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Evaluating the Impact of Patient Photographs for Preventing Wrong-Patient Errors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03626766
Recruitment Status : Recruiting
First Posted : August 13, 2018
Last Update Posted : September 25, 2018
Sponsor:
Collaborator:
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
Jason Adelman, Columbia University

Brief Summary:

This is a multi-site, cluster-randomized controlled trial to test the effectiveness of patient photographs displayed in electronic health record (EHR) systems to prevent wrong-patient order errors. The study will be conducted at three academic medical centers that utilize two different EHR systems. Because EHR systems have different functionality for displaying patient photographs, two different study designs will be employed. In Allscripts EHR, a 2-arm randomized trial will be conducted in which providers are randomized to view order verification alerts with versus without patient photographs when placing electronic orders. In Epic EHR, a 2x2 factorial trial will be conducted in which providers are randomized to one of four conditions: 1) no photograph; 2) photograph displayed in the banner only; 3) photograph displayed in a verification alert only; or 4) photograph displayed in the banner and verification alert. The main hypothesis of this study is that displaying patient photographs in the EHR will significantly reduce the frequency of wrong-patient order errors, providing health systems with the evidence needed to adopt this safety practice.

We will use the Wrong-Patient Retract-and-Reorder (RAR) measure, a valid, reliable, and automated method for identifying wrong-patient orders, as the primary outcome measure. The RAR measure identifies orders placed for a patient that are retracted within 10 minutes, and then reordered by the same provider for a different patient within the next 10 minutes. These are near-miss errors, self-caught by the provider before they reach the patient and cause harm. In one study, the RAR measure identified more than 5,000 wrong-patient orders in 1 year, with a rate of 58 wrong-patient errors per 100,000 orders. Real-time telephone interviews with clinicians determined that the RAR measure correctly identified near-miss errors in 76.2% of cases. Thus, the RAR measure provides sufficient valid and reliable outcome data for this study.


Condition or disease Intervention/treatment Phase
Medical Errors Electronic Medical Records Behavioral: Photo in Verification Alert Behavioral: Photo in Banner Behavioral: Photo in Banner and Verification Alert Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20268 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A Randomized Controlled Trial Evaluating the Effectiveness of Displaying Patient Photographs in an Electronic Health Record to Prevent Wrong-Patient Electronic Orders
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021

Arm Intervention/treatment
Active Comparator: Photo in Verification Alert
Patient photo displayed in a patient ID verification alert when placing electronic orders in the electronic health record.
Behavioral: Photo in Verification Alert
Patient photograph displayed in a patient ID verification alert when placing electronic orders in the electronic health record.

Active Comparator: Photo in Banner
Patient photo displayed in the banner (at the top of the screen).
Behavioral: Photo in Banner
Patient photograph will be displayed in the banner at the top of the screen in the electronic health record.

Active Comparator: Photo in Banner and Verification Alert
Patient photograph displayed in the banner (at the top of the screen) AND patient photo displayed in a verification alert when placing electronic orders.
Behavioral: Photo in Banner and Verification Alert
Patient photograph will be displayed in the banner at the top of the screen in the electronic health record AND patient photograph displayed in a patient ID verification alert when placing electronic orders in the electronic health record.

No Intervention: No Photo
No patient photographs displayed in the electronic health record.



Primary Outcome Measures :
  1. Frequency of order sessions with at least one Retract-and-Reorder (RAR) event as identified by the Wrong-Patient Retract-and-Reorder (RAR) measure. [ Time Frame: 2.5 years ]
    The Wrong-Patient Retract-and-Reorder (RAR) measure is an automated, validated, and reliable measure endorsed by the National Quality Forum (NQF #2723). The RAR measure identifies orders placed for a patient that are retracted within 10 minutes, and then placed by the same provider for a different patient within the next 10 minutes. These are near-miss errors, self-caught by the provider before they reach the patient and cause harm. In one study, the RAR measure identified more than 5,000 wrong-patient orders in 1 year, with a rate of 58 wrong-patient errors per 100,000 orders. Real-time telephone interviews with providers determined that the RAR measure correctly identified near-miss errors in 76.2% of cases). Thus, the RAR measure provides sufficient valid and reliable outcome data for this study.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients for whom an order was placed in the study period.
  • All providers with the authority to place electronic orders and who placed electronic orders during the study period.

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03626766


Contacts
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Contact: Jason Adelman, MD,MS 646-317-4803 adelman.jason@columbia.edu
Contact: Jo Applebaum, MPH 212-304-5540 joa9145@nyp.org

Locations
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United States, Maryland
Johns Hopkins Medicine Not yet recruiting
Baltimore, Maryland, United States, 21287
Contact: Allen Chen, MD, PhD         
United States, New York
Montefiore Medical Center Not yet recruiting
Bronx, New York, United States, 10461
Contact: William Southern, MD, MS         
New York-Presbyterian Hospital Recruiting
New York, New York, United States, 10032
Principal Investigator: Jason S Adelman, MD         
Sponsors and Collaborators
Columbia University
Agency for Healthcare Research and Quality (AHRQ)
Investigators
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Principal Investigator: Jason Adelman, MD,MS Columbia University
Publications:
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Responsible Party: Jason Adelman, Assistant Professor of Medicine, Chief Patient Safety Officer, Columbia University
ClinicalTrials.gov Identifier: NCT03626766    
Other Study ID Numbers: AAAR0080
First Posted: August 13, 2018    Key Record Dates
Last Update Posted: September 25, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No