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

针对老年女性尿路感染症状的文化导向方法的随机试验和可行性研究：混合方法评估 - REDUCTION 试验

• 批准号: 10586250
• 负责人: Megan Bradley
• 金额: $ 34.08万
• 依托单位: MAGEE-WOMEN'S RES INST AND FOUNDATION
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-01-01 至 2024-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10586250
• 关键词: Acute; Acute Cystitis; Address; Adherence; Adoption; Adverse event; Affect; Age; Antibiotic Therapy; Antibiotics; Bacterial Antibiotic Resistance; Bacterial Infections; Bacteriuria; Bladder; Characteristics; Chronic; Clinical; Clinical Sciences; Clinical Trials; Cohort Studies; Communication; Communities; Consultations; Data; Diagnosis; Disease Progression; Electronics; Eligibility Determination; Enrollment; Ensure; Evaluation; Feasibility Studies; Focus Groups; Funding; Future; Gender; Guidelines; Health; High Prevalence; Hour; Individual; Infrastructure; Interview; Knowledge; Laboratories; Methods; Morbidity - disease rate; Outcome; Outpatients; Patients; Pelvis; Persons; Pilot Projects; Population; Prevalence; Probability; Procedures; Protocols documentation; Provider; Pyelonephritis; Questionnaires; Randomized; Randomized, Controlled Trials; Recording of previous events; Recurrence; Registries; Reporting; Research; Resistance; Resolution; Safety; Sepsis; Structure; Surveys; Symptoms; Telephone; Time; Translational Research; Universities; Urinalysis; Urinary tract infection; Urine; Uropathogen; Voice; Woman; antimicrobial; arm; care seeking; clinical practice; compliance behavior; design; eligible participant; experience; follow-up; human old age (65+); improved; insight; lower urinary tract symptoms; member; novel; older women; pilot trial; prospective; randomized trial; recruit; secondary outcome; shared decision making; side effect; treatment strategy; trial comparing; trial design; trial planning; young woman

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.

项目摘要 尿路感染（UTI）在个人和社会层面上都造成了明显的发病率。乌蒂斯是 在老年妇女和子集中尤其常见，容易发生尿路斯（RUTIS）。当前对 患者报告鲁蒂妇女的尿路病的自然进展受到限制 将最初的非抗生素策略的先前随机对照试验纳入其中。目的1：我们试图 评估招募合格参与者的可行性 老年妇女中患者报告的UTI符号的经验性抗生素策略和依从性 程序。我们将探讨以文化为导向的UTI治疗策略和初步次要的安全性 分配治疗的结果。对于目标2：我们将调查以前的UTI经验和可接受性 试用设计/未来的招聘工作通过焦点小组与被招募为试验审判的女性以及 在关键的社区利益相关者中。对于AIM 3，我们将通过试用评估促进者和障碍 参与和 代表性的非参与提供者。我们计划通过我们的临床招募鲁蒂的老年妇女 实践和匹兹堡大学的临床与转化科学学院（CTSI）PITT+ME® 研究注册表。当对UTI有症状时，总共将招募70名女性并随机分配给 培养指导或经验性抗生素策略。经验手臂中的那些将在 标准方案和以培养为导向的手臂的方案将根据尿液培养规定抗生素 敏感性结果在〜48-72小时内返回。在基线时，受试者将完成人口统计和 症状问卷。当尿液培养结果可用，然后每周一次，将遵循受试者 直到症状发作28天（带有电子调查和电话）。后续问题将 调查症状的缓解，抗生素副作用以及症状进展的任何治疗方法（任何一种） 肾上腺炎或尿素）。受试者将向我们团队成员提供联系信息 24/7。共有30名女性（10名完成学习，10名拒绝参与和10个社区 利益相关者）将通过焦点小组进行采访，以确保考虑患者声音 关于未来的审判计划。我们还将招募提供商（参加招聘的人中有10名 10个非招募提供商），以完成对他们的试验经验的半结构化定性访谈。我们的 混合方法试验研究将产生必要的初步可行性，可接受性，有效性/证明 概念和安全数据，以告知设计定向的定向的确定随机试验 治疗患者的经验性抗生素策略报告了我们寻求的鲁蒂老年妇女的UTI 当前处方实践的驱动器变化。