Clinical trial NCT01589120: Using Videos to Facilitate Advance Care Planning for Patients With Heart Failure
Official title: Using Videos to Facilitate Advance Care Planning for Patients With Heart Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: CHF
Keywords: CHF
video decision aid
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: University of Colorado, Denver
name: Vanderbilt University
name: South Shore Hospital
name: Brigham and Women's Hospital
name: Boston Medical Center
First posted: 2012-05-01
Enrollment: 248
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

Eligibility criteria: 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.

Primary outcomes:
measure: knowledge
timeFrame: 5 minutes after survey
measure: preferences
timeFrame: 5 minutes after survey
Secondary outcomes:
measure: decisional conflict
timeFrame: 5 minutes after survey
measure: stability
timeFrame: 5 minutes after survey and then at 1, 3, and 6 months
measure: concordance of preferences
timeFrame: by the end of one year
measure: advance care planning discussion
timeFrame: by 6 months
measure: quality of life
timeFrame: after 6 months
measure: referral to hospice
timeFrame: by one year
measure: place of death
timeFrame: by one year
measure: caregiver bereavement score
timeFrame: by one year
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References:
citation: 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.