Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2026-01-28 @ 6:18 PM
Study NCT ID:
NCT01589120
Status:
UNKNOWN
Last Update Posted:
2020-11-17
First Post:
2012-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Using Videos to Facilitate Advance Care Planning for Patients With Heart Failure
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': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 248}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'lastUpdateSubmitDate': '2020-11-16', 'studyFirstSubmitDate': '2012-04-28', 'studyFirstSubmitQcDate': '2012-04-28', 'lastUpdatePostDateStruct': {'date': '2020-11-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-05-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'knowledge', 'timeFrame': '5 minutes after survey', 'description': 'knowledge of the goals of care for CHF'}, {'measure': 'preferences', 'timeFrame': '5 minutes after survey', 'description': 'preferences for goals of care'}], 'secondaryOutcomes': [{'measure': 'decisional conflict', 'timeFrame': '5 minutes after survey', 'description': 'decisional conflict regarding decision making'}, {'measure': 'stability', 'timeFrame': '5 minutes after survey and then at 1, 3, and 6 months', 'description': 'stability of preferences for goals of care'}, {'measure': 'concordance of preferences', 'timeFrame': 'by the end of one year', 'description': 'concordance of stated preferences with documented preferences in the medical record'}, {'measure': 'advance care planning discussion', 'timeFrame': 'by 6 months', 'description': 'self reported completion of advance care planning discussion'}, {'measure': 'quality of life', 'timeFrame': 'after 6 months', 'description': 'better quality of life using FACIT questionnaire after 6 months'}, {'measure': 'referral to hospice', 'timeFrame': 'by one year', 'description': 'referral to hospice for patients who die'}, {'measure': 'place of death', 'timeFrame': 'by one year', 'description': 'place of death for those patients that die'}, {'measure': 'caregiver bereavement score', 'timeFrame': 'by one year', 'description': 'caregiver bereavement score for those subjects that die'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['CHF', 'video decision aid'], 'conditions': ['CHF']}, 'referencesModule': {'references': [{'pmid': '27358437', 'type': 'DERIVED', 'citation': 'El-Jawahri A, Paasche-Orlow MK, Matlock D, Stevenson LW, Lewis EF, Stewart G, Semigran M, Chang Y, Parks K, Walker-Corkery ES, Temel JS, Bohossian H, Ooi H, Mann E, Volandes AE. Randomized, Controlled Trial of an Advance Care Planning Video Decision Support Tool for Patients With Advanced Heart Failure. Circulation. 2016 Jul 5;134(1):52-60. doi: 10.1161/CIRCULATIONAHA.116.021937.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the decision making of subjects with advanced CHF having a verbal discussion about goals of care compared to subjects using a video.', 'detailedDescription': 'Aim #1: To compare the impact of the intervention on the distribution of end-of-life knowledge, decisional conflict, and preferences among 248 subjects with advanced heart failure randomly assigned to one of two ACP modalities: 1. a video visually depicting the goals of care along with a patient checklist (intervention, 124 subjects), or 2. usual care, i.e., verbal narrative (control, 124 subjects).\n\nHypothesis #1: Compared to subjects randomized to the verbal narrative group, subjects randomized to the video intervention will be significantly more likely to:\n\n1a. Have more knowledge about their choices\n\n1b. Have less decisional conflict about their decisions\n\n1c. Opt for comfort care and less likely to choose life-prolonging measures\n\nAim #2: To compare stability of preferences over time (1, 3, and 6 months), concordance rate of preferences (preferences expressed vs. preferences documented in the medical record - both inpatient and outpatient records), and advance care planning discussions (as reported by the patient), among 248 subjects randomized to the video (N=124) vs. verbal narrative (N=124).\n\nHypothesis #2: Compared to subjects randomized to the verbal narrative group, subjects randomized to the video intervention will be significantly more likely to:\n\n1a. Have more stable preferences over time\n\n1b. Higher concordance rates\n\n1c. Have had an advance care planning discussion\n\nAim #3: To compare quality of life, anxiety and depression, referral to hospice, place of death, after death bereavement (caregiver), and resource utilization after 6 months and 1 year (or death) among 248 subjects randomized to the video (N=124) vs. verbal narrative (N=124).\n\nHypothesis #3: Compared to subjects randomized to the verbal narrative group, subjects randomized to the video intervention will be significantly more likely to:\n\n1a. Have a better quality of life (FACIT-Pal, FACIT-Sp-12)\n\n1b. Have earlier referral to hospice in subjects who die\n\n1d. Die at home or hospice (or inpatient hospice setting) in subjects who die\n\n1e. Have better caregiver bereavement score (for caregiver subjects who die).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. A diagnosis of advanced heart failure as defined by ALL THREE of the following:\n\n • New York Heart Association Class III or IV (NYHA III or IV) (III: marked limitation in activity due to symptoms, even during less-than-ordinary activity; IV: severe limitations, experiences symptoms while at rest).\n\n AND\n * Hospitalization for heart failure within the last six months. AND\n * Age greater than or equal to 65.\n2. Additionally ONE of the following must be met:\n\n * According to the attending physician's best judgment the patient's survival is limited to 2 years but may very well be less than 1 year (i.e. the physician would not be surprised if the patient died within one year from any cause) OR\n * Three heart failure hospitalizations in the last year OR\n * One of the following:\n\n * Two Systolic Blood Pressures \\< 90 within the last 6 months in the ambulatory setting\n * Na \\< 130 within the last 6 months\n * NTproBNP \\> 3,000\n * EGFR \\< 35\n * High diuretic use (160 mg po Lasix or 100 mg po torsemide or equivalent total daily dose)\n\nExclusion Criteria:\n\n* New patient\n* A transplant or mechanical circulatory support candidate\n* Major psychiatric illness as determined by the attending that would make this study inappropriate.\n* Any patient that has been excluded for transplant or mechanical circulatory support due to psychological or psychiatric co-morbidities."}, 'identificationModule': {'nctId': 'NCT01589120', 'acronym': 'VIDEO-HF', 'briefTitle': 'Using Videos to Facilitate Advance Care Planning for Patients With Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Using Videos to Facilitate Advance Care Planning for Patients With Heart Failure', 'orgStudyIdInfo': {'id': '2012-P-000341'}, 'secondaryIdInfos': [{'id': '1R01HL107268-01', 'link': 'https://reporter.nih.gov/quickSearch/1R01HL107268-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'Verbal description of goals of care reflecting usual care'}, {'type': 'EXPERIMENTAL', 'label': 'Video Arm', 'description': 'Video intervention group', 'interventionNames': ['Behavioral: Video decision aid']}], 'interventions': [{'name': 'Video decision aid', 'type': 'BEHAVIORAL', 'description': 'Video decision aid of the goals of care', 'armGroupLabels': ['Video Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Angelo Volandes, MD', 'role': 'CONTACT'}, {'name': 'Angelo Volandes, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'Angelo Volandes, MD', 'role': 'CONTACT', 'email': 'avolandes@partners.org', 'phone': '617 643 4266'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}, {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, {'name': 'Vanderbilt University', 'class': 'OTHER'}, {'name': 'South Shore Hospital', 'class': 'OTHER'}, {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, {'name': 'Boston Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Angelo E. Volandes, MD', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}