A Pilot Study of an RCT to Improve Infection Management in Advanced Dementia

描述（由申请人提供）：晚期痴呆症是一种常见的、病态的、昂贵的疾病。老年痴呆症终末期的特点是发病感染和抗菌药物的广泛使用。先前和正在进行的研究表明，这种使用可能是不适当的。抗菌药物的使用也是导致耐药细菌（ARB）的主要因素；公众健康问题日益严重。此外，对于大多数患有晚期痴呆症的养老院（NH）居民来说，姑息治疗是护理的目标，对于这些感染往往是终末期事件的居民来说，抗菌剂的益处尚不清楚。因此，无论是从生命末期的个人获益和负担的角度，还是从ARB出现的公共卫生角度来看，在晚期痴呆症中滥用抗菌药物都引起了人们的关注。来自共同项目正在进行的nih资助的R01前瞻性队列研究（痴呆症中病原体耐药性和抗微生物药物暴露研究（SPREAD））的初步数据表明，在患有晚期痴呆症的NH居民中，约70%的抗微生物药物是不适当的（即，尽管缺乏临床证据表明基于共识指南的感染，但仍开始使用）。居民代理人不知道约50%的疑似感染，67%的居民被ARB定植。这些发现促使联合pi设计一种实践干预措施，以提高该人群中疑似尿路感染和下呼吸道感染的护理质量。干预有两个组成部分：1。提供者培训使用在线教育课程（晚期痴呆感染管理）和算法和清单来指导抗菌素启动；为代理人提供印刷材料，告知他们有关晚期痴呆的感染和治疗注意事项。利用SPREAD的基础设施，目标是：1：建立在4个设施（2对匹配的干预/对照对）中对约60名NH晚期痴呆患者进行实践干预的集群随机对照试验的可行性；2 .开展一项干预措施的聚类随机对照试验的试点研究，其中主要结果是由2个因素定义的疑似LRIs和uti的百分比：1 .根据共识指南满足开始使用抗菌素的最低临床标准；治疗与代理偏好一致。次要结局包括：对决策的代理满意度、居民住院次数的百分比和总抗菌药物暴露。分析将集中于提供效应大小和设计效应的估计。意义：迫切需要提高晚期痴呆患者感染的护理质量。对实践干预进行试点测试是实现这一目标的下一个合乎逻辑的步骤。本R21中提出的探索性工作将提供进行更大规模随机对照试验所需的试点数据。最终，这项研究有可能通过促进符合他们偏好的护理，并通过减少NH中抗菌素耐药细菌日益增长的公共卫生威胁，为数百万患有晚期痴呆症的美国人做出临床和政策相关的贡献。

DESCRIPTION (provided by applicant): Advanced dementia is a common, morbid and costly condition. The end-stage of dementia is characterized by the onset infections and antimicrobial use is extensive. Prior and on-going research suggests that much of this use may be inappropriate. Antimicrobial use also is the main factor leading to antimicrobial-resistant bacteri (ARB); a growing public health concern. Moreover, palliation is the goal of care for the majority of nursing home (NH) residents with advanced dementia and the benefits of antimicrobials remain unclear for these residents for whom infections are often a terminal event. Thus, antimicrobial misuse in advanced dementia raises concerns both from the perspective of individual benefits and burdens near the end-of-life, and also from a public health standpoint with respect to the emergence of ARB. Preliminary data from the co-PIs' on-going NIH-funded R01 prospective cohort study (Study of Pathogen Resistance and Exposure to Antimicrobials in Dementia (SPREAD)), suggest that ~70% of antimicrobials are initiated inappropriately in NH residents with advanced dementia (i.e.,started despite the lack of clinical evidence to suggest an infection based on consensus guidelines). The residents' proxies were unaware ~50% of suspected infections, and 67% of residents were colonized with an ARB. These findings motivated the co-PIs to design a practice intervention to improve the quality of care for suspected urinary (UTI) and lower respiratory (LRI) tract infections in this population. The intervention has two components: 1. Provider training using an on-line education course (Infection Management in Advanced Dementia) and algorithms and checklists to guide antimicrobial initiation, and 2. Printed material for proxies to inform them about infections and treatment considerations in advanced dementia. Leveraging infrastructure from SPREAD, the Aims are: 1: To establish the feasibility of conducting a cluster RCT of the practice intervention in ~ 60 NH residents with advanced dementia in 4 facilities (2 matched intervention/control pairs); and 2: To conduct a pilot study of a cluster RCT of the intervention where the primary outcome is the % of suspected LRIs and UTIs for which antimicrobials were initiated appropriately defined by 2 factors: i. minimal clinical criteria to start antimicrobials were met based on consensus guidelines, and ii. treatment was consistent with proxy preferences. Secondary outcomes include: proxy satisfaction with decision-making, % episodes for which residents were hospitalized, and total antimicrobial exposure. Analyses will focus on providing estimates of effect sizes and design effect. IMPLICATIONS: There is a critical need to improve the quality of care for infections in advanced dementia. Pilot testing a practice intervention is te next logical step towards this goal. The exploratory work proposed in this R21 will provide the pilot data needed to conduct a larger RCT. Ultimately this research has the potential to make clinical and policy-relevant contributions for the millions of Americans with advanced dementia by promoting care that is consistent with their preferences, and by reducing the growing public health threat of antimicrobial resistant bacteria in the NH.