Population Health Management Approaches to Increase Lung Cancer Screening in Community Health Centers - UG3 Pilot Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Engagement - Lung Cancer Screening (LCS)
研究概览
简要总结
LungSMART Utah utilizes a Population Health Management (PHM) approach that addresses key barriers to Lung Cancer Screening (LCS) implementation by deploying a centralized Hub infrastructure for eligibility assessment, individualized risk assessment and Shared Decision Making (SDM), LCS referral, and screening completion assistance, thereby increasing LCS reach at scale among Community Health Centers (CHCs) patients across the state of Utah.
详细描述
LungSMART Utah is a Sequential Multiple Assignment Randomized Trial (SMART) that promotes the reach of lung cancer screening (LCS) among patients who receive medical services at Utah Community Health Centers (CHCs). The study design consists of two sequential stages: an Eligibility Assessment phase to identify and engage individuals at risk to participate in a shared decision-making (SDM) session to assess LCS eligibility, recommendation, and preference, followed by an LCS Completion phase to promote follow-through with recommended screening.
In this pilot trial, 50 current or former tobacco users aged 50-80 who receive medical services at the Mountainlands CHC and have no recorded history of lung cancer and have not participated in a SDM about LCS will be identified for the study. In the Eligibility Assessment Phase, patients will be assessed for LCS eligibility through digital health interventions and, if eligible, will engage with a qualified registered nurse (RN) at a centralized "Hub" for a SDM session, with and be offered a referral for LCS if screening is recommended and preferred. Phase 1 interventions include repeated text messaging (TM+), conversational agent (CA), and educational video (VID) to engage patients in a SDM session. The LCS Completion phase evaluates telehealth interventions designed to address logistical barriers and hesitancy among referred patients in completing LCS. Interventions include CA and either proactive- or reactive-patient navigation (PN) to increase LCS completion among CHC patients. Clinic staff will also be queried to examine if further refinement of research workflow and procedures is needed. Mountainlands CHC has agreed to partner with us to recruit patient participants for this pilot study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is currently a patient at Mountainlands CHCs
- •Speak English or Spanish
- •Current or former male or female smokers
- •Age 50-80
- •Have a phone that can receive text messages
- •Electronic health records indicate they have not opted out of receiving text contact from the clinic
排除标准
- •Persons with lung cancer or previous SDM
研究组 & 干预措施
Repeated Text Messages (TM+)
Repeated text messages notifying patients that they may be eligible for Lung Cancer Screening (LCS).
干预措施: Repeated Text Messages (TM+) (Other)
Repeated Text Messages plus a Conversational Agent (TM+, CA)
Repeated text messages notifying patients that they may be eligible for LCS. In addition to text messages, patients will receive an automated, scripted, and interactive CA.
干预措施: Repeated Text Messages (TM+) (Other)
Repeated Text Messages plus a Conversational Agent (TM+, CA)
Repeated text messages notifying patients that they may be eligible for LCS. In addition to text messages, patients will receive an automated, scripted, and interactive CA.
干预措施: Conversational Agent (CA) (Other)
Repeated Text Messages plus a Video (TM+, Video)
Repeated text messages notifying patients that they may be eligible for LCS. In addition to text messages, patients will receive an educational video sent directly to their cell phone.
干预措施: Repeated Text Messages (TM+) (Other)
Repeated Text Messages plus a Video (TM+, Video)
Repeated text messages notifying patients that they may be eligible for LCS. In addition to text messages, patients will receive an educational video sent directly to their cell phone.
干预措施: Educational Video (Other)
Repeated Text Messages plus a Conversational Agent and Video (TM+, CA, Video)
Repeated text messages notifying patients that they may be eligible for LCS. In addition to text messages, patients will receive an educational video sent directly to the patient's cell phone, along with a conversational agent to answer frequently asked LCS questions.
Additionally, patients will receive an educational video sent directly to the patient's cell phone and a chatbot to answer frequently asked LCS questions.
干预措施: Repeated Text Messages (TM+) (Other)
Repeated Text Messages plus a Conversational Agent and Video (TM+, CA, Video)
Repeated text messages notifying patients that they may be eligible for LCS. In addition to text messages, patients will receive an educational video sent directly to the patient's cell phone, along with a conversational agent to answer frequently asked LCS questions.
Additionally, patients will receive an educational video sent directly to the patient's cell phone and a chatbot to answer frequently asked LCS questions.
干预措施: Conversational Agent (CA) (Other)
Repeated Text Messages plus a Conversational Agent and Video (TM+, CA, Video)
Repeated text messages notifying patients that they may be eligible for LCS. In addition to text messages, patients will receive an educational video sent directly to the patient's cell phone, along with a conversational agent to answer frequently asked LCS questions.
Additionally, patients will receive an educational video sent directly to the patient's cell phone and a chatbot to answer frequently asked LCS questions.
干预措施: Educational Video (Other)
CA/PPN
A conversational agent to answer frequently asked LCS questions. In addition to proactive patient navigation.
干预措施: Conversational Agent (CA) (Other)
CA/PPN
A conversational agent to answer frequently asked LCS questions. In addition to proactive patient navigation.
干预措施: Proactive Patient Navigation (PPN) (Other)
CA/RPN
A conversational agent to answer frequently asked LCS questions. In addition to reactive patient navigation.
干预措施: Conversational Agent (CA) (Other)
CA/RPN
A conversational agent to answer frequently asked LCS questions. In addition to reactive patient navigation.
干预措施: Reactive Patient Navigation (RPN) (Other)
结局指标
主要结局
Engagement - Lung Cancer Screening (LCS)
时间窗: up to 3 months from study enrollment
This outcome measure will report the proportion of enrolled subjects who engaged with Lung Cancer Screening (LCS) text messages during the study period. LCS Engagement will be defined as any documented interaction with the text messaging system, as recorded by the study platform.
Engagement - Shared Decision Making (SDM)
时间窗: up to 3 months from study enrollment
This outcome measure will report the proportion of enrolled subjects who engaged with Shared Decision Making (SDM) conversations during the study period. SDM Engagement will be defined as any documented interaction with SDM conversations, as recorded in study documentation.
次要结局
- Trustworthiness(up to 3 months from study enrollment)
- Acceptability(up to 3 months from study enrollment)
- Usefulness(up to 3 months from study enrollment)