Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2026-01-08 @ 4:05 PM
Study NCT ID:
NCT06975033
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-16
First Post:
2025-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact of an Educational Discharge Video on Post-Operative Health Care Utilization After Holmium Laser Enucleation of the Prostate (HoLEP) Procedures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017060', 'term': 'Patient Satisfaction'}], 'ancestors': [{'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, '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': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 114}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-07', 'studyFirstSubmitDate': '2025-04-04', 'studyFirstSubmitQcDate': '2025-05-07', 'lastUpdatePostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Healthcare Utilization', 'timeFrame': 'up to 60 days (estimated time frame between initial surgery and first follow up visit)', 'description': 'Healthcare utilization will include MyChart messages, phone calls to clinic, unscheduled clinic visits, emergency/urgent care visits, etc.'}, {'measure': 'Participant Satisfaction', 'timeFrame': 'up to 60 days (estimated time frame between initial surgery and first follow up visit)', 'description': 'Patients will complete a patient satisfaction survey .This survey ranges from 1 (strongly agree) to 5 (strongly disagree).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HoLEP', 'Patient Satisfaction', 'Educational Video Intervention']}, 'descriptionModule': {'briefSummary': 'This will be a randomized interventional study. Patients scheduled to undergo a HoLEP at UCSF will be randomized into two groups after the procedure: one group will watch a scripted educational HoLEP video and the other group will not receive a video. We will monitor the post-operative care utilization after discharge. Secondary outcomes will include patient satisfaction.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adults aged 18+\n2. Patients scheduled for a HoLEP procedure\n3. Patients willing to complete both baseline and follow up surveys\n4. Patients able to provide informed consent\n5. Patients are English-speaking and understand English\n\nExclusion Criteria:\n\n1. Patients under 18+\n2. Patients unable to consent\n3. Patients unable to complete surveys\n4. Patients without a prostate.\n5. Patients are non-English speakers'}, 'identificationModule': {'nctId': 'NCT06975033', 'briefTitle': 'The Impact of an Educational Discharge Video on Post-Operative Health Care Utilization After Holmium Laser Enucleation of the Prostate (HoLEP) Procedures', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'The Impact of Discharge Educational Discharge Videos on Post-Operative Care Utilization After Holmium Laser Enucleation of the Prostate (HoLEP) Procedures', 'orgStudyIdInfo': {'id': '25-43311'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Video', 'description': 'Participants will watch video.', 'interventionNames': ['Other: Video']}, {'type': 'NO_INTERVENTION', 'label': 'No Video', 'description': 'Participants will not watch video.'}], 'interventions': [{'name': 'Video', 'type': 'OTHER', 'description': 'Participants will watch video.', 'armGroupLabels': ['Video']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'contacts': [{'name': 'David Bayne Bayne', 'role': 'CONTACT', 'email': 'david.bayne@ucsf.edu', 'phone': '617-571-5870'}], 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '14620', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'contacts': [{'name': 'Scott Quarrier Quarier', 'role': 'CONTACT', 'email': 'scott_quarrier@urmc.rochester.edu'}, {'name': 'Rajat Jain', 'role': 'CONTACT', 'email': 'rajat_jain@urmc.rochester.edu'}], 'facility': 'University of Rochester Medical Center', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '13210', 'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'contacts': [{'name': 'Scott Wiener Wiener', 'role': 'CONTACT', 'email': 'wienersc@upstate.edu', 'phone': '774-239-2512'}], 'facility': 'Scott SUNY Upstate Medical University', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}], 'centralContacts': [{'name': 'David Bayne, MD, MPH', 'role': 'CONTACT', 'email': 'david.bayne@ucsf.edu', 'phone': '617-571-5870'}], 'overallOfficials': [{'name': 'David Bayne, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'State University of New York - Upstate Medical University', 'class': 'OTHER'}, {'name': 'University of Rochester', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}