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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Bacterial Infections
• Intervention / Treatment: Other: Virtual Antimicrobial stewardship Team (VAT)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 54
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kelly KC Paap, Msc; Phone Number: +31618083470; Email: k.c.paap@amsterdam.nl
• Study Contact Backup: Name: Sacha SD Kuil, MD, PhD; Phone Number: +31205555293; Email: skuil@ggd.amsterdam.nl

Study Locations

• Netherlands
  • Noord-Holland
    • Amsterdam, Noord-Holland, Netherlands, 1018WT
      • Recruiting
      • Public Health Service of Amsterdam
      • Contact: Maarten MF Schim van der Loeff, Prof.dr.; Phone Number: 0031205555083; Email: mschimvdloeff@ggd.amsterdam.nl
      • Contact: Kelly KC Paap, Msc.; Phone Number: 0031618083470; Email: k.c.paap@amsterdamumc.nl
      • Sub-Investigator: Kelly KC Paap, Msc
      • Sub-Investigator: Sacha SD Kuil, MD, PhD
      • Principal Investigator: Menno MD de Jong, Prof. dr.
      • Sub-Investigator: Laura LW van Buul, PhD
      • Principal Investigator: Maarten MF Schim van der Loeff, Prof. dr.
      • Sub-Investigator: Lisa LM Kolodziej, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard care (control group); 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.
Experimental: Virtual Antimicrobial stewardship Team (VAT) (intervention group); 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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence rate (IR)	Incidence rate (IR) of antibiotic prescriptions in each group.	9 months
Barriers and facilitators	Identify the barriers and facilitators for VAT implementation through questionnaires.	9 months
Barriers and facilitators	Identify the barriers and facilitators for VAT implementation through and in-depth interviews.	9 months

Collaborators and Investigators

• Sponsor: Public Health Service of Amsterdam
• Collaborators: Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)
• Investigators: Principal Investigator: Maarten MF Schim van der Loeff, Prof. dr., Public Health Service of Amsterdam

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): May 31, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: August 1, 2023
• First Submitted That Met QC Criteria: August 16, 2023
• First Posted (Actual): August 18, 2023

Study Record Updates

• Last Update Posted (Actual): August 18, 2023
• Last Update Submitted That Met QC Criteria: August 16, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Bacterial Infections; Anti-Bacterial Agents; Anti-Infective Agents
• Other Study ID Numbers: W23_041 #23.064

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No