An Intervention to Improve Outcomes in Patients with Advanced Cancer

描述（由申请人提供）：这项拟议的研究将对新诊断为晚期癌症的手术后癌症患者进行广泛测试的护理干预。当术后并发症高风险患者出院时，症状困扰、未满足的治疗目标、并发症、急诊和昂贵的再入院是常见的，患者的需求未得到满足，护理分散。该研究的总体目的是使用RE-AIM模型（覆盖、有效性、采用、实施、维护）实施我们基于证据的高级实践护士（APN）干预，以评估临床结局和肿瘤内科干预的可持续性。具体目标是：1）将出院计划整合到肿瘤APN为手术后高危晚期癌症患者提供的干预中; 2）评估APN为手术后晚期癌症患者提供的护理干预对改善临床结局、减少并发症和卫生保健利用的效果;及3）探讨APN提供的护理干预的范围、采用、实施和维护，以促进综合癌症中心患者从手术到内科肿瘤学的过渡。整群随机化程序将耶鲁综合癌症中心的疾病特异性医学肿瘤诊所分为2组：治疗组（将实施APN干预）和增强对照组（将提供标准常规护理加上症状管理工具包的副本及其使用说明）。从耶鲁纽黑文医院的外科病房招募的140名晚期癌症患者将提供结局数据，并在3个数据点（基线、术后1个月和3个月）进行比较。出院协调和APN干预的效果将使用自我报告问卷和卫生保健利用结果进行评估。采用、实施和维护过程变量将通过文档和访谈进行评估。该应用程序提供了一个独特的机会，可以实施我们的干预措施，将患者从住院治疗过渡到门诊治疗，并改善他们在整个疾病轨迹中的生活质量。结果将用于提交多中心临床试验。 公共卫生相关性：本研究将循证护理应用于新诊断为晚期癌症的手术后病人。干预措施将促进患者在服务（手术到内科肿瘤学）和环境（住院到门诊护理）之间的过渡。该干预措施将在诊断和治疗开始时启动患者对姑息治疗的介绍，以最大限度地提高他们在整个疾病轨迹中的旅程。

DESCRIPTION (provided by applicant): This proposed study will apply an extensively tested nursing intervention to post-surgical cancer patients who are newly diagnosed with advanced cancer. Symptom distress, unmet treatment goals, complications, emergency visits, and costly readmissions to the hospital are common when patients at high risk for post- operative complications are discharged from the hospital with unmet needs and fragmented care. The study's overall purpose is to implement our evidence based Advanced Practice Nurse (APN) intervention using the RE-AIM model (Reach, Efficacy, Adoption, Implementation, Maintenance) to evaluate clinical outcomes and the sustainability of the intervention in medical oncology. The specific aims are to: 1) Integrate discharge planning into an intervention provided by an oncology APN for high risk adults with advanced cancer after surgery; 2) Evaluate the effects of the nursing intervention provided by APNs to patients with advanced cancer after surgery to improve clinical outcomes, reduce complications and health care utilization; and 3) Explore the reach, adoption, implementation, and maintenance of a nursing intervention delivered by APNs to facilitate the transition of patients from surgery to medical oncology in a comprehensive cancer center. A cluster randomization procedure will assign disease specific medical oncology clinics at Yale Comprehensive Cancer Center into 2 groups: a treatment group (who will implement the APN intervention) and an enhanced control group (who will provide the standard usual care plus a copy of the symptom management toolkit with instructions on its use). One hundred and forty patients with advanced cancer recruited from the surgical units at Yale New Haven Hospital will provide outcome data that will be compared at 3 data points (baseline, 1 and 3 months post-surgery). The effects of the discharge coordination and APN intervention will be evaluated using self-report questionnaires and health care utilization outcomes. The adoption, implementation, and maintenance process variables will be evaluated through documentation and interviews. This application provides a unique opportunity to implement our intervention in transitioning patients across settings: in-patient to ambulatory care and improving the quality of their lives throughout the illness trajectory. The results will be used to submit a multi-site clinical trial. PUBLIC HEALTH RELEVANCE: This proposed study will apply an evidence-based nursing intervention to post-surgical patients who are newly diagnosed with advanced cancer. The intervention will facilitate patients' transitions between services (surgery to medical oncology) and settings (inpatient to ambulatory care). The intervention will jump start patients' introduction to palliative care at the beginning of their diagnosis and treatment in order to maximize their journey throughout the illness trajectory.