Clinical trial NCT05509036: Frailty, Outcomes, Recovery and Care Steps of Critically Ill Patients (FORECAST) Study Multi-Center Study
Official title: Frailty, Outcomes, Recovery and Care Steps of Critically Ill Patients (FORECAST) Multi-Center Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Frailty
Critical Illness
Keywords: Outcomes
Frailty
Lead sponsor: Queen's University
Sponsor class: OTHER
Collaborators: name: Canadian Frailty Network
First posted: 2022-08-19
Enrollment: 700
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critically ill patients over the age of 50 receiving life support interventions in the Intensive Care Unit

Brief summary: A prospective observational study of critically ill patients over the age of 50, studying the occurrence of frailty as measured by a variety of frailty measures, processes of care and long term outcomes.

Detailed description: Frailty is common in critically ill elderly patients, and is associated with adverse impacts on outcomes and is becoming increasingly common in Intensive Care Unit (ICU) populations. However it is not clear as to how to best measure frailty and when to do so. It is also not clear as to how processes of care impact on the outcomes observed. We hypothesize that frailty in survivors of critical illness will be measurable at hospital discharge, will correlate with processes of care while in ICU and will better discriminate long term outcomes when compared to severity of illness or the degree of frailty present on ICU admission.

Eligibility criteria: Inclusion Criteria:

Must Meet both 1 and 2

* 1. Age \> 50 years. We have selected \>50 years in keeping with prior descriptions of critically ill patients \[17\].

  2. Receipt of at least one of the following life support interventions for over 24 hours:
  1. Mechanical ventilation: Both invasive and non-invasive either solely or in combination are acceptable. High flow oxygen (e.g. OPTIFLOW) as a form of Non-Invasive Ventilation (NIV) is acceptable but the patient's Fraction of Inspired Oxygen (FIO2) at the time of enrollment must be greater \> 50%.
  2. Vasoactive medications (vasopressors or inotropes).
  3. Acute renal replacement therapy (RRT). Patient must have been admitted to ICU for the receipt of renal replacement therapy, either intermittent or continuous and after 24 hours of ICU admission, there is a continued need for further RRT.

Exclusion Criteria:

1. ICU admission greater than 5 days at the time of enrollment.
2. Expected to survive for less than 72 hours after study enrollment.
3. No family or caregivers available to collect collateral history.
4. Family or caregivers not able to speak English or French.
5. Projected inability to complete 6 month follow-up either by telephone or in-person.

Primary outcomes:
measure: Frailty status
timeFrame: 6 Months
measure: Frailty status
timeFrame: 6 Months
Secondary outcomes:
measure: Number of patients with a measure of frailty prior to hospital discharge.
timeFrame: 28 days
measure: Correlation of frailty severity at hospital discharge with long term outcomes (mortality, Quality of Life and Need for Institutionalization)
timeFrame: 6 months
measure: Impact of admission critical illness on the development and severity of frailty as measured by a Frailty Index or Clinical Frailty Scale
timeFrame: 28 days and 6 months
measure: Correlation of ICU processes of care (nutritional adequacy, adverse events, mobilization and sedation) with frailty progression as measured by the Clinical Frailty Scale or Frailty Index
timeFrame: 28 days
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Halifax
country: Canada
facility: Dalhousie University - QEII
state: Ontario
city: Hamilton
country: Canada
facility: St Joe's Hamilton
state: Ontario
city: Kingston
country: Canada
facility: Kingston Health Sciences Center
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
city: Laval
country: Canada
facility: Laval University
state: Quebec
city: Montreal
country: Canada
facility: Maisonneuve Rosemont
state: Quebec
city: Montreal
country: Canada
facility: McGill University
state: Quebec
city: Montréal
country: Canada
facility: Hôpital du Sacré-Cœur de Montréal
state: Quebec
Study officials:
affiliation: Queens University
name: John Muscedere, MD
role: PRINCIPAL_INVESTIGATOR
References: