Palliative Care for Persons with Late-stage Alzheimer's and Related Dementias and their Caregivers: a Randomized Clinical Trial

摘要 阿尔茨海默病和相关痴呆症（ADRD）影响560万美国人，每年花费157美元 亿300万美国人患有晚期ADRD，由渐进性依赖引起的痛苦， 痛苦的症状家庭照顾者在身体、情感和经济上都承受着极大的压力。 急性疾病住院治疗在晚期ADRD中很常见，症状恶化， 关于护理和强化治疗目标的痛苦决定。住院治疗也呈现出独特的 痴呆症特异性姑息治疗的机会，以解决痛苦和减少负担的治疗，因为 72%的医院有姑息治疗团队。姑息治疗可改善患者的症状控制和生活质量 严重的疾病，但从来没有适应和测试的独特需求，后期ADRD。 因此，我们开发了ADRD姑息治疗（ADRD-PC）计划。使用一种新的快速筛选 系统中，我们随机选择了62对晚期ADRD住院患者及其家庭照顾者， ADRD-PC程序与教育控制。干预组接受i）痴呆特异性姑息治疗，ii） 标准化的护理人员教育，以及iii）由跨学科姑息治疗团队提供的过渡性护理; 对照组接受关于痴呆症预防的教育材料。ADRD-PC程序运行良好- 接受，并导致显着改善使用临终关怀，症状管理，照顾者 有关预后和护理目标、新的预先指示和“请勿住院”命令的沟通。 推进痴呆症特异性姑息治疗科学的必要下一步是一个足够强大的 ADRD-PC项目改善患者和家庭为中心结局的疗效RCT。 我们的研究目的是进行ADRD-PC项目的多中心疗效RCT。我们将招收 424对晚期ADRD住院患者和家庭照顾者在4个不同地理位置 姑息治疗研究合作组的成员网站。我们的具体目标是： 目的1：对痴呆特异性缓解和过渡期ADRD-PC项目进行多中心RCT 护理（干预组）与痴呆症护理人员（对照组）的公开教育材料， 比较晚期患者60天的医院转移（住院和急诊） ADRD（主要结局）。 目的2：比较干预组和对照组之间以患者为中心的次要结局：a）症状 治疗; B）症状控制; c）急性期后使用社区姑息治疗或临终关怀; d）新护理 家庭过渡。 目的3：比较干预组和对照组之间以患者为中心的次要结局：a） 关于预后和护理目标的沟通; B）共同决策;和c）护理者苦恼。 影响：ADRD-PC有可能减轻数百万晚期ADRD患者的痛苦。

ABSTRACT Alzheimer’s disease and related dementias (ADRD) affect 5.6 million Americans at an annual cost of $157 billion. Three million Americans have late-stage ADRD with suffering caused by progressive dependency and distressing symptoms. Family caregivers experience extraordinary physical, emotional and financial strain. Hospitalizations for acute illnesses are common in late-stage ADRD, with worsened symptoms and distressing decisions about goals of care and intensive treatments. Hospitalizations also present a unique opportunity for dementia-specific palliative care to address suffering and reduce burdensome treatments, since 72% of hospitals have palliative care teams. Palliative care improves symptom control and quality of life in serious illnesses, but has never been adapted and tested for the unique needs of late-stage ADRD. We therefore developed the ADRD Palliative Care (ADRD-PC) program. Using a novel rapid screening system, we randomized 62 dyads of hospitalized patients with late-stage ADRD and their family caregivers to the ADRD-PC program vs education control. Intervention dyads received i) dementia-specific palliative care, ii) standardized caregiver education, and iii) transitional care delivered by an interdisciplinary palliative care team; control dyads received educational material on dementia caregiving. The ADRD-PC program was well- accepted, and resulted in significant improvements in use of hospice, symptom management, caregiver communication about prognosis and goals of care, new advance directives, and “Do Not Hospitalize” orders. The necessary next step to advance the science of dementia-specific palliative care is an adequately powered RCT of the efficacy of the ADRD-PC program to improve patient and family centered outcomes. Our research objective is to conduct a multi-site efficacy RCT of the ADRD-PC program. We will enroll 424 dyads of hospitalized patients with late-stage ADRD and family caregivers at 4 geographically diverse member sites of the Palliative Care Research Cooperative group. Our Specific Aims are: Aim 1: To conduct a multi-site RCT of the ADRD-PC program of dementia-specific palliative and transitional care (intervention arm) vs publicly available educational material for dementia caregivers (control arm) to compare 60-day hospital transfers (hospitalization and emergency room visits) for persons with late-stage ADRD (primary outcome). Aim 2: To compare patient-centered secondary outcomes between intervention and control arms: a) symptom treatment; b) symptom control; c) post-acute use of community palliative care or hospice; and d) new nursing home transitions. Aim 3: To compare caregiver-centered secondary outcomes between intervention and control arms: a) communication about prognosis and goals of care; b) shared decision-making; and c) caregiver distress. IMPACT: ADRD-PC has the potential to reduce suffering for millions of persons with late-stage ADRD.