Reducing Tobacco Use Disparities Among Adults In Safety Net Community Health Centers
Phase: NA
Conditions: Cigarette Smoking, Nicotine Dependence
Sponsor: Northwestern University

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Protocol Title: 
Reducing Tobacco Use Disparities Among Adults in Safety Net 
Community Health Centers 
 
Principal Investigators: 
Brian Hitsman, Ph.D. (Lead PI) 
Northwestern University 
312-503-2074 
b-hitsman@northwestern.edu 
 
 
Alicia K. Matthews, Ph.D. (Co-PI) 
University of Illinois at Chicago 
AliciaK@uic.edu 
 
 
Christina Ciecierski, Ph.D. (Co-PI) 
Northeastern Illinois University 
c-ciecierski@neiu.edu 
 
 
Tim Long, M.D. (Site PI) 
Near North Health Services Corporation 
tlong@alliancechicago.org 
 
 
Nivedita Mohanty, M.D. (Site PI) 
Alliance of Chicago 
 
Biostatistician: 
George D. Papandonatos, Ph.D. 
Brown University 
gdp@stat.brown.edu 
 
Version Date: 
May 14, 2018 
 
ClinicalTrials.gov 
Registration Number: 
 
NCT03077737 
 
 
 
PURPOSE OF STUDY & OBJECTIVES 
 
An estimated 26 million smokers still receive no treatment for their smoking during their primary care 
visits. Given the persistent clinical system, provider, and patient barriers to addressing smoking, especially 
among poor populations, an EHR-automated population health management approach that links a healthcare 
system with community services both clinically and electronically to engage all smokers may increase access 
to effective treatment. Increased access is especially significant for low-income smokers who are underserved 
and carry a disproportionate burden of tobacco-related disease. This 2-group randomized controlled trial will 
evaluate the effectiveness of a person-centered population health management intervention for smoking 
cessation in low-income smokers. The following aims and hypotheses will be tested: 
 
Primary Aim 1 (Effect on Treatment Engagement): Compare Choose to Change versus Usual Care for 
engaging low-income smokers in treatment. Hypothesis: Choose to Change will increase the proportion of 
smokers who complete a behavior counseling call by 6 weeks (24%), compared with Usual Care (10%). 
 
Primary Aim 2 (Effect on Treatment Utilization): Compare Choose to Change versus Usual Care for 
increasing treatment utilization. Hypothesis: Choose to Change will increase the proportion of smokers who 
complete ≥1 additional behavior counseling calls by 14 weeks (15%), compared with Usual Care (7%). 
 
Primary Aim 3 (Effect on Smoking Cessation): Compare Choose to Change versus Usual Care for 
increasing smoking cessation. Hypothesis: Choose to Change will increase the proportion of smokers 

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abstinent at 28 weeks (7%), as defined by bio-verified 7-day point-prevalence abstinence, compared with 
Usual Care (2%). 
 
Secondary Aim 1 (Cost Evaluation): Conduct a cost-analysis to determine the cost of providing effective 
cessation therapy to smokers using this letter-enhanced EHR-referral and outcomes system. Evaluate the cost 
effectiveness of the Choose to Change letter and automated /text messages compared to usual care by 
calculation the cost-effectiveness ratio as the average dollars spent per successful quit. 
 
Exploratory Aim 1 (Moderators of Intervention Effects): Evaluate motivation to quit, time since last clinic 
visit during which smoking was addressed, health literacy, cigarettes per day, recent smoking reduction, initial 
choice of cessation versus reduction, race/ethnicity, and primary language as moderators of effect of Choose 
to Change on treatment engagement, treatment utilization, and smoking cessation. 
 
Exploratory Aim 2 (Mediators of Intervention Effects): Evaluate change in perceived autonomy support, 
autonomous motivation, confidence in ability to quit, and attitude towards NRT as mediators of intervention 
effects on treatment engagement, utilization, and cessation. 
 
BACKGROUND AND RATIONALE FOR STUDY   
 
An estimated 26 million smokers receive no treatment for their smoking during primary care visits.1-3 
Electronic health record (EHR) systems are used to increase smoking cessation treatment delivery, but at best 
only 65% of smokers are offered treatment.4 Given the persistent barriers to addressing smoking, an EHR-
automated population health management approach that links healthcare systems with community services 
electronically to engage all smokers may increase access to effective treatment. While 90% of smokers are not 
ready to quit abruptly, many are interested in cutting down,4,6 and smoking reduction increases the likelihood of 
future quit attempts and cessation.7 According to self-determination theory (SDT),8 smokers who perceive 
themselves to be autonomous partners in their healthcare, and who are empowered to tailor their treatment 
goals to their level of readiness to quit, are more interested and engaged in their treatment. SDT-based 
intervention increases treatment utilization and smoking cessation9, and offering smoking reduction as a 
treatment option increases treatment enrollment.4 Person-centered population outreach that targets low-
income smokers and encourages either quitting or cutting down as a positive first step towards cessation may 
increase the likelihood that they will accept (i.e., engage in) and utilize treatment and achieve abstinence. 
 
This study will evaluate the effectiveness of a person-centered and EHR-automated population health 
management intervention for smoking cessation that is embedded in routine care and designed to engage low-
income smokers outside of the primary care visit. The experimental approach overcomes major barriers to 
addressing smoking in low-income patients. Healthcare delivery and access barriers will be addressed through 
an EHR system that automates identification of smokers, creation of targeted engagement intervention 
material, referral for proactive Quitline treatment, and treatment outcomes feedback to providers to support 
follow-up care. Health literacy barriers will be addressed via messaging (words, graphics) targeted to low-
literacy smokers. Psychological barriers (low motivation, belief that abrupt cessation is the only treatment 
option) will be addressed through a person-centered approach that encourages smokers to choose their own 
initial treatment goals. We expect that for the large proportion of low-income smokers who are ambivalent 
about quitting, the ability to choose between cessation and reduction, in the context of other SDT elements, will 
increase their interest and engagement in treatment. 
 
We will partner with a Federally Qualified Health Center (FQHC) that serves 35,000 diverse low-income 
patients in Chicago. Automated via the EHR system, smokers will be mailed a one-page letter on behalf of 
their primary care provider encouraging smoking cessation or reduction as a first step to cessation. The letter 
will be paired with five automated text/ messages that reinforce the central messaging of the letter (“Choose 
to change and make your own goal”). Two weeks after mailing, patients will receive a call from the Illinois 
Tobacco Quitline and offered free behavior counseling and free nicotine replacement therapy. Treatment 
outcomes will be transmitted directly to the EHR system. Our pilot data show that 24% of low-income smokers 
(31/132) who were sent the letter during a 3-week period accepted a Quitline call and completed ≥1 counseling 
session.  
 
PARTICIPANT ELIGIBILITY: INCLUSION AND EXCLUSION CRITERIA 
Target Population 

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Five hundred thirty adult male and female English- or Spanish-speaking current smokers who are patients at 
one of seven federally qualified health centers (FQHC) within the Near North Health Services Corporation 
(NNHSC) community clinic system will be enrolled in this clinical trial. 
 
Inclusion Criteria 
Eligible participants will be males and females who are: 
1. 18 years of age or older; 
2. A patient at one of the seven participating NNHSC community clinics; 
3. Listed as “current someday smoker” or “current everyday smoker” in their NNHSC EHR; confirms 
current someday or everyday smoking status at phone screen 
4. Have had >1 visit to their NNHSC clinic within the past 12 months  
 
Exclusion Criteria 
Participants who self-report any of the following will not be eligible to participate in the study: 
1. Documented within their NNHSC EHR as preferring a language other than English or Spanish for 
healthcare; 
2. No telephone number or address listed in the EHR; 
3. Does not have a cell phone with texting capabilities; 
4. Lives with another NNHSC patient who is already enrolled in the present study. 
 
Vulnerable Populations 
Children under 18 years of age, fetuses, neonates, or prisoners will not be included in this study. Pregnant 
women will not be actively recruited, but will be eligible for the study if they meet all other inclusion and 
exclusion criteria detailed above. 
 
STUDY DESIGN  
This is a 2-group randomized controlled trial to evaluate the effectiveness of the population health 
management intervention for low-income smokers that aims to promote Quitline treatment, engagement, 
utilization, and smoking cessation (Figure 1). 
 
 
Length of Study Participation 

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Participants will be involved in study-related activities for approximately 7½ months (32 weeks) from initial 
enrollment in the observational study and baseline assessment (week -4) through follow-up (week 28). 
Participants will complete four phone-based assessments during this time (Baseline/Week -4; Week 6; Week 
14, Week 28) and those who report abstinence from cigarettes at the Week 28 phone interview will be asked to 
come in for an in-person clinic visit within 2 weeks of their Week 28 phone session in order to bioverify 
smoking status. 
 
Alternative study timeline: Due to funding constraints, participants enrolled February 2018 or after will be 
involved in study-related activities for about 4 months (18 weeks) from initial enrollment in the observational 
study and baseline assessment (week -4) through a final follow-up at week 14. Participants enrolled in this 
alternative study timeline will complete three phone-based assessments (Baseline/Week -4; Week 6; Week 14) 
and those who report abstinence from cigarettes at the Week 14 phone interview will be invited to come in for 
an in-person clinic visit within 2 weeks of their Week 14 phone session in order to bioverify smoking status. 
Randomization to treatment arm and all other study procedures will be conducted in the same way as for the 
participants completing the full 32 week study timeline. 
 
Study Timeline 
Development of Bilateral EHR Interface with the Quitline. Led by Drs. Mohanty and Long, we will complete 
the testing and refinement of the bilateral EHR interface between NNHSC and the Quitline. Trainings with 
providers in use of the new EHR functionality will also be conducted. The integration of NNHSC and the 
Quitline will enable the NNHSC study care coordinator and providers to make a one-step referral to the 
Quitline. In turn, the Quitline will communicate patient outcomes directly to NNHSC via the EHR. The existing 
EHR content will be modified to automate obtaining and documenting provider approval of patient involvement 
and generating and documenting the mailing of the intervention letters. All clinical information will be 
communicated to the Quitline using Health Level Seven (HL7) standards. The Quitline will use a HL7 interface 
engine to receive and “translate” the information within its secure network. 
 
Development of the EHR Query to Identify Participants. We will use structured query language (SQL) to 
analyze EHR data to identify eligible patients. The data query will be validated by confirming the eligibility 
criteria (denominator) and by performing a spot-check of positive cases (numerator) and cases determined to 
be negative, or failed, according to query specifications. The query will also be used to generate the following 
for each patient: 1) patient ID number; 2) telephone numbers (home, cell); 3) preference for method of 
communication about their healthcare (text message, letter); 4) primary physician; 5) preferred language for 
healthcare; 6) type of health insurance; 7) number of clinic visits during the past year and date of last visit; 8) 

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date of last visit during which smoking was addressed; 9) education level; 10) household income; and 11) 
dates of previous referrals to smoking cessation treatment. The query will be run monthly. 
 
STUDY PROCEDURES 
 
Recruitment and Accrual Procedures  
Study Sites 
NNHSC is a FQHC comprised of eight community health clinics in Chicago. These include Cottage View 
Health Center, Denny Community Health Center, Komed Holman Health Center, Louse Landau Health Center, 
North Kostner Health Center, Reavis School-Based Health Center, Sunnyside Community Health Center 
(previously Uptown), and Winfield Moody Health Center. Dr. Tim Long, the Director of Performance 
Improvement, serves as the study Site-PI for NNHSC.  NNHSC serves 35,000 patients. Racial/ethnic 
composition is 10% Hispanic, 66% African American, 10% Caucasian, 0.8% Asian, and 0.2% multiracial. The 
remainder is classified as unknown. Ninety-six percent of patients are uninsured (56%) or on Medicaid (40%). 
Females account for 63% of patients, and 96% live at or below the Federal Poverty Line. All study sessions, 
both by telephone and in-person, will be conducted at one of the NNHSC primary care home clinic of the 
participants listed above. 
 
 
Participant Recruitment 
All study participants will be patients receiving medical care at one of the seven participating NNHSC 
community clinics. As Reavis School-based Health Center largely serves children under the age of 18 years, 
we will not recruit from Reavis. We will use structured query language (SQL) to analyze EHR data to identify 
eligible patients. NNHSC uses the General Electric Centricity (Practice Solution 14) EHR system for all clinical 
encounters (supported by Alliance of Chicago). The SQL-based data query will be designed and tested by the 
Alliance of Chicago data team, validated by confirming the eligibility criteria (denominator) and by performing a 
spot-check of positive cases (numerator) and cases determined to be negative, or failed, according to query 
specifications. After testing, then sent to the Winfield Mood Health Center (NNHSC site) Care Coordinator via 
secure email. Data to be extracted for each patient will be limited to: 1) medical record number; 2) telephone 
numbers (home, cell); 3) preference for method of communication about their healthcare (text message, letter, 
home phone, etc.); 4) primary physician; 5) preferred language for healthcare; 6) type of health insurance; 7) 
number of clinic visits during the past year and date of last visit; and 8) date of last visit during which smoking 
was addressed. The query will be run monthly. We expect to complete accrual in about 15 months, enrolling 
about 40 participants per month.   
 
Primary medical providers of all candidates identified as eligible for the randomized clinical trial by the SQL 
query will be sent an message alert with the EHR requesting that they review the list of patients identified (lists 
will be provider-specific) and respond within 10 days to identify any patients from the list whom they believe 
would not be appropriate for the survey study or potential Quitline referral. After this 10-day provider opt-out 
period, all patients who have not been opted out will be called by a research assistant to ask if the patient is 
interested in hearing about, screening and if eligible, enrolling in a quality improvement study on “health habits 
of primary care patients at Near North Health Services Corporation.” The study will be described as a way for 
“Near North Health Service Corporation and the doctors and staff to better understand the health habits, risk 
behaviors and wellness service needs of [their] patients” to inform possible enhancements to some of these 
services.  Only NNHSC patients who consent to enroll in this survey study will be randomized to one of the 
treatment conditions (either Choose to Change or Usual Care).  
 
We will conduct a clinic-wide awareness campaign across the seven participating NNHSC clinics describing 
the survey study component of the project in order to generate interest and increase enrollment. For this 
general clinic awareness campaign we will use posters and flyers that promote the health habits survey study 
and will also use small giveaways (e.g., pens, pill boxes, magnets) with graphics aligned with this theme. The 
goal of this general clinic campaign is only to raise awareness of the survey study, but we do not want NNHSC 
patients to call us regarding study enrollment. Therefore, we will not include any study personnel contact 
information on these general campaign flyers or posters. Postcards and magnets with the same messaging as 

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the posters and flyers will be bulk-mailed from NNHSC to the patients identified by the SQL query prior to 
outreach calls with the goal of increasing enrollment once called by the research assistant. 
 
Additionally, for all enrolled participants, we will use a retention campaign consisting of the following: 
1) Reminder letters sent one week prior to their next scheduled telephone survey appointment 
2) Seasonal Newsletters providing updates about study progress on recruitment, patient testimonies about 
their experiences with clinical research, NNHSC clinic updates from Dr. Tim Long, health tips and 
information, and seasonal activities that support healthy lifestyles. The purpose of the newsletters is to 
keep participants engaged with the study in between their telephone interviews, thereby increasing 
retention and minimizing attrition. 
3) Small participant incentive items using the same graphics and messaging from the general clinic 
campaign will be mailed with the reminder letters (e.g., water bottles, draw string bags, small ear buds, 
T-shirts). Consistently using the same images and themes across recruitment and retention materials 
will generate familiarity with the study and will serve to maintain high retention rates. 
 
All recruitment and retention materials will be mailed from NNHSC. 
 
Randomization and Study Conditions 
Smokers identified through the SQL query from NNHSC’s EHR and who consent to enroll in the NNHSC 
“health habits and wellness service needs study” and who complete the baseline survey will be randomized to 
either Usual Care or person-centered population management (Choose to Change) four weeks (week 0) after 
enrollment in the study (week -4). We will use a 6:6 permuted block randomization scheme to assign patients 
to treatment condition. Randomization will be stratified by readiness to quit, as measured using a single item 
question for which participants identify their level of motivation to quit smoking as measured on a 10-piont 
scale (1 = not at all motivated; 10 =extremely motivated), race (African American versus not), and language 
preferred (English versus Spanish). We plan to approach 115 patients per month to enroll 40 participants per 
month and achieve this randomization rate (35% response rate).  
 
Choose to Change (CtC) Intervention:. Choose to Change will comprise two components: 1) a single page 
letter that messages choice of cessation or smoking reduction using words and a graphic; and 2) five 
automated text messages sent on behalf of the NNHSC providers that reinforce the central messaging of the 
letter. 
 
CtC particicpants will be mailed the letter on behalf of their provider encouraging cessation or smoking 
reduction as an initial step to cessation if not ready to set a quit date, provides information about Quitline 
services, including safety and effectiveness, and states that a Quitline coach will be calling within two weeks to 
offer free treatment. The central message developed through our previous focus group work is “Choose to 
change and make your own goals.” The letter also contains the other elements of SDT as well as standard 
evidence-based supportive and motivational statements. Participants who do not want to be called by the 
Quitline will be instructed to contact the NNHSC study care coordinator. Opt-outs and reasons will be recorded. 
In collaboration with Dr. Kenzie Cameron, the letter was designed for smokers with low health literacy based 
on established health communication principles. The written message is one page in length to minimize 
cognitive overload and burden and to maximize the effectiveness of the message.86-89 The estimated 
readability according to the Flesch–Kincaid Grade Level rating is 4.8 (5th grade). The letter will be printed on 
NNHSC letterhead, enclosed in large-sized (6” x 9”) NNHSC envelopes, and sent first-class mail. 
 
One day after letter mailing, the first automated text message will be sent to participants notifying them that 
they will receive the CtC letter in coming days. During the 10 days following the letter mailing, participants will 
receive three more automated text messages on behalf of their healthcare provider three days apart between 
each message. A fifth text message will be sent 8-10 days after the Quitline’s initial outreach call (i.e., Quitline 
outreach takes place two weeks after letter mailing). The purpose of this last text message is to provide the toll 
free Quitline number in case the participant has not yet been able to connect with a Quitline counselor. Also 
informed by SDT and patient feedback, the automated text messages will be used to sustain the motivational 
effects of the letter and maximize the likelihood that participants will engage in and utilize Quitline treatment. 
Participants who do not want to receive these messages will be able to opt-out after each message. The 
automated text messaging procedures were established in our prior work (P01 HS021141; Kenzie Cameron).81 
Text messaging is increasingly used in primary care to support processes of care and improve health 

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outcomes.99 Text messaging improves attendance at healthcare visits,100,101 adherence to diabetes self-care102 
and weight management regimens,103 as well as the effectiveness of smoking cessation treatment.99 Popularity 
of text messaging is high across racial/ethnic groups, socioeconomic levels, and ages.102  
 
Two weeks after letter mailing, participants will be contacted by a Quitline counselor and offered free person-
centered behavior counseling (cessation or reduction-focused depending upon patient preference) and free 
NRT (patch, gum, or lozenge) if determined as safe and appropriate. Please see more detail regarding the 
proactive Quitline treatment below. 
 
Usual Care Condition: Participants assigned to this clinic-based control comparison will receive NNHSC clinic-
based care for smoking that follows the Ask, Advise, Refer approach.19 Following the practice adopted by 
NNHSC in 2011, a Usual Care participant who smokes will receive a referral for proactive Quitline treatment 
according to the following established clinic procedure: If the participant is seen in the clinic for a health 
problem or routine evaluation, a medical assistant will confirm current smoking and advise the participant to 
quit using clear and strong language. Current smoking and advice to quit are documented in the EHR system 
and the participant will be seen by the provider who addresses the purpose of the visit. If the provider also 
addresses the participant’s smoking, establishes that the participant is motivated to set a quit date, and the 
participant agrees to the Quitline referral, a referral form is generated via the EHR system. Referrals are 
transmitted electronically via the Quitline website by the Care Coordinator. Participants who are referred will 
receive a call from the Quitline within 48 hours. Usual Care participants who accept Quitline treatment will 
receive free person-centered smoking cessation counseling and free NRT (patch, gum, or lozenge). Please 
note: providers may still refer patients who are not enrolled in this study to the Quitline. 
 
In both conditions, Quitline treatment will continue as accepted or initiated by participants over 28 weeks. 
 

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Choose to Change Intervention Clinic Workflow 
All recruitment, enrollment, and data collection activities will take place at Winfield Moody Health Center, one 
of the NNHSC community clinics, or in the NU Preventive Medicine Research Clinic. Once eligible participants 
are identified by the monthly EHR query, the care coordinator will securely message the Choose to Change 
participants’ medical providers via the NNHSC EHR messaging system stating that the identified patients 
“have been selected for a smoking cessation initiative in which they may be approached to participate in a 
health behavior survey study and possibly offered cessation treatment through the Illinois Tobacco Quitline. 
You will have a period of ten days to review your patient’s medical record and opt out if you believe that either 
the survey or the treatment would be inappropriate for this/these patient(s) at this time.”  We expect this to be 
rare as none of the providers of patients involved in our pilot study chose to exclude them from participation. 
During the 10-day opt-out period, all patients will be sent recruitment postcards about the possibility of survey 
study participation. After the 10-day opt out period, research assistants will make recruitment calls to all 
patients whose providers have not opted out of the study or Quitline referral. On these recruitment calls, 
research assistants will ask to discuss the study in more detail, conduct initial screening, enroll those who are 
eligible and interested, and complete the baseline study survey. After participants have completed the baseline 
survey, they will be randomized to either Usual Care or the Choose to Change (CtC) intervention. 
 
For those randomized to the CtC intervention group, the CtC letter, electronically signed on behalf of Dr. Tim 
Long of NNHSC, will be created by the EHR system on NNHSC letterhead and mailed by the care coordinator 
or research assistant. One day after CtC letter mailing, the first CtC text message will be sent to notify CtC 
participants of the coming letter. The remaining 4 text messages will be sent per the timeline described above. 
After a 12-day participant opt-out period (described in the letter), names and contact details, including best 
times to be called, will be sent by the EHR referral system to the Quitlineat 7:00pm each day a referral is 
made. Participants will be called within two days of referral. NNHSC and each of its clinics will have a unique 
code that will be sent via the EHR system to the Quitline along with an encrypted referral file of Choose to 
Change participants. A different code, but unique to NNHSC, will be used to identify and track outcomes for 
Usual Care participants. All codes will be specific to this study. They will serve to identify the study protocol: 
cessation-focused counseling and NRT or reduction-refocused counseling and NRT as a first step to smoking 
cessation. Once reached by the Quitline, the participant’s referral data will be shown on one screen and the 
study protocol via the virtual library will be shown on a second screen. The protocol description and required 
data fields will ensure that participants are provided reduction-focused counseling if chosen, free NRT if willing 
and deemed safe, and that additional project-required data are collected. Patient-specific outcomes will be 
transmitted to NNHSC at the end of each day. 
 
Proactive Quitline Treatment for Choose to Change and Usual Care Conditions 
Participants in both treatment conditions will have the opportunity to receive the same proactive Quitline 
treatment consisting of person-centered behavior counseling and NRT. The Quitline protocol relies on 
treatment determined to be effective in the 2008 U.S. PHS Clinical Practice Guideline.5 Participants who are 
reached and who accept treatment will first be asked for basic sociodemographic and smoking information. 
After registration and brief assessment, either smoking cessation- or reduction- focused treatment will be 
delivered depending on patient preference. Participants who choose reduction as their initial treatment goal will 
be guided toward setting a quit date aided by NRT. For all participants who engage in treatment, a self-help 
packet (Quit-Kit) will be mailed to provide written information on the topics covered during the initial phone 
session. Most calls last about 30 minutes, with the behavior counseling portion lasting about 15 minutes. A free 
8-week course of NRT (patch, gum, or lozenge) will be mailed in two week allotments to participants who are 
willing to set a quit date and interested in and eligible to use NRT (i.e., free of medical contraindication). Per 
Quitline policy for Chicago residents, NRT is offered at no cost for uninsured residents and reduced cost for 
those who have Medicaid insurance. Because free NRT increases use of quitline treatment,46,104 NRT will be 
made available at no cost to all participants to eliminate differential cost by insurance type as a potential 
confounder of intervention effects. 
 
 
If a participant is reached by the Quitline counselor but has not received the Choose to Change letter, smoking 
cessation or reduction treatment will be offered and delivered according to the participant’s preference. For 
participants not reached during the first call attempt, the Quitline counselor will make two more calls in the 
following two days. A voice message will only be left if the voicemail inbox belongs to the referred participant. If 
three calls are made without a response, the outreach process will end. The Quitline counselor will either call 
at times designated by the participant to be convenient or at varying times during the day. The Quitline 
provides services seen days per week, from 7:00 AM through 11:00 PM. 

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MEASURES 
EHR Characterization of Population  
The EHR query to identify participants will also generate information on the following characteristics: 
sociodemographic (age, gender, race, ethnicity, marital status, household income, education), smoking history 
(number of years smoking, past year quit attempts, use of multiple tobacco products, past referral for smoking 
cessation treatment, including quitline), and healthcare (e.g., date of last clinic visit, type of health insurance, 
most recent problem list). A second query will be run at the 8-month time point to generate number, dates, 
purpose of any clinic visit(s) during the study period, whether or not smoking was addressed (a required field 
the EHR system), and an updated problem list.  
 
Characterization of Population that Engages in Quitline Treatment  
Participants who accept the Quitline call will complete a registration process that includes brief assessment of 
smoking and smoking history to guide treatment. Information will be obtained on current smoking, including 
frequency and preference for menthol cigarettes. If non-daily smoking is endorsed, counselors will ask about a 
typical smoking day. If daily smoking is endorsed, cigarettes per day and time to first cigarette will be obtained. 
Counselors also ask about how long the participant has been a smoker, number of past quit attempts and, if 
any, by what method.  
 
Telephone Surveys on Health Behaviors 
Because many outcome, moderator, mediator, and control variables cannot be received from the Quitline via 
the EHR system for participants who do not engage in Quitline treatment, enrolled participants will complete 
the “NNHSC Health Habits and Wellness service needs survey” of smoking status and moderator, mediator, 
and control variables via telephone interview at baseline (week -4; 4 weeks before randomization to treatment 
and letter mailing), 6, 14, and 28 weeks.  
 
Treatment Outcomes 
Treatment engagement will be measured at 6, 14, and 28 (as applicable) weeks after letter mailing, and 
operationalized as the proportion of participants who accept the proactive Quitline call and accept treatment as 
defined by completing the counseling session. Participants who return a Quitline call and accept treatment also 
will be counted as having engaged in treatment. Further, we will assess: 1) the proportion of smokers who 
request cessation versus reduction counseling; and 2) the proportion of smokers who engage in treatment and 
who request NRT and (or) schedule a follow-up (proactive or reactive) counseling call.  
 
Treatment utilization will be measured at 6, 14, and 28 (as applicable) weeks and will be defined as the 
proportion of participants who complete ≥1 additional counseling calls and receive and use NRT. The 
frequency and duration of sessions will also be measured.  
 
Smoking cessation at 6 and 14 weeks will be defined as self-reported abstinence (not even a puff of a 
cigarette) for ≥7 days. At 28 weeks, breath CO will be used to verify abstinence for participants in the original 
study timeline. For participants in the alternative shorter study timeline, breath CO will be measured at 14 
weeks to verify abstinence. Participants will be classified as abstinent if they report not smoking (not even a 
puff of a cigarette) for ≥7 days and have a CO ≤8 parts per million (ppm). Participants will be assumed to be 
smoking if they report smoking, cannot be reached to provide data, fail to provide a breath sample, or provide a 
breath sample that is >8 ppm.105 Participants who report abstinence at 28 weeks (original timeline) or 14 weeks 
(alternative shorter timeline) will be invited for an in-person visit for breath carbon monoxide (CO) 
measurement to bio-verify abstinence status. 
 
Moderators, Mediators, and Covariates 
Hypothesized moderators of Choose to Change effects will be measured at baseline and include readiness to 
quit smoking,96,97 recent smoking reduction,51 cigarettes per day, time since last clinic visit during which 
smoking was addressed, initial choice of cessation versus reduction, race/ethnicity, perceived stress, , and 
discrimination. Hypothesized mediators of intervention effects on treatment engagement, utilization, and 
cessation will be measured at each survey time point and will include perceived autonomy support, 
autonomous motivation, confidence in ability to quit, and attitude towards NRT. 
 
Demographic Questionnaire: Age, gender, ethnicity, and race will be measured only at baseline. Current 
regular smoking (daily or weekly), NHHSC home clinic for primary health care, and residential address will be 
confirmed. Participant residential addresses and telephone numbers will be confirmed at the baseline 

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assessment prior to treatment randomization to verify that the address in the EHR is accurate. This will help 
ensure that the participant receives the Choose to Change letter. Residential and email addresses will be 
confirmed at each survey. 
 
Health Behaviors Assessment: This questionnaire will assess diet, alcohol use, physical activity, sedentary 
behavior, perceived stress, cigarette smoking/recent treatment (including Quitline treatment) and motivation to 
quit, and current desire for various health promotion services. Past week physical activity and sedentary 
behavior will be measured using the International Physical Activity Questionnaire short form. Health 
Information National Trends Survey (HINTS) items were used to assess fruit, vegetable, and sugar-sweetened 
beverage consumption. Alcohol consumption over the past 30 days will be assessed using the two-item PhenX 
Alcohol Use module. Perceived Stress will be assessed with the 4 -item Perceived Stress Scale will be used to 
measure general stress experienced over the last month. 
 
Perceived Autonomy Support: The Health Care Climate Questionnaire consists of six statements that 
respondents must indicate the degree to which they experience their health care provider(s) as autonomy 
supportive versus controlling. Each HCCQ statement is scored on a 7-point Likert scale (1=Not at all True, 
7=Very True). E.g., “I feel that my health-care practitioners have provided me with choices and options about 
smoking (including not quitting).” 
 
Attitudes Towards Nicotine Replacement Therapy Scale (ANRT): The ANRT is a 12-item scale consisting of 
two subscales measuring the perception of the advantages of NRT (8-items) and drawbacks (4-items) of 
nicotine replacement therapy to quit smoking. “Advantages” taps beliefs that NRT will provide relief from 
withdrawal and craving during cessation, and “drawbacks” describes concerns about NRT dependence, side-
effects, and efficacy. Scores have been associated with intention to use NRT, prior NRT use, nicotine 
dependence, and among those who have ever used NRT, the number of days of use. 
 
Retention and Adherence 
Based upon our past experience with clinical trial and prospective cohort studies of diverse populations (R01 
DA025078; N01 HC48049), we expect at least a 60% participation rate across the four surveys. In our recent 
smoking cessation trial,94 of the 1,989 sessions scheduled for the 259 participants at the Northwestern clinical 
site over their first 6 months, 1,604 (81%) were completed.  
 
To maximize enrollment in this study, we will:  
1) Target patients who are most likely to view one of the NNHSC clinical sites as their medical home 
through defining eligibility based in part on at least one clinic visit during the past year;107  
2) Include monetary compensation  for each survey completion, plus $50 for completing the in-person 
session at week 28 (original timeline) or week 14 (alternative shorter timeline);107 and  
3) Develop and implement strategies to engage the NNHSC community.108,109 Drs. Alicia Matthews and 
Faith Fletcher, along with Dr. Melissa Simon, will provide critical guidance on best practices and issues 
of cultural competency related to research targeting low-income and African American 
populations.110,111 For example, we plan to conduct a clinic-wide outreach campaign across the seven 
participating NNHC clinics to increase interest in the health habits survey. Additionally, we will use 
small, low-cost giveaways to increase recognition of the survey once research assistants because to 
recruit and enroll patients. 
 
We have developed a plan to maximize retention of participants to overcome follow-up challenges that are 
often experienced in longitudinal studies of low-income populations,112-114 such as residential instability. 
Strategies will include the following:  
1) A user-friendly electronic tracking database of participants;  
2) Elicitation at baseline and every follow-up session of relative and (or) neighbor contacts to locate 
participants if needed;  
3) Research personnel training on team building and positive attitudes;  
4) Flexible scheduling of telephone sessions, including Saturday appointments;  
5) Sending personalized reminder cards and retention items (i.e., water bottles, draw string bags, 
earbuds, T-shirts);  
6) Reminder letters with small giveaway items sent one week prior to their scheduled session and 
reminder calls to participants 1-2 days prior to their scheduled session 
7) Establishing strong rapport with participants by providing a friendly experience during assessments;  

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8) Sending seasonal newsletters about living a healthy lifestyle; 
9) Demonstrating a positive and caring attitude towards participants109;  
10) Rapid rescheduling of missed appointments; and  
11) Acknowledgement and appreciation of participant effort.  
 
These enrollment and retention strategies have been effective in pragmatic clinical trials and community 
studies of underserved populations,112-115 as well as in our ongoing cohort study (N01 HC48049). 
 
STATISTICAL ANALYSIS PLAN 
Power 
 
To address power for hypotheses related to Aim 1 (Treatment Engagement at 6 Weeks), we base our 
estimates for the proportion of participants completing a Quitline session by 6 weeks in the Choose to Change 
condition on our pilot study that resulted in a 24% engagement rate. As for the Usual Care condition, we 
expect that current NNHSC Ask, Advise, Refer practice involving the Quitline as the primary referral program 
will result in a tripling to 10% of the 3.3% engagement rate achieved in our EHR fax-referral project, in which 
our NIH-funded study of long-term nicotine patch treatment, with inclusion and exclusion criteria, served as the 
primary referral program.94 Assumed rates by condition 
for each of the three outcomes of interest and 
participants per condition are presented in Table 3. We 
propose that a minimum of N=265 independent 
participants be randomized to Choose to Change versus 
N=265 to Usual Care, for a total N=530. Such a 1:1 
allocation ratio guarantees 99% power for the 
comparison of Choose to Change versus Usual Care at 
two-sided alpha=.05. This sample size requirement 
equates to 40 participants per month over the 15-month 
randomization period. In our three-week pilot study, 132 
patients were processed through the workflow in Figure 
3, a rate of 175 per month. 
 
 
Our power estimates for Aim 2 (Treatment Utilization at 14 Weeks) will be based on Williams et al.9 who 
reported a 30% utilization rate for combined counseling and medication at a later time point than ours (6 
months), following a face-to-face SDT-based intervention. Assuming 6-month utilization rates (one or more 
counseling calls after the initial counseling call) for the Usual Care and Choose to Change conditions of 7% 
and 15%, respectively, would be consistent with their treatment utilization odds ratio of 2.38 (95% CI=1.67-
3.39), albeit at a lower baseline rate than they report. Our proposed randomization plan guarantees 84% 
power for the comparison of Usual Care versus Choose to Change at two-sided alpha=.05.  
 
 
Our power estimates for Aim 3 (Smoking Cessation at 28 Weeks) will be based primarily on Rigotti et al.27 
who reported 7-day point-prevalence abstinence rates at 14 weeks of 1% for standard care and 5% for 
population mail outreach under an Intent-to-Treat (ITT) approach. We expect that these 12-week ITT rates will 
rise to 3% in our Usual Care condition and 10% in the Choose to Change condition. Even if these rates then 
drop to 2% in our Usual Care and 7% in Choose to Change at 26 weeks, we still have 80% power for the 
comparison of Choose to Change versus Usual Care at two-sided alpha=0.05 
 
 
Data Analysis  
All outcomes of interest for Primary Aims 1-3 are binary (treatment engagement, treatment utilization, 
smoking cessation) and can be analyzed using logistic regression methods. Analyses will be conducted first 
using an ITT principle (missing=treatment failures). We will also conduct an adherence sample analysis that 
includes only participants reached at the 28-week follow-up (≥ 75% of the sample based on our experience). 
This approach addresses the question of effectiveness more directly, but it is subject to more bias if attrition is 
large or differential by treatment condition. Therefore, we will complement it by analysis of non-response 
patterns using sociodemographic (age, gender, race, ethnicity, marital status, household income, education), 
and healthcare (time since last clinic visit, type of health insurance) characteristics. These can be used to 
create propensity scores that allow for inverse-probability-weighing (IPW) of observed outcomes116,117 to 
achieve balance across potential confounders of the treatment-to-outcome relationship. Ideally, the distribution 
of propensity scores will show large overlap across study conditions. If not, that will be taken as evidence that 
completers are not comparable on measured confounders across conditions, and that one should refrain from 

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further comparisons. PROC GENMOD of SAS/STAT 9.2118 can handle subject-level probability weights. 
Similar findings across all three approaches would increase confidence in the results overall. Both raw and 
adjusted rates will be presented for each outcome by study condition. For the cessation outcome, we will also 
explore the impact of smoking history (e.g., past year quit attempts, past referral for Quitline treatment), race, 
and gender on non-response. We will also use propensity score modeling to examine the relationship between 
treatment utilization at 14 weeks and abstinence at 28 weeks. Since available data indicate little effect of NRT 
type on outcome, we will model NRT dose/duration, while controlling for patterns of utilization.  
 
 
Exploratory Aim 1 (Moderators of Choose to Change Effects). We will focus our search for moderators on 
baseline variables such as readiness to quit, health literacy,71 smoking level, time since the patient’s last clinic 
visit in which smoking was addressed, and recent smoking reduction.53 Participants who smoke more than 10 
cigarettes per day, who have recently attempted to reduce their smoking, and those lower on motivational 
readiness to quit are expected to be disproportionately responsive to Choose to Change intervention. In 
addition, participants with lower literacy and those with a more recent clinic visit during which smoking was 
addressed are expected to be especially likely to benefit. These factors are expected to be especially 
responsive to the person-centered and the low-income targeted elements of the Choose to Change 
intervention (Figure 2), though we realize that there may be other potential moderators. Other variables to be 
explored as potential moderators include initial choice of smoking cessation versus reduction, and 
race/ethnicity. Analysis will be conducted using logistic regression, with a separate model for each outcome 
variable. The predictor variables will include treatment condition, the moderator variables, and their two-way 
interactions with condition. Sociodemographic (e.g., gender), psychosocial (e.g., perceived stress), and 
smoking (e.g., menthol cigarette use) variables known to influence smoking cessation will serve as covariates.  
 
Exploratory Aim 2 (Mediators of Choose to Change Intervention Effects) hypothesizes that increases from 
baseline in confidence in one’s ability to quit, positive attitude towards NRT, autonomy support, and 
autonomous motivation will mediate the effects of the Choose to Change intervention on study outcomes 
(Figure 2). We will establish mediation using MacKinnon’s approach,120 which is more powerful than Baron and 
Kenny’s causal-steps method.121 This approach is explained in Cerin and MacKinnon122 and implemented by 
Papandonatos et al.123  Simultaneous estimation of the effect of mediators (e.g., confidence in one’s ability to 
quit, positive attitude towards NRT) will be conducted as in Napolitano et al.124 Although we see value in 
building the model in a piecewise fashion (in terms of evaluating the need to adjust for potential confounders of 
the treatment to outcome relationship) we will complete the mediation analysis by estimating the full model in a 
single step using the structural equation modeling package Mplus 6.0,125 which will allow us to assess the 
statistical significance of any complete mediation path evaluated via bootstrapping.  
 
MULTIPLE SITES 
This research study is part of a larger U54 grant (PI: Simon) that establishes a three-institution partnership 
between Northwestern University, University of Illinois at Chicago, and Northeastern Illinois University. As 
such, there is a Co-PI from each of the partnering institutions (Alicia Matthews, UIC; Christina Ciecierski, NEIU; 
both noted on page 1) for this study. Northwestern is the lead site, and Brian Hitsman serves as the lead 
project PI. All research activities will be conducted at one of the partnering community organizations (Near 
North Health Services Corporation; Tim Long, Site-PI), and the NNHSC research committee has reviewed and 
approved this protocol. All research activities will be conducted by NU research personnel who, in addition to 
the NU IRB-required human subjects protection training, have completed the human resources training and 
HIPAA-compliance training required by NNHSC for all NNHSC clinical personnel, thereby allowing these NU 
research personnel permission to access the NNHSC electronic health record and the data contained therein, 
and the approval to contact NNHSC patients using the procedures described in this protocol. No research 
activities will be conducted at either UIC or NEIU. 
 
Alicia Matthews (UIC Co-PI) and Yamile  Molina (UIC Co-I) contribute their expertise in community-based 
participatory research in smoking cessation among low-income and disenfranchised populations, and Dr. 
Matthews, specifically, designed our recruitment and retention plan. Christina Ciecierski (NEIU Co-PI) will be 
leading the cost evaluation component of the study. 
 
Alliance of Chicago will provide research and EHR technical expertise for NNHSC’s EHR (i.e., Alliance will 
build the e-Referral, e-Outcomes and letter components of the Choose to Change intervention within NNHSC’s 
EHR. 
 

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The Illinois Tobacco Quitline will provide their evidence-based cessation treatment to all participants who 
accept the referral and proactive call from the Quitline counselors. The Quitline staff will conduct the same 
counseling to study participants that they do to any other caller or patient referred for services. They will also 
electronically send the treatment outcomes information to the NNHSC EHR for all participants who complete 
Quitline counseling sessions. 
 
All partners, academic and community-based, will be provided with a current IRB-approved protocol. As all 
staff conducting the research activities are NU staff, we hold regular weekly meetings to ensure successful 
coordination of these activities and ongoing research protocol monitoring. 
 
Community-Based Participatory Research 
The Choose to Change intervention has benefitted from six-year collaboration with NNHSC, including Winfield 
Moody Health Center, Alliance, and the Illinois Tobacco Quitline. NNHSC providers and patients guided and 
contributed to the development of key aspects of the Choose to Change intervention, including the letter, and 
clinical workflow. Because of this long-term partnership, we have established a system to ensure the 
successful coordination of research activities across all collaborating organizations. Specifically, the PIs and 
research managers from NNHSC, NU, and Alliance of Chicago biweekly during the EHR-system build and 
through project launch. Additionally, the Alliance research manager, project director (from NU), and Quitline 
manager meet once monthly to address any issues that arise regarding development, study implementation, 
and evaluation.  
 
Setting  
The setting for this study will be Winfield Moody Health Center, which is the flagship clinic and administrative 
location for NNHSC, and the NU Preventive Medicine Research Clinic (680 N. Lake Shore Drive, Suite 1410, 
Chicago). All aspects of the study, i.e., query list identification, outreach recruitment calls, all telephone 
surveys, intervention letter creation, sending of intervention text messages, mailing of recruitment and retention 
materials, in-person clinic sessions, will take place at either Winfield Moody or the NU Preventive Medicine 
Research Clinic. Additionally, for participants who report abstinence at their week 28 phone session, they will 
be offered the option to conduct the in-person clinic visit at either their home NNHSC clinic location or the NU 
Preventive Medicine Research Clinic. 
 
Prior Approvals 
The NNHSC Research Committee has reviewed and approved the study protocol.   
 
CONSENT PROCESS 
Baseline and follow-up surveys will be completed by telephone; therefore, verbal informed consent will be 
obtained from patients prior to being enrolled. To obtain verbal informed consent, the RA will read the IRB-
approved informed consent document to the candidate that includes all components of a standard informed 
consent form, including study description and procedures, risks and benefits of participation, alternatives to 
participation, financial information, protection measures taken to ensure participant confidentiality, research 
subject rights, and who to contact with any questions or concerns about the study. Enrolled smokers will be 
given the option to receive the informed consent form, via traditional mail or email, that was used to document 
their verbal consent and signed by the RA who obtained the consent. 
 
During each telephone surveys, participants will be encouraged not to answer any question that makes them 
feel uncomfortable. It will be explained during consenting and before administration of all surveys that they may 
stop the survey at any time and that doing so would not negatively affect their healthcare. 
 
Participants enrolled in the alternative/shorter study timeline will be read an edited consent that accurately 
explains the shorter timeline and corresponding compensation. All other aspects of the consenting process will 
be the same as the participants completing the original study timeline. 
 
Incomplete Disclosure 
The verbal consent will include information about the health habits survey only as full disclosure of the content 
and purpose of the Choose to Change intervention could compromise our ability to evaluate the intervention. 
We believe that the randomized controlled trial portion of this study is eligible for a waiver of written informed 
consent because it meets established criteria. First, participation in the RCT poses very low risk to participants, 

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i.e., no more than minimal risk to participants. Second, informed consent cannot be obtained without seriously 
threatening the validity of the study. The focus of this study is to evaluate the extent to which the Choose to 
Change letter motivates patients to engage in and use Quitlince treatment to achieve short-term smoking 
cessation. The Choose to Change intervention is novel in that it attempts to increase engagement in treatment 
through encouraging a variety of initial treatment goals, ranging from abrupt smoking cessation to gradual 
smoking reduction to simply learning about smoking and smoking cessation. The central idea is that smokers 
who are highly ambivalent about quitting will be more motivated to engage in Quitline treatment because there 
will be no pressure to set a quit date and abruptly quit. The usual approach to smoking cessation treatment in 
primary care requires a commitment to abrupt quitting. Disclosure of this flexible approach to addressing 
smoking cessation would expose Usual Care participants to the central message of the Choose to Change 
intervention and significantly undermine our ability to observe an intervention effect on Quitline engagement, 
utilization, and cessation. Disclosure of Quitline treatment would result in a small sample of participants who 
are ready to quit smoking, significantly undermining our intent to address smoking among patients who are not 
ready to attempt quitting (95% of all smokers). As achieved in our past randomized controlled trials,18-20 a 
waiver of informed consent allows for the entire population of eligible smokers to be included in the study, 
thereby achieving a true assessment of the effectiveness of Choose to Change versus Usual Care without 
selection bias. Third, the waiver will not adversely affect the rights and welfare of participants. Patients 
randomized to the Choose to Change arm are given multiple opportunities to opt themselves out of the Choose 
to Change text messages and referral to the Quitline. After the final survey has been completed, Usual Care 
participants who report continued smoking will be offered a referral to the Quitline.   
 
Debriefing 
Once the study is complete and all participants have completed their last follow-up survey, all participants will 
be fully debriefed via newletter (emailed or traditionally mailed, based on participant preference) regarding the 
randomized controlled trial. 
 
Process to Document Consent in Writing 
This research study presents no more than minimal risk to participants and because survey data is collected 
over the telephone, we plan to obtain verbal consent to participate in the survey study and offer the participant 
a hard copy of the consent document.  
 
Withdrawal of Subjects 
Participation in this research study is completely voluntary. Participants do not have to answer any question 
that that they prefer not to and will be told this. It will be explained to participants that they can withdraw at any 
time, that choosing not to be in this study or to stop being in this study will not result in any penalty or loss of 
benefit to which participants are entitled, including health care benefits, and that withdrawal from the study will 
not negatively affect any rights to which they are otherwise entitled, including their right to any present or future 
treatment. Participants will be told that they must confirm verbally with research staff if they are choosing to 
withdraw from the study, after which time no more data will be collected from them. It will also be noted that if 
participants chose to withdraw from the study, any information/data collected prior to their withdrawal of 
consent can be used for research purposes. 
 
Sharing of Results with Subjects 
If requested by participants, overall study results, in aggregate, will be distributed to participants once 
the study has been completed. 
 
RISK/BENEFIT ASSESSMENT 
 
Potential Study Risks 
The risks of participation in this study are very low. The established Business Associate Agreement will allow 
the secure integration of the NNHSC EHR and Quitline networks, effectively making a unified, HIPAA-
compliant system and eliminating typical threats to confidentiality. This unified network system uses HL7, a 
health communication language that provides direct, secure, bi-directional transfer of protected health 
information between the NNHSC EHR and the Quitline’s secure server. The Quitline’s secure server on which 
patient data is stored is completely separate from its other network server that is dedicated to email and other 
functions that do not include protected health information. This provides a higher level of protection of patient 
data confidentiality and privacy. There are three stages at which NNHSC providers, on behalf of their patients, 
or patients themselves can decline participation in the randomized clinical trial: a) prior to any outreach to 

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enroll patients in the study or referral to the Quitline, all NNHSC providers will be able to exclude patients 
whom should not attempt smoking cessation; b) clear instructions for declining participation will be provided in 
the Choose to Change letter, i.e., the patient may call the study care coordinator and request that his/her name 
and contact information not be securely transmitted to the Quitline; and (c) patients will be given the 
opportunity at the start of the Quitline call to decline participation. 
 
Patients who engage in Quitline treatment may experience mild discomfort when asked about smoking or 
concerns related to smoking cessation or gradual smoking reduction. Additionally, for participants who quit 
smoking or reduce, it is possible that they will experience symptoms of tobacco withdrawal. The most common 
symptoms of withdrawal are anxiety, irritability, difficulty concentrating, insomnia, and restlessness. The 
Quitline counselors are trained to help patients manage withdrawal symptoms. Patients will be reminded that 
these symptoms are typically time-limited and they will be taught behavioral strategies to manage symptoms. A 
free 8-week course of nicotine replacement therapy (NRT; patch, gum, or lozenge) will be mailed in two week 
allotments to patients who are free of medical contraindications and complete weekly counseling calls. For 
participants who can safely use nicotine replacement therapy (e.g, the patch, gum, or lozenge) and elect to do 
so, use of NRT will minimize the severity of withdrawal. Participation in the study does not otherwise involve 
any physical or emotional risk to study participants beyond that of everyday life. 
 
Potential Benefits to Subjects 
Potential benefits for patients are smoking cessation and the associated health and psychological benefits. We 
expect that successful smoking reduction will build self-confidence and substantially increase the likelihood of 
the smoker making a quit attempt and achieving successful smoking cessation by eight months. A potential 
benefit for NNHSC is improved preventive care and improved health for its patients. If the proposed 
intervention is determined to be effective, we will be able to disseminate it to Alliance’s 11 safety net health 
centers throughout Chicago, comprising over 85 clinical sites that care for almost 500,000 patients. 
 
Study Subject Compensation 
Participation in this study will involve no cost to study participants. Participants enrolled prior to mid-February 
2018, completing the original study timeline through Week 28 will be compensated for their time and effort up 
to a maximum of $195. They will earn $25 for completing the first telephone survey, $30 for completing the 
second survey, $40 for completing the third survey, and $50 for completing the fourth survey. Participants 
enrolled after mid-February 2018 into the alternative shorter study timeline through Week 14 will be 
compensated for their time up to $175; earning $35 for the baseline telephone survey, $40 for the second 
survey, and $50 for the third survey. Participant incentives will be paid as an electronic gift card after each 
survey. If preferred by the participant, the incentive can be provided to participants as a traditional physical gift 
card/pre-paid debit card to participants if they come into the clinic to pick up the  card and sign paperwork 
confirming their receipt. Those participants who report abstinence at the week 28 (original timeline) or week 14 
(alternative shorter timeline participants only) follow-up survey will be invited to attend an in-person study visit 
to obtain a breath carbon monoxide (CO) measurement to bio-verify abstinence status. Participants who come 
in for the in-person visit will be provided a gift card at the completion of that visit ($40 for the visit, $10 to cover 
travel).  If a participant withdraws from the study, s/he will be compensated for all study sessions completed to 
the point at which s/he withdrew. 
 
We expect that some participants may have cell phones as their primary method of communication with 
monthly plans that limit the number of voice minutes allowed. Therefore, in order to promote completion of the 
telephone survey sessions while not consuming their minute allotments, participants who have government-
issued or pre-paid cell phones with a voice minute limits will be provided with a $5.00 minute replenishment 
card (worth 250 minutes) for each survey completed. The card will be sent within a few days of the completed 
telephone survey. 
 
Compensation for Research-Related Injury 
Not applicable. This research involves no more than minimal risk to study participants and does not involve 
“research-related injury.” 
 
DATA SECURITY AND MANAGEMENT 
Provisions to Protect Privacy Interests of Participants 
Communication of patient information for cessation referrals from Winfield Moody Health Center to the Quitline 
server will be transmitted by a one-step referral through the NNHSC EHR via a direct portal using Health Level 

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&  (HL7) and HL7-compatible language directly to the Quitline internal network. By connecting directly to the 
internal server through this secure portal, no patient information is transmitted out of the Quitline’s internal 
network. The email server used is completely separate from the ALA’s internal email system. It is located 
behind a spam filter and a firewall and uses HL7 standards. 
 
The secure electronic transmission of patient name and telephone number to the Quitline will be covered by 
HIPAA as there is an executed contract currently in place that has established the Quitline as a Business 
Associate of NNHSC and Alliance. A Business Associate is an individual or organization that performs a 
healthcare function involving use or disclosure of protected health information for a covered entity. One 
covered entity may be a Business Associate of another covered entity if it performs such services (i.e., carries 
out healthcare functions) for the other covered entity [HIPAA 45 CFR 164.502(e), 164.504(e), 164.532(d) and 
(e)]. NNHSC, Alliance, and the Quitline have completed the process to establish the necessary Business 
Associate Agreements (BAA) and have all committed to maintaining this clinical partnership.  
  
The automated text messaging procedures to be used in the study were established in our ongoing work (P01 
HS021141). We will use the same HIPPA-compliant, web-based service provider, Touch Point Care 
(www.touchpointcare.com), which specializes in secure healthcare practice-patient communication, such as 
appointment reminders, lab test results reporting, and other brief communications (e.g., influenza vaccine 
availability and clinic times). Participants’ telephone numbers and preferred communication method will be 
uploaded via secure transmission to our study-specific, password-protected account on Touch Point Care’s 
encrypted login page (https://www.touchpointcare.net) and will be used to place four separate text messages 
during the first ten days of study participation, then one final message about 9-10 days after the 4th message. 
Included in each message will be simple instruction on how to opt-out of further messages and the referral to 
the Quitline. Opting-out will require the participant to send a text reply with the word “STOP.” The contact 
information for participants who opt-out will be permanently removed from the Touch Point Care account. The 
research assistant will generate a report within the touchpointcare.net interface that lists all participants who 
chose to opt-out of the Quitline referral. This information will be noted in the participant’s EHR. 
 
Study records generated through the telephone surveys that can identify participants will be kept confidential 
by assigning a unique study ID number to them. Names and identifying information will be kept completely 
separate from survey responses. The REDCap database and the web server are housed on secure servers 
operated by the Northwestern University Biomedical Informatics Center (NUBIC). Access to study data in 
REDCap will be restricted to the research team members by username and password. All paper data will be 
stored in locked cabinets in a locked office at Northwestern University Department of Preventive Medicine.  
 
Data Collection and Management 
The telephone surveys of smoking status and moderator, mediator, and control variables will be conducted at 
NNHSC. Data will be entered and managed using Research Electronic Data Capture software (REDCap), 
which uses a MySQL database via a secure web interface with data checks used during data entry to ensure 
data quality. REDCap includes a complete suite of features to support HIPAA compliance, including a full audit 
trail and user-based privileges. The MySQL database and the web server are housed on secure servers 
operated by the Northwestern University Biomedical Informatics Center (NUBIC). Access to study data in 
REDCap will be restricted to study personnel by username and password. Any paper data will be stored in 
locked cabinets in a locked office at Northwestern University Department of Preventive Medicine. The Alliance-
hosted EHR is linked to a clinical data warehouse that provides for data analysis and reporting at the provider, 
health center, and population levels. Data cleaning and validation will occur in Months 25-33. The Alliance 
Data, Reporting, and Quality Informatics Team, led by Mr. Andrew Hamilton and overseen by Dr. Nita 
Mohanty, will merge the longitudinal survey data with the EHR extracted NNHSC and Quitline data. Once 
validated, a deidentified database will be securely transferred to a File Transfer Protocol site only accessible to 
Alliance and Dr. George Papandonatos at Brown University. 
 
Provisions to Monitor the Data to Ensure the Safety of Subjects 
The proposed study aims to connect patients who smoke with effective, free smoking cessation treatment. 
Quitline services, including behavior counseling, self-help materials, and NRT, pose low risk of adverse effects 
or unsafe use. The four telephone assessments of smoking status and other health behaviors is also a low risk 
activity. Commensurate with the low level of risk, a Data Safety and Monitoring Board (DSMB) will not be 
necessary. The established Business Associate Agreement between NNHSC and the Illinois Tobacco Quitline 
will enable the secure, encrypted network-to-network transmission of protected health information. This system 

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will eliminate the typical risk of threats to patient confidentiality (e.g., use of traditional fax referrals that can be 
misplaced). Secure systems of individualized password-protected access to network folders containing patient 
data provides additional security and confidentiality. 
 
Psychological distress 
Although we will not administer a formal measure of psychological distress, if any such symptoms are reported 
during the telephone interviews or in-person study visits, research staff are trained to offer mental health and 
case management resources at the conclusion of the survey to these participants. This procedure is similar to 
what is currently done as part of the other smoking cessation clinical trials in Dr. Hitsman’s lab and include 
several free, low-cost/sliding scale options. 
 
 
 
STUDY MANAGEMENT FOR HUMAN SUBJECTS PROTECTION 
General Monitoring 
The project will be overseen by the Principal Investigator (Dr. Brian Hitsman), the NNHSC Director of 
Performance Improvement, Health Information Technology, and Research (Dr. Timothy Long), the Alliance of 
Chicago’s Director of Evidence-Based Practice (Dr. Nita Mohanty), the Senior Vice President of Helpline 
Services at the American Lung Association of Illinois (Mr. Michael Mark), the Northwestern project director (Ms. 
Anna Veluz-Wilkins), and the project statistician (Dr. George Papandonatos).  Drs. Alicia Matthews (University 
Illinois at Chicago) and Christina Ciecierski (Northeastern Illinois University) will also assist with general 
monitoring, as will the project collaborators (Drs. Melissa Simon and Kenzie Cameron).  
 
IRB Monitoring 
As the official IRB of record indicated in the approved IRB authorization agreement (IAA, Federalwide 
Assurance #FWA00001549), the protocol will be reviewed by the Northwestern IRB and will only be 
implemented after successful approval. Annual reporting and auditing will be conducted by the Northwestern 
IRB. All procedures will be approved by the Northwestern IRB and accepted by the UIC and NEIU IRBs. The 
Northwestern IRB will review and monitor the research protocol detailing the study, data collection procedures, 
risks and benefits, the waiver of informed consent for the randomized clinical trial, and the verbal informed 
consent for the surveys of smoking status and behaviors. The NU IRB will monitor and review all approved 
protocols annually. The Research Committee at NNHSC has already reviewed and approved this research 
protocol. 
 
Qualifications to Conduct Research and Resources Available  
The Choose to Change intervention has benefitted from six-year collaboration with NNHSC, including Winfield 
Moody Health Center, Alliance, and the Illinois Tobacco Quitline. NNHSC providers and patients guided and 
contributed to the development of key aspects of the Choose to Change intervention, including the letter, and 
clinical workflow.Brian Hitsman, Ph.D., Alicia Matthews, Ph.D., and Christina Ciecierski, Ph.D., serve as PIs of 
the 
Choose to change research project (Reducing tobacco use disparities among adults in safety net community 
health centers) as required by the U54 grant. Dr. Hitsman has a full-time appointment as assistant professor in 
the Department of Preventive Medicine at Northwestern University (NU) Feinberg School of Medicine. He has 
been a member of the NU Robert H. Lurie Comprehensive Cancer Center since 2008 and is Co-director of 
Responsible Conduct of Research Training in the NU Clinical and Translational Sciences Institute. Dr. 
Matthews has a full-time appointment as associate professor in the College of Nursing at the University of 
Illinois at Chicago (UIC). She also serves as Director of the Recruitment and Retention Core in the UIC Center 
for Clinical and Translational Science. Dr. Ciecierski has a full-time appointment as associate professor in the 
Department of Economics at Northeastern Illinois University (NEIU). Led by Dr. Hitsman, the proposed 
research project unites NU, UIC, and NEIU by extending a four-year NCI-funded collaboration with Dr. 
Ciecierski (P20 CA165588; PI, M. Simon) and a two-year collaboration with Dr. Matthews on the pilot studies 
that serve as the critical foundation for the proposed research project. Together, the PIs are committed to 
addressing cancer health equity through reducing racial and socioeconomic disparities in tobacco use. 
 
Dr. Hitsman will work with Drs. Matthews and Ciecierski, in collaboration with the project community partners, 
on finalizing the intervention, on recruitment, enrollment, and retention of participants, and on the repeated 

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assessment of smoking cessation and other variables in the randomized clinical trial. Dr. Matthews will guide 
the implementation of best practices of cultural competency in smoking cessation research with low-income 
minority populations and of community-based participatory research. 
 
Dr. Hitsman will oversee the NU project director and research personnel who will assist with all aspects of 
study implementation, recruitment, enrollment, and retention, and data management and quality control. Dr. 
Hitsman will coordinate regular meetings of the research team and will serve as the principle conduit for 
communication among PIs, Co-Is, and research personnel, as required. As achieved during the development 
of this U54 research project, the PIs and Co-Is of the community partnering organizations will meet biweekly in 
person to review and problem-solve study implementation, evaluation, and administration. Dr. 
Hitsman will hold monthly in-person meetings with the full research team to review achievement of project 
milestones and problem-solve issues as needed. Co-Is from outside of Chicago (Mr. Mark and Dr. George 
Papandonatos, Brown University) will attend by video-conference. As contact PI, Dr. Hitsman will serve will 
assume responsibility for the fiscal and administrative management of the project. In addition, he will be 
responsible for communication with NIH and submission of annual reports to NIH. 
 
Dr. Hitsman will oversee data analysis and interpretation, but will share responsibility with Drs. Matthews and 
Ciecierski in writing and coordinating scientific publications and communications arising from the research 
project. Publication authorship will be based on the relative scientific contributions of the PIs and the rest of the 
research team. If a potential conflict develops, the PIs will meet and attempt to resolve the dispute. If they fail 
to resolve the dispute, the disagreement will be referred to an arbitration committee consisting of one impartial 
senior executive from each PI’s department and a fourth impartial senior executive mutually agreed upon by 
both PIs. No members of the arbitration committee will be involved in the U54 grant. 
 
Near North Health Service Corporation 
NNHSC is a 501(c)(3) non-profit Federally Qualified Health Center (FQHC). It is one of the largest providers of 
community-based primary care in Chicago. NNHSC targets a primary catchment area that encompasses 68 
zip code areas throughout Chicago, serving a diverse and largely underserved population. While disparate, 
NNHSC communities are characterized by large concentrations of Chicago Housing Authority high rise 
apartments, abandoned residential buildings, blighted commercial properties, and an utter absence of basic 
services and healthcare resources. The goal of NNHSC is to provide access to high quality healthcare and to 
improve the health and well-being of the diverse populations and the communities that it serves. NNHSC is a 
culturally sensitive, patient centered community health center that empowers individuals through education and 
health prevention, regardless of one’s ability to pay.  
 
A full array of primary care clinical services and comprehensive social support programs are provided through 
NNHSC’s nine community health centers that serve over 35,000 patients. Seventeen percent of NNHSC users 
are smokers. Over half (56%) of the population is uninsured, 40% have Medicaid coverage, and 4% are 
covered through Medicare. Females account for 63% of NNHSC patients. Ninety-six percent of NNHSC users 
live at or below 100% of the Federal Poverty Index (FPI). Partnering with NNHSC allows the proposed study to 
target a diverse, underserved, low-income population. 
 
Alliance of Chicago 
Alliance of Chicago was built on partnering with community health centers and has an established relationship 
with NU.  Alliance is a Health Resources and Services Administration-funded network of independent primary 
care community health centers that supports a centrally hosted electronic health record (EHR) system shared 
by 32 safety net health centers in 12 states. Eleven of the 32 centers are in Chicago, with over 80 clinical sites 
and 200,000 patients. NNHSC is one of the four founding member centers of Alliance; the others are Erie 
Family Health Center, Howard Brown Health Center, and Heartland Health. The target populations in Chicago 
are low-income and uninsured minorities: Latino, African American, Gay and Lesbian, and Immigrant and 
Homeless.  As a network of Federally-Qualified Health Centers (FQHCs) all on a shared, centrally hosted 
electronic health record (EHR) system, the Alliance of Chicago is uniquely positioned to develop and 
implement a multifaceted, technology-based model for improving smoking rates in the city of Chicago. The 
Alliance EHR system for all clinical encounters (General Electric Centricity, Practice Solution 14) is 
distinguished by the integration of evidence-based practice recommendations into the end user interface to 
provide decision support at the point-of-care and facilitate routine reporting against national performance 
measures. The Alliance-hosted EHR is linked to a clinical data warehouse that provides for more robust data 

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analysis and reporting at the provider, health center, and population levels.  Finally, the Alliance has invested 
in geo-mapping tools (ESRI software) that help convert data into actionable information, by visualizing exactly 
where, on the neighborhood map of Chicago, the greatest opportunities for improvement exist. 
  
Other Members of the Research Team 
The following people will be directly involved with study implementation and execution:   
 
Northwestern: 
Anna Veluz-Wilkins, MA, Project Director 
Amanda Mathew, Ph.D, Collaborator 
Marcia McNutt Tan, PhD., Cancer Prevention Post-Doc and collaborator 
Aida Giachello, Ph.D, Co-investigator (Community outreach expert) 
Kenzie Cameron, Ph.D, MPH, Co-investigator (Health Literacy expert) 
Ronald Ackermann, MD, MPH, Co-investigator 
Emmanuel Cordova, BS, Research Assistant 
Edgardo Ramirez, BS, Research Assistant 
Noelle Torres, Research Intern 
 
UIC: 
Yamile Molina, Ph.D, Co-investigator 
 
Brown University: 
George D. Papandonatos, Ph.D, Biostatistician and Co-investigator 
 
Alliance of Chicago: 
Sarah Rittner, MA, Alliance site research manager 
Pankaja Desai, Ph.D, MPH, MSW, Co-investigator 
Elizabeth McKnight, MMI, EHR-application programmer 
Andrew Hamilton, MS, Clinical Informatics Director 
Jeremy Carr, BS, Senior Application Specialist 
Sebastian Clavijo, BS, Clinical informatics programmer  
 
Illinois Tobacco Quitline: 
Cherylee Bridges, RN, IL Tobacco Quitline Clinical Manager 
Michael Mark, BA, Vice President of IL Tobacco Quitline Services 
Lew Bartfield, BA, president and CEO of the American Lung Association of the upper Midwest 
 
Near North Health Services Corporation: 
Crystal Flowers-Carson, RN, Director of Care Coordination 
 
 

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