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

Not Applicable

• Conditions: Surgery; Trauma
• Interventions: Behavioral: video decision aid

• Registration Number: NCT01589107
• Lead Sponsor: Massachusetts General Hospital

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.

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-04-28
• Study First Submitted QC: 2012-04-30
• Study First Posted: 2012-05-01
• Primary Completion: 2012-12
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-16
• Last Update Posted: 2020-11-18

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 52

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

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Video Arm	video decision aid	-

Primary Outcome Measures

Name	Time	Method
knowledge of risks and benefits of procedures	5 minutes after survey	knowledge of risks and benefits of procedures

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States