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Antimicrobial StewardshipNCT05370846

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

An observational study of Antimicrobial Stewardship, run by University of Ulster.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Antimicrobial Stewardship
What is being tested?
Clinical pharmacy antimicrobial stewardship intervention
How many people
500 participants
Where
No sites listed yet
Study dates
9 May 2022to 12 Apr 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • -

Trial locations and contacts

No sites are listed yet.

About this study

Official title: The Impact of the Establishment of a New Antimicrobial Stewardship (AMS) Clinical Pharmacy Service in a Rural Hospital in Austria

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.

Read the detailed description

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 appropriateness. Significant success following 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 antimicrobial resistance situation but also to encourage Austrian and European stakeholders and politicians to start to implement such programmes on a larger scale across Austria. There are AMS groups in place in larger Austrian healthcare facilities. However, in Austria only 15.3% of all hospitals have a hospital pharmacy and only a small part of them offer clinical pharmacy services (CPS). Clinical pharmacy projects need to be put into place demonstrating the positive impacts for both patients and the healthcare system and the data published to make the advantages publicly available and visible in order to achieve legal changes in Europe. A hospital pharmacy should be a requirement in every hospital and the delivery of CPS should be compulsory. AMS is a well-known expertise in anglophone countries, and this is a great opportunity to demonstrate the importance and need for such a service in all European countries. Setting up AMS groups should be statutory in order to raise awareness of and to combat antimicrobial resistance. Globally speaking, if more small hospitals focus on developing AMS strategies, then it will be possible to deliver the requirements of both the WHO global action plan and the European Commission's "A European One Health Action Plan against Antimicrobial Resistance (AMR)" to optimize the use of antimicrobials in humans.

This will be a very valuable project for Austria as it is a collaboration between Tauernklinikum in Zell am See, Antrim Hospital in Northern Ireland, the Medicines Optimization Innovation Centre (MOIC) and Ulster University. The United Kingdom has been the distinct European leader of clinical pharmacy services (CPS) implementation with an AMS group setup being one of their specialties. The MOIC has pioneered work in many CPS fields and with the support and guidance of MOIC, Antrim hospital and Ulster University as leading institutions for CPS in Europe this project will be a success. It will not only promote AMS across Europe but also strengthen and develop the clinical pharmacy profession. MOIC is currently involved with work in this area in both Poland and Estonia, which will further enable synergies and sharing and learning with this project much more widely.

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.

Data will be collated prior to implementation of the AMS group and after the group has been established (3 months after antimicrobial ward rounds implementation - planned Q4 this year and over the following two years), when it will be compared to the agreed guidelines. Evaluation of this data will determine the impact of the group's activities on prescribing generally and adherence to guidelines specifically.

The AMS group should help ensure effective collaboration between the various members of the healthcare team in the hospital and allow employees to attend relevant training courses or hear educational talks on site. The whole process will raise awareness, improve patient outcomes and prescribing habits and reduce hospital costs. A special focus will be put on enhancing the liaison between laboratory, IT, pharmacy, care personnel and medical staff. Prescribers should be able to rely on their own skills but also collaborate with other professionals' thereby also maximizing their competencies.

Anecdotal evidence suggests that it is difficult to make AMS work when multidisciplinary collaboration is not established. The study site size of a small 350 bed hospital is perfect to analyze the improvement of multiprofessional cooperation in this process. The AMS group will be set up including staff from nursing, medical, pharmacy, laboratory and IT. The effectiveness of the group will be evaluated for via questionnaire and focus groups in the individual departments at the implementation of the ward rounds and again one year later. The patient perspective of the service will also be included.

Being tested
Clinical pharmacy antimicrobial stewardship intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Clinical pharmacy antimicrobial stewardship interventionOther

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 3 years

  2. 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.

    Measured: 3 years

  3. Cost change of effective antibiotic prescribing

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

    Measured: 3 years

Secondary outcomes (4)
  1. Impact of AMS interventions on outcomes

    A new antimicrobial formulary will be implemented and prescribing habits will be assessed against it after implementation. This will be done via data extracted from HyBase anti-infective surveillance software and auditing electronic patient cardexes. As suggested by the WHO DDD defined daily doses will be utilised.

    Measured: 3 years

  2. Cost-consequence analysis

    Cost-consequence analysis will be performed for the implementation of new AMS interventions and the introduction of a new antimicrobial hospital formulary.

    Measured: 3 years

  3. Assessment of patient's Quality of life (QoL)

    The number of hospital bed days (length of stay) will be recorded

    Measured: 3 years

  4. Introduction of antimicrobial surveillance software system

    HyBase software will be introduced which will capture the frequency of "alert" organisms.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2022
  2. Study start9 May 2022 (estimated)
  3. Primary completion12 Apr 2025 (estimated)
  4. Study completion12 Apr 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05370846
Sponsor's protocol ID
437717
Status last verified
May 2022
First submitted
28 Mar 2022
Last updated
12 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Fully anonymised data only will be shared with the wider research team.

Questions about this trial

What is this clinical trial studying?

An observational study of Antimicrobial Stewardship, run by University of Ulster.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 May 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Sonja Guntschnig, MSc (0043(06542) 777 DW 8892, sonja.guntschnig@tauernklinikum.at), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Identifying risk factors for inappropriate antimicrobial prescribing across prescribers and regions and improvement strategies (time frame: 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2022.

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