Clinical trial NCT03187730
Conditions: Smoking Cessation
Keywords: Smoking Cassation Immigrants Economic Disparity
Sponsor: NYU Langone Health
Start date: 2017-09-22; Completion date: 2021-04-30
Enrollment: 410 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a 24 month pilot project that will implement and evaluate an innovative program that integrates financial counseling with smoking cessation counseling for low-income immigrants.

Detailed description:
This is a two-arm randomized, wait-list control study with 610 participants total: 600 patient participants and 10 staff participants. 600 smokers will be recruited to complete a 9-week intervention that integrates financial management and smoking cessation counseling. Participants will be randomized (300 per arm, stratified by site) to receive the intervention immediately after enrolling (Intervention Arm) or 6 months later (Waitlist Control Arm). Both arms will receive nicotine replacement therapy (NRT) for four weeks as part of their time in integrative counseling. Participants will be observed at baseline, 2 months, 6 months and 12 months to assess outcomes and their satisfaction with treatment.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Integrated Smoking Cessation and Financial Counseling intervention 2: Waitlist Integrated Smoking Cessation and Financial Counseling intervention 3: Nicotine Replacement Therapy (NRT)
Intervention descriptions: intervention 1: Participants in the intervention group will receive up to nine counseling sessions that integrate two evidence-based counseling approaches: financial management counseling and smoking cessation counseling. Participants will also be eligible to receive a free four-week supply of NRT. Participants will be surveyed at baseline, 2- months, 6-months and 12-months to assess outcomes and treatment satisfaction. intervention 2: Control participants in the waitlist control group will receive usual care for the first 6 months of the study, while the Intervention Arm receives integrated counseling. The waitlist control group will receive the same counseling program as the Intervention group 6 months after enrollment (up to nine counseling sessions and four weeks of NRT). Participants will be surveyed at baseline, 2-months, 6-months and 12-months to assess outcomes and treatment satisfaction. intervention 3: Participants in both arms will be eligible to receive a free four-week supply of NRT.

Protocol documents:
Prot_SAP_000.pdf: 
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TITLE: 
Integrating Financial Management Counseling and Smoking 
Cessation Counseling to Reduce Health and Economic Disparities in 
Low-Income and Immigrant Smokers 
 
STUDY#: 
s16-02177 
 
Principal Investigator: 
Erin Rogers, DrPH 
 
 
 
NCT03187730 


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1. 
ABSTRACT 
Smoking is the leading preventable cause of death in New York City (NYC), and people with low 
income, including many immigrant populations, living in NYC are more likely to suffer from 
smoking-related mortality. However, there have been limited efforts to develop tobacco use 
programs specifically for low-income or immigrant populations. Prior research has found that 
low-income smokers face unique barriers to cessation, including financial distress, negative 
outcome expectancies, depressed mood, an externalized locus of control, and an increased 
focus on immediate needs at the expense of delayed goals. Financial counseling is effective at 
improving financial knowledge and outcomes, and offers the opportunity to reinforce the 
financial rewards of quitting while simultaneously improving the financial circumstances and 
associated barriers to abstinence in low-income smokers. We propose a pilot project that will 
evaluate an innovative program that integrates financial counseling with smoking cessation 
counseling for low-income and immigrant smokers at Bellevue Hospital Center and Lutheran 
Medical Center. The project will achieve the following specific aims: (1) Estimate the 
acceptability of the integrated program and its effect on participants’ financial stress, mental 
wellness, quit attempts, and abstinence from cigarettes; (2) Estimate the per-patient cost of the 
integrated program; and (3) Identify barriers and facilitators toward wide-scale implementation of 
the program model. To accomplish these aims, we will conduct a two-arm randomized, wait-list 
control study. We will recruit 600 smokers to complete a 9-week intervention that integrates 
financial management and smoking cessation counseling. Participants will be randomized (300 
per arm) to receive the intervention immediately after enrolling (Intervention Arm) or 6 months 
later (Waitlist Control Arm). Both arms will receive nicotine replacement therapy (NRT) for four 
weeks during their time in counseling. We will survey patients at baseline, 6 and 12 months to 
assess outcomes and their satisfaction with treatment. Additionally, we will recruit and interview 
hospital staff (N=5 per site, 10 total) to assess their perceptions regarding barriers and 
facilitators toward downstream implementation of the intervention. 


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2. 
PURPOSE OF THE STUDY AND BACKGROUND 
2.1 
Background 
Smoking is the leading preventable cause of death in New York City (NYC), and people with 
low-income, including many immigrant populations, living in NYC are more likely to suffer from 
smoking-related mortality. Further, immigrants in NYC – particularly those of Chinese, 
Dominican, Mexican, and Puerto Rican descent – often live in poverty, placing them at distinctly 
high risk for smoking, morbidity, and mortality. Indeed, previous research has found that rates of 
smoking among low-income households are three times higher than those among high-income 
households, and this income disparity in tobacco use has persisted over time. However, despite 
the chronic income disparity in tobacco use and high rates of smoking among immigrant 
populations, there have been limited efforts to develop tobacco use programs specifically for 
low-income or immigrant populations. 
Prior research has found that low-income smokers face unique barriers to cessation, including 
financial distress, negative outcome expectancies, depressed mood, an externalized locus of 
control, and an increased focus on immediate needs at the expense of delayed goals. Of 
particular concern is that tobacco use can exacerbate financial strain by limiting funds to pay for 
other goods and services. In New York, smoking households spend approximately $1,100 year 
on tobacco – money that could otherwise be spent on household essentials such as food, 
clothing, and health care. Previous research has found that smoking households are more likely 
to experience food and housing insecurity and spend a larger proportion of their budget on 
tobacco than on health care. In NYC in particular, smokers living in the lowest income level can 
spend almost 30% of their budget on cigarettes. Our prior work has found that tobacco 
cessation is associated with reduced spending on alcohol and entertainment, and with 
increases in household savings. Thus, tobacco cessation can improve both the health and the 
financial well-being of low-income smokers. 
Evidence supports the effectiveness of financial incentives to increase abstinence rates in low- 
income populations by providing reinforcement for quitting. However, providing cash payments 
for quitting may not produce sustained behavior change and raises ethical concerns over the 
exploitation of low-income populations’ economic vulnerability without providing assistance with 
their underlying financial conditions. In contrast, financial counseling is effective at improving 
financial knowledge and outcomes, and offers the opportunity to reinforce the financial rewards 
of quitting while simultaneously improving the financial circumstances and associated barriers to 
abstinence in low-income smokers. Money management counseling has been shown to improve 
health and economic outcomes in patients using cocaine and/or alcohol. We aim to adapt this 
model by integrating money management counseling with smoking cessation counseling. 
2.2 
Aims 
1. Estimate the acceptability of the integrated program and its effect on participants’ 
disposable income, savings, financial stress, mental wellness, and abstinence from 
cigarettes. 
2. Estimate the per-patient cost of the integrated program. 
3. Identify barriers and facilitators toward wide-scale implementation of the program model. 
 
 
2.3 
Study Design 


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We will conduct a two-arm randomized, wait-list control study. We will recruit 610 participants 
total: 600 patient participants and 10 staff participants. We will recruit 600 smokers to complete 
a 9-week intervention that integrates financial management and smoking cessation counseling. 
Participants will be randomized (300 per arm, stratified by site) to receive the intervention 
immediately after enrolling (Intervention Arm) or 6 months later (Waitlist Control Arm). Both 
arms will receive nicotine replacement therapy (NRT) for four weeks as part of their time in 
integrative counseling. We will survey participants at baseline, 6 months and 12 months to 
assess outcomes and their satisfaction with treatment. The first 150 enrollees will complete an 
additional 2 month follow up survey. Additionally, we will recruit and interview hospital staff (N=5 
per site, 10 total) to assess their perceptions regarding barriers and facilitators toward 
downstream implementation of the intervention. 
2.4 
Sites 
The study will be conducted at two sites: 
2.4.1 
Bellevue Hospital Center is the largest public hospital system in the United States and 
is one of the New York City Health and Hospitals Corporation’s member institutions. It is 
also the nation’s oldest public hospital, established in 1736 as a 6-bed infirmary. The 
Adult Primary Care Center at Bellevue Hospital will serve as the site for recruitment from 
Bellevue. The Center provides over 60,000 continuity visits per year to approximately 
28,000 active patients with a variety of chronic conditions. 
2.4.2 
Lutheran Medical Center, Lutheran, which merged with NYULMC January 1, 2016, is 
the largest Federally-Qualified Health Center in NY State and 2nd largest in the US. Its 
109 physicians, 43 NPs and PAs, 19 care managers and 4 community health workers 
care for >100,000 patients at 65 practice sites. As a level 3 patient-centered medical 
home, the Lutheran network offers a full range of health and dental care, including adult 
and family medicine, behavioral health, chronic disease management, comprehensive 
HIV/AIDS services, pediatrics and specialty services. 
3. 
CHARACTERISTICS OF THE RESEARCH POPULATION 
There are two groups of participants in the study: Patient participants and hospital staff 
participants. 
 
3.1 
Number of Subjects 
We will recruit 610 participants total. 600 recruited participants will be smokers enrolled from 
any of our recruitment methods outlined in “Patient Participant Recruitment” below. Half of the 
enrolled participants (300 smokers) will receive the intervention immediately after consent, and 
the other 300 will receive the intervention after 6 months. Additionally, we will recruit 10 staff 
participants: 5 staff from Bellevue Hospital and 5 staff from NYU Lutheran. 
3.2 
Gender of Subjects 
There are no enrollment restrictions based on gender. 
 
3.3 
Age of Subjects 
Age ≥18 years 
 
3.4 
Racial and Ethnic Origin 


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There are no enrollment restrictions based on racial or ethnic origin. 
 
3.5 
Eligibility Criteria 
3.5.1 Patient participants: 
1) 
age ≥18 years 
2) 
Has smoked a cigarette in the past 30 days, even a puff 
3) 
Interested in receiving smoking and financial counseling 
4) 
Self-reported income below 200% of the current federal poverty level for a given 
household composition 
5) 
New York City resident 
6) 
English or Spanish language 
7) 
Able to provide informed consent, and 
8) 
Does not have a representative who manages his/her funds (to ensure the 
participant has the ability to manage household money). We will exclude 
participants who report being pregnant or breastfeeding (unable to receive NRT). 
 
 
3.5.2 Hospital staff participants: 
1) Must be current medical or non-medical provider or administrator at Bellevue 
Hospital or NYU Lutheran Medical Center 
 
3.6 
Vulnerable Population 
We will recruit 5 employees from each location for the hospital staff interviews and 
ensure additional safeguards for these subjects. Employees’ participation is completely 
voluntary and without undue influence. Participants will be assured that their employment will 
not be affected by their decision to participate or not. Any record of staff’s participation will not 
be linked to any type of employee record. None of the study’s primary investigators or study 
team members have any supervisory or management role for the participants in this group nor 
do they have any effect on employees’ evaluation. 
4. 
METHODS AND PROCEDURES 
4.2 
Patient Participant Recruitment 
We will recruit patients using 5 methods. First, we will place flyers (Appendix A) in the waiting 
rooms of the primary care clinics and social work clinics at each hospital and at the elevator 
banks on each floor. We will also distribute flyer advertisements in the AM New York and Metro, 
two free local papers (Appendix Z) and El Especialito, a Spanish local paper (Appendix A). 
Flyers will describe the study, primary eligibility criteria, and a phone number to call. Patients 
who call will be screened for eligibility by a trained Research Assistant (RA) over the phone 
(Appendix C). The RA will schedule eligible participants for an in-person appointment to 
complete an IRB-approved informed consent process. Additionally, we will advertise on 
Facebook to English and Spanish speaking smokers located in New York City (Appendix A). 
Second, this study will utilize NYUMC DataCore to use the Bellevue and NYU Lutheran’s EMR 
data to identify patients who were screened as current tobacco users during a clinical visit in the 


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last 12 months. We will need patients’ names, date they were screened to be a smoker, contact 
information (phone, address), preferred language, primary care provider name, and primary 
health insurance. DataCore will request a report in order to gather the data from 
EPIC/QuadraMed. We would like this query to be completed 4 times (3 months apart). Only the 
PI, Research Coordinator and Research Assistants will have access to the EMR search results. 
For patients assigned a primary care provider in the EHR, the RA will email each patient’s 
primary care provider via secure institutional email (Appendix X) to notify the provider that we be 
contacting their patient(s) about the study and give the provider the opportunity to let us know 
not to contact a specific patient. We will wait 4 business days after sending the email to hear 
back from the provider. If a provider tells us not to contact a patient, we will remove the patient 
from our recruitment list (destroying his/her identifiers). To all patients on our list who are not 
identified by a provider as someone we should not contact, the RA will send a letter (Appendix 
B) and recruitment flyer (Appendix A). One week after mailing the materials, an RA will call the 
patients to discuss the study, screen interested patients for eligibility, and schedule eligible 
participants for an appointment to complete an IRB-approved informed consent process. 
Patients without a primary care provider assigned in the EHR will immediately receive the letter 
and recruitment flyer in the mail. One week after mailing the materials, an RA will call these 
patients to discuss the study. The RA will inform these patients of how we received their contact 
information and also let them know that they do not currently have a PCP listed in their 
electronic medical record. All identifiable screener data for patients who are deemed ineligible or 
who do not wish to participate in the study will be destroyed. We will only keep itemized 
screener data to report to the funding agency, though no PHI will be saved and we will only 
label participants with a pre-screening number. 
Third, at the Bellevue site, we will receive referrals from the hospital’s regular smoking cessation 
program. The smoking cessation program will let patients know about the study and give them 
the study flyer (Appendix A). The program will ask if they are interested in being referred to our 
study to learn more about the study. For patients who give permission to be referred, the 
Belleuve smoking cessation program will send our study team an NYUMC encrypted email with 
the name and preferred contact information. To all referred patients, a study RA will send a 
letter (Appendix B) and the recruitment flyer (Appendix A). Two weeks after mailing the 
materials, an RA will call the patients to discuss the study, screen interested patients for 
eligibility, and schedule eligible participants for an appointment to complete an IRB-approved 
informed consent process. All identifiable screener data for patients who are deemed ineligible 
or who do not wish to participate in the study will be destroyed. We will only keep itemized 
screener data to report to the funding agency, though no PHI will be saved and we will only 
label participants with a pre-screening number. 
Fourth, we will work with medical center IT to set up a consult in EPIC that allows physicians to 
refer Lutheran patients to the program. Providers will be given an overview of the study and 
eligibility criteria prior to implementing the EPIC consult, so that they may filter some of the 
referrals received. If a patient is deemed eligible for referral, physicians will inform their patients 
that someone from the study team will contact them within the next two weeks to screen for 
study eligibility. Providers will also have copies of our study flyer (Appendix A) to hand out to 
patients who are interested, so the patient may also reach out directly to the research 
coordinator as directed by the flyer. Each day, a study team member will check EPIC for a list of 
patients referred by their providers. An RA will contact the patients to screen for eligibility. Those 
who are eligible will be scheduled for a consent appointment. Patients who are ineligible to 
participate in the study will be referred to the NY State Quitline. All identifiable screener data for 
patients who are deemed ineligible or who do not wish to participate in the study will be 
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PHI will be saved and we will only label participants with a pre-screening number. We will also 
use EPIC to reach out to potential patients using MyChart. We will utilize EPIC’s Slicer Dicer 
research tool to identify NYU Langone-Brooklyn adult patients that are listed as current smokers 
in EPIC. If a patient has opted in to being contacted about research studies through MyChart, 
we will send them a notification (Appendix V) about our study through their MyChart portal. 
Patients will be able to reach out to our study team directly for screening. Patients who are 
eligible will be scheduled for consent, and patients who are ineligible will be referred to the NY 
State Quitline. 
Fifth, we will recruit participants in-person by approaching patients in primary care clinic waiting 
rooms. An RA will identify herself/himself as working on a quit smoking research study, ask if 
the patient would like to hear more, and then provide the patient with a screening questionnaire 
to assess eligibility, if interested. If the patient does not fit the eligibility criteria, the RA will thank 
them and move on to the next person waiting for their clinic appointment. If the person is eligible, 
the RA will describe the study further and ask if the patient would be interested in enrolling. If 
the patient is interested in enrolling, the RA will escort the patient to a private room, go through 
the consent process and baseline survey, and randomize the patient. 
Participants will also be recruited through word of mouth referrals. Participants can earn a one- 
time $20 referral bonus for an eligible person referred and successfully randomized into this 
study. This referral process will be detailed in the patient’s consent form and explained to 
participants during their in-person consent appointment. 
4.3 
Patient Participant Consent (Process and Documentation) 
All participants will sign IRB-approved informed consent forms prior to completing any study 
procedures. The study coordinator and/or a trained research assistant will review the contents 
of the consent form and obtain consent from each of the participants, ensuring that each 
participant is fully informed of the details of the study and minor potential risks. The signed 
consent forms will be stored in a locked cabinet within a locked office on NYUMC campus. The 
research records of enrolled participants will be kept for at least six years after the study is over 
or as long as the sponsor requires them to be kept. All identifiable information from participants 
who are deemed ineligible or do not want to enroll in the study will be removed from any 
tracking or RedCap database. 
4.4 
Patient Participant Baseline Interview 
After obtaining informed consent, a RA will administer a baseline survey (Appendix D) 
assessing sociodemographics, tobacco use, motivations and readiness to quit, income, financial 
stress, mood, household spending patterns and other intervention covariates or mechanisms. 
4.5 
Patient Participant Randomization 
At the conclusion of the baseline survey, the RA will open a study database on a computer that 
he/she will have at the time of informed consent and enter a randomly assigned study ID 
number. The database will then use a random-number generator (developed under the 
supervision of the statistician) to assign the patient participant to one of the study arms. The 
database will store the randomization results and display the results on the screen for the RA, 
who will inform the participant of his/her group assignment, discuss the details of the assigned 
intervention, and schedule the patient participant for his/her intervention’s first session and 
follow-up assessments. 
 
4.6 
Patient Participant Intervention Delivery 


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4.6.1 Intervention Arm: Integrated Smoking Cessation and Financial Counseling 
Participants randomized to the Intervention Arm will receive counseling that integrates financial 
counseling and smoking cessation counseling immediately after enrolling in the study. The goal 
of the financial counseling will be presented to participants as helping them enroll in government 
assistance programs when needed and helping them manage their funds better to have more 
for things that make them happy and to improve their quality of life and well-being. The 
counseling content will be as follows: 
  Session 1: Session 1 will be in-person and will focus on a tobacco use intake and 
financial planning and will be comprised of three main components: (1) screening and 
referral for financial assistance programs, (2) money management counseling and (3) 
tobacco use and cessation overview. The designated study site-counselor will help the 
patient participant complete two online surveys assessing their eligibility for New York 
State and federal benefits. These assessments are provided free to the public through 
the www.mybenefits.ny.gov (state) and www.benefits.gov (federal) websites and take 
approximately 10 minutes each to complete. The websites will provide patients with a list 
of benefits to which they may be eligible with instructions on how to enroll. The 
counselor will also provide patients with an overview of programs available in New York 
City (e.g., financial empowerment counseling, housing assistance) and refer the patient 
to the program when appropriate. Patient participants will have the option to call the 
counselor in between sessions with follow-up questions or to request assistance in 
completing online applications for benefits. 
Second, the counselor will initiate money management counseling. Dr. Rosen, a 
collaborator on the project, will train all study counselors in financial counseling prior to 
the first counseling sessions. Dr. Rosen will not have access to PHI, but will act as a 
consultant to the study team regarding any issues that pertain to the financial counseling 
aspect of the study. Participants will first describe their longer-term goals, and based on 
these longer-term goals, will be encouraged to set shorter-term financial goals for their 
money management. Next, participants will, assisted by a timeline follow-back calendar, 
complete an inventory describing their sources of income, expenditures (both monetary 
and in-kind), debts and asset balances. Based on this inventory, participants will be 
asked to make a budget based on smoking cessation at the time of their future quit date. 
This budget will list planned expenditures, with those made possible by smoking 
cessation highlighted and listed separately to increase their saliency and reward value. 
Lastly, the counselor will complete a tobacco use intake and brief counseling (Appendix 
H) with the participant. Topics covered will include: 1) Assessment of smoking and 
quitting history, 2) Assessment of current readiness to quit through ratings of 
“importance” and “confidence”, 3) Strategies to raise importance and confidence ratings, 
4) Preparations for quitting, 5) Identification of top barriers toward quitting and smoking 
triggers, as well as coping strategies to address each trigger, 6) NRT use and barriers to 
use, and 7) Setting a quit date in the next 30 days. Participants will receive a flyer 
(Appendix Q) on how to use NRT and its possible risks and side effects. 
  Session 2 (See Appendix H, p. 17): Session 2 will be completed in-person and will begin 
with follow-up on the prior session’s financial counseling to assess short-term goals (e.g., 
enroll in benefits) and challenges, and then will transition to focus on smoking cessation. 
Topics covered will again include: 1) Assessment of smoking and quitting history, 2) 
Assessment of current readiness to quit through ratings of “importance” and “confidence”, 
3) Strategies to raise importance and confidence ratings, 4) Preparations for quitting, 5) 
Identification of top barriers toward quitting and smoking triggers, as well as coping 


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strategies to address each trigger, 6) NRT use and barriers to use, and 7) Setting a quit 
date in the next 30 days. 
  Sessions 3 – 9 (See Appendix H, p. 23): Sessions 3-9 can be either in-person or over 
the phone (depending on patient preference). The counselor will deliver financial 
counseling prior to the smoking cessation counseling in order to motivate participants to 
attend to the quitting. Participants will track their progress towards adhering to the 
budget by reviewing financial transactions during the preceding week, and adjusting their 
budgets if the original budgets proved to be unrealistic. Tobacco expenditures and 
savings will be highlighted and tracked separately to increase their saliency and reward 
or cost value.64 The composition of the tobacco cessation counseling during these later 
sessions will depend on each patient’s individual quit progress. 
4.6.2 
Control Arm: Waitlisted Integrated Smoking Cessation and Financial Counseling 
Six months after enrolling, participants randomized to the Control Group will receive all of the 
services described in the Intervention Group section above. Starting 3 weeks before their 6- 
month time point, study staff will call patients to schedule a counseling appointment (Appendix I). 
Patients in the control arm will not receive any procedures or counseling in the first six months. 
4.6.3 Both Arms: Nicotine Replacement Therapy (NRT) 
Participants in both arms will be eligible to receive a free four-week supply of NRT. Following 
the US Public Health Service guidelines for the treatment of persons who smoke ≥10 cigarettes 
per day, participants will receive combination NRT (patch plus gum or patch plus lozenge, 
depending on patient preference).50 As we have done on other studies, we will order 
participants’ NRT from drugstore.com after obtaining the participants’ NRT preference during 
counseling. Drugstore.com will mail the NRT to our study office before the first counseling 
session. Counselors will provide the NRT and review proper use during the first session. 
4.6.4 Both Arms: Patient Participant Follow-up Surveys 
We will conduct a telephone follow-up survey 6 months (Appendix F) and 12 months (Appendix 
G) after enrollment with all participants. A study team member will make 10 attempts over 4 
weeks to complete the survey (Appendix J). We will mail a hard copy or email the survey if 
participants do not want to complete the survey over the phone. The surveys will re-assess 
participant behavior and characteristic assessed at baseline, and a short series of close-ended 
and open-ended questions about satisfaction with the interventions. The first 150 participants 
will complete an additional 2 month follow up survey (Appendix E) in order to obtain preliminary 
data. After the first 150 enrollments, the 2 month survey will be retired and the remainder of the 
450 enrollments will only complete surveys at baseline, 6 months and 12 months. All enrollees 
that signed a consent form indicating the additional 2 month survey will be eligible to participate 
in that survey and will be compensated accordingly. Participants will be paid $15 as 
reimbursement for their time completing the surveys. The additional follow-up survey (Appendix 
S) to gain feedback from participants who are NYCHA-residents on their smoking cessation 
needs will be conducted via phone. Patients being contacted are already enrolled in the study. 
 
4.6.5 
Patient Participant Administrative Data 
We will obtain written patient consent and HIPAA authorization to conduct review of their 
medical record to abstract data on health care utilization during the study. This will include total 
number of outpatient visits and total number of inpatient visits in the 12 months before and after 
their study enrollment. Staff will also check the EMR for updated contact info. 
4.7 
Staff Participant Interview Recruitment 


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Staff recruitment procedures were created to minimize staff burden and to ensure we obtain a 
representative staff sample. We will use two methods of identifying and recruiting potential staff 
participants: 
(a) Email and phone recruitment: We will request a list of relevant staff (e.g., nurse, 
physicians at) at each site from clinic and administrative managers. We will send all 
staff on the list a mass email (Appendix K) to their institutional email address notifying 
them of the study. The email will include a phone number and email address to contact 
if they would like to participate or to notify us that they do not want further contact from 
study staff. The email will inform staff that participation is voluntary and refusing to 
participate will not affect their employment. For staff who respond indicating they would 
like to participate, the study’s project manager will email or call the staff member at their 
institutional email or institutional phone number to schedule a time to complete the 
verbal informed consent process and to conduct the interview. For staff who respond 
indicating they do not want further study contact, we will remove their name from our 
recruitment list. 
We will send two additional follow ups via email for staff who do not respond to the 
initial email. The first follow up will be sent one week after the initial email, and the 
second follow up will be sent one week after the first follow up. Staff who would like to 
participate will be scheduled for a time to complete an informed consent process and 
the interview. Staff who refuse participation or whom we are unable to reach will be 
removed from our recruitment list. 
 
4.8 
Staff Participant Interview Consent (Process and Documentation) 
We request a waiver of documentation of consent to obtain verbal consent from staff 
participants. The study coordinator and/or a trained research assistant will obtain verbal 
consent from each of the staff participants, ensuring that each participant is fully informed of 
the details of the study and minor potential risks (Appendix O). Additionally, staff will be 
reassured that their employment will not be affected by their decision to participate or not. Staff 
who do not wish to participate will have their contact information removed from the study 
database. 
4.9 
Staff Participant Interview Procedures 
Interviews will be completed in a private room during business hours at a day and time 
preferred by the staff participant. Using a structured interview guide (Appendix M), the study 
PI, Dr. Rogers, will ask open-ended questions and follow-up probes that capture staff attitudes 
and beliefs about the intervention, their feedback on how to improve the intervention, and 
feedback on how to make it sustainable internally and within other organizations. 
5. 
Data Analysis and Data Monitoring 
5.1 
Data Analysis 
To evaluate the acceptability and feasibility of the integrated intervention, we will calculate the 
number of counseling sessions completed and satisfaction with treatment, which we will 
summarize descriptively using count and frequency statistics. We will calculate additional 
measures of study feasibility and acceptability, including the eligibility rate among people 
screened, enrollment rate among those eligible, reasons for ineligibility or refusal, and the 
proportion of participants who would recommend the intervention to other smokers. To 
estimate the effect of the integrated intervention on outcomes we will use generalized 
estimating equations (GEE) to model the main effects of time (baseline to 6 and 12 months) 


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and treatment group, and the interaction of time and treatment, on each outcome. GEE will 
allow us to determine whether intervention effects are present and whether they change over 
time. 
We will also calculate and sum all time and costs of administering the interventions. Each 
intervention staff member will record their activity in a web-based intervention tracking system 
(using REDCap). Staff prospectively input detailed information for a 1-week sample of their 
activities and associated time required on a monthly basis. Those recording their time and 
activities have flexibility to add or tailor their entry form to match their exact activities. We will 
assign a dollar value for each unit of staff time based on the wage and fringe rate of those who 
perform the activity using regional labor rates from the US Bureau of Labor Statistics. We will 
also keep track of medications ordered and used by participants, which we will assign a dollar 
value to using Red Book, a wholesale pharmaceutical pricing index. Once all costs are compiled 
and summed, they will be adjusted to constant dollars using the medical care component of the 
Consumer Price Index. 
5.2 Data Monitoring Plan 
This study will not have an external data monitoring board. The PI will monitor treatment fidelity 
on a weekly basis by holding meetings with the study counselors to review active patients. 
Counselors will also keep standardized, electronic documentation of every counseling session 
in a REDCAp database created for the study, which will be reviewed weekly with the PI. To 
ensure accuracy of survey data, all paper surveys will be entered twice into study databases, 
and the two entries will be compared for consistency. Inconsistencies in data entry will be 
resolved by a third review of the paper survey records. The study team (PI, Co-Is, Research 
Coordinator) will monitor the quality of patient survey data on a quarterly basis by running data 
reports showing survey responses rates, as well as missing or invalid values. In addition, to 
allow for monitoring of adherence to survey procedures, the RAs will use a REDCap database 
created for the study to document all patient contacts and procedures completed with a patient. 
The PI and Research Coordinator will monitor adherence to data collection procedures by 
reviewing monthly REDCap procedure reports. Protocol deviations (either counseling or survey 
data collection deviations) will be reported to the NYU IRB as per the reporting requirements. 
Study staff will document adverse events in a REDCap database created for the study. Adverse 
events will be monitored daily by the PI. Any adverse event (AE) identified by a study team 
member (e.g., counselor, RA, ) will be reported to the PI within 24 hours. The PI will determine 
whether the event is a) serious or non-serious; b) anticipated or unanticipated, and c) related to 
the study or unrelated to the study. The PI will ensure that any necessary actions are taken 
immediately to address the current patient situation, and then will decide if the team needs to 
make any changes in the protocol and/or consent forms to prevent future occurrences or better 
inform future participants. We will report the event to the NYU IRB as per the reporting 
requirements. Violations of patient privacy/confidentiality will be treated as an AE related to the 
study and will be addressed immediately as appropriate. 
 
5.2 
Data Storage 
All participants will be assigned a unique code number that does not identify him or her as an 
individual. Electronic data will be stored in RedCap and password protected files on NYUMC 
servers. Paper records will be stored in locked filing cabinets within locked offices at each site. 
All data will be stored separately from signed consent forms. These study procedures have 
minimized risk of confidentiality breach in past studies. 
5.3 
Confidentiality 


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All study personnel have already taken or will take the mandatory HIPAA and Patient 
Privacy/Confidentiality training modules required by our institutional IRBs, to ensure that they 
are aware of the importance of patient confidentiality and all appropriate laws regarding 
protection against privacy breaches. Procedures will be in place to ensure that all files 
containing subject information will be kept in locked filing cabinets or password-protected 
electronic databases on a secure server. The majority of study data and all interview transcripts 
will be maintained in electronic files with no patient identifiers other than a study ID number; 
there will be one file maintained separately, with its own password protection, that links study ID 
numbers to patient identifying information. De-identified data will be stored indefinitely. 
No identifiable information about study participants will be disclosed to individuals outside those 
approved by the IRB to be on the study protocol. No publications that result from the study will 
identify individual participants. Identifiable staff participant interview data will not be shared with 
interviewees’ coworkers or supervisors, even those working on the protocol. 
6. 
RISK/BENEFIT ASSESSMENT 
6.1 
Risks 
Participants are expected to encounter no more than minimal risk, as the study will only be 
providing evidence-based tobacco cessation treatments. Participants who quit smoking during 
the study may experience nicotine withdrawal. These may include craving, anxiety, problems 
concentrating, impatience, depression, irritability, restlessness, and weight gain. This risk is 
expected as part of the quitting process and minimal. 
There may also be a slight risk of breach of confidentiality associated with the survey as 
researchers will have access to participant contact information. This risk is also expected to be 
minimal and infrequent and contact information will be stored separately from participant 
responses. 
6.2 
Protection Against Risks 
All study personnel have already taken or will take the mandatory HIPAA and Patient 
Privacy/Confidentiality training modules required by our institutional IRBs, to ensure that they 
are aware of the importance of patient confidentiality and all appropriate laws regarding 
protection against privacy breaches. Procedures will be in place to ensure that all files 
containing subject information will be kept in locked filing cabinets or password-protected 
electronic databases. 
Additionally, all study data, including any participant identifiers, will be stored on NYUMC 
password protected computers, and can only be accessed by study staff. Please see Section 
5.2 above for more details about how data will be stored. To address risks related to the 
possibility of physical or psychological distress, participants will have the option of withdrawing 
from the study without loss of benefit. Additionally all health information will be protected. 
 
Any adverse event (AE) that the research staff thinks may be related to study participation will 
be reported to the site PI within 24 hours. The PI will determine whether the event is a) serious 
or non-serious; b) anticipated or unanticipated, and c) related to the study or unrelated to the 
study. The PI will ensure that any necessary actions are taken immediately to address the 
current patient situation, and then will decide if the team needs to make any changes in the 
protocol and/or consent forms to prevent future occurrences or better inform future participants. 
We will report the event to the NYU IRB as per the reporting requirements. Violations of patient 


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privacy/confidentiality will be treated as an AE related to the study and will be addressed 
immediately as appropriate. 
 
6.3 Benefits 
We do not anticipate that participants will receive any direct benefit from participating. However, 
possible benefits from quitting smoking may include improvement in health. 
 
7. 
Costs to the Subject 
Participants will not incur any costs as a result of participating in the study. 
 
8. 
Payment for Participation 
Patient participants will be compensated $15 for each of the three survey completed during the 
study. Payment can be in cash or check. Additionally, patient participants will be reimbursed by 
Metrocard for the travel to and from counseling appointments. 
 
9. 
Contacting Participants for Follow-Up Feedback Survey 
Participants who are enrolled in the study and are current English-speaking NYCHA- 
residents will be called to complete a voluntary phone survey to gain their feedback on 
their smoking cessation needs. All patients who will be contacted for the feedback 
survey have already been previously enrolled in the study. 
 
10. 
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