Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-03-06 @ 5:46 AM
Study NCT ID:
NCT00256594
Status:
COMPLETED
Last Update Posted:
2011-12-15
First Post:
2005-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of an Outpatient Modified Prescription Form
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2014-01-24', 'releaseDate': '2013-12-09'}], 'estimatedResultsFirstSubmitDate': '2013-12-09'}}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2011-01', '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'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'error rates of standard versus modified prescriptions per prescriber', 'timeFrame': '200 prescriptions each'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Medical Errors', 'Medication Errors', 'Prescriptions, Drug'], 'conditions': ['Medication Errors']}, 'referencesModule': {'references': [{'pmid': '15469125', 'type': 'BACKGROUND', 'citation': 'Kennedy AG, Littenberg B. A modified outpatient prescription form to reduce prescription errors. Jt Comm J Qual Saf. 2004 Sep;30(9):480-7. doi: 10.1016/s1549-3741(04)30056-0.'}, {'pmid': '21200063', 'type': 'RESULT', 'citation': 'Kennedy AG, Littenberg B, Callas PW, Carney JK. Evaluation of a modified prescription form to address prescribing errors. Am J Health Syst Pharm. 2011 Jan 15;68(2):151-7. doi: 10.2146/ajhp100063.'}, {'pmid': '19386937', 'type': 'RESULT', 'citation': 'Kennedy AG, Senders JW, Sellen K, Littenberg B, Callas PW, Carney JK. Perception of drug-name legibility by pharmacists and pharmacy technicians. Am J Health Syst Pharm. 2009 May 1;66(9):794-5. doi: 10.2146/ajhp080189. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if a modified paper prescribing form decreases prescribing errors compared to a traditional or standard paper prescribing form.', 'detailedDescription': 'The broad goal of this proposal is to reduce outpatient prescribing errors in rural primary care practices. Although computerized technology is available for prescribing, it has not yet been implemented in most settings. Additionally, rural prescribers will likely be the last to have the means to adopt this technology. Due to the substantial morbidity and mortality in the United States caused by outpatient medication errors, there is an urgent need for low-cost solutions. This research plan will evaluate a modified paper prescription form that may be implemented in rural primary care settings cheaply and quickly with the goal of outpatient prescription error reduction.\n\nThe specific aims of this project are:\n\n1. To determine if a modified paper prescription form decreases overall prescribing errors compared to a standard paper prescription form\n2. To determine if a modified paper prescription form decreases omission errors compared to a standard paper prescription form\n3. To determine prescriber satisfaction with the modified prescription form\n\nRural prescribers from four states will be randomly recruited to write prescriptions on standard and modified forms. Prescription duplicates of both types will be analyzed for errors. Prescriber satisfaction with the modified form will be evaluated using surveys and focus groups.\n\nMedication errors are a public health problem. Low-cost technology that is shown to reduce medication errors would benefit all rural patients who receive prescriptions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must be a physician, nurse practitioner, or physician assistant with a current license to write outpatient prescriptions\n* Must practice in Family Practice, Internal Medicine, or Pediatrics\n* Must practice in rural Vermont, West Virginia, South Dakota, or Montana\n* Must write outpatient paper prescriptions\n* Must write prescriptions in English\n\nExclusion Criteria:\n\n* Not licensed to write prescriptions\n* Practice in a specialty, inpatient, or long term care setting\n* Do not write paper prescriptions\n* Do not write prescriptions in English'}, 'identificationModule': {'nctId': 'NCT00256594', 'briefTitle': 'Evaluation of an Outpatient Modified Prescription Form', 'organization': {'class': 'OTHER', 'fullName': 'University of Vermont'}, 'officialTitle': 'Evaluation of an Outpatient Modified Paper Prescription Form in 4 Rural States to Address the Public Health Problem of Prescribing Error', 'orgStudyIdInfo': {'id': '1 R04RH05814-01-00'}}, 'armsInterventionsModule': {'interventions': [{'name': 'prescription form', 'type': 'DEVICE', 'description': 'Two prescription pads contained modified forms and two prescription pads were similar to the prescription pads the prescriber had been using. Providers completed 100 standard and 100 modified prescriptions'}]}, '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': 'Health Resources and Services Administration (HRSA)', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Medicine', 'investigatorFullName': 'Amanda Kennedy', 'investigatorAffiliation': 'University of Vermont'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2013-12-09', 'type': 'RELEASE'}, {'date': '2014-01-24', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Amanda Kennedy, Assistant Professor of Medicine, University of Vermont'}}}}