<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/NCT03232853</url>
  </required_header>
  <id_info>
    <org_study_id>RECHMPL17_0226</org_study_id>
    <nct_id>NCT03232853</nct_id>
  </id_info>
  <brief_title>E-learning to Prevent Drug Errors in Anesthesia</brief_title>
  <acronym>ELPdrug</acronym>
  <official_title>Evaluation of an E-learning to Prevent Drug Errors in Anesthesia.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Montpellier</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 purpose of this observational study is to assess the efficiency of an e-learning in order&#xD;
      to put into practice some preventive measures to avoid medication errors during anesthesia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Before the study, the investigators selected 15 preventive measures to avoid medication&#xD;
      errors during anesthesia. These measures were learned to the entire anesthesia team (nurse,&#xD;
      resident and anesthesiologist) during conventional meetings. An initial evaluation of the&#xD;
      application of these measures will be carried out before the introduction of e-learning. This&#xD;
      assessment will be conducted by nurses without the knowledge of the anesthetic team&#xD;
      evaluated. After this initial evaluation, e-learning will be broadcast on the hospital&#xD;
      intranet. Then a second evaluation of the application of the preventive measures will be&#xD;
      carried out 6 month and 1 year after the introduction of e-learning.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 31, 2017</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">November 30, 2018</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of application of the preventive measures after versus before the use of an e-learning.</measure>
    <time_frame>1 day</time_frame>
    <description>Percentage of application of the preventive measures after versus before the use of an e-learning.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the application of each of the 15 preventive measureaccording to various clinical parameters</measure>
    <time_frame>1 day</time_frame>
    <description>Evaluation of the application of each of the 15 preventive measures according to the clinical parameters of the patients followed (age of the patient, physical state of the ASA, type of surgery, type of anesthesia, period of the day or of the week, surgery of Emergency or elective.)emergency or elective surgery. In each completed questionnaire, these clinical parameters are noted.)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Evaluation of the application of the preventive measures following the introduction of the e-learning in the anesthesia team.</measure>
    <time_frame>6 month and 1 year</time_frame>
    <description>The evaluation of the application of the preventive measures will be assess following the introduction of the e-learning in the anesthesia team.</description>
  </other_outcome>
  <enrollment type="Actual">100</enrollment>
  <condition>Medical Errors : Drugs Errors During Anesthesia</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Elearning</intervention_name>
    <description>Elearning</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing anesthesia in Lapeyronie Hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  patient undergoing regional and/or general anesthesia&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  only sedation&#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>BIBOULET Philippe, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University Hospital, Montpellier</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Uhmontpellier</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>July 5, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2017</study_first_posted>
  <last_update_submitted>April 17, 2019</last_update_submitted>
  <last_update_submitted_qc>April 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>medical error in anesthesia</keyword>
  <keyword>drug error in anesthesia</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>NC</ipd_description>
  </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/NCT03232853
org study id: RECHMPL17_0226
nct id: NCT03232853
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this observational study is to assess the efficiency of an e-learning in order
      to put into practice some preventive measures to avoid medication errors during anesthesia.
Before the study, the investigators selected 15 preventive measures to avoid medication
      errors during anesthesia. These measures were learned to the entire anesthesia team (nurse,
      resident and anesthesiologist) during conventional meetings. An initial evaluation of the
      application of these measures will be carried out before the introduction of e-learning. This
      assessment will be conducted by nurses without the knowledge of the anesthetic team
      evaluated. After this initial evaluation, e-learning will be broadcast on the hospital
      intranet. Then a second evaluation of the application of the preventive measures will be
      carried out 6 month and 1 year after the introduction of e-learning.
observational model: Other
time perspective: Prospective
measure: Percentage of application of the preventive measures after versus before the use of an e-learning.
time frame: 1 day
description: Percentage of application of the preventive measures after versus before the use of an e-learning.
measure: Evaluation of the application of each of the 15 preventive measureaccording to various clinical parameters
time frame: 1 day
description: Evaluation of the application of each of the 15 preventive measures according to the clinical parameters of the patients followed (age of the patient, physical state of the ASA, type of surgery, type of anesthesia, period of the day or of the week, surgery of Emergency or elective.)emergency or elective surgery. In each completed questionnaire, these clinical parameters are noted.)
measure: Evaluation of the application of the preventive measures following the introduction of the e-learning in the anesthesia team.
time frame: 6 month and 1 year
description: The evaluation of the application of the preventive measures will be assess following the introduction of the e-learning in the anesthesia team.
intervention type: Other
intervention name: Elearning
description: Elearning
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: BIBOULET Philippe, MD, PhD
role: Study Director
affiliation: University Hospital, Montpellier
facility: 
country: France
responsible party type: Sponsor
sharing ipd: Undecided
ipd description: NC