A Randomized Controlled Trial of a Video Decision Aid in the ICU (VIDEO)

November 16, 2020 updated by: Angelo E. Volandes, MD, Massachusetts General Hospital

Video Images of Disease for Ethical Outcomes

Randomized Controlled Trial of a Video Decision Aid in the ICU in surrogates of admitted patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States
        • Cedars Sinai Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States
        • MGH
      • Boston, Massachusetts, United States
        • BMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: usual care
Experimental: video arm
video decision aid intervention
Behavioral: video decision aid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
at baseline admission to the ICU during family meeting up to one week

Secondary Outcome Measures

Outcome Measure
Time Frame
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
at time of death or discharge from the ICU up to one week
anxiety and depression
Time Frame: anxiety and depression at follow up phone call at 3 months after ICU death or discharge
anxiety and depression at follow up phone call at 3 months after ICU death or discharge
satisfaction with ICU experience
Time Frame: after 3 months from time of death or discharge from ICU
after 3 months from time of death or discharge from ICU
number of medical interventions during ICU stay
Time Frame: during time period in the ICU up to one week
during time period in the ICU up to one week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Investigators

  • Principal Investigator: Angelo Volandes, MGH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

January 22, 2013

First Submitted That Met QC Criteria

January 23, 2013

First Posted (Estimate)

January 28, 2013

Study Record Updates

Last Update Posted (Actual)

November 18, 2020

Last Update Submitted That Met QC Criteria

November 16, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-P-001820 (Other Identifier: MGH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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