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

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 patients with severe acute brain injury (SABI) 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 2 tertiary care US neuroICUs and randomized surrogate participants 1:1 to a tailored paper-based DA provided to surrogates before clinician-family goals-of-care meetings or usual care (no intervention before clinician-family meetings). The primary outcomes were feasibility of deploying the DA (recruitment, participation, and 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). Eighty-two percent 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 toward fewer comfort care decisions (27% vs 56%, = 0.1) and fewer code status changes (no change, 73% vs 44%, = 0.02). At 3 months, fewer patients in the DA group had died (33% vs 69%, = 0.05; median Glasgow Outcome Scale 3 vs1, = 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 NCT03833375.

CLASSIFICATION 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.