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

描述（由申请人提供）：目前有超过500万的美国老年人患有阿尔茨海默病和相关的痴呆症，其中80%的人在社区接受1500万非正式护理人员（CGs）提供的无偿护理痴呆症与高卫生保健费用、长期护理（LTC）安置、医疗并发症、生活质量下降和CG负担有关。针对痴呆症量身定制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维方面，并将健康和社区护理联系起来，这些模式尚未得到充分研究，但可能是一种有希望的机制，可以解决这一不断增长的人口的多重和持续需求，减少诸如过早安置长期护理中心等不良后果，并产生成本效益。我们提出了一项明确的III期疗效试验，以测试最大化家庭独立流线型（MIND-S），这是一种基于家庭的，针对社区生活的残疾人士及其非正式cg的护理协调干预措施，以试点工作为基础。在一项试点试验中，MIND成功地在303名社区生活的记忆障碍患者中实施，并被发现对CG是可接受的，导致从家中过渡的时间延迟，改善了PWD的生活质量，并节省了CG时间我们现在提出了一项为期24个月的前瞻性、单盲、平行组、随机对照试验（RCT），对大巴尔的摩地区300名社区生活的PWD及其非正式CGs进行MIND-S评估。干预组将接受一个跨学科小组18个月的护理，该小组由训练有素的非临床社区工作者（干预学家）、一名精神科护士和老年精神病学家组成。干预措施包括4个关键组成部分：需求识别和个性化护理计划（残疾患者和CG需求）；痴呆症教育和技能培养；协调、转介和联系各项服务；和护理监测。目的1：确定MIND-S在治疗后18个月和24个月（治疗后6个月）按时进行长期护理（LTC）安置或死亡的疗效。目标2：通过在治疗后18个月和24个月（治疗后6个月）进行社会角度的成本抵消分析，估计MIND-S的成本，并评估它是否会产生净经济效益。目的3：确定MIND-S在18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（NPS）和生活质量（QOL）的疗效，以及对CG未满足的需求和负担的疗效。探索目的：探讨干预对死亡或死亡时间影响的调节因子和中介因子。该提案汇集了一个国际和国内公认的研究小组，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具有互补的专业知识。如果证明MIND-S模式是有效和具有成本效益的，它有可能改变在社区一级提供和协调痴呆症护理服务的方式，并成为国家模式。这是对国家阿尔茨海默氏症计划法案（公法111-375）的响应，该法案呼吁开发和测试新的综合痴呆症护理模式。

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.