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Improving Antibiotic Prescribing for Urinary Tract Infections in Frail Elderly (ImpresU-WP2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03970356
Recruitment Status : Suspended (Study paused due to Covid-19 outbreak)
First Posted : May 31, 2019
Last Update Posted : May 29, 2020
Sponsor:
Collaborators:
UMC Utrecht
Medical Universtity of Lodz
University of Oslo
Vastra Gotaland Region
Göteborg University
Information provided by (Responsible Party):
Cees Hertogh, VU University Medical Center

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.

Condition or disease Intervention/treatment Phase
Urinary Tract Infections Other: antibiotic stewardship intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 680 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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] (4 months).

Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : September 1, 2019
Estimated Primary Completion Date : January 22, 2021
Estimated Study Completion Date : January 22, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Other: 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.

No Intervention: control
Usual care



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

For pragmatic reasons we will not include new patients during the last two months of the study. 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03970356


Locations
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Netherlands
University Medical Center Utrecht
Utrecht, Netherlands, 3584 CG
Norway
University of Oslo
Oslo, Norway, 1130
Poland
Medical University of Lodz
Łódź, Poland, 90-153
Sweden
Research and Development Primary Health Care, Region Västra Götaland
Borås, Sweden, SE-503 38
Sponsors and Collaborators
Cees Hertogh
UMC Utrecht
Medical Universtity of Lodz
University of Oslo
Vastra Gotaland Region
Göteborg University
Investigators
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Principal Investigator: Cees MP Hertogh, prof. dr. VU University Medical Center
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
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Responsible Party: Cees Hertogh, Prof. dr., VU University Medical Center
ClinicalTrials.gov Identifier: NCT03970356    
Other Study ID Numbers: 2005035
25 (2017) ( Other Grant/Funding Number: JPIAMR )
549003002 ( Other Grant/Funding Number: ZonMW, Netherlands )
2017/25/Z/NZ7/03024 ( Other Grant/Funding Number: National Science Centre, Poland )
2017-05975 ( Other Grant/Funding Number: The Swedish Research Council )
284253 ( Other Grant/Funding Number: The Research Council of Norway )
First Posted: May 31, 2019    Key Record Dates
Last Update Posted: May 29, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cees Hertogh, VU University Medical Center:
cluster randomized trial
antibiotic stewardship
frail elderly
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Urinary Tract Infections
Urologic Diseases
Anti-Bacterial Agents
Anti-Infective Agents