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Completed

NCT Number: NCT05998226

VAT-2: Evaluation of a Virtual Antimicrobial Stewardship Team (VAT) on Antibiotic Prescriptions in Nursing Homes

The Virtual Antimicrobial stewardship Team (VAT) study aims to evaluate, in a randomized controlled trial (RCT), the effect of a weekly virtual antimicrobial stewardship (AMS) intervention on the appropriateness of prescribing antibiotics for nursing home (NH) residents with urinary tract infections (UTI), respiratory tract infections (RTI) or skin and soft tissue infections (SSTI) compared to standard care for NH residents in Dutch NHs in the provinces of North-Holland and Flevoland. The secondary aim is to identify barriers and facilitators to implement a stewardship intervention and subsequently develop an implementation guide.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Public Health Service of Amsterdam

Amsterdam, North Holland, 1018WT, Netherlands

About this study

Rationale: Antimicrobial stewardship interventions have been extensively studied in hospital settings and have proven effective in reducing the number of infections with multidrug resistant micro-organisms and are also cost-effective. Therefore, AMS teams are mandatory in Dutch hospitals.

The effectiveness of an antimicrobial stewardship intervention is variable in previous studies. Also due to the perceived high workload and costs, AMS has hardly been implemented in Dutch NHs. In order to take the next step towards implementation of AMS in NHs, causality between AMS and reduction in inappropriate antibiotic prescriptions should be demonstrated. The investigators want to evaluate the process and value of the VAT approach to facilitate optimal implementation of VAT in other NHs.

Objective: To demonstrate the efficacy of weekly virtual antimicrobial stewardship team meetings in reducing inappropriate antibiotic prescriptions in Dutch NHs.

Study design: randomized, non-blinded, controlled, multicenter trial.

Study population: Clinicians working in NHs in the provinces North Holland and Flevoland.

Intervention: The VAT consists of at least a clinical microbiologist and a clinician from the NH. Ideally, a pharmacist will also attend. They conduct a weekly (digital) meeting for nine months to evaluate the antibiotic prescriptions of the clinician attending the VAT meeting, based on a standardized protocol according to the current national guidelines.

Main study parameters/endpoints: The primary outcome is the number of inappropriate antibiotic prescriptions, assessed based on an algorithm of the current clinical infection treatment guidelines, antimicrobial susceptibility test results, and clinical characteristics. Each antibiotic prescription is a record and for each record will be assessed whether the antibiotic prescription is appropriate or not. Secondary outcome measures are the incidence rate (IR) of antibiotic prescriptions and facilitators and barriers to VAT implementation.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

of clinicians:

  • Working in nursing homes in the North Holland-Flevoland region and being authorized to prescribe.
  • Agreeing to being randomized to intervention or control group.
  • Working in a nursing home that has a medication prescription system from which prescriptions can easily be obtained for VAT meetings.
  • Working in a nursing home that is connected to a microbiology lab, .that participates in this study and offers VAT meetings.
  • Expected to be employed for at least four months from date of randomization.

Inclusion criteria

of antibiotic prescriptions:

  • All prescriptions for antibiotics with a therapeutic indication regarding urinary tract infections, respiratory tract infections or skin and soft tissue infections for residents of nursing homes, prescribed by clinicians participating in the study, during the study period.

Exclusion criteria

of antibiotic prescriptions:

  • Prescriptions for antibiotics with a prophylactic purpose.
  • Prescriptions given by clinicians not participating in the study
  • Prescriptions prescribed outside the study period.

Treatment and study plan

Virtual Antimicrobial stewardship Team (VAT)

Other

The VAT consists of at least a clinical microbiologist and a clinician from the NH. Ideally, a pharmacist will also attend. They conduct a weekly (digital) meeting for nine months to evaluate the antibiotic prescriptions of the clinician attending the VAT meeting, based on a standardized protocol according to the current national infection treatment guidelines.

Primary outcomes

  1. Inappropriate antibiotic prescriptions

    Time frame: 9 months

    The proportion of inappropriate antibiotic prescriptions in the intervention group compared to the control group (standard of care) according to the current guidelines algorithm.

Secondary outcomes

  1. Incidence rate (IR)

    Time frame: 9 months

    Incidence rate (IR) of antibiotic prescriptions in each group.

  2. Barriers and facilitators

    Time frame: 9 months

    Identify the barriers and facilitators for VAT implementation through questionnaires.

  3. Barriers and facilitators

    Time frame: 9 months

    Identify the barriers and facilitators for VAT implementation through and in-depth interviews.

Sponsors and collaborators

Lead sponsor

Public Health Service of Amsterdam

Other Gov

Collaborators

  • Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)

Registry information

Official study title

Evaluation of a Virtual Antimicrobial Stewardship Team (VAT) on Antibiotic Prescriptions From Clinicians in Nursing Homes: A Multicenter Randomised Controlled Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 18, 2023
Registry last updated
Feb 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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