<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/NCT03265028</url>
  </required_header>
  <id_info>
    <org_study_id>TRACE Implementation</org_study_id>
    <nct_id>NCT03265028</nct_id>
  </id_info>
  <brief_title>TRACE E-learning Implementation in Belgium</brief_title>
  <official_title>National Implementation of a Multifaceted Web-based Communication Training to Reduce of Inappropriate Antibiotic Prescribing for (Lower) Respiratory Tract Infections</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universiteit Antwerpen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Belgian Antibiotic Policy Coordination Committee (BAPCOC)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universiteit Antwerpen</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Antibiotic resistance is a worldwide health care problem. Increasing use of antibiotics is&#xD;
      associated with an increase in the prevalence of bacteria resistant to the antibiotic used.&#xD;
      Reducing antibiotic use can be effected by improving antibiotic prescribing quality in two&#xD;
      complementary ways. One is to limit antibiotic prescribing to those patients who will benefit&#xD;
      from the treatment and two is to prescribe these patients the recommended antibiotic.&#xD;
&#xD;
      International research has shown that a web-based communication training for the prescriber&#xD;
      combined with an interactive booklet containing relevant patient information (Genomics to&#xD;
      combat Resistance against Antibiotics for Community acquired LRTI in Europe INternet Training&#xD;
      for Reducing antibiOtic use (GRACE INTRO)) can significantly and safely reduce antibiotic&#xD;
      prescribing in adults presenting to primary care with acute cough/lower respiratory tract&#xD;
      infections (LRTI). Quality assessment of antibiotic prescribing for respiratory infections in&#xD;
      general practice has revealed the use of far too many (broad-spectrum) antibiotics in&#xD;
      Belgium.&#xD;
&#xD;
      In the proposed project, the investigators aspire to make Belgium the first European country&#xD;
      to implement the most cost-effective part of the GRACE INTRO intervention (Translational&#xD;
      Research on Antimicrobial resistance and Community-acquired infections in Europe (TRACE)&#xD;
      e-learning, www.acutecough.org) at national level and to perform a scientifically sound&#xD;
      assessment of the nationwide implementation on outpatient antibiotic use and societal cost.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The envisaged research aims to implement the most cost-effective part of the GRACE INTRO&#xD;
      intervention (TRACE e-learning, www.acutecough.org), i.e. a web-based communication training&#xD;
      and an interactive patient booklet for adults presenting to primary care with LRTI, at&#xD;
      national level. For that purpose the investigators will perform a stepped wedge&#xD;
      cluster-randomised trial. Stepped wedge randomised trial designs involve sequential roll-out&#xD;
      of an intervention to participants (individuals or clusters) over a number of time periods.&#xD;
      By the end of the study, all participants will have received the intervention, although the&#xD;
      order in which participants receive the intervention is determined at random. Over a period&#xD;
      of one year all practices in the 10 Belgian provinces and Brussels (n=11 clusters) will get&#xD;
      access to the intervention. The order in which the clusters receive the intervention is&#xD;
      determined at random. The general practitioners (GPs) in the intervention phase will be&#xD;
      invited to take an educational web-based module, including communication training, to improve&#xD;
      prescribing of antibiotics for LRTI and will receive patient booklets to be used&#xD;
      interactively during the consultation. The clusters not yet exposed to the intervention will&#xD;
      serve as control group. The effect on prescribing behavior will be assessed using monthly&#xD;
      Intermutualistic Agency (IMA, www.nic-ima.be) data. Hence, the outcome measurement will have&#xD;
      complete response, and will not interfere with the normal routine of the eligible GPs,&#xD;
      allowing a more valid estimate of any intervention effect. Since the training will be&#xD;
      assessed, and not the eligible practices or GPs, IMA has the legal authority (Art. 153 of the&#xD;
      coordinated Law of 14 July 1994) to perform the required analyses. The estimates of the&#xD;
      efficacy of the intervention will at the same time describe its effectiveness in daily&#xD;
      practice, which is unconventional for a randomized trial (on a behavioural intervention).&#xD;
      Given the large sample size, the proposed trial will also provide very precise estimates.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">December 31, 2018</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>2 Years</target_duration>
  <primary_outcome>
    <measure>Antibiotic use (short term)</measure>
    <time_frame>First 2 months after intervention</time_frame>
    <description>Number of packages for antibacterials for systemic use (ATC J01) collected at the pharmacy (reimbursement data) per 1000 inhabitants per day</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Antibiotic use (intermediate term)</measure>
    <time_frame>3-6 months after intervention</time_frame>
    <description>Number of packages for antibacterials for systemic use (ATC J01) collected at the pharmacy (reimbursement data) per 1000 inhabitants per day</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Antibiotic use (long term)</measure>
    <time_frame>6-12 months after intervention</time_frame>
    <description>Number of packages for antibacterials for systemic use (ATC J01) collected at the pharmacy (reimbursement data) per 1000 inhabitants per day</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Response rate (short term)</measure>
    <time_frame>First 2 months after intervention</time_frame>
    <description>The number of invited GPs taking the TRACE e-learning</description>
  </other_outcome>
  <other_outcome>
    <measure>Response rate (long term)</measure>
    <time_frame>First year after intervention</time_frame>
    <description>The number of invited GPs taking the TRACE e-learning</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">15802</enrollment>
  <condition>Respiratory Tract Infections</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <description>Invited to take the TRACE e-learning.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <description>Not (yet) invited to take the TRACE e-learning.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>TRACE e-learning</intervention_name>
    <description>The TRACE e-learning (www.acutecough.org) is an educational web-based module including communication training for physicians, and includes patient booklets to be used interactively during the consultation.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        all clinicians registered as General Practitioner in Belgium&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  all clinicians registered as General Practitioner in Belgium&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Samuel Coenen, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universiteit Antwerpen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>GPs of Henegouwen</name>
      <address>
        <city>Mons</city>
        <state>Henegouwen</state>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GPs of Limburg</name>
      <address>
        <city>Hasselt</city>
        <state>Limburg</state>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GPS of Luik</name>
      <address>
        <city>Liège</city>
        <state>Luik</state>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gps of Luxemburg</name>
      <address>
        <city>Arlon</city>
        <state>Luxemburg</state>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GPs of Namen</name>
      <address>
        <city>Namur</city>
        <state>Namen</state>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GPs of Oost-Vlaanderen</name>
      <address>
        <city>Gent</city>
        <state>Oost-Vlaanderen</state>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GPs of Vlaams-Brabant</name>
      <address>
        <city>Leuven</city>
        <state>Vlaams-Brabant</state>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GPs of Waals-Brabant</name>
      <address>
        <city>Wavre</city>
        <state>Waals-Brabant</state>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GPs of West-Vlaanderen</name>
      <address>
        <city>Brugge</city>
        <state>West-Vlaanderen</state>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GPs of Antwerp</name>
      <address>
        <city>Antwerp</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GPs of Brussels</name>
      <address>
        <city>Brussels</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <link>
    <url>http://www.acutecough.org</url>
    <description>TRACE e-learning</description>
  </link>
  <link>
    <url>http://www.esf.org/trace</url>
    <description>TRACE website</description>
  </link>
  <reference>
    <citation>Anthierens S, Tonkin-Crine S, Douglas E, Fernandez-Vandellos P, Krawczyk J, Llor C, Cals JW, Francis NA, Yardley L, Coenen S, Verheij T, Goossens H, Little P; GRACE INTRO study team. General practitioners' views on the acceptability and applicability of a web-based intervention to reduce antibiotic prescribing for acute cough in multiple European countries: a qualitative study prior to a randomised trial. BMC Fam Pract. 2012 Oct 11;13:101. doi: 10.1186/1471-2296-13-101.</citation>
    <PMID>23110756</PMID>
  </reference>
  <reference>
    <citation>Little P, Stuart B, Francis N, Douglas E, Tonkin-Crine S, Anthierens S, Cals JW, Melbye H, Santer M, Moore M, Coenen S, Butler C, Hood K, Kelly M, Godycki-Cwirko M, Mierzecki A, Torres A, Llor C, Davies M, Mullee M, O'Reilly G, van der Velden A, Geraghty AW, Goossens H, Verheij T, Yardley L; GRACE consortium. Effects of internet-based training on antibiotic prescribing rates for acute respiratory-tract infections: a multinational, cluster, randomised, factorial, controlled trial. Lancet. 2013 Oct 5;382(9899):1175-82. doi: 10.1016/S0140-6736(13)60994-0. Epub 2013 Jul 31.</citation>
    <PMID>23915885</PMID>
  </reference>
  <reference>
    <citation>Tonkin-Crine S, Anthierens S, Francis NA, Brugman C, Fernandez-Vandellos P, Krawczyk J, Llor C, Yardley L, Coenen S, Godycki-Cwirko M, Butler CC, Verheij TJ, Goossens H, Little P, Cals JW; GRACE INTRO team. Exploring patients' views of primary care consultations with contrasting interventions for acute cough: a six-country European qualitative study. NPJ Prim Care Respir Med. 2014 Jul 17;24:14026. doi: 10.1038/npjpcrm.2014.26.</citation>
    <PMID>25030621</PMID>
  </reference>
  <reference>
    <citation>Anthierens S, Tonkin-Crine S, Cals JW, Coenen S, Yardley L, Brookes-Howell L, Fernandez-Vandellos P, Krawczyk J, Godycki-Cwirko M, Llor C, Butler CC, Verheij T, Goossens H, Little P, Francis NA; GRACE/CHAMP INTRO team. Clinicians' views and experiences of interventions to enhance the quality of antibiotic prescribing for acute respiratory tract infections. J Gen Intern Med. 2015 Apr;30(4):408-16. doi: 10.1007/s11606-014-3076-6. Epub 2014 Nov 6.</citation>
    <PMID>25373834</PMID>
  </reference>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>August 25, 2017</study_first_submitted>
  <study_first_submitted_qc>August 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>August 27, 2019</last_update_submitted>
  <last_update_submitted_qc>August 27, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universiteit Antwerpen</investigator_affiliation>
    <investigator_full_name>Niels Adriaenssens</investigator_full_name>
    <investigator_title>Dr.</investigator_title>
  </responsible_party>
  <keyword>primary care</keyword>
  <keyword>antibiotics</keyword>
  <keyword>communication skills</keyword>
  <keyword>general practice</keyword>
  <keyword>outpatient</keyword>
  <keyword>ambulatory care</keyword>
  <keyword>anti-bacterial agents</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Respiratory Tract Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03265028
org study id: TRACE Implementation
nct id: NCT03265028
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Antibiotic resistance is a worldwide health care problem. Increasing use of antibiotics is
      associated with an increase in the prevalence of bacteria resistant to the antibiotic used.
      Reducing antibiotic use can be effected by improving antibiotic prescribing quality in two
      complementary ways. One is to limit antibiotic prescribing to those patients who will benefit
      from the treatment and two is to prescribe these patients the recommended antibiotic.

      International research has shown that a web-based communication training for the prescriber
      combined with an interactive booklet containing relevant patient information (Genomics to
      combat Resistance against Antibiotics for Community acquired LRTI in Europe INternet Training
      for Reducing antibiOtic use (GRACE INTRO)) can significantly and safely reduce antibiotic
      prescribing in adults presenting to primary care with acute cough/lower respiratory tract
      infections (LRTI). Quality assessment of antibiotic prescribing for respiratory infections in
      general practice has revealed the use of far too many (broad-spectrum) antibiotics in
      Belgium.

      In the proposed project, the investigators aspire to make Belgium the first European country
      to implement the most cost-effective part of the GRACE INTRO intervention (Translational
      Research on Antimicrobial resistance and Community-acquired infections in Europe (TRACE)
      e-learning, www.acutecough.org) at national level and to perform a scientifically sound
      assessment of the nationwide implementation on outpatient antibiotic use and societal cost.
The envisaged research aims to implement the most cost-effective part of the GRACE INTRO
      intervention (TRACE e-learning, www.acutecough.org), i.e. a web-based communication training
      and an interactive patient booklet for adults presenting to primary care with LRTI, at
      national level. For that purpose the investigators will perform a stepped wedge
      cluster-randomised trial. Stepped wedge randomised trial designs involve sequential roll-out
      of an intervention to participants (individuals or clusters) over a number of time periods.
      By the end of the study, all participants will have received the intervention, although the
      order in which participants receive the intervention is determined at random. Over a period
      of one year all practices in the 10 Belgian provinces and Brussels (n=11 clusters) will get
      access to the intervention. The order in which the clusters receive the intervention is
      determined at random. The general practitioners (GPs) in the intervention phase will be
      invited to take an educational web-based module, including communication training, to improve
      prescribing of antibiotics for LRTI and will receive patient booklets to be used
      interactively during the consultation. The clusters not yet exposed to the intervention will
      serve as control group. The effect on prescribing behavior will be assessed using monthly
      Intermutualistic Agency (IMA, www.nic-ima.be) data. Hence, the outcome measurement will have
      complete response, and will not interfere with the normal routine of the eligible GPs,
      allowing a more valid estimate of any intervention effect. Since the training will be
      assessed, and not the eligible practices or GPs, IMA has the legal authority (Art. 153 of the
      coordinated Law of 14 July 1994) to perform the required analyses. The estimates of the
      efficacy of the intervention will at the same time describe its effectiveness in daily
      practice, which is unconventional for a randomized trial (on a behavioural intervention).
      Given the large sample size, the proposed trial will also provide very precise estimates.
observational model: Ecologic or Community
time perspective: Prospective
measure: Antibiotic use (short term)
time frame: First 2 months after intervention
description: Number of packages for antibacterials for systemic use (ATC J01) collected at the pharmacy (reimbursement data) per 1000 inhabitants per day
measure: Antibiotic use (intermediate term)
time frame: 3-6 months after intervention
description: Number of packages for antibacterials for systemic use (ATC J01) collected at the pharmacy (reimbursement data) per 1000 inhabitants per day
measure: Antibiotic use (long term)
time frame: 6-12 months after intervention
description: Number of packages for antibacterials for systemic use (ATC J01) collected at the pharmacy (reimbursement data) per 1000 inhabitants per day
measure: Response rate (short term)
time frame: First 2 months after intervention
description: The number of invited GPs taking the TRACE e-learning
measure: Response rate (long term)
time frame: First year after intervention
description: The number of invited GPs taking the TRACE e-learning
arm group label: Intervention
description: Invited to take the TRACE e-learning.
arm group label: Control
description: Not (yet) invited to take the TRACE e-learning.
intervention type: Behavioral
intervention name: TRACE e-learning
description: The TRACE e-learning (www.acutecough.org) is an educational web-based module including communication training for physicians, and includes patient booklets to be used interactively during the consultation.
arm group label: Intervention
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Samuel Coenen, Prof
role: Principal Investigator
affiliation: Universiteit Antwerpen
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Belgium
url: http://www.acutecough.org
description: TRACE e-learning
url: http://www.esf.org/trace
description: TRACE website
citation: Anthierens S, Tonkin-Crine S, Douglas E, Fernandez-Vandellos P, Krawczyk J, Llor C, Cals JW, Francis NA, Yardley L, Coenen S, Verheij T, Goossens H, Little P; GRACE INTRO study team. General practitioners' views on the acceptability and applicability of a web-based intervention to reduce antibiotic prescribing for acute cough in multiple European countries: a qualitative study prior to a randomised trial. BMC Fam Pract. 2012 Oct 11;13:101. doi: 10.1186/1471-2296-13-101.
PMID: 23110756
citation: Little P, Stuart B, Francis N, Douglas E, Tonkin-Crine S, Anthierens S, Cals JW, Melbye H, Santer M, Moore M, Coenen S, Butler C, Hood K, Kelly M, Godycki-Cwirko M, Mierzecki A, Torres A, Llor C, Davies M, Mullee M, O'Reilly G, van der Velden A, Geraghty AW, Goossens H, Verheij T, Yardley L; GRACE consortium. Effects of internet-based training on antibiotic prescribing rates for acute respiratory-tract infections: a multinational, cluster, randomised, factorial, controlled trial. Lancet. 2013 Oct 5;382(9899):1175-82. doi: 10.1016/S0140-6736(13)60994-0. Epub 2013 Jul 31.
PMID: 23915885
citation: Tonkin-Crine S, Anthierens S, Francis NA, Brugman C, Fernandez-Vandellos P, Krawczyk J, Llor C, Yardley L, Coenen S, Godycki-Cwirko M, Butler CC, Verheij TJ, Goossens H, Little P, Cals JW; GRACE INTRO team. Exploring patients' views of primary care consultations with contrasting interventions for acute cough: a six-country European qualitative study. NPJ Prim Care Respir Med. 2014 Jul 17;24:14026. doi: 10.1038/npjpcrm.2014.26.
PMID: 25030621
citation: Anthierens S, Tonkin-Crine S, Cals JW, Coenen S, Yardley L, Brookes-Howell L, Fernandez-Vandellos P, Krawczyk J, Godycki-Cwirko M, Llor C, Butler CC, Verheij T, Goossens H, Little P, Francis NA; GRACE/CHAMP INTRO team. Clinicians' views and experiences of interventions to enhance the quality of antibiotic prescribing for acute respiratory tract infections. J Gen Intern Med. 2015 Apr;30(4):408-16. doi: 10.1007/s11606-014-3076-6. Epub 2014 Nov 6.
PMID: 25373834
responsible party type: Principal Investigator
investigator affiliation: Universiteit Antwerpen
investigator full name: Niels Adriaenssens
investigator title: Dr.
mesh term: Infections
mesh term: Respiratory Tract Infections
sharing ipd: No