Pictographs for Preventing Wrong-Patient Errors in NICUs
|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: NCT03960099|
Recruitment Status : Not yet recruiting
First Posted : May 22, 2019
Last Update Posted : May 22, 2019
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||6250 participants|
|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|
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.
- 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.
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
|Contact: Jason Adelman, MD, MSemail@example.com|
|Contact: Jo Applebaum, MPHfirstname.lastname@example.org|
|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|
|New York, New York, United States, 10032|
|Contact: Jason S Adelman, MD,MS|
|Principal Investigator:||Jason Adelman, MD, MS||Columbia University|