Using Videos to Facilitate Advance Care Planning for Patients With Heart Failure (VIDEO-HF)

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.

Study Overview

• Status: Unknown
• Conditions: CHF
• Intervention / Treatment: Behavioral: Video decision aid

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).

• Study Type: Interventional
• Enrollment (Anticipated): 248
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Angelo Volandes, MD; Phone Number: 617 643 4266; Email: avolandes@partners.org

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Contact: Angelo Volandes, MD
      • Principal Investigator: Angelo Volandes, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control group; Verbal description of goals of care reflecting usual care
Experimental: Video Arm; Video intervention group	Behavioral: Video decision aid; Video decision aid of the goals of care

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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: University of Colorado, Denver; National Heart, Lung, and Blood Institute (NHLBI); Brigham and Women's Hospital; Boston Medical Center; Vanderbilt University; South Shore Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: April 28, 2012
• First Submitted That Met QC Criteria: April 28, 2012
• First Posted (Estimate): May 1, 2012

Study Record Updates

• Last Update Posted (Actual): November 17, 2020
• Last Update Submitted That Met QC Criteria: November 16, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: CHF; video decision aid
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 2012-P-000341; 1R01HL107268-01 (U.S. NIH Grant/Contract)