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

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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.