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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00382434
Other study ID # 1U18HS015818
Secondary ID RSRB #11834
Status Completed
Phase N/A
First received September 27, 2006
Last updated January 13, 2010
Start date August 2005
Est. completion date December 2006

Study information

Verified date January 2010
Source University of Rochester
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical 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 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.


Recruitment information / eligibility

Status Completed
Enrollment 10224
Est. completion date December 2006
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- investigator involved or incomplete chart

Study Design

Time Perspective: Prospective


Related Conditions & MeSH terms

  • Adverse Drug Event, Potential Adverse Drug Event, and Quality Measures
  • Drug-Related Side Effects and Adverse Reactions
  • Emergencies

Intervention

Procedure:
presence of an emergency pharmacist in the ED


Locations

Country Name City State
United States University of Rochester Medical Center Rochester New York

Sponsors (2)

Lead Sponsor Collaborator
University of Rochester Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

External Links