Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

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

11. desember 2020 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Kritisk syk

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Faktiske)

1504

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

80 år og eldre (Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

80+ year old admitted to ICU

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Observasjonsmodeller: Kohort
Tidsperspektiver: Potensielle

Antall grupper / kohorter

Kohorter og intervensjoner

Gruppe / Kohort
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

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Health Related Quality of Life (HRQOL) Tidsramme: 12 months	To determine the 12 month HRQOL of 80+ year olds admitted to the ICU in Canada.	12 months

Sekundære resultatmål

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Daren K. Heyland

Samarbeidspartnere

Canadian Institutes of Health Research (CIHR)

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. september 2009

Primær fullføring (Faktiske)

1. februar 2013

Studiet fullført (Faktiske)

1. februar 2013

Datoer for studieregistrering

Først innsendt

10. februar 2011

Først innsendt som oppfylte QC-kriteriene