Disseminating and Implementing a Smoking Cessation Program Fro Pregnant and Postpartum Women
Phase: NA
Conditions: Smoking, Tobacco Use Disorder
Sponsor: University of Wisconsin, Madison

Disseminating and Implementing a Smoking Cessation Program for 
Pregnant and Postpartum Women 
Study Protocol 
 
PI:  
Michael C. Fiore MD, MPH, MBA 
Professor of Medicine 
Director, Center for Tobacco Research and Intervention 
University of Wisconsin School of Medicine and Public Health 
 
Protocol Version Date:  
August 17, 2016 
 
Co-investigator:  
Bruce Christiansen, PhD 
Senior Scientist 
Center for Tobacco Research and Intervention 
University of Wisconsin School of Medicine and Public Health 
 
Study Coordinator: 
Lisette Khalil, J.D. 
Operations Director 
Wisconsin Women’s Health Foundation 
 
Funding Sponsor: 
UW Institute for Clinical and Translational Research 
 
 

1 
 
Project Summary: 
     There is a compelling need to disseminate and implement effective programs that help 
pregnant women quit smoking and stay quit postpartum. Smoking during pregnancy results in 
unequalled risks to the mother and newborn, (placental abruption, preterm birth, SIDS) and 
markedly increased healthcare costs (NICU admissions).  While prenatal smoking cessation 
interventions do help women quit, postpartum relapse rates can be as high as 85%. This proposal 
will test whether a smoking cessation intervention for pregnant women that extends postpartum 
(Striving to Quit) can be implemented and disseminated outside of the research environment that 
established its effectiveness (40% biochemically verified 6-month postpartum quit rates). 
Research aims include: 
1. Can Striving to Quit, a cessation program for pregnant women who smoke, be 
implemented effectively to low-income pregnant and postpartum women in Northeast 
and Southwest Wisconsin communities (including Milwaukee) outside of a rigorous 
research protocol?  
 
2. Is Striving to Quit more effective in achieving postpartum smoking cessation than “First 
Breath,” the current standard of care for pregnant women in Wisconsin who smoke?  
 
3. What barriers exist to dissemination of Striving to Quit throughout Wisconsin, and how 
can these barriers be addressed?  
     The study applies the Consolidated Framework for Implementation Research (CFIR) and the 
design is an innovative Type II hybrid that combines both comparative effectiveness research 
and dissemination and implementation research to speed the translation of research findings into 
clinical practice.  250 women will be randomized into one of two study groups.  Pregnant women 
in Group A (“FB”, n=125) will receive the existing First Breath prenatal intervention. Those in 
Group B (“STQ”, n=125) will receive all Group A interventions, plus 1 additional prenatal home 
visit, 3 postpartum in-home smoking cessation counseling visits, 3 postpartum phone calls, and 
up to an additional $100 in gift cards. The primary outcome will be biochemically confirmed 
smoking cessation at 6-months postpartum. This dissemination and implementation research will 
include three stakeholder groups: First Breath prenatal care providers, In-home counselors 
(Health Educators), and Policymaker/Purchasers.  Stakeholders will be engaged via 
focus/discussion groups, stakeholder advisory committees, and online surveys.  The RE-AIM 
framework will be used to analyze participant interviews, surveys, and case record reviews that 
measure program adherence, adoption of smoke-free strategies, acceptance of the intervention 
and perceived social support. The dissemination and implementation results will be integrated 
with the comparative effectiveness results to support full-scale STQ dissemination. 
     At the conclusion of this project, we will be poised for statewide dissemination of STQ.  This 
will include a viable plan, which may include combining funds from multiple sources to address 
the anticipated need for system changes. We will seek external funds to support training, 
technical assistance, and evaluation activities, especially measures of fidelity.  
 
 

2 
 
Background and Significance: 
     There is a compelling need to disseminate and implement effective programs that help 
pregnant women quit smoking and stay quit postpartum. Smoking is the leading preventable 
cause of adverse pregnancy outcomes. Smoking one pack of cigarettes/day during pregnancy 
increases the risk of placental abruption by 40%1. Mothers who smoke during pregnancy have a 
23% greater risk for preterm births than nonsmokers2. Preterm birth is a leading risk factor for 
infant mortality, a tremendous problem in Milwaukee County where the infant mortality rate 
(11.3 deaths per 1,000 live births) is the 3rd highest in the nation3. Smoking during pregnancy 
causes between 20% and 29% of deaths due to Sudden Infant Death Syndrome (SIDS)4, and 
increases the risk of admission to an NICU by almost 20%5. In sum, smoking during pregnancy 
results in unequalled risks to the fetus and newborn, as well as markedly increased healthcare 
costs. 
     First Breath, managed by Wisconsin Women’s Health Foundation (WWHF) on behalf of the 
State of Wisconsin, is a well-established prenatal smoking cessation intervention that uses 
evidence-based practices and has served over 17,000 women since 2000. First Breath is 
delivered by health care providers at prenatal care locations where women already receive 
services. Approximately 85% of First Breath participants are Medicaid members. First Breath 
typically consists of 2 prenatal and on postpartum cessation counseling sessions, each lasting 2-5 
minutes, a fax-to-quit connection to the Wisconsin Tobacco Quit Line, and non-financial 
incentive gifts for the mom and expected baby. 
      The opportunity for cessation interventions during pregnancy is high; many pregnant 
smokers quit, at least short-term. At least 30% of First Breath participants self-report quitting 
smoking by their third trimester6.  Unfortunately, postpartum relapse rates are very high – 
approaching 85%7.  
     Stakeholders at First Breath sites (local public health officials, prenatal care providers, and 
WIC providers) have long identified the need to expand prenatal cessation services and extend 
smoking cessation services into the postpartum period. UW-CTRI addressed this need, with its 
partner WWHF, by conducting the 5-year Striving to Quit (STQ) study funded by Center for 
Medicare and Medicaid Services (CMS) (Preliminary STQ study). STQ was designed to address 
the high risk of postpartum relapse by providing in-home counseling sessions, phone call check-
ins, and financial incentives for abstinence. Women enrolled in First Breath (N=1,052) were 
recruited to participate in STQ. A 40% smoke free rate (biochemically verified) was observed at 
six months postpartum.  
     Striving to Quit was an experimental study. Unknown is whether this intervention can be 
implemented effectively outside the confines of a rigorous research protocol. In addition, we 
must present a compelling case for the superiority of STQ over the existing First Breath (FB) 
prenatal program before stakeholders will invest in the system changes required to extend 
smoking cessation interventions into the postpartum period. 
 
 

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Specific Aims/Study Objectives 
A. Specific Aims   
1. Can Striving to Quit, a cessation program for pregnant women who smoke, be 
disseminated and implemented effectively to low-income pregnant and postpartum 
women in Northeast and Southeast Wisconsin communities (including Milwaukee) 
outside of a rigorous research protocol?  
 
2. Is Striving to Quit more effective in achieving postpartum smoking cessation than “First 
Breath,” the current standard of care for pregnant women in Wisconsin who smoke? We 
hypothesize that Striving to Quit will be more effective than First Breath 
 
3. What barriers exist for the wide scale dissemination of Striving to Quit throughout 
Wisconsin, and how can these barriers be addressed?  
 
B. Study Duration  
    18 months 
 
 

4 
 
Research Design and Methods 
A. Study Overview  
     This proposal will test whether a smoking cessation intervention for pregnant women that 
extends into the postpartum period (Striving to Quit [STQ]) can be implemented outside of the 
research environment that established its effectiveness. We will be using the Consolidated 
Framework for Implementation Research (CFIR)8,9, to conduct this implementation study and 
identify barriers and solutions to dissemination. Our preliminary work with stakeholders 
identified the CFIR construct of Relative Advantage10 as a key construct. It determined that our 
approach needs to compare the existing First Breath’s prenatal-only program to an alternative 
solution, STQ, which expands services during pregnancy and includes postpartum home visits. 
This comparison is a key goal because STQ requires more clinical resources than First Breath 
and because First Breath providers currently have limited ability to seek reimbursement for 
postpartum services. Because of the need for compelling evidence of the superiority of STQ over 
the existing First Breath program, this project includes an effectiveness research component. 
Thus, the overall study design is an innovative Type II hybrid design that will efficiently test 
both clinical interventions and evaluate implementation strategies, speeding the translation of 
research findings into clinical practice11. We will use RE-AIM as our measurement 
framework12,13.  Specifically, the comparative effectiveness aspect of the project focuses on real-
world effectiveness while the implementation aspect focuses on adoption of the intervention.  
 
Implementation Evaluation (Aims 1 and 3) We will address aims 1 and 3 by structured 
interactions with three specific Stakeholder groups. Our interactions will be facilitated and 
evaluated using CFIR principles. Based on prior WWHF experience and preliminary stakeholder 
data, we hypothesize the following CFIR constructs to be highly relevant to implementing STQ:  
- 
Intervention characteristics of Relative Advantage; 
- 
Adaptability, Complexity, and Cost;   
- 
Outer setting characteristic of External Policy & Incentives;  
- 
Inner setting characteristics of Implementation Climate (Compatibility and Relative 
Priority) and Readiness (Available Resources); 
- 
Individual characteristics of Self-efficacy and Individual Stage of Change; and  
- 
Process characteristic of Engaging (External Change agents). 
Representatives from these stakeholder groups will only be asked about relevant aspects of 
implementing STQ statewide such as barriers to statewide implementation and resources needed 
for statewide implementation. There will be no personal information collected.  Stakeholder 
participants, are, therefore, not participating in research. The outcome for both aims 1 and 3 will 
be a Statewide Implementation Plan document. This document will describe a strategy for 
statewide implementation, an associated time line, the barriers to statewide implementation and 
sustainability, listed in order of perceived importance, and recommendations about how to 
address the identified barriers and challenges.      
     1) First Breath Providers – We will hold four discussion groups with Prenatal care providers 
currently providing First Breath (6-8 per group) using questions suggested by CFIR14 to identify 
implemnatation barriers, challenges, and needed resources. Since information obtained from 
these discussion groups is intended to inform the statewide expansion (Aim 3), these discussion 
groups will not be limited to the geographic area of this project (northeast and southeast).  
Rather, these discussion groups will take place throughout the entire state.  Recruitment for the 
discussion group will be purposive so that the diversity of First Breath providers is represented. 

5 
 
These groups will take place the first 6 months of the project. Discussion questions will be 
developed by WWHF staff and will come from the pool of recommended questions from the 
Consolidated Framework for Implementation Research (CFIR). WWHF staff will conduct the 
discussion groups. The discussion groups will begin with a description of STQ as First Breath 
providers may not be familiar with it. Participants will be paid $30. The discussion groups will 
be recorded. Recordings are transcribed verbatim and entered into SurveyGizmo (SG). Results 
will be coded using the text analysis tool in SurveyGizmo. 
     Discussion group findings will be used to create an e-survey for all First Breath providers in 
the state. Survey results will further clarify key implementation challenges and barriers for our 
eventual statewide dissemination plan. The purpose of this survey is to collect information from 
all First Breath providers about barriers to statewide implementation of STQ and possible ways 
to address these concerns and barriers. SurveyGizmo, the same software used in the preliminary 
STQ study, will be used to create the survey. It will be sent electronically to First Breath 
providers by WWHF staff using its database of these providers. Two electronic reminders to 
complete the survey will be sent. 
     2) Health Educators providing STQ – Staff providing the STQ intervention will be 
interviewed about the materials employed in the intervention and the intervention procedures by 
Krissy Alaniz, WWHF’s Perinatal Programs Manager, as part of their monthly quality 
assurance/quality improvement (QA/QI) meetings. Ms. Alaniz will develop questions designed 
to gather information about the challenges when delivering STQ, suggestions for improvement, 
and anticipated barriers to statewide implementation. Questions about this latter topic will be 
informed by the characteristics noted in the CFIR framework.  Responses will be recorded and 
integrated into a report. This report will be used with the other qualitative information (aim 1) to 
improve the STQ program in the real world and to prepare for state wide 
implementation/expansion. 
      3) Sustainability Planning Committee -  This group will be made up of First Breath site 
providers, representatives of the Wisconsin Department of Health services (Division of Public 
Health), Prenatal Care providers, and representatives of the BadgerCare Plus HMOs. The 
advisory group will meet four times with check-in calls or emails in between the in-person 
meetings:  at baseline, before enrollment if the comparative effectiveness study begins to provide 
feedback on study feasibility, initial plans, and likely challenges that can be anticipated; at three 
months and at six months after enrollment into the effectiveness study has begun to provide 
feedback on early successes and challenges and advise on potential project modifications that 
could improve implementation; and after the interventions included in the effectiveness study 
have been completed to review preliminary data and to discuss the statewide implementation 
strategy.  
 
Comparative Effectiveness Study (Aim 2) In this comparative effectiveness study we will 
compare the effectiveness of STQ to First Breath (FB) in real world settings. We will recruit 
low-income pregnant women who smoke in Northeastern and Southeastern WI (including 
Milwaukee) and invite them to participate in the study. Invitations will continue until 250 
women agree to participate. These 250 women will be randomized into one of two study groups, 
stratified by race/ethnicity and county as was done in the STQ preliminary study.  Pregnant 
women randomized to Group A (“First Breath/FB”, n=125) will receive the existing First Breath 
prenatal intervention. Pregnant women randomized to Group B (“Striving to Quit/STQ”, n=125) 
will receive all Group A interventions, plus 1 additional prenatal home visit, 3 postpartum in- 

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home smoking cessation counseling visits, 3 postpartum phone calls, and up to an additional 
$100 in gift card payments to increase program adherence and abstinence, similar to the 
preliminary 
STQ study (see 
table 1). The 
primary 
outcome 
measures will 
be women’s  
biochemically 
confirmed 
smoking 
cessation (i.e., 
breath carbon 
monoxide 
[CO] level of < 
6) at six months postpartum during an in-home counseling session.  
 
 
B. Study Population (recruitment, inclusion/exclusion criteria, selection, informed consent 
procedures) 
 
Population description and inclusion/exclusion criteria The participant pool for this study is 
pregnant women who have enrolled in the existing First Breath program in northeast and 
southeast Wisconsin, including Milwaukee (counties of Brown, Door, Kenosha, Manitowoc, 
Milwaukee, Outagamie, Racine, Waukesha and Waupaca). Inclusion criteria includes: age 18 or 
older; English speaking; willingness to quit or reduce smoking in the next 30 days (if not already 
quit) or if already quit, desire to remain quit after delivery; daily smoking (at least one cigarette 
per day for at least a week sometime in the past 6 months); and willing to provide updates in 
contact information.  Exclusion criteria include not being pregnant, not smoking in the past six 
months, not residing in one of the target counties or involved in another smoking research study.  
Based on First Breath enrollment in the target counties, 75% of participants will be low income 
and 48% of study participants will be African American. Health status will be varied, but will 
reflect low income women of child bearing ages.  
 
Recruitment and eligibility screening Participant screening and informed consent procedures are 
the same in this study as were approved for the preliminary STQ study. Potential study 
participants will be identified from existing First Breath sites located in the target counties. A set 
of affiliated providers (providers employed by clinics and community agencies) who have an 
agreement with the Wisconsin Women’s Health Foundation (WWHF) provide First Breath 
program services which includes supportive prenatal services to women who smoke.  Such 
services are designed to encourage smoking cessation during pregnancy and the maintenance of 
abstinence post-delivery.  These organizations are affiliated with, but not part of, the WWHF.  
These clinics and other providers will provide standard First Breath (FB) prenatal services to all 
participants in this study. This protocol refers to these organizations as First Breath sites. Staff at 
these sites will be providing only the existing First Breath services; their care procedures are 
Table 1. Study Conditions and Treatment Components 
Conditions 
Components 
Group A: 
First Breath  
(Prenatal) 
 
Health care provider-delivered First Breath cessation counseling at prenatal 
visits 
 
Link to WI Tobacco Quit Line 
 
One 6-month postpartum in-home abstinence evaluation visit (WWHF staff) 
 
Up to $40 total incentives for participation including $20 for enrollment and 
$20 for completing the six-month biochemical confirmation of abstinence  
Group B: 
Striving to 
Quit 
(Prenatal & 
Postpartum) 
All First Breath Components PLUS: 
 1 prenatal and 3 postpartum in-home counseling visits 
 3 postpartum counseling phone calls 
 Up to $100 additional incentives for participation & abstinence (up to $140 
total) 

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unaffected by this study.  They are not performing any research activities such as obtaining 
informed consent, collecting data or information they wouldn’t ordinarily collect for First Breath, 
or administering any of the clinical services/interventions that are part of this study but not part 
of the standard First Breath Program. Thus, these staffs are not conducting research and these 
First Breath sites are not research sites.  (All staff who are conducting research are employed by 
either UW-CTRI or the WWHF.)  
     Participant recruitment will take place among women enrolled in the First Breath program. 
First Breath program enrollment occurs following an enrollment survey form being sent from a 
First Breath site to the WWHF.  This form includes a wide variety of information including 
county of residence, information about ability to read/speak English, age, and other program-
relevant information. Based upon this First Breath enrollment form completed by the FB 
provider, WWHF staff will determine if the First Breath enrollee might be eligible to participate 
in this study using the inclusion/exclusion criteria above.  WWHF research staff will contact the 
enrollee by phone within one week of receiving the FB enrollment forms.  If after 5 attempts, 
WWHF has been unable to reach the FB enrollee, WWHF will send a letter inviting the enrollee 
to call the WWHF to see if they qualify for the study.  If the FB enrollment form is missing a 
phone number or the listed phone number is non-working, WWHF will send a letter inviting the 
FB enrollee to call the WWHF to see if they qualify for the study and will follow-up with the FB 
site.  If the enrollee hasn’t responded within 2 weeks, WWHF will follow-up with a postcard 
mailing. 
      Postcards announcing the availability of the study will also be provided to First Breath sites. 
Site staff place the postcards in patient folders, in exam rooms and in waiting rooms. In addition, 
the postcards will be distributed at community events in the target area attended by WWHF.     
     If the FB participant is screened to be eligible, the WWHF will: 
a) Describe the study briefly (including the opportunity to receive incentives), and the 
need to do screening, answer any questions the participant has, and then ask if she 
is interested and would be willing to be screened for possible participation 
b) Screen interested pregnant women for entry criteria: i.e., not involved in another 
stop smoking research study, and willingness to quit or cut down on smoking in 
the next 30 days (if not quit) or, if quit, desire to stay quit after the birth: 
c) Ask if she smoked daily (at least one cigarette each day for at least one week) at 
sometime within the last 6 months  
d) Ask about her willingness to complete additional surveys (phone and home) and 
do a CO breath test.  
e) Confirm her willingness to inform the WWHF as to any change in address, phone 
number, or clinic/site attended   
f) Confirm that she wants to quit or remain quit after delivery 
     If the woman does not pass screening, she will be given standard FB services as appropriate. 
De-identified data from such encounters will be kept by WWHF in order to determine sample 
representativeness of those who enter the study. 
Informed consent procedures If the participant completed inclusion questions successfully, the 
WWHF staff member will present the consent information to the participant over the phone and 
obtain and document the participant’s formal (verbal) study consent. This study would not be 
able to be performed with written consent for participation for the following reasons:   

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(a) The characteristics of this low income population include low levels of literacy and 
distrust of written communication requiring signature; a mailed and returned consent 
process would be unworkable, based on our experience with this population, since 
few would return the signed consent. 
(b) All participants receive standard First Breath interventions at First Breath sites at the 
outset of study participation; the first in-person contact with study staff does not 
occur until the first postpartum visit for participants assigned to the STQ condition 
and not until the 6-month postpartum visit for participants assigned to the FB 
condition and ate pregnancy for the STQ group. It is impractical and costly to try to 
perform hundreds of in-person visits for the sole purpose of obtaining consent.  If 
required, valuable resources for the study would be wasted.  Moreover, requiring an 
in-person visit would constitute an additional burden to this at-risk population. 
(c) The study poses very low risk—and offers very large benefits—to the target 
population. 
(d) Through the CMS-funded preliminary STQ study, the WWHF obtained verbal 
consent from 1052 low income pregnant women without incident.  
(e) The study is real world translational research.  An in-person or mailed signed consent 
would introduce barriers that would not be present in translation of its findings into a 
real-world environment.  These barriers would interfere with the study’s aims, since 
the study is designed to evaluate a real-world program. The reasons for this are:  
(i)  As stated above, it is likely that a substantial portion of participants would not 
return a mailed consent.  One of the study’s aims is to determine what the reach 
of such a program would be in the real world setting and this would not be 
possible to do if people were lost because of the required return of a mailed 
consent (which would not be present in a real-world program setting).  
(ii) Introducing a study procedure to reach out to every potential participant to 
complete a signed consent in person at the beginning of the study is equally 
problematic.  First, this would have to be done by WWHF (research) personnel 
(there are too many “affiliated” non-WWHF providers to have them deliver 
research procedures).  Thus, the WWHF personnel would have to contact the 
women and arrange ad hoc, face-to-face visits for each participant.  Without a 
personal relationship, many women would not want a stranger to come to their 
home, there would be missed visits, some women would refuse after the work of 
establishing contact, and so on.  Thus, this would impose two hurdles: getting 
women to take a phone call, and having them agree to a visit with a stranger 
where no services are being provided. The imposition of two hurdles could affect 
the nature of the sample ultimately recruited (and generalizability).  Plus, the 
added expense, especially of in-home visit solely to obtain consent, would 
certainly require a reduction in N’s significantly, reducing power and 
generalizability.   
(f) Offering signed consent at the first in-person visit with research staff from WWHF 
(post-partum Visit 1), was considered but is also problematic. Those women assigned 
to Group A (First Breath) receive only a single in-person contact with study staff, the 
6-month post-partum in-home visit to measure CO, which is the very last study 
contact. It would make little sense to obtain written informed consent at the last 
contact.   

9 
 
Based on this, the team is seeking full verbal consent and proposing that, at the first in-person 
visit with the WWHF research staff, the staff member invite discussion of the study procedures 
and consent at the beginning of the visit.  For the reasons offered above, we believe that this 
method would provide the best estimate of the effectiveness of this intervention as it would occur 
in real world use, and very adequately protects individuals in this low-risk, potentially highly 
beneficial, study.        
     Following verbal consent, the WWHF staff will then mail a brief letter welcoming the woman 
to the study, an informed consent information sheet, and an easy-to-understand list of upcoming 
treatment and research elements (treatment calls, visits, payments to the participant) to the 
participant. This material will include the UW-CTRI Research coordinator number [608-265-
5617] for questions—as well as the UWHC Patient Relations Representative at 608-263-8009 or 
University of Wisconsin Medical Foundation Patient Relations Representative at 800-552-4255 
or 608-821-4819). The woman’s oral consent over the phone will mean that the person is 
officially registered in the trial and will be included in the denominator of the intent-to-treat 
analyses. 
     Also at this initial call: 
a) At least 2-3 additional contacts will be obtained for the participant (i.e., friends, 
family) to try to establish a route to re-contact the participant if she moves or 
changes phones, etc., along with permission to inform those contacts of the 
participant’s research participation.  
b) Because in-home visits are involved, the participant will be informed that the 
Health Educators are required by law to report suspected cases of abuse and 
neglect as well as those situations in which they have reason to believe that a 
person has been threatened with abuse or neglect or that abuse or neglect will 
occur. 
c) Study baseline questions will either be administered via phone at this time, or if the 
participant does not have time to complete the baseline, WWHF staff may either 
complete it later or schedule a follow-up appointment to complete the baseline (see 
F. Collected Information). 
     Randomization will occur via a preset randomization list developed by UW-CTRI.   
Participants will be randomized in separate tables based on race (white/non-white) and county, in 
order to better control for these effects. The First Breath provider will be informed that his/her 
patient has enrolled in the research study. (Permission for this communication will be addressed 
during the consent procedure.)   
 
C. Collaborating Sites 
     The Wisconsin Women’s Health Foundation is a collaborating site. All interventions and data 
collection will take place over the telephone or in the home of study participants and be 
conducted by WWHF staff who have been approved to conduct this study. Collected data will be 
maintained at WWHF. 
 
D. Study Activities  
Standard of care procedures vs. research procedures All study participants will be offered 
standard of care smoking cessation counseling by FB providers (prenatal) (both groups A - FB 

10 
 
and B - STQ, see Table 1). These are not study procedures. Rather, they are standard of care 
cessation services for FB. Additionally, standard care includes prenatal data collection by FB 
providers (attendance and content of visits).  Enrollment in First Breath includes a set of standard 
data questions regarding smoking and pregnancy. While the study will utilize some of these data, 
the collection of this information is not a study procedure. Study research procedure (procedures 
specific to the study and conducted by WWHF research personnel) include the following: 
a) screening, consent and randomization (offered after First Breath enrollment). 
b) baseline study data collection (completed immediately following verbal consent or at 
a scheduled telephone follow-up appointment). 
c) 1 prenatal and 3 postpartum in-home counseling visits (Group B – STQ) conducted 
by WWHF research staff using a counseling protocol developed in accord with the 
US Public Health Service Clinical Practice Guideline. The expected duration of each 
in-home visit is 45 minutes. The prenatal visit will occur in the third trimester, and 
the three postpartum visits will occur in months 1, 3 and 6.   
d) 3 postpartum counseling phone calls (Group B – STQ) will be conducted by WWHF 
research staff using a counseling protocol developed in accord with the US Public 
Health Service Clinical Practice Guideline. The expected duration of each counseling 
phone call is 20 minutes. These calls will occur during months 2, 5, and 5 postpartum.   
e) 6-month postpartum in-home abstinence evaluation visit (Group A - FB and B - STQ) 
conducted by WWHF research staff 
f) postpartum study data collection (collected 6 months postpartum) 
g) CO test (completed at 1-month postpartum visit for STQ participants and at 6-month 
postpartum visit for both FB and STQ participants) 
h) provision of incentives: Group A will receive up to $40: $20.00 for enrollment and 
$20.00 for taking the six-month CO test. Group B will receive $20 for enrollment, 
$20 for each of the four home visits, and a bonus $20 for passing the CO tests at the 
delivery (1 month postpartum) and last home visit (6 months postpartum) (Total of 
$140.00) (It will be specified in the consent that visits where all study procedures are 
not completed will not be eligible for compensation.) 
Attachment 1 presents the study intervention and incentive time line. 
 
Retention Procedures The following procedures are designed to minimize loss of potential 
enrollees or data from these enrollees: 
a) From the point of enrollment, WWHF will track expected due dates and follow-up with 
the prenatal FB provider for any delivery where they have not received notification of 
delivery 14 days after the expected due date.  This will address the potential loss of 
enrollees in the transition between the prenatal FB provider counseling and the start of 
postnatal counseling by the WWHF staff. 
b) There will be reminder calls (up to 5 attempts) about 2 days before every in-home visit. 
c) For each missed in-person visit, WWHF staff will make proactive calls to the participant 
to reschedule. 
d) For each of the telephone counseling sessions, WWHF staff will make 5 call attempts for 
each scheduled call, providing participants with encouragement to return the call.  
e) If the woman is not home for a scheduled home visit, and does not reschedule it, the 
WWHF will make an additional effort to track/contact her by phone (with reminders of 

11 
 
the visit payment she will receive for attending) and, if that fails, by letter and contact 
with people whose names were given as contacts at enrollment.  
f) If the appointment is not completed within 4 additional weeks, this visit will be closed 
and the participant will not be compensated.  An additional call will be made letting the 
person know the window for that visit was passed; if no phone contact can be made in 
three weeks, other contacts (people listed by the participant who will know her location) 
will be contacted.  If this fails, a letter will be sent confirming that this visit is closed and 
encouraging the participant to contact the WWHF office. 
g) Prompt payment of participants is a key variable in retention. WWHF will disperse the 
incentive payments; payments will be in the form of a $20.00 Walmart gift card. 
Enrollment gift cards will be mailed.  The will be distributed in-person, at the completion 
of each home visit/CO test. 
Procedures for incarceration While the study does not target incarcerated individuals, 
incarcerations during the period of study involvement are anticipated within the population being 
recruited for this study.  The study has made the following procedural accommodations for this: 
If an individual is reported to have been incarcerated, all study involvement during the period of 
confinement will be suspended.  No contact will be made with (and no data will be collected 
from) the individual during any period when they are incarcerated.  The appointments during the 
incarceration will be recorded as missed.   If the length of incarceration is known and the 
individual becomes available in the community again, scheduled study contacts will re-
commence at that time.  Follow-up appointments and/or calls that are scheduled subsequent to a 
period of incarceration may occur.  If there is no indication of when the individual will be 
available again, study contacts will be recorded as missed and attempts to contact will start again 
at the next scheduled contact.  Incarcerations will not be reported to the IRB unless the above 
protocol has not been followed. 
 
E. Safety Monitoring Plan 
     Participant risks are minimal.  No drugs are used in this study. The pre-natal smoking 
cessation counseling services (Frist Breath) provided as part of the project have been used with 
this population throughout Wisconsin for 15 years.  No adverse effects have been documented.  
The services provided postpartum are commonly used cessation/relapse prevention counseling 
strategies.  They were used previously in STQ without any adverse effects. Participants may be 
experiencing more stress than normal because they are at home with a new born. In this context, 
smoking relapse may produce some emotional upset. All the health educators are trained to 
recognize this and are prepared to provide support and/or mobilize community resources as 
needed. There is a risk for inadvertent breach of confidentiality. This risk will be highlighted in 
the consent procedures.   
F. Collected Information  
     Some information is provided to WWHF by FB sites when women enroll in FB and again at 
the end of their standard services to the enrolled women.  All other assessment data gathered 
from participants will be obtained by telephone or in person by WWHF staff.  These include: 

12 
 
a) Baseline assessment.  This survey takes approximately 10 minutes to complete and is 
administered by WWHF staff at the time of enrollment and after verbal consent or 
during a separate call if the study participate cannot complete it during this initial call. 
Variables collected include: motivation and confidence to quit/reduce smoking; 
smoking history; current smoking; barriers to cessation; past quit attempts; general 
health information and goals; and perceived social support (via the Wisconsin Social 
Support Scale). 
b) CO test for STQ participants only at the first postpartum visit 
c) CO test at the 6-month postpartum follow-up in-home visit for both STQ and FB 
(primary outcome) 
d) Brief survey (10 minutes) administered at the 6-month postpartum follow-up in-home 
visit. This survey collects information such as smoking status at delivery and at one-
month postpartum as well as re-measures some of the variables collected at the 
baseline assessment. Also measured will be: adoption of smoke free strategies; self-
efficacy to remain smoke free; motivation to remain smoke-free; time to relapse, 
perceived support from others; and birth putcome. 
e) WWHF staff will also record information about pertaining to conducting the study. 
This information includes: screening/informed consent results; participation in 
treatment services; counseling delivered information; and ending study prior to 
completion 
Attachment 2 lists all the information that will be contained in the study data set.   
 
G. Data Security 
     Data collected in the home are entered into SurveyGizomo, (online software).  Survey 
Gizomo is HIPPA compliant and has Safe Harbor certification. Data is encrypted and hyperlinks 
are secure. The research database will be housed at WWHF.  It will be stored on a computer with 
password access controlled by WWHF.  Only WWHF staff approved to work on this study will 
have access. Following conclusion of the study, all research data will be cleaned and verified and 
then placed in a de-identified data set for analysis.  UW-CTRI will assist WWHF with data 
analysis.  To facilitate this, the de-identified database will be provided to UW-CTRI by secure 
FTP. Study records will be kept for seven years. 
 
 
G. Data Analysis Plan 
 
Aim 2:  Is Striving to Quit more effective in achieving postpartum smoking cessation than “First 
Breath,” the current standard of care for pregnant women in Wisconsin who smoke?  
a) Results from screening and enrollments will be analyzed to assess the representativeness 
of the study sample to make inferences regarding the reach of the project among the 
target population. 
b) Groups A (FB) and B (STQ) will be compared on the various background and smoking 
variables to test the assumption that random assignment resulted in equivalent groups. 
Inferential statistics will be used to compare the two groups, Chi Square for nominal 
background/demographic data such as health insurance status and race and t-tests for 
interval data such as age. These variables will also be used to describe the sample using 

13 
 
descriptive statistics. These variables will be used as co-variates in the analysis of the 
primary outcome, smoking abstinence. 
c) The primary outcome is biochemically confirmed reports of abstinence for the past 7 
days (i.e., 7-day point-prevalence abstinence) at six months postpartum. Biochemical 
confirmation will be accomplished with exhaled breath carbon monoxide (CO) testing. 
Experience with First Breath suggests that about 20% of all women receiving services 
will be abstinent at 6 months postpartum after receiving prenatal services only (vs. the 
30% pregnancy abstinence rates). When tested using research protocols, STQ found that 
40% were smoke free at 6 months. Because we anticipate that this rate will be lower 
when implemented in real world settings, we use an estimated 36% rate for power 
calculations. With 125 participants in each condition and two tailed alpha set at .05, we 
have .81 power to detect this hypothesized effect size difference (36% vs. 20%). The 
intent-to-treat principle will be used so that non-ascertainment (i.e., failure to attend the 
Follow-up Visit or a lack of a confirming carbon monoxide value) will be treated as a 
non-abstinent outcome.  Logistic regression will be used to analyze the effect of 
treatment status (FB vs. STQ) on the binary abstinence outcome, and models will be run 
both with and without covariate adjustment.  We predict that STQ will produce higher 
abstinence rates at 6-months postpartum than FB. 
d) Other variables collected at the 6-month postpartum follow-up visit are secondary 
outcomes. These include time to relapse, motivation to quit/remain quit, confidence about 
quitting/remain quit, and birth outcomes. Some of the secondary outcomes will be 
continuous for which linear regression will be used. Demographic variables will be used 
as co-variates in these analyses. The Benjamini-Hochberg approach will be used to control 
experiment-wise error for secondary outcomes. Meaningful missingness is likely for 
variables collected at the 6-month postpartum home visit. For such variables, we assume 
missingness to be nonignorable. We will model or treat missingness in several ways. For 
instance, we will conduct sensitivity analyses with different assumptions about the relation 
of missingness to actual unobserved values, which will provide explicit modeling of the 
impact of missingness assumptions on results. We will also use multiple imputation 
methods appropriate for nonignorable missing data (for both continuous and binary data) 
and will generate imputation models that reflect different assumptions about the missing 
data mechanism. Missing data, due to drop out or otherwise, it will be recorded and its 
causes will be noted. Relevant information will include reasons for dropout, who made the 
decision to drop out, and what type of participation was withdrawn (e.g., termination of 
intervention, refusal to complete survey, etc.). 
 
Aim 1 and Aim 3 
     First Breath Providers Discussion Groups.  The discussion groups will be recorded. 
Recordings are transcribed verbatim and entered into SurveyGizmo (SG). Transcriptions are 
independently reviewed and codes developed by 3 study staff. Staff met to come to a consensus 
on the final list of codes. Final codes entered into SG and transcriptions are coded in SG using 
text analysis tool. The data is qualitatively analyzed for trends, themes, and quotes. Results will 
be used to develop items for the survey to FB providers. 
     First Breath Providers Survey. Survey responses will be analyzed using descriptive statistics 
(percent endorsement, measures of central tendencies, standard deviation). This survey will 
include several questions regarding the First Breath provider characteristics such as location, 

14 
 
length of time as a First Breath site and number of women enrolled annually into the First Breath 
program.  Survey results will be examined as a function of these questions (Do experienced First 
Breath providers perceive different challenges than inexperienced First Breath providers?  Urban 
vs. rural providers?) via inferential statistics.  Finally, this survey will include several open ended 
questions.  Responses will be analyzed for trends and themes. 
     Heath Educator Interviews. Responses to interview questions will be recorded and integrated 
into a report. This report will be used along with the two data sources above to develop an 
implementation plan for state wide expansion and as an assessment of Aims 1 and 3. 
 
      
  
Bibliography and References Cited 
 
1.         U.S. Department of Health and Human Services. The health consequences of smoking: 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; 2004. 
2. 
Aliyu MH, Lynch O, Saidu R, Alio AP, Marty PJ, Salihu HM. Intrauterine exposure to 
tobacco and risk of medically indicated and spontaneous preterm birth. Am J Perinatol. 
2010;27(5):405-410. 
3. 
Kids Count Data Center. Infant mortality. 2013. 
http://datacenter.kidscount.org/data/tables/6051-infant-
mortality?loc=1&loct=2#detailed/2/2-52/false/36,868,867,133,38/any/12718,12719. 
Accessed 9 Mar 2016. 
4. 
Dietz PM, England LJ, Shapiro-Mendoza CK, Tong VT, Farr SL, Callaghan WM. Infant 
morbidity and mortality attributable to prenatal smoking in the U.S. Am J Prev Med. 
2010;39(1):45-52. 
5. 
Adams EK, Miller VP, Ernst C, Nishimura BK, Melvin C, Merritt R. Neonatal health 
care costs related to smoking during pregnancy. Health Econ. 2002;11(3):193-206. 
6. 
Wisconsin Women's Health Foundation. First Breath Program 2013 Annual Report. 
2013. http://www.wwhf.org/wp-content/uploads/2012/05/2013-First-Breath-Annual-
Report-FINAL.pdf. Accessed 9 Mar 2016. 
7. 
Fang WL, Goldstein AO, Butzen AY, et al. Smoking cessation in pregnancy: a review of 
postpartum relapse prevention strategies. J Am Board Fam Pract. 2004;17(4):264-275. 
8. 
Center for Clinical Managment Research, CFIR Research Team. Consolidated 
framework for implementation research. 2009. http://cfirguide.org/index.html. Accessed 
9 Mar 2016. 
9. 
Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering 
implementation of health services research findings into practice: a consolidated 
framework for advancing implementation science. Implement Sci. 2009;4:50. 
10. 
Consolidated Framework for Implementation Research. Relative advantage. 2014. 
http://cfirguide.org/wiki/index.php?title=Relative_Advantage. Accessed 9 Mar 2016. 
11. 
Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation 
hybrid designs: combining elements of clinical effectiveness and implementation 
research to enhance public health impact. Med Care. 2012;50(3):217-226. 

15 
 
12. 
Kessler RS, Purcell EP, Glasgow RE, Klesges LM, Benkeser RM, Peek CJ. What does it 
mean to "employ" the RE-AIM model? Eval Health Prof. 2013;36(1):44-66. 
13. 
Glasgow RE, Vogt TM, Boles SM. Evaluating the public health impact of health 
promotion interventions: the RE-AIM framework. Am J Public Health. 1999;89(9):1322-
1327. 
14. 
Consolidated Framework for Implementation Research. Interview guide tool. 2015. 
http://www.cfirwiki.net/guide/app/index.html#/. Accessed 9 Mar 2016. 
 
 

16 
 
Attachment I 
Striving to Quit Schedule – ICTR Grant 
Group A: First Breath Only 
Group B: First Breath + Striving To Quit 
 
 
Pregnancy  →                                                               Postpartum → 
 
1st 
trimeste
r 
2nd 
trimeste
r 
3rd 
trimeste
r 
1 
mont
h 
2 
month
s 
3 
month
s 
4 
month
s 
5 
month
s 
 
6 
month
s 
 
 
Group
A 
 
 
           Standard First Breath: Brief intervention as part of existing prenatal care 
 
 
 
 
 
 
 
 
 
 
           Striving to Quit: 6 month CO test only 
 
 
 
 
 
 
 
 
 
$20 
Enroll 
 
 
 
 
 
 
 
$20 CO 
Test 
 
 
Group B 
 
 
          Standard First Breath: Brief intervention as part of existing prenatal care                       
 
 
 
 
 
 
 
 
 
 
          Striving to Quit: Intensive counseling with STQ Health Educator + CO tests + 
Incentives 
 
 
 
 
 
 
 
 
 
 
$20 
Enroll 
$20 
$20 + 
$20 
Pass 
CO 
 
$20 
 
 
$20 + 
$20 
Pass 
CO 
 
Key 
= Brief Counseling with 
Prenatal Care Provider 
= Home Visit with STQ 
Health Educator 
 
 
= Phone Call with STQ 
Health Educator 
 
 
 

17 
 
 
Attachment 2: Collected Information 
 
Description 
Study 
Group 
Source 
Purpose 
Time 
Variable 
First Breath 
Enrollment 
Information 
 
Both 
FB and 
STQ 
groups 
First 
Breath 
sites  
Identify 
eligible 
women 
At prenatal 
visit 
 Name 
 DOB 
 Expected delivery 
date 
 Contact Information 
 Smoking Status 
Screening data 
Both 
FB and 
STQ 
groups 
WWHF 
research 
staff 
Establish 
study  
eligibility 
After First 
Breath 
enrollment 
 Smoked daily in last 6 
months 
 Willing to quit or 
stray quit 
 Willing to meet with 
FB provider 
 Willing to have phone 
calls and home visit 
 Willing to take CO 
tests 
 Willing to inform of 
changes in contact 
information 
 Involved in other 
smoking study 
Screening 
results 
Both 
FB and 
STQ 
groups 
WWHF 
research 
staff 
Results of 
eligibility 
screen 
After First 
Breath 
enrollment 
Not willing to be 
screened; screen fail 
(reason); not consented; 
enrolled 
Services 
delivered at 
First Breath 
sites 
Both 
FB and 
STQ 
groups 
Fist Breath 
sites 
Compare 
groups 
At end of 
services 
provided at 
First 
Breath 
sites 
Number of counseling 
sessions delivered 
Baseline 
survey (phone) 
 
Both 
FB and 
STQ 
groups 
WWHF 
research 
staff 
(Health 
Educators)  
Compare 
groups 
At 
enrollment 
Participant Self-Report: 
 Race/ethnicity 
 Income 
 Education 
 Employment status 
 Relationship Status 
 # in Household 

18 
 
 # Smokers in 
Household 
(smokers/nonsmokers) 
 Smoking history 
 Smoking status 
(Current) 
 Nicotine dependency 
 Confidence to 
quit/remain quit 
 Motivation to 
quit/remain quit 
 Perceived support 
 Perceived stress 
 Major stressors 
 Mental health and 
SUD status 
 ETS exposure 
 Quit goals 
CO 
measurement 
(Home visit) 
STQ 
group 
only 
WWHF 
research 
staff 
(Health 
Educators) 
Provide 
feedback 
regarding 
quit 
progress  
1 month 
postpartum 
CO value 
Session 
content 
STQ 
group 
only 
WWHF 
research 
staff 
(Health 
Educators) 
Describe 
services 
delivered 
to STQ 
participants 
Every 
scheduled 
phone call 
and home 
visit, 
including 6 
month 
follow-up 
 Did visit take place 
 Duration 
 Topics discussed 
 6-month 
Postpartum 
survey (Home 
visit) 
Both 
FB and 
STQ 
groups 
WWHF 
research 
staff 
(Health 
Educators) 
Compare 
groups, 
measure 
primary 
and 
secondary 
outcomes  
6-months 
post-
partum 
Participant Self-Report 
 Smoking status 
(Current) 
 Confidence to 
quit/remain quit 
 Time to relapse (if 
applicable) 
 Motivation to 
quit/remain quit 
 Quitting/reduction 
strategies used 
 Perceived support 
 Perceived stress 
 Major stressors 

19 
 
 Household smoking 
 ETS exposure 
 Breastfeeding 
initiation/duration 
 Maternal/child health 
outcomes 
 Barriers and helpful 
factors (open-ended) 
 
HE Documentation: 
 CO Result 
Case summary 
(Home visit) 
STQ 
group 
only 
WWHF 
research 
staff 
(Health 
Educators) 
Describe 
impact on 
STQ 
participants 
6 months 
postpartum 
 Total minutes of 
counseling 
 Level of engagement 
 Difficulty to 
reach/complete 
appointments 
 Number of times 
address changed 
 Referral to Wisconsin 
Tobacco Quit Line 
(WTQL) 
 Education to support 
people 
 Support people 
referred to Texting 
program 
 Support people 
referred to WTQL 
 Topics covered 
 Qualitative case 
summary 
Study status 
Both 
FB and 
STQ 
groups 
WWHF 
research 
staff 
Track 
participants 
through 
study 
End of 
study 
Unable to locate; 
withdrew by participant; 
withdrew by 
experimenter; unknown; 
completed study