Medication ErrorsNCT00287274
Impact of Computerized Physician Order Entry on Medication Prescription Errors in the Intensive Care Unit: a Controlled Cross-Sectional Trial.
A study testing computerized physician order entry in people with Medication Errors and Patient Safety, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Device: computerized physician order entry. We wanted to investigate if the introduction of a computerized intensive care unit system reduced the incidence and severity of medication prescription errors (MPEs). A prospective trial was conducted during 5 weeks in a paper-based unit versus a computerized unit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medication Errors, Patient Safety
- What is being tested?
- computerized physician order entry
- Type of treatment
- Medical device
- How many people
- 160 participants
- Where
- 1 siteBelgium
- Study dates
- Mar 2004to Apr 2004
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients admitted to the Surgical Intensive Care Unit
Who cannot join
- Adult Patients admitted to other units
- Pediatric patients
Trial locations and contacts
1 site in 1 country.
About this study
Device: computerized physician order entry.
We wanted to investigate if the introduction of a computerized intensive care unit system reduced the incidence and severity of medication prescription errors (MPEs). A prospective trial was conducted during 5 weeks in a paper-based unit versus a computerized unit. The registration of different classes of MPEs was done by a clinical pharmacist. An independent panel evaluated the severity of MPEs.
- Conditions
- Medication Errors, Patient Safety
- Being tested
- computerized physician order entry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
computerized physician order entryDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the the incidence and severity of medication prescription errors between a CPOE unit and a paper-based unit at completion of the study.
Secondary outcomes (1)
Description of MPEs in both units at completion of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2006 (estimated)
- Study startMar 2004
- Study completionApr 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 160 participants
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Investigators
- Kirsten Colpaert, MD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00287274
- Sponsor's protocol ID
- 2004/002
- Status last verified
- Dec 2007
- First submitted
- 2 Feb 2006
- Last updated
- 28 Dec 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Colpaert K, Claus B, Somers A, Vandewoude K, Robays H, Decruyenaere J. Impact of computerized physician order entry on medication prescription errors in the intensive care unit: a controlled cross-sectional trial. Crit Care. 2006 Feb;10(1):R21. doi: 10.1186/cc3983.
PubMed 16469126
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Computerized Physician Order Entry on Medication Prescription Errors in the Intensive Care Unit: a Controlled Cross-Sectional Trial.
- ClinicalTrials.gov ID
- NCT00287274
- Acronym / sponsor ID
- 2004/002
- Conditions
- Medication Errors, Patient Safety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Mar 2004
- Study completion
- Apr 2004 (actual)
- First posted
- 6 Feb 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.
Device: computerized physician order entry.
We wanted to investigate if the introduction of a computerized intensive care unit system reduced the incidence and severity of medication prescription errors (MPEs). A prospective trial was conducted during 5 weeks in a paper-based unit versus a computerized unit. The registration of different classes of MPEs was done by a clinical pharmacist. An independent panel evaluated the severity of MPEs.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients admitted to the Surgical Intensive Care Unit
Key exclusion criteria (2 listed)
- Adult Patients admitted to other units
- Pediatric patients
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 |
|---|---|---|
| computerized physician order entry | Device | – |
Primary outcome
To compare the the incidence and severity of medication prescription errors between a CPOE unit and a paper-based unit at completion of the study.
1 secondary outcome
Description of MPEs in both units at completion of the study.
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 28 Dec 2007.
- Results publication: PubMed 16469126Colpaert K, Claus B, Somers A, Vandewoude K, Robays H, Decruyenaere J. Impact of computerized physician order entry on medication prescription errors in the intensive care unit: a controlled cross-sectional trial. Crit Care. 2006 Feb;10(1):R21. doi: 10.1186/cc3983.
- Website University Hospital GhentLink provided by the sponsor.
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Healthy Volunteers
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.
Kirsten Colpaert, MD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing computerized physician order entry in people with Medication Errors and Patient Safety, run by University Hospital, Ghent at 1 site in Belgium.
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: finished, as of the sponsor's last update on 28 Dec 2007. 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 Belgium. 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?
To compare the the incidence and severity of medication prescription errors between a CPOE unit and a paper-based unit at completion of the study.. 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 NCT00287274, which also lists 1 linked publication.
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 28 Dec 2007.