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Not Yet Recruiting NCT05671874

Feasibility of a Digital Goals-of-Care Decision Aid for Clinicians and Families of Patients With SABI

Conditions: Hemorrhagic Stroke, Intracerebral, Acute Ischemic Stroke, Traumatic Brain Injury

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: 1
Phase: NA
Enrollment: 50
Sponsor: University of Massachusetts, Worcester

Location: United States

Summary

The goal is to pilot test a highly accessible, web-based, pragmatic, scalable intervention to overcome ongoing problems with high stakes decision-making by surrogate decision-makers of patients in ICUs with severe acute brain injury (SABI), including those with moderate-severe traumatic brain injury, large hemispheric acute ischemic stroke and intracerebral hemorrhage.

Eligibility Criteria

Inclusion criteria for surrogates and patients:surrogate is age 18 years or older, no upper age limit;documented surrogate decision-maker (official health care proxy, or legal next of kin) of a critically ill severe acute brain injury (SABI) patient ≥ 3 days after admission;patient is age 18 years or older, no upper age limit;patient has SABI; defined as either traumatic brain injury, spontaneous primary intracerebral hemorrhage (not due to tumor or vascular malformation), or hemispheric acute ischemic stroke;patient is"critically ill" defined as either intubated on a mechanical ventilator, or unable to swallow without a feeding tube (even if not intubated/ventilated);patient is judged by the attending physician to have ≥40% risk of death or long-term functional impairment, elicited by asking the attending physician, "does this patient have at least a 40% chance of in-hospital mortality or long-term functional impairment?", defined as needing assistance with at least 1 activity of daily living (ADL).patient has undergone initial stabilization but remains critically ill;surrogate will participate in clinician-family goals of care meeting, either in person or via video- or telephone-conference.surrogate must be English speaking and literateExclusion Criteria for surrogates and patients:devastating patients with severe SABI who die early (within the first 3 days after admission);surrogate decision-maker is non-English speaking;surrogate decision-maker is illiterate.Inclusion criteria for clinicians:clinical treating attending, or physician trainee (fellow, resident), or licensed affiliated practitioner who will lead the clinician-family meeting when goals-of-care are discussed;clinician may decline participation in the outcome measures but cannot restrict the surrogate decision-maker in study participation.Exclusion criteria for clinicians:- unwillingness to comply with study protocol.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05671874). StuddyBuddy aggregates publicly available trial information.