Clinical trial NCT05846841: Personalized Tobacco Treatment in Primary Care (MOTIVATE)
Official title: A Multilevel Intervention to Personalize and Improve Tobacco Treatment in Primary Care (MOTIVATE)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Physician's Role
Smoking Cessation
Smoking
Keywords: genetics
primary care physicians
tobacco treatment
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: National Cancer Institute (NCI)
First posted: 2023-05-06
Enrollment: 850
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Clinicians will be randomized on a 1:1 basis to usual care or precision treatment. Patients will be assigned to the same arm as their clinician.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study examines the application of precision treatment intervention for smoking cessation from both the clinician perspective and patient perspective, and compares it to usual care on tobacco treatment in the primary care setting. The precision treatment intervention includes personalized tobacco treatment recommendations using the patient's clinical, genetic, and biomarker information. This approach may increase effectiveness and adherence for the patient, and increase the clinician's likelihood of prescribing.

Detailed description: 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.

Eligibility criteria: Eligibility Criteria for Primary Care Clinicians

* Clinician from participating clinic
* At least 18 years of age
* Can speak and understand English

Eligibility Criteria for Primary Care Patients

Inclusion:

* Patient at participating clinic
* Age 18 years or older, inclusive
* Current smoking (cigarettes per day \>=5)
* Can speak and understand English
* Willing to consider medication to help reduce craving or smoking such as nicotine patch, lozenge, or varenicline

Exclusion:

* Active use of smoking cessation medication (within the past 30 days)
* Receipt of smoking cessation medication or prescription for smoking cessation medication (within the past 30 days)
* Having a contraindication for cNRT or varenicline (allergic reactions, current cardiac problems, pregnancy)

Primary outcomes:
measure: Patient receipt of tobacco treatment medication for smoking cessation
timeFrame: 6 months post-intervention
measure: Patient use of cessation medication
timeFrame: 6 months post-intervention
measure: Patient smoking abstinence
timeFrame: 6 months post-intervention
Secondary outcomes:
measure: Patient receipt of recommended tobacco treatment
timeFrame: 6 months post-intervention
measure: Patient medication adherence
timeFrame: 6 months post-intervention
measure: Patient smoking abstinence among treated
timeFrame: 6 months post-intervention
measure: Abstinence Outcomes Across Multiple Time Points
timeFrame: From intervention through 12 months post-intervention
measure: Smoking quantity across multiple time points
timeFrame: From intervention through 12 months post-intervention
measure: Quit attempts
timeFrame: 6 and 12 months post-intervention
Other outcomes:
measure: Perceived benefits (Clinician)
timeFrame: Exit interview [after last patient is enrolled per clinician at the time of the last intervention (approximately 3 years)]
measure: Outcome expectancies (Clinician)
timeFrame: Exit interview [after last patient is enrolled per clinician at the time of the last intervention (approximately 3 years)]
measure: Self-efficacy regarding patient-clinician interaction (Clinician)
timeFrame: Exit interview [after last patient is enrolled per clinician at the time of the last intervention (approximately 3 years)]
measure: Self-efficacy regarding patient-clinician interaction (Patient)
timeFrame: From intervention through 12 months post-intervention
measure: Perceived risk (Patient)
timeFrame: From baseline through 12 months post-intervention
measure: Outcome expectancies (Patient)
timeFrame: From baseline through 12 months post-intervention
measure: Withdrawal
timeFrame: From baseline through 12 months post-intervention
measure: Side Effects
timeFrame: From baseline through 12 months post-intervention
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Li-Shiun Chen, ScD, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: