Decision Aid Feasibility Trial for Families of Critically Ill Stroke Patients
Withdrawn before enrolling · Not applicable
Conditions studied: Ischemic Stroke, Ischaemic Stroke With Coma, Intracerebral Hemorrhage, Hemorrhagic Stroke
In brief
Severe strokes, including large artery acute ischemic stroke and intracerebral hemorrhage, continue to be the leading cause of death and disability in adults in the U.S. Due to concerns for a poor long-term quality of life, withdrawal of mechanical ventilation and supportive medical care with transition to comfort care is the most common cause of death in severe strokes, but occurs at a highly variable rate. Decision aids (DAs) are shared decision-making tools which have been successfully implemented and validated for many other diseases to assist difficult decision making. The investigators have developed a pilot DA for goals-of-care decisions for surrogates of severe, critically ill stroke patients. This was developed through qualitative research using semi-structured interviews in surrogate decision makers of traumatic brain injury patients and physicians, and adapted to severe strokes. The investigators now propose to pilot-test a DA for surrogates of critically ill severe stroke patients in a feasibility trial.
Key facts
- Study ID
- NCT04143113
- Run by
- University of Massachusetts, Worcester
- People needed
- 0
- Starts
- 2020-07-01
- Expected to finish
- 2022-06-30
- Last updated by the study team
- 2021-03-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- ≥18 years of age; no upper age limit
- Documented health care proxy or legal next of kin of severe stroke patient admitted to the ICU with intracerebral hemorrhage or acute ischemic stroke.
- ≥3 days after insult ("stabilization period"); clinical team may ask study team to wait longer if clinically indicated
- Severe stroke 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)
You may not qualify if…
- Devastating severe stroke patient 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
Where it is running
- Yale Medical School/Yale New Haven Medical Center — New Haven, Connecticut, United States
- University of Massachusetts, Worcester — Worcester, Massachusetts, United States
Full record on ClinicalTrials.gov
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