Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-26 @ 2:13 AM
Study NCT ID:
NCT05891860
Status:
COMPLETED
Last Update Posted:
2025-02-10
First Post:
2023-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virtual Family Participation in ICU Rounds: a Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-06', 'studyFirstSubmitDate': '2023-03-20', 'studyFirstSubmitQcDate': '2023-05-26', 'lastUpdatePostDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recruitment rate of 3 participants per month per site completing initial FAME questionnaire', 'timeFrame': '6 months', 'description': 'Recruitment rate'}, {'measure': '% of participants completing at least one virtual rounding session', 'timeFrame': 'Within 1-week of ICU discharge', 'description': 'Uptake'}, {'measure': '% of virtual rounds without technical issues', 'timeFrame': 'Within 1-week of ICU discharge', 'description': 'Technical issues'}, {'measure': '% of participants completing follow-up', 'timeFrame': 'Within 1-week of ICU discharge', 'description': 'Follow-up of participants'}], 'secondaryOutcomes': [{'measure': 'Family satisfaction as measured by FS-ICU 24R', 'timeFrame': 'Within 1-week of ICU discharge', 'description': 'Family satisfaction'}, {'measure': 'Anxiety and depression as measured by HADS', 'timeFrame': 'Within 1-week of ICU discharge', 'description': 'Anxiety and depression'}, {'measure': 'Family care engagement as measured by FAME', 'timeFrame': 'Within 1-week of ICU discharge', 'description': 'Family care engagement'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['family engagement', 'virtual', 'critical care'], 'conditions': ['Family Engagement', 'Virtual', 'Critical Care']}, 'referencesModule': {'references': [{'pmid': '36382337', 'type': 'BACKGROUND', 'citation': 'Calderone A, Debay V, Goldfarb MJ. Family Presence on Rounds in Adult Critical Care: A Scoping Review. Crit Care Explor. 2022 Nov 7;4(11):e0787. doi: 10.1097/CCE.0000000000000787. eCollection 2022 Nov.'}, {'pmid': '33230927', 'type': 'BACKGROUND', 'citation': 'Au SS, Roze des Ordons AL, Blades KG, Stelfox HT. Best practices toolkit for family participation in ICU rounds. J Eval Clin Pract. 2021 Oct;27(5):1066-1075. doi: 10.1111/jep.13517. Epub 2020 Nov 23.'}, {'pmid': '27984278', 'type': 'BACKGROUND', 'citation': 'Davidson JE, Aslakson RA, Long AC, Puntillo KA, Kross EK, Hart J, Cox CE, Wunsch H, Wickline MA, Nunnally ME, Netzer G, Kentish-Barnes N, Sprung CL, Hartog CS, Coombs M, Gerritsen RT, Hopkins RO, Franck LS, Skrobik Y, Kon AA, Scruth EA, Harvey MA, Lewis-Newby M, White DB, Swoboda SM, Cooke CR, Levy MM, Azoulay E, Curtis JR. Guidelines for Family-Centered Care in the Neonatal, Pediatric, and Adult ICU. Crit Care Med. 2017 Jan;45(1):103-128. doi: 10.1097/CCM.0000000000002169.'}]}, 'descriptionModule': {'briefSummary': 'Barriers to family participation in ICU rounds exist at the health care system level (e.g., restriction on visitation, infection control) and the individual level (e.g., caretaker role, illness, disability, inability to miss work). While virtual family participation in ICU rounds may contribute to addressing these barriers, its feasibility, impact, and effectiveness are yet unknown. The primary objective of this study is to assess the feasibility of virtual family participation in adult ICU rounds. The secondary objectives are: to assess the effect size of virtual family participation in ICU rounds on family engagement, satisfaction, and anxiety and depression; and to explore family and physician experiences of family participation in ICU rounds.\n\nThis will be a pilot prospective trial of 72 family members at 4 Canadian adult ICUs, with an embedded qualitative study that will sample family members and critical care physicians. The primary outcome will reflect feasibility metrics (i.e., recruitment, uptake, technical, and follow-up). Secondary outcomes include data regarding family engagement, satisfaction, mental health, and perceived experiences of participation in ICU rounds. This study will assess the feasibility of conducting a larger, hypothesis-testing randomized controlled trial to assess virtual family participation in adult ICU rounds.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Family member of ICU patient with expected ICU stay \\> 48 hours (as per treating team)\n* Age ≥ 18 years old\n* Willing and able to participate in virtual ICU rounds\n* Ability to communicate in English or French\n* Able: technological capability and understanding to participate virtually in ICU rounds (must have a phone or computer with internet and audio/video capabilities).\n* "Family member" is anyone with a biological, legal, or emotional relationship with the patient.\n\nExclusion criteria\n\n* Intends to participate in in-person rounds (if available and offered at participating site)\n* Another family member already participating in the study'}, 'identificationModule': {'nctId': 'NCT05891860', 'acronym': 'VR-Family', 'briefTitle': 'Virtual Family Participation in ICU Rounds: a Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'Lady Davis Institute'}, 'officialTitle': 'Virtual Family Participation in ICU Rounds (The VR-Family Study)', 'orgStudyIdInfo': {'id': '2023-3581'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Study participants will be present during daily ICU team rounds by secure video conference.', 'interventionNames': ['Other: Participation in virtual rounds']}], 'interventions': [{'name': 'Participation in virtual rounds', 'type': 'OTHER', 'description': 'Virtual participation in daily ICU team rounds', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H3T1E2', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Jewish General Hospital', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lady Davis Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}, {'name': 'Fonds de la Recherche en Santé du Québec', 'class': 'OTHER_GOV'}, {'name': 'McGill Faculty of Medicine', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending Staff, Division of Cardiology', 'investigatorFullName': 'Michael Goldfarb', 'investigatorAffiliation': 'Lady Davis Institute'}}}}