A Trial of a CPR Video in Heart Failure Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Massachusetts General Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Angelo E. Volandes, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01653938
First received: July 24, 2012
Last updated: July 30, 2012
Last verified: July 2012

July 24, 2012
July 30, 2012
April 2011
September 2012   (final data collection date for primary outcome measure)
preferences [ Time Frame: 5 minutes after survey ] [ Designated as safety issue: No ]
preferences for cpr and intubation
Same as current
Complete list of historical versions of study NCT01653938 on ClinicalTrials.gov Archive Site
  • knowledge [ Time Frame: 5 minutes after survey ] [ Designated as safety issue: No ]
    knowledge of cpr and intubation
  • decisional conflict [ Time Frame: 5 minutes after survey ] [ Designated as safety issue: No ]
    decisional conflict
  • advance care planning documentation [ Time Frame: by the end of one year ] [ Designated as safety issue: No ]
    advance care planning in medical record
Same as current
Not Provided
Not Provided
 
A Trial of a CPR Video in Heart Failure Patients
A Randomized Controlled Trial of a CPR Video in Heart Failure Patients

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

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Congestive Heart Failure
Behavioral: video decision aid
  • No Intervention: control group
  • Experimental: Video Arm
    Use of video decision aid in the experimental arm.
    Intervention: Behavioral: video decision aid
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
Not Provided
September 2012   (final data collection date for primary outcome measure)

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.
Both
65 Years and older
No
United States
 
NCT01653938
2009-P-002083
No
Angelo E. Volandes, MD, Massachusetts General Hospital
Massachusetts General Hospital
Not Provided
Not Provided
Massachusetts General Hospital
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP