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

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ClinicalTrials.gov Identifier: NCT01776333
Recruitment Status : Unknown
Verified January 2013 by Angelo E. Volandes, MD, Massachusetts General Hospital.
Recruitment status was:  Not yet recruiting
First Posted : January 28, 2013
Last Update Posted : January 28, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Randomized Controlled Trial of a Video Decision Aid in the ICU in surrogates of admitted patients.

Condition or disease Intervention/treatment
Admission to the ICU With Life-threatening Advanced Illness Including Advanced Heart Disease, Kidney Disease, Lung Disease, Gastrointestinal Disease and Cancer. Behavioral: video decision aid

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Video Images of Disease for Ethical Outcomes
Study Start Date : January 2013
Estimated Primary Completion Date : December 2015
Arms and Interventions

Arm Intervention/treatment
No Intervention: usual care
Experimental: video arm
video decision aid intervention
Behavioral: video decision aid


Outcome Measures

Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]
  2. anxiety and depression [ Time Frame: anxiety and depression at follow up phone call at 3 months after ICU death or discharge ]
  3. satisfaction with ICU experience [ Time Frame: after 3 months from time of death or discharge from ICU ]
  4. number of medical interventions during ICU stay [ Time Frame: during time period in the ICU up to one week ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01776333


Contacts
Contact: Angelo Volandes 617 726 2000 avolandes@partners.org

Locations
United States, California
Cedars Sinai Medical Center Not yet recruiting
Los Angeles, California, United States
Contact: Jonas Green         
Principal Investigator: Jonas Green         
United States, Massachusetts
BMC Not yet recruiting
Boston, Massachusetts, United States
Contact: Michael Paasche-Orlow         
Principal Investigator: Michael Paasche-Orlow         
MGH Not yet recruiting
Boston, Massachusetts, United States
Contact: Angelo Volandes         
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: NCT01776333     History of Changes
Other Study ID Numbers: 2010-P-001820
2010-P-001820 ( Other Identifier: MGH )
First Posted: January 28, 2013    Key Record Dates
Last Update Posted: January 28, 2013
Last Verified: January 2013

Keywords provided by Angelo E. Volandes, MD, Massachusetts General Hospital:
ICU

Additional relevant MeSH terms:
Kidney Diseases
Heart Diseases
Lung Diseases
Gastrointestinal Diseases
Digestive System Diseases
Urologic Diseases
Cardiovascular Diseases
Respiratory Tract Diseases