1차 진료에서의 맞춤형 담배 치료
1차 진료에서 담배 치료를 개인화하고 개선하기 위한 다단계 개입
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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Li-Shiun Chen, ScD, MD, MPH
- 전화번호: 314-362-3932
- 이메일: li-shiun@wustl.edu
연구 연락처 백업
- 이름: Alex Ramsey, PhD
- 전화번호: 314-362-5370
- 이메일: aramsey@wustl.edu
연구 장소
-
-
Missouri
-
St Louis, Missouri, 미국, 63110
- 모병
- Washington University School of Medicine
-
연락하다:
- Li-Shiun Chen, ScD, MD, MPH
- 전화번호: 314-362-3932
- 이메일: li-shiun@wustl.edu
-
연락하다:
- Alex Ramsey, PhD
- 전화번호: 314-362-5370
- 이메일: aramsey@wustl.edu
-
수석 연구원:
- Li-Shiun Chen, ScD, MD, MPH
-
수석 연구원:
- Alex Ramsey, PhD
-
부수사관:
- Laura Bierut, MD
-
부수사관:
- Esther Lu, PhD
-
부수사관:
- Robert Schnoll, PhD
-
부수사관:
- Timothy Baker, PhD
-
부수사관:
- Hilary Tindle, MD
-
부수사관:
- Rachel Tyndale, PhD
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
활성 비교기: 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). |
|
실험적: 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Patient receipt of tobacco treatment medication for smoking cessation
기간: 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
기간: 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
기간: 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
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Patient receipt of recommended tobacco treatment
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
|
기타 결과 측정
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Perceived benefits (Clinician)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
협력자
협력자
수사관
수사관
- 수석 연구원: Li-Shiun Chen, ScD, MD, MPH, Washington University School of Medicine
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- 202205090
- 1R01DA056050 (미국 NIH 보조금/계약)
- 5U19CA203654 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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 공유 기간
12 months after trial completion
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .