Pilot Randomized Clinical Trial of a Goals-of-Care Decision Aid for Surrogates of Patients With Severe Acute Brain Injury

Abstract

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.

Do They Have a Choice? Surrogate Decision-Making After Severe Acute Brain Injury*

“…Our findings suggest that these approaches need to account not only for surrogates’ “preferred degree of control” over decision-making but also whether surrogates even perceive there being a decision to make. Those surrogates who, for varied reasons, do not perceive themselves as making decisions may not benefit in the same way from strategies like time-limited trials (16), decision-aids (22, 23), or from repeated discussions of prognosis and treatment options, at least during the acute phase of care in the ICU. Instead, our data suggests that “no choice” surrogates might need prognostic communication to focus less on decision-making and more on the acknowledgement of uncertainty and its contribution to the surrogate’s coping, as well as on assurance of a longitudinal relationship.…”

Cognitive Biases and Shared Decision Making in Acute Brain Injury

“…A recent pilot study had promising results for a decision aid created specifically for patients with SABI. 106 Two strategies that have been found to improve SABI outcomes are transferring patients to specialty centers and using dedicated neurointensive care units. [110][111][112][113] One reason for these improved outcomes may be that decision making improves with such specialization, including greater prognostic accuracy and fewer opportunities for cognitive bias.…”

“…The many attempts to improve communication between clinicians and surrogates have had mixed results. [104][105][106] Effective communication may require not just better listening skills, but also guidance in how to convey the uncertain realities, unfamiliar outcomes, and unusual roles inherent to SDM in SABI. Decision science has a long history of communicating technical information to lay decision makers.…”

Helping Families With Fateful Decisions

“…In this issue of Neurology ® , Muehlschlegel et al 5 reported an unblinded, randomized pilot trial conducted at 2 tertiary-level Neuro-ICUs to test the feasibility and utility of this DA to promote education, communication, and preparation for goals of care discussions for surrogates of patients admitted after ischemic stroke, intracerebral hemorrhage, or traumatic brain injury. The authors found that most surrogates randomized to the intervention found it to be "good" or "excellent" (82%) and useful (92%).…”