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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Hemorrhagic Stroke, Intracerebral, Acute Ischemic Stroke, Traumatic Brain Injury

Intervention / Treatment
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* Behavioral: Web/mobile/tablet-based digital decision aid + communication (DA+C) tool


Participation Criteria
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Eligibility Criteria
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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 iscritically 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: stepped-wedge randomized trial (before-after study)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Web-based Decision Aid + Communication (DA+C) tool<br>Surrogate(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. | Behavioral: Web/mobile/tablet-based digital decision aid + communication (DA+C) tool<br>* 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.<br>|
| No Intervention: Usual Care<br>No decision aid | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Duration of ICU stay, an expected average of 4 weeks | 
| Feasibility of enrolling surrogates in a stepped-wedge (before/after) clinical trial in a neurocritical care setting | Measured by meeting target enrollment. | Through study completion, estimated 18 months past primary start date | 
| Feasibility of retaining surrogates in a neurocritical care setting | The number of subjects that complete the long-term follow-up. | Three-months post SABI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants' ratings of usability of the tool (Intervention surrogates only) | Usability of the tool as measured with the System Usability Scale. | Duration of ICU stay, an expected average of 4 weeks | 
| 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. | Duration of ICU stay, an expected average of 4 weeks | 
| 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 | Through study completion, estimated 18 months past primary start date | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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shared decision making, physician-family communication, withdrawal of life sustaining therapies, patient-value congruent care, decision aid, neuroICU, neurocritical care