Improving Antibiotic Prescribing for Urinary Tract Infections in Frail Elderly

Not Applicable

Completed

• Conditions: Urinary Tract Infections

• Registration Number: NCT03970356
• Lead Sponsor: Cees Hertogh

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.

Study Timeline

• Study First Submitted: 2019-05-26
• Study First Submitted QC: 2019-05-29
• Study First Posted: 2019-05-31
• Study Start: 2019-09-01
• Primary Completion: 2021-07-21
• Study Completion: 2021-07-21
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-23
• Last Update Posted: 2022-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1146

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
UTI prescriptions	Assessed during the 7-month follow-up period	Number of prescriptions of antibiotics for suspected urinary tract infections expressed per patient-year

Secondary Outcome Measures

Name	Time	Method
Complications	Assessed during the 7-month follow-up period	Incidence of complications: delirium, pyelonephritis, sepsis and renal failure within 21 days after each UTI suspicion
Hospital referral	Assessed during the 7-month follow-up period	Incidence of referral to a hospital within 21 days after each UTI suspicion
UTI suspicions	Assessed during the 7-month follow-up period	Incidence of suspected UTI expressed per patient-year
Mortality after UTI suspicion	Assessed during the 7-month follow-up period	Mortality within 21 days after each UTI suspicion
UTI prescriptions in office hours	Assessed during the 7-month follow-up period	Number of prescriptions of antibiotics for suspected UTI in office hours expressed per patient-year
Incorrect UTI prescriptions	Assessed during the 7-month follow-up period	Number of incorrect prescriptions of antibiotics for suspected UTI expressed per patient-year
Hospital admission	Assessed during the 7-month follow-up period	Incidence of hospital admission within 21 days after each UTI suspicion
Mortality	Assessed during the 7-month follow-up period	Mortality

Trial Locations

Locations (4)

University Medical Center Utrecht; 🇳🇱 Utrecht, Netherlands

University of Oslo; 🇳🇴 Oslo, Norway

Medical University of Lodz; 🇵🇱 Łódź, Poland

Research and Development Primary Health Care, Region Västra Götaland; 🇸🇪 Borås, Sweden