CHF Clinical Trial
— VIDEO-HFOfficial title:
Using Videos to Facilitate Advance Care Planning for Patients With Heart Failure
NCT number | NCT01589120 |
Other study ID # | 2012-P-000341 |
Secondary ID | 1R01HL107268-01 |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | April 2012 |
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.
Status | Recruiting |
Enrollment | 248 |
Est. completion date | |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital | Boston | Massachusetts |
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 |
United States,
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 |
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