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 because the information has not been verified recently.
Verified May 2012 by 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
  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: 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 Massachusetts General Hospital:

Primary Outcome Measures:
  • knowledge of risks and benefits of procedures [ Time Frame: 5 minutes after survey ] [ Designated as safety issue: No ]
    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
Genders Eligible for Study:   Both
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

No publications provided

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
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 21, 2014