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、病态的和昂贵的疾病。痴呆的终末期以发病感染为特征，抗菌药物应用广泛。先前和正在进行的研究表明，这种用途中的大部分可能是不适当的。抗菌药物的使用也是导致抗菌素耐药细菌(ARB)的主要因素；这是一个日益令人担忧的公共卫生问题。此外，缓解是大多数患有晚期痴呆症的疗养院(NH)居民的护理目标，抗微生物药物对这些居民的好处尚不清楚，对他们来说，感染往往是晚期事件。因此，在晚期痴呆症中滥用抗菌药引起了人们的关注，既从个体的利益和临终时的负担的角度，也从公共卫生的角度考虑ARB的出现。来自共同PIs正在进行的由NIH资助的R01前瞻性队列研究(痴呆症病原体耐药性和抗菌剂暴露研究(传播))的初步数据表明，约70%的抗菌药在晚期痴呆症患者中使用不当(即，尽管根据共识指南缺乏临床证据表明感染)。居民的代理人没有意识到~50%的疑似感染，67%的居民被ARB殖民。这些发现促使合作PIs设计了一种实践干预措施，以改善该人群中疑似尿路(UTI)和下呼吸道(LRI)感染的护理质量。干预包括两个部分：1.提供者培训，使用在线教育课程(晚期痴呆症的感染管理)和指导抗菌药物启动的算法和核对表，以及2.为代理人提供的印刷材料，告知他们晚期痴呆症的感染和治疗考虑。利用传播的基础设施，目标是：1：确定在4个设施(2对匹配的干预/对照对)中对约60名患有晚期痴呆症的NH居民进行实践干预的集群RCT的可行性；以及2：对干预的集群RCT进行试点研究，其中主要结果是可疑的LRIS和UTI的百分比，针对这些可疑的LRIS和UTI，由两个因素适当地定义：i.基于共识指南，满足开始使用抗菌药物的最低临床标准，以及ii.治疗方式与代理人的偏好一致。次要结果包括：对决策的替代满意度、住院患者的事件百分比和总的抗菌药物暴露。分析将侧重于提供对效果大小和设计效果的估计。影响：迫切需要改善晚期痴呆症患者感染的护理质量。试点测试实践干预是朝着这一目标迈出的合乎逻辑的下一步。本R21中提议的探索性工作将提供进行更大规模RCT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中抗菌素耐药性细菌日益增长的公共健康威胁，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.