Clinical trial NCT05671874: Feasibility of a Digital Goals-of-Care Decision Aid for Clinicians and Families of Patients With SABI
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hemorrhagic Stroke, Intracerebral
Acute Ischemic Stroke
Traumatic Brain Injury
Keywords: shared decision making
physician-family communication
withdrawal of life sustaining therapies
patient-value congruent care
decision aid
neuroICU
neurocritical care
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: Worcester Polytechnic Institute
name: National Institutes of Health (NIH)
name: National Institute of Nursing Research (NINR)
name: Johns Hopkins University
First posted: 2023-01-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: stepped-wedge randomized trial (before-after study)
Primary purpose: OTHER

Brief 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 acute ischemic stroke and intracerebral hemorrhage.

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.

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.

Primary outcomes:
measure: Feasibility of tool use by surrogate decision-makers
timeFrame: Duration of ICU stay, an expected average of 4 weeks
measure: Feasibility of enrolling surrogates in a stepped-wedge (before/after) clinical trial in a neurocritical care setting
timeFrame: Through study completion, estimated 18 months past primary start date
measure: Feasibility of retaining surrogates in a neurocritical care setting
timeFrame: Three-months post SABI
Secondary outcomes:
measure: Participants' ratings of usability of the tool (Intervention surrogates only)
timeFrame: Duration of ICU stay, an expected average of 4 weeks
measure: Participants' ratings of perceived effectiveness of the tool in preparing them for decision-making (Intervention surrogates only)
timeFrame: Duration of ICU stay, an expected average of 4 weeks
measure: Fidelity to intervention protocol
timeFrame: Through study completion, estimated 18 months past primary start date
Other outcomes:
measure: Participants' ratings of what they liked and disliked about the DA+C tool (Intervention surrogates only)
timeFrame: Until right before the scheduled clinician-family meeting, an average of 10-14 days after admission
measure: Surrogates' clarity about patient values & preferences
timeFrame: After the scheduled clinician-family meeting, an average of 10-14 days after admission
measure: Surrogates' ratings of the degree of shared decision-making
timeFrame: After the scheduled clinician-family meeting, an average of 10-14 days after admission
measure: Caregiver Burden
timeFrame: Three-months post SABI
measure: Decision Regret
timeFrame: Three-months post SABI
measure: Goals-of-care decision
timeFrame: Hospital discharge up until 3-months post SABI
measure: Mortality
timeFrame: Hospital discharge up until 3-months post SABI
measure: Functional status
timeFrame: 3-months post SABI
measure: Patient-perceived Patient- Centeredness of Care
timeFrame: 3-months post SABI
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Worcester
country: United States
facility: UMass Memorial Hospital
state: Massachusetts
Study officials:
affiliation: University of Massachusetts Chan Medical School
name: Nils Henninger, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: Susanne Muehlschlegel, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: Goostrey K, Muehlschlegel S. Prognostication and shared decision making in neurocritical care. BMJ. 2022 Apr 7;377:e060154. doi: 10.1136/bmj-2021-060154.
citation: 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.