跳至主要内容
临床试验/NCT06290869
NCT06290869招募中3 期

Providing Tobacco Treatment to Patients Undergoing Lung Cancer Screening at MedStar Health: A Randomized Trial (Tobacco Education and Lung Health Study)

Georgetown University1 个研究点 分布在 1 个国家目标入组 1,188 人开始时间: 2024年2月22日最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
招募中
入组人数
1,188
试验地点
1
主要终点
Biochemically verified smoking abstinence--continued MHS arm vs Stepped Care

研究概览

简要总结

Primary Objective To compare two smoking cessation interventions among individuals undergoing lung cancer screening. Primary outcomes are: 3-month self-reported abstinence from cigarettes and 6-month self-reported and bioverified abstinence from cigarettes.

Secondary Objectives 1) To evaluate reach and engagement overall and by subgroup (e.g., race and ethnicity, underinsured, readiness to quit). 2) To conduct an economic analysis to evaluate intervention costs from the health system perspective.

详细描述

Providing smoking cessation treatment in conjunction with the recently expanded lung cancer screening guidelines is estimated to substantially reduce lung cancer deaths and increase life-years gained compared to conducting lung screening alone. Although CMS recommends that individuals undergoing lung screening who currently smoke are offered cessation treatment, there are multiple barriers to treatment delivery. Improving the evidence-base of cessation treatment for patients undergoing lung screening and methods to promote the systematic uptake of cessation treatment into routine practice, particularly among diverse populations, is essential for realizing the maximum benefit of lung screening. Guided by the Practical, Robust, Implementation & Sustainability framework, we will extend our prior work (CA R01207228). We propose a health system-level, pragmatic, randomized trial to compare the effectiveness of two evidence-based cessation treatments, with implementation strategies designed to address barriers to reach and engagement, particularly among underserved groups (e.g., racial and ethnic minority groups, underinsured patients, and patients not ready to quit) who are less likely to receive cessation treatment. To maximize generalizability to other health systems and to improve reach among heterogeneous groups, all patients scheduled at one of the 10 lung screening sites at MedStar Health, the largest and most diverse health system in the Mid-Atlantic, will be identified via the EHR, contacted for enrollment using an opt-out approach, and randomized to: 1) Quitline E-referral (QL-E; N=594) via the EHR and quitline integrated system, including proactive outreach and standard phone-based counseling + nicotine replacement provided by the quitline vs. 2) MedStar Health System (MHS; N=594), centralized, phone-based + NRT intervention adapted and improved from our prior trial, with a randomized stepped care intervention for those who are not abstinent at 3 months. Specific aims are: 1. To compare e-referral to the Quitline vs. the centralized Health System intervention. Primary outcomes are: 3-month self-reported abstinence from cigarettes and 6-month self-reported and bioverified abstinence from cigarettes. We will assess intervention mediators (e.g., treatment engagement) and moderators (e.g., readiness to quit) at 6-months. 2. To evaluate reach and engagement overall and by subgroup (e.g., race and ethnicity, underinsured, readiness to quit) and using mixed-methods to understand the contextual factors related to the feasibility and acceptability of the interventions and implementation strategies. 3. To conduct an economic analysis to evaluate costs, average and incremental cost per quit, and budget impact of the intervention at 3- and 6-months from the health system p0erspective. Proposal strengths include testing the effectiveness and economic outcomes of two cessation interventions while simultaneously laying the groundwork for future implementation within this and other diverse health systems. Our innovative approach capitalizes on the EHR for recruitment, provides multilevel training focused on diverse populations, and accounts for intervention context to inform future care delivery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
50 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • eligible for a screening or diagnostic scan,
  • USPSTF eligibility criteria (50-80 years old and >20-pack years);
  • currently smoking cigarettes (>1 in the past 30 days);
  • English speaking;
  • able to provide meaningful consent.

排除标准

  • prior lung cancer,
  • hearing impairment,
  • cognitive impairment,
  • household member already enrolled.

研究组 & 干预措施

MedStar Health System

Experimental

Phone-based Tobacco Treatment, Nicotine Replacement, and Stepped Care Intervention

干预措施: Phone-based Tobacco Treatment, Nicotine Replacement, and Stepped Care Intervention (Behavioral)

E-Referral to the Tobacco Quitline

Active Comparator

Standard tobacco quitline protocol, including coaching, nicotine replacement, and web-, and text-based resources.

干预措施: E-Referral to the Tobacco Quitline (Behavioral)

结局指标

主要结局

Biochemically verified smoking abstinence--continued MHS arm vs Stepped Care

时间窗: 6-month assessment

Biochemically verified 7-day abstinence rates between the Stepped Care arm and the Continued MHS arm

Biochemically verified smoking abstinence- MHS vs. QL-E arms

时间窗: 6-month assessment

Biochemically verified 7-day point prevalence abstinence rates, comparing the Health System (MHS) arm and the Quitline (QL-E) arm

次要结局

  • cigarettes per day(3-month and 6-month assessments)
  • Costs per arm from the health system perspective(Assessed through study completion, an average of six months.)
  • Patient reach and patient engagement(Assessed through study completion, an average of six months.)
  • self-reported smoking status(3-month and 6-month assessments)
  • readiness to quit(3-month and 6-month assessments)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kathryn L. Taylor, Ph.D.

Professor

Georgetown University

研究点 (1)

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