ObjectiveTo develop and demonstrate early feasibility of a goals-of-care decision aid for surrogates of patients who are critically ill with traumatic brain injury (ciTBI) that meets accepted international decision aid guidelines.MethodsWe developed the decision aid in 4 stages: (1) qualitative study of goals-of-care communication and decision needs of 36 stakeholders of ciTBI (surrogates and physicians), which informed (2) development of paper-based decision aid with iterative revisions after feedback from 52 stakeholders; (3) acceptability and usability testing in 18 neurologic intensive care unit (neuroICU) family members recruited from 2 neuroICU waiting rooms using validated scales; and (4) open-label, randomized controlled feasibility trial in surrogates of ciTBI. We performed an interim analysis of 16 surrogates of 12 consecutive patients who are ciTBI to confirm early feasibility of the study protocol and report recruitment, participation, and retention rates to date.ResultsThe resultant goals-of-care decision aid achieved excellent usability (median System Usability Scale 87.5 [possible range 0–100]) and acceptability (97% graded the tool's content as “good” or “excellent”). Early feasibility of the decision aid and the feasibility trial protocol was demonstrated by high rates of recruitment (73% consented), participation (100%), and retention (100% both after the goals-of-care clinician–family meeting and at 3 months) and complete data for the measurements of all secondary decision-related and behavioral outcomes to date.ConclusionsOur systematic development process resulted in a novel goals-of-care decision aid for surrogates of patients who are ciTBI with excellent usability, acceptability, and early feasibility in the neuroICU environment, and meets international decision aid standards. This methodology may be a development model for other decision aids in neurology to promote shared decision-making.

Background and Objectives:Breakdowns in clinician-family communication in neurologic intensive care units (neuroICUs) are common, particularly for goals-of-care decisions to continue or withdraw life-sustaining treatments while considering long-term prognoses. Shared decision-making interventions (decision aids [DAs]) may prevent this problem and increase patient-centered care, yet none are currently available. We assessed the feasibility, acceptability, and perceived usefulness of a DA for goals-of-care communication with surrogate decision-makers for critically ill severe acute brain injury (SABI) patients after hemispheric acute ischemic stroke, intracerebral hemorrhage, or traumatic brain injury.Methods:We conducted a parallel-arm, unblinded, patient-level randomized, controlled pilot trial at two tertiary-care U.S. neuroICUs and randomized surrogate participants 1:1 to a tailored paper-based DA provided to surrogates prior to clinician-family goals-of-care meetings or usual care (no intervention prior to clinician-family meetings). The primary outcomes were feasibility of deploying the DA (recruitment, participation, retention), acceptability, and perceived usefulness of the DA among surrogates. Exploratory outcomes included outcome of surrogate goals-of-care decision, code-status changes during admission, patients’ 3-month functional outcome, and surrogates’ 3-month validated psychological outcomes.Results:We approached 83 surrogates of 58 patients and enrolled 66 surrogates of 41 patients (80% consent rate). Of 66 surrogates, 45 remained in the study at 3 months (68% retention). Of the 33 surrogates randomized to intervention, 27 were able to receive the DA, and 25 subsequently read the DA (93% participation). 82% rated the DA’s acceptability as good or excellent (median Acceptability score 2 [IQR 2;3]); 96% found it useful for goals-of-care decision-making. In the DA group, there was a trend towards fewer comfort-care decisions (27% vs. 56%, p=0.1) and fewer code-status changes (no change, 73% vs. 44%, p=0.02). At 3 months, fewer patients in the DA group had died (33% vs. 69%, p=0.05; median GOS 3 vs.1, p=0.05). Regardless of intervention, 3-month psychological outcomes were significantly worse among surrogates who had chosen continuation-of-care.Discussion:A goals-of-care DA to support ICU shared decision-making for patients with SABI is feasible to deploy and well-perceived by surrogates. A larger trial is feasible to conduct, although surrogates who select continuation-of-care deserve additional psychosocial support.Clinical Trials registration:Clinicaltrials.gov NCT03833375Classification of Evidence:This study provides Class IV evidence that the use of a DA explaining the goals-of-care decision and the treatment options is acceptable and useful to surrogates of incapacitated critically ill patients with ischemic stroke, intracerebral hemorrhage, or traumatic brain injury.

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