Personalized Tobacco Treatment in Primary Care (MOTIVATE)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Smoking; Smoking Cessation; Physician's Role
• Intervention / Treatment: Behavioral: Usual Care; Behavioral: Precision Treatment

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.

• Study Type: Interventional
• Enrollment (Estimated): 850
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Li-Shiun Chen, ScD, MD, MPH; Phone Number: 314-362-3932; Email: li-shiun@wustl.edu
• Study Contact Backup: Name: Alex Ramsey, PhD; Phone Number: 314-362-5370; Email: aramsey@wustl.edu

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University School of Medicine
      • Contact: Li-Shiun Chen, ScD, MD, MPH; Phone Number: 314-362-3932; Email: li-shiun@wustl.edu
      • Contact: Alex Ramsey, PhD; Phone Number: 314-362-5370; Email: aramsey@wustl.edu
      • Principal Investigator: Li-Shiun Chen, ScD, MD, MPH
      • Principal Investigator: Alex Ramsey, PhD
      • Sub-Investigator: Laura Bierut, MD
      • Sub-Investigator: Esther Lu, PhD
      • Sub-Investigator: Robert Schnoll, PhD
      • Sub-Investigator: Timothy Baker, PhD
      • Sub-Investigator: Hilary Tindle, MD
      • Sub-Investigator: Rachel Tyndale, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual Care; 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; Usual care will be informed by practice guidelines (standard of care, brief advice, and guideline awareness).
Experimental: PrecisionTx; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived benefits (Clinician)	Clinicians' perceived importance and benefits of patients receiving smoking cessation medications will be assessed using a modified version of the Beliefs and Attitudes About Bupropion Scale.	Exit interview [after last patient is enrolled per clinician at the time of the last intervention (approximately 3 years)]
Outcome expectancies (Clinician)	Clinicians' outcome expectancies regarding tobacco treatment will be assessed using a modified version of the Stanford Expectation of Treatment Scale.	Exit interview [after last patient is enrolled per clinician at the time of the last intervention (approximately 3 years)]
Self-efficacy regarding patient-clinician interaction (Clinician)	Clinicians' perceived self-efficacy regarding patient-clinician communication will be assessed using a modified version of the Communication Perceived Self-Efficacy Scale.	Exit interview [after last patient is enrolled per clinician at the time of the last intervention (approximately 3 years)]
Self-efficacy regarding patient-clinician interaction (Patient)	Patients' perceived self-efficacy regarding patient-clinician communication will be assessed using a modified version of the Communication Perceived Self-Efficacy Scale.	From intervention through 12 months post-intervention
Perceived risk (Patient)	Patients' perceived smoking-related disease risks will be assessed using a modified version of the Perceived Susceptibility and Severity Scale.	From baseline through 12 months post-intervention
Outcome expectancies (Patient)	Patients' outcome expectancies regarding tobacco treatment will be assessed using a modified version of the Stanford Expectation of Treatment Scale.	From baseline through 12 months post-intervention
Withdrawal	Withdrawal severity is assessed by Wisconsin Smoking Withdrawal Scale (WSWS).	From baseline through 12 months post-intervention
Side Effects	All reported side effects will be summarized and presented for the study. In addition, the investigators will further identify a pre-specified set of key side effects as being related to drug agonist effects (e.g., nausea, vomiting, racing heart, headache, and sleep disturbance). These will be analyzed as the rate of occurrence during the period of cessation medication use, if applicable.	From baseline through 12 months post-intervention

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Li-Shiun Chen, ScD, MD, MPH, Washington University School of Medicine

Publications and helpful links

Helpful Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2023
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): September 30, 2028

Study Registration Dates

• First Submitted: April 21, 2023
• First Submitted That Met QC Criteria: May 4, 2023
• First Posted (Actual): May 6, 2023

Study Record Updates

• Last Update Posted (Actual): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 11, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: genetics; tobacco treatment; primary care physicians
• Other Study ID Numbers: 202205090; 1R01DA056050 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The University will share anonymized human genomic data and relevant associated data from approximately 800 research participants by depositing these data in a NIH-designated data repository or other repositories that meet the appropriate data security measures, confidentiality, privacy, and data use measures. The genotype data will be made available 12 months after trial completion in a NIH-designated data repository after data cleaning and quality control completion, which we anticipate to be in year 5, without restrictions on publication or other dissemination. In addition, information necessary to interpret the submitted data will be included, such as study protocols, data instruments and survey tools.
• IPD Sharing Time Frame: 12 months after trial completion
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No