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

NCT05509036 | Completed

• 1 other identifier: FORECAST, V4 - June 7, 2019
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 11

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.

Conditions

Frailty; Critical Illness

Keywords

Outcomes; Frailty

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Number of patients with a measure of frailty prior to hospital discharge.

  28 days

• Correlation of frailty severity at hospital discharge with long term outcomes (mortality, Quality of Life 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

  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

  28 days

Study Arms (1)

Critically ill patients

Critically ill adults \> 50 admitted to the ICU and receiving a life support intervention

Other: No interventions

Interventions

No interventions OTHER

No interventions

Critically ill patients

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Must Meet both 1 and 2
• \. Age \> 50 years. We have selected \>50 years in keeping with prior descriptions of critically ill patients \[17\].
• \. Receipt of at least one of the following life support interventions for over 24 hours:
• 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%.
• Vasoactive medications (vasopressors or inotropes).
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Dr. John Muscedere: lead
• Canadian Frailty Network: collaborator

Study Sites (11)

University of Alberta

Edmonton, Alberta, Canada

Location

Dalhousie University - QEII

Halifax, Ontario, Canada

Location

St Joe's Hamilton

Hamilton, Ontario, Canada

Location

Kingston Health Sciences Center

Kingston, Ontario, K7L2V7, Canada

Location

London Health Sciences Centre

London, Ontario, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, Canada

Location

Laval University

Laval, Quebec, Canada

Location

Hôpital du Sacré-Cœur de Montréal

Montreal, Quebec, Canada

Location

Maisonneuve Rosemont

Montreal, Quebec, Canada

Location

McGill University

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

Frailty; Critical Illness

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Officials

• John Muscedere, MD

  Queens University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: August 17, 2022
• First Posted: August 19, 2022
• Study Start: September 1, 2019
• Primary Completion: December 1, 2021
• Study Completion: June 1, 2022
• Last Updated: December 11, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (11)