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 designed solely to improve information sharing between clinicians and family members have been ineffective.
Objectives: To examine the impact of a multicomponent family support intervention on patient and family outcomes Methods: Patient-level randomized clinical trial at 6 intensive care units (ICUs) in a healthcare system in Pennsylvania. An external interventionist interacted daily with surrogate decision-makers of 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: surrogates' score on the Hospital Anxiety and Depression Scale (HADS) at 6 months (range 0-42). 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 1-3 scale, with higher scores indicating higher quality of intervention delivery). There was no intervention effect on the primary outcome, surrogates' HADS total scores at 6-month follow-up (β=0.06; CI: -0.07-0.19; p=0.35), nor on 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 registration available at www.
Clinicaltrials: gov, ID: NCT01982877.
Keywords: Clinical trial; Communication; Critical care; Decision-making; Family support.