プライマリケアにおける個別化されたタバコ治療
プライマリケアにおけるタバコ治療をパーソナライズおよび改善するためのマルチレベルの介入
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Li-Shiun Chen, ScD, MD, MPH
- 電話番号：314-362-3932
- メール：li-shiun@wustl.edu
研究連絡先のバックアップ
- 名前：Alex Ramsey, PhD
- 電話番号：314-362-5370
- メール：aramsey@wustl.edu
研究場所
-
-
Missouri
-
St Louis、Missouri、アメリカ、63110
- 募集
- Washington University School of Medicine
-
コンタクト：
- Li-Shiun Chen, ScD, MD, MPH
- 電話番号：314-362-3932
- メール：li-shiun@wustl.edu
-
コンタクト：
- Alex Ramsey, PhD
- 電話番号：314-362-5370
- メール：aramsey@wustl.edu
-
主任研究者：
- Li-Shiun Chen, ScD, MD, MPH
-
主任研究者：
- Alex Ramsey, PhD
-
副調査官：
- Laura Bierut, MD
-
副調査官：
- Esther Lu, PhD
-
副調査官：
- Robert Schnoll, PhD
-
副調査官：
- Timothy Baker, PhD
-
副調査官：
- Hilary Tindle, MD
-
副調査官：
- Rachel Tyndale, PhD
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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)
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：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). |
|
実験的：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Patient receipt of tobacco treatment medication for smoking cessation
時間枠：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
時間枠：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
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Patient receipt of recommended tobacco treatment
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Perceived benefits (Clinician)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
捜査官
- 主任研究者：Li-Shiun Chen, ScD, MD, MPH、Washington University School of Medicine
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 202205090
- 1R01DA056050 (米国 NIH グラント/契約)
- 5U19CA203654 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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 共有時間枠
12 months after trial completion
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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