Literature DB >> 35853748

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

Susanne Muehlschlegel1,2,3, Kelsey Goostrey4, Julie Flahive5, Qiang Zhang6, Jolanta J Pach6, David Y Hwang6.   

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.
© 2022 American Academy of Neurology.

Entities:  

Year:  2022        PMID: 35853748      PMCID: PMC9576301          DOI: 10.1212/WNL.0000000000200937

Source DB:  PubMed          Journal:  Neurology        ISSN: 0028-3878            Impact factor:   11.800


  33 in total

1.  The role and interpretation of pilot studies in clinical research.

Authors:  Andrew C Leon; Lori L Davis; Helena C Kraemer
Journal:  J Psychiatr Res       Date:  2010-10-28       Impact factor: 4.791

2.  Caution regarding the use of pilot studies to guide power calculations for study proposals.

Authors:  Helena Chmura Kraemer; Jim Mintz; Art Noda; Jared Tinklenberg; Jerome A Yesavage
Journal:  Arch Gen Psychiatry       Date:  2006-05

Review 3.  Systematic review: the effect on surrogates of making treatment decisions for others.

Authors:  David Wendler; Annette Rid
Journal:  Ann Intern Med       Date:  2011-03-01       Impact factor: 25.391

4.  Treatment decisions after severe stroke: uncertainty and biases.

Authors:  Claire J Creutzfeldt; Robert G Holloway
Journal:  Stroke       Date:  2012-11-13       Impact factor: 7.914

5.  Impact of the Ottawa Decision Support Framework on the agreement and the difference between patients' and physicians' decisional conflict.

Authors:  France Légaré; Annette M O'Connor; Ian D Graham; Georges A Wells; Stéphane Tremblay
Journal:  Med Decis Making       Date:  2006 Jul-Aug       Impact factor: 2.583

6.  What Families Need and Physicians Deliver: Contrasting Communication Preferences Between Surrogate Decision-Makers and Physicians During Outcome Prognostication in Critically Ill TBI Patients.

Authors:  Thomas Quinn; Jesse Moskowitz; Muhammad W Khan; Lori Shutter; Robert Goldberg; Nananda Col; Kathleen M Mazor; Susanne Muehlschlegel
Journal:  Neurocrit Care       Date:  2017-10       Impact factor: 3.210

7.  Surrogate decision-makers' perspectives on discussing prognosis in the face of uncertainty.

Authors:  Leah R Evans; Elizabeth A Boyd; Grace Malvar; Latifat Apatira; John M Luce; Bernard Lo; Douglas B White
Journal:  Am J Respir Crit Care Med       Date:  2008-10-17       Impact factor: 21.405

8.  The Impact of Resilience Factors and Anxiety During Hospital Admission on Longitudinal Anxiety Among Dyads of Neurocritical Care Patients Without Major Cognitive Impairment and Their Family Caregivers.

Authors:  Emma E Meyers; Alex Presciutti; Kelly M Shaffer; Melissa Gates; Ann Lin; Jonathan Rosand; Ana-Maria Vranceanu
Journal:  Neurocrit Care       Date:  2020-10       Impact factor: 3.210

9.  Prognostic Uncertainty in Critically Ill Patients with Traumatic Brain Injury: A Multicenter Qualitative Study.

Authors:  Kelsey Jones; Thomas Quinn; Kathleen M Mazor; Susanne Muehlschlegel
Journal:  Neurocrit Care       Date:  2021-06-02       Impact factor: 3.210

10.  Adapting a Traumatic Brain Injury Goals-of-Care Decision Aid for Critically Ill Patients to Intracerebral Hemorrhage and Hemispheric Acute Ischemic Stroke.

Authors:  Kelsey J Goostrey; Christopher Lee; Kelsey Jones; Thomas Quinn; Jesse Moskowitz; Jolanta J Pach; Andrea K Knies; Lori Shutter; Robert Goldberg; Kathleen M Mazor; David Y Hwang; Susanne Muehlschlegel
Journal:  Crit Care Explor       Date:  2021-03-09
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