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

Primary Purpose

CHF

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Video decision aid
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for CHF focused on measuring CHF, video decision aid

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Massachusetts General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

control group

Video Arm

Arm Description

Verbal description of goals of care reflecting usual care

Video intervention group

Outcomes

Primary Outcome Measures

knowledge
knowledge of the goals of care for CHF
preferences
preferences for goals of care

Secondary Outcome Measures

decisional conflict
decisional conflict regarding decision making
stability
stability of preferences for goals of care
concordance of preferences
concordance of stated preferences with documented preferences in the medical record
advance care planning discussion
self reported completion of advance care planning discussion
quality of life
better quality of life using FACIT questionnaire after 6 months
referral to hospice
referral to hospice for patients who die
place of death
place of death for those patients that die
caregiver bereavement score
caregiver bereavement score for those subjects that die

Full Information

First Posted
April 28, 2012
Last Updated
November 16, 2020
Sponsor
Massachusetts General Hospital
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
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1. Study Identification

Unique Protocol Identification Number
NCT01589120
Brief Title
Using Videos to Facilitate Advance Care Planning for Patients With Heart Failure
Acronym
VIDEO-HF
Official Title
Using Videos to Facilitate Advance Care Planning for Patients With Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 2012 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CHF
Keywords
CHF, video decision aid

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
248 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
No Intervention
Arm Description
Verbal description of goals of care reflecting usual care
Arm Title
Video Arm
Arm Type
Experimental
Arm Description
Video intervention group
Intervention Type
Behavioral
Intervention Name(s)
Video decision aid
Intervention Description
Video decision aid of the goals of care
Primary Outcome Measure Information:
Title
knowledge
Description
knowledge of the goals of care for CHF
Time Frame
5 minutes after survey
Title
preferences
Description
preferences for goals of care
Time Frame
5 minutes after survey
Secondary Outcome Measure Information:
Title
decisional conflict
Description
decisional conflict regarding decision making
Time Frame
5 minutes after survey
Title
stability
Description
stability of preferences for goals of care
Time Frame
5 minutes after survey and then at 1, 3, and 6 months
Title
concordance of preferences
Description
concordance of stated preferences with documented preferences in the medical record
Time Frame
by the end of one year
Title
advance care planning discussion
Description
self reported completion of advance care planning discussion
Time Frame
by 6 months
Title
quality of life
Description
better quality of life using FACIT questionnaire after 6 months
Time Frame
after 6 months
Title
referral to hospice
Description
referral to hospice for patients who die
Time Frame
by one year
Title
place of death
Description
place of death for those patients that die
Time Frame
by one year
Title
caregiver bereavement score
Description
caregiver bereavement score for those subjects that die
Time Frame
by one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Angelo Volandes, MD
Phone
617 643 4266
Email
avolandes@partners.org
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angelo Volandes, MD
First Name & Middle Initial & Last Name & Degree
Angelo Volandes, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
27358437
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.
Results Reference
derived

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

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