Critical CareNCT00297609
Prevention of Errors in Resuscitation Medications Orders by Means of a Computerized Physician Order Entry
An observational study of Critical Care and Pediatrics, run by Sheba Medical Center at 1 site in Israel.
Trial summary
Computerized physician order entry with clinical decision support system CPOE+CDSS)completely eliminated errors in filling in the resuscitation medications order forms and significantly reduced time to completing the forms in a pediatric critical care department (PCCD). Read more about this study
- Who is it for?
- Ages 3 days to 18 years
- Conditions the study is for
- Critical Care, Pediatrics
- How many people
- Not given
- Where
- 1 siteIsrael
- Study dates
- Jan 2002to not given
- 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 3 days to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- all admissions to PICU January 2002 - August 2006
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention of Potential Errors in Resuscitation Medications Orders by Means of a Computerized Physician Order Entry With Clinical Decision Support System in Pediatric Critical Care - a Prospective Cohort Study.
Computerized physician order entry with clinical decision support system CPOE+CDSS)completely eliminated errors in filling in the resuscitation medications order forms and significantly reduced time to completing the forms in a pediatric critical care department (PCCD).
Read the detailed description
Introduction: Computerized physician order entry with clinical decision support system (CPOE+CDSS) is an important tool in attempting to reduce medication errors. The objective of this study was to evaluate the impact of a CPOE+CDSS on (1) the frequency of errors in ordering resuscitation (CPR) medications and (2) the time for printing out the order form, in a pediatric critical care department (PCCD).
Methods: Setting: An 18-bed PCCD in a tertiary-care children's hospital. Design: Prospective cohort study. Measures: Compilation and comparison of number of errors and time to fill in forms before and after implementation of CPOE+CDSS. Errors were identified by reviewing orders and classified as potential adverse drug events (ADEs), medication prescribing errors (MPEs), and rule violations (RVs). They were compared during the year preceding and following implementation of CPOE CDSS. Simulated forms were also used to further test error occurrence. Time to fill in conventional, simulated and CPOE forms was measured and compared.
Results: There were 3 reported incidents of errors among 13,124 CPR medications orders during the year preceding implementation of CPOE+CDSS. These represent errors that escaped the triple check by three independent staff members (two nurses and one physician). There was an average of 11.6 errors/100 orders in the simulated CPR form and potential ADEs occurred at a rate of 11.3/100 orders and MPEs at a rate of 0.3/100 orders. There were no errors after CPOE+CDSS was implemented (100% error reduction). Time to completion of drug forms dropped from 14 min 42 sec to 2 min 14 sec (p<0.001).
Conclusions: CPOE+CDSS completely eliminated errors in filling in the forms and significantly reduced time to completing the form.
- Conditions
- Critical Care, Pediatrics
- Keywords
- Resuscitation medication errors, critical care, pediatrics, clinical decision support systems, computerized physician order entry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2006 (estimated)
- Study startJan 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical CareStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- 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
- Defined population
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Investigators
- Amir Vardi, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00297609
- Sponsor's protocol ID
- SHEBA-03-0000-AV-CTIL
- Status last verified
- Feb 2006
- First submitted
- 27 Feb 2006
- Last updated
- 28 Feb 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Potential Errors in Resuscitation Medications Orders by Means of a Computerized Physician Order Entry With Clinical Decision Support System in Pediatric Critical Care - a Prospective Cohort Study.
- ClinicalTrials.gov ID
- NCT00297609
- Acronym / sponsor ID
- SHEBA-03-0000-AV-CTIL
- Conditions
- Critical Care, Pediatrics
- Keywords
- Resuscitation medication errors, critical care, pediatrics, clinical decision support systems, computerized physician order entry
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Jan 2002
- First posted
- 28 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.
Computerized physician order entry with clinical decision support system CPOE+CDSS)completely eliminated errors in filling in the resuscitation medications order forms and significantly reduced time to completing the forms in a pediatric critical care department (PCCD).
Detailed description
Introduction: Computerized physician order entry with clinical decision support system (CPOE+CDSS) is an important tool in attempting to reduce medication errors. The objective of this study was to evaluate the impact of a CPOE+CDSS on (1) the frequency of errors in ordering resuscitation (CPR) medications and (2) the time for printing out the order form, in a pediatric critical care department (PCCD).
Methods: Setting: An 18-bed PCCD in a tertiary-care children's hospital. Design: Prospective cohort study. Measures: Compilation and comparison of number of errors and time to fill in forms before and after implementation of CPOE+CDSS. Errors were identified by reviewing orders and classified as potential adverse drug events (ADEs), medication prescribing errors (MPEs), and rule violations (RVs). They were compared during the year preceding and following implementation of CPOE CDSS. Simulated forms were also used to further test error occurrence. Time to fill in conventional, simulated and CPOE forms was measured and compared.
Results: There were 3 reported incidents of errors among 13,124 CPR medications orders during the year preceding implementation of CPOE+CDSS. These represent errors that escaped the triple check by three independent staff members (two nurses and one physician). There was an average of 11.6 errors/100 orders in the simulated CPR form and potential ADEs occurred at a rate of 11.3/100 orders and MPEs at a rate of 0.3/100 orders. There were no errors after CPOE+CDSS was implemented (100% error reduction). Time to completion of drug forms dropped from 14 min 42 sec to 2 min 14 sec (p<0.001).
Conclusions: CPOE+CDSS completely eliminated errors in filling in the forms and significantly reduced time to completing the form.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 days to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- all admissions to PICU January 2002 - August 2006
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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 28 Feb 2006.
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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.
Amir Vardi, MD principal investigator
Sheba Medical Center
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 Critical Care and Pediatrics, run by Sheba Medical Center at 1 site in Israel.
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 28 Feb 2006. 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 Israel. 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 28 Feb 2006.