A Trial of a CPR Video in Heart Failure Patients

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

Detailed Description
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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.

Official Title
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A Randomized Controlled Trial of a CPR Video in Heart Failure Patients

Conditions
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Congestive Heart Failure

Intervention / Treatment
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* Behavioral: video decision aid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Ability to provide informed consent. Ability to communicate in English. Age 65 or older.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control group<br> | |
| Experimental: Video Arm<br>Use of video decision aid in the experimental arm. | Behavioral: video decision aid<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| preferences | preferences for cpr and intubation | 5 minutes after survey | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| knowledge | knowledge of cpr and intubation | 5 minutes after survey | 
| decisional conflict | decisional conflict | 5 minutes after survey | 
| advance care planning documentation | advance care planning in medical record | by the end of one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CHF