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）：晚期痴呆症是一种常见，病态且昂贵的状况。痴呆症的末端阶段的特征是发作感染，抗菌素的使用广泛。事先和正在进行的研究表明，这种使用中的大部分可能是不合适的。抗菌使用也是导致抗菌细菌（ARB）的主要因素。越来越多的公共卫生问题。此外，抚摸是对大多数患有晚期痴呆症的疗养院（NH）居民进行护理的目标，对于这些居民通常是最终事件的抗菌剂的益处仍然不清楚。因此，从高级痴呆症中的抗微生物滥用从个人利益和寿命终止的个人负担的角度，也从公共卫生的角度出发，就ARB的出现而引起了人们的关注。来自Co-Pis持续资助的R01前瞻性队列研究的初步数据（对痴呆症的病原体抵抗和暴露于抗菌剂的研究研究（散布），表明，在NH居民中，在NH居民中不当启动了抗菌素的抗菌素（即基于先进的dementia nh sative nhs Nabiente nhs Nabiente nhs nabiente nhs nabient in nabient in。居民的代理人不知道约50％的可疑感染，而有67％的居民用ARB定居。这些发现促使Co-Pis设计实践干预措施，以提高该人群中可疑尿（UTI）和下呼吸道（LRI）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（高级痴呆症中的感染管理）和算法和清单来指导抗菌剂的培训，以及2。代理的印刷材料，以告知他们有关高级痴呆症的感染和治疗方面的信息。利用扩散的基础设施，目的是：1：建立在4个设施中患有晚期痴呆症的约60 NH居民中进行实践干预的可行性（2个匹配的干预/控制对）；和2：对干预措施的簇RCT进行试点研究，其中主要结果是可疑的LRI和UTI的百分比，该抗菌药物是由2个因素适当地定义的：i。根据共识准则，符合抗菌剂的最低临床标准，以及II。治疗与代理偏好一致。次要结果包括：对决策的替代满意度，居民住院的％发作和总抗菌暴露。分析将集中于提供效果大小和设计效果的估计。含义：迫切需要提高晚期痴呆症感染的护理质量。试点测试练习干预是朝着这一目标迈出的下一个逻辑步骤。 R21中提出的探索性工作将提供进行较大RCT所需的试验数据。最终，这项研究有可能通过促进与他们的偏好一致的护理，并减少NH中抗菌素抗性细菌的日益增长的公共卫生威胁，从而为数百万具有晚期痴呆症的美国人做出临床和政策贡献。