Ignite Creation Date:
2024-05-06 @ 7:23 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT05998226
Status:
RECRUITING
Last Update Posted:
2023-08-18
First Post:
2023-08-01
Brief Title:
VAT-2 Evaluation of a Virtual Antimicrobial Stewardship Team VAT on Antibiotic Prescriptions in Nursing Homes
Sponsor:
Public Health Service of Amsterdam
Organization:
Public Health Service of Amsterdam
Study Overview
Official Title:
Evaluation of a Virtual Antimicrobial Stewardship Team VAT on Antibiotic Prescriptions From Clinicians in Nursing Homes A Multicenter Randomised Controlled Trial
Status:
RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 parametersendpoints 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
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 parametersendpoints 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None