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

CHF Clinical Trial

— VIDEO-HF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01589120
• Other study ID #: 2012-P-000341
• Secondary ID: 1R01HL107268-01
• Status: Recruiting
• Phase: N/A
• Start date: April 2012

Study information

• Verified date: November 2020
• Source: Massachusetts General Hospital
• Contact: Angelo Volandes, MD
• Phone: 617 643 4266
• Email: avolandes[@]partners.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 248
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• CHF
• Heart Failure

Intervention

Behavioral:
• Video decision aid
Video decision aid of the goals of care

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (7)

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

Country where clinical trial is conducted

United States, 

Outcome

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