A Randomized Controlled Trial of a Video Decision Making Aid to Obtain Informed Consent in the Surgical Intensive Care Unit
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01589107|
Recruitment Status : Unknown
Verified May 2012 by Angelo E. Volandes, MD, Massachusetts General Hospital.
Recruitment status was: Recruiting
First Posted : May 1, 2012
Last Update Posted : May 2, 2012
|Condition or disease||Intervention/treatment||Phase|
|Surgery Trauma||Behavioral: video decision aid||Not Applicable|
Specific Aim 1: To demonstrate that clinical surrogates of SICU patients who view a video decision aid in addition to receiving written and verbal information about procedures and life sustaining therapy in the SICU make more informed decisions than patients and clinical surrogates who receive written and verbal information alone.
Hypothesis 1: Adding a video decision aid to the current informed consent process, for procedures and life sustaining treatments in the SICU, will better inform clinical surrogates of incapacitated patients admitted to the SICU regarding decision making when providing consent for medical treatment.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||52 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||A Randomized Controlled Trial of a Video Decision Making Aid to Obtain Informed Consent in the Surgical Intensive Care Unit|
|Study Start Date :||December 2011|
|Estimated Primary Completion Date :||December 2012|
No Intervention: control group
|Experimental: Video Arm||
Behavioral: video decision aid
video decision aid
- knowledge of risks and benefits of procedures [ Time Frame: 5 minutes after survey ]knowledge of risks and benefits of procedures
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01589107
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Angelo Volandes 617-643-4266 firstname.lastname@example.org|
|Principal Investigator: Angelo Volandes|
|Principal Investigator:||Angelo Volandes||MGH|