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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,146
The intervention is multifaceted, consisting of the implementation of an algorithm for restrictive use of antibiotics as proposed in recent guidelines (Verenso, Dutch guideline), tailored in close collaboration with local stakeholders to the specific implementation setting, by means of a modified participatory-action research (PAR) approach. To support the process of intervention-tailoring and -implementation, a toolbox comprising of materials, aids and actions is developed to be used at the discretion of the local stakeholders to support implementation of the algorithm.The algorithm is congruent with the Swedish and Norwegian guidelines, which also promote more restrictive use of antibiotics in case of non-specific symptoms, even though the algorithm is more detailed.
University Medical Center Utrecht
Utrecht, Netherlands
University of Oslo
Oslo, Norway
Medical University of Lodz
Lodz, Poland
Research and Development Primary Health Care, Region Västra Götaland
Borås, Sweden
UTI prescriptions
Number of prescriptions of antibiotics for suspected urinary tract infections expressed per patient-year
Time frame: Assessed during the 7-month follow-up period
Incorrect UTI prescriptions
Number of incorrect prescriptions of antibiotics for suspected UTI expressed per patient-year
Time frame: Assessed during the 7-month follow-up period
UTI suspicions
Incidence of suspected UTI expressed per patient-year
Time frame: Assessed during the 7-month follow-up period
Complications
Incidence of complications: delirium, pyelonephritis, sepsis and renal failure within 21 days after each UTI suspicion
Time frame: Assessed during the 7-month follow-up period
Hospital referral
Incidence of referral to a hospital within 21 days after each UTI suspicion
Time frame: Assessed during the 7-month follow-up period
Hospital admission
Incidence of hospital admission within 21 days after each UTI suspicion
Time frame: Assessed during the 7-month follow-up period
Mortality
Mortality
Time frame: Assessed during the 7-month follow-up period
Mortality after UTI suspicion
Mortality within 21 days after each UTI suspicion
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Assessed during the 7-month follow-up period
UTI prescriptions in office hours
Number of prescriptions of antibiotics for suspected UTI in office hours expressed per patient-year
Time frame: Assessed during the 7-month follow-up period