The Impact of the Establishment of a New AMS CPS in a Rural Hospital in Austria

NCT05370846 | Unknown

• 1 other identifier: 437717
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief Summary

Antimicrobial stewardship groups ensure the safe and prudent use of antibiotics, decrease antimicrobial resistance, lower costs of antimicrobials in hospital settings and improve patient safety in terms of prescribing plausibility. Significant success of the implementation of antimicrobial stewardship programmes have been shown in studies across the world. It is important to highlight this issue not only because of the current alarming resistance situation but also to encourage Austrian stakeholders and politicians to start to implement such programmes on a larger scale all across Austria.

Conditions

Antimicrobial Stewardship

Outcome Measures

Primary Outcomes (3)

• Identifying risk factors for inappropriate antimicrobial prescribing across prescribers and regions and improvement strategies

  Risk factors for inappropriate prescribing will be determined via using medication appropriateness index (MAI), de-escalation rates and hospital length of stay (considering reduction of bed days both measured in number of days).

  3 years

• Identifying risk factors for ineffective antimicrobial prescribing across prescribers and regions and improvement strategies

  Ineffective antimicrobial prescribing will be addressed as per antibiotic consumption (defined daily doses DDD, antimicrobial therapy duration in numbers of days), patient bed days in numbers of days and readmission rates within six months of last inpatient stay.

  3 years

• Cost change of effective antibiotic prescribing

  Cost change of effective antibiotic prescribing will be measured in Euros.

  3 years

Secondary Outcomes (4)

• Impact of AMS interventions on outcomes

  3 years

• Cost-consequence analysis

  3 years

• Assessment of patient's Quality of life (QoL)

  3 years

• Introduction of antimicrobial surveillance software system

  3 years

Interventions

Clinical pharmacy antimicrobial stewardship intervention OTHER

A new AMS group will be introduced in Tauernklinikum in Zell am See, based on the S3-AWMF-guideline "Strategien zur Sicherung rationale Antibiotika-Anwendung im Krankenhaus" on antibiotic use in hospitals. As part of this, a new formulary will be developed and gradually introduced where we determined which AMS guidelines need to be incorporated. Antimicrobial use will be audited after set-up of the local formulary against the data from before implementation (using defined daily dose, DDD, as suggested by the WHO). Data on antimicrobial use will be obtained from a recently purchased and installed AMS programme called HyBase® by epiNET AG. AMS group will be provided with implementation material and toolkits, baseline data for antimicrobial use within hospital will be obtained.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients from all wards will be included in this study, all adult and paediatric patients will be included. Interpreting services will be available as required.

You may qualify if:

• Patients of Tauernklinikum in Zell am See receiving antimicrobial treatment between 13th April 2022 and 12 April 2025

Sponsors & Collaborators

• University of Ulster: lead
• Northern Health and Social Care Trust: collaborator
• Merck Sharp & Dohme LLC: collaborator

Study Officials

• Aaron Courtenay, Dr.

  PI of the study

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sonja Guntschnig, MSc

CONTACT

0043(06542) 777 DW 8892; sonja.guntschnig@tauernklinikum.at

Aaron Courtenay, Dr.

CONTACT

+44 (0)28 7012 3403; a.courtenay@ulster.ac.uk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer in Clinical Pharmacy

Study Record Dates

• First Submitted: March 28, 2022
• First Posted: May 12, 2022
• Study Start: May 9, 2022
• Primary Completion: April 12, 2025
• Study Completion: April 12, 2025
• Last Updated: May 12, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share