Using Videos to Facilitate Advance Care Planning for Patients With Heart Failure
NCT ID: NCT01589120
Last Updated: 2020-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
248 participants
INTERVENTIONAL
2012-04-30
Brief Summary
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Detailed Description
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Hypothesis #1: Compared to subjects randomized to the verbal narrative group, subjects randomized to the video intervention will be significantly more likely to:
1a. Have more knowledge about their choices
1b. Have less decisional conflict about their decisions
1c. Opt for comfort care and less likely to choose life-prolonging measures
Aim #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).
Hypothesis #2: Compared to subjects randomized to the verbal narrative group, subjects randomized to the video intervention will be significantly more likely to:
1a. Have more stable preferences over time
1b. Higher concordance rates
1c. Have had an advance care planning discussion
Aim #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).
Hypothesis #3: Compared to subjects randomized to the verbal narrative group, subjects randomized to the video intervention will be significantly more likely to:
1a. Have a better quality of life (FACIT-Pal, FACIT-Sp-12)
1b. Have earlier referral to hospice in subjects who die
1d. Die at home or hospice (or inpatient hospice setting) in subjects who die
1e. Have better caregiver bereavement score (for caregiver subjects who die).
Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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control group
Verbal description of goals of care reflecting usual care
No interventions assigned to this group
Video Arm
Video intervention group
Video decision aid
Video decision aid of the goals of care
Interventions
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Video decision aid
Video decision aid of the goals of care
Eligibility Criteria
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Inclusion Criteria
• 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).
AND
* Hospitalization for heart failure within the last six months. AND
* Age greater than or equal to 65.
2. Additionally ONE of the following must be met:
* 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
* Three heart failure hospitalizations in the last year OR
* One of the following:
* Two Systolic Blood Pressures \< 90 within the last 6 months in the ambulatory setting
* Na \< 130 within the last 6 months
* NTproBNP \> 3,000
* EGFR \< 35
* High diuretic use (160 mg po Lasix or 100 mg po torsemide or equivalent total daily dose)
Exclusion Criteria
* A transplant or mechanical circulatory support candidate
* Major psychiatric illness as determined by the attending that would make this study inappropriate.
* Any patient that has been excluded for transplant or mechanical circulatory support due to psychological or psychiatric co-morbidities.
65 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
University of Colorado, Denver
OTHER
Vanderbilt University
OTHER
South Shore Hospital
OTHER
Brigham and Women's Hospital
OTHER
Boston Medical Center
OTHER
Massachusetts General Hospital
OTHER
Responsible Party
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Angelo E. Volandes, MD
Principal Investigator
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Angelo Volandes, MD
Role: primary
References
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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.
Other Identifiers
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2012-P-000341
Identifier Type: -
Identifier Source: org_study_id