Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2026-02-22 @ 6:46 PM
Study NCT ID:
NCT02970435
Status:
TERMINATED
Last Update Posted:
2021-01-25
First Post:
2016-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating the Impact of Video Discharge Instructions for Mohs Surgery Post-Operative Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'whyStopped': 'Slow accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-07-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2019-06-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-21', 'studyFirstSubmitDate': '2016-11-18', 'studyFirstSubmitQcDate': '2016-11-18', 'lastUpdatePostDateStruct': {'date': '2021-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ratio of patients in the intervention group who call the clinic compared to percentage of patients in the control group who call the clinic', 'timeFrame': 'Up to 8 weeks after discharge', 'description': 'Researchers will record when each participant calls the clinic. The number of people who call in the intervention group will be compared to the number of people who call in the control group. This will give an efficacy measure of the video discharge instructions'}], 'secondaryOutcomes': [{'measure': 'Difference in knowledge of discharge instructions in intervention group versus control group', 'timeFrame': 'Up to 8 weeks after discharge', 'description': 'Answers to survey questions investigating knowledge of discharge instruction will be compared between the control and intervention groups.'}, {'measure': 'Difference in confidence in intervention group versus control group', 'timeFrame': 'Up to 8 weeks after discharge', 'description': 'A survey investigating confidence about Mohs surgery post-operative care will be used in this study. This survey will be quantified using the Likert scale.'}, {'measure': 'Difference in satisfaction in intervention group versus control group', 'timeFrame': 'Up to 8 weeks after discharge', 'description': 'A survey investigating patient satisfaction about Mohs surgery post-operative care will be used in this study. This survey will be quantified using the Likert scale.'}, {'measure': 'Difference in self reported anxiety levels in intervention group versus control group', 'timeFrame': 'Up to 8 weeks after discharge', 'description': 'A survey investigating anxiety about Mohs surgery post-operative care will be used in this study. This survey will be quantified using the Likert scale.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['surgery', 'video discharge instructions'], 'conditions': ['Linear Closure', 'Surgery']}, 'descriptionModule': {'briefSummary': 'The purpose of this research is to look at how educational videos provided by doctors might affect patients knowledge, satisfaction, confidence, and anxiety with post-operative Mohs surgery care. Patients will be randomized to either: 1) a group that receives educational videos in addition to standard-of-care written and verbal instructions or 2) a group that receives only standard-of-care written and verbal instructions.', 'detailedDescription': "The Primary Objective of this study is to determine if video discharge instructions, when added to standard of care written and verbal instructions, lead to a decrease in unnecessary phone calls from patients in a Mohs dermatology clinic.\n\nThe Secondary Objectives of this study are to determine if video discharge instructions, when added to standard of care written and verbal instructions, help to improve patients' satisfaction with education materials provided by the clinic, improve patients' knowledge of post-operative management, improve patients' confidence in taking care of their suture site post-operatively, and reduce post-operative anxiety about their suture site.\n\nThis study will be a randomized controlled trial in which the impact of video discharge instructions on patient calls, anxiety, and confidence will be evaluated. Patients will be randomized using a permuted block model generated through SAS."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who underwent a linear closure on the face at UH Mohs clinic\n* Fluent English speakers\n\nExclusion Criteria:\n\n● Non-fluent English speakers'}, 'identificationModule': {'nctId': 'NCT02970435', 'briefTitle': 'Evaluating the Impact of Video Discharge Instructions for Mohs Surgery Post-Operative Care', 'organization': {'class': 'OTHER', 'fullName': 'Case Comprehensive Cancer Center'}, 'officialTitle': 'Evaluating the Impact of Video Discharge Instructions for Mohs Surgery Post-Operative Care', 'orgStudyIdInfo': {'id': 'CASE1616'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Video Discharge Instructions', 'description': 'These videos contain the same instructions that a patient receives via the standard-of-care verbal and written discharge instructions. These instructions will be delivered by the same nursing and medical staff that also regularly provides verbal and written discharge instructions to patients. There will be no difference in the content between the standard-of-care verbal and written instructions and the video discharge instructions. Patients in this group will receive telecommunication reminders on how to access discharge videos.', 'interventionNames': ['Behavioral: Video Discharge Instructions', 'Behavioral: Telecommunication Reminders', 'Behavioral: Standard of Care']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Verbal and Written Discharge Instructions', 'description': 'Nursing and medical staff will provide verbal and written discharge instructions as is standard of care post surgery', 'interventionNames': ['Behavioral: Standard of Care']}], 'interventions': [{'name': 'Video Discharge Instructions', 'type': 'BEHAVIORAL', 'description': 'The video discharge instructions, will be provided to the patient at the time of surgical procedure.', 'armGroupLabels': ['Video Discharge Instructions']}, {'name': 'Telecommunication Reminders', 'type': 'BEHAVIORAL', 'description': 'Telecommunication reminders including text messages, email, or phone calls to remind participants how to access the video discharge instruction up to three times before follow-up', 'armGroupLabels': ['Video Discharge Instructions']}, {'name': 'Standard of Care', 'type': 'BEHAVIORAL', 'description': 'Standard of Care: verbal and written discharge instructions for patients after surgery', 'armGroupLabels': ['Verbal and Written Discharge Instructions', 'Video Discharge Instructions']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44106-5065', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals at Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Jeremy Bordeaux, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Case Comprehensive Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}