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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HL107268-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| University of Colorado, Denver | OTHER |
| Vanderbilt University | OTHER |
| South Shore Hospital |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group | No Intervention | Verbal description of goals of care reflecting usual care | |
| Video Arm | Experimental | Video intervention group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Video decision aid | Behavioral | Video decision aid of the goals of care |
|
| Measure | Description | Time Frame |
|---|---|---|
| knowledge | knowledge of the goals of care for CHF | 5 minutes after survey |
| preferences | preferences for goals of care | 5 minutes after survey |
| Measure | Description | Time Frame |
|---|---|---|
| decisional conflict | decisional conflict regarding decision making | 5 minutes after survey |
| stability | stability of preferences for goals of care |
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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
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:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Angelo Volandes, MD | Contact | 617 643 4266 | avolandes@partners.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27358437 | Derived | 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. |
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| OTHER |
| Brigham and Women's Hospital | OTHER |
| Boston Medical Center | OTHER |
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| 5 minutes after survey and then at 1, 3, and 6 months |
| concordance of preferences | concordance of stated preferences with documented preferences in the medical record | by the end of one year |
| advance care planning discussion | self reported completion of advance care planning discussion | by 6 months |
| quality of life | better quality of life using FACIT questionnaire after 6 months | after 6 months |
| referral to hospice | referral to hospice for patients who die | by one year |
| place of death | place of death for those patients that die | by one year |
| caregiver bereavement score | caregiver bereavement score for those subjects that die | by one year |