Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2026-02-27 @ 6:55 PM
Study NCT ID:
NCT01776333
Status:
UNKNOWN
Last Update Posted:
2020-11-18
First Post:
2013-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomized Controlled Trial of a Video Decision Aid in the ICU
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'lastUpdateSubmitDate': '2020-11-16', 'studyFirstSubmitDate': '2013-01-22', 'studyFirstSubmitQcDate': '2013-01-23', 'lastUpdatePostDateStruct': {'date': '2020-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-01-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'preference for goal of care regarding medical interventions (e.g., CPR, intubation, etc.)', 'timeFrame': 'at baseline admission to the ICU during family meeting up to one week'}], 'secondaryOutcomes': [{'measure': 'level of medical care delivered to patient at time of death or discharge from the ICU', 'timeFrame': 'at time of death or discharge from the ICU up to one week'}, {'measure': 'anxiety and depression', 'timeFrame': 'anxiety and depression at follow up phone call at 3 months after ICU death or discharge'}, {'measure': 'satisfaction with ICU experience', 'timeFrame': 'after 3 months from time of death or discharge from ICU'}, {'measure': 'number of medical interventions during ICU stay', 'timeFrame': 'during time period in the ICU up to one week'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ICU'], 'conditions': ['Respiratory Failure', 'Cardiac Event']}, 'descriptionModule': {'briefSummary': 'Randomized Controlled Trial of a Video Decision Aid in the ICU in surrogates of admitted patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Age 65 or older Patient does not have the capacity to make decisions Patient admitted to the ICU with life threatening illness including advanced heart, renal, lung, gastrointestinal and oncologic disease Patient has English speaking representative to make decisions on his/her behalf Patient critically ill and unlikely to survive to hospital discharge\n\nExclusion Criteria:\n\n\\- Patients who are imminently dying and admitted to the ICU are excluded Wards if the state'}, 'identificationModule': {'nctId': 'NCT01776333', 'acronym': 'VIDEO', 'briefTitle': 'A Randomized Controlled Trial of a Video Decision Aid in the ICU', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Video Images of Disease for Ethical Outcomes', 'orgStudyIdInfo': {'id': '2010-P-001820'}, 'secondaryIdInfos': [{'id': '2010-P-001820', 'type': 'OTHER', 'domain': 'MGH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'usual care'}, {'type': 'EXPERIMENTAL', 'label': 'video arm', 'description': 'video decision aid intervention', 'interventionNames': ['Behavioral: video decision aid']}], 'interventions': [{'name': 'video decision aid', 'type': 'BEHAVIORAL', 'armGroupLabels': ['video arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'contacts': [{'name': 'Jonas Green', 'role': 'CONTACT'}, {'name': 'Jonas Green', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cedars Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'contacts': [{'name': 'Michael Paasche-Orlow', 'role': 'CONTACT'}, {'name': 'Michael Paasche-Orlow', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'BMC', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'contacts': [{'name': 'Angelo Volandes', 'role': 'CONTACT'}, {'name': 'Angelo Volandes', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'MGH', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'Angelo Volandes', 'role': 'CONTACT', 'email': 'avolandes@partners.org', 'phone': '617 726 2000'}], 'overallOfficials': [{'name': 'Angelo Volandes', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MGH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Angelo E. Volandes, MD', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}