Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2026-03-03 @ 2:42 PM
Study NCT ID:
NCT01775969
Status:
COMPLETED
Last Update Posted:
2013-10-25
First Post:
2013-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Modality on Discharge Instruction in Patients Receiving Outpatient Antibiotic Prescriptions From the Emergency Department
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2874}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-24', 'studyFirstSubmitDate': '2013-01-23', 'studyFirstSubmitQcDate': '2013-01-24', 'lastUpdatePostDateStruct': {'date': '2013-10-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '72-hour antibiotic pickup', 'timeFrame': '72 hours', 'description': 'Whether or not the patient picked up their antibiotic prescription at the pharmacy'}, {'measure': 'Antibiotic compliance', 'timeFrame': '30 days', 'description': 'If the patient completed the entire course of antibiotics'}]}, 'conditionsModule': {'conditions': ['Modality of Discharge Instructions']}, 'descriptionModule': {'briefSummary': 'Outpatient antibiotics are frequently prescribed from the emergency department, and limited health literacy may impact compliance with recommended treatments. The investigators are looking to determine if patient preference for multimodality discharge instructions for outpatient antibiotic therapy varies by health literacy level, and if modality effected patient-reported antibiotic compliance and 72-hour antibiotic pick-up.', 'detailedDescription': "This is a prospective randomized trial that includes consenting patients discharged with outpatient antibiotics. Health literacy is assessed using a validated health literacy assessment, the Newest Vital Sign (NVS). Patients are randomized to a discharge instruction modality: 1) standard of care, typed and verbal medication and case-specific instructions; 2) standard of care plus text messaged instructions sent to the patient's cell phone; or 3) standard of care plus voicemailed instructions sent to the patient's cell phone. Antibiotic pick-up is verified with the patient's pharmacy at 72 hours. Patients are called at 30 days to determine antibiotic compliance."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Emergency department patient being prescribed an outpatient antibiotic or the parent of a patient under the age of 18 being prescribed on outpatient antibiotic\n\nExclusion Criteria:\n\n* Doesn't have a cell phone that can receive text messages and voicemail messages\n* Unable to provide informed consent\n* Prisoners"}, 'identificationModule': {'nctId': 'NCT01775969', 'briefTitle': 'Effect of Modality on Discharge Instruction in Patients Receiving Outpatient Antibiotic Prescriptions From the Emergency Department', 'organization': {'class': 'OTHER', 'fullName': 'Hennepin Healthcare Research Institute'}, 'officialTitle': 'Effect of Modality on Discharge Instruction in Patients Receiving Outpatient Antibiotic Prescriptions From the Emergency Department', 'orgStudyIdInfo': {'id': '11-3329'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard of Care', 'description': 'Written discharge instructions only'}, {'type': 'EXPERIMENTAL', 'label': 'Text Message', 'description': 'Written discharge instructions plus a text message with antibiotic prescription instructions', 'interventionNames': ['Other: Text Message']}, {'type': 'EXPERIMENTAL', 'label': 'Voicemail', 'description': 'Written discharge instructions plus a voicemail with antibiotic prescription instructions', 'interventionNames': ['Other: Voicemail']}], 'interventions': [{'name': 'Text Message', 'type': 'OTHER', 'description': 'A text message with instructions is sent to the patient', 'armGroupLabels': ['Text Message']}, {'name': 'Voicemail', 'type': 'OTHER', 'description': 'A voicemail with instructions is sent to the patient', 'armGroupLabels': ['Voicemail']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55415', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Hennepin County Medical Center', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'James R Miner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hennepin Healthcare Research Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hennepin Healthcare Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}