Wrong Patient Computerized Physician Order Entry ErrorsNCT01262053
Investigating Wrong-Patient Computerized Physician Order Entry (CPOE) Errors
A study testing Passive Intervention and Active Intervention in people with Wrong Patient Computerized Physician Order Entry Errors, run by Montefiore Medical Center at 1 site in United States.
Trial summary
With the increased adoption of CPOE systems, it is important to recognize that design flaws have resulted in the creation of new types of iatrogenic medical errors. An example of a new type of iatrogenic medical error introduced by CPOE systems has been named "juxtaposition errors". Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Wrong Patient Computerized Physician Order Entry Errors
- What is being tested?
- Passive Intervention and Active Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,028 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Jun 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All providers that place order in the Computerized Physician Order Entry (CPOE) System
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center
The Bronx, New York, 10467
About this study
Official title: Investigating Wrong-Patient CPOE Errors
With the increased adoption of CPOE systems, it is important to recognize that design flaws have resulted in the creation of new types of iatrogenic medical errors. An example of a new type of iatrogenic medical error introduced by CPOE systems has been named "juxtaposition errors". Juxtaposition errors, as defined by Ash, et al. are "errors that can result when something is close to something else on the screen, and the wrong option is too easily clicked in error." Juxtaposition errors can lead to a patient receiving a medication, a test, or a treatment intended for another patient, sometimes with dire consequences. Juxtaposition errors are likely a subclass of a broader group of wrong-patient CPOE errors that have multiple etiologies.
The primary objectives of this research proposal is to investigate the prevalence of wrong-patient near miss CPOE errors, to investigate the root cause of these errors, and to investigate and compare the efficacy and workflow impact of two distinct interventions to prevent these errors.
Read the detailed description
Computerized Physician Order Entry (CPOE) systems have been shown to prevent medical errors, and have become a major component of the patient safety movement. To accelerate the adoption of clinical information technology including CPOE systems, the American Recovery and Reinvestment Act of 2009 allocated approximately $17 billion as incentive payments to providers and hospitals who implement health information technology. With the increased adoption of CPOE systems, however, it is important to recognize that design flaws have resulted in the creation of new types of iatrogenic medical errors. In addition, CPOE systems developed with suboptimal and onerous user interfaces have contributed to entire systems being rejected by physicians. The ideal CPOE system maximizes medical error reduction, minimizes medical error creation, and has a user friendly interface that is accepted by nurses, physicians, and pharmacists.
An example of a new type of iatrogenic medical error introduced by CPOE systems has been named "juxtaposition errors" . Juxtaposition errors, as defined by Ash, et al. are "errors that can result when something is close to something else on the screen, and the wrong option is too easily clicked in error." Juxtaposition errors can lead to a patient receiving a medication, a test, or a treatment intended for another patient, sometimes with dire consequences.
Juxtaposition errors are likely a subclass of a broader group of wrong-patient CPOE errors that have multiple etiologies. Other possible causes of wrong-patient CPOE orders include interruption errors, or double-interruption errors.
Primary Objectives:
- Specific Aim 1: Investigate the prevalence of wrong-patient near miss CPOE errors.
- Specific Aim 2: Investigate the root cause of wrong-patient near miss CPOE errors.
- Specific Aim 3: Investigate and compare the efficacy and workflow impact of two distinct interventions to prevent wrong-patient near miss CPOE errors against a control.
- Being tested
- Passive Intervention, Active Intervention, Control
- Keywords
- Computerized Physician Order Entry, CPOE, Wrong Patient, Juxtaposition, Patient Safety, Medical Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passive InterventionOther
When a user is about to place orders on a patient, a pop up alert will show the user the name, age, sex, room number and MR# of the patient who is currently activated. The point of the alert is to display identification information about the patient as a double check for the provider to make sure he is on the correct patient. This alert will only occur once at the onset of each order session (i.e. the provider will not be alerted for every single order, but if the provider leaves the order pad and then returns, the alert will reoccur).
Active InterventionOther
The user will be required to enter the initials, age and sex of the activated patient prior to placing any orders. For example, for a patient named Donald Duck who is 76 years old and male, the user will be required to type "dd76m" to unlock the order pad. This step will NOT be required for every order, but WILL be required every time the user enters the order pad (i.e. if a user leaves the order pad and then returns, the system will require the initials, age and sex to be re-entered as above). This will be a forcing function.
ControlOther
Parallel control with no intervention
| Study group | Role | What they receive |
|---|---|---|
| Passive Intervention | Experimental | When a user is about to place orders on a patient, a pop up alert will show the user the name, age, sex, room number and MR# of the patient who is currently activated. Receives: Other: Passive Intervention |
| Active Intervention | Experimental | The user will be required to enter the initials, age and sex of the activated patient prior to placing any orders. Receives: Other: Active Intervention |
| Control | Active comparator | Parallel control with no intervention Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of wrong patient CPOE errors
Compare reduction of wrong patient CPOE errors in each intervention group against a control
Measured: Within one hour of placing an order
Secondary outcomes (1)
Impact of interventions on workflow
Compare the efficacy and workflow impact of two distinct interventions to prevent wrong-patient near miss CPOE errors against a control
Measured: Within one hour of placing an order
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionMay 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Wrong Patient Computerized Physician Order Entry 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
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 4,028 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jason S Adelman, MD, MS, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01262053
- Sponsor's protocol ID
- 10-05-156E
- Status last verified
- Sep 2018
- First submitted
- 15 Dec 2010
- Last updated
- 11 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Ash JS, Sittig DF, Poon EG, Guappone K, Campbell E, Dykstra RH. The extent and importance of unintended consequences related to computerized provider order entry. J Am Med Inform Assoc. 2007 Jul-Aug;14(4):415-23. doi: 10.1197/jamia.M2373. Epub 2007 Apr 25.
PubMed 17460127Koppel R, Metlay JP, Cohen A, Abaluck B, Localio AR, Kimmel SE, Strom BL. Role of computerized physician order entry systems in facilitating medication errors. JAMA. 2005 Mar 9;293(10):1197-203. doi: 10.1001/jama.293.10.1197.
PubMed 15755942Weiner JP, Kfuri T, Chan K, Fowles JB. "e-Iatrogenesis": the most critical unintended consequence of CPOE and other HIT. J Am Med Inform Assoc. 2007 May-Jun;14(3):387-8; discussion 389. doi: 10.1197/jamia.M2338. Epub 2007 Feb 28. No abstract available.
PubMed 17329719Campbell EM, Sittig DF, Ash JS, Guappone KP, Dykstra RH. Types of unintended consequences related to computerized provider order entry. J Am Med Inform Assoc. 2006 Sep-Oct;13(5):547-56. doi: 10.1197/jamia.M2042. Epub 2006 Jun 23.
PubMed 16799128Wachter RM. Expected and unanticipated consequences of the quality and information technology revolutions. JAMA. 2006 Jun 21;295(23):2780-3. doi: 10.1001/jama.295.23.2780. No abstract available.
PubMed 16788133
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Wrong-Patient CPOE Errors
- ClinicalTrials.gov ID
- NCT01262053
- Acronym / sponsor ID
- 10-05-156E
- Keywords
- Computerized Physician Order Entry, CPOE, Wrong Patient, Juxtaposition, Patient Safety, Medical Errors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,028 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- May 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 17 Dec 2010 (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.
With the increased adoption of CPOE systems, it is important to recognize that design flaws have resulted in the creation of new types of iatrogenic medical errors. An example of a new type of iatrogenic medical error introduced by CPOE systems has been named "juxtaposition errors". Juxtaposition errors, as defined by Ash, et al. are "errors that can result when something is close to something else on the screen, and the wrong option is too easily clicked in error." Juxtaposition errors can lead to a patient receiving a medication, a test, or a treatment intended for another patient, sometimes with dire consequences. Juxtaposition errors are likely a subclass of a broader group of wrong-patient CPOE errors that have multiple etiologies.
The primary objectives of this research proposal is to investigate the prevalence of wrong-patient near miss CPOE errors, to investigate the root cause of these errors, and to investigate and compare the efficacy and workflow impact of two distinct interventions to prevent these errors.
Detailed description
Computerized Physician Order Entry (CPOE) systems have been shown to prevent medical errors, and have become a major component of the patient safety movement. To accelerate the adoption of clinical information technology including CPOE systems, the American Recovery and Reinvestment Act of 2009 allocated approximately $17 billion as incentive payments to providers and hospitals who implement health information technology. With the increased adoption of CPOE systems, however, it is important to recognize that design flaws have resulted in the creation of new types of iatrogenic medical errors. In addition, CPOE systems developed with suboptimal and onerous user interfaces have contributed to entire systems being rejected by physicians. The ideal CPOE system maximizes medical error reduction, minimizes medical error creation, and has a user friendly interface that is accepted by nurses, physicians, and pharmacists.
An example of a new type of iatrogenic medical error introduced by CPOE systems has been named "juxtaposition errors" . Juxtaposition errors, as defined by Ash, et al. are "errors that can result when something is close to something else on the screen, and the wrong option is too easily clicked in error." Juxtaposition errors can lead to a patient receiving a medication, a test, or a treatment intended for another patient, sometimes with dire consequences.
Juxtaposition errors are likely a subclass of a broader group of wrong-patient CPOE errors that have multiple etiologies. Other possible causes of wrong-patient CPOE orders include interruption errors, or double-interruption errors.
Primary Objectives:
- Specific Aim 1: Investigate the prevalence of wrong-patient near miss CPOE errors.
- Specific Aim 2: Investigate the root cause of wrong-patient near miss CPOE errors.
- Specific Aim 3: Investigate and compare the efficacy and workflow impact of two distinct interventions to prevent wrong-patient near miss CPOE errors against a control.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Passive Intervention | Experimental | Other: Passive InterventionWhen a user is about to place orders on a patient, a pop up alert will show the user the name, age, sex, room number and MR# of the patient who is currently activated. |
| Active Intervention | Experimental | Other: Active InterventionThe user will be required to enter the initials, age and sex of the activated patient prior to placing any orders. |
| Control | Active comparator | Other: ControlParallel control with no intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All providers that place order in the Computerized Physician Order Entry (CPOE) System
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Passive InterventionWhen a user is about to place orders on a patient, a pop up alert will show the user the name, age, sex, room number and MR# of the patient who is currently activated. The point of the alert is to display identification information about the patient as a double check for the provider to make sure he is on the correct patient. This alert will only occur once at the onset of each order session (i.e. the provider will not be alerted for every single order, but if the provider leaves the order pad and then returns, the alert will reoccur). | Other | Passive Intervention |
| Active InterventionThe user will be required to enter the initials, age and sex of the activated patient prior to placing any orders. For example, for a patient named Donald Duck who is 76 years old and male, the user will be required to type "dd76m" to unlock the order pad. This step will NOT be required for every order, but WILL be required every time the user enters the order pad (i.e. if a user leaves the order pad and then returns, the system will require the initials, age and sex to be re-entered as above). This will be a forcing function. | Other | Active Intervention |
| ControlParallel control with no intervention | Other | Control |
Primary outcome
Reduction of wrong patient CPOE errors
Time frame: Within one hour of placing an order
Compare reduction of wrong patient CPOE errors in each intervention group against a control
1 secondary outcome
Impact of interventions on workflow
Time frame: Within one hour of placing an order
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 11 Sep 2018.
- Background: PubMed 17460127Ash JS, Sittig DF, Poon EG, Guappone K, Campbell E, Dykstra RH. The extent and importance of unintended consequences related to computerized provider order entry. J Am Med Inform Assoc. 2007 Jul-Aug;14(4):415-23. doi: 10.1197/jamia.M2373. Epub 2007 Apr 25.
- Background: PubMed 15755942Koppel R, Metlay JP, Cohen A, Abaluck B, Localio AR, Kimmel SE, Strom BL. Role of computerized physician order entry systems in facilitating medication errors. JAMA. 2005 Mar 9;293(10):1197-203. doi: 10.1001/jama.293.10.1197.
- Background: PubMed 17329719Weiner JP, Kfuri T, Chan K, Fowles JB. "e-Iatrogenesis": the most critical unintended consequence of CPOE and other HIT. J Am Med Inform Assoc. 2007 May-Jun;14(3):387-8; discussion 389. doi: 10.1197/jamia.M2338. Epub 2007 Feb 28. No abstract available.
- Background: PubMed 16799128Campbell EM, Sittig DF, Ash JS, Guappone KP, Dykstra RH. Types of unintended consequences related to computerized provider order entry. J Am Med Inform Assoc. 2006 Sep-Oct;13(5):547-56. doi: 10.1197/jamia.M2042. Epub 2006 Jun 23.
- Background: PubMed 16788133Wachter RM. Expected and unanticipated consequences of the quality and information technology revolutions. JAMA. 2006 Jun 21;295(23):2780-3. doi: 10.1001/jama.295.23.2780. No abstract available.
- Individual participant dataSharing planned: Undecided
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.
Jason S Adelman, MD, MS principal investigator
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Passive Intervention and Active Intervention in people with Wrong Patient Computerized Physician Order Entry Errors, run by Montefiore Medical Center 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 11 Sep 2018. 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?
Reduction of wrong patient CPOE errors (time frame: Within one hour of placing an order). 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 NCT01262053, which also lists 5 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 11 Sep 2018.