Critically IllRealistic 80NCT01293708
Realities, Expectations and Attitudes to Life Support Technologies in Intensive Care for Octogenarians:
An observational study of Critically Ill, run by Daren K. Heyland at 24 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 80 years and older
- Conditions the study is for
- Critically Ill
- How many people
- 1,504 participants
- Where
- 24 sitesCanada
- Study dates
- Sep 2009to Feb 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 80 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: 80+ year old admitted to ICU
Who may be able to join
- 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
Who cannot join
- family caregiver is <= 18
- family caregiver is paid to do so
- family caregivers that do not speak English or French
- previously enrolled
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
Canada24 sites
Peter Lougheed Hospital
Calgary, Alberta, T1Y 6J4
Foothills Hospital
Calgary, Alberta, T2N 2T9
University of Alberta Hospital
Calgary, Alberta, T6G 2B7
Royal Alexandra Hospital
Edmonton, Alberta, T5H 1A8
Grey Nuns Community Hospital
Edmonton, Alberta, T6T 0Z0
St. Joseph's Healthcare
Hamilton, Ontario, L8N 4A6
Kingston General Hospital
Kingston, Ontario, K7L 2V7
Hospital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4
Hospital de Sacre-Coeur
Montreal, Quebec, H4J 1C5
Royal Columbian Hospital
New Westminster, British Columbia, V3L 3W4
Ottawa Hospital
Ottawa, Ontario, K1Y 4E9
Departement d'Anesthesie
Québec, Quebec, G1J 1Z4
Hospital Laval
Québec, Quebec, G1V 4G5
Royal University Hospital
Saskatoon, Saskatchewan, S7N 0W8
Surrey Memorial Hospital
Surrey, British Columbia, V3W
Sunnybrook Health Sciences
Toronto, Ontario, M4N 3M5
St. Michaels Hospital
Toronto, Ontario, M5B 1W8
Mount Sinai
Toronto, Ontario, M5G 1X5
Toronto General Hospital
Toronto, Ontario, M5G 2C4
St.Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
Royal Jubilee Hospital
Vancouver, British Columbia, V8R 1J8
Victoria General Hospital
Vancouver, British Columbia, V8Z 6R5
St. Boniface Hospital
Winnipeg, Manitoba, R2H 2A6
Winnipeg Health Sciences Center
Winnipeg, Manitoba, R3A 1R9
About this study
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.
Read the 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.
- Conditions
- Critically Ill
- Keywords
- Octogenarians, HRQOL, mortality, prospective observational, Elderly
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Related Quality of Life (HRQOL)
To determine the 12 month HRQOL of 80+ year olds admitted to the ICU in Canada.
Measured: 12 months
Secondary outcomes (3)
To determine which patient characteristics are associated with 12-month HRQOL
Measured: 12 month
To determine which patient characteristics are associated with functional status.
Measured: 12 months
To determine which patient characteristics are associated with survival
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2011 (estimated)
- Study startSep 2009
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Critically IllStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,504 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daren K. Heyland
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor-investigator, Daren K. Heyland, Clinical Evaluation Research Unit at Kingston General Hospital
- Investigators
- Daren Heyland, MD, Study chair, Clinical Evaluation Research Unit,, Kingston General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01293708
- Sponsor's protocol ID
- R80
- Acronym
- Realistic 80
- Status last verified
- Dec 2020
- First submitted
- 10 Feb 2011
- Last updated
- 16 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28506243Heyland 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.
PubMed 26306719Heyland 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.
PubMed 25901550Heyland 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.
PubMed 25645668
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Realities, Expectations and Attitudes to Life Support Technologies in Intensive Care for Octogenarians:
- ClinicalTrials.gov ID
- NCT01293708
- Acronym / sponsor ID
- Realistic 80 / R80
- Conditions
- Critically Ill
- Keywords
- Octogenarians, HRQOL, mortality, prospective observational, Elderly
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,504 participants (actual)
- Lead sponsor
- Daren K. HeylandUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Sep 2009
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 11 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 80 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- 80+ year old admitted to ICU
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- family caregiver is <= 18
- family caregiver is paid to do so
- family caregivers that do not speak English or French
- previously enrolled
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2020.
- Derived from this study: PubMed 28506243Chin-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.
- Derived from this study: PubMed 26306719Heyland 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.
- Derived from this study: PubMed 25901550Heyland 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.
- Derived from this study: PubMed 25645668Heyland 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daren Heyland, MD study chair
Clinical Evaluation Research Unit,, Kingston General Hospital
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critically Ill, run by Daren K. Heyland at 24 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health Related Quality of Life (HRQOL) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01293708, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2020.