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

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

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.

Study Overview

• Status: Completed
• Conditions: Medication Compliance; Medication Administered in Error

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 Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Hackensack University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication Administered in Error	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).	six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Timeliness of medication administration	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.	six months

Collaborators and Investigators

• Sponsor: Hackensack Meridian Health
• Collaborators: Omnicell
• Investigators: Principal Investigator: Claudia Douglas, DNP, Hackensack Meridian Health

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: August 8, 2014
• First Submitted That Met QC Criteria: August 27, 2014
• First Posted (Estimate): August 29, 2014

Study Record Updates

• Last Update Posted (Estimate): March 17, 2015
• Last Update Submitted That Met QC Criteria: March 16, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Safety; Time; ADC; Pre installation; Post installation
• Other Study ID Numbers: Pro00004749