A Randomized Controlled Trial of a Video Decision Making Aid to Obtain Informed Consent in the Surgical Intensive Care Unit
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Massachusetts General Hospital.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Massachusetts General Hospital
Information provided by (Responsible Party):
Angelo E. Volandes, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01589107
First received: April 28, 2012
Last updated: May 1, 2012
Last verified: May 2012
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Purpose
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 | Intervention |
|---|---|
|
Surgery Trauma |
Behavioral: video decision aid |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Single Group Assignment Masking: 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 |
Further study details as provided by Massachusetts General Hospital:
Primary Outcome Measures:
- knowledge of risks and benefits of procedures [ Time Frame: 5 minutes after survey ] [ Designated as safety issue: No ]knowledge of risks and benefits of procedures
| Estimated Enrollment: | 52 |
| Study Start Date: | December 2011 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: control group
usual care
|
|
| Experimental: Video Arm |
Behavioral: video decision aid
video decision aid
|
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.
Eligibility| Ages Eligible for Study: | 21 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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:
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01589107
Please refer to this study by its ClinicalTrials.gov identifier: NCT01589107
Locations
| United States, Massachusetts | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Angelo Volandes 617-643-4266 avolandes@partners.org | |
| Principal Investigator: Angelo Volandes | |
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
| Principal Investigator: | Angelo Volandes | MGH |
More Information
| Responsible Party: | Angelo E. Volandes, MD, Principal Investigator, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT01589107 History of Changes |
| Other Study ID Numbers: | 2011-P-001731 |
| Study First Received: | April 28, 2012 |
| Last Updated: | May 1, 2012 |
| Health Authority: | United States: Institutional Review Board |
ClinicalTrials.gov processed this record on September 30, 2016