Realities, Expectations and Attitudes to Life Support Technologies in Intensive Care for Octogenarians: (Realistic 80)
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Quebec、カナダ、G1J 1Z4
- Departement d'Anesthesie
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Quebec、カナダ、G1V 4G5
- Hospital Laval
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Alberta
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Calgary、Alberta、カナダ、T2N 2T9
- Foothills Hospital
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Calgary、Alberta、カナダ、T1Y 6J4
- Peter Lougheed Hospital
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Calgary、Alberta、カナダ、T6G 2B7
- University of Alberta Hospital
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Edmonton、Alberta、カナダ、T5H 1A8
- Royal Alexandra Hospital
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Edmonton、Alberta、カナダ、T6T 0Z0
- Grey Nuns Community Hospital
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British Columbia
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New Westminster、British Columbia、カナダ、V3L 3W4
- Royal Columbian Hospital
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Surrey、British Columbia、カナダ、V3W
- Surrey Memorial Hospital
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Vancouver、British Columbia、カナダ、V6Z 1Y6
- St.Paul's Hospital
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Vancouver、British Columbia、カナダ、V8R 1J8
- Royal Jubilee Hospital
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Vancouver、British Columbia、カナダ、V8Z 6R5
- Victoria General Hospital
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Manitoba
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Winnipeg、Manitoba、カナダ、R2H 2A6
- St. Boniface Hospital
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Winnipeg、Manitoba、カナダ、R3A 1R9
- Winnipeg Health Sciences Center
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Ontario
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Hamilton、Ontario、カナダ、L8N 4A6
- St. Joseph's Healthcare
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Kingston、Ontario、カナダ、K7L 2V7
- Kingston General Hospital
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Ottawa、Ontario、カナダ、K1Y 4E9
- Ottawa Hospital
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Toronto、Ontario、カナダ、M5G 2C4
- Toronto General Hospital
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Toronto、Ontario、カナダ、M5B 1W8
- St. Michaels Hospital
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Toronto、Ontario、カナダ、M4N 3M5
- Sunnybrook Health Sciences
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Toronto、Ontario、カナダ、M5G 1X5
- Mount Sinai
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Quebec
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Montreal、Quebec、カナダ、H1T 2M4
- Hospital Maisonneuve-Rosemont
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Montreal、Quebec、カナダ、H4J 1C5
- Hospital de Sacre-Coeur
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Saskatchewan
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Saskatoon、Saskatchewan、カナダ、S7N 0W8
- Royal University Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：コホート
- 時間の展望：見込みのある
コホートと介入
グループ/コホート |
|---|
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Hospital Cohort
All 80+ year old that had had an ICU stay of >=24 hrs.
Followed until hospital d/c
|
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Longitudinal Cohort
All 80+ year old that had had an ICU stay of >=24 hrs.
Followed for 12 months
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Health Related Quality of Life (HRQOL)
時間枠：12 months
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To determine the 12 month HRQOL of 80+ year olds admitted to the ICU in Canada.
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12 months
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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To determine which patient characteristics are associated with 12-month HRQOL
時間枠：12 month
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12 month
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To determine which patient characteristics are associated with functional status.
時間枠：12 months
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12 months
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To determine which patient characteristics are associated with survival
時間枠：12 months
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12 months
|
協力者と研究者
スポンサー
捜査官
- スタディチェア：Daren Heyland, MD、Clinical Evaluation Research Unit,, Kingston General Hospital
出版物と役立つリンク
一般刊行物
- 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.
- 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.
- 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.
- 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.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。