CHF
Conditions
Keywords
CHF, video decision aid
Brief 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.
Detailed 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).
Interventions
BEHAVIORALVideo decision aid
Video decision aid of the goals of care
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
University of Colorado, Denver
Vanderbilt University
South Shore Hospital
Brigham and Women's Hospital
Boston Medical Center
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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. 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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| knowledge | 5 minutes after survey | knowledge of the goals of care for CHF |
| preferences | 5 minutes after survey | preferences for goals of care |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| concordance of preferences | by the end of one year | concordance of stated preferences with documented preferences in the medical record |
| advance care planning discussion | by 6 months | self reported completion of advance care planning discussion |
| quality of life | after 6 months | better quality of life using FACIT questionnaire after 6 months |
| decisional conflict | 5 minutes after survey | decisional conflict regarding decision making |
| place of death | by one year | place of death for those patients that die |
| caregiver bereavement score | by one year | caregiver bereavement score for those subjects that die |
| referral to hospice | by one year | referral to hospice for patients who die |
| stability | 5 minutes after survey and then at 1, 3, and 6 months | stability of preferences for goals of care |
Countries
United States
Contacts
Primary ContactAngelo Volandes, MD
Outcome results
None listed