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

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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
Sponsor:
Information provided by (Responsible Party):
Angelo E. Volandes, MD, Massachusetts General Hospital

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Surgery Trauma Behavioral: video decision aid Not Applicable

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.


Study Design
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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
Arms and Interventions
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Arm Intervention/treatment
No Intervention: control group
usual care
Experimental: Video Arm Behavioral: video decision aid
video decision aid


Outcome Measures
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Primary Outcome Measures :
  1. knowledge of risks and benefits of procedures [ Time Frame: 5 minutes after survey ]
    knowledge of risks and benefits of procedures


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
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
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Information from the National Library of Medicine

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


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
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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