Realities, Expectations and Attitudes to Life Support Technologies in Intensive Care for Octogenarians: (Realistic 80)
| Tracking Information | |||||
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| First Received Date ICMJE | February 10, 2011 | ||||
| Last Updated Date | February 19, 2013 | ||||
| Start Date ICMJE | September 2009 | ||||
| Primary Completion Date | February 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01293708 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Realities, Expectations and Attitudes to Life Support Technologies in Intensive Care for Octogenarians: | ||||
| Official Title ICMJE | Realities, Expectations and Attitudes to Life Support Technologies in Intensive Care for Octogenarians: | ||||
| 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. |
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| 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:
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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | 80+ year old admitted to ICU |
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| Condition ICMJE | Critically Ill | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | 80+ year olds
All 80+ year old that had had an ICU stay of >=24 hrs. |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 610 | ||||
| Completion Date | February 2013 | ||||
| Primary Completion Date | February 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 80 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Canada | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01293708 | ||||
| Other Study ID Numbers ICMJE | R80 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Daren K. Heyland, Clinical Evaluation Research Unit at Kingston General Hospital | ||||
| Study Sponsor ICMJE | Daren K. Heyland | ||||
| Collaborators ICMJE | Canadian Institutes of Health Research (CIHR) | ||||
| Investigators ICMJE |
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| Information Provided By | Clinical Evaluation Research Unit at Kingston General Hospital | ||||
| Verification Date | February 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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