Improving Antibiotic Prescribing for Urinary Tract Infections in Frail Elderly

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1146 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-01

Study Completion Date

2021-07-21

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Urinary Tract Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

antibiotic stewardship intervention

Intervention Type OTHER

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.

control

Usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Cees Hertogh

Prof. dr.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Cees MP Hertogh, prof. dr.

Role: PRINCIPAL_INVESTIGATOR

Amsterdam UMC, location VUmc

Theo JM Verheij, prof. dr.

Role: PRINCIPAL_INVESTIGATOR

UMC Utrecht

Maciek Godycki-Cwirko, prof.dr.

Role: PRINCIPAL_INVESTIGATOR

Medical University of Lodz

Morten Lindbæk, prof. dr.

Role: PRINCIPAL_INVESTIGATOR

University of Oslo

Pär-Daniel Sundvall, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Göteborg University

Locations

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University Medical Center Utrecht

Utrecht, , Netherlands

Site Status

University of Oslo

Oslo, , Norway

Site Status

Medical University of Lodz

Lodz, , Poland

Site Status

Research and Development Primary Health Care, Region Västra Götaland

Borås, , Sweden

Site Status

Countries

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Netherlands Norway Poland Sweden

References

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Hartman EAR, Groen WG, Heltveit-Olsen SR, Lindbaek M, Hoye S, Lithen SS, Sundvall PD, Sundvall S, Snaebjornsson Arnljots E, Gunnarsson R, Kowalczyk A, Godycki-Cwirko M, van de Pol AC, Platteel TN, Monnier AA, Verheij TJM, Hertogh CMPM. Implementation of a tailored multifaceted antibiotic stewardship intervention to improve antibiotic prescribing for urinary tract infections in frail older adults (ImpresU) in four European countries: a process evaluation alongside a pragmatic cluster randomized controlled trial. Trials. 2024 Oct 18;25(1):691. doi: 10.1186/s13063-024-08545-4.

Reference Type DERIVED

PMID: 39425170 (View on PubMed)

Hartman EAR, van de Pol AC, Heltveit-Olsen SR, Lindbaek M, Hoye S, Lithen SS, Sundvall PD, Sundvall S, Arnljots ES, Gunnarsson R, Kowalczyk A, Godycki-Cwirko M, Platteel TN, Groen WG, Monnier AA, Zuithoff NP, Verheij TJM, Hertogh CMPM. Effect of a multifaceted antibiotic stewardship intervention to improve antibiotic prescribing for suspected urinary tract infections in frail older adults (ImpresU): pragmatic cluster randomised controlled trial in four European countries. BMJ. 2023 Feb 22;380:e072319. doi: 10.1136/bmj-2022-072319.

Reference Type DERIVED

PMID: 36813284 (View on PubMed)

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.

Reference Type DERIVED

PMID: 34620666 (View on PubMed)