- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01293708
Realities, Expectations and Attitudes to Life Support Technologies in Intensive Care for Octogenarians: (Realistic 80)
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Quebec, 캐나다, G1J 1Z4
- Departement d'Anesthesie
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Quebec, 캐나다, G1V 4G5
- Hospital Laval
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Alberta
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Calgary, Alberta, 캐나다, T2N 2T9
- Foothills Hospital
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Calgary, Alberta, 캐나다, T1Y 6J4
- Peter Lougheed Hospital
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Calgary, Alberta, 캐나다, T6G 2B7
- University of Alberta Hospital
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Edmonton, Alberta, 캐나다, T5H 1A8
- Royal Alexandra Hospital
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Edmonton, Alberta, 캐나다, T6T 0Z0
- Grey Nuns Community Hospital
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British Columbia
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New Westminster, British Columbia, 캐나다, V3L 3W4
- Royal Columbian Hospital
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Surrey, British Columbia, 캐나다, V3W
- Surrey Memorial Hospital
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Vancouver, British Columbia, 캐나다, V6Z 1Y6
- St.Paul's Hospital
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Vancouver, British Columbia, 캐나다, V8R 1J8
- Royal Jubilee Hospital
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Vancouver, British Columbia, 캐나다, V8Z 6R5
- Victoria General Hospital
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Manitoba
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Winnipeg, Manitoba, 캐나다, R2H 2A6
- St. Boniface Hospital
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Winnipeg, Manitoba, 캐나다, R3A 1R9
- Winnipeg Health Sciences Center
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Ontario
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Hamilton, Ontario, 캐나다, L8N 4A6
- St. Joseph's Healthcare
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Kingston, Ontario, 캐나다, K7L 2V7
- Kingston General Hospital
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Ottawa, Ontario, 캐나다, K1Y 4E9
- Ottawa Hospital
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Toronto, Ontario, 캐나다, M5G 2C4
- Toronto General Hospital
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Toronto, Ontario, 캐나다, M5B 1W8
- St. Michaels Hospital
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Toronto, Ontario, 캐나다, M4N 3M5
- Sunnybrook Health Sciences
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Toronto, Ontario, 캐나다, M5G 1X5
- Mount Sinai
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Quebec
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Montreal, Quebec, 캐나다, H1T 2M4
- Hospital Maisonneuve-Rosemont
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Montreal, Quebec, 캐나다, H4J 1C5
- Hospital de Sacre-Coeur
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Saskatchewan
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Saskatoon, Saskatchewan, 캐나다, S7N 0W8
- Royal University Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 보병대
- 시간 관점: 유망한
코호트 및 개입
그룹/코호트 |
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Health Related Quality of Life (HRQOL)
기간: 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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2차 결과 측정
결과 측정 |
기간 |
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To determine which patient characteristics are associated with 12-month HRQOL
기간: 12 month
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12 month
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To determine which patient characteristics are associated with functional status.
기간: 12 months
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12 months
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To determine which patient characteristics are associated with survival
기간: 12 months
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12 months
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공동 작업자 및 조사자
스폰서
수사관
- 연구 의자: Daren Heyland, MD, Clinical Evaluation Research Unit,, Kingston General Hospital
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
비판적으로 아프다에 대한 임상 시험
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Medical University Innsbruck완전한