Improving Antibiotic Prescribing for Urinary Tract Infections in Frail Elderly

Not Applicable

Completed

• Conditions: Urinary Tract Infections
• Interventions: Other: antibiotic stewardship intervention

• 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

Arm && Interventions

Group	Intervention	Description
intervention	antibiotic stewardship intervention	The antibiotic stewardship intervention will encourage to prescribe according to the latest relevant UTI guidelines which promote more restrictive use of antibiotics in case of non-specific symptoms.

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)

Medical University of Lodz; 🇵🇱 Łódź, Poland

University of Oslo; 🇳🇴 Oslo, Norway

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

University Medical Center Utrecht; 🇳🇱 Utrecht, Netherlands