Improving Antibiotic Prescribing for Urinary Tract Infections in Frail

Status Completed

Clinical Trial Summary

The purpose of this study is to determine whether a tailored multifaceted antibiotic stewardship intervention reduces antibiotic use for urinary tract infections in residential care homes and nursing homes attended by general practitioners. This will be evaluated in a pragmatic cluster randomised controlled trial using a modified community-based participatory action research approach.

Clinical Trial Description

Rationale: Almost 60% of antibiotics in frail elderly is prescribed for alleged UTI. About half of the antibiotics for UTI in this population are prescribed for non-specific signs and symptoms; a substantial part of these prescriptions might not be necessary. Research question: Does a tailored multifaceted antibiotic stewardship intervention reduce antibiotic use for UTI in residential care homes and nursing homes attended by general practitioners (GPs)? Study design, setting and population: A pragmatic cluster randomised controlled trial using a modified community-based participatory action research approach. In the intervention group the latest UTI guidelines (which are standard care) are actively implemented at the level of the GP/caregivers. Residents ≥ 70 year with ADL dependency from 34 care homes + attending GP practices will participate in Norway, Sweden, Poland and the Netherlands. Methods: The study has two measurement periods; a baseline period (5 months) and a follow-up period (7 months). In between the antibiotic stewardship intervention will be tailored and implemented in intervention practices. GPs will prospectively register suspected UTIs on standardized registration forms and (study) nurses/assistants will follow-up patients at day 7 and day 21 for each UTI. Patients will be enrolled prior to the start of the study. - June-August 2019: patient are recruited, informed consent is obtained, baseline characteristics of patients are recorded - Sept 2019: study starts (from this moment onwards, the outcomes are being assessed). Data analysis: The primary analysis will be to assess the number of prescriptions of antibiotics for suspected UTI in the follow-up period, correcting for the baseline period and controlled for pre-specified confounders, using a generalized linear mixed model for Poisson distributions. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03970356
Study type	Interventional
Source	Amsterdam UMC, location VUmc
Contact
Status	Completed
Phase	N/A
Start date	September 1, 2019
Completion date	July 21, 2021

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Improving Antibiotic Prescribing for Urinary Tract Infections in Frail Elderly — ImpresU-WP2

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms