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Completed

NCT Number: NCT02228694

The IMPROVE Study-IMPact of a Regulated ADC System

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.

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Key information

Age range

22 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hackensack University Medical center

Hackensack, New Jersey, 07601, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Medication Administered in Error

    Time frame: 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 outcomes

  1. Timeliness of medication administration

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hackensack Meridian Health

Other

Collaborators

  • Omnicell

Registry information

Official study title

IMPact of a Regulated ADC System On Medication Distribution and Administration VariablEs

Acronym: IMPROVE

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Aug 29, 2014
Registry last updated
Mar 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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