- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01262053
Investigating Wrong-Patient Computerized Physician Order Entry (CPOE) Errors
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.
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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Bronx, New York, United States, 10467
- Montefiore Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- All providers that place order in the Computerized Physician Order Entry (CPOE) System
Exclusion Criteria:
- none
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Passive Intervention
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.
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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).
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Experimental: Active Intervention
The user will be required to enter the initials, age and sex of the activated patient prior to placing any orders.
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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.
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Active Comparator: Control
Parallel control with no intervention
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Parallel control with no intervention
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reduction of wrong patient CPOE errors
Time Frame: Within one hour of placing an order
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Compare reduction of wrong patient CPOE errors in each intervention group against a control
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Within one hour of placing an order
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Impact of interventions on workflow
Time Frame: Within one hour of placing an order
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Compare the efficacy and workflow impact of two distinct interventions to prevent wrong-patient near miss CPOE errors against a control
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Within one hour of placing an order
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jason S Adelman, MD, MS, Montefiore Medical Center
Publications and helpful links
General 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.
- Koppel 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.
- Weiner 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.
- Campbell 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.
- Wachter 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 10-05-156E
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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