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NCT05671874Completed

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

Pilot Trial of a Web/Mobile/Tablet-based Communication and Goals-of-Care Decision Aid for Clinicians and Families of Severe Acute Brain Injury Patients

Source: ClinicalTrials.gov · Last updated 4 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
50 (actual)
First submitted
3 Jan 2023
Start date
28 Mar 2023
Primary completion date
20 Mar 2026
Lead sponsor
University of Massachusetts, Worcester
Diseases
Stroke
NCT number
NCT05671874

What you commit to

  • Study type: Interventional
  • Participants enrolled: 50
  • From 28 Mar 2023 to the primary completion date, 20 Mar 2026
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • 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.
  • \- unwillingness to comply with study protocol.

Who the study is looking for

  • 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 literate
  • 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.

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Johns Hopkins Bayview Medical Center
Coordinator of this site? Confirm its status
BaltimoreUnited StatesUnknown status
Johns Hopkins Hospital
Coordinator of this site? Confirm its status
BaltimoreUnited StatesUnknown status
UMASS Memorial Hospital
Coordinator of this site? Confirm its status
WorcesterUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.