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Antimicrobial Stewardship in UTIs in Nursing Homes

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ClinicalTrials.gov Identifier: NCT04798365
Recruitment Status : Recruiting
First Posted : March 15, 2021
Last Update Posted : March 15, 2021
Sponsor:
Information provided by (Responsible Party):
Medical University of Graz

Brief Summary:

Background: The widespread inappropriate use of antimicrobial substances drives resistance development at the individual and population level all over the world. In long-term care facilities (LTCF), antibiotics are among the most frequently prescribed medications. More than one third of antibiotics prescribed in LTCFs are for urinary tract infections (UTI). Studies have shown that 30 - 40% of antibiotic courses prescribed in LTCFs were unnecessary and that more than two-thirds were inappropriate based on society guidelines.

Preliminary data: A surveillance study on healthcare-associated UTIs at LTCFs of the Geriatric Health Centers Graz revealed that guideline recommendations on antimicrobial choice were met in only 50% of patients. The most frequently used antimicrobial substances for UTI were quinolones.

Aims: Using a multifaceted bundle of antimicrobial stewardship interventions consisting of clinical practice guidelines, care pathways and local as well as web-based education and training targeting nursing staff as well as physicians we aim to improve the quality of antimicrobial prescriptions for UTIs in four LTCFs in Graz, Austria.

Design: Non-randomized cluster controlled intervention study. Setting: The Geriatric Health Centers Graz are a local institution comprising among others 4 LTCFs (total of 400 beds). These will serve as intervention group. Four LTCFs located in the surroundings of Graz will serve as control group.

Intervention: The main components of the intervention are 1) two sessions of voluntary continuing medical education on the urinary tract infection program in each LTCF for physicians and nursing staff, 2) distribution of educations materials such as written guidelines on antibiotic prescribing including a smart phone friendly version, 3) implementation of the project homepage as a platform to distribute guidelines and educational videos and to enable physicians to ask questions which will be answered by an infectious disease physician.

Outcomes: The primary outcome will be the proportion of adequate prescriptions (adequate in terms of antimicrobial choice). Secondary outcomes include proportion of adequate prescriptions (adequate in terms of decision to treat), number of cases with clinical failure, number of admissions to hospital due to UTI, number of adverse events attributed to antimicrobial treatment for UTI, percentage of extended spectrum betalactamase (ESBL) producing enterobacteria isolated from urinary cultures


Condition or disease Intervention/treatment Phase
Urinary Tract Infections Behavioral: Intervention group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 306 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Implementation of an Antimicrobial Stewardship Program Targeting Residents With Urinary Tract Infections in Long-term Care Facilities
Actual Study Start Date : March 1, 2021
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention group
The main components of the intervention are 1) two sessions of voluntary continuing medical education on the urinary tract infection program in each LTCF for physicians and nursing staff, 2) distribution of educations materials such as written guidelines on antibiotic prescribing including a smart phone friendly version, 3) implementation of the project homepage as a platform to distribute guidelines and educational videos and to enable physicians to ask questions which will be answered by an infectious disease physician.
Behavioral: Intervention group
medical education and distribution of educations materials

No Intervention: Control group
No intervention until end of the stuy.



Primary Outcome Measures :
  1. proportion of adequate prescriptions (adequate in terms of antimicrobial choice) [ Time Frame: 2 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • residents living in the participating long term care facilities who experience urinary tract infections (UTI)

Exclusion Criteria:

  • residents without UTI

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): NCT04798365


Contacts
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Contact: Ines Zollner-Schwetz, MD +43 316 385 ext 81937 ines.schwetz@medunigraz.at

Locations
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Austria
Sonnenhof Recruiting
Fehring, Austria, 8350
Contact: Sonja Dolzer    +43 3155 5175    sonja.dolzer@sonnenhof.co.at   
Geriatric Health Centres of the City of Graz Recruiting
Graz, Austria, 8010
Contact: Christian Pux    +43 316 7060    christian.pux@stadt.graz.at   
Volkshilfe Steiermark Recruiting
Graz, Austria, 8010
Contact: Irmina Gerlich, MA    43 316 8960 ext 79 025    irmina.gerlich@stmk.volkshilfe.at   
Bezirkspflege-und Seniorenheim Voitsberg Recruiting
Voitsberg, Austria, 8570
Contact: Christine Kollmuetzer    +43 3155 5175    c.kollmuetzer@bezirkspflegeheim-voitsberg.at   
Sponsors and Collaborators
Medical University of Graz
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Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT04798365    
Other Study ID Numbers: 33-035 ex 20/21
First Posted: March 15, 2021    Key Record Dates
Last Update Posted: March 15, 2021
Last Verified: March 2021
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 Medical University of Graz:
UTI
antimicrobial stewardship
long term care facility
nursing home
Additional relevant MeSH terms:
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Infection
Urinary Tract Infections
Urologic Diseases