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（由申请人提供）：晚期癌症患者的生活质量急剧下降，并在生命末期接受无益的积极治疗。他们的照顾者承受着很高的负担和心理压力。标准肿瘤治疗的缺陷，包括对症状控制、情感支持和参与预先护理计划的关注不足，导致了这一人群的发病率。虽然姑息治疗专家的早期共同管理可能会改善患者和护理人员的结果，但由于劳动力短缺，这对大多数癌症患者来说并不是一个实际的解决方案。一个切实可行的解决方案，以减轻这些公共卫生问题将需要“初级”姑息治疗干预，这意味着姑息治疗，是整合在肿瘤学的做法和提供的临床医生谁不是专家。肿瘤科护士护理管理（Care management by Oncology Nurses to address Support Care Needs）是一种基于肿瘤学实践的初级姑息治疗干预措施，由国家姑息治疗研究中心和NIH资助，并在工作中成功进行了试点测试。概念上基于瓦格纳的慢性护理模式，肿瘤学ECT采用肿瘤学护士领导的护理管理方法来（1）解决患者的症状需求，（2）让患者和护理人员参与预先护理计划，（3）为患者和护理人员提供情感支持，（4）与肿瘤学家沟通并协调适当的护理。该提案的目的是在16个社区肿瘤诊所的672名晚期癌症患者及其护理人员中进行的一项随机分组试验中测试ECOECT的疗效。目的1：评估ECT对患者生活质量（主要结局，使用慢性病治疗功能评估-姑息治疗测量）、症状负担（埃德蒙顿症状评估量表）以及抑郁和焦虑症状（医院焦虑和抑郁量表）的影响。目的2：评估康复治疗对照顾者负担（Zarit Burden Interview-Short）和照顾者抑郁和焦虑症状（医院焦虑和抑郁量表）的影响。目标3评估了ECOECT对医疗资源使用的影响。将在3个月时评估所有患者和护理人员的结局，选择的时间点允许足够的干预“剂量”，同时最大限度地减少重病人群的随访损失。医疗保健利用率、成本结果和生存率将被测量长达一年，以了解干预期后可能持续存在的影响。如果成功的话，ECOECT干预将产生很大的影响，因为它将是重要公共卫生问题的务实解决方案，这些问题可能影响每年死于晚期癌症的60多万患者及其护理人员。它是创新的转移范式，重点是提供专业姑息治疗，严格测试肿瘤护士主导的初级姑息治疗方法。它是可行的，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，并得到了卫生系统领导和肿瘤临床工作人员的大力支持。