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

改善晚期痴呆症感染管理的随机对照试验试点研究

• 批准号: 8676621
• 负责人: ERIKA M D'AGATA
• 金额: $ 20.63万
• 依托单位: HEBREW REHABILITATION CENTER FOR AGED
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-06-15 至 2016-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8676621
• 关键词: Algorithms; American; Antimicrobial Resistance; Bacteria; Caring; Clinical; Cohort Studies; Communicable Diseases; Consensus; Data; Decision Making; Dementia; Economic Inflation; Education; Event; Exposure to; Facility Controls; Funding; Goals; Guidelines; Hospitals; Individual; Infection; Intervention; Intervention Trial; Interview; Life; Lower Respiratory Tract Infection; Nurse Practitioners; Nursing Homes; Palliative Care; Patient Preferences; Patients; Physician Assistants; Pilot Projects; Policies; Population; Printing; Provider; Proxy; Public Health; Publishing; Quality of Care; Randomized Clinical Trials; Randomized Controlled Trials; Research; Research Infrastructure; Research Personnel; Resistance; Staging; Testing; Time; Training; United States National Institutes of Health; Urinary tract infection; Work; advanced dementia; antimicrobial; base; design; end of life; experience; follow-up; improved; indexing; meetings; palliation; pathogen; preference; primary outcome; prospective; public health relevance; respiratory; satisfaction; secondary outcome; trend; urinary

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.

描述（由申请人提供）：晚期痴呆是一种常见、病态且代价高昂的疾病。痴呆症末期的特点是发病时出现感染，并且广泛使用抗菌药物。先前和正在进行的研究表明，这种用途大部分可能是不合适的。抗菌药物的使用也是导致抗菌药物耐药细菌（ARB）的主要因素；日益增长的公共卫生问题。此外，姑息治疗是大多数患有晚期痴呆症的疗养院 (NH) 居民的护理目标，而对于这些感染往往是终末期事件的居民来说，抗菌药物的益处仍不清楚。因此，从个人临终受益和负担的角度以及从公共卫生角度来看，晚期痴呆症中抗菌药物的滥用引起了人们对 ARB 的出现的担忧。共同PI正在进行的由NIH资助的R01前瞻性队列研究（痴呆症中的病原体耐药性和抗菌药物暴露研究（SPREAD））的初步数据表明，在患有晚期痴呆的新罕布什尔州居民中，约70%的抗菌药物使用不当（即，尽管缺乏临床证据表明根据共识指南存在感染，但仍开始实施）。居民的代理人不知道约 50% 的疑似感染，67% 的居民被 ARB 定植。这些发现促使共同首席研究员设计一种实践干预措施，以提高该人群疑似泌尿道 (UTI) 和下呼吸道 (LRI) 感染的护理质量。该干预措施有两个组成部分：1. 使用在线教育课程（高级痴呆症的感染管理）以及算法和清单来指导抗菌药物启动的提供者培训，以及 2. 为代理人提供印刷材料，提前告知他们感染和治疗注意事项痴呆。利用 SPREAD 的基础设施，目标是： 1：建立对 4 个设施（2 个匹配的干预/对照对）中约 60 名患有晚期痴呆症的 NH 居民进行实践干预的集群随机对照试验的可行性； 2：开展一项针对干预措施的整群随机对照试验的试点研究，其中主要结果是开始使用抗菌药物的可疑 LRI 和 UTI 的百分比，由 2 个因素适当定义：根据共识指南，满足开始使用抗菌药物的最低临床标准，以及 ii．治疗与代理偏好一致。次要结局包括：决策的代理满意度、居民住院的事件百分比以及总抗菌药物暴露量。分析将侧重于提供效应大小和设计效果的估计。影响：迫切需要提高晚期痴呆症感染的护理质量。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。 R21 中提出的探索性工作将提供进行更大规模的 RCT 所需的试点数据。最终，这项研究有可能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，方法是促进符合他们偏好的护理，并减少新罕布什尔州抗菌素耐药细菌日益严重的公共卫生威胁。