跳至主要内容
临床试验/NCT00720200
NCT00720200已完成3 期

A Randomized Trial of an Interdisciplinary Communication Intervention to Improve Patient and Family Outcomes in the Intensive Care Unit

University of Washington2 个研究点 分布在 1 个国家目标入组 593 人开始时间: 2008年6月1日最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
已完成
入组人数
593
试验地点
2
主要终点
Patient Health Questionaire (PHQ-9)

研究概览

简要总结

The purpose of this study is to improve care in the Intensive Care Unit (ICU) by focusing on communication with family members of patients who are too sick to make decisions about their own care while they are in the ICU. The randomized trial will test the efficacy of a communication intervention designed to improve communication between families and clinicians through the use of a facilitator. Outcome evaluation occurs at the level of the individual family with surveys completed by families and clinicians.

详细描述

Three decades of research on end-of-life care in the United States indicate that people who are dying often spend their final days receiving care they would not choose. The intensive care unit (ICU) is an important focus for efforts to improve end-of-life care both because death is common in this setting - approximately 20% of Americans die in or shortly after a stay in the ICU - and also because care is highly technologic and, thus, expensive. As a result of our prior work we have developed a wealth of knowledge about how to improve communication and decision-making concerning end-of-life care in the ICU. One of the important insights from this knowledge was the need for and development of a facilitator-assisted interdisciplinary communication intervention. This intervention, designed to improve communication and decision-making about end-of-life care in the ICU, offers significant potential benefits for improving patient- and family-centered care for five reasons: 1) communication is an integral component of clinician skill that affects all other aspects of end-of-life care; 2) physicians and nurses in practice do not demonstrate adequate skills for communicating about end-of-life care, especially in the ICU or acute care setting; 3) interventions that have focused on improving communication within the ICU team and between the team and the family have been shown to reduce the "prolongation of dying" common in the ICU, but it remains unclear how to generalize these successes to other hospitals; 4) a recent randomized trial in France used an intervention based on our prior research and showed dramatic reductions in symptoms of anxiety, depression, and post-traumatic stress disorder (PTSD) among family members after the patient's death, but it is unclear how to translate these findings to hospitals in the U.S.; and 5) sustainable, generalizable, and widely available interventions that improve communication about end-of-life care are not available.

The long-term objectives are: 1) to demonstrate the efficacy of a generalizable facilitator-assisted interdisciplinary communication intervention in the ICU to improve family and patient outcomes; and 2) to demonstrate the feasibility of making this intervention a routine part of clinical practice in the ICU setting.

The study will advance Nursing science by addressing an important area of emphasis within Nursing science and a key component of the National Institute of Nursing Research's strategic plan. One fifth of deaths in America occur in intensive care units and nurses provide a key component of the care in this setting. With the aging population and coincident advances in medical technology, more patients are likely to die after an unsuccessful trial of intensive care. Prior research suggests that interventions to improve communication about end-of-life care in the ICU may reduce the prolongation of dying that is common in the ICU setting while at the same time improving the quality of care for patients and family members. Unfortunately, this prior research does not provide a clear generalizable intervention that can be easily implemented in academic and community hospitals. The proposed randomized trial will test a feasible and generalizable intervention to improve communication about end-of-life care and improve patient and family outcomes.

The consent forms used for this study address the purpose, procedures, risks, alternatives, benefits, and other information -- including emphasis on the voluntary nature of this research and assurances of confidentiality.

The conceptual model for the intervention addresses three components of self-efficacy theory: 1) knowledge, based on this team's prior research identifying components of communication during ICU family conferences that are associated with improved patient and family outcomes; 2) attitudes, informed by attachment theory as applied to clinician-patient relationships and communication; and 3) communication behaviors informed by principles of mediation based on identifying and resolving conflict in the healthcare setting.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

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

  • Patients, family members, clinicians attending ICU family conferences, and nurses evaluating the quality of care.
  • All ICU patients are eligible if they meet the age criteria, have been in the ICU for at least 12 hours, have acute respiratory failure requiring mechanical ventilation at the time of enrollment, and have an APACHE II score/SOFA score or other diagnosis that predicts a 30-50% or greater risk of mortality.
  • Eligible family members and/or friends may include any of the following: legal guardians, durable power of attorney for healthcare, spouses, adult children, parents, siblings, domestic partners, other relatives, and friends; if they meet the age criteria, and understand English well enough to complete informed consent and study materials.
  • Eligible clinicians include those who are present during a family conference and may include physicians, nurses, nurse practitioners, physician assistants, social workers, respiratory therapists, and clergy.
  • All critical care nurses are eligible to participate in the evaluation if they have provided care to a patient on or before the shift in which he or she died or was discharged from the ICU.

排除标准

  • Legal or risk management concerns (as determined by the attending physician or via hospital record designation);
  • Psychological illness or morbidity; and
  • Physical or mental limitations preventing ability to complete questionnaires.
  • Patients will be excluded if they do not have at least one family member who is eligible and willing to participate in the study.
  • A patient who is readmitted to the ICU, if the patient was enrolled and discharged previously, will not be eligible.
  • Post-operative patients who have been admitted to the ICU after a scheduled surgery without complications will be excluded. These patients may meet other eligibility criteria (ventilation, APACHE scores, etc.) within the first 12 to 48 hours of admission, but will usually improve quite rapidly after that period.

研究组 & 干预措施

1

Experimental

干预措施: Facilitator-Based intervention (Behavioral)

2

Active Comparator

干预措施: Usual Care (Behavioral)

结局指标

主要结局

Patient Health Questionaire (PHQ-9)

时间窗: At 3- and 6- months following the death of the patient

Family symptoms of depression after the patient dies or is discharged from ICU as assessed by a survey

次要结局

  • Generalized Anxiety Disorder (GAD-7) Survey(At 3- and 6- months following the death of the patient)
  • Families' ratings of the quality of communication generally and specifically in the family conference(During ICU length of stay)
  • Clinicians' ratings of the quality of clinician-family in the family conference(During ICU length of stay)
  • Clinicians' ratings of nurse-physician collaboration(During ICU length of stay)
  • Quality of Dying and Death Questionaire(Following death of patient)
  • Evaluate length of stay in ICU/hospital(During hospital stay)
  • Costs during ICU stay including estimated costs of intervention(During ICU length of stay)
  • Post-Traumatic Stress Disorder Checklist (PCL)(At 3- and 6- months following the death of the patient)

研究者

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

J. Randall Curtis

Professor of Medicine

University of Washington

研究点 (2)

Loading locations...

相似试验