<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/NCT03793946</url>
  </required_header>
  <id_info>
    <org_study_id>ZonMw_549003001</org_study_id>
    <nct_id>NCT03793946</nct_id>
  </id_info>
  <brief_title>A Digital Antimicrobial Stewardship Smartphone Application to Combat AMR: the AB-assistant</brief_title>
  <acronym>AB-assistant</acronym>
  <official_title>A Digital Antimicrobial Stewardship Smartphone Application to Combat AMR: the AB-assistant: an International, Multicenter Stepped-wedge Cluster Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Annelies Verbon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Erasmus Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital, Geneva</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Uppsala University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Calgary Cumming School of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Erasmus Medical Center</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>
      Optimal prescribing of antimicrobials is becoming increasingly challenging because of the&#xD;
      growing complexity of guidelines and constantly changing distribution of infectious&#xD;
      pathogens. Prescribing antimicrobials appropriately according to local guidelines optimizes&#xD;
      therapy for the individual patient and reduces the emergence of resistance. By adapting and&#xD;
      evaluating a smartphone based app containing local guidelines we aim to study appropriate&#xD;
      prescribing of antimicrobials by physicians in three hospitals (Netherlands, Sweden and&#xD;
      Switzerland).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Rationale: Antimicrobials are an indispensable part of modern medicine. However, optimal&#xD;
      prescription of these agents is becoming increasingly challenging because of the growing&#xD;
      complexity of guidelines, and constantly changing epidemiology of infectious pathogens.&#xD;
      Moreover, due to local variations in the prevalence of certain pathogens and antimicrobial&#xD;
      resistance (AMR), antimicrobial choices need to be tailored to local epidemiology.&#xD;
      Improvement of antimicrobial use, in particular prevention of overuse and suboptimal use of&#xD;
      antimicrobials, through antimicrobial stewardship (AMS) programs is increasingly regarded as&#xD;
      indispensable, both to optimize therapy for the individual patients as well as to reduce&#xD;
      emergence and spread of AMR. With the widespread use of electronic health records (EHR) and&#xD;
      handheld electronic devices in hospitals, informatics-based AMS interventions hold great&#xD;
      promise as tools to improve antimicrobial prescribing. However, they are still&#xD;
      underdeveloped, understudied and underutilized.&#xD;
&#xD;
      Objective: The study aims to adapt and evaluate the &quot;AB-assistant&quot;, a smartphone based&#xD;
      digital stewardship application that is customizable to local guidelines by local antibiotic&#xD;
      stewards and therefore has the potential to be used worldwide, including in low- and&#xD;
      middle-income countries.&#xD;
&#xD;
      Study design: The existing North American Spectrum app (SpectrumMD; Canada) will be adjusted&#xD;
      and translated for the European market. During a usability study physicians will use the app&#xD;
      for two weeks followed by individual interviews to determine facilitators and barriers of app&#xD;
      use. Based on the results of these interviews the app will be adjusted if necessary. After&#xD;
      adaptation and usability testing, thereafter the AB-assistant app will be evaluated in an&#xD;
      international, multicentre, randomized clinical trial involving centres in 3 countries in&#xD;
      different settings with appropriate antimicrobial use as a primary outcome. In a stepped&#xD;
      wedge cluster randomized trial, wards will be randomised after stratification for specialty.&#xD;
      At baseline a 2-week measurement period will be done, followed by the introduction of the&#xD;
      intervention to 6 wards (in 3 hospitals) with a 4-week interval with 6 inclusion periods.&#xD;
      This cycle will be repeated with the inclusion of all new intervention wards. We include the&#xD;
      36 wards in total during the 6 inclusion phases and at the end of the inclusion time we allow&#xD;
      use of the app by everyone, also wards not included in the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 2020</start_date>
  <completion_date type="Anticipated">January 2022</completion_date>
  <primary_completion_date type="Anticipated">September 2021</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>International, multicenter stepped-wedge cluster randomized trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Masking of care providers and investigators is not feasible. Outcome assessors and data analysts will be blinded to the study arm allocation.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Appropriate empirical antimicrobial therapy</measure>
    <time_frame>12 months</time_frame>
    <description>According to predefined criteria</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total prescription of antimicrobial drugs</measure>
    <time_frame>12 months</time_frame>
    <description>In defined daily dose (DDD)/admission</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total prescription of antimicrobial drugs per AWaRe category in DDD/admission</measure>
    <time_frame>12 months</time_frame>
    <description>Per AWaRe category in DDD/admission</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Antimicrobial costs</measure>
    <time_frame>12 months</time_frame>
    <description>Total costs of antimicrobial drugs administered</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay (LOS)</measure>
    <time_frame>12 months</time_frame>
    <description>(LOS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>In-hospital mortality</measure>
    <time_frame>12 months</time_frame>
    <description>All cause in-hospital mortality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital readmission within 30 days of discharge</measure>
    <time_frame>12 months</time_frame>
    <description>Unplanned hospital readmissions within 30 days after discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Transfer to intermediate care or ICU</measure>
    <time_frame>12 months</time_frame>
    <description>% of admissions transferred to intermediate care or ICU after initial non-intermediate care or non-ICU admission</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence Clostridium difficile infections (CDI)</measure>
    <time_frame>12 months</time_frame>
    <description>Incidence of healthcare facility onset Clostridium difficile</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incident clinical cultures with multi-drug resistant organisms (MDRO)</measure>
    <time_frame>12 months</time_frame>
    <description>Incidence of clinical cultures with multidrug resistant organisms (methicillin-resistant Staphylococcus aureus (MRSA), Extended spectrum beta-lactamase producing Enterobacteriaceae (ESBL-E), carbapenemase-producing Enterobacteriaceae (CPE), vancomycin-resistant enterococci (VRE), multidrug resistant P. aeruginosa) denominated per 1000 patient days and admissions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Uptake of the AB-assistant</measure>
    <time_frame>12 months</time_frame>
    <description>Total users and number of sessions per user, time spent per session, time spent per screen, number of times each screen is viewed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Actual use of AB-assistant and experiences while using it</measure>
    <time_frame>12 months</time_frame>
    <description>Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of infectious diseases consultations</measure>
    <time_frame>12 months</time_frame>
    <description>Total amount of infectious diseases consultations</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1080</enrollment>
  <condition>Anti-Infective Agents</condition>
  <condition>Mobile Applications</condition>
  <condition>Quality Improvement</condition>
  <condition>Antimicrobial Stewardship</condition>
  <arm_group>
    <arm_group_label>AB-assistant</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Use of the AB-assistant app by physicians in intervention wards.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard antimicrobial stewardship</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Physicians on these wards will use conventional ways to assess local guidelines to prescribe antimicrobials.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>AB-assistant</intervention_name>
    <description>The AB-assistant is an antimicrobial stewardship smartphone application that offers local antimicrobial guidelines to physicians currently assessed per website or paper/digital booklet.</description>
    <arm_group_label>AB-assistant</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Cluster level (wards):&#xD;
&#xD;
        • Medical and surgical wards.&#xD;
&#xD;
        Physician level:&#xD;
&#xD;
        • All physicians involved in antibiotic prescribing decisions in the participating wards.&#xD;
&#xD;
        Patient level:&#xD;
&#xD;
        • All patients hospitalized in the participating wards &gt;= 18 years of age to whom systemic&#xD;
        antimicrobials are prescribed.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Cluster level (wards):&#xD;
&#xD;
          -  Outpatient clinics&#xD;
&#xD;
          -  Psychiatry wards&#xD;
&#xD;
          -  ICU&#xD;
&#xD;
        Physician level:&#xD;
&#xD;
        • None&#xD;
&#xD;
        Patient level:&#xD;
&#xD;
        • None&#xD;
&#xD;
        Treatment level:&#xD;
&#xD;
        • Surgical and medical prophylaxis.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>B D Huttner, MD, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Geneva</affiliation>
  </overall_official>
  <overall_official>
    <last_name>T Tängdén, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Uppsala University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>John Conly, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Calgary Cumming School of Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>R I Helou, MD</last_name>
    <phone>+31107033510</phone>
    <email>r.helou@erasmusmc.nl</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>A Verbon, Prof. Dr.</last_name>
    <phone>+31107033510</phone>
    <email>a.verbon@erasmusmc.nl</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Calgary Cumming School of Medicine and Alberta Health Services, Department of Medicine</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2N 2TN</zip>
        <country>Canada</country>
      </address>
    </facility>
    <contact>
      <last_name>John Conly, Prof. Dr.</last_name>
      <email>john.conly@albertahealthservices.ca</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Erasmus Medical Center</name>
      <address>
        <city>Rotterdam</city>
        <state>Zuid Holland</state>
        <zip>3015 CN</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <contact>
      <last_name>A Verbon, Prof. Dr.</last_name>
      <email>a.verbon@erasmusmc.nl</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Uppsala University, Dept of Medical Sciences</name>
      <address>
        <city>Uppsala</city>
        <zip>751 85</zip>
        <country>Sweden</country>
      </address>
    </facility>
    <contact>
      <last_name>T Tängdén, MD, PhD</last_name>
      <email>thomas.tangden@medsci.uu.se</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Geneva University Hospitals</name>
      <address>
        <city>Geneva</city>
        <state>GE</state>
        <zip>1211</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <contact>
      <last_name>B D Huttner, MD, MS</last_name>
      <email>benedikt.huttner@hcuge.ch</email>
    </contact>
    <investigator>
      <last_name>G Catho, MD, MS</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>Netherlands</country>
    <country>Sweden</country>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>January 3, 2019</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 4, 2019</study_first_posted>
  <last_update_submitted>July 31, 2020</last_update_submitted>
  <last_update_submitted_qc>July 31, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Erasmus Medical Center</investigator_affiliation>
    <investigator_full_name>Annelies Verbon</investigator_full_name>
    <investigator_title>Prof. dr.</investigator_title>
  </responsible_party>
  <keyword>Drug Resistance, Microbial</keyword>
  <keyword>Multicenter Study</keyword>
  <keyword>Decision Support Systems, Clinical</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified raw data will be made publicly on request available from the time of publication or within a reasonable time period of the experiments being completed. General project data and metadata will be included in the supplementary data of published articles if needed and or shared through university repositories.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03793946
org study id: ZonMw_549003001
nct id: NCT03793946
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Optimal prescribing of antimicrobials is becoming increasingly challenging because of the
      growing complexity of guidelines and constantly changing distribution of infectious
      pathogens. Prescribing antimicrobials appropriately according to local guidelines optimizes
      therapy for the individual patient and reduces the emergence of resistance. By adapting and
      evaluating a smartphone based app containing local guidelines we aim to study appropriate
      prescribing of antimicrobials by physicians in three hospitals (Netherlands, Sweden and
      Switzerland).
Rationale: Antimicrobials are an indispensable part of modern medicine. However, optimal
      prescription of these agents is becoming increasingly challenging because of the growing
      complexity of guidelines, and constantly changing epidemiology of infectious pathogens.
      Moreover, due to local variations in the prevalence of certain pathogens and antimicrobial
      resistance (AMR), antimicrobial choices need to be tailored to local epidemiology.
      Improvement of antimicrobial use, in particular prevention of overuse and suboptimal use of
      antimicrobials, through antimicrobial stewardship (AMS) programs is increasingly regarded as
      indispensable, both to optimize therapy for the individual patients as well as to reduce
      emergence and spread of AMR. With the widespread use of electronic health records (EHR) and
      handheld electronic devices in hospitals, informatics-based AMS interventions hold great
      promise as tools to improve antimicrobial prescribing. However, they are still
      underdeveloped, understudied and underutilized.

      Objective: The study aims to adapt and evaluate the "AB-assistant", a smartphone based
      digital stewardship application that is customizable to local guidelines by local antibiotic
      stewards and therefore has the potential to be used worldwide, including in low- and
      middle-income countries.

      Study design: The existing North American Spectrum app (SpectrumMD; Canada) will be adjusted
      and translated for the European market. During a usability study physicians will use the app
      for two weeks followed by individual interviews to determine facilitators and barriers of app
      use. Based on the results of these interviews the app will be adjusted if necessary. After
      adaptation and usability testing, thereafter the AB-assistant app will be evaluated in an
      international, multicentre, randomized clinical trial involving centres in 3 countries in
      different settings with appropriate antimicrobial use as a primary outcome. In a stepped
      wedge cluster randomized trial, wards will be randomised after stratification for specialty.
      At baseline a 2-week measurement period will be done, followed by the introduction of the
      intervention to 6 wards (in 3 hospitals) with a 4-week interval with 6 inclusion periods.
      This cycle will be repeated with the inclusion of all new intervention wards. We include the
      36 wards in total during the 6 inclusion phases and at the end of the inclusion time we allow
      use of the app by everyone, also wards not included in the study.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: International, multicenter stepped-wedge cluster randomized trial
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Masking of care providers and investigators is not feasible. Outcome assessors and data analysts will be blinded to the study arm allocation.
measure: Appropriate empirical antimicrobial therapy
time frame: 12 months
description: According to predefined criteria
measure: Total prescription of antimicrobial drugs
time frame: 12 months
description: In defined daily dose (DDD)/admission
measure: Total prescription of antimicrobial drugs per AWaRe category in DDD/admission
time frame: 12 months
description: Per AWaRe category in DDD/admission
measure: Antimicrobial costs
time frame: 12 months
description: Total costs of antimicrobial drugs administered
measure: Length of hospital stay (LOS)
time frame: 12 months
description: (LOS)
measure: In-hospital mortality
time frame: 12 months
description: All cause in-hospital mortality
measure: Hospital readmission within 30 days of discharge
time frame: 12 months
description: Unplanned hospital readmissions within 30 days after discharge
measure: Transfer to intermediate care or ICU
time frame: 12 months
description: % of admissions transferred to intermediate care or ICU after initial non-intermediate care or non-ICU admission
measure: Incidence Clostridium difficile infections (CDI)
time frame: 12 months
description: Incidence of healthcare facility onset Clostridium difficile
measure: Incident clinical cultures with multi-drug resistant organisms (MDRO)
time frame: 12 months
description: Incidence of clinical cultures with multidrug resistant organisms (methicillin-resistant Staphylococcus aureus (MRSA), Extended spectrum beta-lactamase producing Enterobacteriaceae (ESBL-E), carbapenemase-producing Enterobacteriaceae (CPE), vancomycin-resistant enterococci (VRE), multidrug resistant P. aeruginosa) denominated per 1000 patient days and admissions
measure: Uptake of the AB-assistant
time frame: 12 months
description: Total users and number of sessions per user, time spent per session, time spent per screen, number of times each screen is viewed.
measure: Actual use of AB-assistant and experiences while using it
time frame: 12 months
description: Questionnaire
measure: Number of infectious diseases consultations
time frame: 12 months
description: Total amount of infectious diseases consultations
arm group label: AB-assistant
arm group type: Experimental
description: Use of the AB-assistant app by physicians in intervention wards.
arm group label: Standard antimicrobial stewardship
arm group type: No Intervention
description: Physicians on these wards will use conventional ways to assess local guidelines to prescribe antimicrobials.
intervention type: Other
intervention name: AB-assistant
description: The AB-assistant is an antimicrobial stewardship smartphone application that offers local antimicrobial guidelines to physicians currently assessed per website or paper/digital booklet.
arm group label: AB-assistant
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: B D Huttner, MD, MS
role: Principal Investigator
affiliation: University Hospital, Geneva
last name: T Tängdén, MD, PhD
role: Principal Investigator
affiliation: Uppsala University
last name: John Conly, Prof. Dr.
role: Principal Investigator
affiliation: University of Calgary Cumming School of Medicine
last name: R I Helou, MD
phone: +31107033510
email: r.helou@erasmusmc.nl
last name: A Verbon, Prof. Dr.
phone: +31107033510
email: a.verbon@erasmusmc.nl
facility: 
contact: 
facility: 
contact: 
facility: 
contact: 
facility: 
contact: 
investigator: 
country: Canada
country: Netherlands
country: Sweden
country: Switzerland
responsible party type: Sponsor-Investigator
investigator affiliation: Erasmus Medical Center
investigator full name: Annelies Verbon
investigator title: Prof. dr.
sharing ipd: Yes
ipd description: De-identified raw data will be made publicly on request available from the time of publication or within a reasonable time period of the experiments being completed. General project data and metadata will be included in the supplementary data of published articles if needed and or shared through university repositories.
ipd info type: Study Protocol
ipd info type: Clinical Study Report (CSR)