Purpose

This is a randomized controlled trial of a CPR video decision aid in patients with advanced congestive heart failure (CHF).

Condition

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

ArmDescriptionAssigned Intervention
No Intervention
control group
Experimental
Video Arm
Use of video decision aid in the experimental arm.
  • Behavioral: video decision aid

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114
Contact:
Angelo Volandes
617-643-4266
avolandes@partners.org

More Details

Status
Recruiting
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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.