An Intervention to Improve Outcomes in Patients with Advanced Cancer

描述（由申请人提供）：本研究将对新诊断为晚期癌症的术后癌症患者进行广泛测试的护理干预。症状窘迫、治疗目标未实现、并发症、急诊和昂贵的再入院是术后并发症高风险患者出院时未满足需求和零散护理的常见情况。本研究的总体目的是使用RE-AIM模型（Reach, Efficacy, Adoption, Implementation, Maintenance）来实施我们基于证据的高级执业护士（APN）干预，以评估临床结果和肿瘤医学干预的可持续性。具体目的是：1)将出院计划纳入肿瘤APN对手术后晚期癌症高危成人的干预；2)评价APNs对晚期癌症患者术后护理干预的效果，改善临床疗效，减少并发症，提高医疗服务利用率；3)探讨综合癌症中心apn护理干预的范围、采用、实施和维护，促进患者从外科向内科肿瘤的过渡。集群随机化程序将耶鲁大学综合癌症中心的特定疾病肿瘤医学诊所分为两组：治疗组（实施APN干预）和强化对照组（提供标准常规护理和症状管理工具包副本及其使用说明）。从耶鲁大学纽黑文医院外科部门招募的140名晚期癌症患者将提供3个数据点（基线、术后1个月和3个月）的结果数据进行比较。出院协调和APN干预的效果将通过自我报告问卷和卫生保健利用结果进行评估。采用、实现和维护过程变量将通过文档和访谈进行评估。这个应用程序提供了一个独特的机会来实施我们的干预，使患者在不同的环境中过渡：住院病人到门诊护理，并在整个疾病轨迹中提高他们的生活质量。结果将用于提交多地点临床试验。

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.