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

Frailty, Outcomes, Recovery and Care Steps of Critically Ill Patients - A Pilot Study

This pilot study will study the impact of critical illness and ICU processes of care on the trajectory and development of frailty. It is 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.

This pilot study will be conducted in a tertiary medical surgical ICU at Kingston General Hospital- Kingston, Ontario. It will inform the feasibility, timelines and sample size for the multi-center study and will allow for the refinement of study procedures and data collection methods. This study will be published separately as a stand-alone pilot.

Study Overview

• Status: Completed
• Conditions: Critical Illness

Detailed Description

Single Center Observational pilot study to inform on the conduct of a multi-center observational study.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Kingston, Ontario, Canada, K7L 2V7
      • Kingston Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Individuals who are admitted to an intensive care unit requiring therapeutic life support.

Description

Inclusion Criteria:

1. Age > 55 years
2. Admission to ICU for over 24 hours
3. Receipt of at least one therapeutic life support intervention that can only be delivered in the ICU such as mechanical ventilation (both invasive and non-invasive), vasoactive medications (vasopressors or inotropes) or acute renal replacement therapy.

Exclusion Criteria:

1. Lack of consent for study inclusion or lack of consent to be contacted for long term follow-up.
2. Expected to survive for less than 72 hours after ICU admission.
3. Inability to obtain baseline blood work less than 48 hours after ICU admission (i.e. study enrollment must occur within 48 hours of ICU admission allowing for the blood work to be done in the time allowed).
4. No family or caregivers available to collect collateral history.
5. Not able to speak English with lack of available medical translators.

6. Admission to ICU with acute structural neurological disease:

   1. Massive stroke requiring ICU care
   2. Spinal cord injury with neurological deficit

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Critically Ill patients; No Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Number of patients with a measure of frailty prior to hospital discharge.	Measure of the Frailty Index and Clinical Frailty Scale prior to discharge	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 at 6 months
Correlation of ICU processes of care (nutritional adequacy, mobilization and sedation) with frailty progression as measured by the Clinical Frailty Scale or Frailty Index	Correlation of processes of care in ICU (nutritional adequacy, mobilization and sedation) with frailty progression	28 days

Collaborators and Investigators

• Sponsor: Dr. John Muscedere
• Collaborators: Canadian Frailty Network

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2017
• Primary Completion (ACTUAL): December 31, 2019
• Study Completion (ACTUAL): December 31, 2019

Study Registration Dates

• First Submitted: October 30, 2018
• First Submitted That Met QC Criteria: October 21, 2020
• First Posted (ACTUAL): October 27, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 27, 2020
• Last Update Submitted That Met QC Criteria: October 21, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Frailty
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Frailty; Critical Illness
• Other Study ID Numbers: FORECAST

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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