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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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Mass General Brigham

Status

Unknown

Conditions

Trauma
Surgery

Treatments

Behavioral: video decision aid

Study type

Interventional

Funder types

Other

Identifiers

NCT01589107
2011-P-001731

Details and patient eligibility

About

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.

Full 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.

Enrollment

52 estimated patients

Sex

All

Ages

21+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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:

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

52 participants in 2 patient groups

control group
No Intervention group
Description:
usual care
Video Arm
Experimental group
Treatment:
Behavioral: video decision aid

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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