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Completed

NCT Number: NCT05509036

Frailty, Outcomes, Recovery and Care Steps of Critically Ill Patients (FORECAST) Study 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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Alberta, Edmonton, Alberta, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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].
  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

No interventions

Other

No interventions

Primary outcomes

  1. Frailty status

    Time frame: 6 Months

    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.

  2. Frailty status

    Time frame: 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 outcomes

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

    Time frame: 28 days

    Measure of the Frailty Index and Clinical Frailty Scale prior to discharge

  2. Correlation of frailty severity at hospital discharge with long term outcomes (mortality, Quality of Life and Need for Institutionalization)

    Time frame: 6 months

    Clinical outcomes at 6 months will include mortality, Quality of Life (EQ5L) and need for Institutionalization

  3. Impact of admission critical illness on the development and severity of frailty as measured by a Frailty Index or Clinical Frailty Scale

    Time frame: 28 days and 6 months

    Correlation with the progression or presence of frailty as measured with the Frailty Index or Clinical Frailty Scale

  4. 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

    Time frame: 28 days

    Correlation of processes of care in ICU with frailty progression

Sponsors and collaborators

Lead sponsor

Dr. John Muscedere

Other

Collaborators

  • Canadian Frailty Network

Registry information

Official study title

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

Acronym: FORECAST

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Aug 19, 2022
Registry last updated
Dec 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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