Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01293708 |
| Other study ID # |
R80 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 2009 |
| Est. completion date |
February 2013 |
Study information
| Verified date |
December 2020 |
| Source |
Clinical Evaluation Research Unit at Kingston General Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
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.
Description:
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.
