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The IMPROVE Study-IMPact of a Regulated ADC System

Sponsor
Hackensack Meridian Health (Other)
Overall Status
Completed
CT.gov ID
NCT02228694
Collaborator
Omnicell (Industry)
120
Enrollment
1
Location
3
Duration (Months)
40.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    120 participants
    Observational Model:
    Cohort
    Official Title:
    IMPact of a Regulated ADC System On Medication Distribution and Administration VariablEs
    Study Start Date :
    Sep 1, 2014
    Actual Primary Completion Date :
    Dec 1, 2014
    Actual Study Completion Date :
    Dec 1, 2014

    Outcome Measures

    Primary Outcome Measures

    1. Medication Administered in Error [six months]

      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).

    Secondary Outcome Measures

    1. Timeliness of medication administration [six months]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    22 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Subjects treated at study site in units where regulated ADC System was installed where greater number of medications is administered due to patient volume per nurse assignment or where greater throughput occurs

    • Time-sensitive scheduled medications administered on units where administration includes the use of the medication label printer

    • Piperacillin and tazobactam for injection, USP (United States Pharmacopeia)

    • All IV antibiotics

    • Insulin

    • Heparin

    Exclusion Criteria:

    • Medication administration data prior to January 1, 2013;

    • Medication administration data after March 31, 2013 through December 31, 2013;

    • Medication administration data after March 31, 2014.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hackensack University Medical center Hackensack New Jersey United States 07601

    Sponsors and Collaborators

    • Hackensack Meridian Health
    • Omnicell

    Investigators

    • Principal Investigator: Claudia Douglas, DNP, Hackensack Meridian Health

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hackensack Meridian Health
    ClinicalTrials.gov Identifier:
    NCT02228694
    Other Study ID Numbers:
    • Pro00004749
    First Posted:
    Aug 29, 2014
    Last Update Posted:
    Mar 17, 2015
    Last Verified:
    Mar 1, 2015
    Keywords provided by Hackensack Meridian Health
    ADC
    Pre installation
    Post installation
    Safety
    Time

    Study Results

    No Results Posted as of Mar 17, 2015