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有显着的发病率。 在老年女性中尤其常见，并且有一部分女性容易出现复发性尿路感染 (rUTI)。 患有 rUTI 的老年女性患者报告的 UTI 自然进展受到限制，因为 纳入先前关于初始非抗生素策略的随机对照试验：我们寻求 评估招募合格参与者参加文化导向与文化导向的随机试验的可行性 针对老年女性患者报告的尿路感染症状的经验性抗生素策略以及对研究的依从性 我们将探讨培养导向的尿路感染治疗策略和初步二级治疗的安全性。 对于目标 2：我们将调查以前的 UTI 经历和可接受性。 试验设计/未来的招募工作，通过焦点小组与为试点试验招募的女性进行，以及 对于目标 3，我们将通过试验评估促进因素和障碍。 通过对参与者和参与者进行半结构化访谈来实施和招聘 我们计划通过我们的临床招募患有 rUTI 的老年女性。 实践和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，总共 70 名女性将被登记并随机分配到任一组。 培养导向或经验性抗生素策略 经验组中的患者将在接受抗生素治疗后服用抗生素。 标准方案和培养导向组中的人员将根据尿培养开出抗生素 敏感度结果在约 48-72 小时内返回，受试者将完成人口统计和评估。 当尿培养结果可用时，将对受试者进行症状调查问卷，然后每周进行一次。 直到症状出现后 28 天（通过电子调查和电话询问）。 调查症状缓解、抗生素副作用以及症状进展的任何治疗方法（ 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） 利益相关者）将通过焦点小组接受采访，以确保患者的声音得到考虑 关于未来的试验计划，我们将另外招募提供者（参与招募和招募的人员中的10名）。 10 个非招聘提供者）完成关于其试验经历的半结构化、定性访谈。 混合方法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，为设计针对文化导向与 我们寻求针对患有 rUTI 的老年女性患者报告的 UTI 进行经验性抗生素治疗策略 推动该人群当前处方实践的改变。