Using Videos to Facilitate Advance Care Planning for Patients With Heart Failure
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 248
- Locations
- 2
- Primary Endpoint
- knowledge
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
- •Hospitalization for heart failure within the last six months. AND
- •Age greater than or equal to
- •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.
Outcomes
Primary Outcomes
knowledge
Time Frame: 5 minutes after survey
knowledge of the goals of care for CHF
preferences
Time Frame: 5 minutes after survey
preferences for goals of care
Secondary Outcomes
- decisional conflict(5 minutes after survey)
- stability(5 minutes after survey and then at 1, 3, and 6 months)
- concordance of preferences(by the end of one year)
- advance care planning discussion(by 6 months)
- quality of life(after 6 months)
- referral to hospice(by one year)
- place of death(by one year)
- caregiver bereavement score(by one year)
Investigators
Angelo E. Volandes, MD
Principal Investigator
Massachusetts General Hospital