Emergency Pharmacist Safety Study
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | September 27, 2006 | ||||
| Last Updated Date | January 13, 2010 | ||||
| Start Date ICMJE | August 2005 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00382434 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Emergency Pharmacist Safety Study | ||||
| Official Title ICMJE | The ED Pharmacist as a Safety Measure in Emergency Medicine | ||||
| Brief 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. |
||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Time Perspective: Prospective | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | emergency department patients |
||||
| Condition ICMJE | Adverse Drug Event, Potential Adverse Drug Event, and Quality Measures | ||||
| Intervention ICMJE | Procedure: presence of an emergency pharmacist in the ED | ||||
| Study Group/Cohort (s) | EPh Present
the emergency pharmacist is present in the ED when the medical care is provided
Intervention: Procedure: presence of an emergency pharmacist in the ED |
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 10224 | ||||
| Completion Date | December 2006 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | Not Provided | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00382434 | ||||
| Other Study ID Numbers ICMJE | 1U18HS015818, RSRB #11834 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | University of Rochester | ||||
| Collaborators ICMJE | Agency for Healthcare Research and Quality (AHRQ) | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | University of Rochester | ||||
| Verification Date | January 2010 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||