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1500万非正式护理人员（CG）提供的无薪护理。1痴呆症与高医疗保健成本、长期护理（LTC）安置、医疗并发症、生活质量下降和CG负担有关。以患者和家庭为中心的护理模式，专门针对痴呆症，解决痴呆症管理的多方面问题，并链接健康和社区护理研究不足，但可能代表一个有前途的机制，以解决这个不断增长的人口的多重和持续的需求，减少不良后果，如过早的长期护理安置，并产生成本效益。我们提出了一项明确的III期疗效试验，以测试最大限度地提高家庭独立性-简化（MIND-S），这是一种基于试点工作的社区生活PWD及其非正式CG的基于家庭的护理协调干预。在一项试点试验中，MIND在303名社区生活的记忆障碍个体的多样化样本中成功实施，并被发现可被CG接受，导致从家中过渡的时间延迟，改善PWD QOL，并节省CG时间。73，78我们现在提出一个为期24个月的前瞻性单盲平行组，随机对照试验在大巴尔的摩地区的300名社区生活PWD及其非正式CG中评价MIND-S。干预二人组将由一个跨学科小组进行18个月的护理协调，该小组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。干预包括4个关键组成部分：确定需求和个性化护理计划（PWD和CG需求）;痴呆症教育和技能建设;服务协调，转诊和联系;以及护理监测。目的1：确定MIND-S在18个月和24个月（治疗后6个月）的长期护理（LTC）安置时间或死亡时间方面的疗效。目标二：估计MIND-S成本，并通过在18个月和24个月（治疗后6个月）从社会角度进行成本抵消分析来评估其是否产生净经济效益。目标3：确定MIND-S在18个月和24个月（治疗后6个月）时对PWD未满足的护理需求、神经精神症状（EEG）和生活质量（QOL）以及CG未满足的需求和负担的疗效。探索性目的：探索干预的调节者和介导者是否对LTC或死亡的时间产生影响。该提案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具有互补的专业知识。如果被证明是有效的和具有成本效益的，MIND-S模型有可能改变痴呆症护理服务在社区一级的提供和协调方式，并作为一个国家模式。它响应了《国家阿尔茨海默氏症计划法》（公法111-375）的要求，要求开发和测试新的痴呆症护理综合模式。

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.