Randomized Trial of Stepped Palliative Care versus Early Integrated Palliative Care in Patients with Advanced Lung Cancer

项目摘要 背景：早期综合姑息治疗(PC)，需要门诊患者每月去看PC临床医生 在整个疾病过程中为患者提供高级护理，改善了患者报告和 临终(EOL)护理结果。然而，很少有机构拥有足够数量的经过PC培训的临床医生 和资源，为所有晚期癌症患者提供每月与PC临床医生的访问。另外， 对于体力或体力状况较差的患者来说，可能没有必要经常去看PC临床医生 心理症状。分级护理是一种提高可获得性和效率的卫生服务提供模式 在受过专业训练的临床医生数量有限的情况下，这是一项重要的护理工作。在分级护理中，所有患者都得到护理 用最少的必要时间与训练有素的临床医生会面，但要系统地进行监测，以提高到更多 如果他们不能通过低强度治疗获得足够的健康收益，则应进行强化治疗。基于我们的 多学科团队在肿瘤学开发和研究早期集成PC方面的丰富经验，我们 建议将我们有效的门诊PC模式调整为分级护理策略，以确保所有患者都能访问PC 服务，同时根据患者的需要量身定做治疗提供。研究目标：这个多中心的具体目标 随机试验旨在证明阶梯式PC与标准护理早期集成PC相比并不逊色 关于它对生活质量(主要结果)的影响，以及患者与临床医生之间关于 临终关怀偏好和在临终关怀中心的停留时间。我们还将比较PC资源利用率和成本 两种交付模式的有效性。研究设计与方法：招生随机分配 480例新诊断的晚期肺癌患者(每组240例)接受阶梯式PC 或早期的集成PC。试验将在马萨诸塞州总医院、哥伦比亚大学和 杜克大学。被随机分配到阶梯式PC的患者将在登记时和在 在他们的疾病中有临床相关的要点。我们将每六周评估参与者的生活质量，以检测 逐步护理生活质量不断恶化的患者，以使他们能够每月访问PC。 被随机分配到早期集成PC的患者将在整个过程中参与PC临床医生的每月访问 他们的病程。除生活质量外，所有参与者都将完成评估其健康状况的测量 状态、情绪、应对方式、对预后的理解以及关于他们的EOL护理偏好的沟通 一年12周。我们还将从医疗记录和医院成本核算系统中收集数据 关于临终关怀使用、PC资源利用率和医疗保健成本。结论：早期集成PC改善了 患者报告的结果，包括生活质量和情绪，以及EOL护理的交付。基于数据 几个全国性组织推荐早期集成PC，这证明了这种护理模式的有效性 作为护理的标准。我们试图建立阶梯式PC模型与早期PC模型的非劣势 集成PC，作为一种更高效、更易访问、以患者为中心和可扩展的方法来提供早期PC。

Project Summary Background: Early integrated palliative care (PC), entailing monthly visits with a PC clinician in the outpatient setting throughout the course of illness for patients with advanced care, improves both patient-reported and end-of-life (EOL) care outcomes. However, few institutions possess a sufficient number of PC trained clinicians and resources to provide monthly visits with a PC clinician for all patients with advanced cancer. Additionally, such frequent visits with a PC clinician may not be necessary for patients with minimal physical or psychological symptoms. Stepped care is a health service delivery model to increase access to and efficiency of care when there is a limited number of specialty trained clinicians. In stepped care, all patients receive care with the minimal necessary time with the trained clinician, but are monitored systematically to “step up” to more intensive treatment if they do not achieve sufficient health gain with low intensity treatment. Based upon our multidisciplinary teams' extensive experience developing and studying early integrated PC in oncology, we propose to adapt our effective outpatient PC model to a stepped care strategy to ensure all patients access PC service, while tailoring treatment delivery to patients' needs. Study Aims: The specific aims of this multi-center randomized trial are to demonstrate the non-inferiority of stepped PC to standard-of-care early integrated PC with respect to its effects on quality of life (primary outcome), as well as patient-clinician communication about EOL care preferences and length of stay in hospice. We will also compare PC resource utilization and the cost effectiveness of the two delivery models. Study Design and Methods: We will enroll and randomly assign 480 patients newly diagnosed with advanced lung cancer (240 per study group) to receive either stepped PC or early integrated PC. The trial will take place at Massachusetts General Hospital, Columbia University, and Duke University. Patients randomized to stepped PC will meet with the PC clinician at enrollment and at clinically relevant points in their illness. We will assess participants' quality of life every six weeks to detect stepped care patients whose quality of life is deteriorating to allow them to step up to monthly PC visits. Patients randomized to early integrated PC will participate in monthly visits with the PC clinician throughout their course of illness. In addition to quality of life, all participants will complete measures to assess their health status, mood, coping, prognostic understanding, and communication about their EOL care preferences every 12 weeks for one year. We will also collect data from the medical record and hospital cost accounting system on hospice use, PC resource utilization, and health care costs. Conclusions: Early integrated PC improves patient-reported outcomes, including quality of life and mood, and the delivery of EOL care. Based upon data demonstrating the efficacy of this care model, several national organizations recommend early integrated PC as standard of care. We seek to establish the non-inferiority of a stepped PC model compared with early integrated PC, as a more efficient, accessible, patient-centered, and scalable approach to provide early PC.