Medication ErrorsNCT00256568
Outpatient Prescription Errors: Detection, Analysis, and Impact on Safety
An observational study of Medication Errors, run by University of Vermont at 1 site in United States.
Trial summary
The purpose of this study is to better understand outpatient prescribing errors through clinic and pharmacy-based error reporting systems. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Medication Errors
- What is being tested?
- reporting system
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 103 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2003to Aug 2008
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Primary Care Practices
Who may be able to join
- Employed in a physician's office or community pharmacy
Who cannot join
- Not employed in a physician's office or community pharmacy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Vermont, Division of General Internal Medicine
Burlington, Vermont, 05401
About this study
The purpose of this study is to better understand outpatient prescribing errors through clinic and pharmacy-based error reporting systems.
Read the detailed description
Medication errors cause substantial morbidity and mortality in the United States. However, relatively little is known about medication errors in the outpatient setting. The broad goal of this proposal is to improve outpatient safety. Specifically, this research plan promotes the understanding of the causes of outpatient prescription errors. The specific aims of this project are:
- To develop and evaluate a novel reporting system in physicians' offices for detecting prescription errors
- To develop and evaluate a novel improvement system in community pharmacies to increase prescription error reporting by pharmacists
- To analyze reports of outpatient prescription errors and understand their root causes
To achieve these specific aims, statewide research will be conducted utilizing qualitative and quantitative methods including root cause analysis, failure mode and effects analysis, and surveys. This research plan will promote patient safety by furthering the understanding of the causes of outpatient prescription errors in all outpatient populations, including rural, women, children, elderly, low income, and the chronically ill.
- Conditions
- Medication Errors
- Being tested
- reporting system
- Keywords
- Medical Errors, Medication Errors, Prescriptions, Drug, Pharmacies, Ambulatory Care Facilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reporting systemBehavioural
Nurses and office staff were asked to report all communications with community pharmacists regarding prescription problems
| Study group | Role | What they receive |
|---|---|---|
| Primary Care Practices | One hundred and three prescribers, managers, nurses and office staff at seven primary care practices in Vermont Receives: Behavioral: reporting system |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2005 (estimated)
- Study startSep 2003
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Medication ErrorsStudies 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
- Time perspective
- Prospective
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), Vermont Program for Quality in Health Care
- Responsible party
- Principal investigator, Amanda Kennedy, University of Vermont
- Investigators
- Amanda G Kennedy, PharmD, Principal investigator, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00256568
- Sponsor's protocol ID
- K08HS013891
- Status last verified
- Dec 2011
- First submitted
- 17 Nov 2005
- Last updated
- 15 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Kennedy AG, Littenberg B. Medication error reporting by community pharmacists in Vermont. J Am Pharm Assoc (2003). 2004 Jul-Aug;44(4):434-8. doi: 10.1331/1544345041475724.
PubMed 15372863Kennedy AG, Littenberg B, Vezina LC. Vioxx-Viagra confusion. Am J Health Syst Pharm. 2002 Nov 1;59(21):2112. doi: 10.1093/ajhp/59.21.2112a. No abstract available.
PubMed 12434730Kennedy AG, Littenberg B, Senders JW. Using nurses and office staff to report prescribing errors in primary care. Int J Qual Health Care. 2008 Aug;20(4):238-45. doi: 10.1093/intqhc/mzn015. Epub 2008 Apr 22.
PubMed 18430748
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outpatient Prescription Errors: Detection, Analysis, and Impact on Safety
- ClinicalTrials.gov ID
- NCT00256568
- Acronym / sponsor ID
- K08HS013891
- Conditions
- Medication Errors
- Keywords
- Medical Errors, Medication Errors, Prescriptions, Drug, Pharmacies, Ambulatory Care Facilities
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), Vermont Program for Quality in Health Care
- Study start
- Sep 2003
- Study completion
- Aug 2008 (actual)
- First posted
- 21 Nov 2005 (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 purpose of this study is to better understand outpatient prescribing errors through clinic and pharmacy-based error reporting systems.
Detailed description
Medication errors cause substantial morbidity and mortality in the United States. However, relatively little is known about medication errors in the outpatient setting. The broad goal of this proposal is to improve outpatient safety. Specifically, this research plan promotes the understanding of the causes of outpatient prescription errors. The specific aims of this project are:
- To develop and evaluate a novel reporting system in physicians' offices for detecting prescription errors
- To develop and evaluate a novel improvement system in community pharmacies to increase prescription error reporting by pharmacists
- To analyze reports of outpatient prescription errors and understand their root causes
To achieve these specific aims, statewide research will be conducted utilizing qualitative and quantitative methods including root cause analysis, failure mode and effects analysis, and surveys. This research plan will promote patient safety by furthering the understanding of the causes of outpatient prescription errors in all outpatient populations, including rural, women, children, elderly, low income, and the chronically ill.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary Care Practices | – | Behavioral: reporting systemOne hundred and three prescribers, managers, nurses and office staff at seven primary care practices in Vermont |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Primary Care Practices
Key inclusion criteria (1 listed)
- Employed in a physician's office or community pharmacy
Key exclusion criteria (1 listed)
- Not employed in a physician's office or community pharmacy
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 |
|---|---|---|
| reporting systemNurses and office staff were asked to report all communications with community pharmacists regarding prescription problems | Behavioural | Primary Care Practices |
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 15 Dec 2011.
- Background: PubMed 15372863Kennedy AG, Littenberg B. Medication error reporting by community pharmacists in Vermont. J Am Pharm Assoc (2003). 2004 Jul-Aug;44(4):434-8. doi: 10.1331/1544345041475724.
- Background: PubMed 12434730Kennedy AG, Littenberg B, Vezina LC. Vioxx-Viagra confusion. Am J Health Syst Pharm. 2002 Nov 1;59(21):2112. doi: 10.1093/ajhp/59.21.2112a. No abstract available.
- Results publication: PubMed 18430748Kennedy AG, Littenberg B, Senders JW. Using nurses and office staff to report prescribing errors in primary care. Int J Qual Health Care. 2008 Aug;20(4):238-45. doi: 10.1093/intqhc/mzn015. Epub 2008 Apr 22.
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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.
Amanda G Kennedy, PharmD principal investigator
University of Vermont
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 Errors, run by University of Vermont 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 15 Dec 2011. 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?
On the ClinicalTrials.gov record for NCT00256568, which also lists 3 linked publications.
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 15 Dec 2011.