A Randomized Controlled Trial of a Diagnostic Stewardship Intervention to Reduce Inappropriate Antibiotic Use for Urinary Tract Infections in Primary Care

一项诊断管理干预措施的随机对照试验，以减少初级保健中尿路感染的不当抗生素使用

• 批准号: 10716759
• 负责人: Larisa Grigoryan
• 金额: $ 47.13万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-08-01 至 2028-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10716759
• 关键词: Randomized; Controlled; Trial; Diagnostic; Stewardship

Abstract Urine culture is the most common microbiological test in the outpatient setting in the United States. Unfortunately, contamination during collection is prevalent and undermines test accuracy, leading to incorrect diagnosis, unnecessary treatment, wasted laboratory resources, and inflated costs. Unnecessary antibiotic treatment increases the risk of developing antimicrobial resistance, one of the most serious threats to patients and public health. We previously found that more than half of 1,265 urine cultures collected from women and men in two primary care clinics were contaminated. Prior trials that attempted to reduce urine contamination using patient education had mixed results. However, these prior studies did not include stakeholder engagement and were not preceded by pilot studies, a critical step in the process of intervention development. Until we have an effective intervention, contaminated samples will continue to give meaningless results, trigger undue antibiotic use, and inflate costs. The overarching goal of this project is to improve the accuracy of urinary diagnostic testing, thus furthering antibiotic stewardship in ambulatory care settings. We will create a novel patient education intervention that incorporates stakeholder input and addresses previously identified barriers to proper midstream clean-catch urine sample collection. Key barriers include competing nursing priorities, patient language barriers, poor health literacy, and reticence of nurses and medical assistants to discuss essential anatomic details. To address these barriers, our animated video and pictorial flyer in English and Spanish will provide step-by-step guidance for urine collection for women and men. The content and presentation of our intervention will be developed in collaboration with stakeholders central to this process: patients, nurses and medical assistants. The overall objective of the proposed project is to design and test a bilingual educational intervention to reduce urine contamination in a diverse patient population visiting safety net primary care clinics. In Aim 1 (intervention development), we will iteratively develop an educational intervention (instructional video and flyer) with input from a patient advisory board, nurses, and medical assistants. The video and flyer will provide step-by-step guidance to patients for collecting a urine sample. In Aim 2 (pilot study), we will assess and improve the intervention’s acceptability, appropriateness and feasibility using a mixed methods approach that includes a quantitative survey and qualitative interviews with stakeholders. In Aim 3 (randomized controlled trial), we will test the effectiveness of our patient education intervention at reducing urine contamination and antibiotic use associated with urine cultures. The proposed research is significant because it will develop an intervention to reduce contamination of urine cultures. The proposed research is innovative because it uses a stakeholder-centered approach. If successful, this intervention can be disseminated to other clinical settings in which urine culture contamination drives antibiotic overuse, including emergency departments and long-term care settings.

抽象的 尿培养是美国门诊环境中最常见的微生物测试。 不幸的是，收集过程中的污染很普遍，并且破坏了测试准确性，导致不正确 诊断，不必要的治疗，浪费的实验室资源以及成本膨胀。不必要的抗生素 治疗增加了发展抗菌素耐药性的风险，这是对患者的最严重威胁之一 和公共卫生。我们以前发现，从女性那里收集的1,265种尿文化中，超过一半 两家初级保健诊所的男性被污染。试图减少尿液污染的先前试验 使用患者教育的结果不同。但是，这些先前的研究不包括利益相关者 参与和不进行试点研究，这是干预发展过程中的关键步骤。 在我们进行有效的干预之前，受污染的样本将继续给出毫无意义的结果，触发 取消使用抗生素，并膨胀成本。该项目的总体目标是提高 尿液诊断测试，因此在门诊护理环境中进一步的抗生素管理。我们将创建一个 新的患者教育干预措施，结合了利益相关者的意见并解决了先前确定的 适当的中游清洁尿液样品收集的障碍。关键障碍包括竞争护士 优先事项，患者语言障碍，健康素养差以及护士和医疗助理的沉默 讨论基本的解剖细节。为了解决这些障碍，我们的动画视频和英文图画传单 西班牙语将为男性和男性尿液收集逐步指导。内容和 我们的干预措施的介绍将与此过程中心的利益相关者合作开发： 病人，护士和医疗助理。拟议项目的总体目的是设计和测试 双语教育干预措施以减少尿液污染的患者人群访问安全性的尿液污染 净初级保健诊所。在AIM 1（干预开发）中，我们将迭代地发展教育 干预（教学视频和传单）以及患者顾问委员会，护士和医疗的输入 助手。该视频和传单将为患者收集尿液样本提供逐步指导。在 AIM 2（试点研究），我们将评估和改善干预措施的可接受性，适当性和可行性 使用混合方法方法，包括定量调查和与 利益相关者。在AIM 3（随机对照试验）中，我们将测试患者教育的有效性 减少尿液污染和与尿液培养相关的抗生素使用时的干预措施。提议 研究很重要，因为它将开发一种干预措施，以减少尿培养物的污染。 拟议的研究具有创新性，因为它采用了以利益相关者为中心的方法。如果成功，这 干预措施可以传播到其他临床环境中，尿液培养污染驱动抗生素 过度使用，包括急诊科和长期护理环境。