Treating Nicotine Addiction in Caregivers of Children at American Family Children's Hospital
Phase: PHASE4
Conditions: Smoking, Smoking Cessation
Sponsor: University of Wisconsin, Madison

Treating Nicotine Addiction in Caregivers of Children at American 
Family Children’s Hospital 
PI: Brian Williams, MD 
10/27/2023 

Treating Caregivers who Smoke at AFCH 
 
 
 
 
 
 
 
 
 
 
 
 
SCIENTIFIC PROTOCOL 
 
Treating Nicotine Addiction in Caregivers of Children 
 at American Family Children’s Hospital 
 
 
Protocol Number: 2023-0727 
Principal Investigator: Brian Williams, MD 
Funding Source: UW Department of Pediatrics Faculty R&D Grant 
 
[This document is confidential. 
No part of it may be transmitted, reproduced, published, or used by other persons without prior 
authorization from the Sponsor or Principal Investigator.] 
 
Protocol Version History 
 
Protocol 
Version 
Version 
Date 
Summary of Revisions Made 
Rationale 
1.0 
06/30/2023 
Initial version 
 
2.0 
10/27/2023 
Revision #1 
Clarify Informed Consent, simplify 
payment structure, simplify 
contacting participants, simplify 
survey questions 
 
 
 
 
 
 
 
 
 

Treating Caregivers who Smoke at AFCH 
- ii - 
 
REMINDER: update the Table of Contents before considering the document or draft final. To update the Table of 
Contents, right click anywhere below and then select “Update Field.”  
 
Table of Contents 
 
1.0 
STATEMENT OF COMPLIANCE ................................................................................................................ 1 
2.0 
LIST OF ABBREVIATIONS ........................................................................................................................ 2 
3.0 
STUDY SUMMARY ..................................................................................................................................... 2 
 
Synopsis .......................................................................................................................................... 2 
 
Schematic of Study Design .............................................................................................................. 4 
4.0 
KEY ROLES ................................................................................................................................................ 5 
5.0 
INTRODUCTION ......................................................................................................................................... 5 
 
Background: Pediatric Tobacco Smoke Exposure ........................................................................... 5 
 
Current Standard of Care ................................................................................................................. 6 
 
Study Intervention: NRT and Behavioral Counseling ....................................................................... 6 
 
Rationale .......................................................................................................................................... 6 
6.0 
STUDY OBJECTIVES AND ENDPOINTS .................................................................................................. 7 
7.0 
STUDY DESIGN .......................................................................................................................................... 7 
 
General Design ................................................................................................................................ 7 
 
End of Study Definition .................................................................................................................... 8 
8.0 
SUBJECT SELECTION .............................................................................................................................. 8 
 
Inclusion & Exclusion Criteria .......................................................................................................... 8 
 
Vulnerable Populations .................................................................................................................... 8 
 
Lifestyle Considerations ................................................................................................................... 8 
 
Subject Identification ........................................................................................................................ 9 
8.4.1 
Electronic Health Record (EHR) Query ............................................................................................................... 9 
 
Subject Recruitment ......................................................................................................................... 9 
 
Remuneration and Retention Strategies .......................................................................................... 9 
 
Early Termination and Withdrawal ................................................................................................... 9 
9.0 
STUDY AGENT (STUDY DRUG, DEVICE, BIOLOGIC, VACCINE, ETC.) AND/OR PROCEDURAL 
INTERVENTION AND/OR BEHAVIORAL/SOCIAL INTERVENTION ...................................................... 10 
 
Study Agent and Control Description ............................................................................................. 10 
9.1.1 
Source .............................................................................................................................................................. 10 
 
Study Procedural Intervention(s) Description................................................................................. 10 
 
Study Behavioral or Social Intervention Description ...................................................................... 10 
9.3.1 
Administration of Behavioral or Social Intervention ........................................................................................... 11 
9.3.2 
Procedures for Training Interventionalists and Monitoring Intervention Fidelity ................................................ 11 
 
Method for Assigning to Treatment Groups ................................................................................... 11 
 
Unblinding Procedures ................................................................................................................... 11 
 
Study Intervention Compliance ...................................................................................................... 11 
 
Concomitant Therapy ..................................................................................................................... 11 
9.7.1 
Permitted Concomitant Therapy ....................................................................................................................... 11 

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9.7.2 
Prohibited Concomitant Therapy ....................................................................................................................... 11 
10.0 STUDY VISITS AND PROCEDURES ....................................................................................................... 11 
 
Study Calendar .............................................................................................................................. 11 
 
Screening and Enrollment .............................................................................................................. 12 
10.2.1 
Pre-screening .................................................................................................................................................... 12 
10.2.2 
Informed Consent ............................................................................................................................................. 12 
10.2.3 
Screening Visit .................................................................................................................................................. 13 
10.2.4 
Enrollment ......................................................................................................................................................... 13 
10.2.5 
Screen Failure and Re-enrollment .................................................................................................................... 13 
 
On-Study/Follow-up Visits .............................................................................................................. 13 
10.3.1 
Visit 1: Intervention - Counseling and NRT ....................................................................................................... 13 
10.3.2 
Follow-Up Number 1: Discharge Survey ........................................................................................................... 14 
10.3.3 
Follow-Up Number 2: 2-Week Post-Discharge Survey ..................................................................................... 14 
 
Early Termination/Withdrawal Visit ................................................................................................ 14 
 
Long-Term Follow-up | Re-contacting Subjects ............................................................................. 14 
11.0 CORRELATIVE | SPECIAL STUDIES ...................................................................................................... 14 
12.0 DATA HANDLING AND RECORD KEEPING .......................................................................................... 15 
 
Data Collection ............................................................................................................................... 15 
12.1.1 
Data Collection Forms ...................................................................................................................................... 15 
12.1.2 
Data Management Software System(s) ............................................................................................................ 15 
 
Confidentiality and Privacy ............................................................................................................. 15 
 
Records Retention ......................................................................................................................... 16 
 
Retention for Future Research: [Optional or Mandatory] Data, Image, Audio- or Video-
Recording & Biospecimen Banking ................................................................................................ 16 
 
Protocol Deviations ........................................................................................................................ 16 
 
Publication and Data Sharing Policies ........................................................................................... 16 
13.0 STUDY ANALYSIS ................................................................................................................................... 16 
 
Statistical Hypotheses .................................................................................................................... 16 
 
Sample Size Justification ............................................................................................................... 17 
 
Subject Population(s) for Analysis ................................................................................................. 17 
 
Statistical Methods ......................................................................................................................... 17 
 
Planned Interim Analysis ............................................................................................................... 17 
 
Handling of Missing Data ............................................................................................................... 17 
14.0 RISK/BENEFIT ASSESSMENT ................................................................................................................ 17 
 
Known Potential Benefits to the Subjects ...................................................................................... 17 
 
Known Potential Risks ................................................................................................................... 18 
14.2.1 
Known Interventional Risks ............................................................................................................................... 18 
14.2.2 
Other Known Study Risks ................................................................................................................................. 18 
 
Risk/Benefit Analysis ..................................................................................................................... 18 
15.0 DATA AND SAFETY MONITORING ........................................................................................................ 19 
16.0 STUDY FEASIBILITY ................................................................................................................................ 19 
 
Economic Burden to Subjects ........................................................................................................ 19 
 
Facilities and Locations .................................................................................................................. 19 
 
Feasibility of Recruiting the Required Number of Subjects ............................................................ 19 
 
Principal Investigator Considerations ............................................................................................. 19 
16.4.1 
Time Devoted to Conducting the Research ...................................................................................................... 19 

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16.4.2 
Process for Informing Study Teams .................................................................................................................. 19 
 
Availability of Medical or Psychological Resources ....................................................................... 19 
17.0 MULTI-SITE RESEARCH ......................................................................................................................... 20 
18.0 REFERENCES .......................................................................................................................................... 20 
 
Appendix A ..................................................................................................................................... 21 
18.1.1 
Study Invitation and Screening ........................................................................... Error! Bookmark not defined. 
18.1.2 
Study Informed Consent ..................................................................................... Error! Bookmark not defined. 
18.1.3 
Pre-Intervention Survey ...................................................................................... Error! Bookmark not defined. 
18.1.4 
Discharge Survey ................................................................................................ Error! Bookmark not defined. 
18.1.5 
2-week Post-Discharge Survey ........................................................................... Error! Bookmark not defined. 
18.1.6 
Data and Safety Monitoring Plan ........................................................................ Error! Bookmark not defined. 
 
         18.1.7     NRT Handout 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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1.0 
STATEMENT OF COMPLIANCE 
I confirm that I have read this protocol. I will comply with the IRB-approved protocol, and applicable 
regulations, guidelines, laws, and institutional policies. 
  
I agree to ensure that all staff members involved in the conduct of this study are informed about their 
obligations in meeting the above commitment. 
 
Name 
Signature 
Date 
 
Brian Williams, MD 
 
5/22/2023 
_________________________________ 
_____________________________ 
___________________ 
Principal investigator 
 
 
 
 
 

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Williams 
 
 
 
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2.0 
LIST OF ABBREVIATIONS 
AE 
Adverse Event 
AFCH 
American Family Children’s Hospital 
CTRI 
Center for Tobacco Research and Intervention 
DSMB 
Data & Safety Monitoring Board  
DSMC 
Data & Safety Monitoring Committee 
DSMP 
Data & Safety Monitoring Plan 
EHR 
Electronic Health Record 
FDA 
Food and Drug Administration 
HIPAA 
Health Insurance Portability and Accountability Act 
ICTR 
Institute for Clinical and Translational Research 
IRB 
Institutional Review Board 
NIH 
National Institutes of Health 
NRT 
Nicotine Replacement Therapy 
PHI 
Protected Health Information 
PI 
Principal Investigator 
REDCap 
Research Electronic Data Capture 
SAE 
Serious Adverse Event 
TSE 
Tobacco Smoke Exposure 
UW-CTRI 
University of Wisconsin – Center for Tobacco Research and Intervention 
 
 
3.0 
STUDY SUMMARY 
 Synopsis 
Full Title 
Treating Nicotine Addiction in Caregivers of Children at American Family Children’s Hospital 
Short Title 
Treating Caregivers who smoke at AFCH 
Protocol Number 
2023-0727 
ClinicalTrials.gov 
Identifier & 
Summary 
ClinicalTrials.gov ID: NCT06051474 
 
Summary: This study is being done to assess the feasibility and acceptability of providing 
NRT and counseling to caregivers who smoke while their child is hospitalized. We 
hypothesize that 50% of eligible caregivers will enroll in the program, use NRT, and 
recommend program implementation. We will also examine how smoking behavior changes 
for participants who enroll in the study.  
Number of 
Site(s) 
This study is being done at 1 clinical site, American Family Children’s Hospital in Madison, 
WI on the inpatient med-surg (non-ICU) units. 
Phase 
Feasibility 
Main Inclusion 
Criteria 
• 
Adults who identify as the primary caregiver during their child’s hospitalization.   
• 
Smoke ≥5 cigarettes per day 
• 
Willing to use NRT during child’s hospitalization 
Main Exclusion 
Criteria 
• 
Currently using smoking cessation medication (bupropion, varenicline, nicotine 
replacement therapy [NRT]) 
• 
Contraindication to NRT (pregnancy, myocardial infarct in past 2 weeks) 
 
 

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Objective(s) 
Primary Objective 
• 
To evaluate the feasibility and acceptability of a smoking intervention (NRT and cessation 
counseling) for caregivers of children admitted at American Family Children’s Hospital 
(AFCH). 
Secondary Objectives 
• 
To evaluate effects of a smoking intervention on additional key outcomes, such as the 
number of cigarettes a caregiver smokes per day while their child is hospitalized, number 
of times they leave the bedside to smoke per day, and changes in self-efficacy and 
interest in quitting pre- and post-intervention. 
Endpoints 
Primary Endpoint 
• 
Feasibility will be measured by 1) enrollment in study (N of eligible who enroll/N of eligible 
who are invited to enroll) and 2) NRT use (N who use NRT/N enrolled in study).  
• 
Acceptability will be measured using Likert scales assessing participants likelihood to 
recommend program implementation. 
Secondary Endpoints 
• 
Change in cigarettes smoked per day at day of discharge and 2 weeks post-discharge, 
compared to pre-intervention 
• 
Number of times participant left bedside/day to smoke compared to pre-intervention 
prediction 
• 
Changes in self-efficacy score at day of discharge and 2 weeks post-discharge, 
compared to pre-intervention 
• 
Change in interest in quitting at day of discharge and 2 weeks post-discharge, compared 
to pre-intervention   
Study Design 
This is an open label, 2-week single center study assessing the feasibility, acceptability, and 
preliminary efficacy of NRT and counseling in parents who smoke while their child is 
hospitalized.  
FDA Regulatory 
Overview 
The protocol uses nicotine replacement therapy (NRT). NRT is an FDA-approved, over-the-
counter medication. The use of the medication falls under IND Exemptions “Lawfully 
Marketed Drugs (21 CFR 312.2(b)(1)) or Biologics” 
Study 
Intervention 
Adults will receive a 2-week supply of nicotine patches to place on skin (14mg or 21mg; 
dosing depending on tobacco use per package insert) and oral nicotine mini-lozenges (2mg, 
4mg, dosing depending on tobacco use per package insert). All participants will also receive 
a single smoking cessation counseling session with a physician. Surveys will be completed 
pre-intervention, within 24 hours of hospital discharge, and 2-weeks after hospital discharge. 
Total Number of 
Subjects 
A total of 50 subjects will be recruited for the study. 
Study Population Adults of all genders and races/ethnicities, aged ≥18 years, who smoke ≥5 cigarettes per 
day and are the primary caregiver of a hospitalized child at AFCH. 
Statistical 
Methodology 
Basic descriptive statistics will be used to assess feasibility (percentage enrolled, percentage 
using NRT) and acceptability (likelihood to recommend program implementation). General 
linear modeling will be used to assess key smoking outcomes. 
Estimated 
Subject Duration 
The duration of the study for each subject will vary, based on duration of hospitalization, but 
will last approximately 2-3 weeks, on average.  
Estimated 
Enrollment 
Study enrollment and follow-up will occur over 6 months with the total expected duration of 
the trial to be 8 months. 

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Period & Study 
Duration 
 Schematic of Study Design 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Follow-up survey of study endpoints 2-weeks after child’s day of discharge.  
Follow-up survey of study endpoints within 24 hours of child’s discharge. 
 
Final Data Analyses 
Study Coordinator:  Approach potential caregivers at AFCH. Complete eligibility 
screener for interested caregivers. Obtain informed consent from eligible 
caregivers.  
Complete Pre-Intervention Survey. 
Screen potential participants via EHR smoke exposure screening,  
assess for child’s admission duration >24hours via EHR. 
Prior to Enrollment 
Screening/Enrollment 
Visit
Survey 
Day of Discharge 
Survey 
2-week follow-up 
Visit 1 
Intervention 
Study Physician: Provide smoking cessation counseling and NRT (patches and 
mini-lozenges). Review use of medication, provide written instructions for use with 
description of potential side effects 

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4.0 
KEY ROLES 
The following is a list of all key personnel and roles: 
 
Principal Investigator 
Brian Williams, MD 
Assistant Professor of Pediatrics and Medicine 
UW-School of Medicine and Public Health 
600 Highland Ave, H4/418 MC 4108 
Madison, WI 53792 
608-262-9364 
bswillia@medicine.wisc.edu 
Participating Site(s) 
American Family Children’s Hospital 
1675 Highland Ave. 
Madison, WI 53792 
Medical Monitor 
Brian Williams, MD 
Assistant Professor of Pediatrics and Medicine 
UW-School of Medicine and Public Health 
600 Highland Ave, H4/418 MC 4108 
Madison, WI 53792 
608-262-9364 
bswillia@medicine.wisc.edu 
Local Laboratory Services 
N/A  
Central Laboratory Services 
N/A 
Data and Safety Monitoring Board 
UW-CTRI DSMB 
Dr. James Clearly, Dr James Sosman, Dr. Burke 
Richmond 
Funding Sponsor 
UW-SMPH, Department of Pediatrics 
600 Highland Avenue, MC 4108 
608-263-8558 
Rebecca.bound@wisc.edu 
NIH Point of Contact 
N/A 
Biostatistician 
Megan Piper, PhD  
Professor of Medicine  
UW-School of Medicine and Public Health 
1930 Monroe St, Madison, WI, 53711-2059 
608-265-5472 
mep@ctri.wisc.edu 
Data Coordinating Center 
UW-Center for Tobacco Research and Intervention 
1930 Monroe St #200, Madison, WI 53711 
608-262-8673 
jlmatthews@ctri.wisc.edu 
Clinical Coordinating Center 
N/A 
5.0 
INTRODUCTION 
 Background: Pediatric Tobacco Smoke Exposure 
Cigarette smoking is the number one preventable cause of death in the US and worldwide1. Smoking is 
particularly problematic for caregivers of children as tobacco smoke exposure (TSE) can adversely affect 
the health of the exposed child in addition to the caregiver. Children exposed to tobacco smoke are known 
to be sick more frequently2 and have more severe outcomes in cases of asthma3, pneumonia4, 
bronchiolitis5, and influenza6. Furthermore, children with TSE can have lower academic performance7 and 
are at higher risk of becoming smokers themselves8. It is estimated that 38% of children aged 3-11 
experience TSE9. Thus, finding effective interventions to decrease pediatric TSE can have a huge impact 
on the health of a child. 

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The hospitalization of a child is a stressful time for caregivers. In caregivers who smoke, this stress can be 
compounded by nicotine withdrawal (anxiety, irritability, difficulty concentrating) while their child is 
hospitalized. The need to smoke during a child’s hospitalization to prevent withdrawal and cope with stress 
limits a caregiver’s time at the bedside, can lead to a caregiver missing rounds or treatment, and their 
return to the bedside after smoking can expose the child and hospital staff to third-hand smoke. Thus, a 
child’s hospitalization could be a ‘teachable moment’ for caregivers who smoke and presents an 
opportunity to intervene and decrease the negative effects of caregiver smoking. 
 Current Standard of Care 
For caregivers who smoke in the pediatric setting, there is a lack of data on how to effectively intervene, no 
existing standard of care, and interventions with adults who smoke in the pediatric setting are rare. 
 
The current standard of care for treating adult smokers is by combination therapy of both an FDA-approved 
smoking cessation medications and behavioral counseling10. FDA approved medications include NRT, 
Bupropion, and Varenicline. NRT in the form of patches, gum, and lozenges are available over the counter. 
Given the high volume of evidence supporting NRT and counseling for treatment of smoking10, along with 
the low-risk profile of NRT, we chose these two interventions for our study. This approach (NRT + 
Counseling) is similar to what a participant would receive if they were to call the Wisconsin Tobacco Quit 
Line. 
 Study Intervention: NRT and Behavioral Counseling 
Nicotine Replacement Therapy: NRT is a well-established medicine, and standard of care, for the 
treatment of smoking cessation10. We will be using NRT patches and mini-lozenges which are both 
available over the counter. Patches are worn for 24 hours at a time and provide a steady state of nicotine 
to reduce cravings. NRT mini-lozenges will also be used on an as needed basis by participants to treat 
urges to smoke. Patches come in 7mg, 14mg, and 21mg formulations. Dosing will be based on the 
package insert, with the number of cigarettes smoked per day determining patch dosing (>10 cigarettes per 
day = 21mg patch, <10 cigarettes per day = 14mg patch). Participants with a latex allergy will only be 
offered mini-lozenges. Mini-lozenges come in 2mg and 4mg formulations. Dosing will be based on the 
package insert which recommends 2mg mini-lozenges for individuals who smoke their first cigarette >30 
minutes after waking up and 4mg mini-lozenges for individuals who smoke their first cigarette ≤30 minutes 
of waking up. 
 
Behavioral Counseling: Counseling for smoking cessation is also a well-established, evidence-based 
treatment for smoking cessation11. Counseling sessions will last approximately 20 minutes and will focus on 
3 objectives: 1) review participants’ motivation for smoking and for quitting and 2) use the information on 
participants’ motives to provide tailored education regarding a) benefits of quitting smoking to the caregiver 
and the child, b) strategies to reduce nicotine withdrawal symptoms/urges to smoke during the 
hospitalization, and c) benefits of smoke-free home and car rules; and 3) review smoking cessation 
resources.  
 Rationale 
Intervening with caregivers who smoke offers an opportunity to improve the health of both the caregiver 
who smokes and the child who is exposed to tobacco smoke. The pediatric hospital setting offers a 
“teachable moment” where caregivers may be more motivated to change their smoking behavior. Due to 
the lack of data on how to effectively intervene with caregivers who smoke in the pediatric hospital, this 
study will provide data on the feasibility and acceptability of providing a standard of care smoking cessation 
intervention to participants. It will also provide some basic data on treatment outcomes that will be used to 
estimate sample sizes for future, definitive treatment interventions. 

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6.0 
STUDY OBJECTIVES AND ENDPOINTS 
Objectives 
Endpoints 
Primary 
To evaluate the feasibility and 
acceptability of a smoking intervention 
(NRT and cessation counseling) for 
caregivers of children admitted at 
American Family Children’s Hospital 
(AFCH). 
 
Feasibility will be measured by 1) enrollment in 
study (N of eligible who enroll/N of eligible who 
are invited to enroll) and 2) NRT use (N who use 
NRT/N enrolled in study).  
Acceptability will be measured using Likert scales 
assessing participants likelihood to recommend 
program implementation. 
 
Secondary 
To evaluate effects of a smoking 
intervention on additional key outcomes, 
such as the number of cigarettes a 
caregiver smokes per day while their child 
is hospitalized, number of times they 
leave the bedside to smoke per day, and 
changes in self-efficacy and interest in 
quitting pre- and post-intervention. 
Change in cigarettes smoked per day at day of 
discharge and 2 weeks post-discharge, 
compared to pre-intervention. 
Number of times participant left bedside/day to 
smoke compared to pre-intervention prediction. 
Changes in self-efficacy score at day of 
discharge and 2 weeks post-discharge, 
compared to pre-intervention. 
Change in interest in quitting at day of discharge 
and 2 weeks post-discharge, compared to pre-
intervention. 
7.0 
STUDY DESIGN 
 General Design  
This feasibility, single site, prospective, open-label study will assess the feasibility and acceptability of 
providing NRT and counseling to adult caregivers who smoke while their child is hospitalized. Additionally, 
the study will assess preliminary outcomes of the intervention on key smoking outcomes (changes in the 
number of cigarettes a caregiver smokes per day while their child is hospitalized, number of times they 
leave the bedside to smoke per day, and changes in self-efficacy and interest in quitting from pre- to post-
intervention). Subject accrual will occur over 6 months with the total duration of the trial expected to be 8 
months.   
 
Following the completion of screening and informed consent, eligible subjects will complete a pre-
intervention survey. They will then have 1 visit with the study physician during which they will receive 
counseling on smoking cessation as well as a 2-week supply of nicotine patches and mini-lozenges. Within 
24 hours of their child’s discharge, they will complete a second survey describing use of NRT during the 
child’s hospitalization, leaving the bedside to smoke, acceptability of the intervention, and changes in 
smoking behavior and quit interest/efficacy. At 2 weeks post-discharge, subjects will again complete a 
follow-up survey to assess smoking behavior, NRT use, quit interest/efficacy, and implementation of 
smoke-free home/car rules. 
 
If a participant’s child remains hospitalized at 2 weeks, they will be offered an additional 2 weeks of NRT. 

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 End of Study Definition 
The end of the study is defined as the date of completion of any final follow-up activity or data collection 
described in the protocol. 
8.0 
SUBJECT SELECTION 
 Inclusion & Exclusion Criteria  
Eligibility will be determined by inclusion and exclusion criteria below. Inclusion and exclusion criteria will 
be assessed prior to informed consent to minimize burden on potential study participants’ time. Criteria will 
only be reviewed with potential participants who’s child screens positive for tobacco smoke exposure.  
 
Inclusion Criteria  
1. Hospitalized child will have a ‘yes’ response to the screening question, “Does anyone in your 
household smoke” 
2. Hospitalized child is expected to be admitted for >24 hours 
3. Caregiver is at least 18 years of age 
4.  Participant self-identifies as the primary caregiver of the hospitalized child during the 
hospitalization (not limited to one caregiver per child) 
5.  Participant smokes ≥5 cigarettes per day 
6.  Participant is willing and able to use NRT 
7.  Participant is not currently pregnant, trying to get pregnant, or breastfeeding and willing to use 
acceptable birth control for duration of medication use 
8.  Participant is willing to comply with all study procedures and be available for the duration of the 
study 
 
Exclusion Criteria 
1. Contraindication to NRT use (pregnancy, myocardial infarction in past 2 weeks) 
2. Previous reaction to the nicotine patch or mini-lozenge that prevented them from continuing to 
use it 
3. Allergy to Adhesive Tape 
4. Current Diagnosis of congestive heart failure, stomach ulcers, seizure disorder, or diabetes.  
5. Diagnosis of stroke in the past year 
6. Diagnosis of and/or treatment for schizophrenia, other psychotic disorders, or bipolar disorder 
within the last 5 years 
7. High Blood Pressure not controlled with medication 
8. Current use of smoking cessation medications (any NRT, bupropion, varenicline) 
9. Caregiver’s child is being cared for by PI (Dr. Brian Williams) 
10. Need for an interpreter 
 Vulnerable Populations 
No vulnerable populations will participate in this research. 
 Lifestyle Considerations 
N/A 

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 Subject Identification 
8.4.1 Electronic Health Record (EHR) Query  
To identify potential caregivers in the hospital who smoke, the EHR of pediatric patients admitted to the 
med-surg (non-ICU) units at AFCH will be reviewed by Dr. Williams to identify which patients screened 
‘yes’ to the question, “Does anyone in your household smoke”. Dr. Williams will conduct further 
screening to determine if the child is expected to be admitted for >24 hours by reviewing the patient’s 
chart and discuss expected discharge with the bedside nurse. The team will also ensure the pediatric 
patient is not being cared for by Dr. Williams and no interpreter is needed. 
 
This screening protocol is similar to the approach used in prior research at AFCH. See IRB ID: 2019-
0866. 
 Subject Recruitment 
Participants in this study will be caregivers of children admitted at American Family Children’s Hospital 
(AFCH). A total of 50 participants will be recruited from 1 site, AFCH in Madison, WI. Potential participants 
will be identified through the hospitalized child’s EHR. Individuals from populations who are 
underrepresented in clinical research (e.g., racial and ethnic minorities, women, individuals from rural and 
underserved communities, older individuals, federally recognized nations and tribes) will be prioritized for 
enrollment with a goal of ensuring that all eligible individuals are given the opportunity to participate and 
that research findings can be generalizable to the entire population. Please note that due to the limited 
resources available for this pilot study, we will not have access to interpreter services but seek to address 
this in a larger, future study. 
 
Given the specific population being recruited (individuals who smoke and are the primary caregivers of a 
hospitalized child) no additional specific recruitment strategies will be employed.  
 Remuneration and Retention Strategies 
Strategies for retention include:  
• 
Participants will receive a reimbursement of $20 for each completed study survey (pre-intervention, 
within 24 hours of hospitalized child’s discharge, 2 weeks post-discharge) for a maximum total of $60. 
The reimbursement will be provided as cash for the pre-intervention and as a $20 gift card (emailed to 
participant) for surveys completed on day of discharge and 2-weeks after discharge from the hospital. If 
a participant does not have a valid email-address, we would mail them a gift card to their home 
address. 
 Early Termination and Withdrawal 
Subjects are free to withdraw from participation in the study at any time upon request. 
 
The Principal Investigator (PI) may discontinue or withdraw a subject from the study for the following 
reasons at his discretion: 
• 
Pregnancy 
• 
If any clinical adverse event (AE) or other medical condition or situation occurs such that continued 
participation in the study would not be in the best interest of the subject 
 
Given the primary outcome of feasibility, subjects who sign the informed consent form and do not receive 
the study intervention will not be replaced. Similarly, subjects who sign the informed consent form, receive 
the study intervention, then subsequently withdraw, or are withdrawn or discontinued from the study, will 
not be replaced. 

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9.0 
STUDY AGENT (STUDY DRUG, DEVICE, BIOLOGIC, VACCINE, ETC.) AND/OR PROCEDURAL 
INTERVENTION AND/OR BEHAVIORAL/SOCIAL INTERVENTION 
 Study Agent and Control Description 
Study Product 
The study product (medication) is nicotine replacement therapy (NRT) consisting of both nicotine patches 
and nicotine mini-lozenges. These forms of NRT are both FDA-approved medications for smoking 
cessation and are available over the counter for individuals ≥18 years of age. This study meets criteria for 
IND Exemption of a lawfully marketed drug (21 CFR 312.2(B)(1)). NRT meets the following required criteria 
to be listed under the IND exemption of a lawfully marketed drug: (a) the drug or biologic is lawfully 
marketed in the United States, (b) the research is not intended to be reported to the FDA as a well-
controlled study in support of a new indication for use nor intended to be used to support any other 
significant change in the labeling for the drug, (c) the research is not intended to support a significant 
change in the advertising for the product, (d) the research does not involve a route of administration or 
dosage level or use in a patient population or other factor that significantly increases the risks (or 
decreases the acceptability of the risks) associated with the use of the drug product, and (e) the research is 
conducted in compliance with the marketing limitations described in 21 CFR §312.7 
 
Participants in the study will receive a 2-week supply of both nicotine patches and nicotine mini-lozenges. 
Patches are worn for 24 hours at a time and are used to provide a steady state of nicotine to reduce 
cravings. Mini-lozenges are used on an as needed basis to treat acute cravings. The nicotine patch is 
dosed based on the number of cigarettes smoked per day (>10 = 21mg patch per day, <10 = 14mg patch 
per day). Nicotine lozenges are dosed based on how soon after waking an individual smokes the first 
cigarette (≤30 mins after waking = 4mg mini-lozenge, >30 minutes after waking = 2mg mini-lozenge). 
Participants will be provided NRT at the conclusion of their counseling session with Dr. Williams. They will 
be encouraged to begin using NRT at the time that it is dispersed. Recommended dosing schedules are 
provided (patches - apply a new patch daily, mini-lozenges – use as needed for cravings). Only participants 
whose child is still hospitalized 14 days after study enrollment will receive an additional 2-week supply of 
NRT.  
 
Active Control: N/A 
Placebo: N/A 
9.1.1 Source 
Nicotine patches and mini-lozenges will be ordered via standard of care institutional procedures. 
Neither product requires temperature control.  
 Study Procedural Intervention(s) Description  
N/A 
 Study Behavioral or Social Intervention Description 
Counseling Session:  
Counseling sessions will last approximately 20 minutes and will focus on 3 objectives: 1) review 
participants’ motivation for smoking and for quitting and 2) use the information on participants’ motives to 
provide tailored education regarding a) benefits of quitting smoking to the caregiver and the child, b) 
strategies to reduce nicotine withdrawal symptoms/urges to smoke during the hospitalization, and c) 
benefits of smoke-free home and car rules; and 3) review smoking cessation resources.  

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9.3.1 Administration of Behavioral or Social Intervention 
The behavioral intervention will be delivered in person and will consist of a single counseling session 
lasting approximately 20 minutes. It will be delivered by Dr. Brian Williams who is board-certified in both 
internal medicine and pediatrics. The intervention will occur either in the pediatric patient’s room at 
AFCH or in a private conference room on the same floor as the child’s hospital room (per caregiver 
preference). The intervention will occur on the same day as study enrollment. 
9.3.2 Procedures for Training Interventionalists and Monitoring Intervention Fidelity 
The behavioral intervention will be conducted by the PI who will document each counseling component 
that is covered during the session (Review participants motivation for smoking/quitting, Education, 
provide quit resources). If any part of the counseling session is not completed, this will be documented 
along with reason for not completing that component. If NRT is not accepted, this will also be 
documented along with reason for not accepting. Duration of counseling will be documented. 
 Method for Assigning to Treatment Groups 
N/A 
 Unblinding Procedures 
N/A 
 Study Intervention Compliance 
The primary outcome of this study is feasibility. We record whether participants accept NRT and whether 
they complete the behavioral intervention (counseling session). Participants’ use of NRT will be assessed 
via surveys. Given the pilot nature of this study with a focus on feasibility, we will not replace participants if 
they choose to not complete any part of the study intervention or withdraw completely from the study. 
 Concomitant Therapy 
9.7.1 Permitted Concomitant Therapy 
Aside from the prohibited concomitant therapy noted below, all additional medications that patients are 
taking will be allowed (per FDA package insert). 
9.7.2 Prohibited Concomitant Therapy 
Current use of any smoking cessation medications: NRT, bupropion, or varenicline. 
10.0 
STUDY VISITS AND PROCEDURES 
 
Study Calendar 
The procedures performed at each study visit are listed in the table below. 
Procedure 
Screening 
Visit 1 
(MD) 
Within 24h of 
discharge 
Post-Discharge 
Date of Pediatric 
Admission 
+0-23 hours 
+0-23 
hours 
1-14+ days 
+14 days from 
discharge date 
Assess 
Inclusion/Exclusion 
Criteria 
X 
 
 
 
Informed Consent 
X 
 
 
 
Demographics 
X 
 
 
 

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Procedure 
Screening 
Visit 1 
(MD) 
Within 24h of 
discharge 
Post-Discharge 
Complete Survey 
X 
 
X 
X 
Administer Study 
Intervention 
 
X 
 
 
Adverse Event Review and 
Evaluation 
 
 
X 
X 
 
Screening and Enrollment 
The Screening and Enrollment visits and procedures are described in detail below. 
10.2.1 Pre-screening 
Pre-screening will consist of reviewing the charts of pediatric patients admitted to AFCH in the previous 
24 hours. Charts will be reviewed by the study MD who has completed HIPAA and human subjects 
training. Patients who are under the care of the study MD will not be reviewed. Only the nursing intake 
assessment in the EHR will be reviewed to identify if the admitted pediatric patient screened positive for 
“Does anyone in your household smoke”. If the answer is ‘no’, this will be tallied but no additional 
information will be recorded, and the chart will be closed. If the answer is ‘yes’, the study physician will 
review the need for an interpreter as well as the History and Physical to determine if the child is likely to 
be admitted for an additional 24 hours. No information from the child’s chart will be recorded. Hospital 
duration will also be reviewed with the bedside RN. If the child is expected to be admitted for >24 
hours, the research coordinator will be notified to assess caregiver eligibility. 
 
The research coordinator will approach caregivers to introduce themselves and briefly describe the 
study. Potentially interested participants will be screened for eligibility criteria and interest in learning 
more about the study (see document ‘Study Invitation and Screening’). Those who are interested in 
learning more about the study will complete informed consent and all screening procedures as 
described below. Those who are not interested in learning more will have their response tallied but no 
additional information will be collected. The pre-screening discussion with potential participants is 
estimated to take less than 5 minutes. 
10.2.2 Informed Consent 
Overview: The informed consent process will be initiated prior to the individual’s agreeing to participate 
in the study and continue throughout the individual’s study participation. The consent form will be 
Institutional Review Board (IRB)-approved. To minimize the possibility of coercion or undue influence in 
the consent process, participants will be informed that their decision to participate or not participate will 
have no effect on the care their child receives. Only the caregiver who is participating in the study will 
be allowed to provide informed consent. The study will not enroll any individual who cannot provide 
their own informed consent. 
Preliminarily eligible subjects will be approached in the child’s hospital room. They will be invited to a 
separate conference room (or to stay in the child’s room) for informed consent and formal screening. 
The screening questions will be reviewed with the participant after a brief study description. A consent 
waiver to ask the screening questions (prior to obtaining full consent) is being requested due to the 
minimal risk nature of the screening items and the desire not to waste caregivers’ time with consent 
procedures if they are not eligible to participate. The informed consent process will be conducted 
following all federal and institutional regulations relating to informed consent. Informed consent will be 
obtained prior to conducting any study-related activities. 
 
The informed consent process will be performed as follows: 
• 
A video will be played by the research coordinator explaining the study, its risks and benefits, what 
would be required of the research subject, and alternatives to participation. 

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• 
The research coordinator will review the informed consent form and discuss the study in detail with 
the potential research subject.  
• 
The subject will be asked to read and review the informed consent document. 
• 
The subject will have the opportunity to ask questions and have all questions answered by the 
research coordinator and/or PI. 
• 
The research subject will be given the opportunity to discuss it with family members, friends, clergy 
or others as they desire.  
• 
The informed consent document must be signed and dated by the research subject. 
• 
The research coordinator will review the informed consent document to ensure that all fields that 
require a response are completed. 
• 
The research subject will be given a copy of an unsigned consent form. The original signed 
informed consent form is kept in a locked cabinet in the PI’s office (which also requires a key to 
enter). 
10.2.3 Screening Visit 
During the screening visit, the research coordinator will explain the study, review inclusion/exclusion 
criteria, and obtain informed consent as described in section 10.2.2. If Inclusion/Exclusion criteria are 
not met, the reason will be recorded. Once informed consent is obtained and the participant meets all 
inclusion/exclusion criteria, the participant will be provided a study tablet to complete a baseline survey.  
10.2.4 Enrollment 
A research subject will be defined as “enrolled” in the study when they meet the following criteria: 
• 
The subject has been consented by study staff.  
• 
The subject and study staff have completed all screening documentation. 
• 
The PI has verified that the subject meets all the inclusion criteria. 
• 
The PI has verified that subject meets none of the exclusion criteria. 
• 
The subject has scheduled a study visit. 
10.2.5 Screen Failure and Re-enrollment 
Individuals who do not meet the criteria for participation in this trial (screen failure) will not be 
rescreened during their child’s hospitalization. They will be offered a referral to the Wisconsin Tobacco 
Quit Line.  
 
On-Study/Follow-up Visits 
After subjects have been enrolled, the visit activities and follow-up surveys are described in detail below. 
10.3.1 Visit 1: Intervention - Counseling and NRT 
All participants will receive a one-time visit with the study PI who also serves as the study physician. 
This visit will occur on the day of study enrollment, either in the patient’s room or in a private 
conference room on the same floor as the child’s hospital room – per caregiver preference. This visit 
will consist of a brief counseling session. Counseling sessions will last approximately 20 minutes and 
cover the 3 objectives of 1) review participants’ motivation for smoking and for quitting and 2) use the 
information on participants’ motives to provide tailored education regarding a) benefits of quitting 
smoking to the caregiver and the child, b) strategies to reduce nicotine withdrawal symptoms/urges to 
smoke during the hospitalization, and c) benefits of smoke-free home and car rules; and 3) review 
smoking cessation resources. 
After the counseling session, participants will also be provided a 2-week supply of nicotine patches and 
nicotine mini-lozenges, along with instructions for their use. The study physician will review how to use 
the medication, dosing, benefits of use, and potential side effects of use. Data collected at this visit will 
include whether each objective of the counseling session was covered (participant motivations, 
education, smoking cessation resources), duration of counseling, and dose of NRT provided. If any 

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portion of the intervention is not completed, reasons for not completing will be documented. Participants 
whose child remains hospitalized 14 days after study enrollment will be offered an additional 2-week 
supply of both NRT patches and NRT mini-lozenges. 
10.3.2 Follow-Up Number 1: Discharge Survey  
Within 24 hours of discharge, participants will be contacted to complete a post-intervention survey via 
UW REDCap. Attempts will be made to complete the survey on a study tablet at the bedside. If we are 
unable to complete the survey using a study tablet, a link to the UW REDCap survey will be emailed to 
the participant from a secure, University of Wisconsin email and will assess NRT use during the 
hospitalization and likelihood that the participant would recommend program implementation in the 
hospital. If the survey is not completed within 48 hours, one follow-up email will be sent. If there is still 
no response after an additional 48 hours, we will call the participant to attempt to fill out the survey via 
phone. In the case that the participant does not have an email address, the survey will be mailed to 
them along with a pre-addressed stamped envelope. Smoking behavior during the child’s 
hospitalization will be examined, including assessments of 1) number of cigarettes smoked per day and 
2) number of times participant left the bedside to smoke per day. Participant’s self-efficacy and interest 
in quitting smoking will be assessed, using the same questions from the pre-intervention survey, to 
assess for changes after the intervention. Any questions or concerns the participant has, along with 
changes in physical or mental health will also be assessed in this survey. Any positive response will 
lead to a phone call from the study physician within 24 hours. Participants will receive a $20 gift card to 
Amazon via email for completing the discharge survey. If an email address is not available, the gift card 
will be mailed to them. 
10.3.3 Follow-Up Number 2: 2-Week Post-Discharge Survey 
Participants will be contacted again via email 2 weeks after discharge with a link to complete the follow-
up survey via UW REDCap (or mailed a copy if preferred). If the survey is not completed within 48 
hours, one follow-up email will be sent. If there is still no response after an additional 48 hours, we will 
call the participant to attempt to fill out the survey via phone. In the case that the participant does not 
have an email address, the survey will be mailed to them along with a pre-addressed stamped 
envelope.  Using similar questions as the discharge survey, we will again assess current smoking 
status, use of NRT post-hospitalization, self-efficacy and interest in quitting smoking, establishment of 
smoke-free home and car rules, and interest in ongoing smoking cessation treatment. Any questions or 
concerns the participant has, along with changes in physical or mental health will also be assessed in 
this survey. Any positive response will lead to a phone call from the study physician within 24 hours. 
Participants will have a $20 gift card to Amazon emailed to them within 24 hours of completing this 
survey. If the participant does not have an email address, the survey and gift card will be mailed to 
them. 
 
Unscheduled visits will not occur for the study. 
 
Early Termination/Withdrawal Visit 
Subjects who are either withdrawn or terminated early from the study will not have any additional follow-up.  
 
Long-Term Follow-up | Re-contacting Subjects 
N/A 
11.0 
CORRELATIVE | SPECIAL STUDIES 
[N/A] 

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12.0 
DATA HANDLING AND RECORD KEEPING 
 
Data Collection  
12.1.1 Data Collection Forms 
Standardized data collection forms (e.g., source standardized assessment forms, etc.) will be used to 
ensure data collected are consistent and compliant with the protocol and IRB application. 
 
Data collection is the responsibility of study team members under the supervision of the Principal 
Investigator (PI). The PI is responsible for ensuring the accuracy, completeness, legibility, and 
timeliness of the recorded and reported data. 
 
All data collection will be completed electronically, ensuring legibility; any missing data will be 
explained. The only exception will be follow-up survey paper forms mailed to participants (if requested 
by participant) 
 
Data collection forms are maintained in the subject files and retained as described in Section 12.3: 
Records Retention. 
12.1.2 Data Management Software System(s) 
Participant data (demographics, survey responses, intervention completion, AE’s) will be entered into 
the following data management software system(s) to ensure consistent data entry and data quality: 
REDCap. 
 
REDCap 
The UW REDCap system is used to manage the data for this study. REDCap is a largely self-service, 
secure, web-based application for building and managing data collection forms. REDCap provides data 
management functionality by allowing the development of instrument and surveys to support data 
capture for research studies. 
 
 
Confidentiality and Privacy 
Subject confidentiality and privacy are strictly held in trust by the participating investigators, their staff, and the 
sponsor. Therefore, the study documentation, data, and all other information generated will be held in strict 
confidence. No information concerning the study, or the data, will be released to any unauthorized third party 
without prior written approval of the sponsor. All research activities will be conducted in as private a setting as 
possible. 
 
All study staff engaged in the conduct of this project have completed training on the protection of human 
subjects and the Health Insurance Portability and Accountability (HIPAA) Privacy Rule. In addition, all key 
personnel (i.e., Principal Investigator, individuals involved in identifying/recruiting subjects, obtaining informed 
consent, or interacting and intervening with subjects) have undergone Good Clinical Practice (GCP) training. 
 
Data generated through study participant survey completion using UW REDCap will be stored in secure 
databases under protections and procedures consistent with the guidelines and regulations of the UW School 
of Medicine and Public Health (UW-SMPH).. 
  
As stated above, no data are stored on individual computer hard drives. All data are transmitted from the point 
of collection to the UW REDCap system through a secure, encrypted web connection. On those rare occasions 
when, due to a loss of internet access or computer hardware failure, data are collected in paper forms, these 
forms will be stored securely in a locked cabinet within the PI’s locked office. Any data collected on paper will 

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be entered into the computer and the paper document disposed of securely. Consent forms are obtained in 
paper copy; these forms contain the participant’s name and signature. These are retained in secure files at the 
PI’s office, where they are securely stored. 
Study staff may use e-mail, mail or phone calls to communicate with research subjects, if the subject has 
agreed (in the informed consent form) to using email, phone, and mail . The information contained in the email 
will be limited to a link to complete the study survey. Emails will be sent from secure institution-based 
accounts; personal, home or Gmail email or texting accounts will not be used.  
 
Records Retention 
It is the investigator’s responsibility to retain study essential documents for a minimum period of 7 years 
following completion of the study per UW-Madison institutional policy. 
 
Retention for Future Research: [Optional or Mandatory] Data, Image, Audio- or Video-
Recording & Biospecimen Banking  
Not Applicable 
 
Protocol Deviations 
A protocol deviation is any noncompliance with the clinical trial protocol. The noncompliance may be either 
on the part of the subject, the investigator, or the study site staff. As a result of deviations, corrective 
actions are to be developed by the site and implemented promptly. 
 
It is the responsibility of the Principal Investigator and study staff to use continuous vigilance to identify and 
report deviations. The Principal Investigator is responsible for assessing whether the deviation constitutes 
noncompliance as defined by the reviewing IRB and if so, reporting it within the required time frame(s). The 
PI is responsible for knowing and adhering to the reviewing IRB requirements. 
 
Publication and Data Sharing Policies 
The study sponsor (UW Department of Pediatrics) does not have a specific public data sharing policy. 
Authorship guidelines will be strictly followed based on the publishing journal’s authorship policy. 
13.0 
STUDY ANALYSIS 
 
Statistical Hypotheses 
• 
Primary objective(s): Our primary objective is to evaluate the feasibility and acceptability of a smoking 
intervention (NRT and cessation counseling) for caregivers of children admitted at American Family 
Children’s Hospital (AFCH). 
Our primary hypothesis is that more than 50% of eligible caregivers offered will enroll in the study, use 
NRT, and recommend program implementation in the hospital. 
 
• 
Secondary Objective(s): Our secondary objectives are to evaluate effects of a smoking intervention 
on additional key outcomes, such as the number of cigarettes a caregiver smokes per day while their 
child is hospitalized, number of times they leave the bedside to smoke per day, and changes in self-
efficacy and interest in quitting pre- and post-intervention 
 
Our secondary hypothesis is that caregivers who participate in the intervention will be able to reduce their 
smoking by 50% during their child’s hospitalization, will leave the bedside to smoke 50% less frequently 

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than they predicted, and report an increase in scores assessing self-efficacy and interest in quitting 
smoking after completing the study intervention. 
 
Sample Size Justification 
This is a pilot study focusing on feasibility and acceptability of a smoking cessation intervention at AFCH. 
The sample size of 50 will permit estimates of effect sizes but will not be powered to detect statistical 
differences in outcomes. Findings will be used to estimate sample sizes needed for a fully powered future 
trial.   
 
We anticipate enrollment rate of 1 in 8 charts reviewed (approximately 25% of charts will have documented 
smoke exposure, of those we estimate 50% will enroll). This means we anticipate needing to screen 400 
charts to reach our enrollment population of 50 participants. 
 
Subject Population(s) for Analysis 
The primary outcome of this study is feasibility and acceptability. See statistical methods below (Section 
13.4) for details on statistical approach to our study population. 
 
Statistical Methods 
Basic cohort demographics will be evaluated using descriptive statistics. Aim 1 objectives will be achieved 
via descriptive statistics regarding feasibility (percentage who enrolled, percentage who used NRT) and 
acceptability of the interventions (likelihood to recommend program implementation). For Aim 2, 
comparative analyses will be used to identify differences between the baseline survey and both the 
discharge survey and 2-week follow-up survey regarding key outcomes: cigarettes smoked per day (pre-
hospitalization vs during hospitalization and at 2-week follow-up), leaving the bedside (predicted vs actual), 
and pre- and post-intervention changes on self-efficacy and interest in quitting smoking. Frequency of non-
smoking home and car rules will also be assessed by comparing pre-intervention and 2-week follow-up 
survey responses. Specifically, for Aim 2, we will use general linear modeling which will allow us to control 
for baseline levels of the outcome variables.  
 
Planned Interim Analysis 
Not Applicable 
 
Handling of Missing Data 
Not applicable. 
14.0 
RISK/BENEFIT ASSESSMENT 
 
Known Potential Benefits to the Subjects 
The potential benefits to research subjects associated with this study include the possible reduction in, or 
cessation of, smoking as well as reduction of withdrawal symptoms when they are not able to go outside to 
smoke due to their caretaking responsibilities. These potential benefits will also be provided to the 
participant’s informed consent and in the package inserts from the nicotine patch and mini-lozenges. 
 
If this study is able to show a therapeutic benefit of reduced smoking in caregivers while their child is 
hospitalized, the community at large would benefit by the availability of a future standardized approach to 
all caregiver’s who smoke at AFCH while their child is hospitalized.  

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Known Potential Risks 
The one-time counseling session could lead to adverse psychological feelings of guilt, shame, sadness, 
anxiety around smoking, exposing a child to tobacco smoke, and anxiety over thoughts of quitting. The use 
of cessation medications poses a risk of side-effects. Participants will be made aware of the common 
nicotine replacement side effects before they consent to participate in the study. It should be noted that the 
nicotine patch and nicotine mini-lozenge are available over the counter. The Food and Drug Administration 
(FDA) has approved using a combination of two forms of NRT (e.g., nicotine patch + nicotine mini-lozenge) 
for smoking cessation. These interventions have also been studied and used safely in multiple clinical 
trials, are used by clinicians in clinical practice, are available over-the-counter, and are reviewed in the 
2008 PHS Guideline10. The PHS Guideline, in fact, recommends combination NRT as a particularly 
effective treatment. The self-assessment follow-up surveys ask about smoking behavior and any new 
medical or emotional symptoms. These questions may make participants feel uncomfortable. 
 
There is always a remote, but existing, possibility that sensitive or personal information about a participant 
could be divulged as a function of his/her research participation. No information about illegal behavior will 
be collected by research staff. Finally, smoking withdrawal is associated with a number of unpleasant 
symptoms, such as sleep disturbance, hunger, craving, and negative mood. Most smokers have tried to 
quit before and are familiar with these phenomena. Though unpleasant, smoking withdrawal symptoms 
pose minimal health risk. Participants will be informed about the possible effects of smoking withdrawal 
should they decide to quit or cut down on their smoking. Individuals who elect not to participate in this 
research, or are eliminated due to screening failure, will be provided a referral to the Wisconsin Tobacco 
Quit Line.  
14.2.1 Known Interventional Risks 
The nicotine patch is generally well tolerated, but up to 50% of participants may have a local skin 
reaction, and rarely, individuals may have a more systemic allergic reaction. The nicotine patch is also 
known to cause vivid dreams or other sleep disturbances. If this occurs, participants are instructed to 
remove the patch at bedtime. The most likely side effects associated with the nicotine mini-lozenge are 
heartburn, hiccup, nausea, upper respiratory tract infections, coughing, and sore throat. Although most 
smokers have tolerance to nicotine, symptoms of acute nicotine toxicity (nausea and vomiting) are 
possible. Information about side effects can be found on the package insert for both products and will 
be provided to participants.  
 
The risk of NRT in pregnancy is unclear. Per the package insert “If you are pregnant or breast-feeding, 
only use this medicine on the advice of your health care provider. Smoking can seriously harm your 
child. Try to stop smoking without using any nicotine replacement medicine. This medicine is believed 
to be safer than smoking. However, the risks to your child from this medicine are not fully known”. 
Pregnancy or intention to get pregnant are exclusion criteria and a voluntary statement of intent to 
avoid pregnancy is listed at the end of the informed consent document.  
14.2.2 Other Known Study Risks 
N/A 
 
Risk/Benefit Analysis 
Given the limited risks of NRT, the rigorous pre-treatment screening, and the availability of both a physician 
and psychologist to address any adverse effects, we believe that the potential risks involved in participating 
in the study are low and outweighed by the benefits to both the individual study participant and society. 
 

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15.0 
DATA AND SAFETY MONITORING  
Please see the Data Safety and Monitoring Plan (DSMP), which has been added to the ARROW application. 
 
16.0 
STUDY FEASIBILITY  
 
Economic Burden to Subjects 
Subjects will not have to pay for study procedures (counseling) or medications (NRT). Subjects will be 
responsible for any costs related to follow-up from smoking cessation such as clinic visits (including out of 
pocket costs) for change in mood or side effects from use of NRT. This is included in the informed consent 
document.    
 
Facilities and Locations 
American Family Children’s Hospital: Study participants consist of caregivers of children who are admitted 
to a Med-Surg floor (non-ICU) at American Family Children’s Hospital. The study intervention (smoking 
counseling and distribution of NRT) will occur in-person, either in the child’s room or in a separate, private, 
conference room on the same floor of the child’s hospital room (per caregiver preference). 
 
Feasibility of Recruiting the Required Number of Subjects 
Approximately 25% of children at AFCH are documented as having smoke exposure. We anticipate half of 
those will agree to participate in the study. Thus, with a sample size of 50, we anticipate we will need to 
screen 400 charts in order to meet our sample size of 50. On average, there are an average of 8 
admissions to AFCH Med/Surg units per day, thus we anticipate being able to recruit the required sample 
within 3-6 months. 
 
Principal Investigator Considerations 
16.4.1 Time Devoted to Conducting the Research 
Dr. Williams currently has 30% FTE devoted to clinical research via internal start-up funds. It is 
estimated that he will spend 1.5 hours per day on this research project (18.75% FTE) for a 3-month 
period (active enrollment) and 1 hour per day (12.5% FTE) on this project for an additional 3 months 
(data analysis, abstract/manuscript preparation). He is also currently involved in additional studies at 
UW-CTRI though has flexible FTE allowing for this project. 
16.4.2 Process for Informing Study Teams 
Prior to the commencement of research, Dr. Williams and the research coordinator will review the study 
protocol in detail. The research coordinator has experience in study recruitment and obtaining informed 
consent. We will perform mock trials of recruitment, participant screening, obtaining informed consent, 
and counseling sessions to ensure adherence to study protocol. 
 
Availability of Medical or Psychological Resources 
Smoking cessation has the potential for psychological consequences including increased stress, anxiety, 
and depression. Use of NRT is associated with side effects. Participants will have access to the study 
physician, should any psychological or medication side effects occur. They will also have access to Dr. 
Megan Piper (Co-Investigator) who is a licensed clinical psychologist, should any psychological concerns 
develop. 

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17.0 
MULTI-SITE RESEARCH 
Not Applicable 
18.0 
REFERENCES 
1. U.S. Department of Health and Human Services. The Health Consequences of Smoking—50 Years of Progress: A 
Report of the Surgeon General. Atlanta (GA): U.S. Department of Health and Human Services, Centers for 
Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on 
Smoking and Health, 2014. 
2. U.S. Department of Health and Human Services. The Health Consequences of Involuntary Exposure to 
Tobacco Smoke: A Report of the Surgeon General. Atlanta: U.S. Department of Health and Human Services, 
Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health 
Promotion, Office on Smoking and Health, 2006 [accessed 2022 Nov 5]. 
3.  Pyle RC, Divekar R, May SM, et al. Asthma-associated comorbidities in children with and without secondhand 
smoke exposure. Ann Allergy Asthma Immunol. 2015;115(3):205–210 
4. Ahn A, Edwards KM, Grijalva CG, et al. Secondhand smoke exposure and illness severity among children 
hospitalized with pneumonia. J Pediatr. 2015;167(4): 869–874.e1 
5. Behrooz L, Balekian DS, Faridi MK, Espinola JA, Townley LP, Camargo CA Jr. Prenatal and postnatal tobacco 
smoke exposure and risk of severe bronchiolitis during infancy. Respir Med. 2018;140: 21–26 
6. Wilson KM, Pier JC, Wesgate SC, Cohen JM, Blumkin AK. Secondhand tobacco smoke exposure and severity of 
influenza in hospitalized children. J Pediatr. 2013;162(1):16–21 
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Appendices 

Treating Caregivers who Smoke at AFCH 
 
Williams 
 
 
 
Version 1: Research Protocol  
Version Date: [04/30/2023] 
Page 21 of 21 
 
 
Appendix A