The investigators will conduct a pilot randomized controlled trial of an avatar-delivered
computerized intervention for tobacco cessation and CHW support to collect data on the
feasibility of recruitment, intervention engagement and completion, and short-term
smoking cessation outcomes. Individuals will be assessed at baseline, one month, three
months, and six months. The investigators will conduct follow-up interviews with a subset
of pilot participants to collect qualitative data on intervention acceptability. Based on
the information collected in these efforts, the investigators will make iterative
improvements to the existing intervention, aligned with user-experience design
procedures.
Participants (N=30) will be recruited through referrals from resident clinicians as well
as flyers in the clinic space. Flyers will describe the study and contain a study phone
number to call. Information may also be distributed by study staff during
non-study-related health and wellness activities conducted at the site. At initial
contact, a study staff member will discuss the study purpose and determine eligibility.
If eligible, the staff member will proceed to discuss requirements, review risks and
benefits, and obtain informed consent from interested participants.
Consent process: After confirming eligibility with screening questions, potential
participants will complete the consent process and sign the consent form at the beginning
of the first in-person visit.
Randomization: Following consent, participants will be randomized to the intervention
group or a control group. The control group will not receive any intervention during the
first 6 months of the study, but at the end of 6 months will receive the full computer
intervention and abbreviated CHW support to ensure access to treatment for all
participants.
Baseline Assessment: This will occur on the same day as the in-person portion of the
consent process. Initial evaluation will comprise a number of questionnaires/assessments,
including demographics, a clinical history, a tobacco use history, and a number of
tobacco-related measures. Assessments will be self-administered via tablet computer.
Intervention:
Computer-Delivered Intervention (CDI) Session 1: Following the baseline assessment,
participants will receive computer-delivered counseling via a study-provided iPad
delivered in a private room. The CDI consists of 1) a menu-driven, web-based intervention
that is delivered by a virtual counselor. The intervention takes 20 minutes to complete.
At the conclusion of session 1, the participant will be offered nicotine patches provided
by the study (1 month supply, remainder given at follow-up visits). The initial dosing of
the nicotine patches will be determined based on cigarettes consumed per day (>10: 21mg
patch, 5-10: 14mg patch, <5: 7mg patch). If there is any question regarding eligibility
or appropriate dosing, the CHW will consult with a study physician. With the CHW, the
participant will learn correct application, and will monitor the participants nicotine
replacement therapy (NRT) experience in discussion with the CHW.
Computer-Delivered Intervention (CDI) Session 2: Session 2, delivered approximately one
week later, focuses on the cycle of addiction and use of pharmacotherapy (e.g., NRT,
bupropion, varenicline). This intervention also takes about 20 minutes to complete. At
the conclusion of session 2, the participant will be offered nicotine gum or lozenges
provided by the study (1 month supply, remainder given at follow-up visits). This session
also includes an in-session experience of using NRT gum or lozenge, with CHW guidance to
ensure correct use.
Community Health Workers (CHWs): A CHW will meet with each participant for both Sessions
1 and 2 and will do the following: 1) Teach appropriate NRT use technique as above, 2)
Follow up with patients remotely via phone or video conference whenever possible, up to
twice weekly for 12 weeks (4 weeks for control group receiving delayed intervention), to
discuss barriers/facilitators to maintenance of NRT use and tobacco cessation; 3) Review
a video and decision-making guide for lung cancer screening and provide linkage to lung
cancer screening if the participant is eligible and interested, including linkage to
insurance enrollment assistance, if needed; 4) For individuals requiring follow up for
positive findings on lung CT, work with participants to navigate the process; 5) Link
interested participants to the QuitLine; 6) At the end of the study, link to medical
providers for additional tobacco cessation therapy if participant interested (e.g.,
varenicline, bupropion).
Linkage to Lung Cancer Screening: Participants eligible for and interested in CT lung
cancer screening (age ≥50, ≥20 pack year smoking history) will be referred to the
participant's primary care physician (PCP) or existing specialist for further discussion
and ordering. The CTs are optional and will not be provided as part of the research
study. The CHW will assist with linking patients without a PCP or existing specialist
with resources to establish care. For participants who choose to proceed with screening,
the investigators will request the results of the CT scan to track completion and general
result category (Normal/Normal with Minor Findings/Abnormal Needing Short-Term
Follow-Up/Abnormal Needing Immediate Follow-Up).
