Provider Support and Patient Outreach in Lung Cancer Screening

我们建议在四个卫生系统中进行多水平干预随机试验（Christiana Care 卫生系统（CCHS），杰斐逊健康（JH），利哈伊谷健康网络（LVHN）和宾夕法尼亚州健康 （PSH）），以测试提供者支持干预和患者外展的综合和单独效果 在初级保健实践中对SDM和LCS干预。使用混合方法2x2析因设计，我们最初 将招募28名初级保健实践和提供者，并将其随机分配到提供者支持组（N=14） 或对照组（N=14）。在三年内，我们还将确定大约4，480名患者， 可能符合LCS的资格，并有计划的初级保健访视。每周，我们将分配 确定队列中的患者，并开始与每个队列进行电话联系，以验证筛选合格性， 同意，并完成基线调查。我们将至少672名患者随机分为 患者外展组（N=336）或对照组（N=336）。因此，审判将涉及提供方 支持+患者外展组、提供者支持组、患者外展组和对照组 组我们将收集卫生系统电子病历（EMR）数据、研究管理数据， 医生和患者调查数据，以及来自医生、执业人员、卫生系统护理人员的访谈数据。 协调员和卫生系统领导人，用于解决试验目的。审判的具体目的是 目标1.评估干预措施对肺癌筛查（LCS）的影响;目标2。评估干预措施 对共同决策的影响;目标3。确定筛选的中介者和主持者;以及，目标 4.评估干预措施的实施情况。我们将使用卫生系统的电子病历数据，研究管理数据， 提供者基线和终点调查数据，以及患者基线和终点调查数据，焦点小组数据， 和卫生系统领导者访谈数据，以确定影响的实践，提供者和患者层面的因素 干预对筛查的影响。就整体影响而言，这项试验将确定有效的战略， 提高初级保健中的SDM和LCS比率，并在卫生系统中实施有效战略。我们 将通过参与卫生系统的沟通渠道传播研究结果， 广泛地通过在ClinicalTrials.gov上报告结果，在卫生保健专业组织会议上，通过 地方、州和区域会议，并通过在同行评审期刊上发表文章。

We propose to conduct a multi-level intervention randomized trial in four health systems (Christiana Care Health System (CCHS), Jefferson Health (JH), Lehigh Valley Health Network (LVHN), and PennState Health (PSH)) to test the combined and separate effects of a provider support intervention and a patient outreach intervention on SDM and LCS in primary care practice. Using a mixed methods 2x2 factorial design, we initially will recruit and randomize 28 primary care practices and providers either to a Provider Support Group (N=14) or a Control Group (N=14). Over three years, we will also identify approximately 4,480 patients who are potentially eligible for LCS and have a scheduled primary care visit. On a weekly basis, we will allocate identified patients to cohorts and initiate telephone contact with each cohort to verify screening eligibility, obtain consent, and complete a baseline survey. We will randomize at least 672 patient participants either to a Patient Outreach Group (N=336) or a Control Group (N=336). Thus, the trial will involve a Provider Support + Patient Outreach Group, a Provider Support Group, a Patient Outreach Group, and a Control Group. We will collect health system electronic medical records (EMRs) data, study administrative data, physician and patient survey data, and interview data from physicians, practice staff, health system care coordinators, and health system leaders for use in addressing trial aims. Specific aims of the trial are as follows: Aim 1. Assess intervention impact on Lung Cancer Screening (LCS); Aim 2. Assess intervention impact on Shared Decision Making (SDM); Aim 3. Identify mediators and moderators of screening; and, Aim 4. Assess intervention implementation. We will use health system EMR data, study administrative data, provider baseline and endpoint survey data, and patient baseline and endpoint survey data, focus group data, and health system leader interview data to identify practice-, provider- and patient-level factors that impact intervention effects on screening. In terms of overall impact, this trial will identify effective strategies for increasing SDM and LCS rates in primary care and for implementing effective strategies in health systems. We will disseminate study findings through communication channels in participating health systems and more broadly by reporting results on ClinicalTrials.gov, at health care professional organization meetings, through local, state and regional conferences, and via publications in peer-reviewed journals.