Susanne Muehlschlegel1,2,3, Kelsey Goostrey4, Julie Flahive5, Qiang Zhang6, Jolanta J Pach6, David Y Hwang6. 1. Department of Neurology, University of Massachusetts Chan Medical School, Worcester, MA susanne.muehlschlegel@umassmemorial.org. 2. Department of Anesthesiology, University of Massachusetts Chan Medical School, Worcester, MA. 3. Department of Surgery, University of Massachusetts Chan Medical School, Worcester, MA. 4. Department of Neurology, University of Massachusetts Chan Medical School, Worcester, MA. 5. Department of Population and Quantitative Health Sciences, University of Massachusetts Chan Medical School, Worcester, MA. 6. Division of Neurocritical Care and Emergency Neurology, Department of Neurology, Yale School of Medicine, New Haven, CT.
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 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.
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 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.
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