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.

摘要 尿培养是美国门诊最常见的微生物检测。 不幸的是，在收集过程中污染是普遍的，并破坏测试的准确性，导致不正确的 诊断，不必要的治疗，浪费实验室资源和膨胀的成本。不必要的抗生素 治疗增加了产生抗生素耐药性的风险，这是对患者最严重的威胁之一 和公共卫生。我们以前发现，在1,265例女性尿培养中， 两个初级保健诊所的男子受到污染。先前尝试减少尿液污染的试验 使用病人教育的结果好坏参半。然而，这些先前的研究没有包括利益相关者， 在此之前，没有进行试点研究，而试点研究是制定干预措施过程中的一个关键步骤。 除非我们有有效的干预措施，否则受污染的样本将继续给出毫无意义的结果， 过度使用抗生素，并抬高成本。该项目的首要目标是提高 泌尿诊断检测，从而进一步加强门诊护理环境中的抗生素管理。我们将创建一个 一种新的患者教育干预措施，包括利益相关者的意见和先前确定的解决方案 阻碍了适当的中游清洁收集尿液样本。主要障碍包括竞争性护理 优先事项，患者语言障碍，健康素养差，护士和医疗助理的沉默， 讨论重要的解剖细节为了解决这些障碍，我们的动画视频和英文图片传单 和西班牙语将提供一步一步的指导，为妇女和男子的尿液收集。内容和 我们将与对这一进程至关重要的利益攸关方合作，制定我们的干预措施： 病人、护士和医疗助理。拟议项目的总体目标是设计和测试一个 双语教育干预以减少不同患者人群的尿液污染 净初级保健诊所。在目标1（干预开发）中，我们将迭代开发一个教育 干预（教学视频和传单）与输入从病人咨询委员会，护士，和医疗 助手录像带和传单将为患者提供收集尿液样本的分步指导。在 目标2（先导研究），我们会评估及改善干预措施的可接受性、适切性及可行性 使用混合方法，包括定量调查和定性访谈， 持份者在目标3（随机对照试验）中，我们将测试患者教育的有效性 减少尿污染和与尿培养相关的抗生素使用。拟议 这项研究意义重大，因为它将开发一种干预措施，以减少尿液培养物的污染。的 拟议的研究是创新的，因为它使用了以股东为中心的方法。如果成功，这 干预可以传播到尿培养污染驱动抗生素其它临床环境 过度使用，包括急诊室和长期护理机构。