The IMPROVE Study-IMPact of a Regulated ADC System

Medication Compliance Clinical Trial

— IMPROVE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02228694
• Other study ID #: Pro00004749
• Status: Completed
• Phase: N/A
• First received: August 8, 2014
• Last updated: March 16, 2015
• Start date: September 2014
• Est. completion date: December 2014

Study information

• Verified date: March 2015
• Source: Hackensack University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 22 Years and older

Eligibility

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 Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Medication Administered in Error
• Medication Compliance

Locations

Country	Name	City	State
United States	Hackensack University Medical center	Hackensack	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Hackensack University Medical Center	Omnicell

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes