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: 9268708
• 负责人: Yael Schenker
• 金额: $ 58.78万
• 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/9268708
• 关键词: Address; Advance Care Planning; Advanced Malignant Neoplasm; Affect; American; Anxiety; Attention; Award; 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; 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; psychological distress; public health relevance; randomized trial; reduce symptoms; skills; successful intervention; 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痛苦。标准肿瘤学护理的缺陷--包括对症状控制、情感支持和参与提前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照顾者的结果，但由于劳动力短缺，这对大多数癌症患者来说并不是一个可行的解决方案。缓解这些公共卫生问题的实际解决办法将需要“初级”姑息治疗干预--这意味着将姑息治疗纳入肿瘤学实践，并由非专家的临床医生提供。CONNECT(由肿瘤学护士进行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初级姑息护理干预措施，由国家姑息护理研究中心和NIH资助的工作开发并成功地进行了试点测试。在概念上，CONNECT以瓦格纳的慢性护理模式为基础，采用肿瘤学护士主导的护理管理方法，以(1)解决患者的症状需求，(2)让患者和护理人员参与提前护理计划，(3)为患者和护理人员提供情感支持，以及(4)与肿瘤学家沟通并协调适当的护理。这项建议的目的是在一项分组随机试验中测试CONNECT的有效性，该试验在16个社区肿瘤诊所接受护理的672名晚期癌症患者和他们的照顾者中进行。目的1评估CONNECT对患者生活质量(主要结果，使用慢性病治疗功能评估-姑息治疗)、症状负担(Edmonton症状评估量表)和抑郁和焦虑症状(医院焦虑和抑郁量表)的影响。目的2评估CONNECT对照顾者负担(Zarit Burden访谈-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CONNECT对医疗资源使用的影响。所有患者和照顾者的结果将在3个月时进行评估，选择一个时间点，以允许进行足够的干预，同时将重病人群的随访损失降至最低。将在长达一年的时间内测量医疗保健利用率、成本结果和生存时间，以了解在干预期之后可能持续的影响。如果成功，CONNECT干预将产生很高的影响，因为它将是对可能影响到每年死于晚期癌症的60多万患者及其照顾者的重要公共卫生问题的务实解决方案。它在转变专注于提供专业姑息治疗的范式方面具有创新性，以严格测试肿瘤学护士领导的初级姑息治疗方法。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，并得到卫生系统领导层和肿瘤学临床工作人员的大力支持。