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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04798365
Other study ID # 33-035 ex 20/21
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2021
Est. completion date December 31, 2022

Study information

Verified date March 2023
Source Medical University of Graz
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 326
Est. completion date December 31, 2022
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - residents living in the participating long term care facilities who experience urinary tract infections (UTI) Exclusion Criteria: - residents without UTI

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Intervention group
medical education and distribution of educations materials

Locations

Country Name City State
Austria Sonnenhof Fehring
Austria Geriatric Health Centres of the City of Graz Graz
Austria Volkshilfe Steiermark Graz
Austria Bezirkspflege-und Seniorenheim Voitsberg Voitsberg

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary proportion of adequate prescriptions (adequate in terms of antimicrobial choice) 2 weeks
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