Pictographs for Preventing Wrong-Patient Errors in NICUs
Assessing the Effectiveness of Pictographs for Preventing Wrong-Patient Errors in Neonatal Intensive Care Units: A Randomized Controlled Trial
2 other identifiers
interventional
6,250
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2022
Longer than P75 for not_applicable
4 active sites
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
First Submitted
Initial submission to the registry
May 20, 2019
CompletedFirst Posted
Study publicly available on registry
May 22, 2019
CompletedStudy Start
First participant enrolled
March 16, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2028
March 16, 2026
March 1, 2026
5.3 years
May 20, 2019
March 12, 2026
Conditions
Outcome Measures
Primary Outcomes (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.
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.
2.5 years
Study Arms (2)
Pictograph in Banner and Verification Alert
ACTIVE COMPARATORPatient Pictograph displayed in the banner (at the top of the screen) AND Pictograph displayed in a verification alert when placing electronic orders.
No Pictograph
NO INTERVENTIONNo patient Pictographs displayed in the electronic health record.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Columbia Universitylead
- Albert Einstein College of Medicinecollaborator
- Johns Hopkins Universitycollaborator
- Brigham and Women's Hospitalcollaborator
- Weill Medical College of Cornell Universitycollaborator
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)collaborator
Study Sites (4)
Johns Hopkins Medicine
Baltimore, Maryland, 21287, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
New York-Presbyterian Hospital
New York, New York, 10032, United States
Montefiore Medical Center
The Bronx, New York, 10461, United States
Related Publications (5)
Adelman JS, Kalkut GE, Schechter CB, Weiss JM, Berger MA, Reissman SH, Cohen HW, Lorenzen SJ, Burack DA, Southern WN. Understanding and preventing wrong-patient electronic orders: a randomized controlled trial. J Am Med Inform Assoc. 2013 Mar-Apr;20(2):305-10. doi: 10.1136/amiajnl-2012-001055. Epub 2012 Jun 29.
PMID: 22753810BACKGROUNDAdelman JS, Aschner JL, Schechter CB, Angert RM, Weiss JM, Rai A, Berger MA, Reissman SH, Yongue C, Chacko B, Dadlez NM, Applebaum JR, Racine AD, Southern WN. Evaluating Serial Strategies for Preventing Wrong-Patient Orders in the NICU. Pediatrics. 2017 May;139(5):e20162863. doi: 10.1542/peds.2016-2863.
PMID: 28557730BACKGROUNDAdelman JS, Aschner JL, Schechter CB, Angert RM, Weiss JM, Rai A, Parakkattu V, Goffman D, Applebaum JR, Racine AD, Southern WN. Babyboy/Babygirl: A National Survey on the Use of Temporary, Nondistinct Naming Conventions for Newborns in Neonatal Intensive Care Units. Clin Pediatr (Phila). 2017 Oct;56(12):1157-1159. doi: 10.1177/0009922817701178. Epub 2017 Apr 12. No abstract available.
PMID: 28403654BACKGROUNDAdelman JS, Applebaum JR, Schechter CB, Berger MA, Reissman SH, Thota R, Racine AD, Vawdrey DK, Green RA, Salmasian H, Schiff GD, Wright A, Landman A, Bates DW, Koppel R, Galanter WL, Lambert BL, Paparella S, Southern WN. Effect of Restriction of the Number of Concurrently Open Records in an Electronic Health Record on Wrong-Patient Order Errors: A Randomized Clinical Trial. JAMA. 2019 May 14;321(18):1780-1787. doi: 10.1001/jama.2019.3698.
PMID: 31087021BACKGROUNDAdelman J, Aschner J, Schechter C, Angert R, Weiss J, Rai A, Berger M, Reissman S, Parakkattu V, Chacko B, Racine A, Southern W. Use of Temporary Names for Newborns and Associated Risks. Pediatrics. 2015 Aug;136(2):327-33. doi: 10.1542/peds.2015-0007. Epub 2015 Jul 13.
PMID: 26169429BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Jason Adelman, MD, MS
Columbia University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Medicine, Chief Patient Safety Officer
Study Record Dates
First Submitted
May 20, 2019
First Posted
May 22, 2019
Study Start
March 16, 2022
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
June 30, 2028
Last Updated
March 16, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- 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.
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.