A Trial of a CPR Video in Heart Failure Patients

This study is currently recruiting participants.

Verified July 2012 by Massachusetts General Hospital

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

History of Changes

Tracking Information
First Received Date ^ICMJE	July 24, 2012
Last Updated Date	July 30, 2012
Start Date ^ICMJE	April 2011
Estimated Primary Completion Date	September 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 30, 2012)	preferences [ Time Frame: 5 minutes after survey ] [ Designated as safety issue: No ] preferences for cpr and intubation
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01653938 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: July 30, 2012)	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
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Trial of a CPR Video in Heart Failure Patients
Official Title ^ICMJE	A Randomized Controlled Trial of a CPR Video in Heart Failure Patients
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 Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Health Services Research
Condition ^ICMJE	Congestive Heart Failure
Intervention ^ICMJE	Behavioral: video decision aid
Study Arm (s)	No Intervention: control group Experimental: Video Arm Use of video decision aid in the experimental arm. Intervention: Behavioral: video decision aid
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	50
Completion Date	Not Provided
Estimated Primary Completion Date	September 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	65 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01653938
Other Study ID Numbers ^ICMJE	2009-P-002083
Has Data Monitoring Committee	No
Responsible Party	Angelo E. Volandes, MD, Massachusetts General Hospital
Study Sponsor ^ICMJE	Massachusetts General Hospital
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Massachusetts General Hospital
Verification Date	July 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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