Personalized Tobacco Treatment in Primary Care
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 and patient use of medication for smoking cessation. The investigators hypothesize that clinician prescribing, as measured by the proportion of patients who receive a prescription for tobacco treatment, and patient medication use 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, perceived risk/ benefit, and withdrawal suppression). The investigators will also evaluate implementation outcomes (e.g., reach, adoption, acceptance, and costs) associated with the intervention. 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 clinician prescribing of any cessation medication, patient use of cessation medication, and patient smoking abstinence. Secondary outcomes include clinician prescribing 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 Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- Patient receipt of prescription for tobacco treatment medication for smoking cessation [6 months post-intervention]
This will be quantified by the proportion of enrolled patients who receive a clinician prescription for cessation medication.
- Patient use of cessation medication [6 months post-intervention]
This will be quantified by the proportion of patients taking any cessation medication from time of enrollment through 6 months post-intervention.
- Patient smoking abstinence [6 months post-intervention]
This will be quantified by the proportion of smokers with bioverified point-prevalent abstinence at 6 months.
Secondary Outcome Measures
- Patient receipt of prescription for recommended tobacco treatment [6 months post-intervention]
This will be quantified by the proportion of enrolled patients who received a prescription for recommended cessation medication.
- Patient medication adherence [6 months post-intervention]
This will be quantified by the proportion of medication taken among medication prescribed.
- Patient smoking abstinence among treated [6 months post-intervention]
This will be quantified by the proportion of smokers with bioverified point-prevalence abstinence among those receiving cessation medication.
- Abstinence Outcomes Across Multiple Time Points [From intervention through 12 months post-intervention]
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.
- Smoking quantity across multiple time points [From intervention through 12 months post-intervention]
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.
- Quit attempts [6 and 12 months post-intervention]
This outcome measures the number of quit attempts in the past 30 days prior to the assessment over these time points.
Other Outcome Measures
- Perceived benefits (Clinician) [Exit interview [after last patient is enrolled per clinician at the time of the last intervention (approximately 3 years)]]
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.
- Outcome expectancies (Clinician) [Exit interview [after last patient is enrolled per clinician at the time of the last intervention (approximately 3 years)]]
Clinicians' outcome expectancies regarding tobacco treatment will be assessed using a modified version of the Stanford Expectation of Treatment Scale.
- Self-efficacy regarding patient-clinician interaction (Clinician) [Exit interview [after last patient is enrolled per clinician at the time of the last intervention (approximately 3 years)]]
Clinicians' perceived self-efficacy regarding patient-clinician communication will be assessed using a modified version of the Communication Perceived Self-Efficacy Scale.
- Self-efficacy regarding patient-clinician interaction (Patient) [From intervention through 12 months post-intervention]
Patients' perceived self-efficacy regarding patient-clinician communication will be assessed using a modified version of the Communication Perceived Self-Efficacy Scale.
- Perceived risk (Patient) [From baseline through 12 months post-intervention]
Patients' perceived smoking-related disease risks will be assessed using a modified version of the Perceived Susceptibility and Severity Scale.
- Outcome expectancies (Patient) [From baseline through 12 months post-intervention]
Patients' outcome expectancies regarding tobacco treatment will be assessed using a modified version of the Stanford Expectation of Treatment Scale.
- Withdrawal [From baseline through 12 months post-intervention]
Withdrawal severity is assessed by Wisconsin Smoking Withdrawal Scale (WSWS).
- Side Effects [From baseline through 12 months post-intervention]
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.
Eligibility Criteria
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
Exclusion:
-
Active use of smoking cessation medication (within the past 30 days)
-
Receipt of prescription for smoking cessation medication (within the past 30 days)
-
Having a contraindication for cNRT or varenicline (allergic reactions, current cardiac problems, pregnancy)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Washington University School of Medicine | Saint Louis | Missouri | United States | 63110 |
Sponsors and Collaborators
- Washington University School of Medicine
- National Institute on Drug Abuse (NIDA)
Investigators
- Principal Investigator: Li-Shiun Chen, ScD, MD, MPH, Washington University School of Medicine
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 202205090
- 1R01DA056050