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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01589107
• Other study ID #: 2011-P-001731
• Status: Recruiting
• Phase: N/A
• Start date: December 2011

Study information

• Verified date: November 2020
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Surgery
• Trauma

Intervention

Behavioral:
• video decision aid
video decision aid

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	knowledge of risks and benefits of procedures	knowledge of risks and benefits of procedures	5 minutes after survey