Remote Carbon Monoxide Monitoring and Incentives for Tobacco Cessation in Quitlines
Phase: PHASE1
Conditions: Tobacco Dependence
Sponsor: Consumer Wellness Solutions

 
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Proprietary and confidential property of UnitedHealth Group. Do not distribute. OHRA Template V.04/2021 
 
 
 
 
Breath Monitor Study 
Protocol 
KELLY CARPENTER, PH.D. 

 
 
 
 
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Version 
Date 
Notes 
Initials 
1.0 
8/6/21 
Version 1 draft 
kc 
1.1 
9/24/21 
Response to IRB feedback 
kc 
1.2 
9/29/21 
Update study name to Breath Monitor 
HB 
1.3 
04/19/22 
Update recruitment to up to 350 from 300 
CC 
 
 
SYNOPSIS 
Tracking IDs 
OHRA protocol number, 2021-0056 
Full Title  
(Scientific) 
Breath Monitor Carbon Monoxide Monitoring Study 
Short Title  
(Public Facing) 
Breath Monitor Study 
Type of Project 
Description 
Interventional Research   
 
Focus 
Area/Category 
Product Development 
Primary Objective 
Conduct a 3-arm randomized pilot study to determine the value of adding CO 
Monitoring (with and without financial incentives) to standard Quit For Life tobacco 
cessation service offerings.   
  
Anticipated 
Duration 
Launch: 10/2021  -- Publication: 06/2023 
Primary Target 
Population 
Quitline callers who 18+ years old from participating states who are current smokers 
 
PERSONNEL – FULL NAME, CREDENTIALS, AFFILIATION, EMAIL ADDRESS 
Principal 
Investigator  
Kelly Carpenter, Ph.D., Optum Health, Kelly.Carpenter@optum.com 
Owner/Primary 
Contact 
Caryn Chalmers, MPH, Optum Health, Caryn.Chalmers@optum.com 
Clinical Lead 
Etta Short, MS, Optum Health/Rally, etta.short@rallyhealth.com (She will be moving to 
Optum proper 9/26/21) 
Data Scientist 
TBD 
Operations 
Architect 
NA 
Internal  
Sub-Investigators 
Etta Short, MS 
External  
Sub-Investigators 
None 
 

 
 
 
 
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COLLABORATING ENTITIES 
Study Sponsor 
Quit For Life, Coaching Prevention and Wellness (internally sponsored) 
Funding Sponsor 
Internally funded with additional funding provided by participating states 
Regulatory Sponsor 
N/A 
Partners 
Vincere Health 
Vendors 
Vincere Health 
Research Sites  
Conducted remotely via phone by Optum Consumer Wellness Solution’s Quit For Life 
(Tobacco Quitline) Product and Optum Center for Wellbeing Research and via the 
Vincere Health CO monitoring app. 
 
1. SPECIFIC AIMS 
Aim 1 + Hypothesis 1: 
Conduct a 3-arm randomized pilot study to determine the value of adding carbon monoxide (CO) monitoring (with 
and without financial incentives) to standard Quit For Life tobacco cessation service offerings. We 
hypothesize that the CO monitoring will be feasible and acceptable to deliver (measured by app download rates 
and CO compliance rates). 
Aim 2 + Hypothesis 2: 
Conduct a 3-arm randomized pilot study to determine the value of adding CO monitoring (with and without 
financial incentives) to standard Quit For Life tobacco cessation service offerings. We hypothesize that the CO 
monitoring will increase engagement in quitline treatment (measured by calls completed). 
Aim 3 + Hypothesis 3: 
Conduct a 3-arm randomized pilot study to determine the value of adding CO monitoring (with and without 
financial incentives) to standard Quit For Life tobacco cessation service offerings. We hypothesize that the CO 
monitoring will increase tobacco cessation and satisfaction rates compared with treatment as usual (TAU).  We 
will also examine cost effectiveness of the intervention as compared to TAU.  
2. BACKGROUND & SIGNIFICANCE  
Carbon Monoxide (CO) is an invisible, odorless, but toxic gas that is formed during tobacco smoking and can be 
measured in the exhaled air of smokers using CO monitors. CO levels, measured as particles per million (ppm), 
can help distinguish between different levels of smoking, with levels below 10 ppm commonly used as indicators 
of abstinence. CO testing acts as an objective non-invasive measure of harm from exposure to smoking and 
conveys more information than that provided by the number of cigarettes smoked alone (e.g., CO levels can be 
affected by the intensity with which cigarettes are smoked). Exposure to CO via smoking is associated with 
incidents of stroke and other cardiovascular diseases. CO levels are not affected by concurrent use of nicotine-
containing products such as e-cigarettes or nicotine replacement which increases its value as a testing tool for 
smoking cessation studies and, thus, CO testing is widely used in research as an outcome measurement.  

 
 
 
 
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CO testing has also been identified as a valuable monitoring and feedback component of effective stop smoking 
programs and benefits cessation through making the health impact of smoking more salient. Smaller and more 
affordable CO monitors have made CO monitoring feasible for home use. The iCOTM Smokerlyzer® 
manufactured by Bedfont® Scientific Ltd. (Harrietsham, UK) is currently the only such device available for 
purchase. It connects to smartphones via bluetooth and requires a dedicated app to compute and display CO 
levels. This provides momentary feedback on behavioral outcomes, which are important self-regulatory and 
behavior change techniques in smoking cessation. Preliminary research suggests that personal use of CO 
monitors is acceptable, valued and potentially highly motivating for smokers. No large scale studies of CO 
monitoring as a component of a comprehensive tobacco cessation program have been published. 
Vincere Health (VH; www.vincere.health) is a small business who joined United Healthcare’s (UHC) 
Accelerator program in 2020. VH has developed a proprietary smartphone app that transforms data from the 
Bedfont CO monitor (cited above) into user-friendly pictorial displays and graphs. The app also connects to 
coaches, offers notifications/reminders for CO monitoring and can deliver monetary incentives (see below for 
screenshots). The UHC Accelerator program connected the VH business leads to the Quit For Life (QFL) 
smoking cessation program operated by Optum. Optum’s QFL business has noted competitors who use CO 
monitoring as a cessation tool (e.g., Carrot, Inc.) and clients have asked why QFL does not offer CO monitoring 
as part of its program.  
While there is preliminary research showing that smartphone-based CO monitoring is feasible, there is limited 
evidence that adding CO monitoring to a comprehensive cessation program increases cessation rates, 
engagement or satisfaction. The purpose of the present study is to conduct a pilot study examining the use of the 
VH monitoring device (“breath pen”) and app as an adjunct to the evidence-based QFL program. Results from the 
pilot will be used to determine the need for further study of CO monitoring and may provide data for a grant 
application to conduct a larger RCT.  
The state of Maryland’s tobacco cessation quitline is operated by Optum and the Maryland Department of Health 
has partnered with Optum to conduct this study with its quitline’s participants. They have signed an agreement to 
that effect. The participant pool for this pilot is Maryland residents who call the tobacco quitline wanting to enroll 
in a quit smoking program.  
This study is funded by Optum’s QFL program and participating states (currently Maryland). Scientific oversight is 
provided by Kelly Carpenter, PhD, Principal scientist at the Optum Center for Wellbeing Research.  
3. PRELIMINARY STUDIES 
1. Dallery J, Raiff BR, Grabinski MJ. Internet-based contingency management to promote smoking 
cessation: a randomized controlled study. J Appl Behav Anal. 2013;46(4):750-764. doi:10.1002/jaba.89 
 
Showed that home/internet-based CO monitoring decreased compliance barriers. 
2. Kendzor DE, Businelle MS, Waring JJC, et al. Automated Mobile Delivery of Financial Incentives for 
Smoking Cessation Among Socioeconomically Disadvantaged Adults: Feasibility Study. JMIR Mhealth 
Uhealth. 2020;8(4):e15960. Published 2020 Apr 15. doi:10.2196/15960 
 
Preliminary evidence of feasibility of smart-phone based CO testing in low income adults.  
3. Herbeć A, Perski O, Shahab L, West R. Smokers' Views on Personal Carbon Monoxide Monitors, 
Associated Apps, and Their Use: An Interview and Think-Aloud Study. Int J Environ Res Public Health. 
2018;15(2):288. Published 2018 Feb 7. doi:10.3390/ijerph15020288 
 
Qualitative study of smartphone-based CO monitor use found wide variation among smokers’ motivations  
  
and preferences.  
 

 
 
 
 
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4. Shahab L, West R, McNeill A. A randomized, controlled trial of adding expired carbon monoxide 
feedback to brief stop smoking advice: evaluation of cognitive and behavioral effects. Health Psychol. 
2011 Jan;30(1):49-57. doi: 10.1037/a0021821. PMID: 21299294. 
 
CO monitoring increased salience to health impacts of smoking but did not impact cessation rates. Those  
  
with high self-efficacy did have improved cessation rates with the CO monitoring intervention.   
5. Seijo-Bestilleiro R, Seoane-Pillado T, Pertega-Diaz S, et al. Randomized clinical trial to determine the 
effectiveness of CO-oximetry and anti-smoking brief advice in a cohort of kidney transplant patients who 
smoke. Int J Med Sci. 2020;17(17):2673-2684. Published 2020 Sep 23. doi:10.7150/ijms.49401CO 
monitoring did not increase cessation rates in kidney transplant patients.  
4. RESEARCH DESIGN & METHODS 
4.1. General Design 
Quitline registration agents will screen callers for study eligibility criteria during the state quitline enrollment 
process. Interested and eligible participants will be transferred to a research trained quitline coach who will 
conduct the informed consent discussion. After giving verbal consent, participants will complete the baseline 
assessment and be randomized to one of 3 arms: quitline treatment as usual, quitline plus CO monitoring 
or quitline plus CO monitoring and financial incentives. Participants will complete coaching calls. 
Approximately 60 days after randomization, participants will complete an outcomes survey and all participants will 
complete a final CO test to determine smoking status. 
Interventions-There will be three treatment arms in this trial: 
 
Arm 1:  Standard quitline (treatment as usual: TAU). This arm consists of the state quitline services as offered by 
participating states (currently MD).  These state quitlines offer five proactive coaching calls, mailed support 
materials, access to text messaging and web-based supplemental programs, plus at least two weeks of free 
nicotine replacement (NRT).  This arm will be mailed a personal CO monitor device and be instructed to 
download the Vincere Health smartphone app 60 days after randomization in order to complete the final 
outcome assessment.  
  
Arm 2: TAU plus CO monitoring. Participants in this arm will receive all treatment component of TAU. They will 
also receive a personal CO monitor by mail immediately after study enrollment and they will be instructed to 
download the Vincere Health CO Monitoring App. The app will lead participants through a 2x/day CO 
monitoring program via the Vincere Health Breath Monitor - CO Monitoring device used in conjunction with the 
smartphone app. The app includes providing CO monitoring results and visualizations of CO results over time as 
well as reminders and reinforcement for compliance with the CO monitoring program.   
 
Arm 3: TAU plus CO monitoring plus financial incentives. Participants in this arm will received all intervention 
components described above for Arms 1 & 2. In addition, they will receive financial incentives for engagement 
with the CO monitoring program. They will receive up to $1.50 for each use of the CO monitor (up to 2x per day 
for up to 60 days). Incentives will accrue and be visible on the app. Incentives will be delivered by gift card of the 
participant’s choice. 
  
4.2. Study Measures & Methods 
SCREENING- Participants will answer questions if interested in study participation. If eligible, participants will be 
transferred to a research trained coach.  
INFORMED CONSENT – If interested and eligible, participant will hear the consent form read to them by 
the research trained Quit Coach. The participant may ask questions before giving their consent. The coach will 
note the participant has provided their verbal informed consent.   
BASELINE SURVEY – Participant will spend approximately 10 minutes answering baseline assessment 
questions.  Participants will be sent a gift card of their choice for $15 after completing the baseline survey. 
 

 
 
 
 
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Table 2. Measures   
Screen  
Baseline  
Program 
utilization 
2-month follow-
up  
Demographics (gender, age, race/ethnicity, 
pregnancy/breastfeeding status)  
x  
  
 
  
Tobacco/E-Cigarette/Cannabis use  
  
x  
 
x  
Self-efficacy & motivation for quitting tobacco  
  
x  
 
x  
Cessation medication use  
  
  
 
x  
Nicotine dependence (cigarettes per day, time to 
first cigarette)  
x  
  
 
x  
Outcomes  
  
  
 
  
Program satisfaction and acceptability 
(usefulness, would recommend the program to 
others)  
  
  
 
x  
7- and 30-day point prevalence tobacco 
abstinence. CO-verified tobacco abstinence  
  
  
 
x  
Treatment Engagement 
 
 
x 
 
 
 
Study inclusion/exclusion criteria 
 
Callers to the MD state quitline 18+, daily smokers, not pregnant/post-partum, enrolling into an English 
quitline program, are not offered or in another study managed by the Optum quitlines, and have not been 
previously offered this study will be offered study screening.  
 
If callers agree to be screened for the study: inclusion criteria include possession of a smartphone with a 
data plan (needed for use of the Vincere app), agreement to download the app onto their phone, agreement to 
use a personal CO monitoring device.   
 
Days 1-55  
 
Tobacco Cessation Coaching Calls 1-5 – Participants will engage in coaching calls about quitting 
smoking. There will be brief discussion of the CO monitoring program and smartphone app for Arms 2 and 
3. Call 1 may take place on Day 1. Other calls will be scheduled as per standard quitline 
procedures. Participants will be referred to Vincere’s technology helpline for questions about the app and CO 
device. 
 
CO monitoring program (Arms 2 and 3). Participants will be sent a Vincere “breath pen” CO monitoring 
device and given instructions to download the Vincere Health smartphone app. The app also has an 
incentive/gift card feature where money earned is tallied and participants will receive a gift card through text 
message. This is how incentives will be delivered. Arm 2 and 3 participants will be asked to take 2 CO tests 
per day; only Arm 3 participants will earn incentives for CO monitoring. Participants will receive regular 
reminders and reinforcement for CO monitoring via the app.  
 
Day 55  
Arm 1 receives CO monitoring device and instructions to download Vincere Health smartphone 
app.  They will be asked to try out the Breath Monitor device to make sure they know how to use it and to 
call Vincere if they experience any issues. On day 60 they will be prompted to complete a CO breath test 
in the same way as Arms 2 and 3.  
 
Day 60  
Follow-up Survey: Participants will be sent information for completing the follow up survey via the Vincere 
app. $20 will be added to the gift card total on the app after survey is completed.   
Biochemical Verification: If participant self-reports being quit from tobacco at follow up, they will be asked 
to complete a final CO monitoring test (or tests) to verify quit status. Those who complete this final test will be 
given an additional $20 via the app.  
  

 
 
 
 
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4.3. Drugs & Devices Being Studied 
Participants will be provided access to the Vincere Health smartphone app available for Apple or Android 
devices. The app will be used for CO monitoring and compliance reminders and delivering survey questions (at 
end of study). Additionally, participants are sent in the mail an iCOquit “Breath Pen” personal Bluetooth CO 
monitor with a user guide. The device is classified as a low risk 'general wellness device'. As such, we make no 
claims that the device will help participants quit; it's only used as a (helpful) tool to monitor progress. There are no 
restrictions on use. 
Nicotine replacement (NRT) is provided by participating state quitlines as part of standard services. NRT is not 
under investigation in this study. 
 
4.4. Intervention or Observation Procedures 
All participants will receive the standard quitline coaching intervention. Coaches will review and discuss CO 
monitoring compliance and readings with participant in Arms 2 and 3.  Arm 2 and 3 participants will be asked to 
take 2 CO tests per day; only Arm 3 participants will earn incentives for CO monitoring. Participants will receive 
regular reminders and reinforcement for CO monitoring via the app.  Voice recording is standard procedure for all 
quitline calls. Calls are reviewed to ensure coaches are following study protocols.  
4.5. Data Sources and Variables 
Research Question/Aim/Objective: 
Data Variables: 
Data Source 
• 
To determine eligibility 
• 
Enrollment 
screening 
• 
Service utilization 
(Apollo – Clinical 
Management 
System) 
• 
To determine tobacco quit outcomes 
• Baseline and 
follow-up survey 
• CO readings 
 
• 
Datstat (Survey 
software) 
• 
VH app & CO 
monitor 
• 
To determine satisfaction with the program 
 
• 
Follow up 
survey 
• 
Data from VH 
App 
• 
Service utilization 
(Apollo – Clinical 
Management 
System) 
• 
VH app & CO 
monitor 
• 
Treatment Engagement 
• 
Call completion 
• 
Service utilization 
(Apollo – Clinical 
Management 
System) 
 
 
See screening and survey documents for full outline of data variables. 
4.6. Justification of Sample Size & Power 
For the study there will be 300 up to 350 individuals per participating Optum state quit line (currently only 
Maryland is participating). The target recruitment was selected based on estimates regarding how many 

 
 
 
 
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participants could be recruited in the given time frame. This pilot study is not powered to detect a significant 
difference, but outcomes will be used to determine the need for continued study. 
4.7. Statistical Methods 
For the proposed pilot study we plan to use summary statistics with confidence intervals (CIs), means with 
standard errors (SE) and graphical displays (histograms, pie charts, Box plots, etc.) as appropriate to describe 
participant self-reported demographic characteristics, use of tobacco and other variables measured at baseline 
and at 2 months. We will use logistic or linear regression analyses to compare intervention and control groups on: 
mean number of calls completed; proportion completing at least two calls and, at 2 months, mean satisfaction 
ratings, mean change in cigarettes per day (cpd) and smoking cessation rates. We will conduct sensitivity 
analyses to determine the potential range of treatment effects on abstinence taking into account 1) different 
assumptions concerning the probability of relapse among survey non-responders, 2) substitution of biochemical 
results for those who claimed abstinence in the absence of agreement, and 3) the application of biochemical 
validation confirmation rate of abstinence to individuals who claimed abstinence but did not return their 
biochemical test results. Our analyses will include independent variables for state and gender to increase 
precision. We stratified randomization by state because of state variability and by gender because of the impact 
that gender has on treatment engagement and tobacco cessation. We will address missing values in three ways; 
1) we will analyze responders only, 2) we will impute missing tobacco use as ‘smoking’ and 3) we will conduct 
sensitivity analyses (as discussed above) by modeling the proportion of smokers among non-respondents, and 
the applying of biochemical validation results to individuals who stated that they were abstinent.  
 
4.8. Control of Bias & Confounding 
State quitlines may differ in the services that are provided (e.g. amount of NRT and coaching calls) that are 
provided. There might also be variability that gender has on treatment engagement and tobacco cessation. 
Randomization will be stratified by state quitline and gender to address these potential confounding variables.  
Follow up survey is collected via the app, so there is no bias in follow up data collection. 
4.9. Primary & Secondary Endpoints 
Approximately 60 days after randomization, participants will complete an outcomes survey and a final CO test to 
determine smoking status.  Participants will be sent information for completing the follow up survey via the 
Vincere app and email. Participants will be asked to complete a final CO monitoring test (or tests) to verify quit 
status.   
4.10. 
Interim Analysis and Stopping Rules 
N/A this is a minimal risk study.  
4.11. 
Case Ascertainment for Synthetic Controls 
N/A 
4.12. 
Duration 
Projected Start of Recruitment Date (month/year) : October 2021 
Projected Enrollment Period (days, weeks, months, accrual driven) : Accrual driven 
Active Participation time (time for 1 participant to complete activity) : Participation will last about 3 months.  
Projected Data Collection Cut off (month/year) :  est. Sept 2022 (based on recruitment ending in June 2022) 
4.13. 
Intended Use of Learnings 
4.13.1 Internal use of findings plan and relevant enterprise segments: Research findings will be used to 
inform product development if found compliance and satisfaction rates are high and results indicate a 
potential for improved tobacco quit rates, treatment engagement, and/or program satisfaction. 
 

 
 
 
 
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4.13.2 External presentation or publication plan: Research findings will be disseminated as peer-reviewed 
publications and conference presentations. If applicable, findings may be used to secure funding for 
additional research.  
 
4.14 Future Utilization of Collected Data or Specimens 
Data may be used for additional analyses required for product development. Published or unpublished 
aggregated data may be used for marketing the effectiveness of a product resulting from this research. 
5. HUMAN SUBJECTS 
5.1. Participant Safety, Risks and Risk Mitigation 
The primary risk of participating in this study is the risk of breach of confidentiality. A breach could potentially 
occur, for example, if an unauthorized individual accesses the study’s database records.   Quitline calls are 
recorded as standard procedure. Voice recordings are considered identifiable. Additionally, some participants 
may experience emotional discomfort that might occur during discussion of smoking and impacts on their own 
health. Persons who quit smoking may experience temporary discomfort associated with nicotine withdrawal 
symptoms such as irritability, mood changes, headaches, trouble sleeping, and cravings to smoke.    
 
Risks of NRT.  NRT is provided as part of standard QUITLINE protocol and not specific to the study. These 
are detailed by the quit coach during coaching calls, and so are not listed in the consent form. As part of 
standard service offerings from their state or district quitline, nicotine replacement therapy (NRT) in the form of 
the nicotine patch, gum or lozenge will be offered to participants in this trial. The study will follow standard NRT 
protocols as provided through the quitlines. For each participant who opts to use NRT, Optum coaches will 
assess their medical safety to use NRT and then determine the appropriate dose according to clinical practice 
guidelines. Optum will then mail the NRT to the participant along with instructions on how to use the 
medications. The NRT in this trial is being used for its FDA-approved purpose and will be offered to all 
participants, and therefore, the effect of NRT is not being evaluated as part of the trial, although use of NRT will 
be assessed at follow-up. As part of standard quitline services, coaches ask about possible side-effects of its use 
during telephone counseling sessions. According to the FDA-approved product insert, possible side effects 
associated with the patch include headache, dizziness, lightheadedness, drowsiness, stomach upset, nausea, or 
flushing the first few days as a user adjusts to the medication. The area around the patch may become red, itchy 
or irritated. Rarely, users may experience breathing difficulties, chest pain, irregular heartbeat, nervousness, 
anxiety, or tremors. Very rarely, a user of the patch may experience an allergic reaction such as a rash, itching, 
swelling, dizziness, or trouble breathing. Side effects will be disclosed in the study consent form. Optum 
distributes NRT to 65,000 of its 250,000 callers per year and has established protocols for addressing side effects 
with callers.  
 
Risk of using the Breath Montior (personal CO monitoring device.  The device used in this study is the 
Beford iCOquit® Smokerlyzer®, a personal Bluetooth carbon monoxide monitor that has been in use since 
2015 and is a low risk device.  Intended Use: The iCOquit® Smokerlyzer® breath carbon monoxide (CO) monitor 
is intended for single patient use by cigarette smoking individuals, notifying the individual user of the amount of 
CO on their breath produced as a consequence of smoking activity. Safety Information: Participant will receive a 
user manual with their device. The user manual includes the following: “Please do not attempt to modify the 
equipment in any way or use accessories not specified by the manufacturer. Any attempt to do so will invalidate 
the warranty and may compromise the safety of the device”. For additional safety information and GMP 
information, participants are referred to the "Safety Information" section located on page 27 of the iCOquit User 
Manual. https://www.icoquit.com/wp-content/uploads/2021/01/LAB806-iCOquit-manual-issue-2.pdf  
  
Alternatives to these risks include not participating in the study.  
  
Protections against Risk  
Protection against breach of confidentiality:   

 
 
 
 
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o 
Security at Optum. Optum’s quitline business is a HIPAA-covered entity and complies with all HIPAA 
regulations regarding data security. The Optum offices provide physical and electronic access security, 
automated backup power for the servers, isolated environmental controls, and fault-warning systems to 
maintain a stable production environment for their quitline services. Servers, storage appliances and 
network components are housed in a dedicated server room at the corporate headquarters. All electronic 
and paper records, including voice recordings, that contain identifiable health information are secured 
and their use is limited to persons with a direct business-related need for access to this information. All 
hardware is handled as if it contains protected health information (PHI). Hardware that is no longer used 
is electronically and physically destroyed. The same security standards that apply to Optum normal 
business practices will be used to secure data collected for this study. Paper measures will be stored in 
locked file cabinets.  All Service Delivery and Research Staff Members receive biannual Human Subjects 
training, yearly HIPAA training, sign a confidentiality statement, and are required to adhere to 
confidentiality and security policies and procedures.  
o 
Security at Vincere Health. Vincere Health, Inc. is a HIPAA-covered entity and complies with all HIPAA 
regulations regarding data security. Of note, Vincere does not physically house any systems used by its 
Platform in Vincere facilities – all Vincere systems and servers are deployed on secure AWS and Azure 
Cloud services hosted in AWS / Azure-controlled facilities. Vincere does not store or host PHI on any 
workstations or mobile devices – all Vincere-maintained PHI is hosted and stored within our private and 
secure AWS cloud infrastructure as required by Vincere's System Access Policy. All Vincere offices 
provide physical access security in accordance with Vincere's Facility Access Policy. All electronic 
records and paper records that contain identifiable health information are secured or stored in locked file 
cabinets, and their use is limited to persons with a direct business-related need for access to this 
information according to Vincere's Restricted Internal Access to Protected Health Information (PHI) 
Policy. All hardware is handled as if it contains protected health information (PHI) – Hardware that is no 
longer used is electronically and physically destroyed according to Vincere's Disposable Media 
Policy. The same security standards that apply to Vincere's normal business practices will be used to 
secure data collected for this study. All Vincere employees receive yearly HIPAA training, sign a 
confidentiality statement, and are required to adhere to confidentiality and security policies and 
procedures according to Vincere's Employees Policy. For the purposes of this study, all Vincere Health 
employees who may see study participant data  and any coaches who may talk to a participant have 
taken Human Subjects training from CITI (certificates available upon request).   
  
Distress due to participation in the study intervention or assessment. It is possible that some 
participants may be upset or embarrassed by participating in the study intervention. Consent scripts will 
advise potential participants about the study intervention and their right to terminate participation at any time 
without risk or penalty. Participants are free to refuse to participate in any element of the study or treatment 
and to refuse to answer any question during the assessments. Expert clinicians are available to counsel any 
participant who becomes distressed, including Dr. Carpenter a licensed clinical psychologist, and the clinical 
supervisory teams at Optum and Vincere Health.  
 
Nicotine withdrawal. Nicotine withdrawal symptoms are temporary and balanced by long term 
improvements in health. NRT can help mitigate nicotine withdrawal. Coaches are trained to help participants 
cope with short-term effects of quitting/reducing tobacco and/or adjust their dose of NRT.   
 
NRT side effects (Standard service-Not part of study intervention). Participants enrolled in state quitlines 
have access to nicotine replacement therapy (NRT). Before recommending any medication or dosage, a 
participant’s health condition is assessed with a series of screening questions. Coaches assess medical 
safety for NRT use by screening for Use Exclusion (UE) factors. Use Exclusions include: diagnoses of heart 
attack, stroke, or TIA within the past two weeks; being told by a health care provider within the past 6 months 
of a rapid or irregular heartbeat that required a change in activities or medication; being told by a health care 
provider in the past 6 months that they have serious or worsening angina; or a previous reaction to patch 
medication or adhesive tape that caused a rash or hives over the body, swelling of face or throat, wheezing 
or shortness of breath, or high fever, or that required the participant to discontinue use, or caused irritation 
that continued after rotating the patch and/or using hydrocortisone cream. If a participant is not eligible for 
NRT due to a UE, then a Medical Doctor (MD) Override Letter is sent to the participant. Once Optum receives 
the completed MD Override form from the participants MD and confirms NRT dosing with the participant, 
Optum sends the participant’s NRT shipment.  The screening questions were designed by Optum’s medical 

 
 
 
 
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team and they are intended for use by non-clinical staff to exclude any individuals with specific conditions. 
Quit Coaches will also educate participants on the utilization of the products and related side effects. 
Manufacturers’ information about side effects is given to participant in written form and via a 1-800 number 
that has recorded information.  Quit coaches help participants problem solve around minor side effects (such 
as minor rash at site of the patch) and recommend that participants seek medical help for more serious side 
effects.  
 
Study Benefits. Study participants may be offered intervention components that are hypothesized to 
increase success in quitting smoking. Interactions with coaches may facilitate the development of new skills 
and habits leading to a healthier lifestyle. Participants may also benefit from knowing that they are 
contributing to the advance of knowledge leading to better understanding of how smokers respond to 
smoking cessation treatment and may lead to improvement in future cessation programs. 
5.2. Recruitment Plan 
Optum’s participant record/treatment management system will use answers to standard enrollment questions to 
determine who should receive the study invitations/screening offer. Only daily cigarette smokers from 
participating quitlines who are 18+ years old, speak English, and are not pregnant/post-partum will be screened 
for the study. Registration agents will ask three additional screening questions . These questions include: 
possession of a smartphone with a data plan, willingness to download an app onto their phone, and willingness to 
use a CO monitor. Eligible participants who  have an interest in study participation will be called by a research-
trained quitline coach who will describe the study in more detail, obtain informed consent and deliver the baseline 
assessment and the post-randomization script.  
5.3. Enrollment Plan, Consent & HIPAA Authorization 
Research-trained coaches will describe the study, read aloud the information/consent document verbatim, 
answer questions, and obtain verbal informed consent.  A copy of the consent form will be sent to participants. 
 
The informed consent will include authorization for use and disclosure of HIPAA protected health information.As 
all study activities will be conducted remotely, obtaining a signed consent form will not be possible. A partial 
waiver of HIPAA authorization is requested for this study. 
5.4. Eligibility Screening & Medical Clearance 
Study participants will be daily tobacco smokers aged 18 and older that are recruited from participating 
state quitlines who have a smartphone, provide an email address, and agree to download the Vincere Health 
smartphone app and use a CO monitor. Exclusion criteria include being unable to speak and read English, limited 
access to a telephone, or enrollment in another study operated by the quitline. Pregnant or post-partum women 
are also excluded because they are offered a tailored quitline protocol that differs from the standard call 
program. Participants are only eligible to be screened for the study once. 
5.5. Participant Engagement, Results, & Withdrawal 
All counseling calls will be attempted at least five times over different days. We will increase retention at 
the 2 month follow up survey by notifying participants via text message (on the app) that their survey is due. For 
those who do not complete the survey via the app, we will mail participants a print version of the survey along 
with a stamped return envelope. Print surveys will be mailed by the OCWR research team and returned to the 
Vincere Health office in Boston. Incentives will be given for survey completion. Strategies such as these have 
proven to be effective in our quitline research studies resulting in higher recruitment and retention rates.  
 
Noted previously, participants are free to refuse to participate in any element of the study or treatment and to 
refuse to answer any question during the assessments with no repercussions. Study participants must request in 
writing to be withdrawn from the study and/or revoke their authorization to use their data. This information is 
outlined in the informed consent. 
 
Participants will be restricted from re-enrolling into standard state quitline programs until their study activity is 
completed (whichever comes first of completion of final assessment and breath test, 90 days, or withdrawal from 
the study). 

 
 
 
 
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5.6. Compensation / Remuneration / Reimbursement 
Research Incentives: Participants will receive $15 for completing the baseline survey, $20 for completing the 
outcome survey and $20 for completing the final CO test (biochemical verification of smoking status). These 
incentives will be provided to all participants.  
Intervention incentives: Participants in Arm 3 will also be able to earn incentives for CO monitoring 
compliance. They will earn $1.50 for each test and asked to complete 2 tests per day ($3 per day). During the 60 
day study period, participants will have about 55 days of CO monitoring in which to earn incentives (we anticipate 
approximately 5 days for mailing the device). 55 days with $3 per day incentives means Arm 3 participants could 
earn up to $165 for CO monitoring compliance. This amount is in line with previous financial incentive for tobacco 
cessation research.   
 
5.7. Diversity Considerations: 
TARGETED/PLANNED ENROLLMENT: Number of Subjects 
Ethnic Category 
Females 
Males 
Total 
Hispanic or Latino 
67 
45 
1012 
Not Hispanic or Latino 
178207 
112131 
290338 
Ethnic Category: Total of All Subjects * 
184214 
116136 
300350 
Racial Categories 
 
American Indian/Alaska Native 
2 
1 
3 
Asian 
1214 
89 
2023 
Native Hawaiian or Other Pacific Islander  
1 
1 
2 
Arab or Arab American 
1 
12 
23 
Black or African American  
8599 
5262 
137159 
White 
8498 
5260 
136158 
Racial Categories: Total of All Subjects * 
185215 
115135 
300350 
 
These estimates are representative of the target population: existing callers into a single state quitline (Maryland).  
5.8. Protected Populations:  
The following populations are being targeted for participation and are necessary for this project (Check all that 
apply): 
☐ UnitedHealth Group Employees -- (Requires Human Capital support during development) 
☐ UnitedHealthcare Members -- (Requires UHC support. Please specify targeted plan types below. Protocol 
requires UHC specific intake form) 
 
☐ Medicare & Retirement Plan Members (M&R) 
 
☐ Employer & Individual Plan Members (E&I) 

 
 
 
 
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☐ Community & State Plan Members (C&S) 
 
☐ Global Markets 
 
☐ Children – (Requires age range justification, assent & parental permission process / materials. OHRA must 
apply additional regulations) 
☐ Pregnant Women - project is specific to pregnancy or includes intervention that may affect the fetus (OHRA 
must apply additional regulations) 
☐ Intellectually / Cognitively / Developmentally Disabled Persons (requires LAR considerations for recruitment, 
enrollment & all procedures) 
☐ Economically Disadvantaged Persons (requires careful consideration of compensation amounts) 
☐ Prisoners (Requires convened review & must include qualified prisoner representative. OHRA must apply 
additional regulations.) 
Protected Populations Justifications: For each population please provide justification for why their involvement 
is necessary and explain how the project is designed to appropriately accommodate and protect them from undue 
influence and risk of harm.  
6. ADMINISTRATION, QUALITY CONTROL, MONITORING & REPORTING 
6.1. Materials for Internal Development & Procurement 
The system used to manage and deliver services to quitline participants will be modified to selectively offer the 
study to those who answer enrollment questions indicating eligibly and deliver study procedures and coaching 
calls. 
6.2. Research Site Management Plan, Delegation & Training 
Service Delivery registration staff, Quit Coaches and all study staff are required to complete the appropriate 
version of the CITI Human Subjects Research Training. Select coaches will be utilized for research procedures 
for this project. Breath Monitor coaches will receive additional training in research methods.  Study coaches are 
trained Tobacco Specialists.  
 
Quality assurance protocols. Under the guidance of the principal investigator, OCWR grant managers and 
research assistants perform regular checks to ensure that all processes are working as intended. This includes 
reviewing reports to ensure the correct people are being offered screening, reviewing screening calls to ensure 
enrollment agents are asking questions appropriately and choosing the current answer choice in the participant 
record system, reviewing consent/baseline/randomization calls to ensure all procedures are being followed 
correctly, reviewing randomization as it occurs to ensure the system is utilizing randomization tables correctly, 
and reviewing treatment calls to ensure coaches are following study protocols. Feedback on performance is sent 
to supervisors of enrollment agents and coaches as needed.  
 
6.3. Deviations & Adverse Events Recording and Reporting 
Our research team follows Good Clinical Practice guidelines for documenting research procedures, including the 
development of a Standard Operating Procedures (SOP) manual to document standard practices and daily 
processes conducted to assure execution of research tasks in accordance with institutional, state and federal 
guidelines. During a study, all changes in procedures and deviations are documented in the SOP. Human 
Subjects training from CITI are also completed (certificates available upon request).   
Any participant adverse or health events reported during coaching calls are recorded in the clinical management 
system as part of the standard or care. Any reported health events that are outside of expected side effects 

 
 
 
 
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related to NRT use will be escalated and reviewed by the PI within 2 business days. Any deemed by the PI to be 
related to the research will be reported to the IRB.  
6.4. Data Handling: Security, Protection, Storage and Transfer Plan 
  
Any personal information will be stored as electronic data in password-protected secure computer files, secured 
from unauthorized access. Data will be kept for at least 6 years after the study ends and related reports are 
published. Data will be completely destroyed once it is no longer needed.   
Any published results will take the form of summary results; they will not report anything that would identify a 
specific person.  The research team at Optum will have access to the study data Only the minimal data required 
to complete the research will be accessed and analyzed.  
 
Some study data may be shared with research partners and regulatory bodies.  This includes:   
o 
Study team at Optum 
o 
Partners at Vincere Health  
o 
Office of Human Research Affairs (OHRA) at United Health Group, who oversees our research, 
and; the parties named above may need to look at study records for this research study and related 
quality assurance, survey completion, or data analysis.   
6.5. Financial Conflicts of Interest Reporting 
Optum employees conducting this research may participate in the Employee Stock Purchase Program. 
Otherwise, there are no Financial Conflicts of Interest to declare. 
7.  LIST OF ABBREVIATIONS 
Application (App)  
Carbon monoxide (CO) 
Carbon monoxide monitoring (COM) 
Cigarettes per day (CPD) 
Confidence intervals (CIs) 
Medical Doctor (MD) 
Nicotine Replacement Therapy (NRT) 
Office of Human Research Affairs (OHRA) 
Principal Investigator (PI) 
Quit For Life (Q4L) 
Research Implementation Unit (RIU) 
Standard Operating Procedures (SOP) 
Standard Errors (SE) 
Treatment as usual (TAU) 
 
7. REFERENCES 
Goldstein A.O., Gans S.P., Ripley-Moffitt C., Kotsen C., Bars M. Use of Expired Air Carbon Monoxide Testing in 
Clinical Tobacco Treatment Settings. Chest. 2017 doi: 10.1016/j.chest.2017.11.002 
Middleton E.T., Morice A.H. Breath Carbon Monoxide as an Indication of Smoking Habit. Chest. 2000;117:758–
763. doi: 10.1378/chest.117.3.758.  
West R., Hajek P., Stead L., Stapleton J. Outcome criteria in smoking cessation trials: Proposal for a common 
standard. Addiction. 2005;100:299–303. doi: 10.1111/j.1360-0443.2004.00995.x.  

 
 
 
 
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Brose L.S., Tombor I., Shahab L., West R. The effect of reducing the threshold for carbon monoxide validation of 
smoking abstinence—Evidence from the English Stop Smoking Services. Addict. Behav. 2013;38:2529–2531. 
doi: 10.1016/j.addbeh.2013.04.006.  
Beard E., West R. Pilot Study of the Use of Personal Carbon Monoxide Monitoring to Achieve Radical Smoking 
Reduction. J. Smok. Cessat. 2012;7:12–17. doi: 10.1017/jsc.2012.1.  
Jarvis C.M., Russell M.A., Feyerabend C. Absorption of nicotine and carbon monoxide from passive smoking 
under natural conditions of exposure. Thorax. 1983;38:829–833. doi: 10.1136/thx.38.11.829.  
Shahab L., West R., McNeill A. A randomized, controlled trial of adding expired carbon monoxide feedback to 
brief stop smoking advice: Evaluation of cognitive and behavioral effects. Health Psychol. 2011;30:49–57. doi: 
10.1037/a0021821. 
8. APPENDICES 
N/A