Recruiting

Advance Care Planning

Sponsor:

Massachusetts General Hospital

Code:

NCT01589120

Conditions

CHF

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

Video decision aid

Study Details

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.

Conditions

CHF

Study ID

NCT01589120

Start date

Apr, 2012

Status verified date

Nov, 2020

Primary completion date

Apr, 2014

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

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 Design

Enrollment

248 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

no intervention: control group

Verbal description of goals of care reflecting usual care

experimental: Video Arm

Video intervention group

Interventions

Video decision aid

Video decision aid of the goals of care

Primary outcome measure

  • knowledge [ Time Frame: 5 minutes after survey ]
  • preferences [ Time Frame: 5 minutes after survey ]

Central Contacts and Locations

Central contacts

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Principal Investigator:

Angelo Volandes, MD

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Nov 17, 2020

Last verified

Nov, 2020

Keywords

  • CHF
  • video decision aid

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2020-11-17.