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

Completed

• Conditions: Critical Illness; Frailty
• Interventions: Other: No interventions

• Registration Number: NCT05509036
• Lead Sponsor: Dr. John Muscedere

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.

Study Timeline

• Study Start: 2019-09-01
• Primary Completion: 2021-12-01
• Study Completion: 2022-06-01
• Study First Submitted: 2022-08-17
• Study First Submitted QC: 2022-08-18
• Study First Posted: 2022-08-19
• Status Verified: 2023-09
• Last Update Submitted: 2023-12-04
• Last Update Posted: 2023-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 700

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:

  3. 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%.

  4. Vasoactive medications (vasopressors or inotropes).

  5. 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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Critically ill patients	No interventions	Critically ill adults \> 50 admitted to the ICU and receiving a life support intervention

Primary Outcome Measures

Name	Time	Method
Frailty status	6 Months	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.

Secondary Outcome Measures

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

Trial Locations

Locations (11)

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada

Maisonneuve Rosemont; 🇨🇦 Montreal, Quebec, Canada

Dalhousie University - QEII; 🇨🇦 Halifax, Ontario, Canada

University of Alberta; 🇨🇦 Edmonton, Alberta, Canada

Mount Sinai Hospital; 🇨🇦 Toronto, Ontario, Canada

McGill University; 🇨🇦 Montreal, Quebec, Canada

St Joe's Hamilton; 🇨🇦 Hamilton, Ontario, Canada

Laval University; 🇨🇦 Laval, Quebec, Canada

Kingston Health Sciences Center; 🇨🇦 Kingston, Ontario, Canada

The Ottawa Hospital; 🇨🇦 Ottawa, Ontario, Canada

Hôpital du Sacré-Cœur de Montréal; 🇨🇦 Montréal, Quebec, Canada