Status:
COMPLETED
Shared Decision Making to Improve Goals-of-Care Decisions for Families of Severe Acute Brain Injury Patients
Lead Sponsor:
University of Massachusetts, Worcester
Collaborating Sponsors:
Yale University
University of Florida
Conditions:
Traumatic Brain Injury
Ischemic Stroke
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Severe acute brain injury (SABI), including large artery acute ischemic stroke, intracerebral hemorrhage, and severe traumatic brain injury continue to be the leading cause of death and disability in ...
Detailed Description
Severe acute brain injury (SABI), including large artery acute ischemic stroke, intracerebral hemorrhage, and severe traumatic brain injury continue to be the leading cause of death and disability in ...
Eligibility Criteria
Inclusion
- ≥18 years of age; no upper age limit
- Documented health care proxy or legal next of kin of admitted SABI patient with traumatic brain injury, intracerebral hemorrhage or acute ischemic stroke.
- ≥3 days after insult ("stabilization period"); clinical team may ask study team to wait longer if clinically indicated
- SABI patient remains "critically ill" after 3 days defined as: either intubated and mechanically ventilated, or unable to swallow, needing feeding tube beyond hospital discharge (even if not intubated)
- Surrogate is physically present in ICU to receive decision aid and participate in planned family meeting in person (not over phone)
Exclusion
- Devastating SABI near death
- Patient will be extubated and pass swallow evaluation (as deemed by clinical team)
- Surrogate is non-English speaking and no interpreter available to translate decision aid (no available validated, translated decision aid version)
- Surrogate is illiterate
Key Trial Info
Start Date :
February 11 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 9 2020
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT03833375
Start Date
February 11 2018
End Date
March 9 2020
Last Update
June 17 2020
Active Locations (2)
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1
Yale Medical School/Yale New Haven Medical Center
New Haven, Connecticut, United States, 06520
2
University of Massachusetts Medical School
Worcester, Massachusetts, United States, 01655