<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/NCT02228694</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00004749</org_study_id>
    <nct_id>NCT02228694</nct_id>
  </id_info>
  <brief_title>The IMPROVE Study-IMPact of a Regulated ADC System</brief_title>
  <acronym>IMPROVE</acronym>
  <official_title>IMPact of a Regulated ADC System On Medication Distribution and Administration VariablEs</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hackensack Meridian Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Omnicell</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Hackensack Meridian Health</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      An automated dispensing cabinet (ADC) is a computerized drug storage device or cabinet&#xD;
      designed for hospitals. ADCs allow medications to be stored and dispensed near the point of&#xD;
      care while controlling and tracking drug distribution.This study seeks to obtain quantitative&#xD;
      measurements of the impact of the regulated ADC System installed in select high volume units&#xD;
      throughout the hospital.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The goal of this study is to evaluate the impact of the regulated ADC Systems on the&#xD;
      medication administration processes. HackensackUMC is specifically interested in measuring&#xD;
      the time to first dose administration from scheduled dosing times of the IV antibiotic&#xD;
      piperacillin and tazobactam for injection, USP. and we are interested in assessing a&#xD;
      reduction in time from scheduled dosage times of first dose to documented administration&#xD;
      after the implementation of the regulated ADC system compared to before.&#xD;
&#xD;
      Timely administration of antibiotics improves morbidity, mortality, and length of hospital&#xD;
      stay.Early and effective antibiotic therapy is essential in the management of infection in&#xD;
      critical illness. The loading dose is probably the most important dose and is a function of&#xD;
      the volume of distribution of the drug and the desired plasma concentration but independent&#xD;
      of renal function.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
  </study_design_info>
  <primary_outcome>
    <measure>Medication Administered in Error</measure>
    <time_frame>six months</time_frame>
    <description>Medication error rates for heparin and insulin pre-install of regulated ADC system compared to post installation. For each drug, heparin and insulin, the number of medication errors will be enumerated based on event type of the voluntary reporting event report data. For each drug, medication error rates will be calculated by dividing the number medication errors by the number of medication orders multiplied by 1,000. Comparison of medication error rates pre-install and post-install will be conducted using simple Poisson regression analysis obtained in, results of which will be expressed as incidence rate ratio (IRR) and 95% confidence intervals (CI).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Timeliness of medication administration</measure>
    <time_frame>six months</time_frame>
    <description>We are measuring timeliness of medication administration - CMS describes time-critical scheduled medications as those scheduled medications that are identified under the hospital's policies and procedures as time-critical must be administered within thirty minutes before or after their scheduled dosing time, for a total window of 1 hour. First dose IV antibiotics are time-critical. We intend to demonstrate a 10% reduction in time from scheduled dosing times to first dose for the IV piperacillin and tazobactam for injection, USP and for all dose IV antibiotcs post install of the regulated ADC System compared to pre-installation in the medical-surgical, orthopedic, and oncology units.</description>
  </secondary_outcome>
  <enrollment type="Actual">120</enrollment>
  <condition>Medication Administered in Error</condition>
  <condition>Medication Compliance</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Number of Participants by Group&#xD;
&#xD;
          -  Children (Minor Subjects): 0&#xD;
&#xD;
          -  Cognitively Impaired Participants:0&#xD;
&#xD;
          -  Employees and Students: 120&#xD;
&#xD;
          -  Patients: 25238&#xD;
&#xD;
          -  Prisoners: 0&#xD;
&#xD;
          -  Normal Healthy Volunteers: 0&#xD;
&#xD;
          -  Pregnant Women-Human Fetuses: 0&#xD;
&#xD;
          -  Wards: 0&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects treated at study site in units where regulated ADC System was installed where&#xD;
             greater number of medications is administered due to patient volume per nurse&#xD;
             assignment or where greater throughput occurs&#xD;
&#xD;
          -  Time-sensitive scheduled medications administered on units where administration&#xD;
             includes the use of the medication label printer&#xD;
&#xD;
          -  Piperacillin and tazobactam for injection, USP (United States Pharmacopeia)&#xD;
&#xD;
          -  All IV antibiotics&#xD;
&#xD;
          -  Insulin&#xD;
&#xD;
          -  Heparin&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Medication administration data prior to January 1, 2013;&#xD;
&#xD;
          -  Medication administration data after March 31, 2013 through December 31, 2013;&#xD;
&#xD;
          -  Medication administration data after March 31, 2014.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Claudia Douglas, DNP</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hackensack Meridian Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hackensack University Medical center</name>
      <address>
        <city>Hackensack</city>
        <state>New Jersey</state>
        <zip>07601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>August 8, 2014</study_first_submitted>
  <study_first_submitted_qc>August 27, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2014</study_first_posted>
  <last_update_submitted>March 16, 2015</last_update_submitted>
  <last_update_submitted_qc>March 16, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 17, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ADC</keyword>
  <keyword>Pre installation</keyword>
  <keyword>Post installation</keyword>
  <keyword>Safety</keyword>
  <keyword>Time</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/NCT02228694
org study id: Pro00004749
nct id: NCT02228694
lead sponsor: 
collaborator: 
has dmc: No
An automated dispensing cabinet (ADC) is a computerized drug storage device or cabinet
      designed for hospitals. ADCs allow medications to be stored and dispensed near the point of
      care while controlling and tracking drug distribution.This study seeks to obtain quantitative
      measurements of the impact of the regulated ADC System installed in select high volume units
      throughout the hospital.
The goal of this study is to evaluate the impact of the regulated ADC Systems on the
      medication administration processes. HackensackUMC is specifically interested in measuring
      the time to first dose administration from scheduled dosing times of the IV antibiotic
      piperacillin and tazobactam for injection, USP. and we are interested in assessing a
      reduction in time from scheduled dosage times of first dose to documented administration
      after the implementation of the regulated ADC system compared to before.

      Timely administration of antibiotics improves morbidity, mortality, and length of hospital
      stay.Early and effective antibiotic therapy is essential in the management of infection in
      critical illness. The loading dose is probably the most important dose and is a function of
      the volume of distribution of the drug and the desired plasma concentration but independent
      of renal function.
observational model: Cohort
measure: Medication Administered in Error
time frame: six months
description: Medication error rates for heparin and insulin pre-install of regulated ADC system compared to post installation. For each drug, heparin and insulin, the number of medication errors will be enumerated based on event type of the voluntary reporting event report data. For each drug, medication error rates will be calculated by dividing the number medication errors by the number of medication orders multiplied by 1,000. Comparison of medication error rates pre-install and post-install will be conducted using simple Poisson regression analysis obtained in, results of which will be expressed as incidence rate ratio (IRR) and 95% confidence intervals (CI).
measure: Timeliness of medication administration
time frame: six months
description: We are measuring timeliness of medication administration - CMS describes time-critical scheduled medications as those scheduled medications that are identified under the hospital's policies and procedures as time-critical must be administered within thirty minutes before or after their scheduled dosing time, for a total window of 1 hour. First dose IV antibiotics are time-critical. We intend to demonstrate a 10% reduction in time from scheduled dosing times to first dose for the IV piperacillin and tazobactam for injection, USP and for all dose IV antibiotcs post install of the regulated ADC System compared to pre-installation in the medical-surgical, orthopedic, and oncology units.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 22 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Claudia Douglas, DNP
role: Principal Investigator
affiliation: Hackensack Meridian Health
facility: 
country: United States
responsible party type: Sponsor