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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

Tracking Information
First Submitted Date  ICMJE May 26, 2019
First Posted Date  ICMJE May 31, 2019
Last Update Posted Date May 29, 2020
Actual Study Start Date  ICMJE September 1, 2019
Estimated Primary Completion Date January 22, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 29, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 9, 2019)
  • 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
  • UTI suspicions [ Time Frame: Assessed during the 7-month follow-up period ]
    Incidence of suspected UTI expressed per patient-year
  • 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
  • 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
  • Hospital admission [ Time Frame: Assessed during the 7-month follow-up period ]
    Incidence of hospital admission within 21 days after each UTI suspicion
  • Mortality [ Time Frame: Assessed during the 7-month follow-up period ]
    Mortality
  • Mortality after UTI suspicion [ Time Frame: Assessed during the 7-month follow-up period ]
    Mortality within 21 days after each UTI suspicion
Original Secondary Outcome Measures  ICMJE
 (submitted: May 29, 2019)
  • 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
  • UTI suspicions [ Time Frame: Assessed during the 7-month follow-up period ]
    Incidence of suspected UTI expressed per patient-year
  • 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
  • Hospital referral [ Time Frame: Assessed during the 7-month follow-up period ]
    Incidence of referral for UTI to a hospital within 21 days after each UTI suspicion
  • Hospital admission [ Time Frame: Assessed during the 7-month follow-up period ]
    Incidence of hospital admission for UTI within 21 days after each UTI suspicion
  • Mortality [ Time Frame: Assessed during the 7-month follow-up period ]
    Mortality
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Improving Antibiotic Prescribing for Urinary Tract Infections in Frail Elderly
Official Title  ICMJE 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
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Urinary Tract Infections
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Other: antibiotic stewardship intervention
  • No Intervention: control
    Usual care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: May 29, 2019)
680
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 22, 2021
Estimated Primary Completion Date January 22, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 70 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands,   Norway,   Poland,   Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03970356
Other Study ID Numbers  ICMJE 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 )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Cees Hertogh, VU University Medical Center
Study Sponsor  ICMJE Cees Hertogh
Collaborators  ICMJE
  • UMC Utrecht
  • Medical Universtity of Lodz
  • University of Oslo
  • Vastra Gotaland Region
  • Göteborg University
Investigators  ICMJE
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
PRS Account VU University Medical Center
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP