NCT01589120

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
248

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

April 28, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 1, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Last Updated

November 17, 2020

Status Verified

November 1, 2020

Enrollment Period

2 years

First QC Date

April 28, 2012

Last Update Submit

November 16, 2020

Conditions

CHF

Keywords

CHFvideo decision aid

Outcome Measures

Primary Outcomes (2)

  • knowledge

    knowledge of the goals of care for CHF

    5 minutes after survey

  • preferences

    preferences for goals of care

    5 minutes after survey

Secondary Outcomes (8)

  • decisional conflict

    5 minutes after survey

  • stability

    5 minutes after survey and then at 1, 3, and 6 months

  • concordance of preferences

    by the end of one year

  • advance care planning discussion

    by 6 months

  • quality of life

    after 6 months

  • +3 more secondary outcomes

Study Arms (2)

control group

NO INTERVENTION

Verbal description of goals of care reflecting usual care

Video Arm

EXPERIMENTAL

Video intervention group

Behavioral: Video decision aid

Interventions

Video decision aidBEHAVIORAL

Video decision aid of the goals of care

Video Arm

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 27358437DERIVED

Central Study Contacts

Angelo Volandes, MD

CONTACT

617 643 4266avolandes@partners.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 28, 2012

First Posted

May 1, 2012

Study Start

April 1, 2012

Primary Completion

April 1, 2014

Last Updated

November 17, 2020

Record last verified: 2020-11

Locations

US(1)