<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/NCT02265471</url>
  </required_header>
  <id_info>
    <org_study_id>PHRQ1277</org_study_id>
    <nct_id>NCT02265471</nct_id>
  </id_info>
  <brief_title>Knowledge and Perception of Resistance to Antimicrobials Among Healthcare Workers in France</brief_title>
  <acronym>PerceptR</acronym>
  <official_title>Knowledge and Perception of Resistance to Antimicrobials in French Healthcare Facilities</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objectives of this survey are to determine the level of antimicrobial resistance&#xD;
      knowledge and perception of health care workers (HCW) in France, to measure the impact of&#xD;
      health care facilities (HCF) and to identify the drivers and barriers to change. To achieve&#xD;
      this goal, a cross-sectional survey on one day with a self-administered questionnaire and&#xD;
      semi-structured interviews with HCWs is proposed. This study will be planned in 60 different&#xD;
      HCFs randomly selected and expected to include of 2,100 to 10,000 respondents.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      BACKGROUND The landscape of antibiotic resistance in hospital has dramatically evolved over&#xD;
      the past 10 years, with rapid change of multidrug resistant organisms (MDROs), i.e.&#xD;
      decreasing rate of methicillin-resistant Staphylococcus aureus (MRSA) and increasing&#xD;
      prevalence of Extended-spectrum beta-lactamase (ESBL) - producing Enterobacteriaceae in the&#xD;
      community and the hospital, emergence of highly resistant bacteria (HRB) especially&#xD;
      vancomycin-resistant enterococci (VRE) and carbapenemase-producing Enterobacteriaceae (CPE)&#xD;
      that are most often imported for foreign countries.&#xD;
&#xD;
      Schematically, the control of bacterial resistance is based on the modulation of antibiotics&#xD;
      prescription and on the interruption of HRB or MDRO cross-transmission. Many recommendations&#xD;
      have recently been issued for the management of patients carrying HRB or MDRO, but their&#xD;
      level of knowledge and implementation in health care facilities (HCF) remains unclear.&#xD;
&#xD;
      Knowledge and perception of resistance to antimicrobials in among health care workers (HCW)&#xD;
      are influenced by individual and societal determinants, professional environment and personal&#xD;
      experience. The willing of improving antimicrobial resistance awareness and changing&#xD;
      behaviors requires an accurate overview of the knowledge and perceptions of the HCW within&#xD;
      the French health care settings.&#xD;
&#xD;
      OBJECTIVES The main objective is to determine the level of antimicrobial resistance knowledge&#xD;
      among HCWs in France.&#xD;
&#xD;
      The secondary objectives are: 1) to determine the antimicrobial resistance perception of HCW&#xD;
      in France; 2) to measure the impact of HCF organisation and the perception on the knowledge&#xD;
      of HCW; 3) to identify and analyse the drivers and barriers to change.&#xD;
&#xD;
      MATERIALS AND METHODS The methodology used is a cross-sectional survey on one day with a&#xD;
      self-administered questionnaire and semi-structured interviews with HCW (doctors, nurses and&#xD;
      aides, employed or in training, and directly participating in care). This survey will be&#xD;
      implemented in a random sample representative of the French HCFs. The questionnaires include&#xD;
      data on HCF and individual data on respondents and evaluations regarding: the knowledge of&#xD;
      HCW (landscape of resistance, the role and control of cross-transmission, the role of&#xD;
      selective pressure caused by antibiotics), the perception of antimicrobial resistance (using&#xD;
      the Health Belief Model), a measure of organization's workplace culture (based on leadership,&#xD;
      commitment, team communication and level of stress / chaos). Semi-structured interviews have&#xD;
      been planned to complement the assessment.&#xD;
&#xD;
      JUDGING CRITERIA The main criterion is the level of knowledge with binary encoding. The&#xD;
      secondary criteria are based on the psycho-social-cognitive determinants of knowledge and&#xD;
      perceptions and the culture of the organisation.&#xD;
&#xD;
      INCLUSIONS Six types of HCF (university hospital, large or small public hospitals, private&#xD;
      HCFs, referral centers for cancer, and a mixed group of local hospitals, long term care and&#xD;
      post-op and rehabilitation facilities, and nursing homes in each of the 5 interregional&#xD;
      coordination centers for infection control (CCLIN). All eligible HCWs working during the&#xD;
      survey day will be included. A minimum of 2,100 HCW is required to properly estimate the rate&#xD;
      of HCW with the minimum core of knowledge (p&lt;0.05). Actually, a larger number of 5,000 to&#xD;
      10,000 participants should be included.&#xD;
&#xD;
      All HCWs, employed or training, working during the day of the survey (day and night) in the&#xD;
      selected HCF will be included except the health workers who are not involved in direct care,&#xD;
      non-medical staff other than nurses or nursing auxiliary.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">February 2016</completion_date>
  <primary_completion_date type="Actual">February 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>percentage of healthcare workers with appropriate knowledge and related environmental conditions</measure>
    <time_frame>1 day</time_frame>
    <description>psycho-social-cognitive determinants of knowledge and perceptions and the culture of the organisation</description>
  </primary_outcome>
  <number_of_groups>6</number_of_groups>
  <enrollment type="Actual">10000</enrollment>
  <condition>Knowledge, Perception and Behaviour of Resistance to Antimicrobial Among HCW</condition>
  <arm_group>
    <arm_group_label>university hospital</arm_group_label>
    <description>university hospital</description>
  </arm_group>
  <arm_group>
    <arm_group_label>large or small public hospitals</arm_group_label>
    <description>large or small public hospitals</description>
  </arm_group>
  <arm_group>
    <arm_group_label>private HCFs</arm_group_label>
    <description>private HCFs</description>
  </arm_group>
  <arm_group>
    <arm_group_label>referral centers for cancer</arm_group_label>
    <description>referral centers for cancer</description>
  </arm_group>
  <arm_group>
    <arm_group_label>chirurgical facilities, clinic</arm_group_label>
    <description>chirurgical facilities, clinic</description>
  </arm_group>
  <arm_group>
    <arm_group_label>mixed group</arm_group_label>
    <description>local hospitals, long term care and post-op and rehabilitation facilities, and nursing homes</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        health care workers (medical or not)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  doctors, nurses and aides, employed or in training, and directly participating in care&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  physicians not participating in care, pharmacist, laboratory employees, administrative&#xD;
             employees&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jean Christophe Lucet, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistance Publique - Hôpitaux de Paris</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU Bichat-Claude Bernard</name>
      <address>
        <city>Paris</city>
        <zip>75018</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2014</verification_date>
  <study_first_submitted>May 27, 2014</study_first_submitted>
  <study_first_submitted_qc>October 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 16, 2014</study_first_posted>
  <last_update_submitted>July 20, 2018</last_update_submitted>
  <last_update_submitted_qc>July 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02265471
org study id: PHRQ1277
nct id: NCT02265471
lead sponsor: 
has dmc: No
The objectives of this survey are to determine the level of antimicrobial resistance
      knowledge and perception of health care workers (HCW) in France, to measure the impact of
      health care facilities (HCF) and to identify the drivers and barriers to change. To achieve
      this goal, a cross-sectional survey on one day with a self-administered questionnaire and
      semi-structured interviews with HCWs is proposed. This study will be planned in 60 different
      HCFs randomly selected and expected to include of 2,100 to 10,000 respondents.
BACKGROUND The landscape of antibiotic resistance in hospital has dramatically evolved over
      the past 10 years, with rapid change of multidrug resistant organisms (MDROs), i.e.
      decreasing rate of methicillin-resistant Staphylococcus aureus (MRSA) and increasing
      prevalence of Extended-spectrum beta-lactamase (ESBL) - producing Enterobacteriaceae in the
      community and the hospital, emergence of highly resistant bacteria (HRB) especially
      vancomycin-resistant enterococci (VRE) and carbapenemase-producing Enterobacteriaceae (CPE)
      that are most often imported for foreign countries.

      Schematically, the control of bacterial resistance is based on the modulation of antibiotics
      prescription and on the interruption of HRB or MDRO cross-transmission. Many recommendations
      have recently been issued for the management of patients carrying HRB or MDRO, but their
      level of knowledge and implementation in health care facilities (HCF) remains unclear.

      Knowledge and perception of resistance to antimicrobials in among health care workers (HCW)
      are influenced by individual and societal determinants, professional environment and personal
      experience. The willing of improving antimicrobial resistance awareness and changing
      behaviors requires an accurate overview of the knowledge and perceptions of the HCW within
      the French health care settings.

      OBJECTIVES The main objective is to determine the level of antimicrobial resistance knowledge
      among HCWs in France.

      The secondary objectives are: 1) to determine the antimicrobial resistance perception of HCW
      in France; 2) to measure the impact of HCF organisation and the perception on the knowledge
      of HCW; 3) to identify and analyse the drivers and barriers to change.

      MATERIALS AND METHODS The methodology used is a cross-sectional survey on one day with a
      self-administered questionnaire and semi-structured interviews with HCW (doctors, nurses and
      aides, employed or in training, and directly participating in care). This survey will be
      implemented in a random sample representative of the French HCFs. The questionnaires include
      data on HCF and individual data on respondents and evaluations regarding: the knowledge of
      HCW (landscape of resistance, the role and control of cross-transmission, the role of
      selective pressure caused by antibiotics), the perception of antimicrobial resistance (using
      the Health Belief Model), a measure of organization's workplace culture (based on leadership,
      commitment, team communication and level of stress / chaos). Semi-structured interviews have
      been planned to complement the assessment.

      JUDGING CRITERIA The main criterion is the level of knowledge with binary encoding. The
      secondary criteria are based on the psycho-social-cognitive determinants of knowledge and
      perceptions and the culture of the organisation.

      INCLUSIONS Six types of HCF (university hospital, large or small public hospitals, private
      HCFs, referral centers for cancer, and a mixed group of local hospitals, long term care and
      post-op and rehabilitation facilities, and nursing homes in each of the 5 interregional
      coordination centers for infection control (CCLIN). All eligible HCWs working during the
      survey day will be included. A minimum of 2,100 HCW is required to properly estimate the rate
      of HCW with the minimum core of knowledge (p<0.05). Actually, a larger number of 5,000 to
      10,000 participants should be included.

      All HCWs, employed or training, working during the day of the survey (day and night) in the
      selected HCF will be included except the health workers who are not involved in direct care,
      non-medical staff other than nurses or nursing auxiliary.
observational model: Other
time perspective: Cross-Sectional
measure: percentage of healthcare workers with appropriate knowledge and related environmental conditions
time frame: 1 day
description: psycho-social-cognitive determinants of knowledge and perceptions and the culture of the organisation
arm group label: university hospital
description: university hospital
arm group label: large or small public hospitals
description: large or small public hospitals
arm group label: private HCFs
description: private HCFs
arm group label: referral centers for cancer
description: referral centers for cancer
arm group label: chirurgical facilities, clinic
description: chirurgical facilities, clinic
arm group label: mixed group
description: local hospitals, long term care and post-op and rehabilitation facilities, and nursing homes
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jean Christophe Lucet, PHD
role: Principal Investigator
affiliation: Assistance Publique - Hôpitaux de Paris
facility: 
country: France
responsible party type: Sponsor
sharing ipd: Undecided