<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/NCT01734642</url>
  </required_header>
  <id_info>
    <org_study_id>31025</org_study_id>
    <nct_id>NCT01734642</nct_id>
  </id_info>
  <brief_title>Observational Study to Reduce Medication Errors</brief_title>
  <acronym>OSME</acronym>
  <official_title>A Regional Project to Reduce Adverse Drug Reactions Due to Medication Errors in Hospital</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universita di Verona</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ospedale S.Bortolo -Vicenza, Italy</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ospedale Mater Salutis-Legnago(Verona), Italy</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ospedale Fra Castoro- San Bonifacio (Verona), Italy</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Azienda Ospedaliera Universitaria Integrata Verona</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universita di Verona</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A medication error is a failure in the treatment process that leads to, or has the potential&#xD;
      to lead, to harm to the patient.1 Medication errors are a common unfortunate occurrence in&#xD;
      hospital. They can occur in different phases of the therapeutic process (prescribing,&#xD;
      distribution, administration and monitoring) and have significant impact on morbidity and&#xD;
      mortality. Prescribing faults and prescription errors are major problem among medication&#xD;
      errors .Prescription errors account for 70 % of medication errors that could potentially&#xD;
      result in adverse drug effects.2 Overall it has been estimated prescription errors affect 7 %&#xD;
      of medication orders, 2% of patient days and 50 % of hospital admissions.3,4 When harm arises&#xD;
      from a medication error it is potentially preventable. The medication errors project was&#xD;
      devised to analyze and limit through educational audit and other tools, as much as possible,&#xD;
      damages due to the therapeutic process. The project will include 5 phases. Preliminary phase:&#xD;
      organizational meetings. Phase I: Patient monitoring: a monitor in collaboration with health&#xD;
      professionals of involved units will review all patient charts and will register all adverse&#xD;
      drug reactions(ADRs). All ADRs will be introduced by the monitor in a database. Health&#xD;
      professional will be invited to send the reports of observed ADRs. Evaluation of ADRs : a&#xD;
      panel of experts will evaluate if the ADRs are due to medication errors or not. Phase II&#xD;
      :educational audits directed to health professionals will be organized. Tools to reduce the&#xD;
      medication errors will be proposed. Phase III: the same procedure of the first phase. Final&#xD;
      phase (IV): analysis of data with publication of a scientific article.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2013</start_date>
  <completion_date type="Anticipated">December 2013</completion_date>
  <primary_completion_date type="Anticipated">November 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with adverse drug reactions due to medication errors occurring during hospitalization</measure>
    <time_frame>within the first 3 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with preventable ADRs due to medication errors</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>the impact of educational audit will be evaluated</measure>
    <time_frame>during the final phase</time_frame>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">8000</enrollment>
  <condition>Medication Errors</condition>
  <arm_group>
    <arm_group_label>PATIENT HOSPITALIZED</arm_group_label>
    <description>ALL THE PATIENTS HOSPITALIZED IN THE INVOLVED UNITS WHO GAVE THEIR INFORMED CONSENT. PATIENTS HOSPITALIZED DURING THE WEEK-END WILL BE ENROLLED ON the next MONDAY</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        All patients from 18 to 65 and over 65 years old hospitalized in the involved departments&#xD;
        during the study period.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  all patients hospitalized in the involved units who gave their informed consent.&#xD;
             Patients hospitalized during the week-end will be enrolled on the next monday.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  all patients with evident mental and physical problems and all patients who did not&#xD;
             give their informed consent.&#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>Giampaolo Velo, Medicine and Surgery</last_name>
    <role>Study Director</role>
    <affiliation>The University of Verona, Verona , Italy</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lara Magro, Chemistry and pharm. technol.</last_name>
    <phone>0039 045/8027147</phone>
    <email>lara.magro@univr.it</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ermelinda Viola, Chemistry and pharm. technol.</last_name>
    <phone>0039 045/8124904</phone>
    <email>ermelinda.viola@univr.it</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Mater Salutis Hospital</name>
      <address>
        <city>Legnago</city>
        <state>Verona</state>
        <zip>37045</zip>
        <country>Italy</country>
      </address>
    </facility>
    <contact>
      <last_name>Giampaolo Velo, medicine</last_name>
      <phone>0039 045/8127450</phone>
      <email>giampaolo.velo@univr.it</email>
    </contact>
    <contact_backup>
      <last_name>Lara Magro, pharmacy</last_name>
      <phone>0039 045/8027147</phone>
      <email>lara.magro@univr.it</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Fracastoro Hospital</name>
      <address>
        <city>San Bonifacio</city>
        <state>Verona</state>
        <zip>37047</zip>
        <country>Italy</country>
      </address>
    </facility>
    <contact>
      <last_name>Giampaolo Velo, Medicine</last_name>
      <phone>0039 045/8127450</phone>
      <email>giampaolo.velo@univr.it</email>
    </contact>
    <contact_backup>
      <last_name>Ermelinda Viola, pharmacy</last_name>
      <phone>0039 045/8124904</phone>
      <email>ermelinda.viola@univr.it</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>University Hospital of Verona (AOUI), Verona, Italy</name>
      <address>
        <city>Verona</city>
        <zip>37100</zip>
        <country>Italy</country>
      </address>
    </facility>
    <contact>
      <last_name>Giampaolo Velo, Medicine</last_name>
      <phone>0039 045/8127450</phone>
      <email>giampaolo.velo@univr.it</email>
    </contact>
    <contact_backup>
      <last_name>Lara Magro, pharmacy</last_name>
      <phone>0039 045/8027147</phone>
      <email>lara.magro@univr.it</email>
    </contact_backup>
    <investigator>
      <last_name>Giampaolo Velo, Medicine</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>San Bortolo Hospital</name>
      <address>
        <city>Vicenza</city>
        <zip>36100</zip>
        <country>Italy</country>
      </address>
    </facility>
    <contact>
      <last_name>Giampaolo Velo, Medicine</last_name>
      <phone>0039 045/8127450</phone>
      <email>giampaolo.velo@univr.it</email>
    </contact>
    <contact_backup>
      <last_name>Ermelinda Viola, Pharmacy</last_name>
      <phone>0039 045/8124904</phone>
      <email>ermelinda.viola@univr.it</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <reference>
    <citation>Aronson JK. Medication errors: definitions and classification. Br J Clin Pharmacol. 2009 Jun;67(6):599-604. doi: 10.1111/j.1365-2125.2009.03415.x.</citation>
    <PMID>19594526</PMID>
  </reference>
  <reference>
    <citation>Velo GP, Minuz P. Medication errors: prescribing faults and prescription errors. Br J Clin Pharmacol. 2009 Jun;67(6):624-8. doi: 10.1111/j.1365-2125.2009.03425.x.</citation>
    <PMID>19594530</PMID>
  </reference>
  <reference>
    <citation>Bates DW, Teich JM, Lee J, Seger D, Kuperman GJ, Ma'Luf N, Boyle D, Leape L. The impact of computerized physician order entry on medication error prevention. J Am Med Inform Assoc. 1999 Jul-Aug;6(4):313-21. doi: 10.1136/jamia.1999.00660313.</citation>
    <PMID>10428004</PMID>
  </reference>
  <reference>
    <citation>Lewis PJ, Dornan T, Taylor D, Tully MP, Wass V, Ashcroft DM. Prevalence, incidence and nature of prescribing errors in hospital inpatients: a systematic review. Drug Saf. 2009;32(5):379-89. doi: 10.2165/00002018-200932050-00002.</citation>
    <PMID>19419233</PMID>
  </reference>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 21, 2012</study_first_submitted>
  <study_first_submitted_qc>November 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 27, 2012</study_first_posted>
  <last_update_submitted>November 28, 2012</last_update_submitted>
  <last_update_submitted_qc>November 28, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 29, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universita di Verona</investigator_affiliation>
    <investigator_full_name>GIAMPAOLO VELO</investigator_full_name>
    <investigator_title>Prof. of Pharmacology and Director of the Clinical Pharmacology Unit, Verona, Italy</investigator_title>
  </responsible_party>
  <keyword>Medication errors, patients hospitalized, ADRs, adverse events</keyword>
  <pending_results>
    <submitted>February 21, 2019</submitted>
    <returned>May 17, 2019</returned>
  </pending_results>
  <!-- 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/NCT01734642
org study id: 31025
nct id: NCT01734642
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
A medication error is a failure in the treatment process that leads to, or has the potential
      to lead, to harm to the patient.1 Medication errors are a common unfortunate occurrence in
      hospital. They can occur in different phases of the therapeutic process (prescribing,
      distribution, administration and monitoring) and have significant impact on morbidity and
      mortality. Prescribing faults and prescription errors are major problem among medication
      errors .Prescription errors account for 70 % of medication errors that could potentially
      result in adverse drug effects.2 Overall it has been estimated prescription errors affect 7 %
      of medication orders, 2% of patient days and 50 % of hospital admissions.3,4 When harm arises
      from a medication error it is potentially preventable. The medication errors project was
      devised to analyze and limit through educational audit and other tools, as much as possible,
      damages due to the therapeutic process. The project will include 5 phases. Preliminary phase:
      organizational meetings. Phase I: Patient monitoring: a monitor in collaboration with health
      professionals of involved units will review all patient charts and will register all adverse
      drug reactions(ADRs). All ADRs will be introduced by the monitor in a database. Health
      professional will be invited to send the reports of observed ADRs. Evaluation of ADRs : a
      panel of experts will evaluate if the ADRs are due to medication errors or not. Phase II
      :educational audits directed to health professionals will be organized. Tools to reduce the
      medication errors will be proposed. Phase III: the same procedure of the first phase. Final
      phase (IV): analysis of data with publication of a scientific article.
observational model: Cohort
time perspective: Prospective
measure: Number of participants with adverse drug reactions due to medication errors occurring during hospitalization
time frame: within the first 3 months
measure: Number of participants with preventable ADRs due to medication errors
time frame: 3 months
measure: the impact of educational audit will be evaluated
time frame: during the final phase
arm group label: PATIENT HOSPITALIZED
description: ALL THE PATIENTS HOSPITALIZED IN THE INVOLVED UNITS WHO GAVE THEIR INFORMED CONSENT. PATIENTS HOSPITALIZED DURING THE WEEK-END WILL BE ENROLLED ON the next MONDAY
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Giampaolo Velo, Medicine and Surgery
role: Study Director
affiliation: The University of Verona, Verona , Italy
last name: Lara Magro, Chemistry and pharm. technol.
phone: 0039 045/8027147
email: lara.magro@univr.it
last name: Ermelinda Viola, Chemistry and pharm. technol.
phone: 0039 045/8124904
email: ermelinda.viola@univr.it
facility: 
contact: 
contact backup: 
facility: 
contact: 
contact backup: 
facility: 
contact: 
contact backup: 
investigator: 
facility: 
contact: 
contact backup: 
country: Italy
citation: Aronson JK. Medication errors: definitions and classification. Br J Clin Pharmacol. 2009 Jun;67(6):599-604. doi: 10.1111/j.1365-2125.2009.03415.x.
PMID: 19594526
citation: Velo GP, Minuz P. Medication errors: prescribing faults and prescription errors. Br J Clin Pharmacol. 2009 Jun;67(6):624-8. doi: 10.1111/j.1365-2125.2009.03425.x.
PMID: 19594530
citation: Bates DW, Teich JM, Lee J, Seger D, Kuperman GJ, Ma'Luf N, Boyle D, Leape L. The impact of computerized physician order entry on medication error prevention. J Am Med Inform Assoc. 1999 Jul-Aug;6(4):313-21. doi: 10.1136/jamia.1999.00660313.
PMID: 10428004
citation: Lewis PJ, Dornan T, Taylor D, Tully MP, Wass V, Ashcroft DM. Prevalence, incidence and nature of prescribing errors in hospital inpatients: a systematic review. Drug Saf. 2009;32(5):379-89. doi: 10.2165/00002018-200932050-00002.
PMID: 19419233
responsible party type: Principal Investigator
investigator affiliation: Universita di Verona
investigator full name: GIAMPAOLO VELO
investigator title: Prof. of Pharmacology and Director of the Clinical Pharmacology Unit, Verona, Italy
submitted: February 21, 2019
returned: May 17, 2019