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Personalizovaná léčba tabáku v primární péči

2. listopadu 2026 aktualizováno: Washington University School of Medicine

Víceúrovňová intervence k personalizaci a zlepšení léčby tabáku v primární péči

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.

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

850

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

  • Jméno: Li-Shiun Chen, ScD, MD, MPH
  • Telefonní číslo: 314-362-3932
  • E-mail: li-shiun@wustl.edu

Studijní záloha kontaktů

  • Jméno: Alex Ramsey, PhD
  • Telefonní číslo: 314-362-5370
  • E-mail: aramsey@wustl.edu

Studijní místa

  • Spojené státy
    • Missouri
      • St Louis, Missouri, Spojené státy, 63110
        • Nábor
        • Washington University School of Medicine
        • Kontakt:
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Li-Shiun Chen, ScD, MD, MPH
        • Vrchní vyšetřovatel:
          • Alex Ramsey, PhD
        • Dílčí vyšetřovatel:
          • Laura Bierut, MD
        • Dílčí vyšetřovatel:
          • Esther Lu, PhD
        • Dílčí vyšetřovatel:
          • Robert Schnoll, PhD
        • Dílčí vyšetřovatel:
          • Timothy Baker, PhD
        • Dílčí vyšetřovatel:
          • Hilary Tindle, MD
        • Dílčí vyšetřovatel:
          • Rachel Tyndale, PhD

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

Eligibility Criteria for Primary and Specialty Care Clinicians

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

Eligibility Criteria for Primary Care and Specialty 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)

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Aktivní komparátor: 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.
Behaviorální: Usual Care

Usual care will be informed by practice guidelines (standard of care, brief advice, and guideline awareness).
Experimentální: 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.
Behaviorální: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Patient receipt of tobacco treatment medication for smoking cessation
Časové okno: 6 months post-intervention

This will be quantified by the proportion of enrolled patients who receive cessation medication.
6 months post-intervention
Patient use of cessation medication
Časové okno: 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.
6 months post-intervention
Patient smoking abstinence
Časové okno: 6 months post-intervention

This will be quantified by the proportion of smokers with bioverified point-prevalent abstinence at 6 months.
6 months post-intervention

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Patient receipt of recommended tobacco treatment
Časové okno: 6 months post-intervention

This will be quantified by the proportion of enrolled patients who received recommended cessation medication.
6 months post-intervention
Patient medication adherence
Časové okno: 6 months post-intervention

This will be quantified by the proportion of medication taken among medication prescribed.
6 months post-intervention
Patient smoking abstinence among treated
Časové okno: 6 months post-intervention

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
Časové okno: 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.
From intervention through 12 months post-intervention
Smoking quantity across multiple time points
Časové okno: 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.
From intervention through 12 months post-intervention
Quit attempts
Časové okno: 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.
6 and 12 months post-intervention

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Perceived benefits (Clinician)
Časové okno: Exit interview [after clinician has been enrolled in the trial for approximately 6 months]

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 clinician has been enrolled in the trial for approximately 6 months]
Outcome expectancies (Clinician)
Časové okno: Exit interview [after clinician has been enrolled in the trial for approximately 6 months]

Clinicians' outcome expectancies regarding tobacco treatment will be assessed using a modified version of the Stanford Expectation of Treatment Scale.
Exit interview [after clinician has been enrolled in the trial for approximately 6 months]
Self-efficacy regarding patient-clinician interaction (Clinician)
Časové okno: Exit interview [after clinician has been enrolled in the trial for approximately 6 months]

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 clinician has been enrolled in the trial for approximately 6 months]
Self-efficacy regarding patient-clinician interaction (Patient)
Časové okno: 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.
From intervention through 12 months post-intervention
Perceived risk (Patient)
Časové okno: 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.
From baseline through 12 months post-intervention
Outcome expectancies (Patient)
Časové okno: 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.
From baseline through 12 months post-intervention
Withdrawal
Časové okno: From baseline through 12 months post-intervention

Withdrawal severity is assessed by Wisconsin Smoking Withdrawal Scale (WSWS).
From baseline through 12 months post-intervention
Side Effects
Časové okno: 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.
From baseline through 12 months post-intervention

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Washington University School of Medicine

Spolupracovníci

National Institute on Drug Abuse (NIDA)
National Cancer Institute (NCI)

Vyšetřovatelé

  • Vrchní vyšetřovatel: Li-Shiun Chen, ScD, MD, MPH, Washington University School of Medicine

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Užitečné odkazy

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

29. září 2023

Primární dokončení (Odhadovaný)

31. března 2028

Dokončení studie (Odhadovaný)

30. září 2028

Termíny zápisu do studia

První předloženo

21. dubna 2023

První předloženo, které splnilo kritéria kontroly kvality

4. května 2023

První zveřejněno (Aktuální)

6. května 2023

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

3. listopadu 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

2. listopadu 2026

Naposledy ověřeno

1. listopadu 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 202205090
  • 1R01DA056050 (Grant/smlouva NIH USA)
  • 5U19CA203654 (Grant/smlouva NIH USA)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

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.

Časový rámec sdílení IPD

12 months after trial completion

Typ podpůrných informací pro sdílení IPD

  • PROTOKOL STUDY
  • MÍZA

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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