Randomized Clinical Trial of the Four Supports Intervention for Surrogate Decision-Makers in Intensive Care Units.

Prior interventions that were designed solely to improve information sharing between clinicians and family members have been ineffective.

先前设计的仅旨在改善临床医生与家庭成员间信息共享的干预措施已被证明无效。

Objectives: We sought to examine the impact of a multicomponent family support intervention on patient and family outcomes.

目的：我们旨在检查多组分家庭支持干预措施对患者和家庭结果的影响。

Methods: We conducted a patient-level randomized clinical trial at six ICUs in a healthcare system in Pennsylvania.

方法：我们在宾夕法尼亚州的一个医疗系统中的六个重症监护病房进行了患者级别的随机临床试验。

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.

一位外部干预者每天与无法自理、病情危重且面临高死亡风险或严重长期功能障碍的患者的代理决策者互动，以提供四种类型的标准化支持：情感支持；沟通支持；决策支持；如有需要，提前悲伤支持。

The control condition involved usual care plus two brief education sessions about critical illness.

对照条件包括常规护理加上两次关于危重病的简短教育课程。

Measurements and Main Results: Primary outcome was the surrogates' scores on the Hospital Anxiety and Depression Scale at 6 months (range = 0-42).

测量和主要结果：主要结果是6个月时代理人在医院焦虑和抑郁量表上的得分（范围=0-42）。

A total of 444 surrogates of 291 patients were enrolled (233 surrogates in intervention and 211 in control).

共有291名患者的444名代理人参与了研究（干预组233名，对照组211名）。

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).

四维支持干预措施的实施具有很高的忠实度（关键干预元素按协议交付的频率为97.1%；干预交付质量评分为2.9 ± 0.2，评分范围为1至3，分数越高表示干预交付质量越高）

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.

干预措施对主要结果没有影响，即在6个月随访时代理人的医院焦虑和抑郁量表总分（β = 0.06；95%置信区间，-0.07至0.19；P = 0.35），或预先设定的次要结果也没有影响。

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).

结论：对于高风险死亡或功能障碍的危重病患者，由外部干预者提供的家庭支持干预并未减轻代理人长期的心理症状负担。临床试验已注册于www.clinicaltrials.gov (NCT01982877)。