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Abstract Details

A Two-Center, Parallel-Arm Randomized-Controlled Feasibility Trial Of A Goals-Of-Care Decision Aid For Surrogates Of Severe Acute Brain Injury Patients
Neuro Trauma, Critical Care, and Sports Neurology
Neurocritical Care Posters (7:00 AM-5:00 PM)
049
To determine feasibility of goals-of-care(GOC) decision aids(DAs) for surrogates of critically-ill severe acute brain injury (ciSABI) patients.
To promote shared decision-making in ciSABI patients, we recently developed three GOC-DAs for surrogates of ciSABI patients using a systematic development process adherent to International Patient DA Standards. No DAs have ever been tested in neuroICUs.
Between 2/2018-12/2019 we conducted a two-center, parallel-arm randomized-controlled feasibility trial enrolling surrogates of ciSABI patients (ICH, TBI, or hemispheric acute ischemic stroke requiring tracheostomy and/or feeding-tube). Surrogates were randomized 1:1 at the patient-level >1day(s) before the GOC family-meeting to intervention (DA [paper-based informational booklet]) or control (no DA). Primary feasibility outcomes were screening, recruitment, participation, and retention. Secondary outcomes included surrogates’ decisional-conflict, decision-regret, psychological burden, and decision-confidence, assessed with validated scales.
We approached the surrogates of 58 of 74 (78%) eligible patients. We consented 66/95 surrogates approached (70%), with n=33 randomized to each study arm. Baseline characteristics were balanced except for more ICU-complications in the control group (p=0.03). In the intervention arm, 27 surrogates remained in the study at the family-meeting-time-point; 15 had read and fully completed the DA (56% participation in intervention group). Study retention rates at 3-months were 23/33(70%) for intervention and 22/33(67%) for control. There were no between-group differences in surrogates’ decisional-conflict and decision-confidence. Mean Hospital-Anxiety-and-Depression-Scale (HADS) scores were high in both groups at baseline (I:C.18±7 vs.17±7.5;p=0.82), remained high after the family-meeting (I:C.18±8.8 vs.18±7.9;p=0.81), but declined in the control group at 3-months (I:C.18±8.8 vs.11±7.6;p=0.01). PTSD (mean Impact-of-Events-Scale-Revised, IES-R) results mirrored HADS (3-months I:C.32±18 vs. 21±15;p=0.04). Median decision-regret trended lower in the control group (I:C.15[5,35] vs.5[0,15];p=0.09).
GOC-DA use is feasible in neuroICUs. The small sample-size with imbalance in patients’ ICU complications, parallel-arm design limitations (control-group contamination), and low protocol fidelity may explain the secondary outcomes. Our study offers important “lessons-learned” for future neuroICU DA studies.
Authors/Disclosures
Susanne Muehlschlegel, MD, MPH, FAAN (Johns Hopkins School of Medicine)
PRESENTER 		Dr. Muehlschlegel has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Acasti Pharma Inc.. Dr. Muehlschlegel has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Acasti Pharma Inc.. The institution of Dr. Muehlschlegel has received research support from NIH. The institution of Dr. Muehlschlegel has received research support from NIH. The institution of an immediate family member of Dr. Muehlschlegel has received research support from NIH. The institution of Dr. Muehlschlegel has received research support from Johns Hopkins Stimulating and Advancing Anesthesiology & Critical Care Medicine Research (StAAR) Award. The institution of Dr. Muehlschlegel has received research support from Trustees of The Patrick and Catherine Weldon Donaghue Medical Research Foundation. The institution of Dr. Muehlschlegel has received research support from Harkin Family Fund (Johns Hopkins Dept. of Neurology). Dr. Muehlschlegel has received personal compensation in the range of $500-$4,999 for serving as a Speaker and Author with 好色先生. Dr. Muehlschlegel has a non-compensated relationship as a Member of Board of Directors with Neurocritical Care Society that is relevant to AAN interests or activities.
No disclosure on file
No disclosure on file
Qiang Zhang Mrs. Zhang has nothing to disclose.
No disclosure on file
David Y. Hwang, MD, FAAN (University of North Carolina School of Medicine) The institution of Dr. Hwang has received research support from NIH. The institution of Dr. Hwang has received research support from Neurocritical Care Foundation. Dr. Hwang has received publishing royalties from a publication relating to health care. Dr. Hwang has received personal compensation in the range of $10,000-$49,999 for serving as a Associate Medical Director with New England Donor Services.