A Trial of a CPR Video in Heart Failure Patients

Congestive Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01653938
• Other study ID #: 2009-P-002083
• Status: Recruiting
• Phase: N/A
• Start date: April 2011

Study information

• Verified date: November 2020
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

Behavioral:
• video decision aid

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	preferences	preferences for cpr and intubation	5 minutes after survey
Secondary	knowledge	knowledge of cpr and intubation	5 minutes after survey
Secondary	decisional conflict	decisional conflict	5 minutes after survey
Secondary	advance care planning documentation	advance care planning in medical record	by the end of one year