MIND: An RCT of care coordination for community-living persons with dementia

描述(申请人提供)：目前有500多万美国老年人患有阿尔茨海默病和相关痴呆症，其中80%在社区接受1500万非正式照顾者(CG)的无偿护理1痴呆症与高昂的医疗费用、长期护理(LTC)安置、医疗并发症、生活质量下降和CG负担有关。针对痴呆症量身定做的以患者和家庭为中心的护理模式，解决了痴呆症管理的多个方面，并将卫生保健和社区护理联系起来，尚未得到充分研究，但可能代表着一种有希望的机制，以满足不断增长的人口的多重和持续需求，减少LTC过早放置等不良后果，并产生成本效益。我们提出了一个最终的第三阶段疗效试验来测试最大化家庭独立性-精简(心灵-S)，这是一种基于家庭的、针对社区生活的残疾患者及其非正式CGs的护理协调干预措施，建立在试点工作的基础上。在一项试点试验中，在303名患有记忆障碍的社区生活个体的不同样本中成功地实施了Mind，并发现CGs可以接受，导致从家里过渡的时间延迟，改善了PWD生活质量，节省了CG时间。73，78我们现在提出一个为期24个月的前瞻性、前瞻性、单盲、平行小组RCT评估Mind-S在大巴尔的摩地区300名社区生活的Pwd及其非正式CG的队列中评估Mind。干预二人组将由一个由训练有素的非临床社区工作者(干预者)、一名精神科护士和老年精神病学家组成的跨学科团队进行为期18个月的护理协调。干预措施涉及四个关键部分：确定需求和个性化护理规划(残障和慢性疾病需求)；痴呆症教育和技能培养；服务的协调、转介和联系；以及护理监测。目的1：比较心智-S在18个月和24个月(治疗后6个月)对长期护理时间和死亡的影响。目的2：通过从社会角度进行成本抵消分析，在治疗后18个月和24个月(治疗后6个月)估计心智S的成本，并评估其是否产生净经济效益。目的：评价心智-S在18个月和24个月(治疗后6个月)对PWD未满足的护理需求、神经精神症状和生活质量的疗效，以及对CG未满足的需求和负担的影响。探索性目的：探讨干预的调解人和调解人对终末期死亡或死亡时间的影响。这项建议汇集了一批国际和国内公认的研究人员，他们在社区痴呆症护理、临床试验、卫生经济学和生物统计学方面拥有免费的专业知识。如果被证明是有效和具有成本效益的，Mind-S模式有可能改变社区层面提供和协调痴呆症护理服务的方式，并成为全国模式。它响应《国家阿尔茨海默氏症计划法》(公法111-375)，呼吁开发和测试新的全面的痴呆症护理模式。

DESCRIPTION (provided by applicant): Over 5 million older Americans currently suffer from Alzheimer's disease and related dementias with 80% receiving care in the community by 15 million informal caregivers (CGs) providing unpaid care.1 Dementia is associated with high health care costs, long term care (LTC) placement, medical complications, reduced quality of life, and CG burden. Patient and family centric care models tailored to dementia that address the multidimensional aspects of dementia management, and link health and community care are understudied but may represent a promising mechanism to address the multiple and on-going needs of this growing population, reduce adverse outcomes such as premature LTC placement, and produce cost benefits. We propose a definitive Phase III efficacy trial to test Maximizing Independence at Home-Streamlined (MIND-S), a home- based, care coordination intervention for community-living PWD and their informal CGs that builds on pilot work. In a pilot trial, MIND was successfully implemented in a diverse sample of 303 community-living individuals with memory disorders and was found to be acceptable to CGs, led to delays in time to transition from home, improved PWD QOL, and CG time savings.73,78 We now propose a 24-month, prospective, single- blind, parallel group, RCT evaluating MIND-S in a cohort of 300 community-living PWD and their informal CGs in the Greater Baltimore area. Intervention dyads will receive 18 months of care coordination by an interdisciplinary team comprised of trained non-clinical community workers (Interventionists), a psychiatric nurse, and geriatric psychiatrist. The intervention involves 4 key components: identification of needs and individualized care planning (PWD and CG needs); dementia education and skill building; coordination, referral and linkage of services; and care monitoring. Aim 1: To determine the efficacy of MIND-S on time to long term care (LTC) placement or death at 18 months and 24 months (6 months post treatment). Aim 2: To estimate MIND-S cost and assess whether it results in net financial benefits by conducting a cost-offset analysis taking the societal perspective at 18 months and 24 months (6 months post treatment). Aim 3: To determine the efficacy of MIND-S on PWD unmet care needs, neuropsychiatric symptoms (NPS), and quality of life (QOL), and on CG unmet needs and burden at 18 and 24 months (6 months post treatment). Exploratory aims: To explore whether the moderators and mediators of the intervention's effect on time to LTC or death. This proposal brings together an internationally and nationally recognized group of researchers with complimentary expertise in community-based dementia care, clinical trials, health economics, and biostatistics. If proven efficacious and cost efficient, the MIND-S model has the potential to change how dementia care services are provided and coordinated at the community level and serve as a national model. It is responsive to the National Alzheimer's Plan Act (Public Law 111-375) calling for development and testing of new comprehensive models of dementia care.