Improving Antibiotic Prescribing for Urinary Tract Infections in Frail Elderly

NCT03970356 | Completed

• 6 other identifiers: 200503525 (2017)5490030022017/25/Z/NZ7/030242017-05975284253
• Study Type: interventional
• Target: 1,146
• Locations: 4 countries
• Sites: 4

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.

Conditions

Urinary Tract Infections

Keywords

cluster randomized trial; antibiotic stewardship; frail elderly

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Incorrect UTI prescriptions

  Assessed during the 7-month follow-up period

• UTI suspicions

  Assessed during the 7-month follow-up period

• Complications

  Assessed during the 7-month follow-up period

• Hospital referral

  Assessed during the 7-month follow-up period

• Hospital admission

  Assessed during the 7-month follow-up period

Study Arms (2)

intervention

EXPERIMENTAL

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.

Other: antibiotic stewardship intervention

control

NO INTERVENTION

Usual care

Interventions

antibiotic stewardship intervention 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.

intervention

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cees Hertogh: lead
• UMC Utrecht: collaborator
• Medical University of Lodz: collaborator
• University of Oslo: collaborator
• Vastra Gotaland Region: collaborator
• Göteborg University: collaborator

Study Sites (4)

University Medical Center Utrecht

Utrecht, 3584 CG, Netherlands

Location

University of Oslo

Oslo, 1130, Norway

Location

Medical University of Lodz

Lodz, 90-153, Poland

Location

Research and Development Primary Health Care, Region Västra Götaland

Borås, SE-503 38, Sweden

Location

Related Publications (3)

• 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.

  PMID: 39425170 DERIVED

• 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.

  PMID: 36813284 DERIVED

• 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.

  PMID: 34620666 DERIVED

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Cees MP Hertogh, prof. dr.

  Amsterdam UMC, location VUmc

  PRINCIPAL INVESTIGATOR

• Theo JM Verheij, prof. dr.

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

• Maciek Godycki-Cwirko, prof.dr.

  Medical University of Lodz

  PRINCIPAL INVESTIGATOR

• Morten Lindbæk, prof. dr.

  University of Oslo

  PRINCIPAL INVESTIGATOR

• Pär-Daniel Sundvall, MD PhD

  Göteborg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. dr.

Model Details: 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 \[no measurements are taken\].

Study Record Dates

• First Submitted: May 26, 2019
• First Posted: May 31, 2019
• Study Start: September 1, 2019
• Primary Completion: July 21, 2021
• Study Completion: July 21, 2021
• Last Updated: May 24, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1); NL (1); NO (1); PL (1)