Contemporary clinical trials · 2026
Protocol for a randomized trial of a scalable, interactive tool to support surrogate decision-makers of critically ill patients.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
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Olszewski Aleksandra E, Butler Rachel A, Ashana Deepshikha C, Carson Shannon, Cox Christopher E, Hough Catherine L, Hwang David Y, Maloney David, Mayr Florian, Menon Vidya, Steingrub Jay S, Sullivan Donald R, Vincent Grace, Wendlandt Blair, White Douglas
Аннотация
BACKGROUND: Patients, particularly those at the end of their lives, frequently receive goal-discordant care, and their surrogate decision-makers suffer long-term psychological injury. Contributors to these issues may include infrequent communication between clinicians and surrogates, failure to discuss prognosis, values, and treatment options that include comfort-focused care, and surrogates facing high-stakes decision-making while underprepared and overwhelmed psychologically and emotionally.
DESIGN: This is a multicenter, patient-randomized efficacy trial of a multi-component intervention, versus usual care, for 370 incapacitated, critically ill adults at high risk of death or severe disability, and their surrogate decision-makers, from 7 hospitals across the United States.
INTERVENTION: The intervention combines surrogate utilization of a digital Family Support Tool (FST) in real-time during their loved one's hospitalization with proactively scheduled family meetings, for which both surrogates and clinicians receive additional preparation, at set intervals during the ICU hospitalization. Those in the control arm will receive usual ICU care.
OUTCOMES: Our primary outcome is patient-centeredness of care, measured using the modified Patient Perceived Patient-Centeredness of Care (PPPC) scale. Secondary outcomes include surrogates' psychological symptom burden, communication and decision quality, and patients' health resource utilization and clinical outcomes.
CONCLUSION: This trial will provide robust evidence about the impact of combining the FST with increased and intentional communication, on patient, family, and health system outcomes for those hospitalized in the ICU.
DESIGN: This is a multicenter, patient-randomized efficacy trial of a multi-component intervention, versus usual care, for 370 incapacitated, critically ill adults at high risk of death or severe disability, and their surrogate decision-makers, from 7 hospitals across the United States.
INTERVENTION: The intervention combines surrogate utilization of a digital Family Support Tool (FST) in real-time during their loved one's hospitalization with proactively scheduled family meetings, for which both surrogates and clinicians receive additional preparation, at set intervals during the ICU hospitalization. Those in the control arm will receive usual ICU care.
OUTCOMES: Our primary outcome is patient-centeredness of care, measured using the modified Patient Perceived Patient-Centeredness of Care (PPPC) scale. Secondary outcomes include surrogates' psychological symptom burden, communication and decision quality, and patients' health resource utilization and clinical outcomes.
CONCLUSION: This trial will provide robust evidence about the impact of combining the FST with increased and intentional communication, on patient, family, and health system outcomes for those hospitalized in the ICU.