A Trial of a CPR Video in Heart Failure Patients
Purpose
This is a randomized controlled trial of a CPR video decision aid in patients with advanced congestive heart failure (CHF).
Condition
- Congestive Heart Failure
Eligibility
- Eligible Ages
- Over 65 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Criteria
Inclusion Criteria:
1. A diagnosis of advanced heart failure:
- New York Heart Association Class 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
- Two or more hospitalizations for heart failure in the last year. AND
- Either a systolic blood pressure ≤ 120 mm Hg OR Na ≤ 135 mEq/L.
2. Ability to provide informed consent.
3. Ability to communicate in English.
4. Age 65 or older.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Health Services Research
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
No Intervention control group |
|
|
|
Experimental Video Arm |
Use of video decision aid in the experimental arm. |
|
Recruiting Locations
Boston, Massachusetts 02114
More Details
- Status
- Unknown status
- Sponsor
- Massachusetts General Hospital
Study Contact
Detailed Description
Aim 1: To compare the care preferences for CPR and intubation among subjects randomized to video and subjects randomized to the current standard of care without the video. Hypothesis 1: Subjects randomized to the video intervention will be significantly more likely to opt against CPR and intubation compared to those who do not see the video. Aim 2: To compare code-status documentation in the electronic medical records between subjects randomized to the video and those who are receiving the current standard of care without the video. Hypothesis 2: Subjects randomized to the video are more likely to have their code status correctly documented in the electronic medical records compared to those who do not see the video. Aim 3: To compare knowledge and decisional conflict of subjects randomized to video and subjects randomized to the current standard of care without the video. Hypothesis 3: When compared to subjects randomized to the current standard of care, subjects in the video intervention group will have higher knowledge and lower decisional conflict (lower decisional conflict scores) when asked to choose CPR and intubation preferences.