• N. Engl. J. Med. · Jun 2018

    Randomized Controlled Trial Multicenter Study Comparative Study

    A Randomized Trial of a Family-Support Intervention in Intensive Care Units.

    • Douglas B White, Derek C Angus, Anne-Marie Shields, Praewpannarai Buddadhumaruk, Caroline Pidro, Cynthia Paner, Elizabeth Chaitin, Chang Chung-Chou H CH From the Program on Ethics and Decision Making in Critical Illness (D.B.W., A.-M.S., P.B.), Clinical Research, Investigation, and Systems Modeling o, Francis Pike, Lisa Weissfeld, Jeremy M Kahn, Joseph M Darby, Amy Kowinsky, Susan Martin, Robert M Arnold, and PARTNER Investigators.
    • From the Program on Ethics and Decision Making in Critical Illness (D.B.W., A.-M.S., P.B.), Clinical Research, Investigation, and Systems Modeling of Acute Illness Center (D.B.W., D.C.A., A.-M.S., P.B., C. Pidro, C.-C.H.C., J.M.K.), Department of Critical Care Medicine (D.B.W., D.C.A., A.-M.S., P.B., C. Pidro, C.-C.H.C., J.M.K., J.M.D.), and the Section of Palliative Care and Medical Ethics, Division of General Internal Medicine (R.M.A.), Department of Medicine (C.-C.H.C., R.M.A.), University of Pittsburgh School of Medicine, and the Intensive Care Unit Service Center (D.B.W., D.C.A., J.M.K.), the Wolff Center (C. Paner, A.K., S.M.), and the Palliative and Supportive Institute (E.C., R.M.A.), UPMC Health System - all in Pittsburgh; Eli Lilly, Indianapolis (F.P.); and the Statistics Collaborative, Washington, DC (L.W.).
    • N. Engl. J. Med. 2018 Jun 21; 378 (25): 2365-2375.

    BackgroundSurrogate decision makers for incapacitated, critically ill patients often struggle with decisions related to goals of care. Such decisions cause psychological distress in surrogates and may lead to treatment that does not align with patients' preferences.MethodsWe conducted a stepped-wedge, cluster-randomized trial involving patients with a high risk of death and their surrogates in five intensive care units (ICUs) to compare a multicomponent family-support intervention delivered by the interprofessional ICU team with usual care. The primary outcome was the surrogates' mean score on the Hospital Anxiety and Depression Scale (HADS) at 6 months (scores range from 0 to 42, with higher scores indicating worse symptoms). Prespecified secondary outcomes were the surrogates' mean scores on the Impact of Event Scale (IES; scores range from 0 to 88, with higher scores indicating worse symptoms), the Quality of Communication (QOC) scale (scores range from 0 to 100, with higher scores indicating better clinician-family communication), and a modified Patient Perception of Patient Centeredness (PPPC) scale (scores range from 1 to 4, with lower scores indicating more patient- and family-centered care), as well as the mean length of ICU stay.ResultsA total of 1420 patients were enrolled in the trial. There was no significant difference between the intervention group and the control group in the surrogates' mean HADS score at 6 months (11.7 and 12.0, respectively; beta coefficient, -0.34; 95% confidence interval [CI], -1.67 to 0.99; P=0.61) or mean IES score (21.2 and 20.3; beta coefficient, 0.90; 95% CI, -1.66 to 3.47; P=0.49). The surrogates' mean QOC score was better in the intervention group than in the control group (69.1 vs. 62.7; beta coefficient, 6.39; 95% CI, 2.57 to 10.20; P=0.001), as was the mean modified PPPC score (1.7 vs. 1.8; beta coefficient, -0.15; 95% CI, -0.26 to -0.04; P=0.006). The mean length of stay in the ICU was shorter in the intervention group than in the control group (6.7 days vs. 7.4 days; incidence rate ratio, 0.90; 95% CI, 0.81 to 1.00; P=0.045), a finding mediated by the shortened mean length of stay in the ICU among patients who died (4.4 days vs. 6.8 days; incidence rate ratio, 0.64; 95% CI, 0.52 to 0.78; P<0.001).ConclusionsAmong critically ill patients and their surrogates, a family-support intervention delivered by the interprofessional ICU team did not significantly affect the surrogates' burden of psychological symptoms, but the surrogates' ratings of the quality of communication and the patient- and family-centeredness of care were better and the length of stay in the ICU was shorter with the intervention than with usual care. (Funded by the UPMC Health System and the Greenwall Foundation; PARTNER ClinicalTrials.gov number, NCT01844492 .).

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