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Pictographs for Preventing Wrong-Patient Errors in NICUs

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ClinicalTrials.gov Identifier: NCT03960099
Recruitment Status : Not yet recruiting
First Posted : May 22, 2019
Last Update Posted : May 22, 2019
Sponsor:
Collaborators:
Albert Einstein College of Medicine
Johns Hopkins University
Brigham and Women's Hospital
Information provided by (Responsible Party):
Jason Adelman, Columbia University

Brief Summary:

Newborns in the neonatal intensive care unit (NICU) are at high risk for wrong-patient errors. Effective 2019, The Joint Commission requires that health systems adopt distinct methods of newborn identification as part of its National Patient Safety Goals. Displaying patient photographs in the electronic health record (EHR) is a promising strategy to improve identification of children and adults, but is unlikely to be effective for identifying newborns. This study assesses the use of Pictographs as a "photo equivalent" for improving identification of newborns in the NICU.

This multi-site, two-arm, parallel group, cluster randomized controlled trial will test the effectiveness of Pictographs for preventing wrong-patient order errors in the NICU. Pictographs consist of three elements: 1) pictorial symbols of easy-to-remember objects (e.g., rainbow, lion); 2) the infant's given name (when available); and 3) a color-coded border indicating the infant's sex. The study will be conducted at three academic medical centers that utilize Epic EHR. All parents or guardians will be asked to select a unique Pictograph for each infant admitted to the NICU to be displayed on the isolette and in the EHR for the duration of the infant's hospital stay. All clinicians with the authority to place electronic orders in the study NICUs will be randomly assigned to either the intervention arm (Pictographs displayed in the EHR) or the control arm (no Pictographs displayed in the EHR). The main hypothesis is that clinicians assigned to view Pictographs in the EHR will have a significantly lower rate of wrong-patient order errors in the NICU versus clinicians assigned to no Pictographs.

The primary outcome is wrong-patient order sessions, defined as a series of orders placed for a single patient by a single clinician that contains at least one wrong-patient order. The Wrong-Patient Retract-and-Reorder (RAR) measure, a validated, reliable, and automated method for identifying wrong-patient orders, will be used as the primary outcome measure. The Wrong-Patient RAR measure identifies one or more orders placed for a patient that are retracted within 10 minutes, and then reordered by the same clinician for a different patient within the next 10 minutes. In the validation study conducted at a large academic medical center, real-time telephone interviews with clinicians confirmed that 76.2% of RAR events were correctly identified by the measure as wrong-patient orders.


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

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Assessing the Effectiveness of Pictographs for Preventing Wrong-Patient Errors in Neonatal Intensive Care Units: A Randomized Controlled Trial
Estimated Study Start Date : January 1, 2020
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022

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

No Intervention: No Pictograph
No patient Pictographs displayed in the electronic health record.



Primary Outcome Measures :
  1. Wrong-patient order sessions that contain 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 primary outcome is wrong-patient order sessions, defined as a series of orders placed for a single patient by a single clinician that contains at least one wrong-patient order. We will use the Wrong-Patient Retract-and-Reorder (RAR) measure, a validated, reliable, and automated method endorsed by the National Quality Forum (NQF #2723) to identify wrong-patient orders. The Wrong-Patient RAR measure identifies RAR events, defined as one or more orders placed for a patient that are retracted within 10 minutes, and then reordered by the same clinician for a different patient within the next 10 minutes.



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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 infants receiving care in the study NICUs for whom an order was placed during the study period.
  • All clinicians with the authority to place electronic orders in the NICU 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): NCT03960099


Contacts
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Contact: Jason Adelman, MD, MS 646-317-4803 jsa2163@cumc.columbia.edu
Contact: Jo Applebaum, MPH 347-802-5923 joa9145@nyp.org

Locations
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United States, Maryland
Johns Hopkins Medicine
Baltimore, Maryland, United States, 21287
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10461
New York-Presbyterian Hospital Not yet recruiting
New York, New York, United States, 10032
Contact: Jason S Adelman, MD,MS         
Sponsors and Collaborators
Columbia University
Albert Einstein College of Medicine
Johns Hopkins University
Brigham and Women's Hospital
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: NCT03960099     History of Changes
Other Study ID Numbers: AAAR0800
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be shared with qualified investigators whose research protocols have been IRB-approved by their institutions. The final data set will include retract-and-reorder events (representing near-miss, wrong-patient errors), as well as clinician, patient, and order level characteristics. The final data set will be de-identified, with personal identifiers replaced with pseudo-identifiers. Data will be made available to potential users under a data-sharing agreement that ensures that: (1) data are used only for research purposes and does identify individual participants; (2) data are handled in a secure and confidential way; and (3) data are destroyed or returned after analyses are completed.
Time Frame: Data will be made available upon publication of the primary results.
Access Criteria: Data will be transferred using a secure file transfer protocol upon request to the PI.

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