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New app aims to ease tough choices for brain injury families

NCT ID NCT05671874

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This pilot study tested a web-based tool designed to improve communication and decision-making between doctors and families of patients with severe acute brain injuries, such as stroke or traumatic brain injury. The tool helps prepare families for their role as decision-makers and gives doctors tailored patient information. The study enrolled 50 surrogate decision-makers to see if the tool is feasible and easy to use.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
web/mobile/tablet-based digital decision aid and communication tool
What this could lead to
If successful, this tool could improve how families and doctors make difficult decisions together for patients with severe brain injuries.
What could go wrong
This is a small pilot study with only 50 participants, so results may not apply to all hospitals or families. The tool is meant to support decisions, not change medical outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

50 people

The number who actually took part.

Started

Mar 2023

Finished

Mar 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 literate Exclusion 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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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Johns Hopkins Bayview Medical Center

    Baltimore, Maryland, 21224, United States

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287, United States

  • UMass Memorial Hospital

    Worcester, Massachusetts, 01655, United States

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