Pragmatic Trial of the Effectiveness and Cost-Effectiveness of Dementia Care

项目摘要 在美国，估计有550万人患有阿尔茨海默病，这是最常见的疾病。 痴呆的类型。痴呆症的临床表现是毁灭性的，往往导致照顾者的压力， 职业倦怠和疾病痴呆症是一种具有复杂需求的疾病的原型， 病人和护理人员、医疗和社会领域以及卫生系统和社区组织。 作为回应，已经制定了几个痴呆症护理计划，以更全面地满足需求 患者及其护理人员，包括卫生保健系统内的人员和 社区这些方案要么在单个地点实施，要么规模相对较小; 由于关于有效性和成本效益的问题没有得到解答， 2017年11月，以患者为中心的结局研究所（PCARI）批准了一项4中心务实的 临床试验，以比较健康系统为基础的护理（基于加州大学洛杉矶分校阿尔茨海默氏症和 痴呆症护理计划）与社区护理（基于本杰明·罗斯研究所护理咨询 计划）对患者和患者报告的结果测量，包括行为症状和照顾者 痛苦（共同主要结局），以及照顾者压力、未满足的需求和抑郁的次要结局 超过18个月。由于PCORI的授权，这两种干预措施都不会与常规护理进行比较（因此，仅 可以确定相对有效性）。也不会评估任何一种干预措施的成本效益。 拟议中的研究将增加第三个常规护理（UC）分支，并将结果扩展到包括成本和健康 护理利用率这种扩展将允许将每个干预组与当前的常规护理进行比较， 从而为两种活性药物的有效性提供多中心实用的随机临床试验证据， 治疗手臂它还将允许评估支付此类护理费用是否会抵消成本， 确定哪种干预措施更具成本效益。该研究还将对以下方面进行探索性分析： 两种干预措施与常规护理的三级结局，包括死亡率、在家时间、长期 护理之家安置，医生和病人/照顾者的满意度，并比较所有三组 几种类型的使用和自付费用。 这项研究的问题是规划痴呆症患者的临床护理的基础。他们 解决临床有效性和成本效益。通过回答这些问题，临床医生，健康 保险公司可以决定推广、扩大和传播哪些项目。

PROJECT SUMMARY In the United States, an estimated 5.5 million persons are affected by Alzheimer's disease, the most common type of dementia. The clinical manifestations of dementia are devastating and often lead to caregiver stress, burnout, and medical illnesses. Dementia is a prototype of a disorder with complex needs that span both the patient and caregiver, medical and social domains, and health system and community-based organizations. In response, several dementia care programs have been developed to more comprehensively meet the needs of patients and their caregivers, including those based within health care systems and those based in the community. These programs have been implemented at either single sites or on a relatively small scale; none has been replicated widely because of unanswered questions about effectiveness and cost-effectiveness. In November 2017, the Patient Centered Outcomes Research Institute (PCORI) approved a 4-site pragmatic clinical trial to compare the effectiveness of health-systems-based care (based on the UCLA Alzheimer's and Dementia Care program) with community-based care (based on the Benjamin Rose Institute Care Consultation program) on patient- and caregiver-reported outcome measures, including behavioral symptoms and caregiver distress (co-primary outcomes), and secondary outcomes of caregiver strain, unmet needs, and depression over 18-months. Because of PCORI's mandate, neither intervention will be compared to usual care (thus, only relative effectiveness can be determined). Nor will cost-effectiveness of either intervention be evaluated. The proposed research will add a third usual care (UC) arm and expand outcomes to include costs and health care utilization. This expansion will permit comparison of each of the intervention arms to current usual care, thereby providing multisite pragmatic randomized clinical trial evidence for effectiveness of the two active treatment arms. It will also allow evaluation of whether paying for such care will offset the costs and determination of which intervention is more cost effective. The study will also conduct exploratory analyses of tertiary outcomes of both interventions versus usual care including mortality, time spent at home, long-term nursing home placement, physician and patient/caregiver satisfaction and comparing all three groups on several types of utilization and out-of-pocket expenses. The study's questions are fundamental to planning for the clinical care of persons with dementia. They address both clinical effectiveness and cost-effectiveness. By answering these questions, clinicians, health systems, and insurers can make decisions about which programs to promote, scale and disseminate.