Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

All Drugs and Chemicals

Central Nervous System Stimulants

Nicotine

Nicotinic Agonists

Cholinergic Agents

Neurotransmitter Agents

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

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

In the MedStar Health System (MHS) arm, we offer 5 phone sessions with a tobacco treatment specialist (TTS) during the first 3 months of treatment plus combination nicotine replacement (patches and lozenges). For those who have not quit at 3 months, 50% will be randomly assigned to stepped care (3 phone sessions with RN/NP + prescription medications as needed) vs. the continued TTS + NRT intervention. Those who have quit at 3 months will be offered 3 relapse prevention phone sessions with the TTS. Thus, all are offered 8 sessions. The TTS will use motivational interviewing to address ambivalence about quitting, education about the risks of continued smoking, encouragement to use and adhere to NRT, and the impact of the screening result (the teachable moment) by framing it as a potential motivator or opportunity to reduce future health risks and to maximize quality of life.

In the Quitline E-Referral arm, an e-referral will be generated from the EHR by our staff, will be signed by the LCS ordering provider and sent to the quitline through the closed-looped quitline's success.58-61,123 The quitline is an important comparator, given that it is an evidence-based and low-cost intervention already employed by many LCS sites system and the standard quitline protocol will then occur: 5 proactive contact attempts, up to 5 sessions, and up to 8 weeks of free NRT (depending on supplies). Quitline counselors are highly trained to conduct cessation treatment and extensive research has validated the quitline's success. The quitline is an important comparator, given that it is an evidence-based and low-cost intervention already employed by many LCS sites.

E-Referral to the Tobacco Quitline

Kathryn L Taylor, PhD

Randi M. Williams, PhD

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.

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.

Tobacco Education and Lung Health Study (TEAL)

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

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

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

self-reported abstinence (defined as in the past 7 days and in the past 30 days)

readiness to quit (defined as ready to quit in the next 30 days, the next six months, or not ready to quit)

Reach: % of eligible smokers enrolled in trial; Engagement: % who receive the intervention, both overall and among subgroups

Staff time costs; fixed costs, and variable costs

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Tobacco Education and Lung Health Study (TEAL)	NCT06290869	Smoking Cessati...	Phone-based Tob... E-Referral to t...	50 Years - 80 Years	Georgetown University
Tobacco Education and Lung Health Study (TEAL)	NCT06290869	Smoking Cessati...	Phone-based Tob... E-Referral to t...	50 Years - 80 Years	Georgetown University
Tobacco Education and Lung Health Study (TEAL)	NCT06290869	Smoking Cessati...	Phone-based Tob... E-Referral to t...	50 Years - 80 Years	Georgetown University

Spots Global Cancer Trial Database for high risk for lung cancer