A Pragmatic Randomized-Controlled Trial of a Digital Outreach Intervention for Lung Cancer Screening: mPATH-Lung (Mobile Patient Technology for Health-Lung)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26,998
- 试验地点
- 2
- 主要终点
- Number of Participants With Electronic Health Record-verified Completion of a Chest CT Scan
研究概览
简要总结
mPATH-Lung (mobile Patient Technology for Health - Lung) is an innovative digital outreach program that identifies patients who qualify for lung cancer screening and helps them get screened. The study will: 1) Determine the effect of mPATH-Lung on receipt of lung cancer screening in a pragmatic randomized-controlled trial conducted with primary care patients in two large health networks, 2) Elucidate the drivers of patients' screening decisions and screening behavior; and 3) Explore implementation outcomes that will impact the sustainability and dissemination of mPATH-Lung using program data, surveys, and interviews.
This project will determine how mPATH-Lung affects patients' screening decisions and their completion of screening.
详细描述
Primary Objective: Determine the effectiveness of mPATH-Lung on receipt of LCS in a randomized pragmatic clinical trial of 1318 patients recruited from two large health networks, Wake Forest Baptist Health and the University of North Carolina at Chapel Hill.
Secondary Objectives:
- Elucidate the drivers of patients' decisions to receive or forgo LCS through a values clarification exercise embedded within mPATH-Lung and supplemental semi-structured interviews of at least 50 patients.
- Assess several critical implementation outcomes (reach, acceptability, and appropriateness) to inform the sustainability and scalability of mPATH-Lung across diverse primary care settings
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 77 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Meet the Medicare criteria for lung cancer screening, as updated in February 2022:
- •Age 50 - 77 years
- •Smoked at least 20 pack years
- •Current smoker or quit smoking within the past 15 years
- •Be scheduled to see a primary care provider within the health network in the next 3-4 weeks
- •Have a patient portal account or cellphone number listed in the electronic health record
排除标准
- •Patients flagged as needing a language interpreter in the electronic health record (electronic messages and intervention is delivered in English only).
- •Those for whom lung cancer screening would be inappropriate:
- •Prior history of lung cancer
- •Chest CT within the last 12 months
- •Those with medical conditions predicting shorter life expectancy
- •Patients whose home address is not within the state of North Carolina. (Due to telehealth guidelines)
研究组 & 干预措施
mPATH-Lung
Participants randomized to the mPATH arm will be shown a 5-minute animated LCS decision aid video, personalized risk/benefit information, and a values clarification exercise. The participants in this group will be given an option to request a screening appointment via the program.
干预措施: mPATH-Lung (Other)
Usual care (CONTROL)
Participants randomized to the control arm will be advised that they qualified for lung cancer screening and directed to speak with their provider if interested. The web app then displayed a 5-minute video about exercise for lung health before ending. They will not be offered the opportunity to estimate their predicted benefits and harms of screening or to request a lung cancer screening visit.
干预措施: Lung health video (Other)
结局指标
主要结局
Number of Participants With Electronic Health Record-verified Completion of a Chest CT Scan
时间窗: Within 16 weeks of enrollment
Participants who have completed any chest CT within 16 weeks of study randomization, as determined by electronic health record review
次要结局
- Proportion of Patients With LCS Scans Ordered(16 weeks)
- Proportion of Patients With LCS Clinic Visits Scheduled(16 weeks)
- LCS Screening Decision(Up to 16 weeks after day of enrollment)
- Proportion of Patients With LCS Clinic Visits Completed(16 weeks)
- LCS Clinic Referral Requested Through mPATH(16 weeks)
- Lung Cancer Screening Test Results(16 weeks)
- Number of LCS False Positives(1 year)
- Invasive Procedures Following LCS Scan(1 year)
- Proportion of Patients With Complications Following LCS(1 year)
- Number of Diagnosed Lung Cancers(16 months after randomization)
- How Diagnosed Lung Cancers Were Detected(16 months after randomization)
- Stage of Lung Cancers Diagnosed(16 months after randomization)
- Overscreening(1 year)
- Reach of Digital Outreach Strategy(16 weeks)
- Completion of mPATH-Lung Program(16 weeks)