Temporal Intervention Trial of a CPR Video in the ICU

The recruitment status of this study is unknown because the information has not been verified recently.

Verified April 2011 by Massachusetts General Hospital.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Massachusetts General Hospital

ClinicalTrials.gov Identifier:

NCT01241955

First received: November 15, 2010

Last updated: April 4, 2011

Last verified: April 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	November 15, 2010
Last Updated Date	April 4, 2011
Start Date ^ICMJE	February 2011
Estimated Primary Completion Date	February 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 15, 2010)	CPR preferences [ Time Frame: within 48 hours of ICU admission ] [ Designated as safety issue: No ] CPR preferences for patients admitted to the ICU
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01241955 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Temporal Intervention Trial of a CPR Video in the ICU
Official Title ^ICMJE	A Temporal Intervention Trial of a CPR Video in the ICU
Brief Summary	To compare the decision making of family members of patients admitted to the ICU in regards to their CPR preferences for their loved ones with and without the use of a video decision aid.
Detailed Description	Surrogate decision makers of patients admitted to an ICU and UNABLE to make decisions for themselves will be asked their choice for CPR preferences for their loved ones. This will occur during the first six months of the study. After six months, surrogate decision makers of patients admitted to an ICU and unable to make decisions for themselves will view a video decision aid for CPR and then asked their choice for CPR preferences for their loved ones.
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Health Services Research
Condition ^ICMJE	Admission to ICU
Intervention ^ICMJE	Behavioral: video decision aid video of CPR
Study Arm (s)	No Intervention: verbal description of CPR verbal description of CPR Experimental: Video decision aid Video decision aid of CPR 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	100
Completion Date	Not Provided
Estimated Primary Completion Date	February 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: patient admitted to ICU and unable to make decisions with a known surrogate decision maker Exclusion Criteria: Cannot speak English
Gender	Both
Ages	21 Years and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01241955
Other Study ID Numbers ^ICMJE	2010-P-001820/1
Has Data Monitoring Committee	No
Responsible Party	Angelo Volandes, 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	April 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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