Trattamento personalizzato del tabacco nelle cure primarie
Un intervento multilivello per personalizzare e migliorare il trattamento del tabacco nelle cure primarie
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Li-Shiun Chen, ScD, MD, MPH
- Numero di telefono: 314-362-3932
- Email: li-shiun@wustl.edu
Backup dei contatti dello studio
- Nome: Alex Ramsey, PhD
- Numero di telefono: 314-362-5370
- Email: aramsey@wustl.edu
Luoghi di studio
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Missouri
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St Louis, Missouri, Stati Uniti, 63110
- Reclutamento
- Washington University School of Medicine
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Contatto:
- Li-Shiun Chen, ScD, MD, MPH
- Numero di telefono: 314-362-3932
- Email: li-shiun@wustl.edu
-
Contatto:
- Alex Ramsey, PhD
- Numero di telefono: 314-362-5370
- Email: aramsey@wustl.edu
-
Investigatore principale:
- Li-Shiun Chen, ScD, MD, MPH
-
Investigatore principale:
- Alex Ramsey, PhD
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Sub-investigatore:
- Laura Bierut, MD
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Sub-investigatore:
- Esther Lu, PhD
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Sub-investigatore:
- Robert Schnoll, PhD
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Sub-investigatore:
- Timothy Baker, PhD
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Sub-investigatore:
- Hilary Tindle, MD
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Sub-investigatore:
- Rachel Tyndale, PhD
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: 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. |
Usual care will be informed by practice guidelines (standard of care, brief advice, and guideline awareness). |
|
Sperimentale: 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. |
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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Patient receipt of tobacco treatment medication for smoking cessation
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Patient receipt of recommended tobacco treatment
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Perceived benefits (Clinician)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Investigatori
- Investigatore principale: Li-Shiun Chen, ScD, MD, MPH, Washington University School of Medicine
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 202205090
- 1R01DA056050 (Sovvenzione/contratto NIH degli Stati Uniti)
- 5U19CA203654 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano 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.
Periodo di condivisione IPD
12 months after trial completion
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
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