NCT01262053

Brief 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". 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,028

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

December 15, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 17, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

September 11, 2018

Status Verified

September 1, 2018

Enrollment Period

5 months

First QC Date

December 15, 2010

Last Update Submit

September 7, 2018

Conditions

Keywords

Computerized Physician Order EntryCPOEWrong PatientJuxtapositionPatient SafetyMedical Errors

Outcome Measures

Primary Outcomes (1)

  • Reduction of wrong patient CPOE errors

    Compare reduction of wrong patient CPOE errors in each intervention group against a control

    Within one hour of placing an order

Secondary Outcomes (1)

  • Impact of interventions on workflow

    Within one hour of placing an order

Study Arms (3)

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.

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.

Other: Active Intervention

Control

ACTIVE COMPARATOR

Parallel control with no intervention

Other: Control

Interventions

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).

Passive Intervention

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.

Active Intervention
ControlOTHER

Parallel control with no intervention

Control

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All providers that place order in the Computerized Physician Order Entry (CPOE) System

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Related Publications (5)

  • 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.

    PMID: 17460127BACKGROUND
  • 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.

    PMID: 15755942BACKGROUND
  • 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.

    PMID: 17329719BACKGROUND
  • 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.

    PMID: 16799128BACKGROUND
  • 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.

    PMID: 16788133BACKGROUND

Study Officials

  • Jason S Adelman, MD, MS

    Montefiore Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
OTHER
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2010

First Posted

December 17, 2010

Study Start

December 1, 2010

Primary Completion

May 1, 2011

Study Completion

June 1, 2011

Last Updated

September 11, 2018

Record last verified: 2018-09

Locations