Prevalence and Long Term Effects of Frailty in Elderly Intensive Care Patients (SkrInt)

The primary aim is to study change of critical frailty scale (CFS) and health related quality of life (EQ-5D-5L) in a long-term follow-up of ICU survivors. We aim to identify important ICU related predictors for change in CFS and EQ-5D-5L in long term follow up (1 yr).

Secondary aim is to investigate how CFS pre-admission is related to intrahospital treatment intensity level, severity score and mortality.

Study Overview

• Status: Recruiting
• Conditions: Critical Illness; Frailty

Detailed Description

This is a multi-centre norwegian observational, prospective multicenter Norway coordinated from University hospital North Norway, Tromso.

The study is approved by The Regional Committee for Medical Research Ethics Northern Norway.

The following scores will be assessed by asking the patient and relative during ICU stay: CFS, EQ5DL before current critical illness.

The following demographic and clinical data will be retrieved from the medical records: Comorbidity before critical illness, reasons for ICU admission, daily severity score (SOFA- score), length of mechanical ventilation, dialysis, tracheostomy, Habitat before and after ICU treatment, ICU and hospital length of stay, complications retrieved during intensive care treatment, mortality, limitation of treatment.

The patients will be followed up with telephone interview after hospital discharge for evaluation of: Comorbidity, CFS, EQ5DData for all sites are collected and managed using RedCap electronic data capture tools.

Three research nurses will do the follow up with telephone interviews on all sites and record the data in RedCap.

We aim to enroll 300 patients before 31. Des 2024.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Bjørn A Kroken, MD; Phone Number: +47 77669863; Email: bjorn.anders.kroken@unn.no
• Study Contact Backup: Name: Shirin K Frisvold, MD/PhD; Phone Number: +47 77669605; Email: shirin.kordasti@unn.no

Study Locations

• Norway
  • Bergen, Norway, 5021
    • Recruiting
    • Haukeland University hospital, General Intensive care unit
    • Contact: Reidar Kvåle, MD7PhD; Email: reidar.kvale@helse-bergen.no
  • Bodø, Norway, 8005
    • Recruiting
    • Nordlandssykehuset Bodø, Intensivavdelingen
    • Contact: Kristin S Berg, MD/PhD; Email: kristin.berg2@nordlandssykehuset.no
  • Tromsø, Norway, 9038
    • Recruiting
    • University Hospital of North Norway
    • Contact: Bjørn A Kroken, MD; Phone Number: +47 97514485; Email: bjorn.anders.kroken@unn.no
  • Trondheim, Norway, 7006
    • Recruiting
    • Trondheim University hospital, General Intensive care department
    • Contact: Daniel Bergum, MD/PhD; Email: Daniel.Bergum@stolav.no
  • Nordbyhagen
    • Lørenskog, Nordbyhagen, Norway, 1478
      • Recruiting
      • Akershus University hospital, General Intensive care department
      • Contact: Ole Kristian Fossum, MD/PhD; Email: Ole.Kristian.Fossum@ahus.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

ICU patients above 65 years old requiring invasive mechanical ventilation> 24 hours are screened for inclusion during the intensive care stay.

Description

Inclusion Criteria:

• >= 65 years
• ≥ 24 hours mechanical ventilation
• Written informed consent from patient or next of kin

Exclusion Criteria:

• Readmission of patient included in the study
• Not possible to obtain a valid CFS or and EQ-5D-5L at admission or follow-up of CFS because of social context or language.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Clinical frailty score	Score from 1 to 9.	Change in Clinical Frailty score from 3 months to 12 months follow up
EuroQol 5-Dimension 5-Level (EQ-5D-5L)	The scale measures quality of life on a 5-component scale	Change in EQ-5D-5L from 3 months to 12 months
Mortality	Mortality during ICU-stay or subsequent 12 months.	ICU-stay or subsequent 12 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ICU readmission	ICU readmission rate	Long-term follow up (1 yr)
ICU-LOS	ICU length of stay	Through total ICU stay, up to 3 months
Treatment intensity level	ICU treatment intensity level	From inclusion in the study to discharge from intensive care unit, up to three months.

Collaborators and Investigators

• Sponsor: University Hospital of North Norway
• Collaborators: Haukeland University Hospital; University Hospital, Akershus; Bodø Hospital; The Royal Norwegian Ministry of Health; Trondheim University Hospital
• Investigators: Principal Investigator: Shirin K Frisvold, MD/PhD, University Hospital of North Norway

Publications and helpful links

General Publications

• Flaatten H, De Lange DW, Morandi A, Andersen FH, Artigas A, Bertolini G, Boumendil A, Cecconi M, Christensen S, Faraldi L, Fjolner J, Jung C, Marsh B, Moreno R, Oeyen S, Ohman CA, Pinto BB, Soliman IW, Szczeklik W, Valentin A, Watson X, Zaferidis T, Guidet B; VIP1 study group. The impact of frailty on ICU and 30-day mortality and the level of care in very elderly patients (>/= 80 years). Intensive Care Med. 2017 Dec;43(12):1820-1828. doi: 10.1007/s00134-017-4940-8. Epub 2017 Sep 21.
• Flaatten H, Beil M, Guidet B. Prognostication in older ICU patients: mission impossible? Br J Anaesth. 2020 Nov;125(5):655-657. doi: 10.1016/j.bja.2020.08.005. Epub 2020 Aug 14. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2022
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: February 22, 2023
• First Submitted That Met QC Criteria: August 21, 2023
• First Posted (Actual): August 28, 2023

Study Record Updates

• Last Update Posted (Actual): August 28, 2023
• Last Update Submitted That Met QC Criteria: August 21, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: mechanical ventilation; elderly; EQ-5D-5L; clinical frailty scale
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Frailty; Critical Illness
• Other Study ID Numbers: HNF1632-22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported, after deidentification (text, tables, figures and appendices).
• IPD Sharing Time Frame: Beginning 12 months and ending 5 years following article publication.
• IPD Sharing Access Criteria: The presented dataset will be considered available from the corresponding author on reasonable request based on formal national approvals.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

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