Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

Personlig tobaksbehandling inom primärvården

2 november 2026 uppdaterad av: Washington University School of Medicine

En intervention på flera nivåer för att anpassa och förbättra tobaksbehandlingen i primärvården

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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

850

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

  • Namn: Li-Shiun Chen, ScD, MD, MPH
  • Telefonnummer: 314-362-3932
  • E-post: li-shiun@wustl.edu

Studera Kontakt Backup

Studieorter

  • Förenta staterna
    • Missouri
      • St Louis, Missouri, Förenta staterna, 63110
        • Rekrytering
        • Washington University School of Medicine
        • Kontakt:
        • Kontakt:
        • Huvudutredare:
          • Li-Shiun Chen, ScD, MD, MPH
        • Huvudutredare:
          • Alex Ramsey, PhD
        • Underutredare:
          • Laura Bierut, MD
        • Underutredare:
          • Esther Lu, PhD
        • Underutredare:
          • Robert Schnoll, PhD
        • Underutredare:
          • Timothy Baker, PhD
        • Underutredare:
          • Hilary Tindle, MD
        • Underutredare:
          • Rachel Tyndale, PhD

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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)

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: 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.
Beteende: Usual Care

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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Patient receipt of tobacco treatment medication for smoking cessation
Tidsram: 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
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Patient receipt of recommended tobacco treatment
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Perceived benefits (Clinician)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Washington University School of Medicine

Samarbetspartners

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

Utredare

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

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

29 september 2023

Primärt slutförande (Beräknad)

31 mars 2028

Avslutad studie (Beräknad)

30 september 2028

Studieregistreringsdatum

Först inskickad

21 april 2023

Först inskickad som uppfyllde QC-kriterierna

4 maj 2023

Första postat (Faktisk)

6 maj 2023

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

3 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

2 november 2026

Senast verifierad

1 november 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 202205090
  • 1R01DA056050 (U.S.S. NIH-anslag/kontrakt)
  • 5U19CA203654 (U.S.S. NIH-anslag/kontrakt)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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.

Tidsram för IPD-delning

12 months after trial completion

IPD-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • SAV

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera