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

This study is currently recruiting participants.
Verified May 2012 by Massachusetts General Hospital
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
University of Colorado, Denver
Vanderbilt University
South Shore Hospital
Brigham and Women's Hospital
Boston Medical Center
Information provided by (Responsible Party):
Angelo E. Volandes, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01589120
First received: April 28, 2012
Last updated: May 1, 2012
Last verified: May 2012
History of Changes
  Purpose

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.


Condition Intervention
CHF
 Behavioral: Video decision aid

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Using Videos to Facilitate Advance Care Planning for Patients With Heart Failure

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • knowledge [ Time Frame: 5 minutes after survey ] [ Designated as safety issue: No ]
    knowledge of the goals of care for CHF

  • preferences [ Time Frame: 5 minutes after survey ] [ Designated as safety issue: No ]
    preferences for goals of care


Secondary Outcome Measures:
  • decisional conflict [ Time Frame: 5 minutes after survey ] [ Designated as safety issue: No ]
    decisional conflict regarding decision making

  • stability [ Time Frame: 5 minutes after survey and then at 1, 3, and 6 months ] [ Designated as safety issue: No ]
    stability of preferences for goals of care

  • concordance of preferences [ Time Frame: by the end of one year ] [ Designated as safety issue: No ]
    concordance of stated preferences with documented preferences in the medical record

  • advance care planning discussion [ Time Frame: by 6 months ] [ Designated as safety issue: No ]
    self reported completion of advance care planning discussion

  • quality of life [ Time Frame: after 6 months ] [ Designated as safety issue: No ]
    better quality of life using FACIT questionnaire after 6 months

  • referral to hospice [ Time Frame: by one year ] [ Designated as safety issue: No ]
    referral to hospice for patients who die

  • place of death [ Time Frame: by one year ] [ Designated as safety issue: No ]
    place of death for those patients that die

  • caregiver bereavement score [ Time Frame: by one year ] [ Designated as safety issue: No ]
    caregiver bereavement score for those subjects that die


Estimated Enrollment: 248
Study Start Date: April 2012
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01589120

Contacts
Contact: Angelo Volandes, MD 617 643 4266 avolandes@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Angelo Volandes, MD            
Principal Investigator: Angelo Volandes, MD            
Sponsors and Collaborators
Massachusetts General Hospital
National Heart, Lung, and Blood Institute (NHLBI)
University of Colorado, Denver
Vanderbilt University
South Shore Hospital
Brigham and Women's Hospital
Boston Medical Center
  More Information

No publications provided

Responsible Party: Angelo E. Volandes, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01589120     History of Changes
Other Study ID Numbers: 2012-P-000341, 1R01HL107268-01
Study First Received: April 28, 2012
Last Updated: May 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
CHF
video decision aid

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 18, 2013