Medication ErrorsEarly Phase 1NCT00845494
Efficacy of a Behavioral Based Education Intervention to Decrease Medication History Errors Among Professional Nurses.
A Early Phase 1 study testing cognitive behavioral intervention in people with Medication Errors, run by Waukesha Memorial Hospital at 1 site in United States.
Trial summary
The purpose of the study is to determine if a behavioral knowledge based education intervention will decrease medication transcription errors among professional nurses when admitting elder patients to a hospital. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Medication Errors
- What is being tested?
- cognitive behavioral intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Oct 2010
- Phase
- Early Phase 1
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Nurses working 20 hours a week or more
Who cannot join
- Nurses working less than 20 hours a week
- Nurse working as a float or pool nurse
Trial locations and contacts
1 site in 1 country.
United States1 site
Waukesha Memorial Hospital
Waukesha, Wisconsin, 53188
Michael whittaker, M.D., 262-288-7570, Michael.whittaker@phci.org
Kathy A Becker, PhD
About this study
The purpose of the study is to determine if a behavioral knowledge based education intervention will decrease medication transcription errors among professional nurses when admitting elder patients to a hospital. The hypothesis is those professional nurses who receive the behavioral-cognitive eduction medication taking intervention will have fewer medication errors than those professional nurses who do not.
- Conditions
- Medication Errors
- Being tested
- cognitive behavioral intervention
- Keywords
- Medication history, medication errors, Reduction of admission medication history errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive behavioral interventionBehavioural
The intervention will consist of an hour of cognitive behavioral education. The first 15 minutes spent discussing cases examples of medication errors. The next 15 minutes will include identifying old rules or assumptions nurses have about medication history obtainment. The next 15 minutes will be utilized reviewing a medication tool to be used, and the last 15 minutes will be discussing techniques to help nurse obtain information from elderly patients.
| Study group | Role | What they receive |
|---|---|---|
| medication history education | Other | Four hospital unit nurses asked to participate in the study. Two nursing units will receive the cognitive behavioral intervention. Receives: Behavioral: cognitive behavioral intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in medication errors on admission medication history form after intervention
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionFeb 2010 (estimated)
- Study completionOct 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Early Phase 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Waukesha Memorial Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00845494
- Sponsor's protocol ID
- 554
- Status last verified
- Feb 2009
- First submitted
- 17 Feb 2009
- Last updated
- 18 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Behavioral Based Education Intervention to Decrease Medication History Errors Among Professional Nurses.
- ClinicalTrials.gov ID
- NCT00845494
- Acronym / sponsor ID
- 554
- Conditions
- Medication Errors
- Keywords
- Medication history, medication errors, Reduction of admission medication history errors
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Waukesha Memorial HospitalUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Feb 2010 (estimated)
- Study completion
- Oct 2010 (estimated)
- First posted
- 18 Feb 2009 (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 the study is to determine if a behavioral knowledge based education intervention will decrease medication transcription errors among professional nurses when admitting elder patients to a hospital. The hypothesis is those professional nurses who receive the behavioral-cognitive eduction medication taking intervention will have fewer medication errors than those professional nurses who do not.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| medication history education | Other | Behavioral: cognitive behavioral interventionFour hospital unit nurses asked to participate in the study. Two nursing units will receive the cognitive behavioral intervention. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Nurses working 20 hours a week or more
Key exclusion criteria (2 listed)
- Nurses working less than 20 hours a week
- Nurse working as a float or pool nurse
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 |
|---|---|---|
| cognitive behavioral interventionThe intervention will consist of an hour of cognitive behavioral education. The first 15 minutes spent discussing cases examples of medication errors. The next 15 minutes will include identifying old rules or assumptions nurses have about medication history obtainment. The next 15 minutes will be utilized reviewing a medication tool to be used, and the last 15 minutes will be discussing techniques to help nurse obtain information from elderly patients. | Behavioural | medication history education |
Primary outcome
Reduction in medication errors on admission medication history form after intervention
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2009.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing cognitive behavioral intervention in people with Medication Errors, run by Waukesha Memorial Hospital 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 2 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: status not confirmed, as of the sponsor's last update on 18 Feb 2009. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kathy A Becker, PhD(c) (262-928-7887, Kathy.becker@phci.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in medication errors on admission medication history form after intervention (time frame: 1 year). It is what the study was designed to measure, not a finding.
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 18 Feb 2009.