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

对晚期阿尔茨海默病和相关痴呆症患者及其护理人员的姑息治疗：一项随机临床试验

• 批准号: 10461880
• 负责人: LAURA C HANSON
• 金额: $ 87.33万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-10 至 2025-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10461880
• 关键词: Acute; Address; Advance Directives; Affect; Alzheimer' s Disease; Alzheimer' s disease related dementia; American; Awareness; Caregivers; Caring; Colorado; Communication; Communities; Decision Making; Dehydration; Dementia; Dementia caregivers; Dependence; Distress; Education; Educational Materials; Elderly; Emergency department visit; Emotional; Enrollment; Equipment and supply inventories; Family; Family Caregiver; Financial Hardship; General Hospitals; Geography; Goals; Health care facility; Healthcare; Home; Hospitalization; Hospitals; Indiana; Infection; Intervention; Learning; Length of Stay; Massachusetts; Nomads; North Carolina; Nursing Homes; Outcome; Palliative Care; Palliative Care Nursing; Patient-Focused Outcomes; Patients; Persons; Prognosis; Quality of Care; Quality of life; Questionnaires; Randomized; Randomized Clinical Trials; Rapid screening; Reporting; Research; Science; Self Perception; Services; Site; Standardization; Symptoms; System; Testing; Universities; advanced dementia; arm; base; caregiver education; caregiver strain; case finding; comorbidity; cost; dementia caregiving; design; end of life; experience; fall injury; hospice environment; improved; improved outcome; indexing; member; neuropsychiatric symptom; neuropsychiatry; novel; palliative; patient oriented; physical symptom; primary outcome; prognostic; programs; secondary outcome; shared decision making; symptom management; symptom treatment; symptomatic improvement; treatment arm

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.

摘要 阿尔茨海默病和相关痴呆症(ADRD)影响着560万美国人，每年花费1.57亿美元 十亿美元。300万美国人患有晚期ADRD，患有渐进性依赖和 令人痛苦的症状。家庭照顾者经历着非同寻常的身体、情感和经济压力。 在ADRD晚期，因急性疾病住院是常见的，症状恶化和 关于护理和重症治疗目标的令人痛苦的决定。住院治疗也是一种独特的 提供针对痴呆症的姑息治疗的机会，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。姑息治疗改善了患者的症状控制和生活质量 严重疾病，但从未针对晚期ADRD的独特需求进行过调整和测试。 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查 系统中，我们随机选择了62名ADRD晚期住院患者及其家庭照顾者 ADRD-PC程序与教育控制。接受干预的二人组：i)痴呆症特效性姑息治疗；ii) 标准化的照顾者教育，以及iii)由跨学科姑息治疗小组提供的过渡性护理； 对照二人组接受了有关痴呆症护理的教育材料。ADRD-PC计划非常好- 接受，并在临终关怀、症状管理、护理者的使用方面取得显著改善 关于预后和护理目标的沟通，新的预先指令，以及“不要住院”的命令。 推进痴呆症特定姑息治疗的科学的必要的下一步是充分的动力 对ADRD-PC计划改善以患者和家庭为中心的结果的有效性进行随机对照试验。 我们的研究目标是进行ADRD-PC计划的多点疗效随机对照试验。我们将招收 424对晚期ADRD住院患者和4个地理位置不同的家庭照顾者的研究 姑息治疗研究合作小组的成员网站。我们的具体目标是： 目的1：进行痴呆特异性姑息性和过渡性ADRD-PC计划的多点随机对照试验 护理(干预ARM)与痴呆症照顾者(对照ARM)可公开获得的教育材料 比较晚期患者60天的医院转院(住院和急诊室就诊) ADRD(主要结果)。 目的2：比较干预组和对照组以患者为中心的二次结局：a)症状 治疗；b)症状控制；c)急性后使用社区姑息治疗或临终关怀；d)新护理 主转场。 目标3：比较干预组和对照组以照顾者为中心的二次结局：a) 关于预后和护理目标的沟通；b)共同决策；c)照顾者痛苦。 影响：ADRD-PC有可能减少数百万晚期ADRD患者的痛苦。