NCT05998226

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 1, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

August 18, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

February 6, 2025

Status Verified

February 1, 2025

Enrollment Period

1.5 years

First QC Date

August 1, 2023

Last Update Submit

February 4, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Inappropriate antibiotic prescriptions

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

    9 months

Secondary Outcomes (3)

  • Incidence rate (IR)

    9 months

  • Barriers and facilitators

    9 months

  • Barriers and facilitators

    9 months

Study Arms (2)

Standard care (control group)

NO INTERVENTION

The clinicians from the control arm do not participate in VAT meetings. The antibiotic prescriptions prescribed by clinicians in the control group are extracted from the prescription system after the study period. Two researchers independently extract the data from patient files, including any culture results, and assess the antibiotic use based on the algorithm from the current guidelines that are used in NHs.

Virtual Antimicrobial stewardship Team (VAT) (intervention group)

EXPERIMENTAL

The VAT consists at least of a medical microbiologist and a clinician from the NH. Depending on the NH organization concerned and cooperation agreements, a pharmacist will or will not be involved. They conduct weekly consultations during 9 months to evaluate the antibiotic prescriptions of the clinician based on algorithms from current guidelines in use in the NH. This is an evaluation of standard care .

Other: Virtual Antimicrobial stewardship Team (VAT)

Interventions

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.

Virtual Antimicrobial stewardship Team (VAT) (intervention group)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Public Health Service of Amsterdam

Amsterdam, North Holland, 1018WT, Netherlands

Location

Related Publications (1)

  • Paap KC, Kolodziej LM, van Buul LW, de Jong MD, van der Loeff MFS, Kuil SD. The impact of a weekly antimicrobial stewardship team intervention on antibiotic prescriptions in Dutch nursing homes: a protocol for a randomised controlled trial. Trials. 2025 Dec 29;26(1):587. doi: 10.1186/s13063-025-09303-w.

MeSH Terms

Conditions

Bacterial Infections

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfections

Study Officials

  • Maarten MF Schim van der Loeff, Prof. dr.

    Public Health Service of Amsterdam

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: The investigators will conduct a multi-center, two-arm, randomized controlled trial to evaluate a virtual antibiotic stewardship team (VAT) compared to standard care in Dutch NHs. After assessment of eligibility, the participants (clinicians) in the study are randomized (1:1) to the standard of care arm or to the intervention arm (weekly VAT meeting for 9 months). Randomization will be done stratified on the basis of function (group 1. elderly care physicians, group 2. physicians in training to become a specialist/ other physicians, group 3. nurse practitioners/ physician assistants).
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 1, 2023

First Posted

August 18, 2023

Study Start

July 1, 2023

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

February 6, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations