Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2025-12-26 @ 2:02 AM
Study NCT ID:
NCT00153205
Status:
WITHDRAWN
Last Update Posted:
2017-02-16
First Post:
2005-09-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Serious Medication Errors in Pediatrics: Evaluation of Prevention Strategies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D050316', 'term': 'Medical Order Entry Systems'}], 'ancestors': [{'id': 'D006751', 'term': 'Hospital Information Systems'}, {'id': 'D006739', 'term': 'Hospital Administration'}, {'id': 'D058016', 'term': 'Health Facility Administration'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D008331', 'term': 'Management Information Systems'}, {'id': 'D016347', 'term': 'Medical Records Systems, Computerized'}, {'id': 'D008499', 'term': 'Medical Records'}, {'id': 'D011996', 'term': 'Records'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2000-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-14', 'studyFirstSubmitDate': '2005-09-08', 'studyFirstSubmitQcDate': '2005-09-08', 'lastUpdatePostDateStruct': {'date': '2017-02-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'serious medication errors'}]}, 'conditionsModule': {'keywords': ['medication errors', 'medical records systems, computerized', 'patient safety'], 'conditions': ['Medication Errors']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine how effective ward-based clinical pharmacists and computerized physician order entry systems are in reducing serious medication errors in pediatric inpatients.', 'detailedDescription': "This is a prospective cohort study at Children's Hospital and Brigham and Women's Hospital (BWH), before and after the introduction of two distinct interventions. The first intervention at Children's Hospital was the introduction of clinical pharmacists on inpatient pediatric wards to target errors at the stages of physician ordering and nurse transcription. The second intervention is technological: the introduction of physician computer order entry at the BWH neonatal intensive care unit (NICU). This intervention will most effectively target errors at the stage of physician ordering, and secondarily address errors at the stage of pharmacy dispensing and nurse transcription. Data on serious medication errors will be collected pre and post each intervention."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients in the BWH NICU in the study pods during the study period\n\nExclusion Criteria:\n\n* Patients in other units, non-study pods, or outside of the study period'}, 'identificationModule': {'nctId': 'NCT00153205', 'briefTitle': 'Serious Medication Errors in Pediatrics: Evaluation of Prevention Strategies', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'Serious Medication Errors in Pediatrics: Evaluation of Prevention Strategies', 'orgStudyIdInfo': {'id': '2005-P-000322/1; BWH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Introduction of A Clinical Pharmacist', 'interventionNames': ['Behavioral: computerized physician order entry']}, {'type': 'EXPERIMENTAL', 'label': 'Technological', 'interventionNames': ['Behavioral: computerized physician order entry']}], 'interventions': [{'name': 'computerized physician order entry', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Introduction of A Clinical Pharmacist', 'Technological']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02120', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Rainu Kaushal', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'BWH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'National Patient Safety Foundation', 'class': 'OTHER'}, {'name': "Boston Children's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Rainu Kaushal, MD', 'investigatorFullName': 'Rainu Kaushal, MD', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}