Clinical trial NCT01293708: Realities, Expectations and Attitudes to Life Support Technologies in Intensive Care for Octogenarians:
Official title: Realities, Expectations and Attitudes to Life Support Technologies in Intensive Care for Octogenarians:
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critically Ill
Keywords: Octogenarians
HRQOL
mortality
prospective observational
Elderly
Lead sponsor: Clinical Evaluation Research Unit at Kingston General Hospital
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2011-02-11
Enrollment: 1504
Sex: ALL
Minimum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 80+ year old admitted to ICU

Brief 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.

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:

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.

Eligibility criteria: 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

Primary outcomes:
measure: Health Related Quality of Life (HRQOL)
timeFrame: 12 months
Secondary outcomes:
measure: To determine which patient characteristics are associated with 12-month HRQOL
timeFrame: 12 month
measure: To determine which patient characteristics are associated with functional status.
timeFrame: 12 months
measure: To determine which patient characteristics are associated with survival
timeFrame: 12 months
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Peter Lougheed Hospital
state: Alberta
city: Calgary
country: Canada
facility: Foothills Hospital
state: Alberta
city: Calgary
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Edmonton
country: Canada
facility: Royal Alexandra Hospital
state: Alberta
city: Edmonton
country: Canada
facility: Grey Nuns Community Hospital
state: Alberta
city: New Westminster
country: Canada
facility: Royal Columbian Hospital
state: British Columbia
city: Surrey
country: Canada
facility: Surrey Memorial Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: St.Paul's Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: Royal Jubilee Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: Victoria General Hospital
state: British Columbia
city: Winnipeg
country: Canada
facility: St. Boniface Hospital
state: Manitoba
city: Winnipeg
country: Canada
facility: Winnipeg Health Sciences Center
state: Manitoba
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare
state: Ontario
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences
state: Ontario
city: Toronto
country: Canada
facility: St. Michaels Hospital
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
city: Montreal
country: Canada
facility: Hospital Maisonneuve-Rosemont
state: Quebec
city: Montreal
country: Canada
facility: Hospital de Sacre-Coeur
state: Quebec
city: Saskatoon
country: Canada
facility: Royal University Hospital
state: Saskatchewan
city: Quebec
country: Canada
facility: Departement d'Anesthesie
city: Quebec
country: Canada
facility: Hospital Laval
Study officials:
affiliation: Clinical Evaluation Research Unit,, Kingston General Hospital
name: Daren Heyland, MD
role: STUDY_CHAIR
References:
citation: Chin-Yee N, D'Egidio G, Thavorn K, Heyland D, Kyeremanteng K. Cost analysis of the very elderly admitted to intensive care units. Crit Care. 2017 May 16;21(1):109. doi: 10.1186/s13054-017-1689-y.
citation: Heyland DK, Garland A, Bagshaw SM, Cook D, Rockwood K, Stelfox HT, Dodek P, Fowler RA, Turgeon AF, Burns K, Muscedere J, Kutsogiannis J, Albert M, Mehta S, Jiang X, Day AG. Recovery after critical illness in patients aged 80 years or older: a multi-center prospective observational cohort study. Intensive Care Med. 2015 Nov;41(11):1911-20. doi: 10.1007/s00134-015-4028-2. Epub 2015 Aug 26.
citation: Heyland D, Cook D, Bagshaw SM, Garland A, Stelfox HT, Mehta S, Dodek P, Kutsogiannis J, Burns K, Muscedere J, Turgeon AF, Fowler R, Jiang X, Day AG; Canadian Critical Care Trials Group; Canadian Researchers at the End of Life Network. The Very Elderly Admitted to ICU: A Quality Finish? Crit Care Med. 2015 Jul;43(7):1352-60. doi: 10.1097/CCM.0000000000001024.
citation: Heyland DK, Dodek P, Mehta S, Cook D, Garland A, Stelfox HT, Bagshaw SM, Kutsogiannis DJ, Burns K, Muscedere J, Turgeon AF, Fowler R, Jiang X, Day AG; Canadian Critical Care Trials Group and Canadian Researchers at End of Life Network (CARENET). Admission of the very elderly to the intensive care unit: family members' perspectives on clinical decision-making from a multicenter cohort study. Palliat Med. 2015 Apr;29(4):324-35. doi: 10.1177/0269216314566060. Epub 2015 Feb 2.