Medication ErrorsNCT00256594
Evaluation of an Outpatient Modified Prescription Form
A study testing prescription form in people with Medication Errors, run by University of Vermont at 1 site in United States.
Trial summary
The purpose of this study is to determine if a modified paper prescribing form decreases prescribing errors compared to a traditional or standard paper prescribing form. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Medication Errors
- What is being tested?
- prescription form
- Type of treatment
- Medical device
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to Jan 2011
- Phase
- Interventional
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be a physician, nurse practitioner, or physician assistant with a current license to write outpatient prescriptions
- Must practice in Family Practice, Internal Medicine, or Pediatrics
- Must practice in rural Vermont, West Virginia, South Dakota, or Montana
- Must write outpatient paper prescriptions
- Must write prescriptions in English
Who cannot join
- Not licensed to write prescriptions
- Practice in a specialty, inpatient, or long term care setting
- Do not write paper prescriptions
- Do not write prescriptions in English
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
Official title: Evaluation of an Outpatient Modified Paper Prescription Form in 4 Rural States to Address the Public Health Problem of Prescribing Error
The purpose of this study is to determine if a modified paper prescribing form decreases prescribing errors compared to a traditional or standard paper prescribing form.
Read the detailed description
The broad goal of this proposal is to reduce outpatient prescribing errors in rural primary care practices. Although computerized technology is available for prescribing, it has not yet been implemented in most settings. Additionally, rural prescribers will likely be the last to have the means to adopt this technology. Due to the substantial morbidity and mortality in the United States caused by outpatient medication errors, there is an urgent need for low-cost solutions. This research plan will evaluate a modified paper prescription form that may be implemented in rural primary care settings cheaply and quickly with the goal of outpatient prescription error reduction.
The specific aims of this project are:
- To determine if a modified paper prescription form decreases overall prescribing errors compared to a standard paper prescription form
- To determine if a modified paper prescription form decreases omission errors compared to a standard paper prescription form
- To determine prescriber satisfaction with the modified prescription form
Rural prescribers from four states will be randomly recruited to write prescriptions on standard and modified forms. Prescription duplicates of both types will be analyzed for errors. Prescriber satisfaction with the modified form will be evaluated using surveys and focus groups.
Medication errors are a public health problem. Low-cost technology that is shown to reduce medication errors would benefit all rural patients who receive prescriptions.
- Conditions
- Medication Errors
- Being tested
- prescription form
- Keywords
- Medical Errors, Medication Errors, Prescriptions, Drug
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prescription formDevice
Two prescription pads contained modified forms and two prescription pads were similar to the prescription pads the prescriber had been using. Providers completed 100 standard and 100 modified prescriptions
What is being measured
The primary outcome is the main question the study is designed to answer.
error rates of standard versus modified prescriptions per prescriber
Measured: 200 prescriptions each
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 startAug 2005
- Primary completionFeb 2010
- Study completionJan 2011
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Collaborators
- Health Resources and Services Administration (HRSA)
- 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
- NCT00256594
- Sponsor's protocol ID
- 1 R04RH05814-01-00
- 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. A modified outpatient prescription form to reduce prescription errors. Jt Comm J Qual Saf. 2004 Sep;30(9):480-7. doi: 10.1016/s1549-3741(04)30056-0.
PubMed 15469125Kennedy AG, Littenberg B, Callas PW, Carney JK. Evaluation of a modified prescription form to address prescribing errors. Am J Health Syst Pharm. 2011 Jan 15;68(2):151-7. doi: 10.2146/ajhp100063.
PubMed 21200063Kennedy AG, Senders JW, Sellen K, Littenberg B, Callas PW, Carney JK. Perception of drug-name legibility by pharmacists and pharmacy technicians. Am J Health Syst Pharm. 2009 May 1;66(9):794-5. doi: 10.2146/ajhp080189. No abstract available.
PubMed 19386937
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
- Evaluation of an Outpatient Modified Paper Prescription Form in 4 Rural States to Address the Public Health Problem of Prescribing Error
- ClinicalTrials.gov ID
- NCT00256594
- Acronym / sponsor ID
- 1 R04RH05814-01-00
- Conditions
- Medication Errors
- Keywords
- Medical Errors, Medication Errors, Prescriptions, Drug
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Collaborators
- Health Resources and Services Administration (HRSA)
- Study start
- Aug 2005
- Primary completion
- Feb 2010 (actual)
- Study completion
- Jan 2011 (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 determine if a modified paper prescribing form decreases prescribing errors compared to a traditional or standard paper prescribing form.
Detailed description
The broad goal of this proposal is to reduce outpatient prescribing errors in rural primary care practices. Although computerized technology is available for prescribing, it has not yet been implemented in most settings. Additionally, rural prescribers will likely be the last to have the means to adopt this technology. Due to the substantial morbidity and mortality in the United States caused by outpatient medication errors, there is an urgent need for low-cost solutions. This research plan will evaluate a modified paper prescription form that may be implemented in rural primary care settings cheaply and quickly with the goal of outpatient prescription error reduction.
The specific aims of this project are:
- To determine if a modified paper prescription form decreases overall prescribing errors compared to a standard paper prescription form
- To determine if a modified paper prescription form decreases omission errors compared to a standard paper prescription form
- To determine prescriber satisfaction with the modified prescription form
Rural prescribers from four states will be randomly recruited to write prescriptions on standard and modified forms. Prescription duplicates of both types will be analyzed for errors. Prescriber satisfaction with the modified form will be evaluated using surveys and focus groups.
Medication errors are a public health problem. Low-cost technology that is shown to reduce medication errors would benefit all rural patients who receive prescriptions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Must be a physician, nurse practitioner, or physician assistant with a current license to write outpatient prescriptions
- Must practice in Family Practice, Internal Medicine, or Pediatrics
- Must practice in rural Vermont, West Virginia, South Dakota, or Montana
- Must write outpatient paper prescriptions
- Must write prescriptions in English
Key exclusion criteria (4 listed)
- Not licensed to write prescriptions
- Practice in a specialty, inpatient, or long term care setting
- Do not write paper prescriptions
- Do not write prescriptions in English
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 |
|---|---|---|
| prescription formTwo prescription pads contained modified forms and two prescription pads were similar to the prescription pads the prescriber had been using. Providers completed 100 standard and 100 modified prescriptions | Device | – |
Primary outcome
error rates of standard versus modified prescriptions per prescriber
Time frame: 200 prescriptions each
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 15469125Kennedy AG, Littenberg B. A modified outpatient prescription form to reduce prescription errors. Jt Comm J Qual Saf. 2004 Sep;30(9):480-7. doi: 10.1016/s1549-3741(04)30056-0.
- Results publication: PubMed 21200063Kennedy AG, Littenberg B, Callas PW, Carney JK. Evaluation of a modified prescription form to address prescribing errors. Am J Health Syst Pharm. 2011 Jan 15;68(2):151-7. doi: 10.2146/ajhp100063.
- Results publication: PubMed 19386937Kennedy AG, Senders JW, Sellen K, Littenberg B, Callas PW, Carney JK. Perception of drug-name legibility by pharmacists and pharmacy technicians. Am J Health Syst Pharm. 2009 May 1;66(9):794-5. doi: 10.2146/ajhp080189. No abstract available.
Related trials for Medication Errors
Active, not recruitingPhase 2
MT2013-31: Allo HCT for Metabolic Disorders and Severe Osteopetrosis
Mucopolysaccharidosis Disorders, Hurler Syndrome
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruitingObservational study
A Survey to Assess Participants', Caregivers', and Nurses' Use and Understanding of Educational Material on Velaglucerase Alfa (VPRIV) Home Infusion
Gaucher Disease
RecruitingObservational study
Pompe Disease RWE Long-term Monitoring Program
Pompe Disease
Active, not recruitingPhase 2/3
A Multi-cohort Study of Safety, Efficacy, PK and PD of GNR-055 in Patients With Mucopolysaccharidosis Type II
Mucopolysaccharidosis Type II, Metabolic Diseases
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?
A study testing prescription form in people with 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 5 inclusion and 4 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.
What does the primary outcome measure?
error rates of standard versus modified prescriptions per prescriber (time frame: 200 prescriptions each). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00256594, 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.