Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-26 @ 1:25 AM
Study NCT ID:
NCT04796233
Status:
UNKNOWN
Last Update Posted:
2021-09-01
First Post:
2021-03-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Patient Perspectives on Advance Care Planning Discussions Prior to Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2023-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-31', 'studyFirstSubmitDate': '2021-03-10', 'studyFirstSubmitQcDate': '2021-03-11', 'lastUpdatePostDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Interview', 'timeFrame': '30-35 Minute interview', 'description': 'Patient perspectives and attitudes regarding advance care planning (ACP) with a focus on patient values and goals prior to cardiac surgery.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Advance Care Planning'], 'conditions': ['Cardiac Surgery']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to explore patient perspectives on Advance Care Planning (ACP) prior to cardiac surgery, including perceptions of benefits, drawbacks, and barriers to ACP.', 'detailedDescription': 'In this study, we plan to interview 40 patients who are scheduled to undergo cardiac surgery about their perspectives on preoperative ACP and discussion of their values, goals of care, and preferences for prolonged care in hospital prior to having surgery. We plan to conduct and audio record one-on-one interviews that are structured around standard questions about ACP. After recordings are completed, we plan to conduct an analysis of the interviews to find common themes and ideas that participants have about preoperative advance care planning. These results will help us understand whether patients value and wish to participate in advance care planning prior to major surgery, and will help to guide the structure and content of preoperative advance care plan programs in the future.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'We will enroll patients at Toronto General Hospital, a tertiary cardiac surgery centre in Toronto. We will include patients undergoing any cardiac surgery procedures that involve cardiopulmonary bypass, as well as patients undergoing off-pump coronary bypass procedures and any other high-risk cardiac surgery patients, for example, those undergoing ventricular assist device insertion or pericardectomy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients undergoing cardiac surgical procedures that involve a sternotomy, thoracotomy, or cardiopulmonary bypass for any indication.\n* Age \\> 18\n* English-speaking\n\nExclusion Criteria:\n\n* Emergency surgery, regardless of indication or procedure\n* Minor/percutaneous cardiac procedure\n* Lack of decisional capacity due to dementia or other neurocognitive dysfunction\n* Previously decided upon advance care directives\n* Still considering surgery or not yet booked for an operation'}, 'identificationModule': {'nctId': 'NCT04796233', 'briefTitle': 'Patient Perspectives on Advance Care Planning Discussions Prior to Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': 'Patient Perspectives on Advance Care Planning Discussions Prior to Cardiac Surgery', 'orgStudyIdInfo': {'id': '19-5910'}}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G 2C4', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'contacts': [{'name': 'Michael Tylee, MD', 'role': 'CONTACT', 'email': 'michael.tylee@uhn.ca', 'phone': '(416) 340-5164'}], 'facility': 'Toronto General Hospital - University Health Network', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Michael Tylee, MD', 'role': 'CONTACT', 'email': 'michael.tylee@uhn.ca', 'phone': '(416) 340-5164'}, {'name': 'Jo Carroll', 'role': 'CONTACT', 'email': 'jo.carroll@uhn.ca', 'phone': '416-340-4800', 'phoneExt': '3243'}], 'overallOfficials': [{'name': 'Michael Tylee, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Health Network, Toronto'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sunnybrook Health Sciences Centre', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}