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临床试验/NCT02984124
NCT02984124已完成2 期

Communication During Hospitalization About Resuscitation Trial

University of Vermont8 个研究点 分布在 1 个国家目标入组 182 人开始时间: 2016年12月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
182
试验地点
8
主要终点
Quality of Communication Questionnaire (QOCQ), slightly modified to focus on communication about cardiopulmonary resuscitation

研究概览

简要总结

This multicenter RCT of 200 hospitalized patients and their family members evaluates an "informed assent" approach to discussing cardiopulmonary resuscitation, compared to usual care, in older seriously ill hospitalized patients with severe life-limiting illness or severe functional impairment.

详细描述

Increasing evidence suggests that high quality palliative care in older patients improves quality of care, patient and family satisfaction, and costs of care. However, while some specific palliative care interventions have been investigated, exactly how we should provide this care remains unclear. One important component of high quality provider-patient communication is discussing cardiopulmonary resuscitation (CPR) within the context of the patient's values and goals of care. Unfortunately, these conversations are often rushed, focused only on the procedure rather than the patient's goals and values, and CPR is often offered as if a choice on a menu. Elderly hospitalized patients are unlikely to have made decisions about CPR prior to hospitalization, and these discussions often leave patients and families feeling burdened, stressed, and concerned. Outcomes after in-hospital CPR in chronically ill older patients continue to be very poor, despite decades of efforts toward improvement.

The investigators aim to change the paradigm of CPR discussions with older adults unlikely to benefit from CPR. This study is a randomized controlled trial comparing an innovative "informed assent" approach to discussing CPR versus usual care with attention control for older hospitalized adults with life-limiting illness or severe functional impairment, enrolling patients and family members at three different study sites. Informed assent includes: 1) eliciting values and goals, 2) explaining CPR in the context of illness, and 3) a caring statement that the patient should not receive CPR if values include avoiding burdensome therapies unlikely to provide benefit. Thus, the provider can elicit values, convey information, and state an assessment, while allowing the patient or family to disagree. The investigators hypothesize that informed assent will improve quality of and satisfaction with communication about CPR; reduce the burden of potentially harmful CPR discussions, including reduced patient and family symptoms of depression and anxiety; and reduce intensity of care and health care utilization. The intervention builds on prior work investigating CPR outcomes in older adults and performing pilot studies of the informed assent intervention in both inpatients and outpatients.

研究设计

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

入排标准

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

入选标准

  • >65 years old
  • English speaking
  • Must have one or more of the following:
  • Chronic life-limiting illness with median survival <2 years defined as: 1) metastatic cancer or inoperable lung cancer; 2) COPD requiring oxygen; 3) New York Heart Association Class III or IV heart failure, 4) Child's Class C cirrhosis or MELD score of >20, 5) End-stage renal disease (must be on dialysis and ≥ 75 years old), 6) Advanced pulmonary fibrosis/interstitial lung disease, 7) Advanced pulmonary hypertension
  • Severe functional impairment defined as dependence with >4 activities of daily living (ADLs) on Katz Index of Independence in ADLs.

排除标准

  • Has already definitively chosen DNR status
  • Unable to provide informed consent
  • Refused consent
  • Currently listed on a transplant list (awaiting transplant)
  • Inappropriate for study enrollment per clinician
  • Known to have a left ventricular assist device (LVAD)
  • Research team unavailable
  • Patient discharged from hospital prior to enrollment

研究组 & 干预措施

Intervention

Experimental

Participants (n= approximately 100 plus family members) who are randomized to the intervention arm of the study will participate in a discussion about CPR with a study doctor.

干预措施: Informed Assent Discussion (Behavioral)

Usual Care with Attention Control

Placebo Comparator

Participants (n= approximately 100 plus family members) who are randomized to the usual care arm will receive a friendly visit in the hospital from research personnel to ask if they have any questions or concerns. Follow up assessments and time windows will be explained. Importance of their participation in the study will be emphasized.

干预措施: Usual Care with Attention Control (Behavioral)

结局指标

主要结局

Quality of Communication Questionnaire (QOCQ), slightly modified to focus on communication about cardiopulmonary resuscitation

时间窗: Study day 5 +/- 1 or hospital discharge, whichever is earlier

Patient-Assessed Quality of Communication about CPR

次要结局

  • Quality of Communication Questionnaire (QOCQ), slightly modified to focus on communication about cardiopulmonary resuscitation(Study day 5 +/- 1 or hospital discharge, whichever is earlier)
  • Tracheostomy placement (yes/no)(Measured at the time hospital discharge, which will likely occur at an average of 6 days after admission, but will be assessed for up to 6 months.)
  • Receipt of cardiopulmonary resuscitation (yes/no)(Measured at the time hospital discharge, which will likely occur at an average of 6 days after admission, but will be assessed for up to 6 months.)
  • Do-Not-Resuscitate Orders (yes/no)(Study day 5 +/- 1 or hospital discharge (whichever is earlier), 3 months, and 6 months)
  • Time to Do-Not-Resuscitate Orders(To 6 months post-randomization)
  • Admission to the intensive care unit (ICU) 9yes/no)(Measured at the time hospital discharge, which will likely occur at an average of 6 days after admission, but will be assessed for up to 6 months.)
  • ICU length of stay (days)(Measured at the time hospital discharge, which will likely occur at an average of 6 days after admission, but will be assessed for up to 6 months.)
  • Gastrostomy tube placement (yes/no)(Measured at the time hospital discharge, which will likely occur at an average of 6 days after admission, but will be assessed for up to 6 months.)
  • Receipt of renal replacement therapy (yes/no)(Measured at the time hospital discharge, which will likely occur at an average of 6 days after admission, but will be assessed for up to 6 months.)
  • Cost of health care after initial hospitalization(3 months and 6 months post-randomization)
  • Receipt of mechanical ventilation (yes/no)(Measured at the time hospital discharge, which will likely occur at an average of 6 days after admission, but will be assessed for up to 6 months.)
  • Mortality (dead or alive)(To 6 months post-randomization)
  • 5-question communication domain of the CANHELP Questionnaire, slightly modified to focus on communication about cardiopulmonary resuscitation(Study day 5 +/- 1 or hospital discharge, whichever is earlier)
  • Hospital Anxiety and Depression Survey (HADS)(Study day 5 +/- 1 or hospital discharge (whichever is earlier), 3 months, and 6 months)

研究者

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

Renee Stapleton

Associate Professor of Medicine

University of Vermont

研究点 (8)

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