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
  Purpose

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


Condition Intervention
Congestive Heart Failure
Behavioral: video decision aid

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: A Randomized Controlled Trial of a CPR Video in Heart Failure Patients

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • preferences [ Time Frame: 5 minutes after survey ] [ Designated as safety issue: No ]
    preferences for cpr and intubation


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 50
Study Start Date: April 2011
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: control group
Experimental: Video Arm
Use of video decision aid in the experimental arm.
Behavioral: video decision aid

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01653938

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Angelo Volandes    617-643-4266    avolandes@partners.org   
Principal Investigator: Angelo Volandes         
Sponsors and Collaborators
Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Angelo E. Volandes, MD, PI, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01653938     History of Changes
Other Study ID Numbers: 2009-P-002083
Study First Received: July 24, 2012
Last Updated: July 30, 2012
Health Authority: United States: Federal Government

Keywords provided by Massachusetts General Hospital:
CHF

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 30, 2014