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

2020. december 11. frissítette: Daren K. Heyland

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.

A tanulmány áttekintése

Állapot

Befejezve

Körülmények

Kritikusan beteg

Részletes leírás

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.

Tanulmány típusa

Megfigyelő

Beiratkozás (Tényleges)

1504

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi helyek

Kanada
- - Quebec, Kanada, G1J 1Z4
    - Departement d'Anesthesie
  - Quebec, Kanada, G1V 4G5
    - Hospital Laval
- Alberta
  - Calgary, Alberta, Kanada, T2N 2T9
    - Foothills Hospital
  - Calgary, Alberta, Kanada, T1Y 6J4
    - Peter Lougheed Hospital
  - Calgary, Alberta, Kanada, T6G 2B7
    - University of Alberta Hospital
  - Edmonton, Alberta, Kanada, T5H 1A8
    - Royal Alexandra Hospital
  - Edmonton, Alberta, Kanada, T6T 0Z0
    - Grey Nuns Community Hospital
- British Columbia
  - New Westminster, British Columbia, Kanada, V3L 3W4
    - Royal Columbian Hospital
  - Surrey, British Columbia, Kanada, V3W
    - Surrey Memorial Hospital
  - Vancouver, British Columbia, Kanada, V6Z 1Y6
    - St.Paul's Hospital
  - Vancouver, British Columbia, Kanada, V8R 1J8
    - Royal Jubilee Hospital
  - Vancouver, British Columbia, Kanada, V8Z 6R5
    - Victoria General Hospital
- Manitoba
  - Winnipeg, Manitoba, Kanada, R2H 2A6
    - St. Boniface Hospital
  - Winnipeg, Manitoba, Kanada, R3A 1R9
    - Winnipeg Health Sciences Center
- Ontario
  - Hamilton, Ontario, Kanada, L8N 4A6
    - St. Joseph's Healthcare
  - Kingston, Ontario, Kanada, K7L 2V7
    - Kingston General Hospital
  - Ottawa, Ontario, Kanada, K1Y 4E9
    - Ottawa Hospital
  - Toronto, Ontario, Kanada, M5G 2C4
    - Toronto General Hospital
  - Toronto, Ontario, Kanada, M5B 1W8
    - St. Michaels Hospital
  - Toronto, Ontario, Kanada, M4N 3M5
    - Sunnybrook Health Sciences
  - Toronto, Ontario, Kanada, M5G 1X5
    - Mount Sinai
- Quebec
  - Montreal, Quebec, Kanada, H1T 2M4
    - Hospital Maisonneuve-Rosemont
  - Montreal, Quebec, Kanada, H4J 1C5
    - Hospital de Sacre-Coeur
- Saskatchewan
  - Saskatoon, Saskatchewan, Kanada, S7N 0W8
    - Royal University Hospital

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

80 év és régebbi (Idősebb felnőtt)

Egészséges önkénteseket fogad

Nem

Tanulmányozható nemek

Összes

Mintavételi módszer

Nem valószínűségi minta

Tanulmányi populáció

80+ year old admitted to ICU

Leírás

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

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

Megfigyelési modellek: Kohorsz
Időperspektívák: Leendő

Csoportok/kohorszok száma

Kohorszok és beavatkozások

Csoport / Kohorsz
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

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő	Intézkedés leírása	Időkeret
Health Related Quality of Life (HRQOL) Időkeret: 12 months	To determine the 12 month HRQOL of 80+ year olds admitted to the ICU in Canada.	12 months

Másodlagos eredményintézkedések

Eredménymérő	Időkeret
To determine which patient characteristics are associated with 12-month HRQOL Időkeret: 12 month	12 month
To determine which patient characteristics are associated with functional status. Időkeret: 12 months	12 months
To determine which patient characteristics are associated with survival Időkeret: 12 months	12 months

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

Daren K. Heyland

Együttműködők

Canadian Institutes of Health Research (CIHR)

Nyomozók

Tanulmányi szék: Daren Heyland, MD, Clinical Evaluation Research Unit,, Kingston General Hospital

Publikációk és hasznos linkek

A vizsgálattal kapcsolatos információk beviteléért felelős személy önkéntesen bocsátja rendelkezésre ezeket a kiadványokat. Ezek bármiről szólhatnak, ami a tanulmányhoz kapcsolódik.

Általános kiadványok

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete

2009. szeptember 1.

Elsődleges befejezés (Tényleges)

2013. február 1.

A tanulmány befejezése (Tényleges)

2013. február 1.

Tanulmányi regisztráció dátumai

Először benyújtva

2011. február 10.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak