跳至主要内容
临床试验/NCT01293708
NCT01293708已完成不适用

Realities, Expectations and Attitudes to Life Support Technologies in Intensive Care for Octogenarians:

Daren K. Heyland24 个研究点 分布在 1 个国家目标入组 1,504 人开始时间: 2009年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,504
试验地点
24
主要终点
Health Related Quality of Life (HRQOL)

研究概览

简要总结

The purpose of this study is to understand the realities, expectations and attitudes of patients 80+ and their families about the use of life-sustaining technology, and to document the patient outcomes and family experiences associated with surviving and not surviving critical illness. Specifically in this project the investigators will determine the real outcomes of critical illness experienced by octogenarians.

详细描述

Seriously ill hospitalized elderly patients rate 'not being kept alive on prolonged life supports' as the most important aspect of good quality care at the end of life (EOL). Across Canada, large numbers of elderly patients near the EOL and their families are faced with decisions about whether or not to use mechanical ventilation or other forms of life support technology used in intensive care units (ICUs). The investigators do not know whether these patients and their families are informed about the realities of intensive care - that is, if they are aware of the likelihood of surviving a critical illness and the resultant health states. The outcomes of critical illness for this patient population and their families are unknown, despite the crucial importance of this information to guide clinical decision making. The goals of our research program are to understand the realities of critical care, and the expectations and attitudes of patients 80 years of age or older (80+) and their families about the use of life sustaining technology. Specifically, in this project, the investigators want to determine the realities or outcomes of surviving critical illness.

Our primary research question is:

  1. What are the 12-month health-related quality of life (HRQOL), functional status, and survival of patients admitted to ICU who are 80+ years old?

Our secondary research questions are: 2. Which patient characteristics are associated with 12-month HRQOL, functional status, and survival? 3. What is the satisfaction of family members with critical care, as measured by the Family Satisfaction in ICU (FS-ICU 24) instrument? 4. For patients surviving their ICU stay, what is the experience of family members caring for the patient during follow up, as measured by the Caregiver Reaction Assessment (CRA) instrument? 5. For patients who do not survive their ICU stay, what is the family satisfaction with EOL care, as measured using the CANHELP Satisfaction (Bereavement) instrument? 6. What is the health-related financial burden experienced by patients and their caregivers during their initial ICU hospitalization and up to 12 months after the index ICU admission? 7. What is the quality of decision making regarding the goals of care for an 80+ ICU patient? 8. What are the values that influence decisions about the goals of care for this population?

To answer these questions, the investigators are conducting a national, multicentre, cohort study of 800 patients age 80+ years who are admitted to Canadian ICUs. The investigators will follow these patients prospectively for 12 months to measure study outcomes. In addition, using novel instruments that the investigators have already developed and validated, the investigators will follow family members of these patients to document their experience as caregivers, their satisfaction with care of their relatives, and the financial implications of having a critically ill loved one. This quantitative project will be complemented by a separate qualitative study in the community setting to further understand the expectations and attitudes of persons over 80 years of age regarding the use of life sustaining technology. Data emerging from this work will inform important clinical decisions regarding critical care and EOL care for this aged population.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • minimum stay in the ICU of 24 hrs
  • patient is >=80 years old
  • patient is a resident of Canada and has a permanent address in this country
  • patient has an eligible family caregiver who has visited the patient at least once within 96 hours of the current ICU admission

排除标准

  • family caregiver is <= 18
  • family caregiver is paid to do so
  • family caregivers that do not speak English or French
  • previously enrolled

结局指标

主要结局

Health Related Quality of Life (HRQOL)

时间窗: 12 months

To determine the 12 month HRQOL of 80+ year olds admitted to the ICU in Canada.

次要结局

  • To determine which patient characteristics are associated with survival(12 months)
  • To determine which patient characteristics are associated with 12-month HRQOL(12 month)
  • To determine which patient characteristics are associated with functional status.(12 months)

研究者

发起方
Daren K. Heyland
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Daren K. Heyland

Dr. Daren Heyland

Clinical Evaluation Research Unit at Kingston General Hospital

研究点 (24)

Loading locations...

相似试验