Empowering Patients' Lung Cancer Screening Uptake (Empower LCS/Call+): A Multi-Site Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 57
- 主要终点
- Completion of lung cancer screening with low-dose computed tomography (LDCT)
研究概览
简要总结
Lung cancer screening (LCS) with low-dose computed tomography (LDCT) can reduce the risk of dying from lung cancer, but many people who are eligible for screening do not receive it. The purpose of the Empower LCS/Call+ study is to evaluate new strategies to improve lung cancer screening among adults who are eligible for screening based on current U.S. Preventive Services Task Force (USPSTF) guidelines.
This pilot randomized controlled trial will enroll approximately 80 participants from UC Irvine Health and Emory Healthcare. Participants will be randomly assigned to receive either enhanced usual care or the Empower LCS/Call+ intervention. The intervention includes educational materials, reminders for patients and primary care providers, and information about financial and community resources when appropriate. Participants who do not complete lung cancer screening after the initial intervention may receive additional telephone-based navigation through the Call+ program to help identify and address barriers to screening and help with scheduling.
Participants will complete a baseline survey and follow-up surveys at 4 and 8 months, and researchers will review electronic health record information to determine whether lung cancer screening was discussed, ordered, and completed. Some participants will also be invited to complete a one-time interview about their experiences with the study.
The results of this study will help determine the feasibility, acceptability, and preliminary effectiveness of the Empower LCS/Call+ intervention and will inform future efforts to improve equitable access to lung cancer screening.
详细描述
Lung cancer is the leading cause of cancer-related death in the United States. Although annual lung cancer screening with LDCT is recommended for adults at high risk and has been shown to reduce lung cancer mortality, screening uptake remains low. Barriers to screening exist at the patient, provider, and health system levels, including limited awareness of screening eligibility, incomplete documentation of smoking history in the electronic health record, logistical challenges, financial concerns, and psychosocial barriers such as fear, stigma, and mistrust.
The Empower LCS is a multilevel intervention designed to improve lung cancer screening uptake by combining patient education, provider notification, patient reminders, and information on financial and community resources. The intervention demonstrated improvements in lung cancer screening discussions and low-dose computed tomography ordering and completion compared with enhanced usual care in prior pilot study.
The current study evaluates an enhanced version of the intervention, Empower LCS/Call+. Participants who have not completed lung cancer screening after the initial intervention will be eligible to receive the Call+ telephone navigation intervention. Call+ is delivered by lay navigators and is designed to identify participant-specific barriers to screening, provide education and motivational support, facilitate primary care or imaging scheduling when appropriate, connect participants with available financial or community resources, and encourage completion of recommended lung cancer screening.
This prospective, multi-site, pilot randomized controlled trial will enroll participants from UC Irvine Health and Emory Healthcare. Potentially eligible participants will be identified using a combination of structured data and natural language processing of free text notes to extract smoking history from electronic medical records. Eligibility will be confirmed via self-report.
Participants will be randomly assigned to receive either the Empower LCS/Call+ intervention or enhanced usual care. Data will be collected through participant surveys, electronic health record review, intervention process measures, and qualitative interviews with a subset of participants to evaluate implementation experiences.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
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
- •Must meet current USPSTF eligibility criteria for lung cancer screening (Current criteria: age 50-80 years old with a 20 pack-year smoking history, who currently smoke or have quit within the last 15 years)
- •Must have an electronic health record-assigned primary care provider within University of California Irvine Health or Emory Healthcare
- •Must have recent engagement with respective health system (i.e., office or emergency department (ED) visit, hospitalization with discharged home in the last 12 months, or a scheduled office visit in the next 3 months).
- •Must speak English or Spanish
- •Able and willing to provide informed consent
排除标准
- •Meet the eligibility upper age limit during initial 4-month participation.
- •Have a prior history of lung cancer.
- •Have a new diagnosis of other cancers in the 12 months
- •Have a chest CT or LDCT in the last 12 months
- •Have ICD-10 code of Alzheimer's disease in EHR
研究组 & 干预措施
Enhanced Usual Care
Usual care + educational brochure
干预措施: Usual Care (Other)
Enhanced Usual Care
Usual care + educational brochure
干预措施: Education (Other)
Empower LCS/Call+
Empower LCS with Call+ offered to non-responders
干预措施: Usual Care (Other)
Empower LCS/Call+
Empower LCS with Call+ offered to non-responders
干预措施: Empower LCS (Behavioral)
Empower LCS/Call+
Empower LCS with Call+ offered to non-responders
干预措施: Call+ Telephone Navigation (Behavioral)
结局指标
主要结局
Completion of lung cancer screening with low-dose computed tomography (LDCT)
时间窗: 4 months after randomization
Completion of LDCT lung cancer screening, determined by electronic health record review.
Completion of lung cancer screening with low-dose computed tomography (LDCT)
时间窗: 8 months after randomization
Completion of LDCT lung cancer screening, determined by electronic health record review.
次要结局
- Completion of any chest CT(4 months after randomization)
- Completion of any chest CT(8 months after randomization)
- Ordering of low-dose computed tomography (LDCT)(4 months after randomization)
- Ordering of low-dose computed tomography (LDCT)(8 months after randomization)
- Discussion of lung cancer screening with a primary care provider(4 months after enrollment)
- Discussion of lung cancer screening with a primary care provider(8 months after enrollment)
- Lung cancer screening scheduling(4 months post-randomization)
- Patient knowledge of lung cancer screening(4 months after randomization)
- Decisional conflict regarding lung cancer screening(4 months after randomization)
- Perceived lung cancer risk(4 months after randomization)
- Perceived lung cancer severity(4 months after randomization)
- Perceived lung cancer screening benefits(4 months after randomization)
- Perceived lung cancer screening barriers(4 months after randomization)
- Perceived lung cancer screening self-efficacy(4 months after randomization)
研究者
Gelareh Sadigh
Associate Professor of Radiology
University of California, Irvine