Personalized Tobacco Treatment in Primary Care (MOTIVATE)

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Multilevel Intervention to Personalize and Improve Tobacco Treatment in Primary Care (MOTIVATE)

Conditions
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Physician's Role, Smoking Cessation, Smoking

Intervention / Treatment
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* Behavioral: Precision Treatment
* Behavioral: Usual Care


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual Care<br>The arm will represent usual care in the primary care clinics. Physicians will receive a report designed to recommend guideline-based tobacco treatment. Patients will receive a report on guideline-based advice about smoking cessation and a brief discussion with a behavior interventionist. | Behavioral: Usual Care<br>* Usual care will be informed by practice guidelines (standard of care, brief advice, and guideline awareness).<br>|
| Experimental: PrecisionTx<br>Physicians will receive PrecisionTx, an intervention designed to recommend precision tobacco treatment. Patients will receive PrecisionTx, an intervention designed to recommend precision tobacco treatment, and a brief discussion with a behavior interventionist. | Behavioral: Precision Treatment<br>* Precision treatment will be informed by practice guidelines (standard of care, brief advice, and guideline awareness), plus patient-specific risk feedback and personalized tobacco treatment recommendations using patients' clinical, genetic, and biomarker information.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient receipt of tobacco treatment medication for smoking cessation | This will be quantified by the proportion of enrolled patients who receive cessation medication. | 6 months post-intervention | 
| Patient use of cessation medication | This will be quantified by the proportion of patients taking any cessation medication from time of enrollment through 6 months post-intervention. | 6 months post-intervention | 
| Patient smoking abstinence | This will be quantified by the proportion of smokers with bioverified point-prevalent abstinence at 6 months. | 6 months post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking quantity across multiple time points | The outcome measures smoking quantity (self-reported average cigarettes smoked per day for the past 30 days prior to the assessment) over these time points. | From intervention through 12 months post-intervention | 
| Quit attempts | This outcome measures the number of quit attempts in the past 30 days prior to the assessment over these time points. | 6 and 12 months post-intervention | 
| Patient receipt of recommended tobacco treatment | This will be quantified by the proportion of enrolled patients who received recommended cessation medication. | 6 months post-intervention | 
| Patient medication adherence | This will be quantified by the proportion of medication taken among medication prescribed. | 6 months post-intervention | 
| Patient smoking abstinence among treated | This will be quantified by the proportion of smokers with bioverified point-prevalence abstinence among those receiving cessation medication. | 6 months post-intervention | 
| Abstinence Outcomes Across Multiple Time Points | The outcome measures abstinence (self-reported no smoking (not even a puff of a cigarette) for at least 7 days prior to the assessment) over these time points. | From intervention through 12 months post-intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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genetics, primary care physicians, tobacco treatment