Status:
COMPLETED
Informing Decisions in Chronic Critical Illness: A Randomized Control Trial (RCT)
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborating Sponsors:
National Institute of Nursing Research (NINR)
University of North Carolina
Conditions:
Chronic Critical Illness
Prolonged Mechanical Ventilation
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
The purpose of this study is to test a communication intervention to support family decision-making for patients with chronic critical illness.
Detailed Description
Increasing use of intensive care therapies by an aging population has created a new medical syndrome - "chronic critical illness" - encompassing multi-system derangements, recurrent complications, and...
Eligibility Criteria
Inclusion
- Mechanically ventilated ≥ 7 days
- Mechanically ventilated without \> 96 hour interruption
- Age ≥ 21 years
- ICU MD does not expect patient will die within 72 hours
- ICU MD does not expect patient will be liberated from the ventilator within 72 hours.
Exclusion
- Previous admission to study ICU this hospitalization Mechanically ventilated at outside hospital for \> 7 days before transfer
- Chronic Neuromuscular (NM) Disease
- Trauma
- Burn
- Previous palliative care consultation in this hospitalization
- No family or other surrogate decision-maker
- Family not available
- Surrogate lacks English proficiency
- Physician refused permission for research staff to approach the family
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
622 Patients enrolled
Trial Details
Trial ID
NCT01230099
Start Date
October 1 2010
End Date
October 1 2014
Last Update
October 29 2015
Active Locations (4)
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1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
2
University of North Carolina School of Medicine
Chapel Hill, North Carolina, United States, 27599
3
Durham Regional Medical Center
Durham, North Carolina, United States, 27704
4
Duke University School of Medicine
Durham, North Carolina, United States, 27710