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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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05066984
Study type Interventional
Source Radboud University
Contact Dries van Sleeuwen, MSc
Phone +31 24 3617273
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date November 1, 2021
Completion date March 1, 2026

See also
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