Ignite Creation Date:
2025-12-24 @ 5:35 PM
Ignite Modification Date:
2025-12-24 @ 5:35 PM
Study NCT ID:
NCT03832868
Status:
COMPLETED
Last Update Posted:
2019-09-12
First Post:
2019-02-04
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Syngery-Evaluating the Impact of Decision Aid
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', 'interventionModelDescription': 'Clinic sites will be block-randomized to eliminate contamination induced by individual-level randomization for a system-level intervention. Each site will rotate on a monthly basis whether the decision aid is administered pre- or post-office visit, and this will be applied to all ICD patients. Each site will have a minimum of 2 months exposure to each "arm." No blinding will occur.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2019-09-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-10', 'studyFirstSubmitDate': '2019-02-04', 'studyFirstSubmitQcDate': '2019-02-05', 'lastUpdatePostDateStruct': {'date': '2019-09-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Decisional ICDs knowledge score among pre-visit arm participants compare to post-visit arm participants', 'timeFrame': 'Date of ICD implantation (up to 60 days from the date of receiving the decision aid)', 'description': 'Patients will receive a survey including 11 questions to gauge decisional knowledge about ICDs. The survey is expected to take no more than 10-15 minutes to complete, which should allow adequate time for completion in the pre-procedure area without interrupting clinical workflow.'}], 'secondaryOutcomes': [{'measure': 'Decision Conflict Scale score among pre-visit arm participants compare to post-visit arm participants', 'timeFrame': 'Date of ICD implantation (up to 60 days from the date of receiving the decision aid)', 'description': 'Patients will receive a survey including 12 questions to measure decisional conflict. The surveys are expected to take no more than 10-15 minutes to complete, which should allow adequate time for completion in the pre-procedure area without interrupting clinical workflow.'}, {'measure': 'Values-choice ICDs concordance score among pre-visit arm participants compare to post-visit arm participants', 'timeFrame': 'Date of ICD implantation (up to 60 days from the date of receiving the decision aid)', 'description': 'Patients will receive a survey including 12 questions to measure values-choice concordance. The surveys are expected to take no more than 10-15 minutes to complete, which should allow adequate time for completion in the pre-procedure area without interrupting clinical workflow.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Decision aid'], 'conditions': ['Implantable Cardioverter-defibrillators (ICDs)']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to determine whether it is better to give patients an implantable cardioverter-defibrillators (ICDs) decision aid before they have their first consultation with an implanting cardiac electrophysiologist or after the consult.', 'detailedDescription': 'There are many unanswered questions about how shared decision making should be executed and how decision aids should be employed. The aim of this study is to determine whether it is better to give patients an implantable cardioverter-defibrillators (ICDs) decision aid before they have their first consultation with an implanting cardiac electrophysiologist or after the consult.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years old and older\n* evaluated for primary prevention implantable cardioverter-defibrillators (ICDs)'}, 'identificationModule': {'nctId': 'NCT03832868', 'briefTitle': 'Syngery-Evaluating the Impact of Decision Aid', 'organization': {'class': 'OTHER', 'fullName': 'Emory University'}, 'officialTitle': 'Evaluating the Impact of Decision Aid Timing on Mandatory Shared Decision Making for Defibrillator Implantation', 'orgStudyIdInfo': {'id': 'IRB00107168'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pre-visit decision aid', 'description': 'Patients receiving the decision aid pre-visit will be given a paper copy of the decision aid in the waiting room and will have a minimum of 15 minutes to review it - either in the waiting room or in the exam room while waiting for the electrophysiologist.', 'interventionNames': ['Behavioral: Pre-visit timing of receipt of the ICDs implantation decision aid']}, {'type': 'EXPERIMENTAL', 'label': 'Post-visit decision aid', 'description': 'Patients receiving the decision aid after the encounter will meet with the electrophysiologist first and receive the aid afterward.', 'interventionNames': ['Behavioral: Post-visit timing of receipt of the ICDs implantation decision aid']}], 'interventions': [{'name': 'Pre-visit timing of receipt of the ICDs implantation decision aid', 'type': 'BEHAVIORAL', 'description': 'The intervention is the timing of receipt of the decision aid. The decision aid is designed to facilitate informing patients and helping to reach a decision.The implantable cardioverter-defibrillators (ICDs) implantation decision aid presents treatment options, risks, and benefits in lay terms.It is currently utilized in all of the Emory cardiac electrophysiology clinics as part of usual clinical care.', 'armGroupLabels': ['Pre-visit decision aid']}, {'name': 'Post-visit timing of receipt of the ICDs implantation decision aid', 'type': 'BEHAVIORAL', 'description': 'The intervention is the timing of receipt of the decision aid. The decision aid is designed to facilitate informing patients and helping to reach a decision.The implantable cardioverter-defibrillators (ICDs) implantation decision aid presents treatment options, risks, and benefits in lay terms.It is currently utilized in all of the Emory cardiac electrophysiology clinics as part of usual clinical care.', 'armGroupLabels': ['Post-visit decision aid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': "Emory St. Joseph's Hospital", 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University Hospital Midtown', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'overallOfficials': [{'name': 'Faisal Merchant, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Data will be available immediately following publication and for 3 years after.', 'ipdSharing': 'YES', 'description': 'Data is being collected in REDCAP and is deidentified. The study team will have the tool to match subjects if needed. The team has no current plans to share data, but can if necessary (including the data dictionaries). All data can be shared after being deidentified.The study team can share the protocol, statistical plan, ICF, and survey tool. The decision tool is already available. Data will be available immediately following publication and for 3 years after. Those requesting access to data should contact the principal investigator (Dr. Faisal Merchant). Requests will be evaluated based on need and data usage agreement.', 'accessCriteria': 'Those requesting access to data should contact the principal investigator (Dr. Faisal Merchant). Requests will be evaluated based on need and data usage agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emory University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Faisal Merchant MD', 'investigatorAffiliation': 'Emory University'}}}}