A Trial of a CPR Video in Heart Failure Patients

Not Applicable

• Conditions: Congestive Heart Failure
• Interventions: Behavioral: video decision aid

• Registration Number: NCT01653938
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2012-07-24
• Study First Submitted QC: 2012-07-30
• Study First Posted: 2012-07-31
• Primary Completion: 2012-09
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-16
• Last Update Posted: 2020-11-18

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Video Arm	video decision aid	Use of video decision aid in the experimental arm.

Primary Outcome Measures

Name	Time	Method
preferences	5 minutes after survey	preferences for cpr and intubation

Secondary Outcome Measures

Name	Time	Method
knowledge	5 minutes after survey	knowledge of cpr and intubation
decisional conflict	5 minutes after survey	decisional conflict
advance care planning documentation	by the end of one year	advance care planning in medical record

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States