A Randomized Controlled Trial of a Video Decision Making Aid to Obtain Informed Consent in the Surgical Intensive Care Unit

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified May 2012 by Angelo E. Volandes, MD, Massachusetts General Hospital.
Recruitment status was: Recruiting

Sponsor:

Information provided by (Responsible Party):

Angelo E. Volandes, MD, Massachusetts General Hospital

ClinicalTrials.gov Identifier:

NCT01589107

First received: April 28, 2012

Last updated: May 1, 2012

Last verified: May 2012

History of Changes

Purpose

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.

Condition	Intervention
Surgery Trauma	Behavioral: video decision aid


Study Type:	Interventional
Study Design:	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

Further study details as provided by Angelo E. Volandes, MD, Massachusetts General Hospital:

Primary Outcome Measures:

knowledge of risks and benefits of procedures [ Time Frame: 5 minutes after survey ]
knowledge of risks and benefits of procedures


Estimated Enrollment:	52
Study Start Date:	December 2011
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
No Intervention: control group usual care
Experimental: Video Arm	Behavioral: video decision aid video decision aid

Detailed Description:

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.

Eligibility


Ages Eligible for Study:	21 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Clinical surrogates of the following patients will be eligible to participate in this opinion survey:
1. All patients admitted to the SICU and not expected to die within 48 hours.
2. Patient has been admitted to the acute care surgical service,
3. 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:

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: NCT01589107

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

Investigators


Principal Investigator:	Angelo Volandes	MGH

More Information


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
Study First Received:	April 28, 2012
Last Updated:	May 1, 2012

ClinicalTrials.gov processed this record on September 21, 2017

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