BACKGROUND: Urinary tract infection (UTI) is the most common reason for antibiotic prescription in nursing homes. Overprescription causes antibiotic-related harms in those who are treated and others residing within the nursing home. The diagnostic process in nursing homes is complicated with both challenging issues related to the elderly population and the nursing home setting. A physician rarely visits a nursing home for suspected UTI. Consequently, the knowledge of UTI and communication skills of staff influence the diagnosis.

OBJECTIVE: The objective of this study is to describe a cluster randomized controlled trial with a tailored complex intervention for improving the knowledge of UTI and communication skills of nursing home staff in order to decrease the number of antibiotic prescriptions for UTI in nursing home residents, without changing hospitalization and mortality.

METHODS: The study describes an open-label cluster randomized controlled trial with two parallel groups and a 1:1 allocation ratio. Twenty-two eligible nursing homes are sampled from the Capital Region of Denmark, corresponding to 1274 nursing home residents. The intervention group receives a dialogue tool, and all nursing home staff attend a workshop on UTI. The main outcomes of the study are the antibiotic prescription rate for UTI, all-cause hospitalization, all-cause mortality, and suspected UTI during the trial period.

RESULTS: The trial ended in April 2019. Data have been collected and are being analyzed. We expect the results of the trial to be published in a peer-reviewed journal in the fall of 2020.

CONCLUSIONS: The greatest strengths of this study are the randomized design, tailored development of the intervention, and access to medical records. The potential limitations are the hierarchy in the prescription process, Hawthorne effect, and biased access to data on signs and symptoms through a UTI diary. The results of this trial could offer a strategy to overcome some of the challenges of increased antibiotic resistance and could have implications in terms of how to handle cases of suspected UTI.

TRIAL REGISTRATION: ClinicalTrials.gov NCT03715062; https://clinicaltrials.gov/ct2/show/NCT03715062.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/17710.