Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2025-12-25 @ 3:14 PM
Study NCT ID:
NCT00256568
Status:
COMPLETED
Last Update Posted:
2011-12-15
First Post:
2005-11-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Outpatient Prescription Errors: Detection, Analysis, and Impact on Safety
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016907', 'term': 'Adverse Drug Reaction Reporting Systems'}], 'ancestors': [{'id': 'D011358', 'term': 'Product Surveillance, Postmarketing'}, {'id': 'D005069', 'term': 'Evaluation Studies as Topic'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D004346', 'term': 'Drug Information Services'}, {'id': 'D010593', 'term': 'Pharmaceutical Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 103}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-12-14', 'studyFirstSubmitDate': '2005-11-17', 'studyFirstSubmitQcDate': '2005-11-17', 'lastUpdatePostDateStruct': {'date': '2011-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-11-21', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Medical Errors', 'Medication Errors', 'Prescriptions, Drug', 'Pharmacies', 'Ambulatory Care Facilities'], 'conditions': ['Medication Errors']}, 'referencesModule': {'references': [{'pmid': '15372863', 'type': 'BACKGROUND', 'citation': 'Kennedy AG, Littenberg B. Medication error reporting by community pharmacists in Vermont. J Am Pharm Assoc (2003). 2004 Jul-Aug;44(4):434-8. doi: 10.1331/1544345041475724.'}, {'pmid': '12434730', 'type': 'BACKGROUND', 'citation': 'Kennedy AG, Littenberg B, Vezina LC. Vioxx-Viagra confusion. Am J Health Syst Pharm. 2002 Nov 1;59(21):2112. doi: 10.1093/ajhp/59.21.2112a. No abstract available.'}, {'pmid': '18430748', 'type': 'RESULT', 'citation': 'Kennedy AG, Littenberg B, Senders JW. Using nurses and office staff to report prescribing errors in primary care. Int J Qual Health Care. 2008 Aug;20(4):238-45. doi: 10.1093/intqhc/mzn015. Epub 2008 Apr 22.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to better understand outpatient prescribing errors through clinic and pharmacy-based error reporting systems.', 'detailedDescription': "Medication errors cause substantial morbidity and mortality in the United States. However, relatively little is known about medication errors in the outpatient setting. The broad goal of this proposal is to improve outpatient safety. Specifically, this research plan promotes the understanding of the causes of outpatient prescription errors. The specific aims of this project are:\n\n1. To develop and evaluate a novel reporting system in physicians' offices for detecting prescription errors\n2. To develop and evaluate a novel improvement system in community pharmacies to increase prescription error reporting by pharmacists\n3. To analyze reports of outpatient prescription errors and understand their root causes\n\nTo achieve these specific aims, statewide research will be conducted utilizing qualitative and quantitative methods including root cause analysis, failure mode and effects analysis, and surveys. This research plan will promote patient safety by furthering the understanding of the causes of outpatient prescription errors in all outpatient populations, including rural, women, children, elderly, low income, and the chronically ill."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Primary Care Practices', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Employed in a physician's office or community pharmacy\n\nExclusion Criteria:\n\n* Not employed in a physician's office or community pharmacy"}, 'identificationModule': {'nctId': 'NCT00256568', 'briefTitle': 'Outpatient Prescription Errors: Detection, Analysis, and Impact on Safety', 'organization': {'class': 'OTHER', 'fullName': 'University of Vermont'}, 'officialTitle': 'Outpatient Prescription Errors: Detection, Analysis, and Impact on Safety', 'orgStudyIdInfo': {'id': 'K08HS013891', 'link': 'https://reporter.nih.gov/quickSearch/K08HS013891', 'type': 'AHRQ'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Primary Care Practices', 'description': 'One hundred and three prescribers, managers, nurses and office staff at seven primary care practices in Vermont', 'interventionNames': ['Behavioral: reporting system']}], 'interventions': [{'name': 'reporting system', 'type': 'BEHAVIORAL', 'description': 'Nurses and office staff were asked to report all communications with community pharmacists regarding prescription problems', 'armGroupLabels': ['Primary Care Practices']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05401', 'city': 'Burlington', 'state': 'Vermont', 'country': 'United States', 'facility': 'University of Vermont, Division of General Internal Medicine', 'geoPoint': {'lat': 44.47588, 'lon': -73.21207}}], 'overallOfficials': [{'name': 'Amanda G Kennedy, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Vermont'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Vermont', 'class': 'OTHER'}, 'collaborators': [{'name': 'Agency for Healthcare Research and Quality (AHRQ)', 'class': 'FED'}, {'name': 'Vermont Program for Quality in Health Care', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Medicine', 'investigatorFullName': 'Amanda Kennedy', 'investigatorAffiliation': 'University of Vermont'}}}}