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Realities, Expectations and Attitudes to Life Support Technologies in Intensive Care for Octogenarians: (Realistic 80)

2020年12月11日 更新者:Daren K. Heyland
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.

研究概览

地位

完全的

条件

详细说明

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.

The investigators presume that the short- and long-term mortality of 80+ year olds admitted to Canadian ICUs will be high and that the self-reported health-related quality of life and functional status of survivors after hospital discharge will be low. The investigators anticipate that pre-morbid illnesses and functional status before admission to ICU will correlate with long-term clinical outcomes. The investigators are uncertain as to the psychological and financial burden experienced by families when a loved one is in the ICU and during the recovery phase; our study will be the first to furnish such important information. By using administrative databases to complement information already being collected in this study, the investigators will obtain a better understanding of the healthcare resource utilization and longer term survival of this cohort, and will be better positioned to offer effective ICU and follow-up care for this at-risk patient population.

研究类型

观察性的

注册 (实际的)

1504

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Quebec、加拿大、G1J 1Z4
        • Departement d'Anesthesie
      • Quebec、加拿大、G1V 4G5
        • Hospital Laval
    • Alberta
      • Calgary、Alberta、加拿大、T2N 2T9
        • Foothills Hospital
      • Calgary、Alberta、加拿大、T1Y 6J4
        • Peter Lougheed Hospital
      • Calgary、Alberta、加拿大、T6G 2B7
        • University of Alberta Hospital
      • Edmonton、Alberta、加拿大、T5H 1A8
        • Royal Alexandra Hospital
      • Edmonton、Alberta、加拿大、T6T 0Z0
        • Grey Nuns Community Hospital
    • British Columbia
      • New Westminster、British Columbia、加拿大、V3L 3W4
        • Royal Columbian Hospital
      • Surrey、British Columbia、加拿大、V3W
        • Surrey Memorial Hospital
      • Vancouver、British Columbia、加拿大、V6Z 1Y6
        • St.Paul's Hospital
      • Vancouver、British Columbia、加拿大、V8R 1J8
        • Royal Jubilee Hospital
      • Vancouver、British Columbia、加拿大、V8Z 6R5
        • Victoria General Hospital
    • Manitoba
      • Winnipeg、Manitoba、加拿大、R2H 2A6
        • St. Boniface Hospital
      • Winnipeg、Manitoba、加拿大、R3A 1R9
        • Winnipeg Health Sciences Center
    • Ontario
      • Hamilton、Ontario、加拿大、L8N 4A6
        • St. Joseph's Healthcare
      • Kingston、Ontario、加拿大、K7L 2V7
        • Kingston General Hospital
      • Ottawa、Ontario、加拿大、K1Y 4E9
        • Ottawa Hospital
      • Toronto、Ontario、加拿大、M5G 2C4
        • Toronto General Hospital
      • Toronto、Ontario、加拿大、M5B 1W8
        • St. Michaels Hospital
      • Toronto、Ontario、加拿大、M4N 3M5
        • SunnyBrook Health Sciences
      • Toronto、Ontario、加拿大、M5G 1X5
        • Mount Sinai
    • Quebec
      • Montreal、Quebec、加拿大、H1T 2M4
        • Hospital Maisonneuve-Rosemont
      • Montreal、Quebec、加拿大、H4J 1C5
        • Hospital de Sacre-Coeur
    • Saskatchewan
      • Saskatoon、Saskatchewan、加拿大、S7N 0W8
        • Royal University Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

80年 及以上 (年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

80+ year old admitted to ICU

描述

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:队列
  • 时间观点:预期

队列和干预

团体/队列
Hospital Cohort
All 80+ year old that had had an ICU stay of >=24 hrs. Followed until hospital d/c
Longitudinal Cohort
All 80+ year old that had had an ICU stay of >=24 hrs. Followed for 12 months

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Health Related Quality of Life (HRQOL)
大体时间:12 months
To determine the 12 month HRQOL of 80+ year olds admitted to the ICU in Canada.
12 months

次要结果测量

结果测量
大体时间
To determine which patient characteristics are associated with 12-month HRQOL
大体时间:12 month
12 month
To determine which patient characteristics are associated with functional status.
大体时间:12 months
12 months
To determine which patient characteristics are associated with survival
大体时间:12 months
12 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 学习椅:Daren Heyland, MD、Clinical Evaluation Research Unit,, Kingston General Hospital

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2009年9月1日

初级完成 (实际的)

2013年2月1日

研究完成 (实际的)

2013年2月1日

研究注册日期

首次提交

2011年2月10日

首先提交符合 QC 标准的

2011年2月10日

首次发布 (估计)

2011年2月11日

研究记录更新

最后更新发布 (实际的)

2020年12月16日

上次提交的符合 QC 标准的更新

2020年12月11日

最后验证

2020年12月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • R80

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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