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Increasing Lung Cancer Screening Among Emergency Department Patients - LCS R01

2026年4月28日 更新者:David Adler、University of Rochester

Increasing Lung Cancer Screening Uptake Among Emergency Department Patients - LCS R01

This randomized clinical trial evaluates the effectiveness of text messaging and facilitated referral strategies to increase lung cancer screening uptake among emergency department patients who meet lung cancer screening eligibility criteria.

研究概览

详细说明

This randomized clinical trial will evaluate strategies to improve lung cancer screening uptake among emergency department patients who meet lung cancer screening eligibility criteria based on age and smoking history. Participants will be randomized using a 2 by 2 factorial design into one of four groups: basic referral, basic referral plus text messaging, facilitated referral, or facilitated referral plus text messaging.

The basic referral strategy includes verbal referral to the lung cancer screening program and primary care provider, if applicable, along with written contact information for the lung cancer screening program navigator. The facilitated referral strategy includes submission of a lung cancer screening requisition to the lung cancer screening program on behalf of the participant during the emergency department visit.

The text messaging intervention includes a series of theory informed messages designed to increase intention and motivation to complete lung cancer screening. Lung cancer screening uptake will be assessed at 120 days after enrollment using participant follow up and electronic health record review.

研究类型

介入性

注册 (估计的)

1036

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Age 50 - 80
  • ≥ 20 pack-year smoking history
  • current smoker or quit within 15 years
  • English/Spanish speaking
  • Registered in the Emergency Department as a patient

Exclusion Criteria:

  • Non-English/Spanish
  • Inability to provide consent (e.g. high clinical acuity, cognitive deficit)
  • Lack of text-capable mobile phone and/or inability to use text function

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:放映
  • 分配:随机化
  • 介入模型:阶乘赋值
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
有源比较器:Basic Referral (enhanced control arm)
Participants assigned to this arm will be notified that they are eligible and meet federal recommendations for lung cancer screening. They will be verbally referred to a lung cancer screening program and their primary care provider (if they have one) to discuss lung cancer screening. They will also be provided with written materials that include telephone contact information for the lung cancer screening program navigator. If contacted, the LCS Program Navigator will conduct a discussion, schedule a screening CT scan at one of the 8 regional American College of Radiology-designated lung cancer screening centers and arrange clinical follow-up as needed.
Participants are verbally referred to the lung cancer screening program and their primary care provider if applicable. Written materials with contact information for the lung cancer screening program navigator are provided.
实验性的:Basic Referral plus Text Messaging
Participants assigned to this arm will receive the basic referral as described in the previous arm. In addition, they will receive a series of text messages, aimed at generating intention and motivation to get lung cancer screening. Patients will receive a total of 9 messages.
Participants are verbally referred to the lung cancer screening program and their primary care provider if applicable. Written materials with contact information for the lung cancer screening program navigator are provided.
Participants receive a series of up to 9 theory informed text messages designed to increase awareness, motivation, and completion of lung cancer screening.
有源比较器:Facilitated Referral
Participants assigned to this arm will be notified that they are eligible and meet federal recommendations for lung cancer screening. Rather than the basic referral received in the arms above, a lung cancer screening requisition form will be submitted to the lung cancer screening program on behalf of the participant during their emergency department visit.
A lung cancer screening requisition form is submitted to the lung cancer screening program on behalf of the participant during the emergency department visit. The screening program will contact the participant to discuss screening and schedule a low dose CT scan if appropriate.
实验性的:Facilitated Referral plus Text Messaging
Participants assigned to this arm will receive facilitated referral plus the series of text messages described above. Among these participants, contact with the lung cancer screening program is likely to occur after receipt of the initial text messages but prior to receipt of all text messages.
Participants receive a series of up to 9 theory informed text messages designed to increase awareness, motivation, and completion of lung cancer screening.
A lung cancer screening requisition form is submitted to the lung cancer screening program on behalf of the participant during the emergency department visit. The screening program will contact the participant to discuss screening and schedule a low dose CT scan if appropriate.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Proportion of Participants Who Complete Lung Cancer Screening Within 120 Days After Enrollment
大体时间:Up to 120 Days After Enrollment
Lung cancer screening uptake is defined as completion of a low dose computed tomography scan for lung cancer screening within 120 days after enrollment. Screening completion will be confirmed using electronic health record review, lung cancer screening program records, or participant self report obtained during follow up. The outcome is reported as the proportion of participants who complete screening.
Up to 120 Days After Enrollment

次要结果测量

结果测量
措施说明
大体时间
Proportion of Participants Who Participate in Shared Decision Making for Lung Cancer Screening Within 120 Days After Enrollment
大体时间:Up to 120 Days After Enrollment
Participation in shared decision making is defined as documentation of a shared decision making discussion regarding lung cancer screening or participant self report of completing such a discussion within 120 days after enrollment. The outcome is reported as the proportion of participants who participate in shared decision making.
Up to 120 Days After Enrollment
Frequency of Reported Barriers to Lung Cancer Screening at 120 Days
大体时间:120 Days After Enrollment
Barriers to lung cancer screening are assessed using participant responses to a structured questionnaire administered at follow up. The questionnaire includes items on transportation challenges, cost concerns, scheduling difficulties, and fear of screening results. The outcome is reported as the number and proportion of participants reporting each barrier.
120 Days After Enrollment
Acceptability of Emergency Department Based Lung Cancer Screening Interventions at 120 Days
大体时间:Up to 120 Days After Enrollment
Acceptability is assessed using participant responses to Likert scale questionnaire items evaluating the degree to which participants find the emergency department based lung cancer screening interventions acceptable. Each item is scored on a 5 point Likert scale ranging from 1 to 5, with higher scores indicating greater acceptability. The outcome is reported as summary scores based on participant responses.
Up to 120 Days After Enrollment
Appropriateness of Emergency Department Based Lung Cancer Screening Interventions at 120 Days
大体时间:120 Days After Enrollment
Appropriateness is assessed using participant responses to Likert scale questionnaire items evaluating the perceived fit and relevance of emergency department based lung cancer screening interventions. Each item is scored on a 5 point Likert scale ranging from 1 to 5, with higher scores indicating greater perceived appropriateness. The outcome is reported as summary scores based on participant responses.
120 Days After Enrollment
Frequency of Reported Facilitators to Lung Cancer Screening at 120 Days
大体时间:120 Days After Enrollment
Facilitators to lung cancer screening are assessed using participant responses to a structured questionnaire administered at follow up. The questionnaire includes items related to factors such as access to care, health literacy, prior healthcare engagement, and presence of a primary care provider. The outcome is reported as the number and proportion of participants reporting each facilitator.
120 Days After Enrollment

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2027年3月1日

初级完成 (估计的)

2030年12月1日

研究完成 (估计的)

2031年12月1日

研究注册日期

首次提交

2026年4月27日

首先提交符合 QC 标准的

2026年4月28日

首次发布 (实际的)

2026年5月5日

研究记录更新

最后更新发布 (实际的)

2026年5月5日

上次提交的符合 QC 标准的更新

2026年4月28日

最后验证

2026年4月1日

更多信息

与本研究相关的术语

其他研究编号

  • FP00007604

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

IPD 计划说明

Undecided

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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