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The IMPROVE Study-IMPact of a Regulated ADC System (IMPROVE)

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ClinicalTrials.gov Identifier: NCT02228694
Recruitment Status : Completed
First Posted : August 29, 2014
Last Update Posted : March 17, 2015
Sponsor:
Collaborator:
Omnicell
Information provided by (Responsible Party):
Hackensack Meridian Health

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
Medication Administered in Error Medication Compliance

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.


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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 : September 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Number of Participants by Group

  • Children (Minor Subjects): 0
  • Cognitively Impaired Participants:0
  • Employees and Students: 120
  • Patients: 25238
  • Prisoners: 0
  • Normal Healthy Volunteers: 0
  • Pregnant Women-Human Fetuses: 0
  • Wards: 0
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02228694


Locations
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United States, New Jersey
Hackensack University Medical center
Hackensack, New Jersey, United States, 07601
Sponsors and Collaborators
Hackensack Meridian Health
Omnicell
Investigators
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Principal Investigator: Claudia Douglas, DNP Hackensack Meridian Health

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Responsible Party: Hackensack Meridian Health
ClinicalTrials.gov Identifier: NCT02228694     History of Changes
Other Study ID Numbers: Pro00004749
First Posted: August 29, 2014    Key Record Dates
Last Update Posted: March 17, 2015
Last Verified: March 2015
Keywords provided by Hackensack Meridian Health:
ADC
Pre installation
Post installation
Safety
Time