A Randomized Pilot and Feasibility Study of a cultuRE-Directed approach to Urinary traCT Infection symptoms in older womeN: a mixed methods evaluation - the REDUCTION trial

项目摘要 尿路感染（UTIs）占显着的发病率在个人和社会层面。UTI是 尤其常见于老年妇女，并且一个子集易于复发性UTI（rUTI）。目前了解的 在患有鲁蒂的老年女性中，患者报告的UTI的自然进展是有限的， 纳入先前关于初始非抗生素策略的随机对照试验。目标1：我们力求 评估招募合格受试者参加一项文化导向与 老年女性患者报告的UTI症状的经验性抗生素治疗策略和对研究的依从性 程序.我们将探讨培养导向的UTI治疗策略的安全性，并初步评估其继发性感染。 分配治疗的结果。对于目标2：我们将调查以前的UTI经验和 试验设计/未来招募工作，通过重点小组与为试点试验招募的女性进行， 关键的社区利益相关者。对于目标3，我们将通过试验评估促进者和障碍 通过对参与者和 不参与的供应商。我们计划通过我们的临床试验和临床试验招募患有鲁蒂的老年女性。 匹兹堡大学临床与转化科学研究所（CTSI）Pitt+Me® 研究登记处。当出现UTI症状时，将招募总计70名女性，并随机分配至 培养导向或经验性抗生素策略。经验组的患者将在以下情况下使用抗生素： 标准方案和那些在培养导向臂将有抗生素处方的基础上尿培养 和灵敏度结果在约48-72小时内返回。在基线时，受试者将完成人口统计学和 症状问卷当获得尿培养结果时，将对受试者进行随访，然后每周一次 直到症状发作后28天（通过电子调查和电话）。后续问题将 调查症状缓解、抗生素副作用和任何症状进展的治疗（ 肾盂肾炎或尿脓毒症）。受试者将获得我们团队成员的联系信息， 24/7.共有30名女性（10名完成研究，10名拒绝参与，10名社区参与） 利益相关者）将通过焦点小组进行访谈，以确保考虑到患者的声音 未来的审判计划我们将额外招募供应商（10名参与招募的供应商， 10名非招募提供者）就其试验经验完成半结构化定性访谈。我们 混合方法的试点研究将产生必要的初步可行性，可接受性，有效性/证据， 概念和安全性数据，以告知一项确定性的随机试验的设计， 经验性抗生素策略用于治疗老年鲁蒂女性患者报告的UTI， 推动该人群当前处方实践的改变。

PROJECT ABSTRACT Urinary tract infections (UTIs) account for significant morbidity on both an individual and societal level. UTIs are especially common in older women and a subset are prone to recurrent UTIs (rUTIs). Current understanding of the natural progression of patient reported UTIs in older women with rUTI is limited due to low levels of inclusion in previous randomized controlled trials on initial non-antibiotic strategies. For Aim 1: We seek to evaluate the feasibility of recruiting eligible participants into a randomized trial of a culture-directed versus empiric antibiotic strategy for patient-reported UTI symptoms in older women and the adherence to study procedures. We will explore the safety of a culture-directed UTI treatment strategy and preliminary secondary outcomes of assigned treatments. For Aim 2: We will investigate previous UTI experiences and acceptability of trial design/future recruitment efforts via focus groups with women that are recruited for the pilot trial and also among key community stakeholders. For Aim 3, we will assess facilitators and barriers with trial implementation and recruitment through semi-structured interviews among both participating and representative non-participating providers. We plan to recruit older women with rUTI through both our clinical practice and the University of Pittsburgh’s Clinical and Translational Science Institute (CTSI) Pitt+Me® Research Registry. When symptomatic for UTI, a total of 70 women will be enrolled and randomized to either a culture-directed or empiric antibiotic strategy. Those in the empiric arm will be prescribed antibiotics following a standard protocol and those in the culture-directed arm will have antibiotics prescribed based on urine culture and sensitivity results that return in ~48-72 hours. At baseline, subjects will complete demographic and symptom questionnaires. Subjects will be followed when urine culture results are available and then weekly until they are 28 days from symptom onset (with electronic survey and phone call). Follow-up questions will investigate symptom resolution, antibiotic side effects, and any treatment for progression of symptoms (either pyelonephritis or urosepsis). Subjects will have contact information to a member of our team that is available 24/7. A total of 30 women (10 who complete study, 10 who declined participation and 10 community stakeholders) will be interviewed through focus groups to ensure the patient-voice is taken into consideration on future trial planning. We will additionally recruit providers (10 of those who participated in recruitment and 10 non-recruiting providers) to complete semi-structured, qualitative interviews on their trial experiences. Our mixed-methods pilot study will generate the requisite preliminary feasibility, acceptability, efficacy/proof of concept, and safety data to inform the design of a definitive randomized trial of a culture-directed versus empiric antibiotic strategy for the treatment of patient reported UTI in older women with rUTI as we seek to drive change in current prescribing practices in this population.