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

Primary Purpose

Bacterial Infections

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Virtual Antimicrobial stewardship Team (VAT)
Sponsored by
Public Health Service of Amsterdam
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Bacterial Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Public Health Service of AmsterdamRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard care (control group)

Virtual Antimicrobial stewardship Team (VAT) (intervention group)

Arm Description

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.

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 .

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Incidence rate (IR)
Incidence rate (IR) of antibiotic prescriptions in each group.
Barriers and facilitators
Identify the barriers and facilitators for VAT implementation through questionnaires.
Barriers and facilitators
Identify the barriers and facilitators for VAT implementation through and in-depth interviews.

Full Information

First Posted
August 1, 2023
Last Updated
August 16, 2023
Sponsor
Public Health Service of Amsterdam
Collaborators
Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)
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1. Study Identification

Unique Protocol Identification Number
NCT05998226
Brief Title
VAT-2: Evaluation of a Virtual Antimicrobial Stewardship Team (VAT) on Antibiotic Prescriptions in Nursing Homes
Official Title
Evaluation of a Virtual Antimicrobial Stewardship Team (VAT) on Antibiotic Prescriptions From Clinicians in Nursing Homes: A Multicenter Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Public Health Service of Amsterdam
Collaborators
Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Infections

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard care (control group)
Arm Type
No Intervention
Arm Description
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.
Arm Title
Virtual Antimicrobial stewardship Team (VAT) (intervention group)
Arm Type
Experimental
Arm Description
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 .
Intervention Type
Other
Intervention Name(s)
Virtual Antimicrobial stewardship Team (VAT)
Intervention Description
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 Outcome Measure Information:
Title
Inappropriate antibiotic prescriptions
Description
The proportion of inappropriate antibiotic prescriptions in the intervention group compared to the control group (standard of care) according to the current guidelines algorithm.
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Incidence rate (IR)
Description
Incidence rate (IR) of antibiotic prescriptions in each group.
Time Frame
9 months
Title
Barriers and facilitators
Description
Identify the barriers and facilitators for VAT implementation through questionnaires.
Time Frame
9 months
Title
Barriers and facilitators
Description
Identify the barriers and facilitators for VAT implementation through and in-depth interviews.
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kelly KC Paap, Msc
Phone
+31618083470
Email
k.c.paap@amsterdam.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Sacha SD Kuil, MD, PhD
Phone
+31205555293
Email
skuil@ggd.amsterdam.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maarten MF Schim van der Loeff, Prof. dr.
Organizational Affiliation
Public Health Service of Amsterdam
Official's Role
Principal Investigator
Facility Information:
Facility Name
Public Health Service of Amsterdam
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1018WT
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maarten MF Schim van der Loeff, Prof.dr.
Phone
0031205555083
Email
mschimvdloeff@ggd.amsterdam.nl
First Name & Middle Initial & Last Name & Degree
Kelly KC Paap, Msc.
Phone
0031618083470
Email
k.c.paap@amsterdamumc.nl
First Name & Middle Initial & Last Name & Degree
Kelly KC Paap, Msc
First Name & Middle Initial & Last Name & Degree
Sacha SD Kuil, MD, PhD
First Name & Middle Initial & Last Name & Degree
Menno MD de Jong, Prof. dr.
First Name & Middle Initial & Last Name & Degree
Laura LW van Buul, PhD
First Name & Middle Initial & Last Name & Degree
Maarten MF Schim van der Loeff, Prof. dr.
First Name & Middle Initial & Last Name & Degree
Lisa LM Kolodziej, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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