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

痴呆症护理有效性和成本效益的务实试验。

• 批准号: 10420646
• 负责人: DAVID B. REUBEN
• 金额: $ 38.55万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-30 至 2024-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10420646
• 关键词: Address; Adult; Affect; Aggressive behavior; Agitation; Alzheimer' s Disease; Aspiration Pneumonia; Award; Behavioral; Behavioral Symptoms; Caregiver Burden; Caregiver support; Caregivers; Caring; Clinical; Clinical effectiveness; Communities; Complex; Consultations; Cost Effectiveness Analysis; Data; Day center care; Decision Making; Deglutition Disorders; Dementia; Disease; Disinhibition; Distress; Educational Materials; Effectiveness; Effectiveness of Interventions; Elderly; Electronic Health Record; Evaluation; Funding; Hallucinations; Health Professional; Health system; Healthcare Systems; Home; Impaired cognition; Institutes; Insurance Carriers; Intervention; Lead; Location; Medical; Medicare; Mental Depression; Nursing Homes; Outcome; Outcome Measure; Participant; Patient Education; Patient-Focused Outcomes; Patients; Persons; Physicians; Pragmatic clinical trial; Quality Indicator; Quality of Care; Randomized Clinical Trials; Reporting; Research; Research Institute; Resources; Services; Site; Time; Uninsured Medical Expense; United States; active method; arm; base; burnout; caregiver strain; clinical care; community based care; comparative; comparative effectiveness; compare effectiveness; cost; cost effective; cost effectiveness; dementia care; falls; health care service utilization; improved; innovation; insight; intervention cost; mortality; pragmatic trial; primary outcome; programs; prototype; provider adherence; relative effectiveness; response; satisfaction; secondary outcome; social; treatment arm; treatment as usual; usual care arm

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.

项目概要 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 痴呆症的类型。痴呆症的临床表现是毁灭性的，常常导致照顾者压力， 倦怠和医疗疾病。痴呆症是一种具有复杂需求的疾病的原型，涵盖了 患者和护理人员、医疗和社会领域以及卫生系统和社区组织。 为此，制定了多项痴呆症护理计划，以更全面地满足需求 患者及其护理人员，包括医疗保健系统内的患者及其护理人员 社区。这些计划要么在单个地点实施，要么规模相对较小；没有任何 由于有关有效性和成本效益的问题尚未得到解答，该方案已被广泛复制。 2017 年 11 月，以患者为中心的结果研究所 (PCORI) 批准了 4 个站点的务实项目 比较基于卫生系统的护理有效性的临床试验（基于加州大学洛杉矶分校阿尔茨海默病和 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）关于患者和护理人员报告的结果测量，包括行为症状和护理人员 痛苦（共同主要结果），以及照顾者压力、未满足的需求和抑郁等次要结果 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）。也不会评估这两种干预措施的成本效益。 拟议的研究将增加第三个常规护理（UC）部门，并扩大结果以包括成本和健康 护理利用。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随机临床试验证据 治疗臂。它还将允许评估支付此类护理费用是否可以抵消成本和 确定哪种干预措施更具成本效益。该研究还将进行探索性分析 两种干预措施与常规护理相比的三级结果，包括死亡率、在家度过的时间、长期护理 疗养院安置、医生和患者/护理人员满意度以及比较所有三组 几种类型的使用和自付费用。 该研究的问题对于规划痴呆症患者的临床护理至关重要。他们 兼顾临床效果和成本效益。通过回答这些问题，临床医生、健康 系统，保险公司可以决定推广、扩展和传播哪些项目。