Facilitating communication for critically ill patients and their family members: Study protocol for two randomized trials implemented in the U.S. and France.

Facilitating communication for critically ill patients and their family members: Study protocol for two randomized trials implemented in the U.S. and France.
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DOI:
10.1016/j.cct.2021.106465
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发表时间:
2021-08
影响因子:
2.2
通讯作者:
Engelberg RA
Engelberg RA
中科院分区:
医学4区
文献类型:
--
作者:
Curtis JR;Kentish-Barnes N;Brumback LC;Nielsen EL;Pollak KI;Treece PD;Hudson L;Garzio G;Im J;Weiner BJ;Khandelwal N;Resche-Rigon M;Azoulay E;Engelberg RA

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危重患者及其家属承受着心理症状的沉重负担,部分原因是在危重疾病期间和之后,临床医生和环境之间发生了许多转变,导致护理支离破碎。沟通促进者可能会有所帮助。我们正在进行两项集群随机试验,一项在美国,一项在法国,目的是评估一名经过培训的护士辅导员,以支持、示范和教授沟通策略,使患者和家属能够确保符合患者目标的护理,从ICU开始,持续3个月。我们将在美国随机抽取376名危重患者,在法国随机抽取400名危重患者进行干预或常规护理。符合条件的患者医院死亡风险大于15%或患有慢性疾病,中位生存期约为2年或更短。在随机化后1、3和6个月,我们评估了以患者和家庭为中心的结果的有效性,包括抑郁、焦虑和创伤后应激症状,以及目标一致性护理的评估。主要结果是家庭抑郁症状超过6个月。我们还评估了干预是否通过降低利用率来提高价值,同时改善结果。最后,我们使用混合方法来探索与实施结果相关的实施因素(可接受性、保真度、可接受性、渗透率),以便为传播提供信息。在美国和法国进行试验将有助于了解各国之间的异同。我们描述了两项随机试验的设计,旨在改善两个国家危重患者及其家属的沟通促进器的结果。
Critically-ill patients and their families suffer a high burden of psychological symptoms due, in part, to many transitions among clinicians and settings during and after critical illness, resulting in fragmented care. Communication facilitators may help. We are conducting two cluster-randomized trials, one in the U.S. and one in France, with the goal of evaluating a nurse facilitator trained to support, model, and teach communication strategies enabling patients and families to secure care consistent with patients’ goals, beginning in ICU and continuing for 3 months. We will randomize 376 critically-ill patients in the US and 400 in France to intervention or usual care. Eligible patients have a risk of hospital mortality of greater than15% or a chronic illness with a median survival of approximately 2 years or less. We assess effectiveness with patient- and family-centered outcomes, including symptoms of depression, anxiety, and post-traumatic stress, as well as assessments of goal-concordant care, at 1-, 3-, and 6-months post-randomization. The primary outcome is family symptoms of depression over 6 months. We also evaluate whether the intervention improves value by reducing utilization while improving outcomes. Finally, we use mixed methods to explore implementation factors associated with implementation outcomes (acceptability, fidelity, acceptability, penetration) to inform dissemination. Conducting the trial in U.S. and France will provide insights into differences and similarities between countries. We describe the design of two randomized trials of a communication facilitator for improving outcomes for critically ill patients and their families in two countries.
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