xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05998226</url>
    </required_header>
    <id_info>
      <org_study_id>W23_041 #23.064</org_study_id>
      <nct_id>NCT05998226</nct_id>
    </id_info>
    <brief_title>VAT-2: Evaluation of a Virtual Antimicrobial Stewardship Team (VAT) on Antibiotic Prescriptions in Nursing Homes</brief_title>
    <official_title>Evaluation of a Virtual Antimicrobial Stewardship Team (VAT) on Antibiotic Prescriptions From Clinicians in Nursing Homes: A Multicenter Randomised Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Public Health Service of Amsterdam</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Public Health Service of Amsterdam</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The Virtual Antimicrobial stewardship Team (VAT) study aims to evaluate, in a randomized&#xD;
        controlled trial (RCT), the effect of a weekly virtual antimicrobial stewardship (AMS)&#xD;
        intervention on the appropriateness of prescribing antibiotics for nursing home (NH)&#xD;
        residents with urinary tract infections (UTI), respiratory tract infections (RTI) or skin and&#xD;
        soft tissue infections (SSTI) compared to standard care for NH residents in Dutch NHs in the&#xD;
        provinces of North-Holland and Flevoland. The secondary aim is to identify barriers and&#xD;
        facilitators to implement a stewardship intervention and subsequently develop an&#xD;
        implementation guide.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Rationale: Antimicrobial stewardship interventions have been extensively studied in hospital&#xD;
        settings and have proven effective in reducing the number of infections with multidrug&#xD;
        resistant micro-organisms and are also cost-effective. Therefore, AMS teams are mandatory in&#xD;
        Dutch hospitals.&#xD;
  &#xD;
        The effectiveness of an antimicrobial stewardship intervention is variable in previous&#xD;
        studies. Also due to the perceived high workload and costs, AMS has hardly been implemented&#xD;
        in Dutch NHs. In order to take the next step towards implementation of AMS in NHs, causality&#xD;
        between AMS and reduction in inappropriate antibiotic prescriptions should be demonstrated.&#xD;
        The investigators want to evaluate the process and value of the VAT approach to facilitate&#xD;
        optimal implementation of VAT in other NHs.&#xD;
  &#xD;
        Objective: To demonstrate the efficacy of weekly virtual antimicrobial stewardship team&#xD;
        meetings in reducing inappropriate antibiotic prescriptions in Dutch NHs.&#xD;
  &#xD;
        Study design: randomized, non-blinded, controlled, multicenter trial.&#xD;
  &#xD;
        Study population: Clinicians working in NHs in the provinces North Holland and Flevoland.&#xD;
  &#xD;
        Intervention: The VAT consists of at least a clinical microbiologist and a clinician from the&#xD;
        NH. Ideally, a pharmacist will also attend. They conduct a weekly (digital) meeting for nine&#xD;
        months to evaluate the antibiotic prescriptions of the clinician attending the VAT meeting,&#xD;
        based on a standardized protocol according to the current national guidelines.&#xD;
  &#xD;
        Main study parameters/endpoints: The primary outcome is the number of inappropriate&#xD;
        antibiotic prescriptions, assessed based on an algorithm of the current clinical infection&#xD;
        treatment guidelines, antimicrobial susceptibility test results, and clinical&#xD;
        characteristics. Each antibiotic prescription is a record and for each record will be&#xD;
        assessed whether the antibiotic prescription is appropriate or not. Secondary outcome&#xD;
        measures are the incidence rate (IR) of antibiotic prescriptions and facilitators and&#xD;
        barriers to VAT implementation.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 1, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">May 31, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_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).</intervention_model_description>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Inappropriate antibiotic prescriptions</measure>
      <time_frame>9 months</time_frame>
      <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.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Incidence rate (IR)</measure>
      <time_frame>9 months</time_frame>
      <description>Incidence rate (IR) of antibiotic prescriptions in each group.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Barriers and facilitators</measure>
      <time_frame>9 months</time_frame>
      <description>Identify the barriers and facilitators for VAT implementation through questionnaires.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Barriers and facilitators</measure>
      <time_frame>9 months</time_frame>
      <description>Identify the barriers and facilitators for VAT implementation through and in-depth interviews.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">54</enrollment>
    <condition>Bacterial Infections</condition>
    <arm_group>
      <arm_group_label>Standard care (control group)</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Virtual Antimicrobial stewardship Team (VAT) (intervention group)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <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 .</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Virtual Antimicrobial stewardship Team (VAT)</intervention_name>
      <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.</description>
      <arm_group_label>Virtual Antimicrobial stewardship Team (VAT) (intervention group)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria of clinicians:&#xD;
  &#xD;
            -  Working in nursing homes in the North Holland-Flevoland region and being authorized to&#xD;
               prescribe.&#xD;
  &#xD;
            -  Agreeing to being randomized to intervention or control group.&#xD;
  &#xD;
            -  Working in a nursing home that has a medication prescription system from which&#xD;
               prescriptions can easily be obtained for VAT meetings.&#xD;
  &#xD;
            -  Working in a nursing home that is connected to a microbiology lab, .that participates&#xD;
               in this study and offers VAT meetings.&#xD;
  &#xD;
            -  Expected to be employed for at least four months from date of randomization.&#xD;
  &#xD;
          Inclusion Criteria of antibiotic prescriptions:&#xD;
  &#xD;
          • All prescriptions for antibiotics with a therapeutic indication regarding urinary tract&#xD;
          infections, respiratory tract infections or skin and soft tissue infections for residents&#xD;
          of nursing homes, prescribed by clinicians participating in the study, during the study&#xD;
          period.&#xD;
  &#xD;
          Exclusion Criteria of antibiotic prescriptions:&#xD;
  &#xD;
            -  Prescriptions for antibiotics with a prophylactic purpose.&#xD;
  &#xD;
            -  Prescriptions given by clinicians not participating in the study&#xD;
  &#xD;
            -  Prescriptions prescribed outside the study period.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Maarten MF Schim van der Loeff, Prof. dr.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Public Health Service of Amsterdam</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Kelly KC Paap, Msc</last_name>
      <phone>+31618083470</phone>
      <email>k.c.paap@amsterdam.nl</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Sacha SD Kuil, MD, PhD</last_name>
      <phone>+31205555293</phone>
      <email>skuil@ggd.amsterdam.nl</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Public Health Service of Amsterdam</name>
        <address>
          <city>Amsterdam</city>
          <state>Noord-Holland</state>
          <zip>1018WT</zip>
          <country>Netherlands</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Maarten MF Schim van der Loeff, Prof.dr.</last_name>
        <phone>0031205555083</phone>
        <email>mschimvdloeff@ggd.amsterdam.nl</email>
      </contact>
      <contact_backup>
        <last_name>Kelly KC Paap, Msc.</last_name>
        <phone>0031618083470</phone>
        <email>k.c.paap@amsterdamumc.nl</email>
      </contact_backup>
      <investigator>
        <last_name>Kelly KC Paap, Msc</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Sacha SD Kuil, MD, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Menno MD de Jong, Prof. dr.</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Laura LW van Buul, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Maarten MF Schim van der Loeff, Prof. dr.</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Lisa LM Kolodziej, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Netherlands</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Public Health Service of Amsterdam</investigator_affiliation>
      <investigator_full_name>Maarten Schim van der Loeff</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Bacterial Infections</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Anti-Infective Agents</mesh_term>
      <mesh_term>Anti-Bacterial Agents</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05998226
  org study id: W23_041 #23.064
  nct id: NCT05998226
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention 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).
  primary purpose: Health Services Research
  masking: None (Open Label)
  measure: Inappropriate antibiotic prescriptions
  time frame: 9 months
  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.
  measure: Incidence rate (IR)
  time frame: 9 months
  description: Incidence rate (IR) of antibiotic prescriptions in each group.
  measure: Barriers and facilitators
  time frame: 9 months
  description: Identify the barriers and facilitators for VAT implementation through questionnaires.
  measure: Barriers and facilitators
  time frame: 9 months
  description: Identify the barriers and facilitators for VAT implementation through and in-depth interviews.
  arm group label: Standard care (control group)
  arm group type: No Intervention
  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 group label: Virtual Antimicrobial stewardship Team (VAT) (intervention group)
  arm group type: Experimental
  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: Virtual Antimicrobial stewardship Team (VAT)
  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.
  arm group label: Virtual Antimicrobial stewardship Team (VAT) (intervention group)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Maarten MF Schim van der Loeff, Prof. dr.
  role: Principal Investigator
  affiliation: Public Health Service of Amsterdam
  last name: Kelly KC Paap, Msc
  phone: +31618083470
  email: k.c.paap@amsterdam.nl
  last name: Sacha SD Kuil, MD, PhD
  phone: +31205555293
  email: skuil@ggd.amsterdam.nl
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  country: Netherlands
  responsible party type: Principal Investigator
  investigator affiliation: Public Health Service of Amsterdam
  investigator full name: Maarten Schim van der Loeff
  investigator title: Professor
  mesh term: Bacterial Infections
  mesh term: Anti-Infective Agents
  mesh term: Anti-Bacterial Agents
  sharing ipd: No