Development and Testing of a Smoking Cessation E-Visit for Implementation in Primary Care
Phase: NA
Conditions: Smoking
Sponsor: Medical University of South Carolina

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
NCT04316260 
 
Protocol Approval Date: 12/6/2018 
 
Development and Testing of a Smoking Cessation E-Visit for Implementation in Primary Care 
 

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PROTOCOL TITLE: Development and Testing of a Smoking Cessation E-Visit for Implementation 
in Primary Care 
 
PRINCIPAL INVESTIGATOR: Jennifer Dahne, Ph.D. 
 
 
 

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1.0 
Objectives / Specific Aims 
The goal of this work is to develop, refine, and pilot test a smoking cessation electronic visit (e-visit) for 
implementation in primary care/family medicine. We will conduct a pilot RCT (n=90, up to 118 assuming 
20% attrition) of the smoking cessation e-visit as compared to treatment as usual (TAU), delivered via 
primary care, with primary objective to provide effect size estimates for a larger RCT. Primary outcomes 
include: 1) evidence-based cessation treatment utilization as a function of treatment group and 2) 
cessation-related outcomes (quit attempt incidence, abstinence). We hypothesize that participants 
randomized to the e-visit condition as compared to those randomized to the TAU condition will have 
higher (numerically, if not statistically significant) rates of cessation treatment utilization (medications, 
counseling) and superior cessation-related outcomes.  
 
Secondary outcomes will focus on treatment feasibility specifically for the smoking cessation e-visit. 
Outcomes related to e-visit feasibility will be examined descriptively and include: 1) treatment 
acceptability (i.e., e-visit uptake and self-reported acceptability) and 2) self-reported treatment 
satisfaction.  
 
2.0 
Background 
Cigarette smoking is the leading cause of preventable death nationwide. In South Carolina, 20% of adults 
smoke, 30% of cancer deaths are caused by smoking, and 7,200 adults die annually from smoking. South 
Carolina smoking prevalence has plateaued in recent years, decreasing only 3% from 2011 to 2016. Key 
factors accounting for this are stagnant rates of quit attempts and low use of evidence-based treatment. 
Engaging smokers in cessation via healthcare resources they already utilize is promising for promoting 
cessation and decreasing statewide healthcare costs. At least 70% of smokers visit a primary care 
physician (PCP) annually1. Thus, primary care offers a powerful opportunity to identify many smokers 
and engage them in quitting. United States Public Health Services (USPHS) guidelines advise the 5As 
model (Ask, Advise, Assess, Assist, Arrange) for cessation treatment, but compliance with this model is 
modest, leaving many smokers untreated2. One recent study of smokers who visited a health professional 
within the last year (N=10,801) found that 5As compliance dropped precipitously across steps: Ask 
smoking status (88%), Advise quitting (66%), Assess motivation (43%), Assist with referrals (39%), and 
Arrange follow-up (6%)3. Typical obstacles at the provider level include lack of familiarity with 
guidelines, lack of confidence to counsel cessation, and inadequate knowledge or skills. It is clear that 
PCPs need more and better tools to treat smokers. These tools must be brief, easy to implement, and 
widely accessible to both patients and providers. Telehealth can fill this treatment gap by facilitating a 
systematic, protocolled, convenient approach to cessation in primary care.  
 
3.0 
Intervention to be studied  
We are currently in the process of developing an asynchronous smoking cessation e-visit with MUSC’s 
Epic development team. This e-visit is based on USPHS guidelines and serves to automate much of the 
5As process. Smokers are proactively invited via electronic message (e.g., via MyChart) to initiate an 
asynchronous smoking cessation e-visit. The e-visit is a questionnaire administered via MyChart. The 
initial asynchronous e-visit gathers information about smoking and quit histories, followed by questions 
to assess motivation to quit and an algorithm to determine the best smoking cessation medication to 
prescribe for each patient by assessing contraindications and preferences for FDA-approved first line 
cessation medications (i.e., nicotine replacement therapy, varenicline, bupropion). The e-visit will be sent 
to an attending physician (for the purposes of the present trial, Drs. Diaz and Player will be the attending 
physicians), who will review the recommendations, e-prescribe (when indicated) medication, make 
referrals to additional smoking cessation resources (e.g., state quitline), and schedule a follow-up e-visit. 
Varenicline, a class C medication, may be prescribed as a result of the e-visit. Because risks during 

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pregnancy related to Varenicline are unknown, women under the age of 55 who receive a 
recommendation for Varenicline as a result of the e-visit algorithm will subsequently be asked if they 
would be willing to complete a pregnancy test that will be mailed to them. Women under the age of 55 
who are respond “No” to this item will not be prescribed Varenicline. The follow-up e-visit will assess 
tobacco use, medication adherence, side effects, and determine if further cessation treatment is needed 
(e.g., an additional follow-up e-visit, referral to counseling). All patients will be scheduled for at least one 
follow-up e-visit within a month after the initial e-visit. E-visits will also include a SmartSet (i.e., a group 
of orders and other elements that are commonly used together to document a specific type of visit) to 
streamline provider documentation and treatment plans. E-visits typically delivered for clinical purposes 
via Epic at MUSC cost $25, but this cost will be waived for participants in this study.  
 
Participants enrolled in the present study who are randomized to the TAU condition will be provided 
information about the state quitline and about the importance of quitting smoking and it will be 
recommended that they contact their PCP to schedule a medical visit to discuss quitting smoking.  
 
4.0 
Study Endpoints (if applicable) 
Primary outcome variables include: 
• Evidence-based cessation treatment utilization will be assessed via participant self-report. At each 
follow-up assessment, participants in both groups will be queried for: 1) use of a smoking 
cessation medication since the last assessment, 2) how the medication was obtained (e.g., via the 
study or another outlet such as MUSC’s existing smoking cessation service), and 3) receipt of the 
5As from their PCP4. 
• Cessation-related outcomes will be assessed via participant self-report. Cigarette smoking, use of 
other tobacco products (e.g., e-cigarettes), and quit attempts/quit duration will be assessed at each 
follow-up using a timeline followback for the last 6-months at baseline and since prior follow-up 
for each subsequent assessment5,6.  
Secondary outcome variables include: 
• E-visit acceptability and feasibility will be assessed both by examining the percentage of patients 
who complete the initial and follow-up e-visits, and by participant self-report during follow-up 
assessments. Participants will respond to items assessing ease of use, satisfaction, and pros/cons of 
the e-visit. Analytics data (e.g., amount of time it takes to complete the e-visit, amount of time it 
takes the provider to review the e-visit) will also be collected as will data on provider fidelity to e-
visit recommendations (captured by reviewing within Epic whether the provider administered 
treatment consistent with e-visit recommendations). 
 
We will also assess: 
• Nicotine dependence will be assessed at baseline via the Fagerstrom Test of Nicotine 
Dependence7. 
• Motivation to quit and confidence in quitting will be assessed via participant self-report using a 
modified Contemplation Ladder8.  
 
• Participation in MUSC’s existing smoking cessation service will be assessed via participant self-
report. We assume participation in this service will be random across groups and is one 
component of standard smoking cessation treatment to which both groups have access.   
 
5.0 
Inclusion and Exclusion Criteria/ Study Population 
Participants will complete a REDCap survey to be screened for eligibility.  Inclusion criteria include: 1) 
current smoking, defined as smoking 5+ cigarettes/day, for 20+ days out of the last 30, for the last 6+ 
months, 2) age 18+, 3) enrolled in Epic’s MyChart program or willing to sign up for MyChart, 4) possess 

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a valid e-mail address that is checked daily to access follow-up assessments and MyChart messages, and 
5) English fluency. No exclusion criteria will be applied.   
 
6.0 
Number of Subjects 
We will recruit up to 118 subjects. 
 
7.0 
Setting 
Research will be conducted remotely via REDCap and MyChart. Participants will be recruited remotely 
and will be patients of MUSC’s Department of Family Medicine (DFM) or MUSC Health Primary Care.  
 
8.0 
Recruitment Methods 
Participants will be recruited in the following ways: 
1) Via MyChart: MUSC DFM and MUSC Health Primary Care patients who have previously been 
identified as smokers will be sent a secure message via MyChart inviting them to complete a 
preliminary eligibility screening. These patients will have either agreed to research contact 
within MyChart or their attending physician will have agreed to contact their patients who 
smoke cigarettes via MyChart. Within the message, potential participants will be invited to click 
a link to complete an eligibility screening via REDCap. 
2) In Clinic: Participants may be recruited in clinic either after being identified as a smoker by 
research personnel listed on this application. 
3) Via advertisements (e.g., flyers) and online postings  
 
Note, that while we include the options to recruit in clinic and via advertisements, these will be used as 
backup options should recruitment via MyChart be slow and/or result in an insufficient number of 
participants recruited.  
 
Recruitment of Minority Smokers 
Minority smokers will be included in this trial. All participants will be recruited from MUSC Department 
of Family Medicine practices, which primarily serve residents of Charleston County, South Carolina. 
United States Census data from 2015 (the most recent Census year available) reveal that the population 
within Charleston County is 68.2% White, 28.1% Black, 2.2% American Indian/Alaskan Native, Asian, 
or Pacific Islander, 1.5% reporting two or more races, and 5.0% are Hispanic or Latino. Compared to 
Charleston County demographics, members of racial and/or ethnic minority groups tend to be 
overrepresented among smokers treated via MUSC’s Department of Family Medicine clinics. Roughly 
half of smokers treated via these clinics are members of a racial or ethnic minority group. We will 
monitor closely our minority recruitment goals on an ongoing basis. If the recruitment of minorities is 
lower than expected (< 10% projected enrollment), efforts will be made to improve recruitment of 
minorities into the study through oversampling.  
 
9.0 Consent Process 
Signed informed consent will be obtained from study participants. The consent process will take place via 
one of the following modalities: 1) Remote electronic consent (e-consent) via REDCap facilitated with a 
discussion over the phone, 2) Remote consent via doxy.me facilitated with either a discussion over the 
phone or video connection via doxy.me, 3) Mailed (paper) consent facilitated with a discussion over the 
phone, or 4) in person consent (e.g., in clinic). Because study participants will be recruited remotely, we 
anticipate that all participants will be consented remotely, but also build in the option for in person 
consent. 
 

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All participants will be provided with a hard copy and/or an electronic copy of the consent form. 
Participants will be informed that participation in this research is strictly voluntary. Informed consent will 
include a detailed description of the purpose and the procedure of the study emphasizing our policy 
regarding privacy and confidentiality and an opportunity for the individual to ask any questions or voice 
concerns. Signatures on the consent form may be obtained with paper and pen OR electronically via 
REDCap/doxy.me. Participants who do not have access to the required technology to complete consent 
remotely via REDCap or doxy.me will be given the option to complete consent via mail facilitated with a 
discussion over the phone.  
 
10.0 Study Design / Methods 
 
A two-arm pilot RCT (N=90, up to 118 assuming 20% attrition) will test cessation treatment utilization 
and smoking cessation outcomes as a function of smoking cessation e-visit vs. TAU. Recruitment will 
primarily occur proactively and remotely via the EMR. We will conduct an automated EMR search via 
established procedures for all patients treated within MUSC DFM clinics during the past 12 months who: 
1) smoke, 2) are age 18+, and 3) have MyChart accounts. These patients will be sent an e-mail via 
MyChart from their family medicine physician (or from the research team if they have agreed to 
research contact via Epic) inviting them to participate in a research study for cigarette smokers. 
These messages will only be sent to patients of PCPs who have agreed to contact their patients for 
the purpose of this study. After sending these automated e-mail messages via MyChart, the study team 
may also call, e-mail, and/or text message potential participants to notify them that a message was sent to 
them via MyChart. Again, such contact will only be made to patients of PCPs who have agreed to contact 
their patients for the purpose of this study. If interested, participants will complete a screening online to 
determine study eligibility (see above for inclusion criteria). After completing determination of eligibility, 
if eligible and interested in participating in the study, participants will be scheduled for a time to complete 
informed consent (see 9.0 Consent Process). After consent is obtained, participants will be randomized 
2:1 to receive either the smoking cessation e-visit or TAU. If randomized to the e-visit condition, 
participants will be sent a link to initiate the e-visit. All e-visit medication recommendations will be 
reviewed by Drs. Diaz/Player and e-prescribed to the participant’s pharmacy of choice. Note that only 
FDA approved cessation medications will be recommended, which include nicotine replacement therapy 
(patch, gum, lozenge), varenicline, or bupropion. Medications will only be recommended if a participant 
does not have a contraindication for that medication. Women who indicate during the e-visit that they are 
currently pregnant or are planning to become pregnant within the next 6 months will not receive a 
medication recommendation/prescription as a result of the e-visit. These women will receive a counseling 
referral. Any woman under the age of 55 who receives a varenicline recommendation as a result of the e-
visit will subsequently be asked within the e-visit if she is willing to complete a pregnancy test that will 
be mailed to her at no cost to verify that she is not pregnant prior to taking varenicline. Women under the 
age of 55 who respond “Yes” to this item will be mailed a pregnancy test by study staff and will be 
required to verify (with signature) that they completed the test and are not pregnant via REDCap. Women 
under the age of 55 who respond “No” to this item will not receive a varenicline prescription as a result of 
the e-visit. These women instead will either receive a recommendation for NRT, bupropion and/or 
counseling based on other contraindications and medication preferences indicated throughout the e-visit. 
Participants will be scheduled for a follow-up e-visit one month following their initial e-visits. If 
randomized to the TAU condition, participants will be provided information on quitting smoking, 
including information about the state quitline, and will be provided a recommendation to contact their 
PCP to schedule a medical visit to discuss quitting smoking.  
 
All participants will subsequently be text messaged and/or emailed a REDCap link, accessible via 
smartphone, tablet, or computer to complete study assessments. These assessments will occur at baseline 

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(following consent), 1-month following study enrollment, and 3-months following study enrollment. 
Assessments are estimated at 20 minutes each and will be administered remotely via REDCap through our 
established procedures. Participants will be compensated $20 in electronic gift codes (e.g., Amazon) for 
completion of each and will receive a $20 bonus if all 3 assessments are completed. E-visit acceptability 
and feasibility will be assessed both by examining the percentage of patients who complete the initial and 
follow-up e-visits, and by participant self-report during follow-up assessments. Participants will respond 
to items assessing ease of use, satisfaction, and pros/cons of the e-visit. Analytics data (e.g., amount of 
time it takes to complete the e-visit, amount of time it takes the provider to review the e-visit) will also be 
collected as will data on provider fidelity to e-visit recommendations (captured by reviewing within Epic 
whether the provider administered treatment consistent with e-visit recommendations). Cigarette smoking, 
use of other tobacco products (e.g., e-cigarettes), and quit attempts/quit duration will be assessed at each 
follow-up using a timeline followback for the last 6-months at baseline and since prior follow-up for each 
subsequent assessment5,6. Nicotine dependence will be assessed at baseline via the Fagerstrom Test of 
Nicotine Dependence7. Participants will report motivation to quit and confidence in quitting using a 
modified Contemplation Ladder8. Treatment utilization will be assessed via participant self-report. At 
each follow-up assessment, participants in both groups will be queried for: 1) use of a smoking cessation 
medication since the last assessment, 2) how the medication was obtained (e.g., via the study or another 
outlet such as MUSC’s existing smoking cessation service), and 3) receipt of the 5As from their PCP4.  
 
11.0 Data Analysis and Data Management  
 
Data Analysis 
 
As this is a pilot trial, our primary goal is to estimate an intervention effect size and out secondary goal is 
to examine the feasibility/acceptability of the e-visit. Precise parameter estimation can be achieved with 
25-30 participants per group9. To estimate an effect size for the smoking cessation e-visit intervention, we 
will randomize participants 2:1 (active:control), with 60 participants in the active condition and 30 in the 
control condition. Primary smoking-related outcomes for this trial include cessation treatment utilization 
(e.g., medication) and quit attempts. Assuming a cessation treatment utilization rate of 48% in the active 
condition and 11% in the control condition, with 2:1 randomization we will have 95% power to detect an 
effect. For quit attempts, assuming a quit attempt rate of 24% in the e-visit condition and 6% in the TAU 
condition, we will have 56% power to detect an effect. Our intent here is not a fully powered trial for 
cessation, but is rather to collect preliminary data to inform future trials.   
 
Data analysis for the primary objective will focus on descriptive analysis of primary smoking-related 
outcomes. Descriptive statistics (e.g., frequencies, percentages) will be calculated for the primary 
smoking-related outcomes (treatment utilization, quit attempts). Because rates of these primary outcomes 
are expected to be low in control group, we will utilize Fisher’s exact tests to compare rates between the 
e-visit and TAU groups. Secondary exploratory analyses for this primary objective will examine changes 
in these outcomes over time by treatment condition. We will utilize Generalized Estimating Equations 
(GEEs) with log link functions, which will allow us to account for correlated repeated measures within 
study participants. Planned covariates include sex and the main effect of time.   
 
Data analysis for the secondary objective to examine treatment feasibility specifically for the smoking 
cessation e-visit will focus on descriptive analysis of: 1) % of those initiate the baseline e-visit who 
complete it, 2) % of those who complete the baseline e-visit who subsequently complete the follow-up e-
visit, 3) average time to complete the e-visit (for patients), 4) average time to review the e-visit (for 
providers), 5) provider fidelity to e-visit recommendations, and 6) participant self-report of e-visit ease of 
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completing the e-visit. The e-visit will be considered feasible and acceptable if: 1) >90% of those who 
initiate the baseline e-visit complete it, 2) >75% of those who complete the baseline e-visit complete the 
follow-up e-visit, 3) providers are faithful to e-visit recommendations >80% of the time, and 4) self-report 
data indicate participant benefits and ease of use (average score for each > 4 on 5-point scale).  
 
Data Management 
 
Regarding questionnaire data, data will be obtained for research purposes only. All data will be collected, 
stored, and managed via REDCap, which is a secure, web-based application designed exclusively to support 
data capture for research studies. REDCap provides secure, web-based flexible applications, including real 
time validation rules with automated data type and range checks at the time of entry. The underlying 
database is hosted in a secure data center at MUSC, a secure environment for data systems and servers on 
campus, and includes redundancy, failover capability, backups and extensive security checks. The system 
has several layers of protection including user/group account management, "Data Access Groups" which 
allow data to be entered by multiple groups in one database with segmented user rights for entered data, 
audit trails for all changes, queries and reports, and Secure Sockets Layer (SSL) encryption. Name and 
relevant contact information will be obtained to provide compensation and every effort will be made to 
maintain subject confidentiality, in accordance with HIPAA. All data will be identified only by code 
numbers (participant IDs). Participant IDs will be linked to participants’ names in a password-protected file 
that is accessible only to the PI and trained research staff.  
 
12.0 Provisions to Monitor the Data to Ensure the Safety of Subjects (if applicable) 
 
This section is based on the recommendations in NIDA’s “Guidelines for developing a Data and Safety 
Monitoring Plan” as well as NCI’s “Essential Elements of a Data and Safety Monitoring Plan for Clinical 
Trials Funded by the National Cancer Institute.”  
 
Summary of the Protocol 
We will develop and iteratively test a comprehensive smoking cessation e-visit for delivery to smokers 
treated via primary care. Through an established partnership with MUSC Epic developers, we will develop 
the smoking cessation e-visit consistent with USPHS best practice guidelines for smoking cessation 
treatment via primary care. We will then complete a randomized pilot trial of 1) smoking cessation e-visit 
vs. 2) TAU.  
 
Trial Management 
The study will be managed from the Addiction Sciences Division within the Department of Psychiatry and 
Behavioral Sciences at the Medical University of South Carolina (MUSC). Recruitment, data collection, 
data management, and treatment provision will be coordinated and centrally managed at our research lab at 
MUSC and will be implemented within local Family Medicine/Primary Care clinics that are part of MUSC’s 
Department of Family Medicine.  
 
Data Management and Analysis 
Participants will enter data in REDCap, a secure, web-based application designed exclusively to support 
data capture for research studies. REDCap provides: 1) an intuitive interface for data entry (with data 
validation); 2) audit trails for tracking data manipulation and export procedures; 3) automated export 
procedures for seamless data downloads to common statistical packages (SPSS, SAS, Stata, R); 4) 
procedures for importing data from external sources; and 5) advanced features, such as branching logic and 
calculated fields. These procedures are effective in minimizing data entry errors (e.g., missing or errant 
data). The data analysis plan is outlined above. 

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Quality Assurance 
Accuracy and completeness of the data collected will be ensured by weekly review. The REDCap system 
does not accept outliers, illogical response patterns, etc. The PI and research assistants will have weekly 
meetings to discuss any qualitative comments received during data collection and any problems in data 
collection. The PI will examine the database for potential irregularities monthly. Initial data analyses will 
examine distributions of variable scores and comparability of baseline characteristics across conditions in 
case analyses need to be adjusted for these. Confidentiality procedures are outlined above.  
 
Regulatory Issues 
All serious AEs will be reported to the MUSC Committee on Human Research within 48 hrs. Follow-up of 
all unexpected and serious AEs will also be reported. All AEs will be reviewed weekly by the PI and yearly 
by the IRB. Any significant actions taken by the local IRB, and protocol changes will be relayed to the 
funding agency. We estimate the significant AE rate to be 5% or less. Potential conflicts of interest (COI) 
will be reported using the SRNT rules for disclosure as well as the rules of MUSC’s COI committee. 
 
Trial Safety 
The potential risks and benefits and methods to minimize these risks are outlined in the “Risks to Subjects” 
section. AEs will be tracked and rated as mild, moderate or severe and as related to medication by the 
participant. We will determine if any AEs result in dropouts, or are serious according to FDA guidelines. 
The PI (Dr. Dahne) will serve as the Program Manager for AEs. All unexpected AEs will be monitored 
while they are active to determine if treatment is needed. Risk profiles for smoking cessation medications 
that may be prescribed as an outcome of the e-visit are minimal, with the most common side effects being 
nausea, headache, and dry mouth. All patients will be active patients in MUSC Family Medicine/Primary 
Care. As such, we expect AEs will be rare. Nonetheless, they will be coded on a weekly basis using the 
FDA’s COSTART rules12 and entered into a database. For each weekly study meeting, the research 
assistant(s) will prepare a summary of all AEs, including their severity, whether they caused a dropout, 
required treatment and presumed relation to drug intake. The PI will review this at the weekly study meeting 
(or before if more urgent). Drs. Diaz and Player, board-certified Family Medicine physicians, will be 
available for on-site medical supervision for any issues that cannot be resolved by Dr. Dahne.  
 
Study procedures will follow as much as possible the FDA’s Good Clinical Practice Guidelines and our 
research team has found Spilker’s comprehensive text on conducting clinical trials to be useful13. The 
research assistants will be instructed not to reveal whether a person is a participant in the study and will 
report to the PI any outside requests for information about a participant or any breaches in confidentiality. 
All requests by participant’s physicians and other medical providers will be referred directly to the PI.  
 
Data and Safety Monitoring Plan Administration 
The PI will be responsible for monitoring the trial. The PI will examine monthly the outcomes database for 
missing data, unexpected distributions or responses, and outliers. The PI will check weekly the AE database 
prepared by the research assistant(s) immediately prior to the lab meeting a) to see if any particular 
COSTART categories are being endorsed more frequently than normal and b) to determine if any side-
effect symptom checklist scores are higher than expected. A DSM report will be filed with the IRB and 
funding agency on a yearly basis, unless greater than expected problems occur. The report will include 
participant characteristics, retention and disposition of study participants, quality assurance issues and 
reports of AEs, significant/unexpected AEs and serious AEs. We will report efficacy at the end of the trial. 
 
13.0 Risks to Subjects 
 

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This is considered a minimal risk study. Minimal risk means the probability and magnitude of harm or 
discomfort anticipated in the research are not greater in and of themselves other than those ordinarily 
encountered in daily life or during performance of routine physical or psychological examinations or tests. 
The potential risks in this study include those related to: a) smoking cessation medications, b) 
confidentiality, and c) frustration.  
 
a) Smoking cessation medications: Participants in both treatment arms may receive a prescription for 
an FDA-approved smoking cessation medication. Participants in the e-visit condition may receive a 
prescription as an outcome of the e-visit and participants in the TAU condition may receive a 
prescription if they contact their PCP to discuss quitting smoking. These medications include: nicotine 
replacement therapy (NRT), varenicline, and/or bupropion. Participants will be educated about their 
smoking cessation medication as part of the e-visit or during their normally scheduled medical 
appointment if randomized to the TAU condition. Pregnancy or intention to become pregnant will be 
assessed during the e-visit. Medication will only be prescribed if a participant does not have 
contraindications for that medication. Participants will be provided with our study phone number and 
instructed to call our study personnel should they experience AEs or if they have questions/concerns 
about medication use. Given the relatively benign risk profiles of these medications, we expect AEs, 
which will be assessed across follow-up timepoints via REDCap, to be rare and mild. Participants will 
be encouraged to contact Dr. Dahne as soon as possible for serious AEs and for those conditions that 
labeling suggests seeing a provider. We will withdraw participants who have a serious AE. For other 
AEs, if the participant wishes it, the participant will be withdrawn from the study. 
 
b) Confidentiality: Participants will be made aware of limits to confidentiality at the beginning of 
screening and when reviewing study procedures/during informed consent which include report of 
suicidal or homicidal intent or report of abuse or neglect. If the participant reports suicidal or homicidal 
intent or abuse/neglect, Dr. Dahne will take appropriate action as outlined by the MUSC IRB, NIH, and 
the State of South Carolina, which may include contacting the authorities and/or pursuing involuntary 
commitment at a mental health facility. If participants present no imminent danger but also need more 
extensive treatment of mental health concerns, they will be given appropriate referrals and instructed to 
contact their physician.  
 
c) Frustration: Participants may become frustrated while completing study assessments. Participants 
will be informed that they may refuse to answer any question(s) that they do not wish to answer and 
that they may discontinue study participation at any time. 
 
Since patients will all currently be receiving medical care at MUSC, there are no additional risks associated 
with participation in this study. 
 
Adequacy of Protection Against Risks 
 
Recruitment and Informed Consent 
Study participants will be recruited from local MUSC Family Medicine/Primary Care clinics. Smoking 
status is assessed for every patient, consistent with MUSC’s best practice guidelines. Patients identified as 
smokers via the EMR will be sent a message inviting them to participate in a research study. Interested 
patients will complete determination of eligibility via MUSC’s REDCap system, a secure, HIPAA-
compliant data management system. All participants will review consent documents (i.e., statements of 
research) and will be invited to contact the study team by phone or e-mail to answer questions about the 
trial. Consent will be implied by continuing with the study screener. Participants will be given the 
opportunity to ask questions about their participation throughout the course of the study. A copy of the 
informed consent will be kept centrally at our study office within locked filing cabinets, and a copy will be 

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given to each study participant as well. Participants will be given a study phone number and e-mail address 
to contact for questions. 
 
Protections Against Risk 
All screening information will be kept in a password protected REDCap database. Only key study personnel 
will have access to the database. If an individual is not eligible to participate, his/her screener will include 
his/her first name and last initial and the reason for disqualification. Eligible participants’ full name, 
telephone number and e-mail address will be recorded in the database. This is the only place where 
participants’ names and subject identification numbers appear together. Eligible participants will be 
assigned a subject number, will complete informed consent, will be randomized, will complete baseline 
assessments, and subsequently will receive their randomized intervention. 
 
Upon completing eligibility screening, if study eligible, individuals will be provided with an overview of 
the study, asked to review study procedures via a consent form, and asked to provide signed consent (. 
Participants will be informed of limitations of confidentiality (i.e., abuse or neglect, intention to harm self 
or someone else) both verbally and/or in writing during the informed consent process. The consent form 
will include the participant’s name, but not his/her subject number. Consent forms will be provided in 
English. As utilization of the smoking cessation e-visit requires that participants are able to read, 
participants unable to read the consent form on their own will not be included. 
 
Regarding questionnaire data, data will be obtained for research purposes only. All data will be collected, 
stored, and managed via REDCap, which is a secure, web-based application designed exclusively to support 
data capture for research studies. REDCap provides secure, web-based flexible applications, including real 
time validation rules with automated data type and range checks at the time of entry. The underlying 
database is hosted in a secure data center at MUSC, a secure environment for data systems and servers on 
campus, and includes redundancy, failover capability, backups and extensive security checks. The system 
has several layers of protection including user/group account management, "Data Access Groups" which 
allow data to be entered by multiple groups in one database with segmented user rights for entered data, 
audit trails for all changes, queries and reports, and Secure Sockets Layer (SSL) encryption. Name and 
relevant contact information will be obtained to provide compensation and every effort will be made to 
maintain subject confidentiality, in accordance with HIPAA. All data will be identified only by code 
numbers (participant IDs). Participant IDs will be linked to participants’ names in a password-protected file 
that is accessible only to the PI and trained research staff.  
 
Protection against risks associated with smoking cessation medications include a Data and Safety 
Monitoring Plan that includes monitoring of AEs. FDA contraindications for each smoking cessation 
medication will be factored into the smoking cessation e-visit. Through informational material provided via 
the e-visit and with standard medication packaging, participants will be educated about potential AEs and 
nicotine intoxication symptoms (for NRT medications). We anticipate very few AEs. AE’s will be discussed 
with Drs. Diaz and/or Player.  
 
14.0 Potential Benefits to Subjects or Others 
 
All smokers in this trial will receive at minimum standard smoking cessation care via Family 
Medicine/Primary Care and evidence-based educational information about quitting smoking. We will not 
augment standard smoking cessation care as provided by Family Medicine/Primary Care. The majority of 
participants will also receive an invitation to complete a smoking cessation e-visit. The major benefit to 
society will be whether this smoking cessation e-visit will improve cessation outcomes relative to TAU. 
Potential issues of medication risks, confidentiality, and frustration are a high priority and will be closely 

Version 3; Version Date 11/27/2018 
 
Page 11 of 12 
 
monitored throughout the study. Consequently, the risk to benefit ratio in the proposed study appears to be 
acceptable. 
 
 
15.0 Sharing of Results with Subjects 
 
Study enrollment and study outcomes will not be shared with medical staff, including the participant’s 
physician. 
 
 
 

Versi o n 3 ; Versi o n D ate 1 1/ 2 7/ 2 0 1 8 
 
Pa ge 1 2 of 1 2  
 
R E F E R E N C E S  
 
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