跳至主要内容
临床试验/NCT06745258
NCT06745258尚未招募不适用

ICARE-LCS QUERI Partnered Evaluation Initiative: Integrating Comprehensive Tobacco Treatment to Enhance Lung Cancer Screening (PEC 24-239)

VA Office of Research and Development1 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2026年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
7
试验地点
1
主要终点
Receipt of Combined Tobacco Dependence Treatment

研究概览

简要总结

Lung cancer is the leading cause of cancer-related death among Veterans with 90% of cases attributable to smoking. Lung cancer screening (LCS) combined with smoking cessation saves the most lives. ICARE-LCS seeks to decrease health inequality and improve Veteran health by reducing smoking rates among Veterans receiving LCS. ICARE-LCS will use implementation methods to inform national cancer prevention efforts and build infrastructure necessary to support broad implementation of high-impact tobacco dependence treatment (TDT) processes in LCS programs.

详细描述

The primary goal is to improve the delivery of tobacco dependence treatment (TDT) within Veterans Affairs (VA) lung cancer screening (LCS) programs. LCS with annual low-dose computed tomography saves lives through the early detection of lung cancer and is being broadly deployed, now at 113 VA medical centers. Due to the eligibility criteria selecting for current or previous smoking, 50-60% of LCS participants currently smoke. Modeling studies support that integrating TDT into LCS nearly doubles the benefit of the screening itself. Therefore, access to high-quality TDT is a program requirement per the VA LCS guidance memo.

Though a robust integration of LCS and TDT is a VA priority, in reality there remains a gap in both reach and intensity of TDT for LCS participants. Guidelines and evidence support TDT processes that include 1) systematic assessment and connection to treatment (e.g. Ask-Advise-Connect, motivational interviewing, optout or proactive strategies) and 2) treatment that includes the evidence-based combination of intensive pharmacologic and behavioral treatments ('combined TDT'). Recent trials in LCS participants found high rates of agreeing to treatment using 'opt-out' motivational referral strategies and the highest cessation rates using a longitudinal "chronic disease" model that delivers combined TDT over a period up to a year. Unfortunately, relatively few Veterans in LCS receive any TDT and the treatment is usually inconsistent with guidelines and this evidence. In a national sample of LCS participants who smoke, only 16.4% received any pharmacotherapy for TDT, many under-dosed with short-acting nicotine replacement alone, and fewer than 1% received the recommended combination of behavioral and pharmacologic treatment. This represents a significant gap in care. Improving quality of TDT for Veterans in LCS has been identified as a priority area by multiple stakeholders including the Office of Oncology and Precision Medicine (OPM), the investigators' operational partner, the VA Lung Precision Oncology Program (LPOP), the White House Prevention and Screening Task Force, the National Committee for Quality Assurance and Veterans engagement groups. Each care process-LCS and TDT-is complex on its own, which has hampered integration. While some LCS processes are standardized across VA through use of the tools provided by the National Center for Lung Cancer Screening (NCLCS), individual LCS programs use varied care models. Programs can be 'centralized' (most LCS-related care is delivered by dedicated program staff) or 'hybrid,' where responsibilities are shared between primary care and LCS staff. NCLCS has worked with VAs across the country to enhance LCS quality and uptake. Individual LCS programs deliver combined TDT variably, and many processes are not adapted for the longitudinal, annual LCS process. The VA Tobacco Use Treatment Program Office (TUT) is currently conducting a pilot funded by the Cancer Moonshot to demonstrate feasibility of integrating TDT into LCS, recently expanded from 11 to 15 sites. The Minneapolis VA has conducted a VISN 23-Quality Enhancement Research Initiative (QUERI) partnered implementation pilot to understand barriers and needs among diverse LCS programs, identifying many modifiable targets. The VISN 23 QUERI Team and TUT have collaborated to design an LCS-TDT toolkit that will soon be nationally available. While an important step, a toolkit alone may be insufficient to increase uptake of best practices. Tailored implementation support through intensive external facilitation may be necessary to effectively integrate TDT processes within the VA LCS landscape. With support from the operational partner, OPM, this project proposes to work with TUT and the NCLCS to build on existing efforts to increase participation in combined TDT for LCS participants. This project will utilize both retrospective data analysis and prospective data gathering to inform and tailor a toolkit for national dissemination. ICARE-LCS is an implementation evaluation study model.

Specific Aims:

Aim 1: Identify key process components of effective tobacco treatment programs in LCS and success factors for providing combined TDT. A mixed methods assessment will be conducted at 10 sites in the TUT Moonshot pilot, first qualitatively assessing their current TDT-LCS processes, success factors and perceived barriers to implementation of combined TDT. Data will then be linked with quantitative data of treatment participation and short-term cessation. Findings will be used to refine the toolkit for use in Aim 2 and nationally.

Aim 2: Test a multicomponent facilitation package to improve integration of TDT and LCS.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •This is a VAMC based Quality Improvement Partnered Evaluation Initiative. VA sites from around the country that agreed to participate are included.

排除标准

  • 未提供

研究组 & 干预措施

Veterans Participating in Lung Cancer Screening who Smoke

Veterans participating in lung cancer screening who smoke and are receiving care at participating VA medical centers

Participating VA Medical Centers

Seven sites that have agreed to participate in implementation intervention

干预措施: External Facilitation (Other)

结局指标

主要结局

Receipt of Combined Tobacco Dependence Treatment

时间窗: Approximately 3 years

Participation in counseling and pharmacotherapy within 90 days of lung cancer screening referral

次要结局

  • Number of Veterans Receiving ANY Tobacco Dependence Treatment Therapy(Approximately 3 years)
  • Number of Veterans Receiving of Pharmacotherapy or Counseling Alone(Approximately 3 years)
  • Cost Associated with Tobacco Dependence Treatment Among Lung Cancer Screening Participants who Smoke(Approximately 3 years)
  • Rate of Short-term Cessation Among Veterans In Lung Cancer Screening who Smoke(Approximately 3 years)
  • Implementation Outcomes Assessed at Participating Sites(Approximately 3 years)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (1)

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