Centralized Lung Cancer Screening Engagement in At-Risk Populations (CLEAR)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 2,000
- 试验地点
- 2
- 主要终点
- Proportion of individuals completing low-dose CT (LDCT) within 15 months of randomization.
研究概览
简要总结
This study will assess the impact of centralized outreach on lung cancer screening completion among individuals served by Federally Qualified Health Centers.
详细描述
This will be a two-arm, parallel, pragmatic randomized controlled trial (RCT) to evaluate the effectiveness of a centralized patient outreach strategy in increasing lung cancer screening (LCS) completion among populations served by Federally Qualified Health Centers (FQHCs). This study will randomize individuals potentially eligible for LCS (50-80 years, current or past smokers) to receive centralized patient outreach in addition to usual care (outreach arm) and usual care alone (usual care arm). Individuals assigned to the outreach arm will receive centralized patient outreach from the Lung screening team through a letter followed by up to three attempts of telephone contact. Individuals assigned to the usual care arm will not receive any contact during the study period and the referral for LCS will be made at the treating physician's discretion.
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
- •Adults aged 50 to 80 years
- •Current or past smokers
- •Individuals without a recorded LDCT scan within the past year
- •Individuals without a prior lung cancer diagnosis
- •Active patients of Ryan Health
- •Individuals with a mailing address in the New York City area and a phone number on file
排除标准
- •Individuals aged less than 50 or above 80 years
- •Individuals without smoking history
- •Individuals with a recorded LDCT scan within the past year
- •Individuals with a prior lung cancer diagnosis
- •Individuals without a mailing address in the New York City area or a phone number on file
- •Individuals served by one of Ryan Health clinics where the centralized patient outreach was developed
研究组 & 干预措施
Outreach arm
Individuals in the outreach arm will receive centralized patient outreach for lung cancer screening in addition to usual care.
干预措施: Centralized patient outreach for lung cancer screening (Behavioral)
Usual care arm
Individuals in the usual care arm will receive usual care and will not receive any outreach contacts (mail or telephone) within 15 months after randomization.
结局指标
主要结局
Proportion of individuals completing low-dose CT (LDCT) within 15 months of randomization.
时间窗: Within 15 months of randomization
次要结局
- Average costs of implementing centralized outreach per individual(Within 15 months of randomization)
- LDCT scan findings: Lung Imaging Reporting and Data System (Lung-RADS)(Within 15 months of randomization)
- LDCT incident findings(Within 15 months of randomization)
- Follow-up care(Within 6 months after screening)