Integrating Telehealth to Advance Lung Cancer Screening
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 6,000
- 试验地点
- 2
- 主要终点
- Shared decision making (SDM) for lung cancer screening (LCS)
研究概览
简要总结
The goal of this pragmatic trial is to learn if telehealth strategies can increase shared decision-making (SDM) for lung cancer screening (LCS). It will also learn about the equity of these strategies by conducting non-inferiority analysis by race and sex. The main questions it aims to answer are:
- Does patient outreach using synchronous and asynchronous telehealth strategies increase completion of SDM visits for LCS?
- Is the effectiveness of these telehealth strategies similar by race and sex?
The study uses a Sequential Multiple Assignment Randomized Trial (SMART) design and includes two stages of interventions. The first stage of intervention includes direct patient outreach with an invitation to schedule either a 1) telehealth SDM visit or 2) telehealth or in-person SDM visit. Participants that do not respond to the first stage interventions receive a text message reminder encouraging SDM visit completion with or without digital care coordination.
详细描述
Annual lung cancer screening using low-dose computed tomography (LDCT) is associated with decreased lung cancer mortality but also with harms. As such, it is recommended, and required for reimbursement, that patients complete an shared decision-making visit (SDM) prior to screening to discuss potential risks and benefits in the context of patient values. Despite guidelines recommending screening and national insurance coverage of LDCT, uptake of SDM visits and subsequent LDCT is remarkably low. We aim to address these gaps by comparing the effectiveness of synchronous and asynchronous telehealth strategies on SDM visits and subsequent LDCT in a pragmatic trial using a Sequential Multiple Assignment Randomized Trial (SMART) design. The specific first stage strategies to be tested are: a) Active Choice Outreach (invitation to schedule a telehealth or in-person SDM visit) vs b) Telehealth Only Outreach (invitation to schedule a telehealth SDM visit). The specific second stage strategies (delivered only if participants do not respond to first stage interventions) are a) text message reminders encouraging SDM visit completion (low-touch) alone or b) in combination with phone-based digital care coordination (high-touch). We will also assess non-inferiority of strategies by race and sex to assess equity of effectiveness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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
- •Participants will be eligible if:
- •are aged 50 to 80
- •have a history of tobacco use indicated by either: Documented 20 pack-year or greater smoking history in their electronic health record (EHR); OR Self-report via structured survey
- •currently smoke or formerly smoked cigarettes
- •have no documented history of lung cancer
- •have no documented history of lung cancer screening in the 24 months prior to study enrollment
- •have completed at least one primary care visit at Penn Medicine in the 3 years prior to study enrollment.
排除标准
- •Participants who do not meet inclusion criteria will not be eligible.
研究组 & 干预措施
Active Choice (Stage 1) + Low Touch (Stage 2)
Participants in this arm will be offered the option via outreach letter to complete an SDM visit via telehealth or in-person (Stage 1) and if individuals do not schedule an SDM visit within 30 days (non-responders), they will receive asynchronous text messages alone (Stage 2)
干预措施: Active Choice (Behavioral)
Active Choice (Stage 1) + Low Touch (Stage 2)
Participants in this arm will be offered the option via outreach letter to complete an SDM visit via telehealth or in-person (Stage 1) and if individuals do not schedule an SDM visit within 30 days (non-responders), they will receive asynchronous text messages alone (Stage 2)
干预措施: Low Touch Strategy (Behavioral)
Active Choice (Stage 1) + High Touch (Stage 2)
Participants in this arm will be offered the option via outreach letter to complete an SDM visit via telehealth or in-person (Stage 1) and if individuals do not schedule an SDM visit within 30 days (non-responders), they will receive asynchronous text messages in combination with synchronous digital care coordination (Stage 2).
干预措施: Active Choice (Behavioral)
Active Choice (Stage 1) + High Touch (Stage 2)
Participants in this arm will be offered the option via outreach letter to complete an SDM visit via telehealth or in-person (Stage 1) and if individuals do not schedule an SDM visit within 30 days (non-responders), they will receive asynchronous text messages in combination with synchronous digital care coordination (Stage 2).
干预措施: High Touch Strategy (Behavioral)
Telehealth Only (Stage 1) + Low Touch (Stage 2)
Participants in this arm will be offered the option via outreach letter to complete an SDM visit via telehealth only (Stage 1) and if individuals do not schedule an SDM visit within 30 days (non-responders), they will receive asynchronous text messages alone (Stage 2).
干预措施: Telehealth Only (Behavioral)
Telehealth Only (Stage 1) + Low Touch (Stage 2)
Participants in this arm will be offered the option via outreach letter to complete an SDM visit via telehealth only (Stage 1) and if individuals do not schedule an SDM visit within 30 days (non-responders), they will receive asynchronous text messages alone (Stage 2).
干预措施: Low Touch Strategy (Behavioral)
Telehealth Only (Stage 1) + High Touch (Stage 2)
Participants in this arm will be offered the option via outreach letter to complete an SDM visit via telehealth only (Stage 1) and if individuals do not schedule an SDM visit within 30 days (non-responders), they will receive asynchronous text messages in combination with synchronous digital care coordination (Stage 2).
干预措施: Telehealth Only (Behavioral)
Telehealth Only (Stage 1) + High Touch (Stage 2)
Participants in this arm will be offered the option via outreach letter to complete an SDM visit via telehealth only (Stage 1) and if individuals do not schedule an SDM visit within 30 days (non-responders), they will receive asynchronous text messages in combination with synchronous digital care coordination (Stage 2).
干预措施: High Touch Strategy (Behavioral)
结局指标
主要结局
Shared decision making (SDM) for lung cancer screening (LCS)
时间窗: 90 days after randomization
Completion of an SDM visit (in person or telehealth) defined as any completed encounter that has documented SDM for LCS as indicated by 1) procedure code (G0296 or equivalent), or documentation of SDM conversation related to LCS in associated progress notes.
次要结局
- Low-dose computed tomography (LDCT)(6 months after randomization)
研究者
Katharine Rendle
Associate Professor
Abramson Cancer Center at Penn Medicine