The Improving Rational Prescribing for Urinary Tract Infections in Frail Elderly (ImpresU) Project - Work Package 2 (WP2): a Cluster Randomised Multifaceted Antibiotic Stewardship Intervention Study
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Urinary Tract Infections
- Sponsor
- Cees Hertogh
- Enrollment
- 1146
- Locations
- 4
- Primary Endpoint
- UTI prescriptions
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief 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.
Detailed 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.
Investigators
Cees Hertogh
Prof. dr.
Amsterdam UMC, location VUmc
Eligibility Criteria
Inclusion Criteria
- •physical and/or mental disabilities and ADL dependency requiring residential care or nursing home care
- •attended by general practitioners
- •not on continuous prophylactic antibiotic use
Exclusion Criteria
- •in hospice-care
- •very limited life expectancy (≤1 month)
- •no longer wish to participate
- •start continuous antibiotic (prophylaxis)
- •die or move away from the residential care home / nursing home
- •If patients are excluded within 2 months after inclusion, they will be taken out of the study. In other words: patients need to be included for at least 2 months to contribute data to the study.
Outcomes
Primary Outcomes
UTI prescriptions
Time Frame: Assessed during the 7-month follow-up period
Number of prescriptions of antibiotics for suspected urinary tract infections expressed per patient-year
Secondary Outcomes
- Complications(Assessed during the 7-month follow-up period)
- Hospital referral(Assessed during the 7-month follow-up period)
- UTI suspicions(Assessed during the 7-month follow-up period)
- Mortality after UTI suspicion(Assessed during the 7-month follow-up period)
- UTI prescriptions in office hours(Assessed during the 7-month follow-up period)
- Incorrect UTI prescriptions(Assessed during the 7-month follow-up period)
- Hospital admission(Assessed during the 7-month follow-up period)
- Mortality(Assessed during the 7-month follow-up period)