Frailty, Outcomes, Recovery and Care Steps of Critically Ill Patients (FORECAST) Study Multi-Center Study (FORECAST)

Frailty, Outcomes, Recovery and Care Steps of Critically Ill Patients (FORECAST) Multi-Center Study

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.

Study Overview

• Status: Completed
• Conditions: Critical Illness; Frailty
• Intervention / Treatment: Other: No interventions

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.

• Study Type: Observational
• Enrollment (Actual): 700

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada
      • University of Alberta
  • Ontario
    • Halifax, Ontario, Canada
      • Dalhousie University - QEII
    • Hamilton, Ontario, Canada
      • St Joe's Hamilton
    • Kingston, Ontario, Canada, k7l2v7
      • Kingston Health Sciences Center
    • London, Ontario, Canada
      • London Health Sciences Centre
    • Ottawa, Ontario, Canada
      • The Ottawa Hospital
    • Toronto, Ontario, Canada
      • Mount Sinai Hospital
  • Quebec
    • Laval, Quebec, Canada
      • Laval University
    • Montreal, Quebec, Canada
      • McGill University
    • Montreal, Quebec, Canada
      • Maisonneuve Rosemont
    • Montréal, Quebec, Canada
      • Hôpital du Sacré-Cœur de Montréal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Critically ill patients over the age of 50 receiving life support interventions in the Intensive Care Unit

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Critically ill patients; Critically ill adults > 50 admitted to the ICU and receiving a life support intervention	Other: No interventions; No interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frailty status	Frailty as measured with the Clinical Frailty Scale (CFS). CFS is a 9 point scale with frailty defined as a CFS > 4 with higher scores indicating greater degrees of frailty.	6 Months
Frailty status	Frailty as measured with the Frailty Index (FI). The FI is indicated by the proportion of deficits present over the number measured and is scored as a fraction between 0 and 1.0. Frailty is considered to be present when the FI is > 0.20 and the severity of frailty is considered higher with increasing values for the FI.	6 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with a measure of frailty prior to hospital discharge.	Measure of the Frailty Index and Clinical Frailty Scale prior to discharge	28 days
Correlation of frailty severity at hospital discharge with long term outcomes (mortality, Quality of Life and Need for Institutionalization)	Clinical outcomes at 6 months will include mortality, Quality of Life (EQ5L) and need for Institutionalization	6 months
Impact of admission critical illness on the development and severity of frailty as measured by a Frailty Index or Clinical Frailty Scale	Correlation with the progression or presence of frailty as measured with the Frailty Index or Clinical Frailty Scale	28 days and 6 months
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	Correlation of processes of care in ICU with frailty progression	28 days

Collaborators and Investigators

• Sponsor: Dr. John Muscedere
• Collaborators: Canadian Frailty Network
• Investigators: Principal Investigator: John MUSCEDERE, MD, Queens University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Actual): December 1, 2021
• Study Completion (Actual): June 1, 2022

Study Registration Dates

• First Submitted: August 17, 2022
• First Submitted That Met QC Criteria: August 18, 2022
• First Posted (Actual): August 19, 2022

Study Record Updates

• Last Update Posted (Estimated): December 11, 2023
• Last Update Submitted That Met QC Criteria: December 4, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Outcomes; Frailty
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Frailty; Critical Illness
• Other Study ID Numbers: FORECAST, V4 - June 7, 2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No