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

Esther A R Hartman, Wim G Groen, Silje Rebekka Heltveit-Olsen, Morten Lindbaek, Sigurd Hoye, Pär-Daniel Sundvall, Ronny Gunnarsson, Ingmarie Skoglund, Egill Snaebjörnsson Arnljots, Maciej Godycki-Cwirko, Anna Kowalczyk, Tamara N Platteel, Nicolaas P A Zuithoff, Annelie A Monnier, Theo J M Verheij, Cees M P M Hertogh, Alma C van de Pol, Esther A R Hartman, Wim G Groen, Silje Rebekka Heltveit-Olsen, Morten Lindbaek, Sigurd Hoye, Pär-Daniel Sundvall, Ronny Gunnarsson, Ingmarie Skoglund, Egill Snaebjörnsson Arnljots, Maciej Godycki-Cwirko, Anna Kowalczyk, Tamara N Platteel, Nicolaas P A Zuithoff, Annelie A Monnier, Theo J M Verheij, Cees M P M Hertogh, Alma C van de Pol

Abstract

Introduction: Almost 60% of antibiotics in frail elderly are prescribed for alleged urinary tract infections (UTIs). A substantial part of this comprises prescriptions in case of non-specific symptoms or asymptomatic bacteriuria, for which the latest guidelines promote restrictiveness with antibiotics. We aim to reduce inappropriate antibiotic use for UTIs through an antibiotic stewardship intervention (ASI) that encourages to prescribe according to these guidelines. To develop an effective ASI, we first need a better understanding of the complex decision-making process concerning suspected UTIs in frail elderly. Moreover, the implementation approach requires tailoring to the heterogeneous elderly care setting.

Methods and analysis: First, we conduct a qualitative study to explore factors contributing to antibiotic prescribing for UTIs in frail elderly, using semi-structured interviews with general practitioners, nursing staff, patients and informal caregivers. Next, we perform a pragmatic cluster randomised controlled trial in elderly care organisations. A multifaceted ASI is implemented in the intervention group; the control group receives care as usual. The ASI is centred around a decision tool that promotes restrictive antibiotic use, supported by a toolbox with educational materials. For the implementation, we use a modified participatory-action-research approach, guided by the results of the qualitative study. The primary outcome is the number of antibiotic prescriptions for suspected UTIs. We aim to recruit 34 clusters with in total 680 frail elderly residents ≥70 years. Data collection takes place during a 5-month baseline period and a 7-month follow-up period. Finally, we perform a process evaluation. The study has been delayed for 6 months due to COVID-19 and is expected to end in July 2021.

Ethics and dissemination: Ethical approvals and/or waivers were obtained from the ethical committees in Poland, the Netherlands, Norway and Sweden. The results will be disseminated through publication in peer-reviewed journals and conference presentations.

Trial registration number: NCT03970356.

Keywords: medical education & training; primary care; urinary tract infections.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.

Figures

Figure 1
Figure 1
Schematic overview of the interplay between the two studies. The qualitative study offers insights to tailor the antibiotic stewardship intervention in the cluster randomised controlled trial (RCT), through a country-specific local analysis. The cluster RCT consists of a baseline and follow-up period for data collection, with an intervention period or usual care in between (the timeline is provided in figure 3). A process evaluation follows at the end of the cluster RCT. GP, general practitioner; UTI, urinary tract infection.
Figure 2
Figure 2
Toolbox. The educational materials and targeted stakeholders in the generic toolbox are listed, and the tailoring process is shown. GP, general practitioner.
Figure 3
Figure 3
Timeline of the cluster randomised controlled trial. The periods of data collection and procedures are shown for the clusters and participating patients. CRF, case report form; UTI, urinary tract infection.

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