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Completed

NCT Number: NCT03970356

Improving Antibiotic Prescribing for Urinary Tract Infections in Frail Elderly

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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Key information

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center Utrecht, Utrecht, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. UTI prescriptions

    Time frame: Assessed during the 7-month follow-up period

    Number of prescriptions of antibiotics for suspected urinary tract infections expressed per patient-year

Secondary outcomes

  1. Incorrect UTI prescriptions

    Time frame: Assessed during the 7-month follow-up period

    Number of incorrect prescriptions of antibiotics for suspected UTI expressed per patient-year

  2. UTI suspicions

    Time frame: Assessed during the 7-month follow-up period

    Incidence of suspected UTI expressed per patient-year

  3. Complications

    Time frame: Assessed during the 7-month follow-up period

    Incidence of complications: delirium, pyelonephritis, sepsis and renal failure within 21 days after each UTI suspicion

  4. Hospital referral

    Time frame: Assessed during the 7-month follow-up period

    Incidence of referral to a hospital within 21 days after each UTI suspicion

  5. Hospital admission

    Time frame: Assessed during the 7-month follow-up period

    Incidence of hospital admission within 21 days after each UTI suspicion

  6. Mortality

    Time frame: Assessed during the 7-month follow-up period

    Mortality

  7. Mortality after UTI suspicion

    Time frame: Assessed during the 7-month follow-up period

    Mortality within 21 days after each UTI suspicion

  8. UTI prescriptions in office hours

    Time frame: Assessed during the 7-month follow-up period

    Number of prescriptions of antibiotics for suspected UTI in office hours expressed per patient-year

Sponsors and collaborators

Lead sponsor

Cees Hertogh

Other

Collaborators

  • Göteborg University
  • Medical University of Lodz
  • UMC Utrecht
  • University of Oslo
  • Vastra Gotaland Region

Registry information

Official study 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

Acronym: ImpresU-WP2

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
May 31, 2019
Registry last updated
May 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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