Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2026-01-04 @ 5:09 PM
Study NCT ID:
NCT03626766
Status:
COMPLETED
Last Update Posted:
2025-03-17
First Post:
2018-08-06
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluating the Impact of Patient Photographs for Preventing Wrong-Patient Errors
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'akl17@cumc.columbia.edu', 'phone': '(917) 628-6522', 'title': 'Dr. Anthony Lin', 'organization': 'Columbia University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected over 2 years (11/17/2021 - 11/16/2023).', 'eventGroups': [{'id': 'EG000', 'title': 'Photo in Verification Alert', 'description': 'Patient photo displayed in a patient ID verification alert when placing electronic orders in the electronic health record.\n\nPhoto in Verification Alert: Patient photograph displayed in a patient ID verification alert when placing electronic orders in the electronic health record.', 'otherNumAtRisk': 2171, 'deathsNumAtRisk': 2171, 'otherNumAffected': 0, 'seriousNumAtRisk': 2171, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Photo in Banner', 'description': 'Patient photo displayed in the banner (at the top of the screen).\n\nPhoto in Banner: Patient photograph will be displayed in the banner at the top of the screen in the electronic health record.', 'otherNumAtRisk': 2202, 'deathsNumAtRisk': 2202, 'otherNumAffected': 0, 'seriousNumAtRisk': 2202, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Photo in Banner and Verification Alert', 'description': 'Patient photograph displayed in the banner (at the top of the screen) AND patient photo displayed in a verification alert when placing electronic orders.\n\nPhoto 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.', 'otherNumAtRisk': 2196, 'deathsNumAtRisk': 2196, 'otherNumAffected': 0, 'seriousNumAtRisk': 2196, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'No Photo', 'description': 'No patient photographs displayed in the electronic health record.', 'otherNumAtRisk': 2199, 'deathsNumAtRisk': 2199, 'otherNumAffected': 0, 'seriousNumAtRisk': 2199, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Order Sessions With at Least One Retract-and-Reorder (RAR) Event as Identified by the Wrong-Patient Retract-and-Reorder (RAR) Measure.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2171', 'groupId': 'OG000'}, {'value': '2202', 'groupId': 'OG001'}, {'value': '2196', 'groupId': 'OG002'}, {'value': '2199', 'groupId': 'OG003'}]}, {'units': 'order sessions', 'counts': [{'value': '3948077', 'groupId': 'OG000'}, {'value': '3958269', 'groupId': 'OG001'}, {'value': '4028011', 'groupId': 'OG002'}, {'value': '4007833', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Photo in Verification Alert', 'description': 'Patient photo displayed in a patient ID verification alert when placing electronic orders in the electronic health record.\n\nPhoto in Verification Alert: Patient photograph displayed in a patient ID verification alert when placing electronic orders in the electronic health record.'}, {'id': 'OG001', 'title': 'Photo in Banner', 'description': 'Patient photo displayed in the banner (at the top of the screen).\n\nPhoto in Banner: Patient photograph will be displayed in the banner at the top of the screen in the electronic health record.'}, {'id': 'OG002', 'title': 'Photo in Banner and Verification Alert', 'description': 'Patient photograph displayed in the banner (at the top of the screen) AND patient photo displayed in a verification alert when placing electronic orders.\n\nPhoto 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.'}, {'id': 'OG003', 'title': 'No Photo', 'description': 'No patient photographs displayed in the electronic health record.'}], 'classes': [{'categories': [{'measurements': [{'value': '5587', 'groupId': 'OG000'}, {'value': '5836', 'groupId': 'OG001'}, {'value': '5598', 'groupId': 'OG002'}, {'value': '6279', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years', 'description': 'Using the Wrong-Patient (WP) Retract-and-Reorder measure, the outcome was WP order sessions, defined as series of orders placed by 1 clinician for 1 patient that included ≥1 WP order. 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.', 'unitOfMeasure': 'WP Order Sessions', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'order sessions', 'denomUnitsSelected': 'order sessions'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Photo in Verification Alert', 'description': 'Patient photo displayed in a patient ID verification alert when placing electronic orders in the electronic health record.\n\nPhoto in Verification Alert: Patient photograph displayed in a patient ID verification alert when placing electronic orders in the electronic health record.'}, {'id': 'FG001', 'title': 'Photo in Banner', 'description': 'Patient photo displayed in the banner (at the top of the screen).\n\nPhoto in Banner: Patient photograph will be displayed in the banner at the top of the screen in the electronic health record.'}, {'id': 'FG002', 'title': 'Photo in Banner and Verification Alert', 'description': 'Patient photograph displayed in the banner (at the top of the screen) AND patient photo displayed in a verification alert when placing electronic orders.\n\nPhoto 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.'}, {'id': 'FG003', 'title': 'No Photo', 'description': 'No patient photographs displayed in the electronic health record.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2610'}, {'groupId': 'FG001', 'numSubjects': '2608'}, {'groupId': 'FG002', 'numSubjects': '2602'}, {'groupId': 'FG003', 'numSubjects': '2606'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2171'}, {'groupId': 'FG001', 'numSubjects': '2202'}, {'groupId': 'FG002', 'numSubjects': '2196'}, {'groupId': 'FG003', 'numSubjects': '2199'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '439'}, {'groupId': 'FG001', 'numSubjects': '406'}, {'groupId': 'FG002', 'numSubjects': '406'}, {'groupId': 'FG003', 'numSubjects': '407'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2171', 'groupId': 'BG000'}, {'value': '2202', 'groupId': 'BG001'}, {'value': '2196', 'groupId': 'BG002'}, {'value': '2199', 'groupId': 'BG003'}, {'value': '8768', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Photo in Verification Alert', 'description': 'Patient photo displayed in a patient ID verification alert when placing electronic orders in the electronic health record.\n\nPhoto in Verification Alert: Patient photograph displayed in a patient ID verification alert when placing electronic orders in the electronic health record.'}, {'id': 'BG001', 'title': 'Photo in Banner', 'description': 'Patient photo displayed in the banner (at the top of the screen).\n\nPhoto in Banner: Patient photograph will be displayed in the banner at the top of the screen in the electronic health record.'}, {'id': 'BG002', 'title': 'Photo in Banner and Verification Alert', 'description': 'Patient photograph displayed in the banner (at the top of the screen) AND patient photo displayed in a verification alert when placing electronic orders.\n\nPhoto 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.'}, {'id': 'BG003', 'title': 'No Photo', 'description': 'No patient photographs displayed in the electronic health record.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '>18 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2171', 'groupId': 'BG000'}, {'value': '2202', 'groupId': 'BG001'}, {'value': '2196', 'groupId': 'BG002'}, {'value': '2199', 'groupId': 'BG003'}, {'value': '8768', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '2171', 'groupId': 'BG000'}, {'value': '2202', 'groupId': 'BG001'}, {'value': '2196', 'groupId': 'BG002'}, {'value': '2199', 'groupId': 'BG003'}, {'value': '8768', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Sex and gender were not collected from any participant.'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2171', 'groupId': 'BG000'}, {'value': '2202', 'groupId': 'BG001'}, {'value': '2196', 'groupId': 'BG002'}, {'value': '2199', 'groupId': 'BG003'}, {'value': '8768', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '2171', 'groupId': 'BG000'}, {'value': '2202', 'groupId': 'BG001'}, {'value': '2196', 'groupId': 'BG002'}, {'value': '2199', 'groupId': 'BG003'}, {'value': '8768', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-10-01', 'size': 363552, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-02-21T16:12', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10426}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-26', 'studyFirstSubmitDate': '2018-08-06', 'resultsFirstSubmitDate': '2025-01-17', 'studyFirstSubmitQcDate': '2018-08-09', 'lastUpdatePostDateStruct': {'date': '2025-03-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-02-26', 'studyFirstPostDateStruct': {'date': '2018-08-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Order Sessions With at Least One Retract-and-Reorder (RAR) Event as Identified by the Wrong-Patient Retract-and-Reorder (RAR) Measure.', 'timeFrame': '2 years', 'description': 'Using the Wrong-Patient (WP) Retract-and-Reorder measure, the outcome was WP order sessions, defined as series of orders placed by 1 clinician for 1 patient that included ≥1 WP order. 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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Allscripts', 'Epic', 'Electronic Health Record (EHR)', 'Electronic orders'], 'conditions': ['Medical Errors', 'Electronic Medical Records']}, 'referencesModule': {'references': [{'pmid': '22753810', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'This is a multi-site, 4-arm 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 several 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.', 'detailedDescription': "Although Computerized provider order entry (CPOE) systems are associated with a reduction in medical errors, when orders are placed electronically certain types of errors, including placing orders on the wrong patient, may occur more frequently. The danger of wrong-patient electronic orders was highlighted by one hospital's report of over 5,000 wrong patient orders in 1 year. With the growing use of electronic health records (EHRs), an effective method to minimize wrong-patient orders is needed. One study showed that patient photographs displayed in EHR systems decreased wrong-patient orders from 12 to 3 per year after patient photographs were implemented. While encouraging, this study was limited due to its small sample size, compared outcomes of the intervention participants to outcomes of a comparison group similar in demographics but may have differed in ways that were not measured in the study (quasi-experimental design), and reliance on voluntary reporting of errors by providers, which is known to be unreliable and greatly underestimate the actual error rate. This research proposes to use an automated and reliable measure of wrong-patient errors instead of voluntary reporting will demonstrate that patient photographs can significantly prevent wrong-patient orders."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients for whom an order was placed in the study period.\n* All providers with the authority to place electronic orders and who placed electronic orders during the study period.\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT03626766', 'briefTitle': 'Evaluating the Impact of Patient Photographs for Preventing Wrong-Patient Errors', 'organization': {'class': 'OTHER', 'fullName': 'Columbia University'}, 'officialTitle': 'A Randomized Controlled Trial Evaluating the Effectiveness of Displaying Patient Photographs in an Electronic Health Record to Prevent Wrong-Patient Electronic Orders', 'orgStudyIdInfo': {'id': 'AAAR0080'}, 'secondaryIdInfos': [{'id': 'R01HS024713', 'link': 'https://reporter.nih.gov/quickSearch/R01HS024713', 'type': 'AHRQ'}, {'id': 'R01HD094793', 'link': 'https://reporter.nih.gov/quickSearch/R01HD094793', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Photo in Verification Alert', 'description': 'Patient photo displayed in a patient ID verification alert when placing electronic orders in the electronic health record.', 'interventionNames': ['Behavioral: Photo in Verification Alert']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Photo in Banner', 'description': 'Patient photo displayed in the banner (at the top of the screen).', 'interventionNames': ['Behavioral: Photo in Banner']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Photo in Banner and Verification Alert', 'description': 'Patient photograph displayed in the banner (at the top of the screen) AND patient photo displayed in a verification alert when placing electronic orders.', 'interventionNames': ['Behavioral: Photo in Banner and Verification Alert']}, {'type': 'NO_INTERVENTION', 'label': 'No Photo', 'description': 'No patient photographs displayed in the electronic health record.'}], 'interventions': [{'name': 'Photo in Verification Alert', 'type': 'BEHAVIORAL', 'description': 'Patient photograph displayed in a patient ID verification alert when placing electronic orders in the electronic health record.', 'armGroupLabels': ['Photo in Verification Alert']}, {'name': 'Photo in Banner', 'type': 'BEHAVIORAL', 'description': 'Patient photograph will be displayed in the banner at the top of the screen in the electronic health record.', 'armGroupLabels': ['Photo in Banner']}, {'name': 'Photo in Banner and Verification Alert', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Photo in Banner and Verification Alert']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Medicine', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Irving Medical Center / NewYork-Presbyterian Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Weill Cornell Medical Center - Weill Cornell Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Jason S. Adelman, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Columbia University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Agency for Healthcare Research and Quality (AHRQ)', 'class': 'FED'}, {'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}, {'name': 'Montefiore Medical Center', 'class': 'OTHER'}, {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}