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Clinical Trials/NCT01589107
NCT01589107
Unknown
Not Applicable

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

Massachusetts General Hospital1 site in 1 country52 target enrollmentDecember 2011
ConditionsSurgeryTrauma

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Surgery
Sponsor
Massachusetts General Hospital
Enrollment
52
Locations
1
Primary Endpoint
knowledge of risks and benefits of procedures
Last Updated
5 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
December 2011
End Date
December 2012
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Angelo E. Volandes, MD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

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

  • Not provided

Outcomes

Primary Outcomes

knowledge of risks and benefits of procedures

Time Frame: 5 minutes after survey

knowledge of risks and benefits of procedures

Study Sites (1)

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