Back to resultsA Randomized Controlled Trial of a Video Decision Aid in the ICU (VIDEO)
Primary Purpose
Respiratory Failure, Cardiac Event
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
video decision aid
Sponsored by
About this trial
This is an interventional supportive care trial for Respiratory Failure focused on measuring ICU
Eligibility Criteria
Inclusion Criteria:
- Age 65 or older Patient does not have the capacity to make decisions Patient admitted to the ICU with life threatening illness including advanced heart, renal, lung, gastrointestinal and oncologic disease Patient has English speaking representative to make decisions on his/her behalf Patient critically ill and unlikely to survive to hospital discharge
Exclusion Criteria:
- Patients who are imminently dying and admitted to the ICU are excluded Wards if the state
Sites / Locations
- Cedars Sinai Medical Center
- BMC
- MGH
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
usual care
video arm
Arm Description
video decision aid intervention
Outcomes
Primary Outcome Measures
preference for goal of care regarding medical interventions (e.g., CPR, intubation, etc.)
Secondary Outcome Measures
level of medical care delivered to patient at time of death or discharge from the ICU
anxiety and depression
satisfaction with ICU experience
number of medical interventions during ICU stay
Full Information
NCT ID
NCT01776333
First Posted
January 22, 2013
Last Updated
November 16, 2020
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01776333
Brief Title
A Randomized Controlled Trial of a Video Decision Aid in the ICU
Acronym
VIDEO
Official Title
Video Images of Disease for Ethical Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Randomized Controlled Trial of a Video Decision Aid in the ICU in surrogates of admitted patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure, Cardiac Event
Keywords
ICU
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
usual care
Arm Type
No Intervention
Arm Title
video arm
Arm Type
Experimental
Arm Description
video decision aid intervention
Intervention Type
Behavioral
Intervention Name(s)
video decision aid
Primary Outcome Measure Information:
Title
preference for goal of care regarding medical interventions (e.g., CPR, intubation, etc.)
Time Frame
at baseline admission to the ICU during family meeting up to one week
Secondary Outcome Measure Information:
Title
level of medical care delivered to patient at time of death or discharge from the ICU
Time Frame
at time of death or discharge from the ICU up to one week
Title
anxiety and depression
Time Frame
anxiety and depression at follow up phone call at 3 months after ICU death or discharge
Title
satisfaction with ICU experience
Time Frame
after 3 months from time of death or discharge from ICU
Title
number of medical interventions during ICU stay
Time Frame
during time period in the ICU up to one week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- Age 65 or older Patient does not have the capacity to make decisions Patient admitted to the ICU with life threatening illness including advanced heart, renal, lung, gastrointestinal and oncologic disease Patient has English speaking representative to make decisions on his/her behalf Patient critically ill and unlikely to survive to hospital discharge
Exclusion Criteria:
- Patients who are imminently dying and admitted to the ICU are excluded Wards if the state
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Angelo Volandes
Phone
617 726 2000
Email
avolandes@partners.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angelo Volandes
Organizational Affiliation
MGH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars Sinai Medical Center
City
Los Angeles
State/Province
California
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonas Green
First Name & Middle Initial & Last Name & Degree
Jonas Green
Facility Name
BMC
City
Boston
State/Province
Massachusetts
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Paasche-Orlow
First Name & Middle Initial & Last Name & Degree
Michael Paasche-Orlow
Facility Name
MGH
City
Boston
State/Province
Massachusetts
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angelo Volandes
First Name & Middle Initial & Last Name & Degree
Angelo Volandes
12. IPD Sharing Statement
Learn more about this trial
A Randomized Controlled Trial of a Video Decision Aid in the ICU
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