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

摘要

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.