MONITOR-IC Post ICU Care Study — MiCare  

Post ICU Syndrome Clinical Trial

Official title: Evaluation of Structured, Multidisciplinary and Personalized Post-ICU Care on Physical and Psychological Functioning, and Quality of Life of Former ICU Patients

Status Recruiting

Clinical Trial Summary

• OBJECTIVE To evaluate the clinical effectiveness and cost effectiveness of structured, multidisciplinary and personalized post-ICU care versus usual care on physical and psychological functioning, and quality of life (QoL) of ICU survivors one and two years post-ICU.

• RESEARCH QUESTION What is the clinical- and cost effectiveness of structured, personalized post-ICU care versus usual care on physical and psychological functioning, and QoL of ICU survivors?

• HYPOTHESIS Structured, multidisciplinary, and personalized post-ICU care results in improved QoL of ICU survivors and is more cost effective compared to usual care.

Clinical Trial Description

• OBJECTIVE To evaluate the clinical effectiveness and cost effectiveness of structured, multidisciplinary and personalized post-ICU care versus usual care on physical and psychological functioning, and quality of life (QoL) of ICU survivors one and two years post-ICU.

• RESEARCH QUESTION What is the clinical- and cost effectiveness of structured, personalized post-ICU care versus usual care on physical and psychological functioning, and QoL of ICU survivors?

• HYPOTHESIS Structured, multidisciplinary, and personalized post-ICU care results in improved QoL of ICU survivors and is more cost effective compared to usual care.

• STUDY POPULATION Adult patients at high risk of critical illness-associated morbidity post-ICU.

• INTERVENTION Structured, personalized and multidisciplinary post-ICU care tailored to patients' health problems initiated by ICU clinicians and coordinated by GPs.

• USUAL CARE / COMPARISON No or unstructured post-ICU care.

• OUTCOMES Primary: QoL and mental functioning 1-year post-ICU. Secondary: physical and cognitive functioning 1- and 2-year post-ICU, cost effectiveness and cost utility.

• FOLLOW-UP TIME One and two years post-ICU.

• STUDY DESIGN Stepped wedge cluster RCT in 5 hospitals.

• SAMPLE SIZE & DATA ANALYSIS 5 ICUs (11 patients/ICU/month, in total 770 intervention patients, and 1480 (active and historical) controls gives power of 87% to detect effect of 0.074 in EQ-5D (ICC 0.035; SD 0.26). Data will be analysed according to intention to treat principles, also per-protocol analyses will be performed.

• COST-EFFECTIVENESS ANALYSIS / BUDGET IMPACT ANALYSIS Comparison of 'cost per QALY' gained between patients in the intervention and control group. Decision analytical modelling will be used to calculate the average savings per patient; extrapolated to population level using a budget-holders perspective. ;

Related Conditions & MeSH terms

• Post ICU Syndrome

• NCT number: NCT05066984
• Study type: Interventional
• Source: Radboud University Medical Center
• Contact: Dries van Sleeuwen, MSc
• Phone: +31 24 3617273
• Email: dries.vansleeuwen@radboudumc.nl
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2022
• Completion date: July 1, 2026