Improving Antibiotic Prescribing for Urinary Tract Infections in Frail Elderly

Urinary Tract Infections Clinical Trial

— ImpresU-WP2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03970356
• Other study ID #: 2005035
• Secondary ID: 25 (2017)5490030
• Status: Completed
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: July 21, 2021

Study information

• Verified date: May 2022
• Source: Amsterdam UMC, location VUmc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1146
• Est. completion date: July 21, 2021
• Est. primary completion date: July 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Urinary Tract Infections

Intervention

Other:
• antibiotic stewardship intervention
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.

Locations

Country	Name	City	State
Netherlands	University Medical Center Utrecht	Utrecht
Norway	University of Oslo	Oslo
Poland	Medical University of Lodz	Lódz
Sweden	Research and Development Primary Health Care, Region Västra Götaland	Borås

Sponsors (6)

Lead Sponsor	Collaborator
Cees Hertogh	Göteborg University, Medical University of Lodz, UMC Utrecht, University of Oslo, Vastra Gotaland Region

Countries where clinical trial is conducted

Netherlands,  Norway,  Poland,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	UTI prescriptions	Number of prescriptions of antibiotics for suspected urinary tract infections expressed per patient-year	Assessed during the 7-month follow-up period
Secondary	Incorrect UTI prescriptions	Number of incorrect prescriptions of antibiotics for suspected UTI expressed per patient-year	Assessed during the 7-month follow-up period
Secondary	UTI suspicions	Incidence of suspected UTI expressed per patient-year	Assessed during the 7-month follow-up period
Secondary	Complications	Incidence of complications: delirium, pyelonephritis, sepsis and renal failure within 21 days after each UTI suspicion	Assessed during the 7-month follow-up period
Secondary	Hospital referral	Incidence of referral to a hospital within 21 days after each UTI suspicion	Assessed during the 7-month follow-up period
Secondary	Hospital admission	Incidence of hospital admission within 21 days after each UTI suspicion	Assessed during the 7-month follow-up period
Secondary	Mortality	Mortality	Assessed during the 7-month follow-up period
Secondary	Mortality after UTI suspicion	Mortality within 21 days after each UTI suspicion	Assessed during the 7-month follow-up period
Secondary	UTI prescriptions in office hours	Number of prescriptions of antibiotics for suspected UTI in office hours expressed per patient-year	Assessed during the 7-month follow-up period