LEAD Pilot Study: Leveraging the Emergency Department to Address SDOH and Reduce Lung Cancer Screening Disparities
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 19
- 主要终点
- Lung Cancer Screening Uptake
研究概览
简要总结
This is a pilot Type 1 Hybrid Effectiveness-Implementation Trial. The study will first examine reach in a non-traditional setting (the Emergency Department - ED) that uses an Electronic Health Record (EHR)-embedded Social Determinants of Health (SDoH) screening tool to identify lung screening-eligible patients for a tailored intervention to increase lung screening uptake. Reach is defined as the absolute number, proportion, and representativeness of individuals targeted for lung screening knowledge, awareness, and uptake. Then, a pilot trial will be conducted to examine the preliminary effectiveness of a tailored lung screening intervention compared to enhanced usual care to influence individual-level potential drivers of lung screening (health literacy, mistrust, stigma, fatalism, knowledge, lung screening health beliefs) and the ability to increase lung screening uptake among screening-eligible patients. Quantitative (Randomized Controlled Trial and EHR data) methods will be used for data collection and analysis to address the study aims.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
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
- 否
入选标准
- •Aged 50 years to 80 years
- •Currently smoke cigarettes or quit smoking cigarettes within the past 15 years
- •20 pack-year smoking history
- •Has never had lung cancer screening
- •Able to provide informed consent
- •Able to speak and understand English
排除标准
- •Diagnosed with lung cancer
- •Has a history of having a lung cancer screening scan
- •Unable to speak and understand English
研究组 & 干预措施
Non-tailored Lung Screening Pamphlet Group
Non-tailored Lung Screening Pamphlet is a non-tailored educational brochure, What is Lung Cancer Screening from the GO2 Foundation that will be emailed to the patient. This widely used educational standard of care is a 2-page reader-friendly non-tailored electronic brochure about risk and screening for lung cancer used in clinical and community settings.
干预措施: Non-tailored lung screening (Other)
LungTalk Group
LungTalk is a novel theoretically grounded health educational tool that will be delivered via iPad and is an interactive computer-based program that includes audio, video and animation segments with scripts presented from a master content library in consideration of different ways people like to learn. Informed by our prior research, LungTalk tailors its content based on smoking status and perceived barriers. In prior work, LungTalk more than doubled Lung Cancer Screening (LCS) knowledge and health beliefs (p < 0.01), and was associated with a significant increase in deciding to screen for lung cancer compared to control group; OR 1.99; 95% CI, 1.03, 3.85, p = 0.03.
干预措施: LungTalk (Behavioral)
结局指标
主要结局
Lung Cancer Screening Uptake
时间窗: Assessed at 1 month and 6 months post intervention
Completion of a Screening Low-Dose Computed Tomography (LDCT) of the Chest confirmed via Electronic Health Records (EHR))
Stage of Adoption for Lung Cancer Screening
时间窗: Assessed at 1 week and then at 1 month and 6 months post intervention
Screening Intention will be assessed with the Stage of Adoption for Decision- Making About Lung Screening using an algorithm of questions used in our prior studies assessing the 7 stages (unaware, aware but unengaged, undecided, decided not to act, decided to act, action, and maintenance). This will allow investigators to assess intent.
次要结局
- Health Literacy Scale(At one week and one month post intervention)
- Medical Mistrust Scale(At one week and one month post intervention)
- Perceived Stigma Scale(At one week and one month post intervention)
- Perceived Risk of Lung Cancer Scale(At one week and one month post intervention)
- Perceived Benefits of Lung Cancer Screening Scale(At one week and one month post intervention)
- Perceived Barriers to Lung Cancer Screening Scale(At one week and one month post intervention)
- Self-Efficacy for Lung Cancer Screening Scale(At one week and one month post intervention)
- Knowledge: Lung Cancer and Screening Scale(At one week and one month post intervention)
- Lung Cancer Fatalism(At one week and one month post intervention)