<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/NCT03036449</url>
  </required_header>
  <id_info>
    <org_study_id>CHUBX 2014/38</org_study_id>
    <nct_id>NCT03036449</nct_id>
  </id_info>
  <brief_title>Efficacy of a Multifaceted Intervention to Reduce Medication Administration Errors in Neonatal Intensive Care Units</brief_title>
  <acronym>OREANE</acronym>
  <official_title>Efficacy of Tools Associated With a Multifaceted Education Intervention Directed to Health Professionals to Reduce Medication Preparation and Administration Error Rates in Neonatal Intensive Care Units</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Bordeaux</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Bordeaux</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether an educational program for caregivers&#xD;
      associated with convenient tools is effective to reduce medication preparation and&#xD;
      administration errors in the Neonatal Intensive Care Units (NICU).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Medication errors are frequent in neonatal intensive care units and consequences are more&#xD;
      severe than in adults. Although errors happen in each step of medication management process,&#xD;
      a large proportion of errors occur during medication preparation and administration.&#xD;
&#xD;
      This study will test the hypothesis that rates of medication errors during preparation and&#xD;
      administration will be reduced by implementing an education program for NICU caregivers&#xD;
      (Nurses) and providing convenient tools.&#xD;
&#xD;
      The trial has a stepped wedge design, in which the NICU's from three hospitals in France will&#xD;
      be randomized (Group A, B and C) to the timing of implementation of the educational&#xD;
      intervention.&#xD;
&#xD;
      According to the allocation (Group A, B or C), the education intervention will include a&#xD;
      complete main program of nine weeks and one to three maintenance educational periods.&#xD;
&#xD;
      Medication administration errors rates will be measured before (baseline measurements) and&#xD;
      after each educational interventions (main or maintenance interventions).&#xD;
&#xD;
      Errors will be identified by direct observations of nurse's acts by external observers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 13, 2017</start_date>
  <completion_date type="Actual">March 17, 2019</completion_date>
  <primary_completion_date type="Actual">March 17, 2019</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>Medication administration error rates in the patients</measure>
    <time_frame>Baseline and up to 49 weeks</time_frame>
    <description>Assessment of the efficacy of the intervention on reducing the rates of medication administration errors.&#xD;
Error rate: Number of identified errors/Number of observed acts of administration*100, measured by direct observation of nurse's acts by specifically trained external observers.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Levels of safety culture among the caregivers (Nurses)</measure>
    <time_frame>Baseline and up to 49 weeks</time_frame>
    <description>Assessment of the effectiveness of the educational intervention on increasing safety culture measured using Hospital Survey on patient safety.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Levels of medication errors reported by caregivers.</measure>
    <time_frame>Baseline and up to 49 weeks</time_frame>
    <description>Assessment of the efficacy of the educational intervention to increase voluntary reporting of medication errors by caregivers.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acceptance of the educational program</measure>
    <time_frame>Baseline and up to 49 weeks</time_frame>
    <description>Assessment of acceptance by satisfaction questionnaire</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">5143</enrollment>
  <condition>Neonatal Intensive Care</condition>
  <arm_group>
    <arm_group_label>A</arm_group_label>
    <description>Group A: Phase 1: Observations (Baseline rate of errors); Phase 2: Main Educational program; Phase 3: Observations; Phase 4: Maintenance Educational program; Phase 5: Observations; Phase 6: Maintenance Educational program; Phase 7: Observations; Phase 8: Maintenance Educational program; Phase 9: Observations.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B</arm_group_label>
    <description>Group B: Phase 1: Observations (Baseline rate of errors); Phase 2: No intervention; Phase 3: Observations (Baseline rate of errors); Phase 4: Main Educational program; Phase 5: Observations; Phase 6: Maintenance Educational program; Phase 7: Observations; Phase 8: Maintenance Educational program; Phase 9: Observations.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>C</arm_group_label>
    <description>Group C: Phase 1: Observations (Baseline rate of errors); Phase 2: No intervention; Phase 3: Observations (Baseline rate of errors); Phase 4: No intervention; Phase 5: Observations (Baseline rate of errors); Phase 6: Main educational program; Phase 7: Observations; Phase 8: Maintenance educational program; Phase 9: Observations.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Education program for NICU caregivers.</intervention_name>
    <description>Intervention includes a main initial educational program, maintenance education programs and tools supply&#xD;
- Main educational program will include 9 hours of courses into NICU (1 hour each week) and @ learning modules validation.&#xD;
Topics: Main causes of medication errors, How to analyse retrospectively medication errors, Strategies to reduce medication errors, How to improve communication between health professional; Task interruption; Standardisation of preparation…..&#xD;
Maintenance education program will return on specific topics of main program and will be fitted to each NICU needs.&#xD;
Examples of Tools: check lists, medication neonatal formulary, &quot;Sound alike&quot; and &quot;Look alike&quot; drug lists…</description>
    <arm_group_label>A</arm_group_label>
    <arm_group_label>B</arm_group_label>
    <arm_group_label>C</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients less than 2 years old, hospitalized in the intensive care during the observation&#xD;
        periods and receiving drugs.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All nurses working in the intensive care units in the day time.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Nurses working as a float or pool nurses.&#xD;
&#xD;
          -  Nurses working at night.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>2 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Service de pédiatrie - Hôpital Pellegrin</name>
      <address>
        <city>Bordeaux</city>
        <zip>33000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Côte de Nacre</name>
      <address>
        <city>Caen</city>
        <zip>14033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Rouen</name>
      <address>
        <city>Rouen</city>
        <zip>76031</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>December 23, 2016</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 30, 2017</study_first_posted>
  <last_update_submitted>May 12, 2020</last_update_submitted>
  <last_update_submitted_qc>May 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Medication errors</keyword>
  <keyword>Patient safety</keyword>
  <!-- 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/NCT03036449
org study id: CHUBX 2014/38
nct id: NCT03036449
lead sponsor: 
has dmc: No
The purpose of this study is to determine whether an educational program for caregivers
      associated with convenient tools is effective to reduce medication preparation and
      administration errors in the Neonatal Intensive Care Units (NICU).
Medication errors are frequent in neonatal intensive care units and consequences are more
      severe than in adults. Although errors happen in each step of medication management process,
      a large proportion of errors occur during medication preparation and administration.

      This study will test the hypothesis that rates of medication errors during preparation and
      administration will be reduced by implementing an education program for NICU caregivers
      (Nurses) and providing convenient tools.

      The trial has a stepped wedge design, in which the NICU's from three hospitals in France will
      be randomized (Group A, B and C) to the timing of implementation of the educational
      intervention.

      According to the allocation (Group A, B or C), the education intervention will include a
      complete main program of nine weeks and one to three maintenance educational periods.

      Medication administration errors rates will be measured before (baseline measurements) and
      after each educational interventions (main or maintenance interventions).

      Errors will be identified by direct observations of nurse's acts by external observers.
observational model: Cohort
time perspective: Prospective
measure: Medication administration error rates in the patients
time frame: Baseline and up to 49 weeks
description: Assessment of the efficacy of the intervention on reducing the rates of medication administration errors.
Error rate: Number of identified errors/Number of observed acts of administration*100, measured by direct observation of nurse's acts by specifically trained external observers.
measure: Levels of safety culture among the caregivers (Nurses)
time frame: Baseline and up to 49 weeks
description: Assessment of the effectiveness of the educational intervention on increasing safety culture measured using Hospital Survey on patient safety.
measure: Levels of medication errors reported by caregivers.
time frame: Baseline and up to 49 weeks
description: Assessment of the efficacy of the educational intervention to increase voluntary reporting of medication errors by caregivers.
measure: Acceptance of the educational program
time frame: Baseline and up to 49 weeks
description: Assessment of acceptance by satisfaction questionnaire
arm group label: A
description: Group A: Phase 1: Observations (Baseline rate of errors); Phase 2: Main Educational program; Phase 3: Observations; Phase 4: Maintenance Educational program; Phase 5: Observations; Phase 6: Maintenance Educational program; Phase 7: Observations; Phase 8: Maintenance Educational program; Phase 9: Observations.
arm group label: B
description: Group B: Phase 1: Observations (Baseline rate of errors); Phase 2: No intervention; Phase 3: Observations (Baseline rate of errors); Phase 4: Main Educational program; Phase 5: Observations; Phase 6: Maintenance Educational program; Phase 7: Observations; Phase 8: Maintenance Educational program; Phase 9: Observations.
arm group label: C
description: Group C: Phase 1: Observations (Baseline rate of errors); Phase 2: No intervention; Phase 3: Observations (Baseline rate of errors); Phase 4: No intervention; Phase 5: Observations (Baseline rate of errors); Phase 6: Main educational program; Phase 7: Observations; Phase 8: Maintenance educational program; Phase 9: Observations.
intervention type: Behavioral
intervention name: Education program for NICU caregivers.
description: Intervention includes a main initial educational program, maintenance education programs and tools supply
- Main educational program will include 9 hours of courses into NICU (1 hour each week) and @ learning modules validation.
Topics: Main causes of medication errors, How to analyse retrospectively medication errors, Strategies to reduce medication errors, How to improve communication between health professional; Task interruption; Standardisation of preparation…..
Maintenance education program will return on specific topics of main program and will be fitted to each NICU needs.
Examples of Tools: check lists, medication neonatal formulary, "Sound alike" and "Look alike" drug lists…
arm group label: A
arm group label: B
arm group label: C
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 2 Years
healthy volunteers: No
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor