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），需要每月在门诊与PC临床医生进行访视， 在整个疾病过程中为患者提供先进的护理，改善了患者报告的 临终（EOL）护理结果。然而，很少有机构拥有足够数量的PC培训的临床医生 和资源，为所有晚期癌症患者提供PC临床医生的每月访问。此外，本发明还 对于具有最小的身体或精神状况的患者， 心理症状。阶梯式保健是一种保健服务提供模式，以提高获得保健服务的机会和效率。 当经过专业培训的临床医生数量有限时，在分级护理中，所有患者都接受护理 与训练有素的临床医生在一起的必要时间最少，但系统地监测，以“逐步”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，则应接受强化治疗。根据我们 多学科团队在开发和研究肿瘤学早期集成PC方面的丰富经验， 我建议将我们有效的门诊PC模式调整为阶梯式护理策略，以确保所有患者都能使用PC 服务，同时根据患者的需要提供治疗。研究目的：该多中心的具体目的 一项随机试验旨在证明阶梯式PC相对于标准治疗早期整合PC的非劣效性 关于其对生活质量（主要结局）的影响，以及患者-临床医生关于 临终关怀偏好和临终关怀的停留时间。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。研究设计和方法：我们将招募并随机分配 480例新诊断为晚期肺癌的患者（每个研究组240例）接受阶梯式PC 早期的PC集成。试验将在马萨诸塞州总医院、哥伦比亚大学和 杜克大学。随机分配至步进PC的患者将在入组时和 与他们的疾病有临床相关的点。我们将每六周评估参与者的生活质量， 生活质量恶化的分级护理患者，使他们能够增加到每月PC访视。 随机分配至早期整合PC的患者将在整个过程中参加PC临床医生的每月访视 他们的病程。除了生活质量，所有参与者将完成评估其健康状况的措施 状态，情绪，应对，预后的理解和沟通，他们的EOL护理偏好， 一年12周。我们亦会从医疗纪录及医院成本会计系统收集数据 临终关怀使用，PC资源利用率和医疗保健成本。结论：早期整合PC改善 患者报告的结局，包括生活质量和情绪，以及EOL护理的提供。基于数据 为了证明这种护理模式的有效性，一些国家组织建议早期整合PC 作为护理标准。我们试图建立一个逐步PC模型与早期相比的非劣效性。 集成PC，作为一种更有效、更易于访问、以患者为中心且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.