Randomized Test of Financial Incentives for Smoking Cessation Treatment Engagement Among A Healthcare System's Universal Primary Care Population
Phase: NA
Conditions: Quitting Smoking
Sponsor: University of Wisconsin, Madison

Randomized Test of Financial Incentives for Smoking 
Cessation Treatment Engagement among Adult Primary Care 
Patients
Protocol Number: 
Principal Investigator: Michael C. Fiore, MD, MPH, MBA
National Cancer Institute Grant: R35CA19757
[This document is confidential.
No part of it may be transmitted, reproduced, published, or used by other persons without prior 
authorization from the Principal Investigator.]
Protocol Version History
Protocol 
Version
Version 
Date
Summary of Revisions Made
Rationale
1.0
03/27/2020
Initial version
1.1
4/2/2020
Reduce # of experimental arms
Recruitment capacity
1.2
3/22/2020
Medicare & Medicaid exclusions
Federal prohibitions on financial 
incentives
2.0
9/8/2020
•
Switch to ICTR REDCap Instance
•
added nicotine use questions to
3/6mo. follow up assessments
•
rewrote Aims to better conform w/ 
ClinicalTrails.gov requirements
•
Minor wording edits to 
assessments
•
ICTR REDCap allows faster 
launch
•
nicotine use questions were 
noted across protocol but 
not included in follow-up 
instrument, 
•
clarification of Aims required 
for CT.gov entry
•
adapt for CATI delivery
3.0
1/6/2021
Eliminate Contact Incentive and increase 
one arm of Treatment Engagement 
Incentive 
Contact Incentive produced 
insufficient response

- i -
Table of Contents
1.0
LIST OF ABBREVIATIONS..................................................................................................................1
2.0
STUDY SUMMARY ...............................................................................................................................2
Synopsis......................................................................................................................................2
Schematic of Study Design........................................................................................................4
3.0
SIGNIFICANCE......................................................................................................................................5
4.0
GOALS AND AIMS ...............................................................................................................................5
Goals............................................................................................................................................5
Aims .............................................................................................................................................6
5.0
STUDY DESIGN ....................................................................................................................................6
6.0
SUBJECT SELECTION ........................................................................................................................7
Subject Identification ..................................................................................................................7
Inclusion/Exclusion Criteria For Treatment Engagement Incentive.......................................8
Vulnerable Populations ..............................................................................................................9
Consent and Enrollment ............................................................................................................9
Randomiation............................................................................................................................11
7.0
STUDY TREATMENT AND EXPERIMENTAL CONDITIONS........................................................ 12
Incentives .................................................................................................................................. 12
8.0
DETAILED STUDY PROCEDURES: RECRUITMENT AND ASSESSMENTS............................13
Recruitment...............................................................................................................................13
Assessment Plan...................................................................................................................... 14
9.0
ANALYSIS PLAN ..................................................................... 1ERROR! BOOKMARK NOT DEFINED.
Data Sources ............................................................................. 1Error! Bookmark not defined.
Subject Population Initial Analyses.........................................................................................15
Planned Analyses..................................................................................................................... 15
Power.........................................................................................................................................16
10.0 HUMAN SUBJECTS PROTECTIONS AND DATA SHARING ...................................................... 17
Potential Benefits to Subjects and Society ............................................................................17
Potential Risks to Subjects ...................................................................................................... 17
Risks Minimization Plan ...........................................................................................................18
Risk/Benefit Analysis................................................................................................................ 19
Unanticipated Problems or Complications .............................................................................19
Privacy Precautions and Protections...................................................................................... 19
Unauthorized Use or Disclosure Precaustions and Plan...................................................... 19
11.0 REFERENCES..................................................................................................................................... 20
12.0 APPENDICES ...................................................................................................................................... 22

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Appendix A: Enrollment Flowchart..........................................................................................22
Appendix B: Invite Scritps for Treatment Engagement Incentive Study .............................23

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Version #: [1.2] 
Version Date: [05/22/2020] 
Page 1 of 1 
 
1.0 STATEMENT OF LIST OF ABBREVIATIONS 
CI 
Contact Incentive 
EHR 
Electronic Health Record 
GHC-SCW 
Group  Health Cooperative of South Central Wisconsin 
HIPAA 
Health Insurance Portability and Accountability Act 
ICTR 
Institute for Clinical and Translational Research 
IRB 
Institutional Review Board 
NCI 
National Cancer Institute 
NIH 
National Institutes of Health 
NRT 
Nicotine Replacement Therapy 
PHI 
Protected Health Information 
PI 
Principal Investigator 
REDCap 
Research Electronic Data Capture 
SFTXT 
SmokefreeTXT, the NCI text-message smoking cessation support intervention 
TCOS 
Tobacco Cessation Outreach Specialist 
TEI 
Treatment Engagement Incentive 
UW-CTRI 
University of Wisconsin Center for Tobacco Research and Intervention 
WTQL 
Wisconsin Tobacco Quit Line 
 

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2.0 STUDY SUMMARY 
2.1 Synopsis 
Full Title 
Randomized Test of Financial Incentives for Smoking Cessation Treatment Engagement 
Among A Healthcare System’s Universal Primary Care Population 
Short Title 
 [Financial Incentives for Smoking Cessation Treatment Engagement] 
Protocol Number 
 [HS IRB 2020-0717] 
ClinicalTrials.gov 
Identifier & 
Summary 
 [pending] 
[This study is being done to see if financial incentives increase the rate at which smokers 
engage in cessation treatment.] 
Number of 
Site(s) 
 Approximately 6 clinical sites in the United States  
Main Inclusion 
Criteria 
• 
Adult members (patients) of participating healthcare system  
• 
Current smokers 
• 
English- or Spanish-speaking (able to complete questionnaires in English or Spanish 
over the phone) 
Main Exclusion 
Criteria 
• 
Prior participation in the study  
• 
Has a target quit smoking day within the past or next 30 days in the EHR 
• 
Medicare or non-BadgerCare Medicaid billable insurance 
Objective(s) 
Primary Objective  
• 
To determine the relations between treatment engagement financial incentive 
amounts offered and likelihood of patient engagement in smoking cessation treatment 
(defined as setting a target quit day and completing phone counseling).  
Exploratory Objectives  
• 
Conduct exploratory analyses on the effects of different incentive engagement 
amounts on biochemically confirmed point-prevalence abstinence 6 months post-quit-
date, and determine whether incentive condition affects abstinence via effects on 
smoking treatment engagement (i.e., whether smoking treatment engagement 
mediates the relations between engagement incentive condition and 6-month 
smoking abstinence).   
• 
To determine the incremental cost-effectiveness of varying financial engagement 
incentives with regard to total program costs vs. usual care, net monetary benefit 
(NMB), cost per quit, and incremental cost-effectiveness ratios (ICERs), with the last 
determined with regard to cost of each additional smoker engaged in cessation 
treatment and each additional individual who quits smoking. 
• 
To determine the representativeness of smoking treatment reach and smoking 
abstinence effects of various engagement incentive amounts with regard to different 
groups of smokers: e.g., those low in socio-economic status, priority populations, 
different racial and ethnic groups. 
Study Design 
This is a randomized, active placebo-controlled, trial of the effectiveness of financial 
incentives for adults smokers to engage tobacco treatment. 
Study 
Intervention 
Adults meeting Cigarette User Registry criteria who call or are contacted by their healthcare 
system to discuss tobacco use will be randomized to $100, $50, or $0 incentive for 

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participating in quit planning and quit counseling with a tobacco cessation specialist. 
Questionnaires will be completed at Week 1, Week 4, Month 3, and Month 6; exhaled breath 
CO measurements will confirm abstinence at 6 months. 
Total Number of 
Subjects 
A total of 540 subjects will be recruited from 6 primary care clinics of the participating 
healthcare system. 
Study Population Males and females aged 18 or above who are current cigarette smokers.  
Statistical 
Methodology 
An intention‐to‐treat analysis using logistic regression to contrast the likelihood of smoking 
treatment engagement/entry for the three incentive conditions.  
Estimated 
Subject Duration 
The duration of the study for each subject is approximately 28 weeks.  
Estimated 
Enrollment 
Period & Study 
Duration 
Study enrollment and follow-up will occur over 18 months with the total expected duration of 
the trial to be 48 months.  
 
 
 

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2.2 Schematic of Study Design 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Patient completes post-quit follow-up counseling.  Intra-Treatment assessments. Trigger 
partial Incentive Payment 
Patient completes post quit counseling.  Intra-Treatment assessments.  
Perform baseline assessments. 
Total N=540:  Offer Treatment Incentive, as randomized.  Obtain informed consent. 
Screen potential participants by inclusion and exclusion criteria; obtain history, document. 
Among those who contact and engage with TCOS about quitting smoking: 
Randomize  
Arm 3 ($50) 
N=180  
Arm 1 ($0) 
N=180
Participant completes pre-quit counseling. Trigger partial Incentive Payment. 
Final Assessments: 
• 
Questionnaires ($20) 
• 
CO Breath Test ($50) 
Prior to Enrollment 
Recruitment: 
Treatment Planning 
Call 
Week 1 Post-quit 
Counseling  
Time Point 
Week 4 Post-quit 
Follow-up  
Time Point 
6 Month Follow-up 
Time Point
Pre-quit Counseling  
Time Point 
Arm 2 
($100) 
3 Month Follow-up  
Time Point 
 
3-Month Follow-up assessment. 
  Healthcare system Cigarette User Registry members who self-initiate a call with, or are called 
(per tobacco program protocol) by, a Tobacco Cessation Outreach Specialist (TCOS).   
Population 

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3.0 Significance 
Research shows that evidence based cessation treatments such as telephone counseling and 
FDA-approved smoking cessation medications are effective; they increase abstinence rates 
significantly if smokers use them for a quit attempt. However, an important impediment to their 
population impact is that only a relatively small percentage of smokers participate in such 
treatments when offered (that is, smoking cessation treatments have low ‘reach’ in healthcare 
populations). Specifically, when offered smoking treatment perhaps only 20% or so of smokers 
agree to treatment referral, and then perhaps only 5-10% actually enter such treatment1,2.  
Previous research shows that providing financial incentives for participating in smoking 
cessation interventions increases both treatment participation and abstinence rates3-6.  
However, much of that research was conducted in Medicaid populations and did not occur in a 
healthcare setting and with a patient population. Moreover, some of this research used large 
incentives for treatment engagement (e.g., Baker et al., 2018; Fraser et al., 2017, Volpp et al., 
2016)4,5,7 that may be difficult for health systems or insurers to maintain. Thus, at present, little is 
known about the effectiveness of a treatment-engagement incentive program that is offered to 
all smokers in a healthcare system when the incentives are of a magnitude that would make the 
program attractive to, and affordable for, healthcare systems or insurers. This study is designed 
to test the hypothesis that modest incentives offered to all smokers in a healthcare system will 
increase both participation in smoking cessation treatment and resulting abstinence rates. The 
incentive program will involve an ‘engagement incentive’ that is intended to increase patients’ 
engagement in smoking treatment when it is offered by the tobacco cessation outreach 
specialist (TCOS).  Further, in an effort to increase the reach of smoking treatment, all smokers 
listed on the healthcare system’s smoker registry will be alerted about the availability of 
incentives during routine TCOS telephone outreach provided as standard practice 1) within 2 
weeks of each primary care encounter (‘recent visit call’ and 2) at least annually to those without 
a primary care or TCOS encounter in the prior year (‘annual call’); thus, the offer of treatment 
will not depend on smokers’ making a healthcare visit.  If successful, this incentive-based reach 
program could be disseminated to reduce the considerable financial and personal costs 
associated with smoking-related disease. 
 
4.0 Goals/Aims 
4.1 Goals This project will apply a three-armed randomized block design to identify whether 
financial incentives are effective in increasing acceptance of, and engagement in, smoking 
intervention services as well as smoking cessation amongst Group Health Cooperative (GHC-
SCW) patients who smoke.  All members of the GHC-SCW Cigarette Users Registry (i.e., 
individuals who the health system believes are smokers, the ‘Registry’) at the time of 
implementation will be eligible to participate.  Smokers who speak with the TCOS staff when 
called for standard care management outreach following a  recent primary care visit or during an 
annual outreach call and listen to the description of smoking treatments will be randomized to 
receive one of three incentive amounts ($0, $100, & $50) for continuing treatment planning, 
establishing a target quit date and completing two telephone counseling sessions. Participants 
will be told about the size of their incentive, which in theory will increase their likelihood of 
engaging in smoking treatment and therefore, quitting smoking successfully.  For the non-$0 
incentive groups, ½ the total value will be apportioned for completion of each a Pre-quit 

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counseling call and a Week 4 counseling call. Participants (N=540) will be recruited in up to 6 
primary care clinics with randomization blocked on clinic so that roughly 1/3 of all enrollees in a 
given clinic will be in each of the treatment use incentive conditions to avoid incentive by clinic 
confounds.  Sex and minority status will also be used as blocking factors to limit confounding 
the impact of the incentive on these demographic characteristics. 
4.2 Aims 
Primary Aim 
1. To determine the relations between treatment engagement financial incentive amounts 
offered and likelihood of patient engagement in smoking cessation treatment.   
a. Primary outcome measure: Patient engagement in smoking cessation treatment 
(defined as setting a TQD and completing the two phone counseling calls).  
Exploratory Aims 
1. To determine the incremental cost-effectiveness of the different financial engagement 
incentive amounts with regard to total program costs vs. usual care, net monetary benefit 
(NMB), cost per quit, and incremental cost-effectiveness ratios (ICERs), with the last 
determined with regard to cost of additional smoker recruited and each additional individual 
who quits smoking. 
2. To determine the representativeness of smoking treatment reach and smoking abstinence 
outcomes generated by the various engagement incentive amounts with regard to different 
groups of smokers: e.g., those low in socio-economic status, priority populations, different 
racial and ethnic groups. 
3. Conduct exploratory analyses on the effects of the different incentive engagement amounts 
on biochemically confirmed point-prevalence 6-month abstinence, and determine whether 
incentive condition affects abstinence via effects on smoking treatment engagement (i.e., 
whether smoking treatment engagement mediates the relations between different 
engagement incentive conditions and 6-month smoking abstinence).   
 
 
5.0 Study Design 
Design Overview.  In this randomized controlled trial, each patient of participating GHC-SCW 
primary care clinics who is listed in the Cigarette User Registry receiving standard telephone  
contact from their GHC-SCW TCOS to discuss tobacco use treatment options will be reminded 
of GHC-SCW’s commitment to helping them improve their health, advised to quit smoking, 
offered support to quit smoking, recruited, screened, consented, and randomized over the 
phone to one of three conditions of financial engagement incentives ($0, $100, $50).  Smokers 
unwilling to participate in the incentivized treatment program will be offered entry into the 
existing GHC-SCW standard smoking cessation program.  Patients participating in the research 
study will also receive smoking treatment via the existing GHC-SCW standard smoking 
cessation program. Participants in the research study will be told that they may receive a 

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treatment engagement incentive, with the amount consistent with their randomized incentive 
condition; receipt of their assigned incentive amount is dependent upon their setting a quit date 
and completing two smoking cessation treatment counseling contacts. The smoking cessation 
treatment includes medication and 3 quit smoking counseling calls scheduled to occur after the 
recruitment contact call, which is the standard smoking cessation program available to all GHC-
SCW patients. This program entails a brief counseling call a week (typically 5-7 days) Pre-quit, 
i.e. before the patient’s target quit date (TQD), approximately 5-7 days following the TQD (Week 
1), and about one month following the TQD (Week 4).  Research participants will be asked to 
complete brief (3 to 5 minute) assessments during each standard care smoking treatment 
counseling call by GHC-SCW, plus 15-25-minute research study phone interviews 3- and 6--
months post-TQD for study purposes. Those claiming abstinence at the 6-month post-TQD 
phone interview will be asked to return to their primary care clinic to complete breath, urine, 
and/or saliva testing to verify abstinence from combustible tobacco. This will entail providing 
breath samples for carbon monoxide testing and/or a urine or saliva sample for immediate 
cotinine testing (no samples will be stored). Participants may also be asked to collect a saliva 
sample at home and return it in the mail if they do not attend a biochemical verification visit. 
 
6.0 Subject Selection 
6.1 Subject Identification 
Up to 540 adult participants will be recruited from the 6 primary care clinics of the GHC-SCW 
healthcare system over 6-12 months.  All patients who meet criteria for the existing GHC-SCW 
Cigarette Use Registry who do not have an existing Target Quit Date 30 days and who either 
are currently contacted by the TCOS following each primary care encounter or are  identified as 
not having had a primary care encounter in prior 365 days. During this outreach TCOS will 
provide the incentive offer and recruit for participation.  GHC-SCW also currently provides 
quarterly bulk communications promoting the availability of tobacco use treatment through their 
TCOS.  Patients who initiate contact with a TCOS in response to these messages will also be 
offered enrollment.  TCOS are healthcare system employees nationally certified in tobacco 
treatment and will have completed all relevant human subjects research, HIPAA, and good 
clinical practice trainings to enable them to become members of the study team for the 
performance of screening, consenting, randomization, phone-based assessments, and other 
research activities, as required.  Patients can participate in the incentive research program only 
once but can use the GHC-SCW standard smoking treatment program repeatedly.  
The TCOS will explain that the healthcare system is reaching out to all smokers to offer support 
and resources to help them protect their health.  The TCOS will trigger the randomization 
assignment, advise all patients who smoke to quit, let them know that s/he can offer help in 
quitting, and ask if patients are interested in quitting within the next 30 days.  If the patient is 
assigned to either the $100 or $50 incentive, the TCOS will inform the patient that they can earn 
that incentive for setting a quit plan within the next 30 days and completing two smoking 
treatment counseling calls. If patients are in the $0 incentive condition they will be offered the 
opportunity to enter the smoking cessation treatment program with no offer of a financial 
incentive for treatment engagement, which is consistent with usual care. If patients agree to 
receive smoking treatment, they will be asked brief screening questions. 

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6.2 Inclusion/Exclusion criteria  
Inclusion criteria  
• 
Age > 17 years. 
• 
On Cigarette User Registry at a participating clinic 
• 
Able to speak English or Spanish 
Exclusion criteria Activated healthcare power of attorney or cognitive impairment that would 
preclude informed consent.  
• 
Existing target quit date 30 days from date of call to TCOS 
• 
Current billable insurance status in EHR of Medicare or non-BadgerCare Medicaid 
• 
Prior screening for Treatment Engagement incentive enrollment 
Those who agree to and pass screening for the inclusion/exclusion criteria for study 
participation will be asked to complete an oral consent and HIPAA authorization process. Those 
who decline the screening invitation, do not meet eligibility criteria, or do not provide oral 
consent for study participation will be advised to quit smoking and offered standard smoking 
cessation treatment. 
Those who consent to the study will then be asked to complete a baseline assessment and will 
set a quit date with TCOS, which will determine the times of the therapy contacts offered as part 
of the GHC-SCW standard smoking cessation treatment. 
6.3 Vulnerable Populations 
Because we seek to evaluate interventions that will promote use of evidence-based treatment, 
and thereby abstinence from smoking, from the full range of adult daily smokers who receive 
healthcare services from the GHC-SCW healthcare system, we will not exclude members of 
vulnerable populations, including pregnant women (for whom quitting smoking is an important 
goal for the health of both mother and child) or those on parole or probation (this will not be 
assessed, as it is not directly relevant to the study and does not materially alter the risk to 
benefit ratio of participation). Individuals who are in institutional living situations (e.g., in assisted 
living facilities) will also be eligible, if they are adults, smoke daily, are enrolled at a GHC-SCW 
primary care clinic, and are considered competent to make healthcare decisions according to 
existing healthcare system protocols and procedures. TCOS will be trained to check this 
information and to seek only oral consent from those capable of providing such consent. 
Excluding members of these vulnerable populations is not warranted for their protection and 
would instead unjustly prevent their involvement in a minimal-risk program offering benefit 
(information about the opportunity to connect with evidence-based smoking treatment at no 
personal cost, apart from telephone charges where applicable and standard GHC-SCW 
smoking cessation clinical treatment). In addition, while the study does not target incarcerated 
individuals, some participants may be incarcerated during the period of study involvement. All 
study outreach, treatment provision, and assessment will be suspended during a participant’s 
period of incarceration. 

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None of these vulnerable populations will be specifically targeted in recruitment. The proposed 
reach interventions, assessments, and compensation schedule should pose no more risk for 
pregnant women, those on parole or probation, or those in institutionalized settings than for the 
general population, as study procedures confer minimal risk, are informational in nature, and are 
entirely voluntary. As part of the normal delivery of the GHC-SCW smoking treatment program, 
if a patient has contraindications to the use of smoking medication (e.g., pregnancy), that patient 
will not be offered such medication as part of their treatment. 
In addition to the engagement incentives, $20 for completing a telephone survey 6 months after 
their original Target Quit Date and $50 in compensation will be offered to patients for completing 
the 6-month post-enrollment visit for biochemical validation of abstinence from smoking. This 
payment for completing this important research assessment will be available to all enrolled 
participants, regardless of assigned experimental condition.  
6.4 Consent & Enrollment 
GHC-SCW TCOS staff will be responsible for program implementation and data documentation 
(using existing EHR and administrative data fields) except for 3- and 6-month Follow Up survey 
collection completed by the research staff.  Only limited patient and systems data will be shared 
with the research team documenting which patients were called as standard practice but 
declined study participation.   
All patients who agree to the study offer – tailored to their assigned Treatment Engagement 
Incentive value (Attachment B: Invite script), and pass the inclusion and exclusion criteria for 
Treatment Engagement Incentive study participation will be read an oral consent script by a 
healthcare system TCOS (see uploaded Recruitment Call script). The consent script read to 
participants over the phone conveys the key points regarding study procedures; risks; and 
participant rights, protections, and benefits, and does so in accessible language (assessed for 
reading level). The consent will inform patients that some monetary payments may be offered 
as part of the study for engaging in study components, including $20 for completing a telephone 
survey 6 months after their original Target Quit Date and $50 for those who report smoking 
abstinence at 6 months who complete an in-person breath CO breath test, urine, or saliva test, 
but the [incentive] amounts available will not be disclosed (so that some patients will not refuse 
further engagement due to disappointment with their incentive amount).  Prospective 
participants will be given an opportunity to ask questions and raise concerns during this 
process, which will be addressed prior to seeking oral consent. Informed consent for study 
participation will be formally documented electronically in the UW-ICTR REDCap instance study 
database. Following enrollment for those who consent, TCOS staff will send out a letter in hard 
copy to the participant at the address provided (see uploaded Study Information Sheet). This 
letter will remind the participant of study procedures and will include a detailed study information 
enclosure containing all required elements of informed consent and HIPAA authorization. 
Those randomly assigned to either the $100 or $50 incentive conditions will be reminded that 
they can earn the incentive by completing two counseling calls with the TCOS but they will also 
be encouraged to attend all three standard calls. GHC-SCW provides smoking cessation 
treatments at no or almost no cost (e.g., medication copays) for all members targeted by this 
study.   

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Data available to researchers on participants enrolled will include: a) data collected in the 
course of usual clinical care extracted from the EHR, b) research assessments conducted over 
the phone documented in REDCap or other research database, and c) the one-time carbon 
monoxide breath sample captured in-person using a Bedfont Breathalyzer unit, or, alternatively 
urine samples collected in clinic, or saliva samples collected at home or in clinic. 
Given the remote nature of the outreach and because we want to reduce burden (e.g., travel) 
for participants, an oral consent process seems in our view to be most beneficial to participants 
in this minimal risk study. Moreover, this approach will likely protect the external validity of the 
findings by closely resembling steps used in real-world wellness and prevention interventions. 
Collecting consent over the phone also reduces the risk that we will inadvertently bias the 
sample toward the most motivated, stable, or affluent members of the target population as might 
occur with face-to-face or mailed consent processes. Mailing a written consent form and waiting 
for this to be returned would likely result in meaningfully fewer patients following through and 
taking advantage of this incentivized smoking treatment opportunity than would occur with oral 
consent; this would not only reduce patient benefit but would yield data that are less 
representative of the effects of incentive interventions in real world healthcare systems (e.g., by 
over-selecting those who are more motivated), which could affect both treatment engagement 
rates and success rates of the standard smoking treatment.   
For these reasons, we also propose to use an altered HIPAA authorization because it would be 
impracticable to obtain authorization with all elements required under the HIPAA Privacy Rule 
over the phone. We also seek to waive some of the required elements of consent and HIPAA 
authorization over the phone in order to reduce participant burden and to enhance 
comprehension of the material read to participants, without omitting any key information 
pertinent to risks, rights, or protections. Consent and HIPAA authorization over the phone will 
cover the collection of data from the electronic health record for research purposes. The mailed 
Study Information Sheet that will follow the telephone enrollment and oral consent process will 
include all required elements of consent and HIPAA authorization (including a statement 
regarding how long permission to use the PHI will last, how to withdraw permission for PHI use, 
and the mandatory statement that the PHI could be redisclosed without subjects' permission in 
the consent/authorization and enrollment process). The Study Information Sheet also details 
how to withdraw from the study and revoke authorization to use PHI, without penalty or 
punishment. The mailed Study Information Sheet will provide a phone number for participants to 
call should they have questions. 
The TCOS will ask if the participant gives the study permission to stay in touch with them and 
send them reminders about upcoming study contacts during the study via email and/or text 
message. The TCOS will remind them that email and text messaging are generally not a secure 
way to communicate about their health as there are many ways for unauthorized users to 
access email and text messages. The TCOS will also inform them that they do not have to 
provide their email address or text message number to participate in this study. 
With regard to compensation and incentives, the Consent Script and mailed Study Information 
Sheet will make clear distinctions between compensation for completing the 6-month follow-up 
assessment and smoking abstinence biochemical confirmation (available in all conditions), and 
incentives for treatment engagement (available to about 2/3 of participants). This is important for 

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the sake of transparency and to ensure that incentive effects are not masked by misattribution 
of compensation as an incentive by participants. 
 
6.5 Randomization 
Randomization will occur during the contact call immediately after patients have been told of 
their smoking treatment options.  The TCOS will then use randomization tables developed by 
UW-CTRI to randomize potential enrollees, blocked by clinic, sex, and race, into 1 of 3 
engagement incentive conditions ($0, $100, or $50).  After randomization, patients will be 
offered smoking treatment with the incentive for treatment entry (engagement) to which they 
had been randomized. This offer will require the participant to agree to set a stop-smoking quit 
date within the next 30 days. This offer will occur prior to the patient’s provision of consent to 
participate in research. The patient must be offered the incentive up-front to see if this increases 
their treatment engagement (which necessarily includes agreement to it/consent); offering the 
incentive after agreeing to participate in treatment would not reveal the effects of the incentive 
on spurring engagement. Thus, we are interested in the effects of incentives on both agreement 
to enter treatment and actual likelihood of engaging in it. If a patient decides to accept the 
treatment offer, s/he will be consented and will set a target quit date with the TCOS (within 1 
month of the contact phone call). For patients who are unwilling to set a stop-smoking quit date 
within the next 30 days the TCOS will describe all stop-smoking treatment options that are 
available as part of usual care and encourage the patient to call the TCOS back when ready to 
set a quit date within 30 days.  For patients who decline the research study, the TCOS will 
describe all stop-smoking treatment options that are available as part of usual care and provide 
quit smoking treatment as usual. 
 
7.0 Study Treatments and Experimental Conditions 
Smoking cessation treatments will not be experimentally manipulated or varied as a function of 
research participation.  Participants and non-participants will be treated per standard clinical 
protocols for tobacco use.  The experimental conditions (i.e., the incentives) in the study are 
intended to effect smoker engagement in treatment as offered by healthcare system personnel.  
The primary differences between research study participation and usual care with regard to 
smoking treatment are: 1) the consent process, 2) randomization to treatment engagement 
incentive condition and provision of such incentive, 3) follow-up to determine patient smoking 
status. Importantly, actual smoking cessation treatments (counseling and medications, the 
existing GHC-SCW standard of care) will be identical for both those who chose to participate in 
the study and those who do not (Figure 2). 
 
7.1 Incentives In 2 of our recent studies4,5, incentive-driven increases in counseling use 
mediated incentive effects on abstinence in Medicaid-insured smokers. Given the significant 
savings associated with smoking cessation8, modest incentives to engage in treatment may well 
be cost-effective if they increase quitting. Modest incentives ($25 or $50) also improve 
attendance at primary care visits9. Thus, evidence supports modest, utilization-contingent 
incentives for use of both smoking cessation and primary care treatment. The proposed project 

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will evaluate the effects of incentives of varying magnitude for smoking treatment engagement 
(rather than achieving abstinence) in primary care. 
To identify an especially effective incentive amount, three different incentive value conditions 
will be evaluated (0, $100, and $50).  The incentive will be tied to readily observable initiation of 
treatment (i.e., setting a target quit date within 30 days on a call with a TCOS and actually 
engaging in the first phone smoking cessation 
counseling session) and follow through with 
treatment (i.e., engaging in the Week 4 
counseling session). The two positive (non 0) 
incentive tiers were selected based on the 
results of earlier work that used $30 incentives 
to improve counseling session attendance, and 
through this pathway, abstinence rates among 
low-income smokers.  Participants will be paid 
by mailed check or gift card. 
 
8.0 Detailed Study Procedures: Recruitment 
and Assessments 
8.1 Recruitment As noted in the enrollment flow 
diagram in Attachment A, recruitment will occur 
over the phone (in the Treatment Planning call) 
following a patient response to standard TCOS 
outreach.  TCOS as per their current GHC-SCW 
usual care protocol will provide callers with 
advice to quit and an overview of cessation 
treatment options.  The TCOS will assess the 
smoker’s readiness to quit in the next 30 days as 
per usual care.  In accordance with randomized 
condition, the TCOS will offer the appropriate 
intervention incentive per the Invite Script 
(Attachment B). For those who tell the TCOS 
that they are ready to quit within 30 days, the 
TCOS will offer treatment enrollment and 
provide standard care per the existing tobacco 
treatment program of the GHC-SCW healthcare 
system (e.g., setting quit date, arranging timing of treatment contacts: See Figure 2.).   
The TCOS will be trained to present information about the Treatment Engagement Incentive 
offer, assessing eligibility, informed consent, and research assessment processes in a 
standardized manner. 
UW-CTRI personnel will be responsible for: conducting telephone follow-up interviews 3- and 6-
months post-TQD and meeting with patients to verify claimed abstinence 6-months post-TQD 
via biochemical testing (breath CO, urine, and/or saliva testing without biobanking). The 
Figure 2.  GHC-SCW  Healthcare System Standard 
Tobacco Treatment Program 
 
Patients are offered ongoing access to resources 
but expected to set a target quit date (TQD) to 
focus cessation planning and arrange medications.  
Elements include: 
• 
3 brief telephone counseling sessions with a 
Certified Tobacco Treatment Specialist 
(TCOS) 
o 
3-5 days pre-,  
o 
5-7 days post- (Week 1),  
o 
4 weeks post-TQD (Week 4) 
• 
Smoking cessation pharmacotherapy including 
combination NRT, varenicline, or any of 7 FDA 
approved medications. 
• 
Integrated referrals to: 
o 
primary care physician 
o 
WI Tobacco Quit Line 
o 
SmokefreeTXT program 
• 
Weekly facilitated Tobacco Use Support Group 
• 
Ongoing TCOS support through MyChart 
(EHR patient portal) and phone 
All patients on the Cigarette Users Registry 
receive: 
• 
Quarterly Bulk Outreach via postal mail and 
MyChart promoting the tobacco treatment 
program services 
• 
Care Management telephonic outreach calls 
by TCOS following each primary care visit and 
no less than once per year. 

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biochemical testing visit will be conducted at UW-CTRI or a practical location of the participant’s 
choosing. 
Personnel from both the healthcare system and UW-CTRI will therefore have contact with study 
participants and/or their data. Coordination of all activities will be led by UW-CTRI and UW-
CTRI will perform all data analyses. All data transmissions to and from UW-CTRI will occur via 
secure, HIPAA-compliant means via capture in REDCap or SFTP or secure Box file transfers. 
8.2 Assessment Plan 
Baseline assessment (See uploaded Baseline Assessment and uploaded List of EHR Data to 
Be Extracted). At enrollment, TCOS will assess tobacco use history and smoking cessation 
history, dependence, motivation and self-efficacy related to quitting smoking, attitudes about 
and beliefs regarding smoking cessation treatments, and education. EHR data regarding age, 
sex, race, ethnicity, contact information, communication preferences, and documentation 
regarding social determinants of health (e.g., food insecurity, housing insecurity, financial strain) 
educational attainment will be obtained. Chronic medical conditions and healthcare utilization 
over the past year will be extracted from EHR data, as well. 
Intra-treatment assessments (See uploaded Intra-Treatment Assessment).  At the 3 standard 
treatment telephone counseling calls, TCOS will assess daily smoking since last contact, 
counseling engagement, withdrawal, self-efficacy, and use of all nicotine/tobacco products. 
Follow-up assessments (See uploaded Follow-up Assessment).   UW-CTRI staff will conduct 
15-25-minute follow-up interviews 3- and 6-months after study enrollment to assess past 7-day 
smoking, use of smoking cessation treatments, use of all nicotine/tobacco products, brief 
demographic characteristics, and treatment satisfaction. Participants will receive $20 for 
participating in the 6-month follow-up interview and $50 for attending the 6-month biochemical 
confirmation visit at 6 months.  
To enhance follow-up interview and visit completion rates, participants will be texted, mailed, 
sent MyChart messages or sent automated phone calls (depending on their communication 
preferences as noted in the EHR and during enrollment) to remind them of follow-ups.  
Although this program will evaluate interventions delivered by healthcare system personnel 
(Tobacco Cessation Outreach Specialists), follow-up data collection procedures and collation of 
data from multiple sources/sites necessary for thorough program evaluation are the 
responsibility of the UW-CTRI study investigators. To achieve the study aims, UW-CTRI 
investigators require access to identifiable patient data on all enrolled participants. At UW-CTRI, 
all study data will be stored in a HIPAA-compliant and secure manner on Department of 
Medicine servers with UW-CTRI-controlled password access. Staff trained in human subjects 
research and HIPAA compliance will link these datasets using a random subject identifier and 
will then de-identify the data for analyses.  
9.0 Analysis Plan 
9.1. Data Sources 
Data will come from EHR records extracted by healthcare personnel and from research records 
of post-enrollment and follow-up assessments.  

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9.2 Subject Population Initial Analyses Descriptive statistics will be used to characterize the 
participants randomized to all the incentive conditions and these data will be compared with the 
characteristics of all patients who are listed on the Cigarette User Registry and also for just 
those on the Registry who do not participate in the research program. The data from these 
patients will be compared with the data from research participants to assess the 
representativeness of the sample enrolled in the study.   
9.3 Planned Analysis 
Primary Aim 
• 
To determine the relations between treatment engagement financial incentive amounts 
offered and likelihood of patient engagement in smoking cessation treatment (defined as 
setting a TQD and completing the two phone counseling calls (Pre-quit + Week 4).   
Primary analysis. The primary outcome measure will be patient engagement in smoking 
cessation treatment (defined as setting a TQD and the number of completed phone counseling 
contacts). We will determine the percentage of those in each incentive condition who engage in 
smoking cessation treatment. We will use logistic regression analyses to contrast the likelihood 
of engaging in any smoking treatment (vs none) for the three incentive conditions (0 incentive, 
$100, and $50), with the 0 incentive condition being the reference condition in the primary 
analysis. We will also examine incentive condition effects on the number of scheduled 
counseling visits completed (0-3 visits) via ordinal logistic regression. 
Additional exploratory analyses related to the primary aim. In additional exploratory analyses, 
we will determine the percentage of all GHC patients who are contacted by the TCOS and 
offered the Treatment Engagement Incentive. We will separately determine the percentage of 
those in each incentive condition who agree to set a TQD. We will use logistic regression 
analyses to contrast the likelihood of engaging in smoking treatment for the three incentive 
conditions, with (as mentioned above) the 0 incentive condition being the reference condition in 
the primary analysis, followed by comparison of the $100 and $50 conditions both with the 
reference condition and with one another. The primary analyses will not use covariates. Follow-
up analyses will use the patient’s home clinic and the patient’s TCOS as covariates. 
Furthermore, using logistic regression, we will examine the relation between incentive condition 
and use of pharmacotherapy as the outcome (with medication orders and pick-up entered in the 
EHR and/or billing data).  
  
Exploratory Aims 
 
• 
Conduct exploratory analyses on the effects of the different incentive engagement 
amounts on biochemically confirmed point-prevalence 6-month abstinence and 
determine whether incentive conditions affect abstinence via their effects on smoking 
treatment engagement (i.e., whether smoking treatment engagement mediates the 
relations between different engagement incentive conditions and 6-month smoking 
abstinence).   
Analysis. Logistic regression will be used to determine whether the different incentive levels ($0, 
$100, $50) produce effects on 6-month, biochemically confirmed point prevalence smoking 

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abstinence using the strategy described for Primary Aim. Dummy coding will be used to 
compare: 1) each positive incentive condition with the 0 incentive condition, and 2) the two 
positive incentive conditions will be compared with one another. The primary analyses will not 
use covariates. Secondary models will adjust for the patient’s home clinic and the patient’s 
TCOS as covariates, Gender, race, cigarettes smoked/day will be added as covariates in later 
analyses. Mediational analyses will be done using incentive condition as the independent 
variable, engagement data as mediators (attendance at the initial treatment contact, number of 
counseling contacts made, or use of smoking medication). The outcome variable will be 
smoking abstinence at 3 months (self-report only) and 6 months (biochemically confirmed self-
report).  
• 
To determine the incremental cost-effectiveness of the different financial engagement 
incentive amounts with regard to total program costs vs. usual care, net monetary 
benefit (NMB), cost per quit, and incremental cost-effectiveness ratios (ICERs), with the 
last determined with regard to cost of additional smoker engaged in treatment and each 
additional individual who quits smoking. 
Analysis. Cost data will come from: healthcare system costs in terms of outreach 
communications, TCOS time (related to outreach and counseling efforts), implementation costs, 
incentive costs, and medication expenditures (including related physician screening when it 
occurs). We will use methods recommended by the US Panel on Cost-Effectiveness in Health 
and Medicine10 and consistent with our prior research. We will measure costs from a societal 
perspective using data on smoking cessation benefits from publicly available Medicare and 
Medicaid reimbursement rates. Cost estimates will be converted to a common year and QALYs 
will be computed, using a rate of 3% to discount future outcomes and costs to present value. 
We will also conduct probabilistic sensitivity analyses to account for uncertainty. We will 
determine net monetary benefit (NMB), cost per quit (using 6 month abstinence rates), and 
incremental cost-effectiveness ratios (ICERs)11. The components of NMB will be the added 
costs of the various incentive levels and the monetized value of the QALYs added by the 
treatments. Total intervention and implementation costs (including outreach and added TCOS 
time for intervention, implementation, and incentives) will be compared to program costs of the 
usual care approach to tobacco use (the TCOS intervention program prior to the incentive study 
implementation).  
• 
To determine the representativeness of smoking treatment reach and smoking 
abstinence outcomes generated by the various engagement incentive amounts with 
regard to different groups of smokers: e.g., those low in socio-economic status, priority 
populations, different racial and ethnic groups. 
Analysis.  We will extract data from the EHR to characterize the healthcare system population of 
patients who smoke with regard to such factors as: gender, race, ethnicity, insurance mix. Such 
person factors will be related to the likelihood that the patient:  responds to TCOS outreach, 
agrees to accept smoking treatment (agrees to a TQD and completes a counseling call), 
completes up to 3 counseling calls, picks up smoking medications, and achieves long-term 
abstinence. Logistic regression will be used to examine the likelihood that different person 
factors are significantly related to the various outcomes under the different incentive levels.  
9.4 Power 

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This study is powered to detect a 12 percentage point difference in treatment engagement rates 
(defined as setting a TQD and completing 2 treatment phone counseling contacts) as a function 
of incentive amount. We believe that this rate is both feasible and of public health significance.  
We anticipate that the 0 incentive condition will have an engagement rate of about 15%. Since 
the rate of smoking treatment engagement is generally only about 5-7% in studies where 
incentives are not used we believe a 15% rate is conservative. We anticipate increased 
engagement in the control condition, relative to these earlier studies, because we believe it will 
be increased by TCOS contact and the opportunity to set a quit date on the contact call. We 
believe that a 12 percentage point increase above the 15% rate (to 27%) would be of public 
health significance. A total of 180 participants per group are needed to have power of .80 with 
alpha = .05 in a two-tailed test. This would translate into a study N = 540 with 180/condition for 
the comparison of each positive incentive condition vs the control condition. We make no a 
priori prediction about whether the $100 incentive condition will increase engagement relative to 
the $50 condition, but we certainly believe it will increase engagement relative to the 0 incentive 
condition. . Therefore, we propose an overall N=540.  
While engagement is the principal outcome of this research we nevertheless have determined 
the effect size (increment in percent abstinent) we would need to have adequate power to 
detect difference in abstinence rates, as well.  We anticipate that the $0 incentive condition will 
produce abstinence in 15% of those who contact the TCOS. With n=180/condition, we will have 
power=.80 to detect at least an 11 percentage point increase in abstinence above the 15% base 
rate in a 2-tailed test at alpha .05.  
10.0 Human Subjects Protections and Data Sharing 
10.1 Potential Benefits to Subjects and Society 
Every participant in the study will be given information about ways to access evidence-based 
smoking cessation treatment to help them stop smoking and will be given access to that 
treatment within their healthcare system subject to limits and copays based on insurance 
coverage.  One possible direct personal cost could be from telephone charges for telephone-
delivered care such as cessation counseling and care management. Although smokers could 
access this care outside of the study, we know that only about 1-2% of smokers use a quit line 
and only about 5% use both medication and counseling. As such, the proposed study will offer 
all participants the benefit of information about treatment options and a low-barrier method of 
initiating treatment (i.e., by phone). 
The proposed research also has the potential to benefit other smokers by identifying an 
effective population health incentive intervention that expands the reach of existing treatments 
with a feasible, cost-effective, and potentially sustainable approach in primary care settings. 
This work has the potential to accelerate the translation of clinical research on smoking 
interventions into healthcare practice and thereby reduce morbidity and mortality associated 
with smoking.  
To promote public access to the results of this research, and thus its potential benefits, the 
study will be registered as a clinical trial at ClinicalTrials.gov, with information about the study 
purpose, experimental design, outcomes, and analyses available to the general public (with 
results posted within one year of study closing, as required). 

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10.2 Potential Risks to subjects 
This project poses minimal risk to participants, as it entails only limited data collection solely for 
research purposes (up to 2 phone assessments with one possible 5-minute visit over 6 months 
for all enrollees and a modest (non-coercive) incentive to use standard care resources that are 
already available and consistent with FDA guidelines 
The chief risks involved are loss of privacy and breach of confidentiality. Although we will take 
several steps to protect participant privacy, we cannot guarantee that patients may not 
experience an invasion of privacy. Some patients may perceive outreach letters from the health 
system as violating privacy, for example. Likewise, we cannot guarantee the confidentiality of 
the information collected directly from participants. Although we will not collect sensitive data 
directly, some data (i.e., substance use disorder diagnoses) may be included in limited data 
extracted EHR data.  
The outreach message and motivational support given to participants in this project are unlikely 
to induce psychological distress, as they will be positive in tone and will focus on resources 
available to participants to support their efforts to change. Providing breath samples for carbon 
monoxide and/or providing saliva or urine for cotinine testing carries minimal risk, as these are 
minimally invasive procedures.  
It is important to note that all patients will have access to evidence-based smoking cessation 
treatment at no or low cost (through their TCOS or primary care provider, subject to limits and 
copays based on insurance coverage and/or a quit line that offers evidence-based cessation 
treatment no cost to callers) and that receiving such treatment is not contingent on consenting 
to this study. It is also important to note that all patients will have the ability to decline or 
withdraw from the study and any study activities at any time.  
10.3 Risks Minimization Plan. 
To protect against breach of confidentiality or violations of privacy, we will ensure that data are 
stored on secure, encrypted servers at all participating sites, and that transfer of data between 
clinics and the UW-CTRI research team are conducted via HIPAA-compliant means. 
Communication with patients via the MyChart patient portal will likewise be conducted in HIPAA-
compliant ways that conform to healthcare system standards. A unique study ID will be used to 
store all data on individual participants and information linking that study ID to participant 
identifying information will be maintained by the data manager. Data being used for analysis will 
be identified with the study ID only. Participant contact information will only be available to study 
staff having direct contact with participants. Data will be stripped of direct identifiers (limited 
datasets) or completely de-identified prior to sharing with others outside the IRB-approved 
research team.  
In the course of the study participants may reveal important clinical information to their TCOS 
(tobacco cessation outreach specialist) regarding a serious health issue or change, the TCOS, 
who will be an employee of the healthcare system, will be able to communicate directly with the 
patient’s primary care team (e.g., if a patient reports that they are coughing up blood) via the 
EHR and will advise the patient to seek care from their care team or emergency care, as 
appropriate. 

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Routine adverse event assessment will not occur in this study, except in the context of smoking 
cessation treatment episodes, given the minimal and informational nature of the health system 
reach interventions and research assessments. Significant adverse events that occur during 
smoking cessation treatment will be gathered by the TCOS as a part of the patient’s standard 
smoking cessation care. AE’s will not be gathered by research staff. If a patient reports a 
concern AE or health related event to a research staff member, the patient will be encouraged 
to immediately seek medical attention from the participating healthcare system. 
10.4 Risk/Benefit Analysis 
This study carries minimal risk. The financial incentives to be deployed pose no risk above and 
beyond standard treatment and are too small to be coercive. No information about illegal 
behavior will be collected by research staff or entered into research data bases. The risk of 
someone's identity becoming known to unauthorized persons is low. This risk is outweighed by 
the benefits of quitting smoking for any individual, and the benefit to society of having fewer 
people use tobacco products. This research has the potential to benefit smokers in the future by 
helping to identify optimal financial incentive levels to promote use of smoking cessation 
treatments for broader dissemination. Therefore, the potential gain in knowledge regarding 
engagement incentives associated with the proposed study outweigh the risks of participation. 
10.5 Unanticipated Problems or Complications 
The Principal Investigator (PI) will be responsible for routinely monitoring study progress. UW-
CTRI has a quality assurance monitoring protocol and team in place and will alert the study PI 
to significant problems that arise. Any data safety concerns will be reported to the PI 
immediately and addressed. We will report any unanticipated problems to the IRB according to 
posted guidelines. A full data safety and monitoring plan is included at the end of this protocol. 
10.6 Privacy Precautions and Protections 
Collection of sensitive information about subjects will be limited to the amount necessary to 
achieve the aims of the research. Participants will not be asked to disclose any information 
about illegal behavior.   
10.7 Unauthorized Use or Disclosure Precautions and Plan 
Participant study data will be collected by TCOS and UW-CTRI research personnel through the 
UW-ICTR instance of REDCap and will be stored on secure, password protected servers.  Data 
will be accessible only to assigned study staff for their study function; computer workstations will 
be password-protected, and thus secured from unauthorized use. GHC-SCW healthcare system 
will transmit identifying information to UW-CTRI via secure, HIPAA compliant means (either a 
secure FTP site or a secure interface to the EHR).  
During the active phase of the study, required patient identifying data will be stored in REDCap 
and linked to all study data via a study identifier (i.e., to guide randomization, phone calls, and 
assessments). PHI will be made inaccessible as soon as the study has been completed. 
Confidentiality of participant data and information will be accomplished by using participant 
numbers as unique identifiers, allowing us to keep participant data separate from identifying 
information. At UW-CTRI, data generated through study participation and data obtained from 
the EHR (with patient consent) and UW-ICTR instance REDCap will be incorporated into a UW-

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CTRI analytical database and securely stored  under protections and procedures consistent with 
the guidelines and regulations of the UW School of Medicine and Public Health (UW-SMPH). 
Outside access is available only via an encrypted connection to the Department of Medicine 
Citrix server located at the UW Clinical Science Center in Madison. The servers at the UW-CTRI 
Madison office are physically secured in a locked room. Data backups are created nightly and 
stored in a locked safe. Significant safeguards have been implemented to protect data including 
virus and adware protection, firewall, access controls and encryption when appropriate such as 
wireless and remote access. All UW-CTRI staff members have completed HIPAA and human 
subjects training and are aware of the sensitivity of study-related data. The study team has a 
Certificate of Confidentiality from the National Institutes of Health. The UW SMPH has 
developed school-wide data security policies and procedures. UW-CTRI data security policies 
and procedures conform to those of the SMPH. UW-CTRI will use the UW-ICTR instance of 
REDCap that supports audit trails such as access, change logging, and more sophisticated 
access control for managing and tracking user access privileges. No publications or 
presentations resulting from this research program will contain any identifying information about 
individual participants. Following cleaning and verification of data at the conclusion of the study, 
all research data will be placed in a de-identified data set at UW-CTRI. 
 
11.0 References 
 
1. Adsit RT, Fox BM, Tsiolis T, Ogland C, Simerson M, Vind LM, Bell SM, Skora AD, Baker 
TB, Fiore MC. Using the electronic health record to connect primary care patients to 
evidence-based telephonic tobacco quitline services: a closed-loop demonstration 
project. Trans Behav Med. 2014; 4:324-332.  PMCID: PMC4167898. 
2. Fiore MC, Adsit R, Zehner M, McCarthy DE, Lundsten S, Hartlaub P, Mahr T, Gorrilla A, 
Skora A, Baker TB.An EHR-based Interoperable eReferral system to enhance Quitline 
smoking treatment in primary care. 2019. JAMIA. 2019;26(8-9):778-786. PMCID: 
PMC6696502.  
3. Anderson CM, Cummins SE, Kohatsu ND, Gamst AC, & Zhu SH. Incentives and 
patches for Medicaid smokers; an RCT. Am J Prev Med. 2018; 55(6S2), S138-S147. 
doi:10.1016/j.amepre.2018.07.015 
4. Baker TB., Fraser DL., Kobinsky K, Adsit R, Smith SS, Khalil L, . . . Fiore MC.  A 
randomized controlled trial of financial incentives to low income pregnant women to 
engage in smoking cessation treatment: Effects on post-birth abstinence. J Consult Clin 
Psychol. 2018; 86(5), 464-473. doi:10.1037/ccp0000278 
5. Fraser DL, Fiore MC, Kobinsky K, Adsit R, Smith SS, Johnson ML, Baker TB.  A 
randomized trial of incentives for smoking treatment in Medicaid members. Am J Prev 
Med. 2017; 53(6), 754-763. doi:10.1016/j.amepre.2017.08.027 
6. Tong EK, Stewart SL, Schillinger D, Vijayaraghavan M, Dove MS, Epperson AE, . . . 
Kohatsu ND.  The Medi-Cal Incentives to Quit Smoking Project; impact of statewide 

[Incentives for Smoking Treatment Study] 
 
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outreach through health channels. Am J Prev Med. 2018; 55(6S2), S159-S169. 
doi:10.1016/j.amepre.2018.07.031 
7. Volpp KG, Troxel AB, Pauly MV, et al. A randomized, controlled trial of ﬁnancial 
incentives for smoking cessation. N Engl J Med. 2009;360 (7):699–709. 
https://doi.org/10.1056/NEJMsa0806819. 
8. Ku L, Bruen BK, Steinmetz E, Bysshe T. Medicaid tobacco cessation: big gaps remain in 
efforts to get smokers to quit. Health Aff (Millwood). 2016;35(1):62-70. 
9. Bradley CJ, Neumark D. Small cash incentives can encourage primary care visits by 
low-income people with new health care coverage. Health Aff (Millwood). 
2017;36(8):1376-1384. 
10. Sanders, G. D., et al.., Practices and Reporting of Cost-effectiveness AnalysesSecond 
Panel on Cost-Effectiveness in Health and Medicine.  JAMA. 2016;316(10):1093-1103. 
doi:10.1001/jama.2016.1219 
11. Glick HA, Doshi JA, Sonnad SS, Polsky D. Economic evaluation in clinical trials. Oxford: 
Oxford University Press; 2007. 
 
 
 
 
 
 
 

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TCOS conduct typical Recent Visit, No 
Quit Date (RVNQD) and Annual 
telephone outreach to Cigarette User 
Registry members
Patient 
Responds 
(engages TCOS)
No
Eligibility 
verification 
process for study
TCOS draws 
randomization 
assignment
Yes
Eligible
Tobacco Use 
Treatment available 
as needed.
Not eligible
TCOS  - presents 
Invite Script per 
intervention arm
- assess interest to 
participate in 
Treatment 
Engagement 
[Incentive] Study 
(TEI)
Patient 
Interested?
No
Yes
TCOS: - completes 
consent & 
assessments
TCOS: - provides 
treatment as usual
TCOS: - Triggers TEI 
payment
- establishes 
research follow-up 
target dates
How GHC patients enter the study
Screening and study initiation
Population-based Incentive 
Model to Increase Smoking 
Cessation Treatment 
Engagement in Primary Care 
Study 
TCOS= Tobacco Cessation Outreach Specialist (GHC Employee)
Attachment A (revised): Enrollment 
Flowchart

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Bulk Communication [Contact 
Incentive (CI)] Invite to all patients on 
Cigarette User Registry by clinic 
(Incentive expiration date of xx/xx/
202X
Patient 
Responds (calls 
TCOS)
No
Eligibility 
verification 
process for CI
TCOS – 
triggers CI 
payment
- draws 
randomization 
assignment
Yes
Eligible
Tobacco Use 
Treatment available 
as needed.
Not eligible
TCOS  - presents 
Invite Script per 
intervention arm
- assess interest to 
participate in 
Treatment 
Engagement 
[Incentive] Study 
(TEI)
Patient 
Interested
No
Yes
Eligibility 
verification 
process for TEI
Eligible
TCOS: - completes 
consent & 
assessments
TCOS: - provides 
treatment as usual
Not eligible
TCOS: - provides 
treatment as usual
TCOS: - Triggers TEI 
payment
- establishes 
research follow-up 
target dates
How GHC patients enter the study
Screening and study initiation
Population-based Incentive 
Model to Increase Smoking 
Cessation Treatment 
Engagement in Primary Care 
Study 
TCOS= Tobacco Cessation Outreach Specialist (GHC Employee)
Attachment A: Enrollment Flowchart

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Attachment B.  Invite scripts for Treatment Engagement Incentive Study 
Discuss the purpose of of the call 
Hi, I am specialist X____X from your healthcare provider, GHC- SCW, and I’ve called as part of 
an important benefit to our patients to help them quit smoking.   
Let me please confirm whom I’m speaking with. [CONFIRMS CALLER IS MEMBER OF GHC-
SCW.]  We want to make sure all our patients who smoke know about the many ways we can 
help them with their smoking. Quitting smoking is the best thing you can do for your health, but 
quitting can be hard. We are here to help even if you are not ready to quit yet.” 
First, can you confirm your date of birth? 
Check against EHR to make sure you have the 
correct patient on the phone. 
“I see your last your last visit with us was in Y____Y.”  
• 
Ask the patient “Are you still smoking?” 
 
If patient initially responds they are no longer smoking, ask “So, just to confirm, you have not 
had even one puff over the last seven days?”  
If 0, click “No” (Informational Alert should trigger with reminder to adjust Smoking Status in Vital 
Signs/Social History.  Congratulate the patient on quitting and thank them for taking the call.  If 
you need support contact us at xxx-xxx-xxxx. 
If >0, click “Yes” advise them to quit and offer treatment: “The most important thing you can do 
to improve your health is to quit smoking and I can help you.  I can help provide medications, 
and treatment support over the phone and via text messages.   
 
Also, check against EHR that patient: 
a) Is on the Cigarette User Registry for a participating clinic 
b) Does not have an existing target quit date ±30 days from date of call to TCOS 
c) Current billable insurance documented as other than Medicare or non-BadgerCare 
Medicaid 
d) Preferred language is either English or Spanish 
If either a, b, c, or d, is untrue→ offer tobacco use treatment or resources as per usual 
standard care. 
IF a, b, c, & d, true→ Continue 
 
RANDOMIZE 
 

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Randomized to $0 incentive 
“As a GHC-SCW member, you may be eligible for a special study that may include 
receiving money for participating in treatment for those willing to make an attempt to quit 
smoking in the next 30 days.  If you are interested, let’s discuss getting you started now.  
Is this something you are interested in?” 
Randomized to either $100, or $50 incentive 
“As a GHC-SCW member, you may be eligible for $[XX] to make an attempt to quit 
smoking in the next 30 days.  You would receive ½ of it for completing your first 
telephone counseling session and the rest for completing the Week 4 counseling 
session. If you are interested, let’s discuss getting you started now.  Is this something 
you are interested in?” 
 
Are you interested in trying to quit smoking in the next 30 days? 
 
N/A (I DON’T SMOKE) 
YES 
 
NO 
 
 
NO → Thanks, we understand that it’s not always the right time to quit. OK. Would you like my 
direct line or the number of the Wisconsin Tobacco Quit Line? YES  
NO 
  
YES → I can be reached 8-4 at xxx-xxxx, the quit line toll free number is: [1-800-
784-8669].  Their staff are available 7 days a week, 24 hours a day. 
 
NO → Thank you for your time. 
 
YES → We’d  like to ask you to be in a research study to help us figure out the best ways of 
offering this support. We at GHC-SCW and our research partners at the University of 
Wisconsin, or UW-Madison are trying to find ways to help smokers quit right now. If you’re 
interested in the study, we can see if you qualify for it. If you don’t qualify, or you aren’t 
interested in the study, we still have support to offer you to quit. I can help you now or you can 
talk to your doctor or call the Wisconsin Tobacco Quit Line for phone coaching and 2 weeks of 
free nicotine replacement medication. Would you like to hear more about the study now? This 
will take 2 minutes. 
YES  NO 
 
GO TO TREATMENT ENGAGEMENT INCENTIVE STUDY CONSENT PROCESS. 

[Incentives for Smoking Treatment Study] 
 
[Fiore] 
 
 
25 
 
NO→Thanks, we understand that that this may not be the right fit. Would you like my direct line 
or the number of the Wisconsin Tobacco Quit Line? YES  NO 
  
YES → I can be reached 8-4 at xxx-xxxx, the quit line toll free number is: [1-800-
784-8669].  Their staff are available 7 days a week, 24 hours a day.  [confirm 
mailing address for Contact Incentive] 
 
NO → Thank you for your time.  [confirm mailing address for Contact Incentive] 
 
YES → Great, the goal of this study is to see which ways of offering support best help people 
get into stop-smoking treatment. This is a 6-8 month study in which we will help you quit 
smoking. You may get 3 phone calls from me to talk about your quit-smoking options and plans. 
To begin you need to pick a target quit date within the next 30 days. Our research partners at 
the University of Wisconsin (UW) will call you 2 other times over 6 months to see how your quit 
effort went, and ask about any tobacco use and your health. You would be paid $20 for 
completing the 6-month phone survey.  You may be asked to visit UW’s tobacco treatment clinic 
after 6-months to check your breath, urine, and/or saliva for traces of smoking. You would be 
paid $50 for this visit. Your part in the study will end 6 to 8 months after you enroll, but we may 
collect data from GHC-SCW electronic health records from one year ago and up to 1 year from 
now so we can see how study treatments affect people’s health and use of health care. We 
keep information about you confidential and use it just for research. 
 
Would you like to continue?   YES  NO 
 
NO → Thank you for your time.  
 
YES →  Continue 
 
Excellent. Now I would like to tell you more about the study, answer any questions you have, 
and ask if you consent to be in the study. If you do consent, the next step will be to collect more 
information before we end this call.  
I’ve already told you about the study purpose and procedures. Now I want to review some 
reasons you may want to be in the study: 
 

[Incentives for Smoking Treatment Study] 
 
[Fiore] 
 
 
26 
 
• 
The study will give you opportunities to get effective treatments to stop smoking. 
Everyone in the study will be offered our full range of smoking cessation treatment 
options. 
• 
You will help researchers learn how to offer stop smoking treatments in a way that helps 
more people quit smoking and improve their health. 
 
Here are some reasons you might NOT want to take part in this study: 
• 
The study collects information about you and your health. You might be uncomfortable 
providing some of this information, and you have the right to refuse to answer any 
question. 
• 
We will protect your information from unauthorized use and disclosure, but there is still a 
risk that your information could become known to someone not involved in this study.   
 
If you get sick or hurt during this study, please get the help you need right away. Costs for any 
medical care will be billed to you or your insurance, just like any other medical costs. No other 
compensation (such as lost wages or damages) is usually available.  
 
Any questions so far? YES ____________________ 
NO Answer questions 
 
I mentioned we will collect information about you. This information will come from you, and from 
your GHC-SCW health record for up to 3 years. We’ll use this information to see how our ways 
of offering support to smokers affect their use of stop-smoking treatment, ability to quit smoking, 
and overall health. Collecting information from GHC-SCW will not affect your relationship with 
GHC-SCW or the services you receive in any way.  
 
GHC-SCW and the UW-Madison have strict rules to protect your personal and protected health 
information.  We limit who has access to your name, address, phone number, and other 
information that can identify you. We also store this information securely. We also have a 
Certificate of Confidentiality from the National Institutes of Health that prohibits us from 
disclosing information that may identify you in a legal proceeding or in response to a legal 
request without your consent. The UW-Madison may publish and present what we learn from 
this study, but none of this information will identify you directly without your permission.  
 
We cannot promise complete confidentiality, however. Federal or state laws may permit or 
require us to show information to university or government officials responsible for monitoring 
this study, and to the National Cancer Institute, which is funding the study. 
 

[Incentives for Smoking Treatment Study] 
 
[Fiore] 
 
 
27 
 
For this study, the main people who will use your information are researchers at the UW-
Madison Center for Tobacco Research & Intervention. 
 
Any questions so far? NO  YES ________________ 
 Answer questions 
 
Taking part in research is voluntary.  This means that you decide if you want to be in the study 
and you can leave the study at any time.  Your choice will not affect your relationships with 
GHC-SCW, UW-Madison, or any affiliated organizations, or any services you receive from them.  
No matter what decision you make, and even if your decision changes, there will be no penalty 
to you. You will not lose medical care or any legal rights. By agreeing to be in this study, you are 
not giving up any legal rights. You keep your legal rights to seek payment for care required 
because of a sickness or injury resulting from this study. 
 
I’m about to ask if you give your consent to be in the study and to let us collect and use your 
health information for study purposes.  If you decide to take part in the study, I’ll give you 
contact information for the UW-Madison research team in case you have questions.  We’ll also 
send you a written summary of all the information we discussed about this study.  It will include 
contact information for the study team and instructions for what to do if you decide you want to 
leave the study, have any questions about your rights as a research participant, or have any 
complaints you cannot resolve with the research team. 
 
Do you have any questions about the study? NO  YES ________________ 
Answer 
questions 
 
DO YOU CONSENT TO PARTICIPATE IN THE STUDY AND ALLOW FOR THE USE OF 
YOUR HEALTH INFORMATION?      
YES 
 
NO  
 
NO →  Even without participating in the study, although you are not eligible for the financial 
incentive, I can help you now with medications and treatment support over the phone and via 
text messages or you can talk to your doctor or call the Wisconsin Tobacco Quit Line for phone 
coaching and 2 weeks of free nicotine replacement medication. 
 
YES →  Continue 
Great! I’m so glad you’ve decided to join the study! We’ll send you a summary of what we just 
talked about and additional information about the study in the mail. It will also give you the 
phone number of our research partners at UW-Madison.   
 

[Incentives for Smoking Treatment Study] 
 
[Fiore] 
 
 
28 
 
If participant wants to get contact numbers now, provide these over the phone:  
Project Principal Investigator: 608-262-8673 (questions about study)  
UW Health Patient Relations: 608-263-8009 (complaints about study or team) 
We are requesting your email address so we can keep in touch with you. Email is generally not 
a secure way to communicate about your health as there are many ways for unauthorized users 
to access email. You should avoid sending sensitive, detailed personal information by email. 
Email should also not be used to convey information of an urgent nature. If you need to talk to 
someone immediately, please contact [Michael C. Fiore, M.D., Principal Investigator, 608-262-
8673]. You do not have to provide your email address to participate in this study. 
Next I’m going to ask you to answer some questions. This should take 5-10 minutes. Is now a 
good time to do this?  YES  NO 
 
NO → When would be a better time to call?  Schedule a time to call back 
UNSURE OF BETTER TIME→ OK. I’ll call you back later to see if I can catch you at a better 
time. Please feel free to call me back at ###-###-#### when you have time to talk. 
 
YES →  
 
Conduct baseline assessment  
 
SCRIPT FOR LEAVING A MESSAGE ON AN ANSWERING MACHINE 
 
Hello, my name is _____________ and I am calling from GHC-SCW for {RESPONDENT'S 
NAME}.  Please call me back at {TCOS phone number} when you can. 
 
 
SCRIPT FOR LEAVING A MESSAGE FOR A PARTICIPANT WITH ANOTHER 
PERSON 
 
Hello, my name is ______________ and I am calling from GHC-SCW for {RESPONDENT'S 
NAME}.  Please have {RESPONDENT'S NAME} call me back at {TCOS phone number} when 
s/he can. 
 

[Incentives for Smoking Treatment Study] 
 
[Fiore] 
 
 
29