Indiana Palliative Excellence in Alzheimer Care Efforts-RCT

印第安纳州姑息治疗阿尔茨海默病护理工作的卓越成果-随机对照试验

• 批准号: 10394808
• 负责人: GREG A SACHS
• 金额: $ 68.05万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-08-01 至 2024-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10394808
• 关键词: Address; Adult; Advance Care Planning; Adverse effects; Affect; Age-Years; Aggressive behavior; Agitation; Alzheimer' s Disease; Alzheimer' s disease care; Alzheimer' s disease related dementia; American; Anxiety; Blinded; Caregiver Burden; Caregiver support; Caregivers; Caring; Cause of Death; Clinical; Collaborations; Communities; Community Services; Comprehensive Health Care; Control Groups; Dementia; Dementia caregivers; Depressed mood; Distress; Emergency department visit; Enrollment; Ensure; Equipment and supply inventories; Evidence based intervention; Family; Family Caregiver; Family member; Future; Goals; Health; Health system; Home; Hospitalization; Hospitals; Indiana; Interdisciplinary Study; Intervention; Interview; Modeling; Moods; Nature; Network-based; Nursing Homes; Outcome; Outcome Assessment; Pain; Pain management; Palliative Care; Patient Care; Patients; Persons; Pharmaceutical Preparations; Population; Prevalence; Protocols documentation; Provider; Public Health; Randomized; Randomized Controlled Trials; Reaction; Research; Research Assistant; Risk; Shapes; Shoulder; Social Workers; Societies; Stress; Supportive care; Symptoms; Telephone; Testing; Time; United States; Work; base; care providers; care systems; community setting; dementia care; empowered; end of life; evidence base; experience; family support; feeding; hospice environment; improved; innovation; intervention effect; meetings; multi-component intervention; multidisciplinary; neuropsychiatric symptom; neuropsychiatry; palliative; personalized care; preference; recruit; repetitive behavior; symptom management; treatment as usual; treatment group; treatment planning; trial comparing; usual care arm

PROJECT SUMMARY/ABSTRACT Dementia is a prevalent, growing public health problem; over 5 million Americans suffer from the condition and up to 16 million people are projected to be affected by 2050. Neuropsychiatric symptoms in dementia are often treated with medications having greater evidence of adverse effects than benefits. Patients with dementia are at risk for inadequate recognition and management of pain; receive burdensome treatments; and suffer with insufficient involvement of palliative care services. Family caregivers receive inadequate support in the face of substantial stress. Patients and families are poorly served by interventions and models that present dementia- specific care and palliative care as mutually exclusive options. The overarching goal of this research by Dr. Sachs’s team is to improve the care of community dwelling patients with dementia and their family caregivers through an innovative model of supportive care that combines an existing, evidence-based intervention for dementia care with an innovative intervention for palliative care in dementia. The intervention projects this care into the homes of patients and caregivers, empowering caregivers, and integrating with ongoing care. The proposed randomized controlled trial compares the IN-PEACE intervention (Indiana version of Palliative Excellence in Alzheimer Care Efforts) to usual care for community dwelling patients with moderate to severe dementia and their family caregivers. IN-PEACE will enroll 200 patient-caregiver dyads, randomizing 100 dyads each to the intervention and usual care arms and follow for 24 months with outcome assessments at 3, 6, 9, 12, 15, 18, 21 and 24 months by research assistants blinded to treatment group. The core of the multi- component intervention is regular, proactive telephone contact by a dementia care coordinator (DCC; social worker or RN) to anticipate and identify patients’ symptoms and caregivers needs and address them utilizing specific, evidence-based protocols. Protocols cover basic dementia care, caregiver distress, neuropsychiatric symptoms, pain, navigating the hospital, feeding difficulties, and transition to hospice. The intervention also involves advance care planning and support with caregivers tailored to decisions faced in dementia care, highlighting where palliative care options can replace the default that often results in burdensome treatments. DCCs are supported by weekly meetings of the interdisciplinary research team, as well as collaboration with patients’ primary care providers and community services. The primary aim of IN-PEACE is to test the effect of the intervention on patients’ neuropsychiatric symptoms. Other aims include testing the effect of IN-PEACE on patients’ overall symptom outcomes, caregiver mood and distress, and the provision of burdensome treatments to patients (hospitalizations and emergency room visits). IN-PEACE is based on an innovative supportive care model; utilizes an innovative intervention that integrates evidence-based dementia care and palliative care; and is fielded in an innovative practice based network that focuses on enhancing dementia care in the community. This will be the first study of its kind, reshaping the nature of future interventions in this field.

项目总结/摘要 痴呆症是一种普遍的、日益严重的公共卫生问题;超过500万美国人患有这种疾病， 预计到2050年将有多达1 600万人受到影响。痴呆症的神经精神症状通常 用药物治疗，其副作用的证据大于益处。痴呆症患者 存在对疼痛认识和管理不足的风险;接受繁重的治疗;并患有 姑息治疗服务参与不足。家庭照顾者在面临 巨大的压力。呈现痴呆症的干预措施和模型对患者和家庭的服务很差- 具体护理和姑息治疗是相互排斥的选择。这项研究的总体目标是由博士。 萨克斯的团队是为了改善社区居住的痴呆症患者和他们的家庭照顾者的护理 通过创新的支持性护理模式，结合现有的，基于证据的干预措施， 老年痴呆症护理与创新的干预措施，为姑息治疗老年痴呆症。干预计划将这种关怀 进入患者和护理人员的家中，赋予护理人员权力，并与持续护理相结合。的 一项拟定的随机对照试验比较了IN-PEACE干预（印第安纳州版本的姑息治疗）和 卓越的阿尔茨海默氏症护理工作），以常规护理社区居住的患者，中度至重度 老年痴呆症及其家庭护理人员。IN-PEACE将入组200名患者-护理人员配对，随机分配100名 干预组和常规护理组各配对，并随访24个月，结果评估为3， 6、9、12、15、18、21和24个月，研究助理对治疗组设盲。核心的多- 成分干预是由痴呆症护理协调员（DCC;社会 工作人员或RN）预测和识别患者的症状和护理人员的需求，并利用 具体的循证治疗方案协议涵盖基本的痴呆症护理，照顾者的痛苦，神经精神 症状，疼痛，在医院导航，喂养困难，过渡到临终关怀。干预还 涉及提前护理规划和支持，护理人员根据痴呆症护理中面临的决定量身定制， 强调姑息治疗方案可以取代通常导致繁重治疗的默认方案。 DCC由跨学科研究团队的每周会议提供支持，并与 患者的初级保健提供者和社区服务。IN-PEACE的主要目的是测试 对患者神经精神症状的干预。其他目标包括测试国际和平组织对 患者的整体症状结果，照顾者的情绪和痛苦，以及负担的提供 患者的治疗（住院和急诊室就诊）。国际和平组织基于一种创新的 支持性护理模式;采用创新的干预措施，整合了基于证据的痴呆症护理， 姑息治疗;并被派往一个创新的实践为基础的网络，重点是加强痴呆症护理 在社区这将是此类研究中的第一次，重塑这一领域未来干预措施的性质。

项目成果

Indiana Palliative Excellence in Alzheimer's Care Efforts (IN-PEACE): Protocol for a randomized controlled trial in persons with advanced dementia.

印第安纳州阿尔茨海默病姑息治疗卓越计划 (IN-PEACE)：针对晚期痴呆症患者的随机对照试验方案。

• DOI: 10.1016/j.cct.2023.107217
• 发表时间: 2023
• 期刊: Contemporary clinical trials
• 影响因子: 2.2
• 作者: Holtz,LauraR;Kroenke,Kurt;Gao,Sujuan;Hickman,SusanE;Torke,AlexiaM;Johnson,NinaM;Pemberton,Amy;Vrobel,Andrea;Pan,Minmin;Sachs,GregA
• 通讯作者: Sachs,GregA