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

Respiratory Failure Clinical Trial

— VIDEO  

Official title:

Video Images of Disease for Ethical Outcomes

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01776333
• Other study ID #: 2010-P-001820
• Secondary ID: 2010-P-001820
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2013

Study information

• Verified date: November 2020
• Source: Massachusetts General Hospital
• Contact: Angelo Volandes
• Phone: 617 726 2000
• Email: avolandes[@]partners.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Event
• Respiratory Failure
• Respiratory Insufficiency

Intervention

Behavioral:
• video decision aid

Locations

Country	Name	City	State
United States	BMC	Boston	Massachusetts
United States	MGH	Boston	Massachusetts
United States	Cedars Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	preference for goal of care regarding medical interventions (e.g., CPR, intubation, etc.)		at baseline admission to the ICU during family meeting up to one week
Secondary	level of medical care delivered to patient at time of death or discharge from the ICU		at time of death or discharge from the ICU up to one week
Secondary	anxiety and depression		anxiety and depression at follow up phone call at 3 months after ICU death or discharge
Secondary	satisfaction with ICU experience		after 3 months from time of death or discharge from ICU
Secondary	number of medical interventions during ICU stay		during time period in the ICU up to one week