provide care to parents, the proposed project 
sustainably integrates these changes into child healthcare by developing a 
disseminable, innovative electronic health record (iEHR)-based approach 
that supports optimal workflows. Additionally, parents enrolled in the 
study will be offered assistance by a community health navigator (CHN). 
This proposed role of a CHN in the child healthcare setting to address 
household tobacco use has not been studied. This study aims to examine 
how effective the iEHR + Navigator strategy is compared to usual care 
control.  
Study Objective(s) Primary: Parental combusted tobacco quit rate at 1 year, as assessed by 
validated surveys, biochemically-confirmed at 12-months compared 
between iEHR + Navigator vs. usual care control. 
Secondary: 
1. To compare parents’ self-reported adoption of tobacco free 
behaviors (quit attempts, use of pharmacotherapy, use of Quitlines 
and institution of smoking and vaping bans in their homes and 
cars) between the iEHR + Navigator and usual care arms 
2. To establish the incremental cost per quit of the iEHR + Navigator 
vs. usual care arms 
3. To assess the implementation and sustainability of the intervention 
in the iEHR + Navigator arm (NRT prescription and Quitline 
referrals as assessed by the parental report around 12-months, the 

 
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screening survey conducted at check-in, and EHR documentation 
of screening and services delivery fidelity, before and immediately 
following implementation, 6, 12, 18, 24, 30, and 36 months).  
Test Article(s) 
iEHR + Navigator   
Study Design 
2-arm Randomized Control Trial with a stratified cluster randomization 
Subject 
Population 
Inclusion and 
Exclusion 
Criteria: 
Inclusion Criteria 
Parents or legal guardians who smoke, are present at the visit, and whose 
child is seen by a child healthcare clinician in a participating practice. 
“Smoker” will be defined as answering “yes” to either of the screening 
questions: “Have you smoked a cigarette, even a puff, in the past 7 days?” 
and “Have you smoked any other tobacco product (cigars like black and 
mild, hookah), even a puff, in the past 7 days?” Dual users of e-cigarette 
or vaping device will also be included. Eligibility will be confirmed using 
the Eligibility Form. 
Exclusion Criteria 
1. Parent/legal guardian does not speak English; 
2. No telephone; and  
3. Prior enrollment in the study during a previous visit. 
Number of 
Subjects  
 
Total Number of parent subjects: Approximately 800 
Total number of clinicians and staff: Approximately 40  
Total Number at CHOP: Approximately 840 
Total Number of Sites: Minimum 8 
Study Duration 
Each parent participation will last 12 months 
Each clinician and staff participation in the intervention practices will last 
36 months 
The entire study is expected to last 5 years 
Study Phases 
1. Practice 
Selection & 
Randomization 
 
 
 
 
 
At least 8 CHOP practice sites will be approached and selected by PeRC 
network leadership and randomized to: (1) ‘iEHR +Navigator’ and (2) 
‘usual care control’ arms (4 practices in each arm). In the event that a 
practice drops out, we will replace it with the most similar practice based 
on practice size and Medicaid rate from the pool of unassigned and 
interested practices. In the event the enrollment is slower than projected, 
we will add new practices that are similar based on practice size and 
Medicaid rate in each arm. 
 

 
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2. Parent 
Screening & 
Enrollment 
 
 
 
 
3. Intervention 
 
 
 
 
 
 
4. Follow-Up   
In each practice, study team will review patient medical records and those 
parents who identified themselves as smokers, will be offered enrollment 
in the longitudinal cohort. We will continue to enroll parents until 
approximately 100 parents who use combusted tobacco have been enrolled 
in the longitudinal cohort in that practice or approximately 400 
participants have been enrolled in each arm. 
Components of the iEHR part of the intervention will include automated 
EHR-generated NRT prescription, automated enrollment in the free state 
tobacco Quitline and/or SmokefreeTXT, and a brief motivational message 
delivered by the clinician (as prompted by the EHR). 
Additional support of Community Health Navigators (CHNs) will be 
offered to all parents enrolled in the study. CHNs will provide customized 
smoking cessation support to household tobacco users through phone 
follow-up and/or home visits, as requested and as study resources allow. 
Enrolled parents will be followed-up with a survey at approximately 12-
months at their annual check-up or remotely. Parents who self-reported 7-
day combusted tobacco quit rates will be offered the cotinine test. In 
addition to the cotinine test, for parents who report current use of NRT or 
e-cigarettes or have a cotinine level of ≥10ng/ml, the readings from the 
carbon monoxide levels test will also be used to confirm self-reported 
smoking cessation. 
Efficacy 
Evaluations 
1. At the 12-month follow-up the following will be evaluated: parental  
7-day combusted tobacco quit rates and tobacco free behaviors, as 
assessed by validated surveys; cotinine levels for all parents who self-
reported quitting combusted tobacco. 
2. Delivery and sustainability of interventions will be assessed by  
12-month follow-up survey data, pre-visit tobacco screener data, electronic 
health record data and clinician and staff key informant interviews. 
3. Incremental cost per quit of the intervention will be assessed by 
observation and survey of personnel. 
Statistical and 
Analytic Plan 
The primary outcome will compare the parental combusted tobacco 
cessation, biochemically-confirmed between the intervention arm (iEHR + 
Navigator) vs. usual care control. For cotinine confirmed quitting, only 
self-reported non-smokers who have cotinine values <10 ng/ml, a 
consensus cutoff level, will be considered quit. In addition to the cotinine 
test, for parents who report current use of NRT, or e-cigarettes or have a 
cotinine level of ≥10ng/ml, the readings from carbon monoxide levels test 
will be also used to confirm self-reported smoking cessation. For CO 
confirmed quitting, expired-air CO cutoff level of < 5ppm will be 

 
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considered quit.3 E-cigarette use will be noted and analyzed separately as 
the literature emerges. In our intention-to-treat analysis, all participants 
lost to follow-up will be considered smokers. We will also use multiple 
imputation techniques to impute missing data as a sensitivity analysis, as 
appropriate.  
Data and Safety 
Monitoring Plan 
This is a minimal risk clinical trial (as defined in federal regulation at  
45 CFR 46.102(i)). As such, we will implement a Data Safety and 
Monitoring Plan, but not have a formal Data Safety and Monitoring Board.  

 
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TABLE 1: SCHEDULE OF STUDY PROCEDURES  
 
 
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BACKGROUND INFORMATION AND RATIONALE 
 
Introduction 
Helping parents quit smoking tobacco is a national priority. When parents and legal 
guardians (henceforth parents) quit smoking, their life expectancy is increased by an average 
of >10 years,4 future tobacco-related poor pregnancy outcomes are eliminated,5 their 
children have much lower odds of becoming smokers,6–10 and their children may no longer 
be exposed to high levels of tobacco smoke, decreasing the odds of contracting diseases 
caused by tobacco smoke exposure (TSE) and resulting in fewer missed school days.11 
Helping parents quit smoking also improves the financial resources of families,12 decreases 
the risk of developmental delays,13,14 and lowers risk of house fires.15 Parents who smoke 
are often medically underserved, visiting their child’s clinician more often than they see 
their own, if they even have one.16 In addition, dual use of electronic and traditional 
cigarettes has been increasing, putting children at increased risk of unhealthy aerosol 
exposures.17,18 Despite this extraordinary opportunity for intervention, child healthcare 
settings deliver effective tobacco dependence treatment to parents < 2% of the time.1 
Routinely delivered tobacco treatment to parents in child healthcare settings would benefit 
the overall health of the nation, especially vulnerable populations who suffer the majority of 
the 480,000 annual US preventable deaths.14  
 
The effectiveness of smoking cessation strategies is well established, but these methods 
are underutilized. The September 2015 “A” recommendation from the US Preventive 
Services Task Force indicates high certainty of benefit resulting from clinicians asking all 
adults about smoking, prescribing FDA approved cessation medications for those who 
smoke, and offering appropriate behavioral interventions.19 Background quit rates for the US 
population are up to 5% per year.20 Cessation strategies, offered in combination, greatly 
improve the likelihood of success. Physician counseling alone yields a quit rate of 19.9% 
[13.7-26.2], the Quitline alone a cessation rate of 12.7% [11.3-14.2], and using combination 
nicotine replacement therapy (NRT) patch and ad lib NRT gum medications a cessation rate 
of 36.5% [26.6-45.3].21 Moreover, the combination of these therapies, as will be used in the 
proposed intervention, is more effective than individual components alone.21 In addition, a 
meta-analysis recently demonstrated the effectiveness of parental smoking cessation 
initiated in the pediatric context.22 Yet household-centered, systematic tobacco control 
interventions to support parents in quitting are not being used in most child healthcare 
settings.  
 
The Clinical Effort Against Secondhand Smoke (CEASE) intervention effectively 
increases delivery of tobacco cessation interventions for parents, but innovations to 
sustain the intervention are needed. The CEASE intervention has been successfully 
developed and implemented to train child healthcare clinicians to address household 
smoking behavior, and promote smoke-free and e-cigarette free home and car rules in a 

 
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routine and effective manner.18,23–26 Child healthcare offices are trained to change their 
office system to address parental tobacco use, connect smokers to free resources, and 
prescribe medications for cessation.1,27,28 The training is conducted through online American 
Academy of Pediatrics (AAP) continuing education modules, in-person training, phone 
calls, videos, and reference materials, based on the practice needs.25,29,30 Our most recent 
trial R01CA127127 used a tablet screener to replace the previously used paper screening 
system and created a registry of smokers, yielding dramatic increases in NRT and Quitline 
enrollment rates for parents compared to control practices (NRT 38% vs. <1%; Quitline 
32% vs. <1% P<.01 for each).27,31 Despite such strong and effective results, sustainability 
and impact on parental quit rates have been limited due to the lack of fidelity, systems-level 
integration, and methods to facilitate connection to external resources. To address the 
weaknesses of the previous strategy and to best provide care to parents, the proposed project 
sustainably integrates these changes into child healthcare by developing a disseminable, 
innovative electronic health record (iEHR)-based approach that supports optimal workflows. 
 
 
Name and Description of Investigational Product or Intervention 
The iEHR + Navigator intervention consists of an innovative electronic platform for 
smoking screening and automated smoking cessation support to parents who smoke. iEHR 
will include automated EHR-generated NRT prescription, automated enrollment in the free 
Quitline, and a brief motivational message delivered by the clinician (as prompted by the 
EHR) when a parental smoker is identified. The enrolled parents will also be offered support 
from CHNs, who will work with offices to provide customized cessation support to 
household tobacco users, ensuring access to medications and services. 
 
 
Relevant Literature and Data 
Evidence for CEASE: Using a paper-based system, the MGH team’s previous parental 
tobacco control trial (R01-CA127127) demonstrated that effective parental tobacco control 
intervention (CEASE) can be implemented in child healthcare practices by using existing 
systems of care (see A3).1 We subsequently tested the potential benefit of electronic 
screening with CEASE using an electronic tablet (adaptable to other formats (e.g., kiosk, 
smartphone)) to identify parental smokers and delivery of treatment by the child healthcare 
clinician (see Figure 1). The intervention was effectively implemented in five child 
healthcare practices in five states (OH, IN, TN, VA, NC; N=1002 parents) and compared to 
five control practices in the same states (N=936 parents). 70% of parents in intervention 
practices reported being screened for tobacco use vs. 22% in the control practices. Practices’ 
delivery of parental tobacco control assistance (prescription of medication, 34% vs. 0%, 
referral to the state Quitline, 25% vs. 0%) was markedly higher in intervention practices 
post-implementation (P<.0001).31 At two years post-implementation, 1007 parents in 
intervention practices and 943 in control completed the exit interview. Practices’ delivery of 
parental tobacco control assistance (prescription of medication, 10% vs. 0%, referral to the 

 
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state Quitline, 7% vs. 0%) was still markedly higher in the intervention (P<.0001) but had 
dropped from immediate post-implementation levels.32 Overall, the team demonstrated a 
3.7% net reduction in population smoking rate relative to control practices after two years.32 
Despite such strong results, intervention practices did not fully adopt and sustain tobacco 
control service delivery. Critical strengths of the proposed trial address these weaknesses 
with automated household tobacco use screening that integrates into the EHR, delivers 
tobacco dependence treatments through the iEHR intervention, and tests the provision of 
additional support from a CHN. 
 
EHR-based tobacco cessation tools are feasible, acceptable, usable, and impact clinical 
care. In a prospective study of pediatric clinicians and parents at one practice, the CHOP 
team developed and evaluated the feasibility, acceptability, usability, and clinical impact of 
a tool within the EHR to help pediatric primary care clinicians provide smoking cessation 
treatment to parents who smoke.33 Clinicians received training in use of the EHR tool. The 
tool prompted clinicians to ask about tobacco smoke exposure (TSE) at all visits, to print a 
prescription for NRT gum and patch, and to refer to a free, external cessation program. 
Pediatric clinicians used the screening tool at 2286 (76%) of 3023 visits. Parent smokers 
were identified at 308 visits; 55% of smokers were interested in and offered treatment. 24 
(80%) of 30 eligible pediatric clinicians used the tool. Indicating that clinicians uniformly 
found the tool helpful, 94% were satisfied with the tool, and the average System Usability 
Scale score34 was 83/100 (good to excellent range). Of a sample of 100 parents who 
received treatment, 69 parents were reached and surveyed, with 44 (64%) receiving NRT 
prescription. In a randomized controlled trial involving 484 parent smokers at the same 
urban site, the CHOP team subsequently demonstrated that an electronic referral to the 
Quitline, enabled through the EHR, resulted in a significant 8.3 percentage point greater 
enrollment in the Quitline compared to a paper-based referral, a 5-fold increase.35 The 
current R01 incorporates the successful electronic screening and referral strategy above in 
the iEHR to support automated cessation workflows.  
 
Navigators arranged through child healthcare offices are well-received and improve 
outcomes. Drs. Bryant-Stephens, Collins, and Winickoff completed a care coordination 
study at CHOP. Community health workers served as tobacco control navigators. Parents 
were randomized either to receive personalized phone counseling from a navigator to 
promote cessation and SHS protections or to an attention control intervention.36 The 
navigator conducted phone counseling over two weeks and reinforced clinic-level 
messaging. The navigator also provided support, education, and cognitive-behavioral skills 
training to promote TSE reduction and parent cessation. In the overall sample (N=327), 
there was a marked difference in the homes with smoking restrictions from baseline to 3-
month end-of-treatment (96% Intervention vs 81% Control; P<.001). Significantly more 
participants in the navigator condition reported 7-day quit rate (28% Intervention vs. 8% 

 
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Control; p<.001). The proposed study will adapt this feasible, acceptable, and efficacious 
model to deliver CHN assistance for tobacco dependence, helping to ensure smoking parents 
and household members get what they need to quit.37 The study will test the effectiveness of 
CHN support added to the iEHR intervention. 
 
 
Compliance Statement 
This study will be conducted in full accordance all applicable The Children’s Hospital of 
Philadelphia Research Policies and Procedures and all applicable federal and state laws and 
regulations including 45 CFR 46 and the Good Clinical Practice: Consolidated Guideline 
approved by the International Conference on Harmonisation (ICH). All episodes of 
noncompliance will be documented. 
The investigators will perform the study in accordance with this protocol, will obtain 
consent and assent, and will report unanticipated problems involving risks to subjects or 
others in accordance with The Children’s Hospital of Philadelphia IRB Policies and 
Procedures and all federal requirements. Collection, recording, and reporting of data will 
ensure the privacy, health, and welfare of research subjects during and after the study.  
2 
STUDY OBJECTIVES 
To compare the effectiveness of the iEHR + Navigator versus usual care control, we propose 
a 2-arm RCT with a stratified cluster randomization of child primary care practices with 4 
practices each randomized to iEHR + Navigator or usual care control arms.  
 
 
Primary Objective 
Parental combusted tobacco quit rate at 1 year, as assessed by validated surveys, 
biochemically-confirmed at 12-months compared between iEHR + Navigator vs. usual care 
control. 
Hypothesis. Parental 7-day combusted tobacco quit rates, as assessed by validated surveys, 
biochemically-confirmed at 12-months, will be greater for iEHR + Navigator vs. usual care 
control (outcome for which study is powered).  
 
 
Secondary Objectives.  
The secondary objectives are to: 
1. To compare parents’ self-reported adoption of tobacco free behaviors (quit attempts, 
use of pharmacotherapy, use of Quitlines and institution of smoking and vaping bans 
in their homes and cars) between the iEHR + Navigator & usual care arms 
2. To establish the incremental cost per quit of the iEHR + Navigator vs. usual care 
arms  
3. To assess the implementation and sustainability of the intervention in the iEHR + 
Navigator arm (NRT prescription and Quitline referrals as assessed by the parental 
report around 12-months, the screening survey conducted at check-in, and EHR 

 
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documentation of screening and services delivery fidelity, before and immediately 
following implementation, 6, 12, 18, 24, 30, and 36 months).

 
  
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19 
3 
INVESTIGATIONAL PLAN 
 
General Schema of Study Design 
This is a stratified cluster randomized controlled trial of minimum 8 child primary care 
practices with minimum 4 practices each randomized to iEHR + Navigator or usual care 
control arms:  
 
3.1.1 Practice Selection and Randomization 
CHOP primary care practice sites will be approached by PeRC network leadership via 
recruitment email letter or in person discussions/presentations (Appendix 1) 
All practices are eligible to participate. We will preferentially enroll practices with the 
following criteria:  
1. A minimum 10% Medicaid insurance rates for children 
2. An average patient flow of 40 families per day 
3. A willingness to have a Research Assistant in the office setting  
 
Eligible practices will be randomized to: (1) ‘iEHR +Navigator’ and (2) ‘usual care control’ 
arms (4 practices in each arm). Practices will be matched based on practice size (number of 
children seen in a typical year (this will account for COVID-19)) and Medicaid rate at the 
practice. In the event that a practice drops out, we will replace it with the most similar 
practice based on practice size and Medicaid rate from the pool of unassigned and interested 
practices. In the event the enrollment is slower than projected, we will add additional 
practices in each arm to maximize the likelihood of meeting the recruitment goal of at least 
400 parents enrolled in each arm. 
 
Please see the detailed description under section 3.2 Practice Selection, Randomization and 
Blinding. 
 
3.1.2 Parent Screening & Enrollment 
Control and intervention practices will be trained in integrating Research Assistants (RAs) 
who will be hired, trained, and paid by the research study for data collection. A notice may 
be posted at the practice entrance/registration window/waiting room of participating 
practices, informing parents accompanying their children to office visits that the practice is 
participating in the research study (posting details may be modified based on practice layout 
and preferences). We will deploy several in-person (at CHOP pediatric primary care) and 
remote (via e-mail, phone and/or text) strategies for screening and enrolling smoking parents 
to maximize recruitment efforts. 
 

 
  
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20 
The study team will review patient medical records and those parents who identified 
themselves as smokers, will be approached by RAs and offered enrollment in the 
longitudinal cohort. We will continue to enroll parents until approximately 100 parents have 
been enrolled in the longitudinal cohort in that practice. Parent screening and enrollment 
procedures may be modified to kiosk/telephone/remote screening and enrollment due to 
procedures that may be in place at CHOP to protect people from COVID-19 risks.  
 
The detailed description of the screening and enrollment procedures is under section 4.1 
Screening & Enrollment. 
 
3.1.3 Intervention 
The intervention consists of an innovative EHR platform, iEHR, which will be used to 
screen families for tobacco use and refer smoking parents to smoking cessation resources 
and treatment. Components of the iEHR will include automated EHR-generated NRT 
prescription, automated enrollment in the free Quitline and/or SmokefreeTXT program, and 
a brief motivational message delivered by the clinician (as prompted by the EHR). As an 
added service, it may also include a referral to the company called BrightMedical that will 
facilitate the delivery of the NRT medication to interested families. Community Health 
Navigator support will be offered to all smokers enrolled in the intervention arm. CHNs will 
provide customized smoking cessation support to household tobacco users through phone 
follow-up and/or home visits, depending on the needs of each family and as study resources 
allow. 
See a detailed description of the iEHR + Navigator intervention and its components under 
section 4.2.1. 
 
3.1.4 Follow-Up   
Enrolled parents will be followed-up with a survey after approximately 12-months. Those 
parents who do not return at annual check-up will be contacted remotely (e.g., phone, text, 
HIPPA-compliant video system, email, portal (myCHOP) messaging). Parents who self-
report 7-day abstinence at the 12-month surveys (in-person or by phone/text) will be asked 
to submit their saliva for cotinine testing. In addition to the cotinine test, for parents who 
report current use of NRT or e-cigarettes or have a cotinine level of ≥10ng/ml, the readings 
from the carbon monoxide levels test will also be used to confirm self-reported smoking 
cessation. 
 
See a detailed description of the follow-up procedures under section 4.3 Follow-Up. 
 

 
  
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21 
 
Practice Selection, Randomization and Blinding 
At least eight CHOP practice sites will be approached and selected by PeRC network 
leadership.  
All practices are eligible to participate. We will preferentially enroll practices with the 
following criteria:  
1. A minimum 10% Medicaid insurance rates for children 
2. An average patient flow of 40 families per day 
3. A willingness to have a Research Assistant in the office setting  
 
Eligible practices will be randomized to: (1) ‘iEHR + Navigator’ and (2) ‘usual care control’ 
arms (4 practices in each arm). Practices will be matched based on practice size (based on 
the number of children seen in a typical year (this will account for COVID-19)) and the 
Medicaid rate at the practice. 
 
In this 2-arm cluster randomization of practices to ‘iEHR +Navigator’ and ‘usual care 
control’ arms (4 each), we will recruit four matched pairs of practices through the CHOP 
network.  Practices will be matched with respect to size and Medicaid rate. Within each of 
these pairs of practices, we will assign one to the intervention and the other to control, using 
computer generated random allocation. When the four assignments are complete, a fifth 
computer-generated random number will assign either "A" or "B" to the intervention. The 
statisticians will be blinded as to which of "A" and "B" is the intervention until the analyses 
are completed.  In the event that a practice drops out, we will replace it with the most similar 
practice based on practice size and Medicaid rate from the pool of unassigned and interested 
practices. In the event the enrollment is slower than projected, we will add additional 
practices from the CHOP network, with practices matched in pairs based on practice size 
and Medicaid rate, from the pool of unassigned and interested practices. We will randomly 
allocate these practices in pairs to the control and intervention arms, as needed and in 
decreasing order of projected enrollment rate. 
 
A practice leader will be identified in each practice. This person will be the study team’s 
contact person at the practice. 
 
At the end of data collection, all control practices will be offered the iEHR intervention. 
 
 
Study Duration, Enrollment and Number of Sites 
 
3.3.1 Duration of Study Participation 
Each parent participation will last 12 months. 
 

 
  
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Each clinician and staff participation in the intervention practices will last 36 months. 
Clinician and staff participation and study activities are described in detail under section 
4.3.3 Practice Clinicians and Staff Qualitative Interviews. 
 
Practice data will be collected for approximately 36 months post implementation. 
The sections below will focus on the parents’ participants. 
 
3.3.2 Total Number of Study Sites/Total Number of Subjects Projected 
The study will be conducted at a minimum of 8 primary care sites at CHOP with 
approximately 40 clinicians participating across these 8 sites, and proportionally more 
clinicians if other sites are added. 
 
Our goal is to stop recruitment when 400 parent subjects are enrolled per arm in the 
longitudinal cohort (800 across both arms).  The study has been designed to achieve this 
goal by recruiting 100 parents from each of four sites per arm, and for this situation we will 
have 80% power for the primary outcome (iEHR + Navigator vs. usual care control), for a 
clinically meaningful difference in smoking cessation rates. If some practices accrue 
subjects at a rate which makes it unlikely that these practices can achieve the recruitment 
goal of 100 subjects, then we will estimate the likely shortfall, and increase the recruitment 
goals in faster-accruing practices in order to attempt to preserve statistical power. We may 
also add additional practices to maximize the likelihood of meeting the recruitment goal of 
at least 400 parents enrolled in each arm. If we add practices, we will do so in pairs, matched 
by practice size and Medicaid rate, and randomly assigned to the control and intervention 
groups. If the study must be terminated before the recruitment goal, this termination will be 
made exclusively for reasons (such as time and budget) which are unrelated to study 
outcomes. 
 
In the intervention practices, a minimum of one clinician and one key staff will complete an 
in-depth qualitative interviews 6-weeks following implementation and after 12, and 24 
months. 
 
 
Study Population 
3.4.1 Inclusion Criteria 
We will enroll parents or legal guardians who smoke, are present at the visit, and whose 
child is seen by a clinician in the study practice. “Smoker” will be defined as answering 
“yes” to either of the screening questions: “Have you smoked a cigarette, even a puff, in the 
past 7 days?” and “Have you smoked any other tobacco product (cigars like black and 
mild, hookah), even a puff, in the past 7 days?” on the iEHR pre-visit screening 

 
  
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questionnaire (Appendix 5 for intervention practices and Appendix 5A for control 
practices). The eligibility criteria will be confirmed using Eligibility Form (Appendix 10) 
prior to consent and enrollment. Parents will also be screened for JUUL/E-cig use. Each 
eligible parent who indicates cigarette and/or other tobacco product use in the past 7 days 
will be allowed to enroll in the study, regardless of whether or not the parent uses any type 
of e-cigarette or vaping device.  
 
3.4.2 Exclusion Criteria 
1)  Parent/legal guardian does not speak English; 2) No telephone; and 3) Prior 
enrollment in the study during a previous visit.  
Subjects that do not meet all of the enrollment criteria may not be enrolled.  
Over the course of the study, parents who screened positive for smoking on the iEHR pre-
visit screening questionnaire, are prompted to complete it every 3 months if they have a 
visit. Additionally, parents with multiple children, are prompted to complete the iEHR pre-
visit screening questionnaire for each child. As a result, parents may show up as eligible for 
the study in the EHR multiple times despite being already enrolled in the study. We have 
implemented several safeguard mechanisms to avoid duplicate enrollments of such parents 
(checking the reports of already enrolled parents, asking parents whether they have already 
been enrolled in the study). Nevertheless, it is difficult to completely avoid duplicate 
enrollments, especially when a parent chooses not to disclose that they are already taking 
part in the study. The study team will monitor the REDCap projects regularly to identify any 
incidents of duplicate enrollment. If a duplicate enrollment is identified, the study team will 
notify the parent that they can be enrolled in the study only once and their information will 
be kept only under the original enrollment. The study team and the investigator will keep 
track of the duplicate enrollments to ensure validity of the data, and only use the data from 
the initial enrollment. This study is minimal risk, and the second enrollment does not 
disqualify a parent from being kept in the study under the original enrollment.  
 
Any other violations of these exclusion criteria must be reported in accordance with IRB 
Policies and Procedures.  
4 
STUDY PROCEDURES 
 
Screening & Enrollment 
The protocol for the recruitment, consent, and retention of participants will be identical in all 
practices. As part of the clinical workflow, all parents in control and intervention practices 
will be asked about their individual smoking status on the iEHR pre-visit screening 
questionnaire (Appendix 5 for intervention practices and Appendix 5A for control 
practices). We will deploy several strategies to maximize screening and enrollment efforts. 
 

 
  
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The study team/CHOP Clinical Reporting Unit (CRU) and/or Research Enhancement Core 
(REC) will generate rosters of potentially eligible parents for the upcoming visit. Rosters 
will include all upcoming visits at study practices of parents who answered, “yes” to either 
of the screening questions: “Have you smoked a cigarette, even a puff, in the past 7 days?” 
and “Have you smoked any other tobacco product (cigars like black and mild, hookah), 
even a puff, in the past 7 days?” on the iEHR pre-visit screening questionnaire. The study 
team will offer enrollment into the study to these potentially eligible parents in-person at the 
primary care site, via the phone or e-mail. 
 
Additionally, at participating CHOP primary care sites, study team will also review the 
medical records to identify parents who self-reported as smokers (answered “yes” to either 
of the screening questions: “Have you smoked a cigarette, even a puff, in the past 7 days?” 
and “Have you smoked any other tobacco product (cigars like black and mild, hookah), 
even a puff, in the past 7 days?” on the iEHR pre-visit screening questionnaire. (Appendix 5 
for intervention practices and Appendix 5A for control practices) to approach them and offer 
enrollment in the study longitudinal cohort. If a parent is not interested in participating in the 
study, the research team will document this information in REDCap (child’s name, MRN, 
parent’s relationship to the child, practice name and date of the visit). 
 
Potentially eligible families who are missed in the CHOP primary care sites will also be 
reached via recruitment emails, text messages and calls facilitated by the study team and/or 
CHOP Research Enhancement Core (REC). All outreach methods (e-mail, texts, calls) will 
include information about how parents can opt out from being contacted about this study in 
the future. 
 
Smoking parents will by recruited in one of these ways: 
 
1. In-office enrollment: At participating CHOP primary care sites, study team will 
approach eligible parents i.e. those who self-reported as smokers (answered “yes” to 
either of the screening questions: “Have you smoked a cigarette, even a puff, in the 
past 7 days?” and “Have you smoked any other tobacco product (cigars like black 
and mild, hookah), even a puff, in the past 7 days?” on the iEHR pre-visit screening 
questionnaire (Appendix 5 for intervention practices and Appendix 5A for control 
practices) to approach them and offer enrollment in the study longitudinal cohort. 
Study team will confirm eligibility criteria using Eligibility Form (Appendix 10) 
prior to consent and enrollment. If a parent agrees, they will be consented using 
Informed Consent of Parent (Appendix 3b and 3bE (for intervention group) and 3 
and 3E (for control group)). After consent, parents in the intervention arm will also 
be offered the additional support of CHOP CHNs (Attachment 11) (see section 4. 
2.2. Community Health Navigators for more detail).  Parent Enrollment Survey 
(Appendix 4) will be then administered by the RA in both intervention and control 

 
  
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practices. The Parent Enrollment Survey (Appendix 4) includes additional questions 
assessing parental vaping status, stage of readiness to change, demographic 
information, tobacco related attitudes and behaviors and parents’ contact information 
(~ 15 minutes).  
 
In-office enrollment for parents that don’t complete the iEHR pre-visit 
screening questionnaire: At participating CHOP primary care practices, 
screening questionnaires are assigned to a patient record as opposed to each 
parent and that sometimes results only in one parent being screened for smoking 
as opposed to each parent. The study team will fill these gaps by offering 
enrollment into the study for every smoking parent or legal guardian present at 
the visit. 
 
2. Hybrid enrollment from in-office to remote: If during the office visit, the parent 
who was screened positive for smoking and eligible for the study (answered “yes” to 
either of the screening questions: “Have you smoked a cigarette, even a puff, in the 
past 7 days?” and “Have you smoked any other tobacco product (cigars like black 
and mild, hookah), even a puff, in the past 7 days?” on the iEHR pre-visit screening 
questionnaire (Appendix 5 for intervention practices and Appendix 5A for control 
practices) doesn’t have time to complete enrollment or prefers to complete 
enrollment at home, the study team will ask the parent if he/she is interested in 
remote enrollment and will ask to collect their contact information for remote 
enrollment.  
 
Hybrid enrollment if consented in office: If the eligible participant’s 
consent was completed during the visit but the participant doesn’t have time 
to complete the enrollment survey, we will follow up with them remotely to 
complete the survey or complete the survey during a future visit to the 
participating office. 
 
All contact information will be stored and shared in a secure HIPAA compliant way 
(i.e., using CHOP OneDrive). The study team will then attempt to follow up with the 
parent(s) and conduct enrollment remotely. 
 
3. Remote enrollment: We will also deploy additional recruitment approaches, 
including calling, emailing and texting eligible participants (those who answered 
“yes” to either of the screening questions: “Have you smoked a cigarette, even a 
puff, in the past 7 days?” and “Have you smoked any other tobacco product (cigars 
like black and mild, hookah), even a puff, in the past 7 days?)” on the iEHR pre-visit 
screening questionnaire at the study practices. The roster of eligible participants will 

 
  
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26 
be generated by the study team and/or CHOP REC. Parents that were already 
enrolled in the study will be excluded.  
 
For outreach calls, the study team will briefly explain the purpose of the call and 
introduce the study prior to consent. If the parent agrees to participate, the consent 
and survey will be sent to them electronically via text or e-mail. During the phone 
outreach, parents will not be texted or e-mailed the study materials without verbally 
agreeing to it during the call. All outreach emails and texts will contain the REDCap 
link inviting them to consider participation in the study. Parents who choose to 
participate will be screened for eligibility via the REDCap survey (Eligibility Form - 
Appendix 10) and they will provide informed consent/HIPAA authorization 
electronically (Appendix 3bE (for intervention group) and 3E (for control group). 
After they electronically sign the consent, parents in the intervention arm will also be 
offered the additional support of CHOP CHNs (Attachment 11) (see section 4. 2.2. 
Community Health Navigators for more detail).  Then parents in both intervention 
and control groups can complete the enrollment form (Appendix 4) either at home 
themselves or while having a research assistant on the call. If the parent picks up the 
call but it’s not a good a time for them to complete the enrollment, the RA may offer 
them an option to receive follow up with the RA via text to set up the best time for 
the enrollment call. The research presents minimal risk to participants and involves 
no procedures for which written consent is normally required outside of the research 
context.  
 
If the parent has a working e-mail address on record, we may also attempt to 
outreach to them via e-mail (e-mail template: Appendix 12 for intervention and 
Appendix 13 for control). E-mail letters may be customized for each practice based 
on the input from practice physicians and staff.  E-mail letters will include an option 
to opt-out from further communication and will notify the parents that if they do not 
enroll into the study or opt out, within 2 weeks we may follow up with them via 
phone call or text. Follow up texts (with up to 3 reminders if the parent doesn’t opt 
out) will include a brief information about RAs call back number to learn more about 
the study. Parents may opt out at any time.  
 
Using the workflows outlined above, we will continue to enroll parents until 
approximately 400 parents have been enrolled in each arm. If some practices accrue 
subjects at a rate which makes it unlikely that these practices can achieve the 
recruitment goal of 100 subjects, then we will estimate the likely shortfall, and 
increase the recruitment goals in faster-accruing practices in order to attempt to 
preserve statistical power. We may also add additional practices in one or both arms 
to meet the recruitment goal of 400 parents enrolled in each arm. A notice to parents 

 
  
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27 
may be posted where all can see it when entering/registering for their pediatric visit. 
The notice may announce that the practice is participating in a research study and 
that parents/guardians may be approached by a study RA during their office visit. 
Parent screening and enrollment procedures may be modified to 
kiosk/telephone/remote screening and enrollment due to procedures that may be in 
place at CHOP to protect people from COVID-19 risks. 
 
 
Intervention 
4.2.1 iEHR 
The iEHR intervention consists of an innovative electronic platform for smoking screening 
and automated smoking cessation support for parents who smoke. Elements of iEHR will be 
tailored to fit practices’ workflow, staffing, resources, and physical configuration. The 
intervention involves training all office staff to utilize the iEHR system to assist all parents 
who smoke to support sustainable workflows and reduce the clinician burden. Components 
of the iEHR will include: 
(1) Identification of smokers and self-assessment of quitting preferences: Screening for 
parent smoking in the intervention arm will be expanded upon using the iEHR pre-visit 
screening questionnaire (Appendix 5). The final wording and look of the questionnaire may 
be updated when the technical team will start integrating it in the EHR. Parents will 
complete the questionnaire prior to their visit with the clinician, either via MyCHOP prior to 
the office visit or on a tablet or their own device once they arrive to the office. All parents 
will receive this pre-visit screening questionnaire. We will determine the appropriate 
frequency of the screener, so that it’s not burdensome to the parents and does not disrupt 
practice workflow. This workflow, which is already occurring and accepted widely, 
enhances the role of front desk staff to ensure that clinical information is available in the 
chart prior to the visit with the clinician.   
(2) Counseling: Upon review of the pre-visit screener results, the iEHR will automatically 
document a parent’s intention to quit and services requested to help them quit and suggest 
motivational messages to increase parents’ acceptance of services. 
(3) Automatically generated prescription for NRT/NRT delivery: the iEHR will 
automatically generate a prescription for NRT for parents who smoke (unless they opt out of 
receiving the prescription), including for those cutting down to quit as recommended in 
latest guidelines.38 Prescriptions for two forms of NRT (patch and gum) will be printed. 
Based on information available in the EHR for the parent who completed the pre-visit 
screening questionnaire, all identifying fields for the prescription will be populated. 
Prescriptions will be either handed over to the parents or faxed/electronically transmitted to 
their pharmacy or NRT will be mailed/delivered to them. We may use the services of the 
company called, BrightMedical, to facilitate the delivery of the NRT medication to families. 
(4) Automated Quitline and SmokefreeTXT enrollment: 

 
  
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In the CEASE pre-visit screening questionnaire (Appendix 5), smoking parents will be 
offered automatic enrollment in the state’s free tobacco Quitline and the SmokefreeTXT 
program, a text message program offered by the National Cancer Institute. 
4.2.2 Community Health Navigators (CHNs) 
 
Parents in the intervention arm will also be offered the additional support of CHOP CHNs 
(Appendix 11). CHNs are employees of CHOP Community Asthma Prevention Program 
(CAAP) led by the co-PI of this study Dr. Tyra Bryant-Stephens. CHNs are listed on the 
CHOP study team and when additional CHOP CHNs are hired for this study, they will be 
added to the study team. CHNs will work with offices to provide customized smoking 
cessation support to household tobacco users through phone follow-up, ensuring access to 
medications and services, and/or home visits, depending on the needs of each family and as 
study resources allow (Table 2). Home visits could be virtual if there are in-person visit 
restrictions due to COVID-19. 
 
The CHN will contact the smoker within approximately one week following enrollment to 
set up the first telephone, video, or in-home session, if they are interested. At the first 
session, the navigator will discuss various types of services available and work with the 
smoker to determine their best cessation plan. The CHN will ask smokers to set aside up to 1 
hour for the session. The second session will be scheduled for approximately 2-4 weeks 
later, depending on need and availability. After the first session, the CHN will make phone 
calls or texts to review progress of cessation activities, offer support, and connection to 
resources. After the second session, these calls will occur as needed for 1 year. The CHN 
will document any contact made in a standard EHR patient outreach encounter that will be 
sent to the child’s clinician. Using the EHR, clinicians will also be able to message the 
CHN.  
Table 2. Community Health Navigator role 
CHN 
session 
Ask25 
(Assessment)  
Assist 
      (Counseling)                        (Care coordination)  
Refer 
(Resources) 
1 
Identify all household 
tobacco users  
• Readiness to quit 
• Smoke-free home & car 
rules 
• Previous quit attempts 
• NRT insurance coverage  
• Identify pharmacy 
Enhance intervention 
content: 
• Quit smoking tools & 
techniques for all 
tobacco users 
• Thirdhand smoke  
• Set quit date 
• Ensure connection 
to Quitline 
• Ensure NRT access 
at local pharmacy 
• Communicate with 
child’s clinician & if 
possible, parents’ 
clinician about 
household smoking 
status using iEHR 
Follow-up to ensure resource 
awareness & receipt of: 
• NRT scripts 
• Quitline 
• SmokefreeTXT 
2  
 
• Reassess motivation and 
progress 
• NRT script filled  
• Connected with Quitline/ 
local cessation resources 
• Assess smoke-free zones 
Reinforce intervention 
content and all of the 
above 
• All of the above 
• Develop strategies to 
overcome barriers to service 
receipt 
 

 
  
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29 
 
Depending on parent preference, a session could include a telephone or video call with the 
CHN or home visit, if requested. Home visits could be virtual if there are in-person visit 
restrictions due to COVID-19. 
 
 
Follow-up 
4.3.1 Parent Follow-up 
For smoking parents in the longitudinal cohort (See Figure 1), 12-month follow-up in-
person/remote survey (Appendix 6), and biochemical validation of self-reported 7-day 
abstinence will be obtained using proven protocols to collect the samples in-person at the 
practice or by using remote survey and mail-in cotinine swabs for parents not present at the 
practice. 
• Cotinine levels will be measured for all parents who reported quitting smoking 
• In addition to the cotinine test, parents who report current use of NRT or e-cigarettes 
or have cotinine levels ≥10 ng/ml will have the option to get carbon monoxide levels 
tested to confirm combusted tobacco abstinence. 
o For in-office follow ups (see below for more details), to prevent missing 
parents who might be eligible for carbon monoxide test, we may ask parents 
who report current use of NRT or e-cigarettes to get their carbon monoxide 
levels tested in-office without knowing their cotinine levels yet. We will use 
their carbon monoxide test readings only if their cotinine levels are ≥10 
ng/ml (we will get the cotinine results from the lab). 
 
The enrolled parent will be eligible for the 12-month follow-up, about three-weeks before 
their 12-month study enrollment date. We will deploy several strategies to maximize follow-
up efforts. 
 
We will generate rosters of enrolled parents due for their 12-month follow up, who have an 
upcoming visit scheduled during the follow-up window. These reports will be regularly 
updated to reflect newly scheduled appointments.  
 
Enrolled parents eligible for follow-up will complete the follow-up assessment in one of the 
following three ways: 
 
1. Follow-up via text/email/portal message(myCHOP): Parents who consented to 
texting on the baseline Parent Enrollment Survey (Appendix 4) may be texted a 
follow up survey link. Participants may receive several text reminders to remind the 
parent to complete the follow up survey. Parents may also be sent the follow up 
survey link by email or through portal messaging (myCHOP).  
 
If the parent completes the survey via text, email, or myCHOP,and is eligible for the 
cotinine swabs and CO test, the last page of the survey will notify them that they 

 
  
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should expect to receive a pre-paid mail envelope with the swab collection kit and a 
CO test monitor and that we may follow up via phone calls/text/email/myCHOP with 
additional instructions. If the parent has not mailed their salivary cotinine swab kit or 
not uploaded their CO readings (if eligible), then, we may approach them at the 
practice in-person at any upcoming appointment to complete the pending 
assessments. 
 
If the parent hasn’t completed the follow-up survey in-person or remotely and the 
12-month follow-up date has passed and there is no scheduled appointment in the 
next couple of months, we may continue to try to follow-up with the participant 
remotely. 
 
2. In-office follow-up: At the participating CHOP primary care sites, study team may 
approach eligible enrolled parents whose visit falls during the follow up period 
window. To maximize opportunities for follow up, if the parent has a scheduled visit 
at any CHOP locations (e.g., CHOP specialty care), the study team may also 
approach parents that haven’t completed follow up procedures at that CHOP 
location. The study team will first ask for parent’s permission to conduct follow up at 
that CHOP location. Only if the parent feels comfortable, the study team will 
proceed with follow up.  
 
The study team will complete the follow-up survey and if the parent is eligible will 
offer the cotinine swabs and carbon monoxide breath tests for in-person completion. 
If not mailed to the lab immediately, the cotinine tests may be stored in a secure 
location at the corresponding primary care site or at the study team’s CHOP office 
(Roberts) until they are mailed to the lab by the study team. 
 
3. Phone follow-up: The study team may call parents to complete their follow-up 
survey remotely. During the call, the study team member will briefly remind 
participants of their enrollment, and the purpose of the call before completing the 
follow-up survey. If the study team is not able to get in touch with the subject via 
phone, they may send them one or more postcards to remind them of their study 
participation and encourage them to call/text back to complete the follow-up survey 
and get their incentive. The study team may also look for updated contact 
information of the parent in the child’s medical record.  
 
If the parent completes the survey remotely via phone and is eligible for the cotinine 
swabs and CO test, the last page of the survey and the study team member will notify 
them that they should expect to receive a pre-paid mail envelope with the swab 
collection kit and, if eligible, a CO test monitor. They will also be told that they may 
receive a follow up phone calls/text/email/portal message with additional instructions 
after the kits have been mailed. If the parent has not mailed their salivary cotinine 
swab kit or not uploaded their CO readings (if eligible), then, we may approach them 
at CHOP in-person at any upcoming appointment to complete the pending 
assessments. 
 

 
  
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31 
 
4.3.2 Ongoing EHR Documentation & Evaluation 
The EHR documentation of screening and services delivery fidelity, will be ongoing 
throughout the study before and immediately following implementation, 6, 12, 18, 24, 30, 
and 36 months. This data is not available from the longitudinal cohort as it requires an 
assessment of care provided at the practice-level. Specifically, we want to know what 
services are being delivered at the follow-up time period in the practice overall (as opposed 
to the limited subset of the practice that it is in the longitudinal cohort).  
 
4.3.3 Practice Clinicians and Staff Qualitative Interviews 
In-depth qualitative interviews will be conducted with clinicians and key staff from 
the intervention practices 6-weeks following implementation and at 12, and 24 
months. Clinicians and clinical staff may be recruited for qualitative interviews via e-
mail, referral from a colleague, flyer or through a personal solicitation. Prior to the 
interviews, participants will be offered an information sheet (Appendix 2). The 
interview guide (Appendix 7) will be based on questions from RE-AIM tools and the 
CFIR (Consolidated Framework for Implementation Research) interview guide. The 
interview will be conducted to collect data on the factors that influence intervention 
implementation. We will also use data from the interviews to improve 
implementation and sustainability through tailoring the intervention. 
 
The interview process will follow a standard procedure, which is outlined as follows: 
Intervention Practice Respondents: 
• As a condition of participation in the study, clinicians and staff who will complete 
the qualitative interviews will complete consent forms (Appendix 8).  
• Interviews will be scheduled with selected clinicians and staff at intervention 
practices. These selected clinicians and staff we expect to include the practice 
champion and the administrative staff member most involved in the implementation 
of the intervention; other interviews may be scheduled, if the practice has capacity 
for additional interviews. 
 
The interviews will be conducted in person, by phone, or HIPPA-compliant video 
conferencing. The qualitative researcher conducting interviews will begin each 
interview by asking permission to record, outlining the purpose of the interview, 
describing the rights of respondents to stop the interview or recording at any time, 
and giving a brief explanation of how interview data will be used. Interviews will 
only be recorded with permission. 
Recordings will be uploaded to the transcription service provider (ADA 
Transcriptions). ADA Transcriptions is a HIPAA-compliant, full-service 
transcription company specializing in medical and academic research. Additionally, 

 
  
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CHOP has a Master Business Associate agreement with the ADA Transcription. The 
audio-recordings will be uploaded and temporarily stored on ADA Transcriptions 
online platform that is encrypted and HIPAA compliant. ADA Transcriptions will 
de-identify and complete the transcriptions and provide each audio-recording and 
transcription a filename and password-protect it. The password protected 
transcriptions will then be securely transferred to the designated research team listed 
on the online platform system. Only designated CHOP and MGH study team staff 
will be given access to transcriptions. The interview data will be used anonymously 
in conference presentations, articles, and reports. As part of the rapid-response 
quality improvement, data will also be used to improve the intervention and address 
factors that influence implementation of the intervention.  
 
 
Subject Completion/Withdrawal 
Parents 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. If the Investigator 
becomes aware of any serious, related adverse events after the subject completes or 
withdraws from the study, they will be recorded in the source documents and will be 
reported as an adverse event to the IRB. 
 
Clinicians and clinical staff can withdraw their participation from the interviews at any time 
without specific reason.  
 
4.4.1 Early Termination Study Visit  
For the intention to treat analysis, any parent who withdraws or drops out of the study will 
be considered as a smoker. 
5 
STUDY EVALUATIONS AND MEASUREMENTS 
 
Screening and Monitoring Evaluations and Measurements 
5.1.1 Medical Record Review 
The following variables will be abstracted from the EHR to measure the sustainability of the 
intervention. The relevant domains the items address are listed parenthetically: 
• Parental smoking status (Ask) 
• Child’s tobacco smoke exposure at home (Ask) 
• NRT prescription given/referred to BrightMedical (Advise and Refer) 
• Referred to the Quitline (Refer) 
• Referred to the SmokefreeTXT program (Refer) 
• Other smoking or vaping related information collected in the EHR 
• Parent and child health and demographic characteristics (e.g., child’s 
insurance status, child’s race/ethnicity, child’s age, as well as all diagnosis, 
treatment, updated contact information and health care services utilization) 

 
  
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5.1.2 Laboratory Evaluations 
• Salivary cotinine swab will be taken from parents who report quitting smoking at the 
12-month follow-up time period. The participant’s Study ID number will be used to 
identify saliva samples sent to the laboratory for the cotinine analysis. No identifying 
information will be given to the testing laboratory.   
 
• Parents who reported using NRT or e-cigarettes or have cotinine levels ≥10 ng/ml 
will have the option to get carbon monoxide levels tested to confirm combusted 
tobacco abstinence, to confirm self-reported smoking cessation. We will ensure that 
we utilize the leading infection control technologies and practices for any sample 
collection. 
o For in-office follow ups, to prevent missing parents who might be eligible for 
carbon monoxide test, we may ask parents who report current use of NRT or 
e-cigarettes to get their carbon monoxide levels tested in-office without 
knowing their cotinine levels yet. We will use their carbon monoxide test 
readings only if their cotinine levels are ≥10 ng/ml (we will get the cotinine 
results from the lab). 
 
 
5.1.2.1 Laboratory Evaluations 
1. Cotinine 
To confirm cessation at 12 months, parents will complete a salivary cotinine specimen either 
collected in the clinic with a study team member or collected remotely. In the latter case, 
collection will be performed in front of study team member via a live-video conference, 
whenever possible. 
 
• Subjects will use a salivary swab measurement that they are able to perform on their 
own that needs to be mailed to the study team/lab after sample collection. 
 
• 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, if 
possible. No videos will be recorded. The specimen will be mailed by the respondent 
in a pre-stamped envelope to the lab. 
 
We will use a feasible system for salivary cotinine collection that enables study participants 
to easily obtain their own saliva sample and does not require refrigeration. The obtained 
saliva samples will be sent to laboratory for cotinine testing. The RA will explain the 
procedures in detail before and after obtaining the cotinine swab. The sample will be 

 
  
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34 
obtained in a quiet, discreet manner in the most private location possible in the 
practice/CHOP setting. Samples will be subsequently sent to laboratories for analysis. The 
laboratory will send the results via email to the study staff. If requested by the parent, the 
results of the cotinine test will be shared with them. Parents who will consent and provide 
the sample will be given a $50 incentive. The sample will remain anonymous by identifying 
it with the parent’s study ID number.    
 
Parents who do not have a return annual visit or a follow-up visit during the follow-up 
time-period (or if there are in-person visit restrictions due to COVID-19), may be 
contacted remotely for the 12-month survey; parents reporting 7-day abstinence will 
receive a saliva collection kit with instructions by mail. When possible, saliva sample 
collection will be performed in front of study team member via a live-video conference 
call. No videos will be recorded. 
2. Carbon monoxide (CO) 
 
In this study, in addition to the cotinine test, parents reporting 7-day abstinence and who also 
report current use of NRT or e-cigarettes or have cotinine levels ≥10 ng/ml will have the 
option to get carbon monoxide levels tested to confirm combusted tobacco abstinence. The 
breath CO test is non-invasive and an easily administered test. RAs will obtain breath 
samples from all eligible parents who agree to be tested using breath CO monitors.  
 
For in-office follow ups, to prevent missing parents who might be eligible for carbon 
monoxide test, we may ask parents who report current use of NRT or e-cigarettes to get their 
carbon monoxide levels tested in-office without knowing their cotinine levels yet. We will 
use their carbon monoxide test readings only if their cotinine levels are ≥ /ml (we will get 
the cotinine results from the lab). 
 
CO breath levels will be measured using the CO breath analyzer according to the 
manufacturer's recommendations. Parents will be asked to hold their breath for 20 seconds 
and then exhale slowly and fully into the mouthpiece of the instrument during which CO 
breath was recorded. The CO breath levels are given in parts per million (ppm). The device 
will be calibrated according to the manufacturer's instructions prior to use. For CO 
confirmed quitting, expired-air CO cutoff level of < 5ppm will be considered quit.  
 
The single use mouthpieces are individually wrapped for ease of handling and greater 
infection Mouthpieces will be replaced after every use or an individual device will be used 
per parent. The wipes provided with the breath monitors have been tested by the supplier 
and found effective against (COVID-19/SARS-COV-2), as the product shows efficacy 
against feline coronavirus, a surrogate coronavirus (for COVID-19/SARS-COV-2).  
 

 
  
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Those parents who do not have a scheduled visit during the follow-up time-period, may be 
contacted remotely for the 12-month survey; parents reporting 7-day abstinence and on NRT 
or e-cigarettes, or who have a cotinine level of ≥10 ng/ml will be offered to get carbon 
monoxide levels tested to confirm cessation. They will receive a CO monitor in the mail 
with instructions. The results can be uploaded in real-time by the parent via a smartphone 
app and when possible, breath test will be performed in front of study team member via a 
live-video conference call. If a parent does not have a smartphone, they will be able to 
communicate the results back via a call or text to a study team or any other communication 
approach that is most convenient to them.  
 
For remote follow ups, to minimize the burden of data collection, we will aim to send the 
CO monitors to eligible parents after we get their cotinine results back. If this strategy 
impedes the collection of CO readings, we may consider sending the CO monitors and 
cotinine kits simultaneously but will still use the CO readings only of the cotinine level is 
≥10 ng/ml. 
 
Parents who will consent and provide the breath sample (in the clinic or remotely) will be 
given a $50 incentive. They will be compensated for CO test completion regardless of 
whether their CO reading will be used. 
 
5.1.2.2 Table: Clinical Laboratory Tests 
Category 
Tests 
Smoking Cessation Testing 
       1. Saliva Cotinine Test 
2. CO Breath Test 
 
 
 Efficacy Evaluations 
Below is the complete list of all outcomes that will be collected and evaluated throughout 
the study. 
Table 3: Main Outcomes Measurement 
Outcomes 
Operational Definition and 
Assessment Method 
Sources for 
Construct 
Timing 
Parents’ combusted tobacco 
quit rates, and tobacco free 
behaviors 
Assessed by exit or telephone survey 
of parents [longitudinal cohort] 
 
 
7-day abstinence (Primary 
Outcome for Aim #1) 
% of parental smokers who have 7-day 
abstinence (biochemically verified at 
12-months) 
BRFSS42; NHIS43 
12-months post 
initial visit 
Quit attempts 
% of parental smokers who report at 
least one 24-hour quit attempt since 
pediatric visit 
BRFSS42; NHIS43  
12-months post 
initial visit 
Use and Duration of 
pharmacotherapy 
% of parental smokers who report use of 
gum or patch since pediatric visit and 
duration of use 
Winickoff et al.44  
12-months post 
initial visit 

 
  
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36 
Institution of smoking bans 
% of parental smokers who report strict 
smoke-free and e-cigarette free home 
and car rules 
Drehmer at al.18 
Winickoff et 
al.44,45Emmons et 
al46Bauman et 
al.47Ossip et 
al.23Nabi-Burza et 
al.48 
12-months post 
initial visit 
Establish the incremental 
cost per quit of the 
intervention compared to 
usual care control 
Assessed by observation and survey 
of personnel 
 
 
Health care system costs: 
time use of IT personnel, 
CHN, clinician, practice staff, 
and training personnel 
Total time devoted to intervention 
activities using the direct observation 
log (Appendix 9) multiplied by national 
average wage rate for each type of 
personnel 
Neumann et al.,49 
Bureau of Labor 
Statistics50 
Prior to initial 
visit, 12- and 24-
months post initial 
visit, direct 
observation log, 
navigator logs 
Societal costs (exploratory): 
Parent costs (parent time, 
parent out-of-pocket costs for 
medication), Quitline costs, 
medication costs 
Total parent time devoted to 
intervention/usual care activities 
multiplied by national average wage 
rate by age; published data for Quitline 
and medication costs51,52 
Neumann et al.49 
Bureau of Labor 
Statistics50 
Prior to initial 
visit, 12- and 24-
months post initial 
visit, navigator 
logs 
Assess delivery and 
sustainability of 
interventions  
Assessed by 12-month follow-up 
survey of parents, iPad screener, 
EHR data documentation and key 
informant interview 
 
Parental 12-month 
follow-up survey. 
 
Pre-visit screener 
data, EHR data 
documentation 
before and 
immediately 
following 
implementation, 6 
12, 18, 24, 30, and 
36 months post 
implementation 
Delivering cessation 
assistance 
% of parental smokers who received at 
least one of the following  
1. prescription of pharmacotherapy or 2. 
referral to Quitline or SmokefreeTXT 
HEDIS measures;53 
Winickoff et 
al.44,54,55  
Screening for parental 
smoking 
% of all parents seen in practice who are 
screened for smoking status using the 
screener data 
HEDIS measure53 
 
Advising parents to quit 
% of parental smokers advised to quit 
smoking 
HEDIS measure53  
Counseling parents about 
rules 
% of parental smokers counseled about 
strict smoke-free and  
e-cigarette free home and car rules 
Drehmer at al.18 
Winickoff et al.56  
Implementation and 
sustainability factors 
Clinician and key staff member 
assessment of practice change resulting 
from the intervention 
CFIR interview 
guide57  
ACIC,58–60 
PSAT,59,60 
IMPROVE61,62, RE-
AIM63 
6-weeks following 
implementation 
and at 12 and 24 
months 
 

 
  
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37 
5.2.1 Diagnostic Tests, Scales, Measures, etc. 
The list of tests and measures is provided above. 
 
 
Safety Evaluation 
This study presents no more than minimal risk to study participants, as the interventions aim 
to promote adult smoking cessation, which is universally recommended evidence-based 
practice. Though adverse events are not anticipated and will not be formally monitored 
(given the minimal risk nature of the study), should any events be reported to the study 
team, the information will be immediately shared with the CHOP IRB. We do not anticipate 
any physical risks to participants. Participants may experience minor phycological 
discomfort when answering certain questions (e.g., about their smoking habits). In such 
cases they may choose to not answer these questions. 
 
6 
STATISTICAL CONSIDERATIONS  
 
 
Primary Endpoint 
Parental combusted tobacco quit rate at 1 year, as assessed by validated surveys, 
biochemically-confirmed at 12-months compared between iEHR + Navigator vs. usual care 
control. 
• Measured by the percentage of parental smokers who have 7-day abstinence 
(biochemically verified at 12-months). 
 
 
Secondary Endpoints 
 
1. To compare parents’ self-reported adoption of tobacco free behaviors (quit 
attempts, use of pharmacotherapy, use of Quitlines and institution of smoking 
and vaping bans in their homes and cars) between the iEHR + Navigator and 
usual care arms 
2. To establish the incremental cost per quit of the iEHR + Navigator vs. usual care 
arms  
3. To assess the implementation and sustainability of the intervention in the iEHR + 
Navigator arm (NRT prescription and Quitline referrals as assessed by the 
parental report around 12-months, the screening survey conducted at check-in, 
and EHR documentation of screening and services delivery fidelity, before and 
immediately following implementation, 6, 12, 18, 24, 30, and 36 months). 
 
 
Statistical Methods 
 

 
  
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6.3.1 Baseline Data  
The iEHR pre-visit screening questionnaires (Appendix 5 for intervention practices and 
Appendix 5A for control practices) will collect parental baseline smoking status. 
The Parent Enrollment Survey (Appendix 4) will collect additional information about vaping 
status, stage of readiness to change, demographic information tobacco related attitudes and 
behaviors, parent’s name, and contact information (~ 15 minutes). All parents enrolled will 
receive a handout from the Research Assistant with food insecurity resources listed. 
 
The primary effectiveness endpoint will be to compare parents’ combusted tobacco quit 
rates between iEHR + Navigator vs. usual care control at 12-months follow-up time. Parents 
lost to follow-up will be considered as smokers. 
 
The secondary efficacy endpoint will be to compare parents’ adoption of tobacco free 
behaviors between the iEHR + Navigator vs. usual care control arms, to establish the 
incremental cost per quit of the intervention arm compared to usual care control and to 
assess the delivery and sustainability of the intervention. 
 
We will also explore outcomes for clinically meaningful subgroups of participants, such as 
dual users of combustible and e-cigarette tobacco products. 
 
6.3.2 Safety Analysis 
This research does not qualify for oversight by the Data Safety and Monitoring Board as 
defined by NIH guidelines.  It is not necessary to establish a board for this study since the 
interventions aim to promote adult smoking cessation, which is universally recommended 
evidence-based practice. Though adverse events are not anticipated and will not be formally 
monitored (given the minimal risk nature of the study), should any events be reported to the 
study team, the information will be immediately shared with the CHOP and MGH IRBs. 
 
 
Sample Size and Power 
Sample size calculations are based on having at least 8 practices with a minimum of 5 
clinicians per practice. Clinically important and conservative estimates of validated 12-
month quit rates based on prior studies are 13.8% in the iEHR + Navigator group and 7% in 
the usual care control group. These estimates are based on the worst-case scenario from 
prior studies where all enrolled parents lost to follow-up were assumed to be smokers at 12-
month follow-up. The effective sample size needed for the primary outcome accounts for 
clustering at the clinician and practice level (4 practices per arm x 5 clinicians per practice) 
with intra-class correlation of .014 calculated from our previous research. By enrolling 
approximately 100 parents in each practice (400 per arm), we will have 80% power for the 
primary outcome (iEHR + Navigator vs. usual care control). Effect sizes for outcomes other 

 
  
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39 
than cessation will likely be much greater; the study will have adequate power to detect 
these differences, shown in our prior studies. 
 
7 
STUDY INTERVENTION 
 
 
Description 
 
The iEHR part of the intervention arm consists of an innovative electronic platform for 
screening and automated support of the smoking cessation workflow to parents who smoke. 
iEHR will include automated EHR-generated NRT prescription/referral to BrightMedical, 
automated enrollment in the free Quitline and SmokefreeTXT program, and a brief 
motivational message delivered by the clinician (as prompted by the EHR). 
 
Additional support of CHNs will be offered to all parents in the intervention arm. These 
CHNs will work with offices to provide customized smoking cessation support to household 
tobacco users through phone follow-up, ensuring access to medications and services, and/or 
home visits, depending on the needs of each family and as study resources allow. See a 
detailed description of the intervention and its components under section 4.2.1. 
 
7.1.1 Treatment Compliance and Adherence 
N/A 
8 
SAFETY MANAGEMENT 
 
 
Clinical Adverse Events 
Clinical adverse events (AEs) will be monitored throughout the study. This is described in 
9.4.2. 
 
 
Adverse Event Reporting 
Since the study procedures are not greater than minimal risk, serious AEs (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 do not meet prompt reporting requirements will be tracked and 
documented internally by the study team but not submitted to the IRB (as continuing 
reviews are not required). This is described in 9.4.2. 
 
9 
STUDY ADMINISTRATION 
 
 
Treatment Assignment Methods 
 

 
  
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9.1.1 Randomization 
In this 2-arm cluster randomization of practices to ‘iEHR +Navigator’ and ‘usual care 
control’ arms, we will recruit at least four matched pairs of practices through the CHOP 
network. Practices will be matched with respect to size and Medicaid rate. Within each of 
these pairs of practices, we will assign one to the intervention and the other to control, using 
computer generated random allocation. When the four assignments are complete, a fifth 
computer-generated random number will assign either "A" or "B" to the intervention. The 
statisticians will be blinded as to which of "A" and "B" is the intervention until the analyses 
are completed.  In the event that a practice drops out, we will replace it with the most similar 
practice based on practice size and Medicaid rate from the pool of unassigned and interested 
practices. In the event the enrollment is slower than projected, we will add additional 
practices from the CHOP network, with practices matched in pairs based on practice size 
and Medicaid rate, from the pool of unassigned and interested practices.  We will randomly 
allocate these practices in pairs to the control and intervention arms, as needed and in 
decreasing order of projected enrollment rate. 
 
9.1.2 Blinding 
The practices in each pair (the four initial pairs, and any subsequent pairs added in the event 
of slow accrual) will be randomly assigned labels "A" and "B". The intervention will be 
blinded in a separate randomization with either the label "A" or the label "B", and the other 
label will be assigned to the control practice. The statisticians will be blinded as to which of 
"A" and "B" is the intervention until the analyses are completed. 
 
9.1.3 Unblinding 
After the analyses are completed, the arms will be unblinded. 
 
 
Data Collection and Management 
The plan will be consistent with CHOP Policy A-3-6: Acceptable Use of Technology 
Resources that defines the requirements for encryption and security of computer systems. 
Only investigators and trained staff will have access to study information, both raw data and 
machine-readable files. The final dataset that will be used for the analyses will be HIPPA-
limited (e.g., containing birth dates, dates of service, zip codes). Identifiable patient health 
information collected will also be managed in accordance with 42 CFR Parts 160 and 164 
(HIPAA) federal regulations pertaining to the privacy of patient-related health information. 
All investigators and research staff will be HIPAA and human subjects research certified 
through the completion of web-based human subjects protection training, such as the CITI 
course. Additionally, the computer systems at the MGH and CHOP containing confidential 
data will have a level and scope of security that equals or exceeds those established by the 
Office of Management and Budget (OMB) in OMB Circular No. A-130 - Security of 
Federal Automated Information Systems. 

 
  
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9.2.1 Baseline Survey and 12-months Follow-up Data 
At baseline, parents will be screened for enrollment eligibility through a review of patient 
medical records. Eligible parents will be offered enrollment in the study. If a parent agrees, 
they will be consented using Informed Consent of Parent (Appendix 3 (for intervention 
group) and 3A (for control group)) and they will complete the Parent Enrollment Survey 
(Appendix 4) by the RA. The Parent Enrollment Survey (Appendix 4) will collect parental 
vaping status, stage of readiness to change, demographic information, tobacco related 
attitudes and behaviors, their name, and contact information (~ 15 minutes). All the data will 
be collected via REDCap and shared between MGH and CHOP. The list of parents enrolled 
in the intervention arm will be shared with the CHN at CHOP. 
 
9.2.2 Data sharing with the Quitline 
For parent participants consented into the longitudinal cohort (Aims 1 & 2), the generated 
reports that contain parent names and contact information, used to facilitate the clinical 
referral process to the Quitline, will be stored on a secure HIPAA-compliant server managed 
by CHOP. We will use appropriate secure mechanisms with authentication for transferring 
these reports between the research team and the Quitline vendor. The 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 the reports. These reports will then be 
securely sent back to the research team. The reports will contain participants’ identifiable 
information (e.g., name, phone number), so that the study team can link them back with 
other study-related information. These reports will be password protected and will not be 
stored on portable media devices (e.g., flash drives). Access to these reports will be 
restricted to appropriately authorized members of the study team. These reports will be 
transferred between CHOP and MGH teams via a secure HIPAA-compliant file transfer. 
 
Baseline survey data will be collected via 
REDCap either at CHOP practices or remotely.
Data will be shared between MGH and CHOP 
If consent is obtained on paper, consent forms 
will remain at CHOP. If electronic consent is 
obtained, both CHOP and MGH teams can 
access this data from REDCap. 
For the intervention arm, parent names and 
identifying information will be sent to the CHOP 
navigators
Figure 2: Study Data Flows
12-months follow-up survey data will be collected 
via REDCap at CHOP practices or remotely. 
REDCap data will be available for access both by 
CHOP and MGH teams 
Final De-identified dataset will be created 
Baseline Data Flow
12-Month Follow-up Data Flow

 
  
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9.2.3 
Data Sharing with the SmokefreeTXT 
For parent participants consented into the longitudinal cohort (Aims 1 & 2), parent contact 
information and preference to enroll into the SmokefreeTXT program will be stored on a 
secure HIPAA-compliant server managed by CHOP. We will use appropriate secure 
mechanisms with authentication for transferring this information to the SmokefreeTXT 
vendor. The SmokefreeTXT program will provide information about parent smokers’ 
interaction with the program and securely transfer it back to the research team. These reports 
will contain participants’ identifiable information (e.g., name, phone number), so that the 
study team can link them back with other study-related information. These reports will be 
password protected and will not be stored on portable media devices (e.g., flash drives). 
Access to these reports will be restricted to appropriately authorized members of the study 
team. These reports will be transferred between CHOP and MGH teams via a secure 
HIPAA-compliant file transfer. 
 
9.2.4 
Data Sharing with the BrightMedical 
For parent participants consented into the longitudinal cohort (Aims 1 & 2), parent contact 
information and preference to get the NRT medication will be stored on a secure HIPAA-
compliant server managed by CHOP. We will use appropriate secure mechanisms with 
authentication for transferring this information to the BrightMedical, NRT delivery vendor. 
The BrightMedical program will provide information about parent smokers’ interaction with 
the program and securely transfer it back to the research team. These reports will contain 
participants’ identifiable information (e.g., name, phone number), so that the study team can 
link them back with other study-related information. These reports will be password 
protected and will not be stored on portable media devices (e.g., flash drives). Access to 
these reports will be restricted to appropriately authorized members of the study team. These 
reports will be transferred between CHOP and MGH teams via a secure HIPAA-compliant 
file transfer. 
 
 
9.2.5 Data transfer of the EHR extractions between CHOP and MGH 
 
9.2.5.1 Parent-level outcomes (Aims 1 & 2) 
For parent participants consented into the longitudinal cohort (Aims 1 & 2), the research 
team will securely extract electronic health record (EHR) data from CHOP. The data will be 
linked with other study-related information, including surveys, engagement with Quitline, 
SmokefreeTXT, BrightMedical, the navigators, NRT prescriptions, child’s tobacco exposure 
at home, parental smoking status, parent and child health and demographic characteristics 
(e.g., child’s age, race, diagnosis), and other smoking or vaping related information. The 
datasets will contain participants’ identifiable information (e.g., name, phone number). 
These datasets will be password protected and will not be stored on portable media devices 

 
  
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(e.g., flash drives). Access to these datasets will be restricted to appropriately authorized 
members of the study team. These datasets will be transferred between CHOP and MGH 
teams via a secure HIPAA-compliant file transfer. 
 
9.2.5.2 Practice-level outcomes (Aim 3) 
For practice level outcomes (Aim 3), we will generate a HIPAA-limited dataset (e.g., 
containing birth dates, dates of service, zip codes) looking at the clinic level assessment of 
intervention implementation and sustainability. As part of this assessment, we will extract 
information on engagement with Quitline, SmokefreeTXT and BrightMedical referrals, 
NRT prescriptions, child’s tobacco exposure at home, parental smoking status, parent and 
child health and demographic characteristics (e.g., child’s age, race, diagnosis), and other 
smoking or vaping related information. Provider and practice names will be coded, and 
separate crosswalks will be maintained only at CHOP. These HIPAA-limited reports will be 
transferred between CHOP and MGH teams via a secure HIPAA-compliant file transfer. 
 
9.2.6 Data Sharing with the ADA Transcription 
Clinicians and staff interviews will be transcribed. Recordings will be uploaded to the 
transcription service provider (ADA Transcriptions) by CHOP. ADA is a HIPAA-
compliant, full-service transcription company specializing in medical and academic 
research. The audio-recordings will be uploaded and temporarily stored on ADA 
Transcriptions online platform with encryption and HIPAA compliant server. ADA 
Transcriptions will de-identify and complete the transcriptions and provide each audio-
recording and transcription a filename and password-protect it. Only specific personnel from 
ADA transcriptions have access via trackable password-protected logins to the online 
platform system. ADA transcriptions will only temporarily store recordings and 
transcriptions. All data retained by ADA Transcriptions will be destroyed after final 
payment is received, and once transcripts are securely transferred to designated study team. 
This includes hard drives, back up hard drives, and any and all device copies that may exist. 
The password protected transcriptions will then be securely transferred to the designated 
research team listed on the online platform system. Only designated CHOP and MGH study 
team staff will be given access to transcriptions.  
 
9.2.7 Confidentiality 
Comprehensive measures will be implemented to maintain subject confidentiality as 
appropriate. Data will be collected using REDCap (Research Electronic Data Capture) as a data 
collection tool. REDCap is a web-based application developed by Vanderbilt University to 
capture data for clinical research and create databases and projects. It is Health Insurance 
Portability and Accountability Act (HIPAA)–compliant, highly secure, and intuitive to use.  
Data collected using the surveys via REDCap will be identifiable when it is received at 
MGH and CHOP teams. This is necessary so that data quality can be monitored, for CHNs 

 
  
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to contact the enrolled parents in the intervention arm and to complete the 12-month follow-
up survey.  
 
Every parent participant enrolled in the study will be identified by a Study ID number. The 
Study ID number for each subject will be a unique combination of practice and participant 
identifiers. The practice component of the number will be assigned to the practice when it enters 
the study. Personal identifiers or identifiable data will be used by the CHNs to contact the 
parents who enrolled in the study and by the study staff when conducting the 12-month follow-
up survey.  
 
During data collection phase, all enrollment data will be securely stored in REDCap database. 
Both CHOP and MGH teams will have access to the REDCap database. Data collection will be 
closely monitored daily by the study staff. All research assistants will be trained to explain the 
purpose of the study in 1-2 sentences and assure confidentiality of respondents’ comments and 
voluntariness of their participation, all in less than a minute. The RA’s will be trained to show 
the screen with the survey to the participant, so that the participant can point out the answers if 
they would like to do that. Whenever possible, the surveys will be conducted in a private area 
where other people cannot hear the answers of the respondents. If due to COVID parent 
screening and enrollment have to be modified to kiosk/telephone/remote screening, all the 
information will still be securely stored in the REDCap database and the procedures outlined 
below for the telephone surveys will apply.   
 
Similarly, strict data confidentiality measures will be followed when conducting 12-month 
follow-up with the longitudinal cohort. In addition to calls to subjects by the team, parents will 
also be given the option of calling the researchers collect or at a toll-free number at their 
convenience to complete the telephone surveys. Many questions will allow yes/no responses so 
as to minimize the risk of accidental disclosure of potentially sensitive information. Parents will 
be assured that their responses will not be shared with anyone at the practice. Study subjects will 
have the right to discontinue the survey at any time and will be informed of this before starting 
the questionnaire.  
 
Every clinician participant enrolled in the study will be identified by a Practitioner ID number. 
The clinicians and staff at the participating intervention practices who will participate in in-
depth qualitative interviews 6-weeks following implementation and at 12, and 24 months will 
complete consent forms (Appendix 8). These consent forms will contain information about the 
study and about the interviews and the study. The completed paper consent forms will be kept in 
a locked location at CHOP and kept in a locked location at CHOP for 10 years and then 
destroyed. Electronic parent and clinician consent forms will be stored securely on the REDCap 
server for 10 years and then destroyed. 
 

 
  
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All electronic data transferred to MGH will be stored on MGH HIPPA-compliant shared drives 
that only study staff have access to using their MGH login and password. 
 
The final dataset that will be used for the analyses will be HIPPA-limited (e.g., containing birth 
dates, dates of service, zip codes). After the analyses are completed and the study is over the 
datasets will be de-identified. Personal identifiers other than Practitioner or Patient ID numbers 
will be removed from the data files. The dates (e.g., visit dates) will be altered so they can no 
longer be identifiers. 
 
While the analytical datasets will be stripped off identifiers (as described above), in accordance 
with CHOP policy, we will retain paper and electronic raw data with identifiers for at least 6 
years. 
 
Any paper forms (e.g., paper consent forms and paper logs) will be kept in a locked location at 
CHOP for approximately 10 years and then destroyed.  
 
Study consent forms that contain participant identifiers, such as name, will not contain any links 
to the dataset after the study is completed and project data, including electronic files, is 
archived. 
 
During consenting, the study participants will be informed of the steps that will be taken to 
maintain confidentiality. 
 
9.2.7.1 Interviews 
The interviews will be conducted in person, by phone, or HIPPA-compliant video 
conferencing. The qualitative researcher conducting interviews will begin each 
interview by asking permission to record, outlining the purpose of the interview, 
describing the rights of respondents to stop the interview or recording at any time, 
and giving a brief explanation of how interview data will be used. Interviews will 
only be recorded with permission. 
 
Recordings will be uploaded to the transcription service provider (ADA 
Transcriptions). ADA Transcriptions is a HIPAA-compliant, full-service 
transcription company specializing in medical and academic research. Additionally, 
CHOP has a Master Business Associate agreement with the ADA Transcription. The 
audio-recordings will be uploaded and temporarily stored on ADA Transcriptions 
online platform that is encrypted and HIPAA compliant. ADA Transcriptions will 
de-identify and complete the transcriptions and provide each audio-recording and 
transcription a filename and password-protect it. The password protected 
transcriptions will then be securely transferred to the designated research team listed 

 
  
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on the online platform system. Only designated CHOP and MGH study team staff 
will be given access to transcriptions. The interview data will be used anonymously 
in conference presentations, articles, and reports. As part of the rapid-response 
quality improvement, data will also be used to improve the intervention and address 
factors that influence implementation of the intervention.  
 
The transcripts from the interviews will be stored on a secure server, with access 
limited to the researchers who are working with the data. 
 
Transcripts will be de-identified as much as possible. This will be done by providing 
guidance to the interviewees during the introduction to avoid using identifiers, by 
using pseudonyms, removing location names, and/or removing other data that could 
identify the practice, respondent, or location. 
 
9.2.7.1.1 Use and storage 
The de-identified transcripts will be used for coding and analysis.  
When and if needed, the de-identified transcripts will be shared between study team 
researchers at different institutions. These transcripts will be shared via secure file 
transfer.  
The sound files and the transcriptions will be stored electronically; the files will be 
password protected for approximately 10 years and then destroyed. 
 
While the research team will make every effort to maintain practitioner 
confidentiality, it cannot be absolutely guaranteed. Risks will be reduced by deleting 
practitioner names from all study data after data collection is complete and replacing 
them with practitioner identifier numbers, as well as password protecting files. 
Records that identify them and their signed consent forms may be inspected by a 
regulatory agency (the Department of Health and Human Services), MGH and/or 
CHOP. 
 
9.2.8 Security.   
Back-up of the dataset will be saved on the MGH and CHOP’s secure servers. 
 
9.2.9 Anonymization, de-identification or destruction.   
The final dataset that will be used for the analyses will be HIPPA-limited (e.g., containing birth 
dates, dates of service, zip codes). After the analyses are completed and the study is over the 
datasets will be de-identified. Personal identifiers other than Practitioner or Patient ID numbers 
will be removed from the data files. The dates (e.g., visit dates) will be altered so they can no 
longer be identifiers. While the analytical datasets will be stripped off the identifiers, in 

 
  
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accordance with CHOP policy, we will retain paper and electronic raw data with identifiers for 
at least 6 years. Identifiable patient health information collected will also be managed in 
accordance with 42 CFR Parts 160 and 164 (HIPAA) federal regulations pertaining to the 
privacy of patient-related health information. All investigators and research staff will be HIPAA 
and human subjects research certified through the completion of web-based human subjects 
protection training, such as the CITI course. Additionally, the computer systems at the MGH 
and CHOP containing confidential data will have a level and scope of security that equals or 
exceeds those established by the Office of Management and Budget (OMB) in OMB Circular 
No. A-130 - Security of Federal Automated Information Systems. 
 
The results of this research study may be presented at meetings or in publications but will be 
reported in summary form only. 
 
Study consent forms that contain participant identifiers, such as name, will not contain any links 
to the dataset after the study is completed and project data, including electronic files, is 
archived. 
 
All study data that resides on the CHOP server will be saved electronically for 10 years and then 
destroyed. All data collected on paper (e.g., consent forms, paper logs) will be kept in a locked 
cabinet at CHOP and will be destroyed 10 years following the study end date. 
 
 
Confidentiality 
No identifiable data will be used for any future studies. 
 
 
 
Regulatory and Ethical Considerations 
 
9.4.1 Data and Safety Monitoring Plan 
This is a minimal risk clinical trial (as defined in federal regulation at 45 CFR 46.102(i)). 
This trial aims to study the effectiveness of a tobacco control interventions iEHR + 
Navigator in the pediatric office setting to help household members of children seen at the 
office quit smoking. Enrollees will be given information on how to contact the Principal 
Investigator (Dr. Fiks) and the MGH Lead Investigator (Dr. Winickoff) to report any study 
related problems. Drs. Fiks and Winickoff will also work closely with research staff to 
ensure that all data are being stored in password-protected systems and that data collection, 
storage and transfer follow the safety and confidentiality procedures outlined in this 
protocol. CHOP PI (Dr. Fiks) will monitor and review the study progress and the accuracy 
and security of the emerging data at CHOP. Under the NIH policy on the use of a single IRB 
for multi-site research, the Children’s Hospital of Philadelphia (CHOP) Institutional Review 
Board (IRB) will serve as the reviewing IRB for this study. All participating sites will 

 
  
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adhere to the sIRB Policy (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-
094.html). Massachusetts General Hospital’s (MGH) IRB has agreed that CHOP will serve 
as the sIRB. The CHOP PI and MGH Lead Investigator will work closely with the CHOP 
and MGH IRBs for the duration of the study to ensure the safety of the interventions.  
 
9.4.2 Risk Assessment 
Though adverse events are not anticipated (given the minimal risk nature of the study), 
should any events occur, they will be reported to the study team immediately and shared 
with all relevant IRBs. The CHOP PI, MGH Lead Investigator, study coordinators, and all 
members of the research staff are responsible for the assessment and reporting of adverse 
events to the IRB. Weekly reports of practice and parent recruitment will be monitored by 
MGH and CHOP staff. All spontaneous reports by subjects, observations by clinical 
research staff, and reports to research staff by family or healthcare clinicians will be 
investigated by the Steering Committee, as further described in the section C1 of the 
research narrative. In case of an adverse event, all information related to the event will be 
immediately shared with all relevant IRBs. The investigators will assess the relationship of 
the adverse event as not related, possibly related, probably related, or definitely related to 
the intervention; this assessment will be done with standard criteria for clinical trials. 
 
A possible adverse event (to qualify, the adverse event must meet 2 of the following 
conditions): 
1. has a reasonable temporal relationship to the intervention 
2. could not readily have been produced by the subject’s clinical state 
3. could not readily have been due to environmental or other interventions 
4. follows a known pattern of response to intervention 
5. disappears or decreases with reduction in cessation of intervention. 
 
Probably related to the intervention (to qualify, the adverse event must meet 3 of the 
following conditions): 
1. has a reasonable temporal relationship to the intervention 
2. could not readily have been produced by the subject’s clinical state 
3. could not readily have been due to environmental or other interventions 
4. follows a known pattern of response to intervention 
5. disappears or decreases with reduction in cessation of intervention. 
 
Definitely related to the intervention (to qualify, the adverse event must meet at least 4 of 
the following conditions): 
1. has a reasonable temporal relationship to the intervention 
2. could not readily have been produced by the subject’s clinical state 
3. could not readily have been due to environmental or other interventions 

 
  
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4. follows a known pattern of response to intervention 
5. disappears or decreases with reduction in cessation of intervention. 
 
9.4.2.1 Adverse Event Definitions 
Adverse Event: an undesirable and unintended result of therapy, intervention or interaction 
experienced by a subject participating in a research study. 
 
Unexpected Adverse Event: any adverse event, the specificity, severity, frequency or nature 
of which is not consistent with the current general investigational protocol or investigational 
protocol amendments. 
 
Serious Adverse Event: any adverse event that results in any of the following outcomes: 
death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing 
hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth 
defect. Important medical events that may not result in death, may not be life threatening, or 
may not require hospitalization could be considered serious adverse events when, based 
upon appropriate medical judgment, they may jeopardize the patient or subject and may 
require medical or surgical intervention to prevent one of the outcomes listed in this 
definition. Due to the minimal risk nature of this intervention, in which we collect data only 
through surveys, we do not expect serious adverse events. 
 
9.4.2.2 Adverse Event Reporting 
An FDA Medwatch Form will be used to report all Adverse Events. A copy of the adverse 
event report will be retained with the subject’s research records. 
 
Serious Adverse Events must be reported in writing within 7 calendar days of any member 
of the investigative team becoming aware of such an event. These adverse events would be 
reported to NCI and to the CHOP and MGH IRBs.  
 
Unexpected Adverse Events must be reported in writing within 15 calendar days of any 
member of the investigative team becoming aware of such an event. 
 
9.4.2.3 Management of Reported Adverse Events: 
The CHOP PI, MGH Lead Investigator and the study team are responsible for the 
appropriate clinical management of all adverse events. The CHOP PI and MGH Lead 
Investigator will ensure that all appropriate resources are directed toward subject safety and 
well-being. Any subject may discontinue the study at any time at their own discretion or if in 
the opinion of any study staff, their safety or well-being is jeopardized by continued 
participation in the study. If any unanticipated problems related to the research involving 
risks to subjects or others happen during the course of this study (including SAEs) these will 

 
  
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be reported to the IRB in accordance with CHOP IRB SOP 408: Unanticipated Problems 
Involving Risks to Subjects. AEs that do not meet prompt reporting requirements will be 
tracked and documented internally by the study team but not submitted to the IRB (as 
continuing reviews are not required). Otherwise, subject enrollment, project status, 
adherence data will be discussed among the scientific team. A statement reflecting the 
results of ongoing data review will be submitted annually to NIH or as requested in 
accordance with contractual requirements. 
 
9.4.3 Potential Benefits of Trial Participation 
Carrying out this research in the pediatric setting will likely increase the provision of tobacco 
control services for parents who smoke. Increased provision of services has been proven to 
increase the chances of changing smoking behaviors. Parents who successfully quit or reduce 
their tobacco consumption may live longer with a better quality of life, reduce the tobacco 
smoke exposure of their spouses, children, and others, and have increased financial resources. 
Mothers who quit successfully may be non-smokers for subsequent pregnancies, leading to 
better outcomes for their unborn children. The children of parents who quit smoking are less 
likely to grow up to be smokers themselves. However, these benefits cannot be guaranteed to all 
parents and families who participate in the research.  
 
In addition to the potential benefits to participants, the benefits of this study will include 
improvement of science and clinical practice. The results will also help to develop and 
implement fully integrated, cost-effective, disseminable, and sustainable strategies to optimize 
parental smoking cessation outcomes in pediatric settings on a national scale. The minimal risks 
of participation are reasonable in relation to the potential benefits of these interventions. It is 
also possible that the information obtained from this project will be used to develop clinician 
guidelines and education, which could directly benefit the study subjects in the future. 
 
9.4.4 Risk-Benefit Assessment 
Risks to participants will be minimal and include discomfort in discussing personal tobacco 
use with a stranger, and the receipt of tobacco-related services from their child’s clinician. 
Study participants will lose approximately ~ 15 minutes of time that they could have used 
for other activities. In addition, subjects will be asked to participate in the longitudinal 
cohort survey 12 months after the index visit, which will take approximately 15 minutes at 
the practice exit or remotely and if eligible, giving a salivary sample and doing a CO breath 
test. The same risks apply.  
 
Carrying out this research in the pediatric setting will likely increase the provision of 
tobacco control services for parents who smoke. Increased provision of services has been 
proven to increase the chances of changing smoking behaviors. Parents who successfully 
quit or reduce their tobacco consumption may live longer with a better quality of life, reduce 

 
  
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the tobacco smoke exposure of their spouses, children, and others, and have increased 
financial resources. Mothers who quit successfully may be non-smokers for subsequent 
pregnancies, leading to better outcomes for their unborn children. The children of parents 
who quit smoking are less likely to grow up to be smokers themselves. However, these 
benefits cannot be guaranteed to all parents and families who participate in the research.  
 
 
Recruitment Strategy 
As part of the clinical workflow, all parents in control and intervention practices will be 
asked about their individual smoking status on the iEHR pre-visit screening questionnaire 
(Appendix 5 for intervention practices and Appendix 5A for control practices). 
 
The study team/CHOP Clinical Reporting Unit (CRU) and/or Research Enhancement Core 
(REC) will generate rosters of potentially eligible parents for the upcoming visit. Rosters 
will include all upcoming visits at study practices of parents who answered, “yes” to either 
of the screening questions: “Have you smoked a cigarette, even a puff, in the past 7 days?” 
and “Have you smoked any other tobacco product (cigars like black and mild, hookah), 
even a puff, in the past 7 days?” on the iEHR pre-visit screening questionnaire. The study 
team will approach these potentially eligible parents to offer enrollment in the study. 
 
Additionally, at participating CHOP primary care sites, study team will also review the 
medical records to identify parents who self-reported as smokers (answered “yes” to either 
of the screening questions: “Have you smoked a cigarette, even a puff, in the past 7 days?” 
and “Have you smoked any other tobacco product (cigars like black and mild, hookah), 
even a puff, in the past 7 days?” on the iEHR pre-visit screening questionnaire. (Appendix 5 
for intervention practices and Appendix 5A for control practices) to approach them and offer 
enrollment in the study longitudinal cohort.  
 
Potentially eligible families who are missed in the CHOP primary care sites or are not able 
to complete enrollment survey in the office will also be reached via recruitment emails 
(Appendix 12 (for intervention) and 13(control)), text messages and calls facilitated by the 
study team and/or CHOP Research Enhancement Core (REC). 
 
We will deploy several strategies to maximize recruitment. Parents will be recruited in one 
of these ways: (1) In-office enrollment; (2) Hybrid enrollment: from in-office to remote; (3) 
Remote enrollment. The detailed description of each approach and overall recruitment 
strategy is described in detail under section 4.1. Screening & Enrollment. 
 
Using these strategies, we will continue to enroll parents until approximately 100 parents 
who use combusted tobacco have been enrolled in the longitudinal cohort in that practice or 
approximately 400 parents who use combusted tobacco are enrolled in each arm. If some 

 
  
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practices accrue subjects at a rate which makes it unlikely that these practices can achieve 
the recruitment goal of approximately 100 subjects, then we will estimate the likely 
shortfall, and increase the recruitment goals in faster-accruing practices in order to attempt 
to preserve statistical power. If enrollment is slower than projected in some practices, we 
will add new practices that are similar to each other based on practice size and Medicaid rate 
in each arm to reach the goal of 400 parents in each arm. 
 
A notice may be posted at the practice entrance/registration window/waiting room of 
participating practices, informing parents accompanying their children to office visits that 
the practice is participating in the research study (posting details may be modified based on 
practice layout and preferences). Recruitment procedures will be identical across both arms.  
 
 
Informed Consent/Assent and HIPAA Authorization 
For in-person parent consent, the trained research assistants at the practices will approach 
eligible participants (screened through the review of medical records) and ask whether they 
want to participate in the study. They will be given the appropriate consent documents at this 
time to read prior to completing any parent enrollment surveys. REDCap will be the primary 
method of obtaining consent from participants. Research Assistants will provide tablets with the 
REDCap eConsent, and participants will be provided with a copy of the signed document via 
email. The eConsent forms were reviewed and authorized for use by the CHOP REDCap team. 
In case of a tablet failure/unavailability, paper consent forms will be used. For paper consent, 
trained research assistants will document consent by obtaining the participant’s signature on the 
previously approved IRB consent document. 
 
For remote parent consent, consent will be obtained electronically utilizing the REDCap 
interface, accessed by a link emailed or texted to the participant. When consent is obtained 
electronically, participants will be able to read, digitally sign their name and receive an emailed 
copy of the informed consent/HIPAA authorization form. The research presents minimal risk to 
participants and involves no procedures for which written consent is normally required outside 
of the research context. When parent outreach is performed via a phone call, a study team 
member will be able to answer any questions about consent in real time. Study team’s phone 
number and e-mail address will be included in all e-mail and text communication with parents.  
 
The parent consent form (Appendix 3 and 3b (paper) and 3E and 3bE (electronic) will describe 
the risks, benefits, and rights of participation, as well as an assurance of confidentiality, 
including the procurement of a federal Certificate of Confidentiality. The study staff will review 
the documents with the family and answer any questions and give them time to decide if they 
want to enroll in the study. For electronic consent, the parent will be asked to electronically sign 
the REDCap consent form if they elect to participate and will be provided with a copy of the 
signed consent via email. In case of paper consent, the parent will be asked to sign and return 

 
  
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the appropriate consent forms if they elect to participate, retaining a copy of each form for their 
own records. 
 
In intervention practices, in-depth qualitative interviews will be conducted with practice 
clinicians and staff 6-weeks following implementation and at 12, and 24 months.  
The clinician and staff consent form (Appendix 8) will describe the purpose of the interviews, 
risks, benefits and rights of participation, as well as an assurance of confidentiality, including 
the procurement of a federal Certificate of Confidentiality. The completed paper consent forms 
will be kept in a locked location at CHOP and kept in a locked location at CHOP for 10 years 
and then destroyed. Electronic clinician consent forms will be stored securely on the REDCap 
server. 
 
The consent form will be a combined consent-authorization document.  
 
9.6.1 Waiver of Consent 
n/a 
 
9.6.2 Waiver of HIPAA Authorization 
For parent subject, we incorporated a HIPPA Authorization form in the Consent Form using 
appropriate consent templates (Parent Consent Forms Appendix 3, 3b, 3bE, 3E).  
 
For clinician and staff participants of the qualitative interviews we would like to request a 
waiver of HIPPA Authorization as we will not be collecting any protected health 
information for these subjects. 
 
We would like to request a waiver of HIPAA authorization for recruitment of parents, as the 
study staff will need review patient medical records to identify eligible subjects (as part of 
recruitment). This way we can target our recruitment only to those parents who identify as 
smokers. 
 
 
Payment to Subjects/Families 
 
9.7.1 Payments to parent for time and inconvenience (i.e., compensation) 
• $20 gift card will be provided to parents upon participating in the enrollment survey 
at baseline  
• $40 gift card will be provided to parents upon participating in the follow-up survey 
respectively. 
• $50 gift card will be provided to parents who provide a salivary sample to confirm 
quit status. 

 
  
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• $50 gift card will be provided to parents who do the CO breath test to confirm quit 
status. 
 
Participants can get the gift card via e-mail, text, or in-person. 
 
9.7.1.1 Token of Appreciation 
During the navigator sessions (protocol section 4.2.2), the navigator can offer families a 
small item, such as a stress ball, a motivational journal, a key chain, or a coloring book, 
something that parents can use to distract themselves from smoking or remind them why 
they want to quit in the first place. CHOP community health navigators already incorporate 
this strategy when working with families. 
 
9.7.2 Payments to practices for time, effort and inconvenience (i.e., compensation) 
N/A 
 
9.7.3 Payments to clinicians and staff for time, effort and inconvenience (i.e., 
compensation) 
A $50 gift card will be given to the clinicians and staff to recognize their time and effort for 
participating in the qualitative interviews ($50 per interview). 
 
10 PUBLICATION 
There will be sub-committee, “Publications, presentations, and dissemination” which will 
include both MGH and CHOP members. No individually identifiable PHI will be published. 
Both MGH and CHOP team members will have access to the complete trial data and will 
work together to write papers. Both team members will discuss the papers related items and 
analysis plans in this sub-committee meeting. 
 
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APPENDIX 
Appendix 1: Recruitment e-mail letter to CHOP practices  
Appendix 2: Qualitative interview information Sheet 
Appendix 3, 3b, 3E and 3bE: Intervention and Control practices parent consent  
Appendix 4: Parent enrollment survey 
Appendix 5: CEASE pre-visit screening questionnaire (Intervention) 
Appendix 5A: CEASE pre-visit screening questionnaire (Control) 
Appendix 6: 12-month follow-up survey 
Appendix 7: Qualitative interview guides 
Appendix 8: Clinician consent form 
Appendix 9: Cost-effectiveness direct observation log 
Appendix 10: Eligibility Form 
Appendix 11: Navigator Form 
Appendix 12: eCEASE INTERVENTION Recruitment Email Template 
Appendix 13: eCEASE CONTROL Recruitment Email Template