Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2026-01-02 @ 3:05 AM
Study NCT ID:
NCT01374295
Status:
COMPLETED
Last Update Posted:
2014-03-24
First Post:
2011-06-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Video Assisted Informed Consent for Lortab to Improve Patient Satisfaction and Knowledge
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014743', 'term': 'Videotape Recording'}], 'ancestors': [{'id': 'D013637', 'term': 'Tape Recording'}, {'id': 'D001296', 'term': 'Audiovisual Aids'}, {'id': 'D018961', 'term': 'Educational Technology'}, {'id': 'D013672', 'term': 'Technology'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}, {'id': 'D013690', 'term': 'Television'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-21', 'studyFirstSubmitDate': '2011-06-07', 'studyFirstSubmitQcDate': '2011-06-14', 'lastUpdatePostDateStruct': {'date': '2014-03-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'patient satisfaction and knowledge', 'timeFrame': 'survey is completed immediately after education, estimated time to complete survey is 5 minutes', 'description': 'comparison of patient completed survey following education via standard format or 3 minute video'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Non-critical Emergency Room Patients Receiving Lortab Medication or Prescription During Their Emergency Room Visit']}, 'descriptionModule': {'briefSummary': 'In order to compare two different forms of patient education; patients who receive Lortab medication or prescription during their ED visit are randomized to receive either standard patient education (from healthcare provider) or video assisted education. After education, patient completes a survey, estimated to take 5 minutes to complete.', 'detailedDescription': 'The purpose of this study is to compare different methods of teaching patients about their prescription medicines. It is possible that certain teaching methods are better than others at educating patients.\n\nPatients who receive Lortab medication or prescription during their ED visit and agree to the study are randomized to receive either standard patient education (from healthcare provider) or watch a 3 minute video. After the medication teaching has been provided the patient is given the medicine and a asked to complete a ten-question survey. This takes approximately five minutes and asks the patient to rate the quality of the information received.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* non-critical emergency room patients being prescribed Lortab\n* age 18 year or older\n\nExclusion Criteria:\n\n* emergency room patients not receiving Lortab as their first prescribed medication\n* age less than 18 years'}, 'identificationModule': {'nctId': 'NCT01374295', 'briefTitle': 'Video Assisted Informed Consent for Lortab to Improve Patient Satisfaction and Knowledge', 'organization': {'class': 'OTHER', 'fullName': 'Albany Medical College'}, 'officialTitle': 'Video Assisted Informed Consent for Lortab to Improve Patient Satisfaction and Knowledge: A Randomized Control Study', 'orgStudyIdInfo': {'id': '2981'}, 'secondaryIdInfos': [{'id': 'Lortab'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'video', 'description': 'If randomized to this arm patient watches a 3 minute video', 'interventionNames': ['Other: video']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'standard education', 'description': 'If randomized to this arm patient receives standard verbal education from healthcare provider.', 'interventionNames': ['Other: standard education']}], 'interventions': [{'name': 'video', 'type': 'OTHER', 'description': 'watch a 3 minute video', 'armGroupLabels': ['video']}, {'name': 'standard education', 'type': 'OTHER', 'description': 'Receives standard verbal education from healthcare provider', 'armGroupLabels': ['standard education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12208', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'Albany Medical Center', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Albany Medical College', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Dept. of Emergency Medicine', 'investigatorFullName': 'Wayne Triner', 'investigatorAffiliation': 'Albany Medical College'}}}}