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Adverse Drug Event, Potential Adverse Drug Event, and Quality MeasuresNCT00382434

Emergency Pharmacist Safety Study

An observational study of Adverse Drug Event, Potential Adverse Drug Event, and Quality Measures, run by University of Rochester at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The Emergency Department (ED) is a unique environment in medicine, and many safety mechanisms used in other hospital settings cannot be applied in the ED. For example, clinical pharmacists have traditionally provided extra layers of protection to hospital inpatients by cross-checking provider orders for appropriate… Read more about this study

Who is it for?
Any age
What is being tested?
presence of an emergency pharmacist in the ED
Type of treatment
Surgery or procedure
How many people
10,224 participants
Where
1 siteUnited States
Study dates
Aug 2005to Dec 2006
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 Any age
  • All sexes
  • Child, Adult, Older adult

Study population: emergency department patients

Who may be able to join

  • pediatric (less than 19), geriatric (>64), or critically ill (all ages)

Who cannot join

  • investigator involved or incomplete chart

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Rochester Medical Center

    Rochester, New York, 14642

Other trials in United States

About this study

Official title: The ED Pharmacist as a Safety Measure in Emergency Medicine

The Emergency Department (ED) is a unique environment in medicine, and many safety mechanisms used in other hospital settings cannot be applied in the ED. For example, clinical pharmacists have traditionally provided extra layers of protection to hospital inpatients by cross-checking provider orders for appropriate dosing, contraindications, and interactions. Because medications in the ED must be accessed immediately and are often one-time doses, the use of central pharmacy services would introduce an unacceptable delay to the administration of medication. Although some hospitals have programs in place in which a pharmacist responds to the ED for cardiac arrests or trauma team activations, few have reported programs which involve a clinical pharmacist assigned exclusively to the emergency department. Nonetheless, published reports have asserted that ED-based pharmacists can increase patient safety. Although this concept appears logical, no study has attempted to show that these programs reduce potential adverse drug events in the ED. We propose to implement and optimize an ED Pharmacist (EDP) program as a safe practice intervention in a large ED. The hospital has provided funding for two permanent full time positions starting at the beginning of the award period. In the initial phase interviews of physicians, nurses, pharmacists, and patients will be conducted and the results will be used to optimize the EDP role. A large-scale chart review study will then be conducted to evaluate whether there is a reduction in frequency of potential and adverse drug events during times that the EDP is on duty. Staff perceptions of the effectiveness of this program will also be evaluated. The overall goal of this initiative is to create an effective EDP program that will decrease the rate of adverse drug events in ED patients, and to create a "toolkit" to facilitate the introduction of similar programs into other EDs. This toolkit will include a description of the formal, optimized role of the EDP, challenges and solutions in implementation, and evidence to support the efficacy of such a program.

Being tested
presence of an emergency pharmacist in the ED
Keywords
emergency pharmacist, emergency medicine, emergency department, medical error, adverse event, pharmacist, patient safety
Medical subject headings
Drug-Related Side Effects and Adverse Reactions, Emergencies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • presence of an emergency pharmacist in the EDProcedure or surgery

Study groups in NCT00382434
Study groupRoleWhat they receive
EPh Presentthe emergency pharmacist is present in the ED when the medical care is provided
Receives: Procedure: presence of an emergency pharmacist in the ED

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2006 (estimated)
  2. Study startAug 2005
  3. Study completionDec 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Time perspective
Prospective
Enrolment
10,224 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00382434
Sponsor's protocol ID
1U18HS015818
Other IDs
RSRB #11834
Status last verified
Jan 2010
First submitted
27 Sep 2006
Last updated
14 Jan 2010
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Adverse Drug Event, Potential Adverse Drug Event, and Quality Measures, run by University of Rochester 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 1 inclusion and 1 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 14 Jan 2010. 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.

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 14 Jan 2010.

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