Heart Failure Clinical Trial
Using Videos to Facilitate Advance Care Planning for Patients With Heart Failure
Summary
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.
Full Description
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).
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).
Eligibility Criteria
Inclusion Criteria:
A diagnosis of advanced heart failure as defined by ALL THREE of the following:
• 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.
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:
New patient
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.
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There is 1 Location for this study
Boston Massachusetts, 02114, United States More Info
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Principal Investigator
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