A cluster randomized trial of a primary palliative care intervention (CONNECT) for patients with advanced cancer

针对晚期癌症患者进行初级姑息治疗干预 (CONNECT) 的整群随机试验

• 批准号: 9103638
• 负责人: Yael Schenker
• 金额: $ 60.22万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-06-01 至 2021-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9103638
• 关键词: Address; Advance Care Planning; Advanced Malignant Neoplasm; Affect; American; Anxiety; Attention; Cancer Center; Care given by nurses; Caregiver Burden; Caregivers; Caring; Chronic Care; Chronic Disease; Clinic; Clinical; Clinical Oncology; Cluster randomized trial; Communication; Community Clinical Oncology Program; Dose; Emotional; Family; Funding; Future; Goals; Health system; Healthcare; Hospitalization; Hospitals; Inpatients; Intervention; Interview; Lead; Leadership; Learning; Malignant Neoplasms; Measures; Mental Depression; Modeling; Moods; Morbidity - disease rate; Nurses; Oncologic Nursing; Oncologist; Oncology Nurse; Organizational Change; Outcome; Outcome Measure; Palliative Care; Patient Care; Patients; Population; Process; Public Health; Quality of life; Research; Resources; Services; Specialist; Supportive care; Symptoms; Testing; Time; Training; United States National Institutes of Health; Work; anxiety symptoms; base; cancer care; care systems; caregiver depression; chemotherapy; chronic care model; cost; cost effective; depressive symptoms; efficacy testing; emotional symptom; end of life; experience; follow-up; health care service utilization; hospice environment; improved; innovation; insight; medical specialties; member; novel; oncology; physical symptom; primary outcome; psychologic; psychological distress; public health relevance; randomized trial; reduce symptoms; skills; successful intervention; survival outcome; symptom management; treatment as usual

 DESCRIPTION (provided by applicant): Patients with advanced cancer experience steep declines in quality of life and receive non-beneficial aggressive treatments near the end of life. Their caregivers suffer from high rates of burden and psychological distress. Deficiencies in standard oncology care-including inadequate attention to symptom control, emotional support, and engagement in advance care planning-contribute to morbidity in this population. While early co- management by a palliative care specialist may improve patient and caregiver outcomes, this is not a practical solution for most patients with cancer because of workforce shortages. A practical solution to mitigating these public health problems will require `primary' palliative care interventions-meaning palliative care that is integrated within oncology practices and delivered by clinicians who are not specialists. CONNECT (Care management by Oncology Nurses to address supportive care needs) is an oncology practice- based primary palliative care intervention that was developed and successfully pilot-tested in work funded by the National Palliative Care Research Center and the NIH. Conceptually grounded in Wagner's chronic care model, CONNECT employs an oncology nurse-led care management approach to (1) address patients' symptom needs, (2) engage patients and caregivers in advance care planning, (3) provide emotional support to patients and caregivers, and (4) communicate with oncologists and coordinate appropriate care. The objective of this proposal is to test the efficacy of CONNECT in a cluster-randomized trial conducted among 672 patients with advanced cancer and their caregivers receiving care at 16 community oncology clinics. Aim 1 assesses the effects of CONNECT on patient quality of life (primary outcome, measured using the Functional Assessment of Chronic Illness Therapy - Palliative Care), symptom burden (Edmonton Symptom Assessment Scale), and depression and anxiety symptoms (Hospital Anxiety and Depression Scale). Aim 2 assesses the effects of CONNECT on caregiver burden (Zarit Burden Interview-Short) and caregiver depression and anxiety symptoms (Hospital Anxiety and Depression Scale). Aim 3 assesses the effects of CONNECT on healthcare resource use. All patient and caregiver outcomes will be assessed at 3 months, a time-point chosen to allow an adequate "dose" of the intervention while minimizing loss to follow-up in a seriously ill population. Healthcare utilization, cost outcomes, and survival will be measured for up to one year to understand effects that may persist beyond the intervention period. The CONNECT intervention will have a high impact if successful because it will be a pragmatic solution to important public health problems that potentially affect more 600,000 patients who die annually with advanced cancer and their caregivers. It is innovative in shifting the paradigm that has focused on provision of specialty palliative care to rigorously test an oncology nurse-led primary palliative care approach. It is feasible because it builds on extensive pilot work by an experienced research team and enjoys strong support from health system leadership and oncology clinical staff.

 描述（由适用提供）：患有晚期癌症经验的患者的生活质量急剧下降，并在生命即将结束时接受非侵略性治疗。他们的护理人员遭受了高度的烧伤和心理困扰。标准肿瘤学护理的缺陷包括对症状控制，情绪支持和参与的关注，并提前护理计划与该人群的发病率相关。虽然姑息治疗专家的早期共同管理可以改善患者和护理人员的结果，但由于劳动力短缺，对于大多数癌症患者而言，这并不是一个实际解决方案。一种减轻这些公共卫生问题的实用解决方案将需要“主要”姑息治疗干预措施，即遵守姑息治疗，该palliative palliative Care融合在肿瘤学实践中，并由不是专家的临床医生提供。 Connect（肿瘤学护士的护理管理以满足支持性护理需求）是一种基于肿瘤学实践的主要姑息治疗干预措施，在由国家姑息治疗研究中心和NIH资助的工作中开发并成功进行了试点测试。从概念上讲，以瓦格纳的慢性护理模型为基础，将员工连接到肿瘤学护理护理管理方法（1）满足患者的症状需求，（2）让患者和看护人提前护理计划，（3）为患者和护理人员提供情感支持，以及（4）与肿瘤学家交流并协调适当的护理。该提案的目的是测试在672例晚期癌症患者中进行的聚类随机试验中连接的有效性，并在16个社区肿瘤学诊所接受护理的护理人员接受护理。 AIM 1评估联系对患者生活质量的影响（主要结果，使用慢性疾病疗法的功能评估 - 姑息治疗），症状伯恩（Edmonton症状评估量表）以及抑郁症和动画症状（医院焦虑和抑郁量表）。 AIM 2评估Connect对Caregiver Burnen（Zarit Burden访谈 - 短）和护理人员抑郁症和动画症状（医院焦虑和抑郁量表）的影响。 AIM 3评估连接对医疗资源使用的影响。所有患者和护理人员的结果将在3个月时进行评估，这是一个时间点，以允许进行足够的“剂量”干预措施，同时最大程度地减少损失以在严重患病人群中进行随访。最多一年的医疗保健利用，成本成果和生存将衡量，以了解可能会超出干预期的影响。如果成功的话，连接干预措施将产生很大的影响，因为它将是对重要公共卫生问题的实用解决方案，这些问题可能会影响每年患有晚期癌症及其护理人员死亡的60万名患者。它在转移专注于提供专业姑息治疗的范式方面具有创新性，以严格测试由肿瘤学护士领导的主要姑息治疗方法。这是可行的，因为它建立在经验丰富的研究团队的广泛试点工作的基础上，并获得了卫生系统领导力和肿瘤学临床人员的大力支持。