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

This study has been completed.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Daren K. Heyland, Clinical Evaluation Research Unit at Kingston General Hospital
ClinicalTrials.gov Identifier:
NCT01293708
First received: February 10, 2011
Last updated: February 19, 2013
Last verified: February 2013
  Purpose

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.


Condition
Critically Ill

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Realities, Expectations and Attitudes to Life Support Technologies in Intensive Care for Octogenarians:

Further study details as provided by Clinical Evaluation Research Unit at Kingston General Hospital:

Primary Outcome Measures:
  • Health Related Quality of Life (HRQOL) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    To determine the 12 month HRQOL of 80+ year olds admitted to the ICU in Canada.


Secondary Outcome Measures:
  • To determine which patient characteristics are associated with 12-month HRQOL [ Time Frame: 12 month ] [ Designated as safety issue: No ]
  • To determine which patient characteristics are associated with functional status. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • To determine which patient characteristics are associated with survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 610
Study Start Date: September 2009
Study Completion Date: February 2013
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
80+ year olds
All 80+ year old that had had an ICU stay of >=24 hrs.

  Hide Detailed Description

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

Ages Eligible for Study:   80 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

80+ year old admitted to ICU

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01293708

Locations
Canada, Alberta
Foothills Hospital
Calgary, Alberta, Canada, T2N 2T9
University of Alberta Hospital
Calgary, Alberta, Canada, T6G 2B7
Peter Lougheed Hospital
Calgary, Alberta, Canada, T1Y 6J4
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
Royal Jubilee Hospital
Vancouver, British Columbia, Canada, V8R 1J8
Victoria General Hospital
Vancouver, British Columbia, Canada, V8Z 6R5
St.Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
Canada, Manitoba
Winnipeg Health Sciences Center
Winnipeg, Manitoba, Canada, R3A 1R9
St. Boniface Hospital
Winnipeg, Manitoba, Canada, R2H 2A6
Canada, Ontario
St. Joseph's Healthcare
Hamilton, Ontario, Canada, L8N 4A6
Kingston General Hospital
Kingston, Ontario, Canada, K7L 2V7
Ottawa Hospital
Ottawa, Ontario, Canada, K1Y 4E9
Mount Sinai
Toronto, Ontario, Canada, M5G 1X5
Sunnybrook Health Sciences
Toronto, Ontario, Canada, M4N 3M5
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
St. Michaels Hospital
Toronto, Ontario, Canada, M5B 1W8
Canada, Quebec
Hospital Maisonneuve-Rosemont
Montreal, Quebec, Canada, H1T 2M4
Hospital de Sacre-Coeur
Montreal, Quebec, Canada, H4J 1C5
Canada, Saskatchewan
Royal University Hospital
Saskatoon, Saskatchewan, Canada, S7N 0W8
Canada
Departement d'Anesthesie
Quebec, Canada, G1J 1Z4
Hospital Laval
Quebec, Canada, G1V 4G5
Sponsors and Collaborators
Daren K. Heyland
Canadian Institutes of Health Research (CIHR)
Investigators
Study Chair: Daren Heyland, MD Clinical Evaluation Research Unit,, Kingston General Hospital
  More Information

No publications provided

Responsible Party: Daren K. Heyland, Dr. Daren Heyland, Clinical Evaluation Research Unit at Kingston General Hospital
ClinicalTrials.gov Identifier: NCT01293708     History of Changes
Other Study ID Numbers: R80
Study First Received: February 10, 2011
Last Updated: February 19, 2013
Health Authority: Canada: Queen's University Health Sciences and Affliated Teaching Hospitals Research Ethics

Keywords provided by Clinical Evaluation Research Unit at Kingston General Hospital:
Octogenarians
HRQOL
mortality
prospective observational
Elderly

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on July 26, 2014