Using Videos to Facilitate Advance Care Planning for Patients With Heart Failure

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 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).

Official Title
-----------------
Using Videos to Facilitate Advance Care Planning for Patients With Heart Failure

Conditions
-----------------
CHF

Intervention / Treatment
-----------------
* Behavioral: Video decision aid


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control group<br>Verbal description of goals of care reflecting usual care | |
| Experimental: Video Arm<br>Video intervention group | Behavioral: Video decision aid<br>* Video decision aid of the goals of care<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| knowledge | knowledge of the goals of care for CHF | 5 minutes after survey | 
| preferences | preferences for goals of care | 5 minutes after survey | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| decisional conflict | decisional conflict regarding decision making | 5 minutes after survey | 
| stability | stability of preferences for goals of care | 5 minutes after survey and then at 1, 3, and 6 months | 
| concordance of preferences | concordance of stated preferences with documented preferences in the medical record | by the end of one year | 
| advance care planning discussion | self reported completion of advance care planning discussion | by 6 months | 
| quality of life | better quality of life using FACIT questionnaire after 6 months | after 6 months | 
| referral to hospice | referral to hospice for patients who die | by one year | 
| place of death | place of death for those patients that die | by one year | 
| caregiver bereavement score | caregiver bereavement score for those subjects that die | by one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CHF, video decision aid