A protocol for a cluster randomized trial of care delivery models to improve the quality of smoking cessation and shared decision making for lung cancer screening.

Patients eligible for lung cancer screening (LCS) are those at high risk of lung cancer due to their smoking histories and age. While screening for LCS is effective in lowering lung cancer mortality, primary care providers are challenged to meet beneficiary eligibility for LCS from the Centers for Medicare & Medicaid Services, including a patient counseling and shared decision-making (SDM) visit with the use of patient decision aid(s) prior to screening. We will use an effectiveness-implementation type I hybrid design to: 1) identify effective, scalable smoking cessation counseling and SDM interventions that are consistent with recommendations, can be delivered on the same platform, and are implemented in real-world clinical settings; 2) examine barriers and facilitators of implementing the two approaches to delivering smoking cessation and SDM for LCS; and 3) determine the economic implications of implementation by assessing the healthcare resources required to increase smoking cessation for the two approaches by delivering smoking cessation within the context of LCS. Providers from different healthcare organizations will be randomized to usual care (providers delivering smoking cessation and SDM on site) vs. centralized care (smoking cessation and SDM delivered remotely by trained counselors). The primary trial outcomes will include smoking abstinence at 12-weeks and knowledge about LCS measured at 1-week after baseline. This study will provide important new evidence about the effectiveness and feasibility of a novel care delivery model for addressing the leading cause of lung cancer deaths and supporting high-quality decisions about LCS. NCT04200534 TRIAL REGISTRATION: ClinicalTrials.govNCT04200534.

Lowenstein LM ，Shih YT ，Minnix J ，Lopez-Olivo MA ，Maki KG ，Kypriotakis G ，Leal VB ，Shete SS ，Fox J ，Nishi SP ，Cinciripini PM ，Volk RJ ... -  《-》

The TELEhealth Shared decision-making COaching and navigation in Primary carE (TELESCOPE) intervention: a study protocol for delivering shared decision-making for lung cancer screening by patient navigators.

Lung cancer screening (LCS) can reduce lung cancer mortality but has potential harms for patients. A shared decision-making (SDM) conversation about LCS is required by the Centers for Medicare & Medicaid Services (CMS) for LCS reimbursement. To overcome barriers to SDM in primary care, this protocol describes a telehealth decision coaching and navigation intervention for LCS in primary care clinics delivered by patient navigators. The objective of the study is to evaluate the effectiveness of the intervention and its implementation potential, compared with an enhanced usual care (EUC) arm. Patients (n = 420) of primary care clinicians (n = 120) are being recruited to a cluster randomized controlled trial. Clinicians are randomly assigned to 1) TELESCOPE intervention: prior to an upcoming non-acute clinic visit, patients participate in a telehealth decision coaching and navigation session about LCS delivered by trained patient navigators and nurse navigators place a low-dose CT scan (LDCT) order for each TELESCOPE patient wanting LCS, or 2) EUC: patients receive enhanced usual care from a clinician. Usual care is enhanced by providing clinicians in both arms with access to a Continuing Medical Education (CME) webinar about LCS and an LCS discussion guide. Patients complete surveys at baseline and 1-week after the scheduled clinic visit to assess quality of the SDM process. Re-navigation is attempted with TELESCOPE patients who have not completed the LDCT within 3 months. One month before being due for an annual screening, TELESCOPE patients whose initial LCS showed low-risk findings are randomly assigned to receive a telehealth decision coaching booster session with a navigator or no booster. Electronic health records are abstracted at 6, 12 and 18 months after the initial decision coaching session (TELESCOPE) or clinic visit (EUC) to assess initial and annual LCS uptake, imaging results, follow-up testing for abnormal findings, cancer diagnoses, treatment, and tobacco treatment referrals. This study will evaluate factors that facilitate or interfere with program implementation using mixed methods. We will assess whether a decision coaching and patient navigation intervention can feasibly and effectively support high-quality SDM for LCS and guideline-concordant LCS uptake for patients in busy primary care practices serving diverse patient populations. This study was registered at ClinicalTrials.gov (NCT05491213) on August 4, 2022. Version 1, April 10, 2024.

Tan NQP ，Lowenstein LM ，Douglas EE ，Silva J ，Bershad JM ，An J ，Shete SS ，Steinberg MB ，Ferrante JM ，Clark EC ，Natale-Pereira A ，Sahu NN ，Hastings SE ，Hoffman RM ，Volk RJ ，Kinney AY ... -  《-》

How Health-Care Organizations Implement Shared Decision-making When It Is Required for Reimbursement: The Case of Lung Cancer Screening.

The Centers for Medicare and Medicaid Services stipulate shared decision-making (SDM) counseling as a prerequisite to lung cancer screening (LCS) reimbursement, despite well-known challenges implementing SDM in practice. How have health-care organizations implemented SDM for LCS? For this qualitative study, we used data from in-depth, semistructured interviews with key informants directly involved in implementing SDM for LCS, managing SDM for LCS, or both. We identified respondents using a snowball sampling technique and used template analysis to identify and analyze responses thematically. We interviewed 30 informants representing 23 health-care organizations located in 12 states and 4 Census regions. Respondents described two types of SDM for LCS programs: centralized models (n = 7), in which front-end practitioners (eg, primary care providers) referred patients to an LCS clinic where trained staff (eg, advanced practice nurses) delivered SDM at the time of screening, or decentralized models (n = 10), in which front-end practitioners delivered SDM before referring patients for screening. Some organizations used both models simultaneously (n = 6). Respondents discussed tradeoffs between SDM quality and access. They perceived centralized models as enhancing SDM quality, but limiting patient access to care, and vice versa. Respondents reported ongoing challenges with limited resources and budgetary constraints, ambiguity regarding what constitutes SDM, and an absence of benchmarks for evaluating SDM for LCS quality. Those responsible for developing and managing SDM for LCS programs voiced concerns regarding both patient access and SDM quality, regardless of organizational context, or the SDM for LCS model implemented. The challenge facing these organizations, and those wanting to help patients and clinicians balance the tradeoffs inherent with LCS, is how to move beyond a check-box documentation requirement to a process that enables LCS to be offered to all high-risk patients, but used only by those who are informed and for whom screening represents a value-concordant service.

Alishahi Tabriz A ，Neslund-Dudas C ，Turner K ，Rivera MP ，Reuland DS ，Elston Lafata J ... -  《-》

Accelerating integration of tobacco use treatment in the context of lung cancer screening: Relevance and application of implementation science to achieving policy and practice.

Based on the findings from the National Lung Screening Trial, the U.S. Preventive Services Task Force recommends annual low dose computed tomography (LDCT) lung cancer screening (LCS) among high-risk adults. Approximately 54% of individuals seeking LCS report current cigarette smoking. Effective smoking cessation interventions, offered at the time of LCS, enhances the health benefits of screening that are attributable to reductions in lung cancer overall and tobacco-related mortality. Considering these data, the Centers for Medicare & Medicaid Services' (CMS) 2015 decision to cover LCS with LDCT required that radiology imaging facilities make tobacco cessation interventions available for people who smoke. In February 2022, CMS reversed their 2015 coverage requirement for delivering tobacco use treatment at the time of LDCT; CMS retained the requirement for counseling during the shared decision-making visit prior to the exam. The policy change does not diminish the importance of offering high-quality tobacco cessation services in conjunction with routine LDCT for LCS. However, LCS programs face a range of barriers to implementing tobacco use treatment in their settings. As a result, implementation has lagged. Closing the "evidence to practice" gap is the focus of implementation science, a field that offers a set of rigorous methods and a systematic approach to identifying and overcoming contextual barriers to implementing evidence-based guidelines in a range of clinical settings. In this paper, we describe how implementation science frameworks and methods can be used to help guide LCS programs in their efforts to integrate tobacco use treatment and discuss policy changes needed to further facilitate the delivery of TUT as an essential component of the LCS process.

Shelley D ，Wang VH ，Taylor K ，Williams R ，Toll B ，Rojewski A ，Foley KL ，Rigotti N ，Ostroff JS ... -  《-》

An integrated digital/clinical approach to smoking cessation in lung cancer screening: study protocol for a randomized controlled trial.

Graham AL ，Burke MV ，Jacobs MA ，Cha S ，Croghan IT ，Schroeder DR ，Moriarty JP ，Borah BJ ，Rasmussen DF ，Brookover MJ ，Suesse DB ，Midthun DE ，Hays JT ... -  《Trials》