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
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Johns Hopkins Bayview Medical Center Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Johns Hopkins Hospital Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| UMASS Memorial Hospital Coordinator of this site? Confirm its status | Worcester | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.