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

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT01589107
• Collaborator: (none)
• Enrollment: 52
• Location: 1
• Arms: 2

Study Details

Study Description

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	N/A

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

• Study Type: Interventional
• Anticipated 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: Dec 1, 2011
• Actual Primary Completion Date: Dec 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. knowledge of risks and benefits of procedures [5 minutes after survey]

   knowledge of risks and benefits of procedures

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

• Massachusetts General Hospital

Investigators

• Principal Investigator: Angelo Volandes, MGH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Angelo E. Volandes, MD, Principal Investigator, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT01589107
• Other Study ID Numbers: 2011-P-001731
• First Posted: May 1, 2012
• Last Update Posted: Nov 18, 2020
• Last Verified: Nov 1, 2020

Study Results

No Results Posted as of Nov 18, 2020