Rationale: Individuals acting as surrogate decision-makers for critically ill patients frequently struggle in this role and experience high levels of long-term psychological distress. Prior interventions that were designed solely to improve information sharing between clinicians and family members have been ineffective. Objectives: We sought to examine the impact of a multicomponent family support intervention on patient and family outcomes. Methods: We conducted a patient-level randomized clinical trial at six ICUs in a healthcare system in Pennsylvania. An external interventionist interacted daily with surrogate decision-makers for incapacitated, critically ill patients at high risk of death or severe long-term functional impairment to deliver four types of protocolized support during the ICU stay: emotional support; communication support; decisional support; and, if indicated, anticipatory grief support. The control condition involved usual care plus two brief education sessions about critical illness. Measurements and Main Results: Primary outcome was the surrogates' scores on the Hospital Anxiety and Depression Scale at 6 months (range = 0-42). A total of 444 surrogates of 291 patients were enrolled (233 surrogates in intervention and 211 in control). The Four Supports intervention was delivered with high fidelity (frequency of per protocol delivery of key intervention elements, 97.1%; quality rating of intervention delivery, 2.9 ± 0.2 on a scale ranging from 1 to 3, with higher scores indicating higher quality of intervention delivery). There was no intervention effect on the primary outcome, surrogates' Hospital Anxiety and Depression Scale total scores at 6-month follow-up (β = 0.06; 95% confidence interval, -0.07 to 0.19; P = 0.35), or the prespecified secondary outcomes. Conclusions: Among critically ill patients at high risk of death or functional impairment, a family support intervention delivered by an external interventionist did not reduce surrogates' long-term psychological symptom burden.Clinical trial registered with www.clinicaltrials.gov (NCT01982877).
Keywords: clinical trial; communication; critical care; decision-making; family support.