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.
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
- Conditions the study is for
- Adverse Drug Event, Potential Adverse Drug Event, and Quality Measures
- 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
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 group | Role | What they receive |
|---|---|---|
| EPh Present | the 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.
- First posted29 Sep 2006 (estimated)
- Study startAug 2005
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adverse Drug Event, Potential Adverse Drug Event, and Quality MeasuresStudies 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
- Time perspective
- Prospective
- Enrolment
- 10,224 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Investigators
- Rollin J Fairbanks, MD, MS, Principal investigator, University of Rochester
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
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The ED Pharmacist as a Safety Measure in Emergency Medicine
- ClinicalTrials.gov ID
- NCT00382434
- Acronym / sponsor ID
- 1U18HS015818
- Keywords
- emergency pharmacist, emergency medicine, emergency department, medical error, adverse event, pharmacist, patient safety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,224 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Aug 2005
- Study completion
- Dec 2006 (actual)
- First posted
- 29 Sep 2006 (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.
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.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EPh Present | – | Procedure: presence of an emergency pharmacist in the EDthe emergency pharmacist is present in the ED when the medical care is provided |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- emergency department patients
Key inclusion criteria (1 listed)
- pediatric (less than 19), geriatric (>64), or critically ill (all ages)
Key exclusion criteria (1 listed)
- investigator involved or incomplete chart
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| presence of an emergency pharmacist in the ED | Procedure or surgery | EPh Present |
Primary outcome
Not reported in the source record.
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 14 Jan 2010.
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.
Rollin J Fairbanks, MD, MS principal investigator
University of Rochester
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 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.