A Trial of a CPR Video in Heart Failure Patients

Mass General Brigham

Status: Unknown

Conditions: Congestive Heart Failure

Treatments: Behavioral: video decision aid

Study type: Interventional

Funder types: Other

Identifiers

NCT01653938

2009-P-002083

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

control group

No Intervention group

Video Arm

Experimental group

Description:

Use of video decision aid in the experimental arm.

Treatment:

Behavioral: video decision aid