<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/NCT02223676</url>
  </required_header>
  <id_info>
    <org_study_id>1-16-02-379-13</org_study_id>
    <nct_id>NCT02223676</nct_id>
  </id_info>
  <brief_title>Clinical Pharmacists in the Emergency Department</brief_title>
  <official_title>Is Length of Stay in the Emergency Department Reduced When Clinical Pharmacists Conduct Medication History? - a Cluster Randomized Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Randers Regional Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Aarhus University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Randers Regional Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the effect of implementing clinical pharmacists&#xD;
      in the Emergency Department Team at Randers Regional Hospital. The clinical pharmacists&#xD;
      conduct medication history, make medical interaction screenings, -reconciliations and&#xD;
      -reviews on unscheduled patients admitted to the Emergency Department during daytime.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2013</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">June 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Emergency Department Length of stay</measure>
    <time_frame>From arrival to the Emergency Department to either admission or discharge, which in average will be 6 hours.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time from patient arrival to the treatment schedule is ready</measure>
    <time_frame>From arrival to the Emergency Department to either admission or discharge, which in average will be 6 hours.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient safety</measure>
    <time_frame>From arrival to the Emergency Department to either admission or discharge, which in average will be 6 hours.</time_frame>
    <description>Number of recommended changes in drugs or dosage per patient. The changes are rated according to a PCNE-classification for drug-related problems.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>The impact of the intervention in the Emergency Department on the existing medication review by clinical pharmacist at the acute ward</measure>
    <time_frame>1-3 days after admission to Emergency Department when the secondary medication review takes place</time_frame>
    <description>We estimate whether the intervention is time-saving (by recording and comparing time spent for secondary/excisting medication review at the acute ward between patients allocated to the intervention and control group, respectively) and reduce the workload of the clinicians (number and kind of interventions at secondary medication review in the two groups)</description>
  </other_outcome>
  <other_outcome>
    <measure>The impact of the intervention in the Emergency Department on the dispensing of medicine (done by nurses)</measure>
    <time_frame>During actual admission to the Emergency Department and the period after inclusion of patients</time_frame>
    <description>time used and the possibility of substitutions</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">448</enrollment>
  <condition>Medication Reconciliation</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Clinical pharmacists conduct medication history</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>standard procedures for admission is followed</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Clinical pharmacists conduct medication history</intervention_name>
    <description>pharmacists conduct medication history before the physician interviews the patient and does not spend time on conducting medical history</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  unscheduled patients admitted to the Emergency Department at Randers Regional Hospital&#xD;
             at weekdays during daytime (9 am to 16.15 pm)&#xD;
&#xD;
          -  4 or more drugs prescribed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients triage red&#xD;
&#xD;
          -  patients who cannot give informed consent&#xD;
&#xD;
          -  terminal patients&#xD;
&#xD;
          -  patients admitted to detoxification&#xD;
&#xD;
          -  patients refered to the acute outpatient department&#xD;
&#xD;
          -  patients remaining in the Emergency Department overnight&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Randers Regional Hospital</name>
      <address>
        <city>Randers</city>
        <state>Region Midt</state>
        <zip>8900</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>January 7, 2014</study_first_submitted>
  <study_first_submitted_qc>August 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2014</study_first_posted>
  <last_update_submitted>May 17, 2018</last_update_submitted>
  <last_update_submitted_qc>May 17, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 21, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pharmacy</keyword>
  <keyword>Length-of-stay</keyword>
  <keyword>Emergency Department</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Emergencies</mesh_term>
  </condition_browse>
  <!-- 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/NCT02223676
org study id: 1-16-02-379-13
nct id: NCT02223676
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to investigate the effect of implementing clinical pharmacists
      in the Emergency Department Team at Randers Regional Hospital. The clinical pharmacists
      conduct medication history, make medical interaction screenings, -reconciliations and
      -reviews on unscheduled patients admitted to the Emergency Department during daytime.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Emergency Department Length of stay
time frame: From arrival to the Emergency Department to either admission or discharge, which in average will be 6 hours.
measure: Time from patient arrival to the treatment schedule is ready
time frame: From arrival to the Emergency Department to either admission or discharge, which in average will be 6 hours.
measure: Patient safety
time frame: From arrival to the Emergency Department to either admission or discharge, which in average will be 6 hours.
description: Number of recommended changes in drugs or dosage per patient. The changes are rated according to a PCNE-classification for drug-related problems.
measure: The impact of the intervention in the Emergency Department on the existing medication review by clinical pharmacist at the acute ward
time frame: 1-3 days after admission to Emergency Department when the secondary medication review takes place
description: We estimate whether the intervention is time-saving (by recording and comparing time spent for secondary/excisting medication review at the acute ward between patients allocated to the intervention and control group, respectively) and reduce the workload of the clinicians (number and kind of interventions at secondary medication review in the two groups)
measure: The impact of the intervention in the Emergency Department on the dispensing of medicine (done by nurses)
time frame: During actual admission to the Emergency Department and the period after inclusion of patients
description: time used and the possibility of substitutions
arm group label: Intervention
arm group type: Experimental
description: Clinical pharmacists conduct medication history
arm group label: Control
arm group type: No Intervention
description: standard procedures for admission is followed
intervention type: Procedure
intervention name: Clinical pharmacists conduct medication history
description: pharmacists conduct medication history before the physician interviews the patient and does not spend time on conducting medical history
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Denmark
responsible party type: Sponsor
mesh term: Emergencies