Clinical trial NCT03970356: Improving Antibiotic Prescribing for Urinary Tract Infections in Frail Elderly
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Tract Infections
Keywords: cluster randomized trial
antibiotic stewardship
frail elderly
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
Collaborators: name: UMC Utrecht
name: Medical University of Lodz
name: University of Oslo
name: Vastra Gotaland Region
name: Göteborg University
First posted: 2019-05-31
Enrollment: 1146
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The investigators will perform a pragmatic cluster randomised controlled trial (cRCT). The targeted population consists of frail elderly residents of residential care homes and nursing homes attended by general practitioners. The clusters (care home + general practitioners) are assigned to intervention- or control group. In the intervention group, an antibiotic stewardship intervention is actively implemented at the level of the general practitioners and caregivers in the homes.

The study has two measurement periods; a baseline period (5 months) and a follow-up period (7 months). In between there is an implementation period in which the intervention (i.e. active implementation) is started in the intervention homes \[no measurements are taken\].
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: UTI prescriptions
timeFrame: Assessed during the 7-month follow-up period
Secondary outcomes:
measure: Incorrect UTI prescriptions
timeFrame: Assessed during the 7-month follow-up period
measure: UTI suspicions
timeFrame: Assessed during the 7-month follow-up period
measure: Complications
timeFrame: Assessed during the 7-month follow-up period
measure: Hospital referral
timeFrame: Assessed during the 7-month follow-up period
measure: Hospital admission
timeFrame: Assessed during the 7-month follow-up period
measure: Mortality
timeFrame: Assessed during the 7-month follow-up period
measure: Mortality after UTI suspicion
timeFrame: Assessed during the 7-month follow-up period
measure: UTI prescriptions in office hours
timeFrame: Assessed during the 7-month follow-up period
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
city: Oslo
country: Norway
facility: University of Oslo
city: Łódź
country: Poland
facility: Medical University of Lodz
city: Borås
country: Sweden
facility: Research and Development Primary Health Care, Region Västra Götaland
Study officials:
affiliation: Amsterdam UMC, location VUmc
name: Cees MP Hertogh, prof. dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: UMC Utrecht
name: Theo JM Verheij, prof. dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of Lodz
name: Maciek Godycki-Cwirko, prof.dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Oslo
name: Morten Lindbæk, prof. dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Göteborg University
name: Pär-Daniel Sundvall, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hartman EAR, Groen WG, Heltveit-Olsen SR, Lindbaek M, Hoye S, Sundvall PD, Gunnarsson R, Skoglund I, Snaebjornsson Arnljots E, Godycki-Cwirko M, Kowalczyk A, Platteel TN, Zuithoff NPA, Monnier AA, Verheij TJM, Hertogh CMPM, van de Pol AC. Multifaceted antibiotic stewardship intervention using a participatory-action-research approach to improve antibiotic prescribing for urinary tract infections in frail elderly (ImpresU): study protocol for a European qualitative study followed by a pragmatic cluster randomised controlled trial. BMJ Open. 2021 Oct 7;11(10):e052552. doi: 10.1136/bmjopen-2021-052552.