Medication Administered in ErrorIMPROVENCT02228694
The IMPROVE Study-IMPact of a Regulated ADC System
An observational study of Medication Administered in Error and Medication Compliance, run by Hackensack Meridian Health at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Medication Administered in Error, Medication Compliance
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hackensack University Medical center
Hackensack, New Jersey, 07601
About this study
Official title: 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.
Read the 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.
- Keywords
- ADC, Pre installation, Post installation, Safety, Time
- Medical subject headings
- Medication Adherence
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: six months
Secondary outcomes (1)
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.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication Administered in ErrorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hackensack Meridian Health
- Sponsor type
- University, hospital or other
- Collaborators
- Omnicell
- Responsible party
- Sponsor
- Investigators
- Claudia Douglas, DNP, Principal investigator, Hackensack Meridian Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02228694
- Sponsor's protocol ID
- Pro00004749
- Acronym
- IMPROVE
- Status last verified
- Mar 2015
- First submitted
- 8 Aug 2014
- Last updated
- 17 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMPact of a Regulated ADC System On Medication Distribution and Administration VariablEs
- ClinicalTrials.gov ID
- NCT02228694
- Acronym / sponsor ID
- IMPROVE / Pro00004749
- Keywords
- ADC, Pre installation, Post installation, Safety, Time
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Hackensack Meridian HealthUniversity, hospital or other
- Collaborators
- Omnicell
- Study start
- Sep 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 29 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
1 secondary outcome
Timeliness of medication administration
Time frame: six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia Douglas, DNP principal investigator
Hackensack Meridian Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Medication Administered in Error and Medication Compliance, run by Hackensack Meridian Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication Administered in Error (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2015.