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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
Allocation: | Randomized |
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 |
Arm | Intervention/treatment |
---|---|
No Intervention: control group
usual care
|
|
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

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, Learn About Clinical Studies.
Ages Eligible for Study: | 21 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
-
Clinical surrogates of the following patients will be eligible to participate in this opinion survey:
- All patients admitted to the SICU and not expected to die within 48 hours.
- Patient has been admitted to the acute care surgical service,
- The patient is over the age of 50 and does not have decision making capacity.
- Subjects must be over the age of 21 and English speaking to participate in the opinion survey.
Exclusion Criteria:

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 avolandes@partners.org | |
Principal Investigator: Angelo Volandes |
Principal Investigator: | Angelo Volandes | MGH |
Responsible Party: | Angelo E. Volandes, MD, Principal Investigator, Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT01589107 History of Changes |
Other Study ID Numbers: |
2011-P-001731 |
First Posted: | May 1, 2012 Key Record Dates |
Last Update Posted: | May 2, 2012 |
Last Verified: | May 2012 |