Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2025-12-27 @ 9:05 AM
Study NCT ID:
NCT01126034
Status:
COMPLETED
Last Update Posted:
2015-12-04
First Post:
2010-05-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Metoclopramide Prescribing Practices at Penn Through a Physician-targeted Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005764', 'term': 'Gastroesophageal Reflux'}], 'ancestors': [{'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 85}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-03', 'studyFirstSubmitDate': '2010-05-17', 'studyFirstSubmitQcDate': '2010-05-18', 'lastUpdatePostDateStruct': {'date': '2015-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Discontinuation of metoclopramide therapy', 'timeFrame': '12 weeks after intervention period', 'description': 'Twelve weeks after the intervention period, we searched the medical records of patients in the intervention and non-intervention groups to determine whether discontinuation of metoclopramide therapy had taken place.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Metoclopramide', 'Randomized Controlled Trial'], 'conditions': ['Gastroesophageal Reflux Disease', 'Diabetic Gastroparesis']}, 'descriptionModule': {'briefSummary': 'The investigators hypothesized that:\n\n1\\) an intervention targeted at the prescribing physician would increase the rate of a metoclopramide discontinuation among patients prescribed the medication for questionable or unclear indications; and 2) the discontinuation would be durable.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Physicians at University of Pennsylvania Health System who ordered an active metoclopramide prescription with a questionable indication.\n\nExclusion Criteria:\n\n* Physicians-in-training (e.g., residents, fellows)\n* Physicians how were investigators on this study\n* Physicians serving on the the University of Pennsylvania Drug Use and Effects Committee or Information Technology Oversight Board'}, 'identificationModule': {'nctId': 'NCT01126034', 'briefTitle': 'Improving Metoclopramide Prescribing Practices at Penn Through a Physician-targeted Intervention', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Improving Metoclopramide Prescribing Practices at Penn Through a Physician-targeted Intervention', 'orgStudyIdInfo': {'id': 'UPenn - 802142'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intervention', 'description': 'Physicians in the intervention group were mailed a written feedback letter regarding their patients who were prescribed questionable metoclopramide therapy. Non-intervention providers received no letter. The letter consisted of the following components:\n\n1. The name and medical record # of the patients involved\n2. Information regarding the metoclopramide prescription: dates, dosage, indication recorded, and the duration of therapy\n3. A reminder of the adverse effect of long-term metoclopramide therapy\n4. A recommendation to consider having the patient undergo a trial of metoclopramide discontinuation if appropriate, and documentation of a discussion of risk and benefits of metoclopramide therapy with patients\n5. A request that the physician document the discontinuation trial in the electronic medical record', 'interventionNames': ['Other: intervention letter']}, {'type': 'NO_INTERVENTION', 'label': 'non-intervention', 'description': 'No intervention letters were sent to subjects in this arm'}], 'interventions': [{'name': 'intervention letter', 'type': 'OTHER', 'description': 'Physicians in the intervention group were mailed a written feedback letter regarding their patients who were prescribed questionable metoclopramide therapy. Non-intervention providers received no letter. The letter consisted of the following components:\n\n1. The name and medical record # of the patients involved\n2. Information regarding the metoclopramide prescription: dates, dosage, indication recorded, and the duration of therapy\n3. A reminder of the adverse effect of long-term metoclopramide therapy\n4. A recommendation to consider having the patient undergo a trial of metoclopramide discontinuation if appropriate, and documentation of a discussion of risk and benefits of metoclopramide therapy with patients\n5. A request that the physician document the discontinuation trial in the electronic medical record', 'armGroupLabels': ['intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania Center for Clinical Epidemiology and Biostatistics', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Yu-Xiao Yang, MD, MSCE', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}