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临床试验/NCT01844492
NCT01844492已完成不适用

Improving Patient and Family Centered Care in Advanced Critical Illness

University of Pittsburgh2 个研究点 分布在 1 个国家目标入组 1,420 人开始时间: 2012年7月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
1,420
试验地点
2
主要终点
Hospital Anxiety and Depression Scale

研究概览

简要总结

One in five deaths in the U.S. occurs in or shortly after discharge from an intensive care unit (ICU), typically following decisions made by surrogate decision makers to forego life prolonging treatment. A large body of empirical research has identified deficiencies in care processes that contribute to three important problems: 1) family members often experience poor quality communication with ICU clinicians, leading to lasting psychological distress associated with the ICU experience; 2) patients near the end of life frequently receive invasive, expensive treatment that is inconsistent with their values and preferences, and 3) end-of-life care is a major contributor to health care costs.[8, 9] Although advance care planning can prevent some unwanted treatment, many patients wish for a trial of intensive treatment when the prognosis is uncertain, and therefore it seems likely that the need for interventions to improve "in-the-moment" decisions by surrogates will persist.[10, 11]

In a pilot project, the investigators developed the PARTNER intervention (PAiring Re-engineered ICU Teams with Nurse-driven Emotional Support and Relationship-building), an interdisciplinary intervention that 1) gives new responsibilities and advanced communication skills training to existing ICU staff (local nurse leaders and social work members of the ICU team); 2) changes care "defaults" to ensure frequent clinician-family meetings; and 3) adds protocolized, nurse-administered coaching and emotional support of surrogates before and during clinician-family meetings. The objective of this proposal is to conduct a stepped wedge randomized controlled trial testing the PARTNER intervention in 5 ICUs among 1000 patients with advanced critical illness and their surrogates.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years of age or older
  • Surrogate decision maker for ICU patient in one of 5 UPMC ICU's

排除标准

  • Non-English Speaking
  • Surrogate's loved one is for organ transplantation
  • Not physically able to participate in family meeting

研究组 & 干预措施

ICU Usual Care Control

Active Comparator

described below

干预措施: ICU Usual Care Control (Other)

The PARTNER Intervention

Experimental

described below

干预措施: The PARTNER Intervention (Behavioral)

结局指标

主要结局

Hospital Anxiety and Depression Scale

时间窗: At 6 months

Symptom burden of anxiety and depression in family members in a telephone interview 6 months after enrollment using the validated 14-item Hospital Anxiety and Depression scale (HADS).

次要结局

  • Total Hospitalization costs(Duration of hospital stay, an expected average of 4 weeks)
  • Patient-and Family Centeredness of Care Scale(At 6 months)
  • Intensive Care Unit Length of Stay(Participants will be followed for duration of ICU stay, an expected average of 21 days.)
  • Impact of Events Scale of Care Scale(At 6 months)
  • Quality of Communication (QOC) scale(At 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Douglas White

MD

University of Pittsburgh

研究点 (2)

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