Realities, Expectations and Attitudes to Life Support Technologies in Intensive Care for Octogenarians: (Realistic 80)
|ClinicalTrials.gov Identifier: NCT01293708|
Recruitment Status : Completed
First Posted : February 11, 2011
Last Update Posted : February 20, 2013
|Condition or disease|
Hide Detailed 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:
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:
- Which patient characteristics are associated with 12-month HRQOL, functional status, and survival?
- What is the satisfaction of family members with critical care, as measured by the Family Satisfaction in ICU (FS-ICU 24) instrument?
- 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?
- 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?
- 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?
- What is the quality of decision making regarding the goals of care for an 80+ ICU patient?
- 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.
|Study Type :||Observational|
|Actual Enrollment :||610 participants|
|Official Title:||Realities, Expectations and Attitudes to Life Support Technologies in Intensive Care for Octogenarians:|
|Study Start Date :||September 2009|
|Primary Completion Date :||February 2011|
|Study Completion Date :||February 2013|
80+ year olds
All 80+ year old that had had an ICU stay of >=24 hrs.
- Health Related Quality of Life (HRQOL) [ Time Frame: 12 months ]To determine the 12 month HRQOL of 80+ year olds admitted to the ICU in Canada.
- To determine which patient characteristics are associated with 12-month HRQOL [ Time Frame: 12 month ]
- To determine which patient characteristics are associated with functional status. [ Time Frame: 12 months ]
- To determine which patient characteristics are associated with survival [ Time Frame: 12 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01293708
|Peter Lougheed Hospital|
|Calgary, Alberta, Canada, T1Y 6J4|
|Calgary, Alberta, Canada, T2N 2T9|
|University of Alberta Hospital|
|Calgary, Alberta, Canada, T6G 2B7|
|Royal Alexandra Hospital|
|Edmonton, Alberta, Canada, T5H 1A8|
|Grey Nuns Community Hospital|
|Edmonton, Alberta, Canada, T6T 0Z0|
|Canada, British Columbia|
|Royal Columbian Hospital|
|New Westminster, British Columbia, Canada, V3L 3W4|
|Surrey Memorial Hospital|
|Surrey, British Columbia, Canada, V3W|
|Vancouver, British Columbia, Canada, V6Z 1Y6|
|Royal Jubilee Hospital|
|Vancouver, British Columbia, Canada, V8R 1J8|
|Victoria General Hospital|
|Vancouver, British Columbia, Canada, V8Z 6R5|
|St. Boniface Hospital|
|Winnipeg, Manitoba, Canada, R2H 2A6|
|Winnipeg Health Sciences Center|
|Winnipeg, Manitoba, Canada, R3A 1R9|
|St. Joseph's Healthcare|
|Hamilton, Ontario, Canada, L8N 4A6|
|Kingston General Hospital|
|Kingston, Ontario, Canada, K7L 2V7|
|Ottawa, Ontario, Canada, K1Y 4E9|
|Sunnybrook Health Sciences|
|Toronto, Ontario, Canada, M4N 3M5|
|St. Michaels Hospital|
|Toronto, Ontario, Canada, M5B 1W8|
|Toronto, Ontario, Canada, M5G 1X5|
|Toronto General Hospital|
|Toronto, Ontario, Canada, M5G 2C4|
|Montreal, Quebec, Canada, H1T 2M4|
|Hospital de Sacre-Coeur|
|Montreal, Quebec, Canada, H4J 1C5|
|Royal University Hospital|
|Saskatoon, Saskatchewan, Canada, S7N 0W8|
|Quebec, Canada, G1J 1Z4|
|Quebec, Canada, G1V 4G5|
|Study Chair:||Daren Heyland, MD||Clinical Evaluation Research Unit,, Kingston General Hospital|