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Hemorrhagic Stroke, IntracerebralNCT05671874

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

A study testing Web/mobile/tablet-based digital decision aid + communication (DA+C) tool in people with Hemorrhagic Stroke, Intracerebral and Acute Ischemic Stroke, run by University of Massachusetts, Worcester at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Web/mobile/tablet-based digital decision aid + communication (DA+C) tool
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
3 sitesUnited States
Study dates
28 Mar 2023to 20 Mar 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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).
Show all 11Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Johns Hopkins Bayview Medical Center

    Baltimore, Maryland, 21224

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287

  • UMass Memorial Hospital

    Worcester, Massachusetts, 01655

Other trials in United States

About this study

Official title: 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

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.

Read the detailed description

Every 30 seconds an adult in the U.S. suffers a severe acute brain injury (SABI) from traumatic brain injury or large ischemic or hemorrhagic stroke, resulting in 200,000 deaths and >900,000 survivors living with disability annually. Every day, surrogate decision-makers face the difficult "goals of care" decision in intensive care units (ICUs) to continue or withdraw life support while considering the patient's long-term prognosis. In this study, we will pilot test a pragmatic, scalable intervention to overcome ongoing problems with high stakes decision-making by surrogates of patients with SABI in ICUs. These problems are an important target for intervention, because they contribute to 3 major clinical and public health issues: 1) family members struggle in the role of surrogate, leading to lasting symptoms of psychological distress; 2) clinicians are poorly trained in communicating prognosis after SABI, often doing so with variability and bias, inadequately preparing families for their decisions; 3) patients often receive burdensome treatments that they would not choose.

Decision aids improve the quality of patients' decisions based on a large evidence-base, but no empirically validated tools currently exist for surrogate decision-making in SABI patients at high risk for death or disability. This is problematic because surrogates of SABI patients are unprepared for the difficult decisions about the use of life support and patients' potential long-term disability, which hinge on both medical information and the patient's values and preferences. We have developed and refined a tailored digital, web-based decision aid (DA) for families of critically ill SABI patients, conceptually grounded in the Ottawa Decision Support Framework, to enhance, not replace, clinician-family communication. We will leverage a digital platform, which is portable and shareable among family members when geographically distant or not allowed to visit the ICU (as during the COVID-19 pandemic) and allows integration of videos to reach lower-literacy groups. This innovative tool challenges the existing paradigm for decision-making in SABI patients.

This pilot study among 50 surrogates of SABI patients and their clinicians will assess the feasibility of deploying the web-based tool as well as to explore the tools impact on measures of communication and decision-quality.

Being tested
Web/mobile/tablet-based digital decision aid + communication (DA+C) tool
Keywords
shared decision making, physician-family communication, withdrawal of life sustaining therapies, patient-value congruent care, decision aid, neuroICU, neurocritical care
Medical subject headings
Hemorrhagic Stroke, Ischemic Stroke, Brain Injuries, Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Web/mobile/tablet-based digital decision aid + communication (DA+C) toolBehavioural

    The web/mobile/tablet-based digital DA+C toll is designed to enhance communication and shared decision making between clinicians and surrogates of critically ill severe acute brain injury (SABI) with four goals: to 1) prepare families for their surrogate role and discussions with clinicians; 2) provide balanced information to families on prognosis and all available treatment options; 3) provide tailored information about the patient and family to clinicians in advance of family meetings; and 4) serve as a communication guide for clinicians in the clinician-family meeting to facilitate shared decision-making.

Study groups in NCT05671874
Study groupRoleWhat they receive
Web-based Decision Aid + Communication (DA+C) toolExperimentalSurrogate(s) will read/click through the DA+C tool prior to the clinician-family meeting and complete the integrated worksheet. Surrogate(s) will have unlimited access to the DA+C tool and may return to the tool and edit the worksheet at any time.
Receives: Behavioral: Web/mobile/tablet-based digital decision aid + communication (DA+C) tool
Usual CareNo interventionNo decision aid

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of tool use by surrogate decision-makers

    Data tracking analytics built into the tool will be employed to determine the extent to which the tools is used as per protocol.

    Measured: Duration of ICU stay, an expected average of 4 weeks

  2. Feasibility of enrolling surrogates in a stepped-wedge (before/after) clinical trial in a neurocritical care setting

    Measured by meeting target enrollment.

    Measured: Through study completion, estimated 18 months past primary start date

  3. Feasibility of retaining surrogates in a neurocritical care setting

    The number of subjects that complete the long-term follow-up.

    Measured: Three-months post SABI

Secondary outcomes (3)

  1. Participants' ratings of usability of the tool (Intervention surrogates only)

    Usability of the tool as measured with the System Usability Scale.

    Measured: Duration of ICU stay, an expected average of 4 weeks

  2. Participants' ratings of perceived effectiveness of the tool in preparing them for decision-making (Intervention surrogates only)

    Perceived Effectiveness will be measured with an 11-item perceived effectiveness questionnaire using a 5-point Likert scale.

    Measured: Duration of ICU stay, an expected average of 4 weeks

  3. Fidelity to intervention protocol

    Fidelity to the intervention protocol will be measured using self-checklists by clinicians and review of a random selection of 30% of the audio-recorded clinician-family meetings

    Measured: Through study completion, estimated 18 months past primary start date

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2023
  2. Study start28 Mar 2023
  3. Primary completion20 Mar 2026
  4. Study completion20 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Sequential
Model description
stepped-wedge randomized trial (before-after study)
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05671874
Sponsor's protocol ID
H00024195
Other IDs
R21NR020231
Status last verified
Apr 2026
First submitted
3 Jan 2023
Last updated
4 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Anonymized data not published within the final manuscript will be made available by request from any qualified investigator.

Publications

  • Muehlschlegel S, Goostrey K, Flahive J, Zhang Q, Pach JJ, Hwang DY. Pilot Randomized Clinical Trial of a Goals-of-Care Decision Aid for Surrogates of Patients With Severe Acute Brain Injury. Neurology. 2022 Oct 3;99(14):e1446-e1455. doi: 10.1212/WNL.0000000000200937.

    PubMed 35853748

  • Goostrey KJ, Lee C, Jones K, Quinn T, Moskowitz J, Pach JJ, Knies AK, Shutter L, Goldberg R, Mazor KM, Hwang DY, Muehlschlegel S. Adapting a Traumatic Brain Injury Goals-of-Care Decision Aid for Critically Ill Patients to Intracerebral Hemorrhage and Hemispheric Acute Ischemic Stroke. Crit Care Explor. 2021 Mar 9;3(3):e0357. doi: 10.1097/CCE.0000000000000357. eCollection 2021 Mar.

    PubMed 33786434

  • Muehlschlegel S, Perman SM, Elmer J, Haggins A, Teixeira Bailey ND, Huang J, Jansky L, Kirchner J, Kasperek-Wynn R, Lipman PD, Yeatts SD, Fetters MD, Dickert NW, Silbergleit R. The Experiences and Needs of Families of Comatose Patients After Cardiac Arrest and Severe Neurotrauma: The Perspectives of National Key Stakeholders During a National Institutes of Health-Funded Workshop. Crit Care Explor. 2022 Mar 4;4(3):e0648. doi: 10.1097/CCE.0000000000000648. eCollection 2022 Mar.

    PubMed 35265851

  • Goostrey K, Muehlschlegel S. Prognostication and shared decision making in neurocritical care. BMJ. 2022 Apr 7;377:e060154. doi: 10.1136/bmj-2021-060154.

    PubMed 35696329

  • Muehlschlegel S, Hwang DY, Flahive J, Quinn T, Lee C, Moskowitz J, Goostrey K, Jones K, Pach JJ, Knies AK, Shutter L, Goldberg R, Mazor KM. Goals-of-care decision aid for critically ill patients with TBI: Development and feasibility testing. Neurology. 2020 Jul 14;95(2):e179-e193. doi: 10.1212/WNL.0000000000009770. Epub 2020 Jun 17.

    PubMed 32554766

Questions about this trial

What is this clinical trial studying?

A study testing Web/mobile/tablet-based digital decision aid + communication (DA+C) tool in people with Hemorrhagic Stroke, Intracerebral and Acute Ischemic Stroke, run by University of Massachusetts, Worcester at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of tool use by surrogate decision-makers (time frame: Duration of ICU stay, an expected average of 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05671874, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.

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