The overarching goal of this study is to test the impact of a multilevel precision
treatment intervention aiming to address gaps in clinician and patient uptake of tobacco
treatment and overall treatment effectiveness. This study builds on evidence that (1)
genetic and metabolic factors may inform precision tobacco treatment and (2) increasingly
high demand for precision treatment, in particular, may signal its potential to activate
behavior change. The multilevel precision treatment intervention to be
tested--PrecisionTx-- provides the opportunity to present personalized risk, benefit, and
treatment recommendation to increase clinician ordering, patient uptake, and overall
effectiveness of tobacco treatment. This study aims to understand the relative benefit of
precision treatment over usual care and associated mechanistic and implementation
outcomes. Therefore, the investigators propose a 2-arm cluster randomized controlled
trial of 50 clinicians and 800 screen-eligible patients (~16 per clinician) from diverse
primary care settings. Clinicians and patients will be randomized with 1:1 allocation to
usual care (UC) vs. precision treatment (PT) to evaluate the effect of precision
treatment on smoking cessation success. In Aim 1, the investigators will test the effect
of PT on clinician prescribing (or patient receipt of medication when prescription is not
needed) and patient use of medication for smoking cessation. The investigators
hypothesize that patient receipt of tobacco treatment medication for smoking cessation at
6 months post-intervention will be higher in PT vs UC. The investigators also hypothesize
that patient use of cessation medication at 6 months post-intervention will be higher in
PT vs. UC. In Aim 2, the investigators will test the effect of PT on patient smoking
abstinence. The investigators hypothesize that patient bioverified smoking abstinence at
6 months will be higher in PT vs. UC. In Aim 3, the investigators will examine mechanisms
of behavior change and implementation outcomes. The investigators will evaluate putative
mechanisms for PT (e.g., outcome expectancy and withdrawal suppression). The
investigators will conduct assessments at baseline, intervention, and 1-month, 3-month,
6-month, and 12-month post-intervention follow-ups.
Primary outcomes include patient receipt of tobacco treatment, patient use of tobacco
treatment, and patient smoking abstinence. Secondary outcomes include patient receipt of
recommended medication, patient medication adherence, and additional patient smoking
cessation outcomes. Mechanistic outcomes include clinician level (perceived benefit,
outcome expectancy), clinician-patient interaction (self-efficacy), patient-level
(perceived risk, outcome expectancy, withdrawal suppression, adverse events).
Implementation outcomes will be evaluated based on the RE-AIM framework. The study is an
innovative paradigm shift from a traditional treatment model to precision treatment that
includes both metabolic and genetic markers to motivate and guide tobacco treatment for
both clinicians and patients, integrated within primary care.
Smoking is a leading cause of premature death, causing more than half of all cancer
deaths. However, tobacco treatment is often not provided and is not highly effective in
primary care. New evidence suggests that a precision treatment approach to motivate and
guide treatment based on personal genetic and metabolic markers could improve treatment
uptake and quit success. This study will test the impact of a multilevel precision
treatment intervention on improving tobacco treatment and health outcomes in primary
care.