Capitalizing on Hospitalization to Engage Low SES Smokers in LDCT Screening: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Completion of LDCT screening
研究概览
简要总结
Current smokers who undergo annual low dose CT (LDCT) lung cancer screening and successfully quit smoking derive the greatest reduction in lung cancer mortality. Unfortunately, those at highest risk of lung cancer death- those with low socioeconomic status, blacks, and current smokers- are the same individuals that typically have reduced access to preventive healthcare such as smoking cessation services and screening tests. Furthermore, patients from underserved communities often have lower health literacy, less awareness of lung cancer screening, and a poor understanding of the trade-offs of LDCT screening. In 2015 the Center for Medicare and Medicaid Services began requiring (1) a shared decision-making (SDM) discussion including use of a patient decision aid and (2) smoking cessation counseling in order to receive reimbursement for LDCT screening. There is little guidance, however, to help healthcare systems implement this requirement. Furthermore, primary care physicians (PCPs) report time constraints, competing demands, and knowledge deficiencies as barriers to optimizing utilization of LDCT screening.
详细描述
The goal of this study is to create and evaluate an intervention that capitalizes on hospitalization at an urban safety net hospital as an opportunity to connect high risk smokers to lung cancer screening and smoking cessation services. Building on the well-established inpatient tobacco dependence consult service at Boston Medical Center, the investigators will study the effect of adding a nurse-driven LDCT screening SDM intervention to inpatient smoking cessation counseling among screen-eligible hospitalized smokers. Hospitalization may be an ideal time-point for this intervention as it offers 1) a "teachable moment" for patients, when they may be particularly receptive to interventions to reduce smoking-related disease, and 2) an opportunity to offload busy PCPs of the obligation to conduct SDM for LDCT screening.
In Aim 1, screen-eligible patients who are smokers will be randomized into one of the study arms (n=284, 142 per arm) to receive either inpatient 1) SDM (SDM by a thoracic oncology nurse using a decision aid) or 2) usual care and a LDCT informational brochure during inpatient smoking cessation consultation visits. In both arms the thoracic oncology nurse will counsel patients on smoking cessation. The investigators hypothesize that for screen-eligible smokers, inpatient SDM will increase (1) LDCT screening rates, (2) patient knowledge of LDCT screening, and (3) 1 month smoking quit rates compared to usual care.
In Aim 2, the potential for future implementation of the intervention will be evaluated by incorporating stakeholder impressions of the intervention through qualitative interviews. By study end, an inpatient intervention will be created to promote both LDCT screening and smoking cessation among low income and minority smokers. This hybrid study will allow te investigators to establish not only the effectiveness of the intervention, but also help inform future implementation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •hospitalized smokers at BMC meeting LDCT screening eligible criteria
- •males and females 55-80 years of age
- •≥30-pack years smoking
- •current smoker
- •able to speak, read, and understand English
- •able and willing to participate and provide informed consent
排除标准
- •severe co-morbidities expected to limit life expectancy or ability to tolerate surgical resection of a lung cancer, including patients requiring home oxygen therapy (an indicator of severe lung or heart disease), and patients with active cancer
- •patients who have already had LDCT screening in the past year
研究组 & 干预措施
SDM + decision aid + tobacco counseling
Participants will receive tobacco dependence/smoking cessation counseling by a nurse, SDM and a decision aid.
干预措施: tobacco dependence/smoking cessation counseling (Behavioral)
SDM + decision aid + tobacco counseling
Participants will receive tobacco dependence/smoking cessation counseling by a nurse, SDM and a decision aid.
干预措施: SDM (Behavioral)
SDM + decision aid + tobacco counseling
Participants will receive tobacco dependence/smoking cessation counseling by a nurse, SDM and a decision aid.
干预措施: Decision Aid (Other)
LDCT brochure + tobacco counseling
Participants will receive tobacco dependence/smoking cessation counseling by a nurse and a LDCT informational brochure.
干预措施: tobacco dependence/smoking cessation counseling (Behavioral)
LDCT brochure + tobacco counseling
Participants will receive tobacco dependence/smoking cessation counseling by a nurse and a LDCT informational brochure.
干预措施: LDCT brochure (Other)
结局指标
主要结局
Completion of LDCT screening
时间窗: 3 months
The electronic records review and from the Lung Cancer Screening clinical database created by the Department of Pulmonary Disease and Critical Care at BMC will be reviewed to determine which participants have completed LDCT screening designated as yes or no and if yes the date of the LDCT screening will be recorded..
次要结局
- Knowledge of LDCT screening (experimental group)(Baseline, immediately post SDM, 1 month)
- Knowledge of LDCT screening (active comparator group)(Baseline, 1 month)
- smoking cessation(4 weeks)