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

Critical Illness Clinical Trial

— FORECAST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05509036
• Other study ID #: FORECAST, V4 - June 7, 2019
• Status: Completed
• Start date: September 1, 2019
• Est. completion date: June 1, 2022

Study information

• Verified date: September 2023
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 700
• Est. completion date: June 1, 2022
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Critical Illness
• Frailty

Intervention

Other:
• No interventions
No interventions

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Dr. John Muscedere	Canadian Frailty Network

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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