Facilitation of Information eXchange for Shared Decision Making for Lung Cancer Screening
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Completion of Lung Cancer Screening (LCS) within 3 months
研究概览
简要总结
The goal of this pilot clinical trial is to learn whether the patient and provider support program, called FIX-SDM, helps patients and providers engage in shared decision-making for lung cancer screening during primary care visits and increases the number of patients who complete lung cancer screening. The investigators will also assess the acceptability of the support program and the feasibility of the study protocol to prepare for a future large-scale trial. The main questions this trial aims to answer are:
- Does the patient and provider support increase the number of patients who complete lung cancer screening?
- Does the patient and provider support help patients and health care providers engage more in shared decision-making and improve the quality of the patient's decision regarding lung cancer screening?
- Is the study protocol feasible? The investigators will compare the patient and provider support program to usual care to see if the support increases the number of patients who complete lung cancer screening.
Primary care provider participants will:
- Receive the provider support session and educational materials, or follow usual practice
- Answer a baseline survey and a follow-up survey in 6 months
- Answer additional survey questions regarding the acceptability of the provider support session if they receive it
Patient participants will
- Receive a smoking history survey, a decision aid, and text messages about lung cancer screening prior to the primary care visit, or receive usual care
- Complete the baseline survey and two follow-up surveys, one right after the primary care visit and another 3 months after the visit.
详细描述
Facilitation of Information eXchange for Shared Decision Making (FIX-SDM) for lung cancer screening is a multi-strategy implementation program designed to help patients eligible for lung cancer screening and their primary care providers (PCPs) prepare for shared decision-making (SDM). The investigators will conduct a cluster-randomized pilot study of FIX-SDM plus the standard electronic alert (e-alert) notification of a patient's possible lung cancer screening eligibility (FIX-SDM arm), compared with the standard e-alert notification alone (usual care comparison arm).
The investigators hypothesized that, compared to the usual care comparison arm, more patients in the FIX-SDM arm will complete lung cancer screening 3 months after the primary care visit. This study will also provide feasibility data and preliminary results to help prepare for a future large-scale trial.
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
- None
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
- 否
入选标准
- •Primary care provider (PCP) participants:
- •Inclusion criteria
- •PCPs (physicians or advanced practitioners)
- •Who practice in general internal medicine or family medicine clinics in UMass Memorial Health
- •Who care for more than 5 potentially LCS-eligible patients in their practice
排除标准
- •Participation in the previous study to co-develop the provider intervention (to avoid bias)
- •Patient participants
- •Inclusion Criteria:
- •Adults between the ages of 50 and 77
- •Meets criteria for Lung Cancer Screening (LCS) (Current eligibility includes: An individual who currently smokes or quit smoking within 15 years with at least a 20 pack-year smoking history)
- •Has a smartphone with texting capability
- •English-speaking
- •Has a scheduled PCP visit in the next ~3-6 weeks from study enrollment with one of the PCP participants enrolled in the study
- •Exclusion Criteria:
- •Prior LCS
- •Chest CT within the last 12 months
- •History of lung cancer
- •Active cancer requiring treatment
- •Supplemental oxygen use
- •Pregnancy
- •Participation in the previous study to co-develop the patient intervention (to avoid bias)
研究组 & 干预措施
FIX-SDM
Primary care providers (PCPs) will receive a support session and educational materials, in addition to the standard electronic alert (e-alert) notification of a patient's possible lung cancer screening eligibility implemented within the healthcare system.
Patients will receive a smoking history survey, a decision aid, and text messages about lung cancer screening prior to the primary care visit.
干预措施: FIX-SDM (Behavioral)
Comparator: Usual Care
PCPs will receive the standard e-alert notification implemented within the healthcare system (usual practice). Patients will receive the usual care.
干预措施: Usual Care (Behavioral)
结局指标
主要结局
Completion of Lung Cancer Screening (LCS) within 3 months
时间窗: 3 months after the index visit
The proportion of patients in each arm who completed LCS within 3 months of the index primary care visit
次要结局
- Completion of LCS within 6 months(6 months after the index visit)
- LCS order(3 and 6 months after the index visit)
- LCS appointment(3 and 6 months after the index visit)
- Patient-reported LCS discussion(Within 10 days after the index visit)
- Content of LCS discussion(Within 10 days after the index visit)
- Patient perceived quality of LCS discussion(Within 10 days after the index visit)
- Patient-reported shared decsion making (SDM) for LCS(Within 10 days after the index visit.)
- Patient knowledge of LCS(Within 10 days after the index visit.)
- Patient decisional conflict(Within 10 days after the index visit and 3 months after the index visit)
- Patient acceptability of FIX-SDM(Within 10 days after the index visit.)
- Patient decision satisfaction(3 months after the index visit)
- Patient decision regret(3 months after the index visit)
- Patient decision intention to follow-up LCS(3 months after the index visit)
- Provider acceptability of FIX-SDM(Immediately after the PCP intervention)
- Provider report on decision aid use(6 months after the provider baseline survey)
- Provider reports on the content of the LCS discussion(6 months after the provider baseline survey)
- Sustainability of shared decision making for LCS(6 months after the provider baseline survey)
研究者
Mayuko Ito Fukunaga
Assistant Professor of Medicine
University of Massachusetts, Worcester