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.

中文翻译：

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四项支持对重症监护病房代理决策者进行干预的随机试验。


基本原理 作为危重病人的代理决策者，个人经常在这个角色中挣扎，并经历高水平的长期心理困扰。先前的干预措施仅旨在改善临床医生和家庭成员之间的信息共享，但效果不佳。目的 检查多组分家庭支持干预对患者和家庭结局的影响 方法： 在宾夕法尼亚州医疗保健系统的 6 个重症监护病房 （ICU） 进行患者水平随机临床试验。外部干预人员每天与死亡风险高或严重长期功能障碍的无行为能力、危重病人的代理决策者互动，在 ICU 住院期间提供四种类型的协议化支持——情绪支持、沟通支持、决策支持，以及（如果有指征）预期悲伤支持。控制条件包括常规护理和两次关于危重疾病的简短教育会议。测量和主要结果主要结果：6 个月时医院焦虑和抑郁量表 （HADS） 的代理人评分（范围 0-42）。招募了 291 名患者的 444 名替代者（干预 233 名替代者，对照 211 名替代者）。四项支持干预以高保真度提供（每个方案的关键干预要素的交付频率为 97.1%;干预实施的质量评分为 2.9 ± 0.2（1-3 分制），分数越高表示干预实施的质量越高）。对主要结局，即 6 个月随访时替代者的 HADS 总分没有干预影响 （β=0.06;CI： -0.07-0.19;p=0.35），也不在预先指定的次要结局上。 结论 在死亡或功能障碍高危的危重症患者中，由外部干预者提供的家庭支持干预并未减轻代理人的长期心理症状负担。临床试验注册可在 www.CLINICALTRIALS gov，ID：NCT01982877。