Frailty and health-related life quality in long-term follow up of intensive care patients above 65 years old: Protocol for a Norwegian prospective, observational multicenter study.

Background: Frailty is strongly correlated with mortality in intensive care unit patients, yet routine screening among intensive care patients is rarely performed. The aim of this study is to assess frailty and health-related quality of life (HRQoL) in patients before intensive care admission and to compare this with outcomes after 3 and 12-months. The Clinical Frailty Scale and EQ-5D-5L will be used to assess frailty and HRQoL, respectively.

Methods: This is an ongoing, prospective observational study including patients from five Norwegian ICU's. Inclusion criteria are patients aged ≥65 years requiring invasive mechanical ventilation for ≥24 h. The Clinical Frailty Scale and EQ-5D-5L are administered at baseline (before critical illness) and at 3- and 12-months post-inclusion. Additional data collected includes patient characteristics, ICU treatment details, illness severity and mortality. The EQ-5D-5L will be compared to Norwegian population norms and assessed for measurement properties.

Results: Inclusion started July 2022 and will be stopped at 350 patients. The study will be completed in 2025.

Conclusion: The study will assess the feasibility and measurement properties of the Clinical Frailty Scale and EQ-5D-5L in ICU survivors by telephone at long-term follow-up study and will give additional information on the frailty and HRQoL of intensive care survivors.

Clinical trial registration: The study is registered in ClinicalTrials.gov NCT06012942. Protocol version 2.7.1, 19.05.2023.