Digital decision aid for families of patients with severe acute brain injury

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

This study is testing a new online tool to help families make tough decisions about life support for loved ones with severe brain injuries in the ICU.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Massachusetts, Worcester (Academic / other)
• Locations: 3 sites (Baltimore, Maryland and 2 other locations)
• Trial ID: NCT05671874 on ClinicalTrials.gov

What this trial studies

This study aims to pilot a web-based decision aid designed to assist surrogate decision-makers of patients with severe acute brain injury (SABI) in intensive care units. The intervention addresses the challenges faced by families when making high-stakes decisions about life support, particularly in cases of traumatic brain injury, hemorrhagic stroke, and ischemic stroke. By providing a structured communication tool, the study seeks to improve the decision-making process and reduce psychological distress among surrogates. The goal is to ensure that treatment decisions align with the patient's values and preferences, ultimately enhancing the quality of care provided.

Who should consider this trial

Good fit: Ideal candidates include adult patients aged 18 and older with severe acute brain injury who are critically ill and have a high risk of death or long-term disability.

Not a fit: Patients who are not critically ill or do not have a severe acute brain injury may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could empower families to make more informed decisions that align with their loved ones' values, potentially improving patient outcomes and family satisfaction.

How similar studies have performed: While decision aids have been successful in other contexts, this specific approach for surrogate decision-making in SABI patients is novel and has not been empirically validated.

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 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.

Where this trial is running

Baltimore, Maryland and 2 other locations

• Johns Hopkins Bayview Medical Center — Baltimore, Maryland, United States (Recruiting)
• Johns Hopkins Hospital — Baltimore, Maryland, United States (Recruiting)
• UMass Memorial Hospital — Worcester, Massachusetts, United States (Recruiting)

Study contacts

• Principal investigator: Nils Henninger, MD, PhD — University of Massachusetts Chan Medical School
• Study coordinator: Susanne Muehlschlegel, MD, MPH

Conditions Hemorrhagic Stroke, Intracerebral; Acute Ischemic Stroke; Traumatic Brain Injury; shared decision making; physician-family communication; withdrawal of life sustaining therapies; patient-value congruent care; decision aid