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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2013 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Angelo E. Volandes, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01776333
First received: January 22, 2013
Last updated: January 23, 2013
Last verified: January 2013
  Purpose

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


Condition Intervention
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 Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Video Images of Disease for Ethical Outcomes

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • anxiety and depression [ Time Frame: anxiety and depression at follow up phone call at 3 months after ICU death or discharge ] [ Designated as safety issue: No ]
  • satisfaction with ICU experience [ Time Frame: after 3 months from time of death or discharge from ICU ] [ Designated as safety issue: No ]
  • number of medical interventions during ICU stay [ Time Frame: during time period in the ICU up to one week ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: January 2013
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: usual care
Experimental: video arm
video decision aid intervention
Behavioral: video decision aid

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
MGH Not yet recruiting
Boston, Massachusetts, United States
Contact: Angelo Volandes         
Principal Investigator: Angelo Volandes         
BMC Not yet recruiting
Boston, Massachusetts, United States
Contact: Michael Paasche-Orlow         
Principal Investigator: Michael Paasche-Orlow         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Angelo Volandes MGH
  More Information

No publications provided

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
Study First Received: January 22, 2013
Last Updated: January 23, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:
ICU

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

ClinicalTrials.gov processed this record on July 29, 2014