MiCare study, an evaluation of structured, multidisciplinary and personalised post-ICU care on physical and psychological functioning, and quality of life of former ICU patients: a study protocol of a stepped-wedge cluster randomised controlled trial.

Introduction: Over 70% of the intensive care unit (ICU) survivors suffer from long-lasting physical, mental and cognitive problems after hospital discharge. Post-ICU care is recommended by international guidelines, but evidence for cost-effectiveness lacks. The aim of this study is to evaluate the clinical effectiveness and cost-effectiveness of structured, multidisciplinary and personalised post-ICU care versus usual care on physical and psychological functioning and health-related quality of life (HRQoL) of ICU survivors, 1- and 2-year post-ICU discharge.

Methods And Analysis: The MONITOR-IC post-ICU care study (MiCare study) is a multicentre stepped-wedge randomised controlled trial conducted in five hospitals. Adult patients at high risk for critical illness-associated morbidity post-ICU will be selected and receive post-ICU care, including an invitation to the post-ICU clinic 3 months after ICU discharge. A personalised long-term recovery plan tailored to patients' reported outcome measures will be made. 770 (intervention) and 1480 (control) patients will be included. Outcomes are 1- and 2-year HRQoL (EuroQol Instrument (EQ-5D-5L)), physical (fatigue and new physical problems), mental (anxiety, depression and post-traumatic stress disorder), and cognitive symptoms and cost-effectiveness. Medical data will be retrieved from patient records and cost data from health insurance companies.

Ethics And Dissemination: Due to the lack of evidence, Dutch healthcare insurers do not reimburse post-ICU care. Therefore, evaluation of cost-effectiveness and integration in guidelines supports the evidence. Participation of several societies for physicians, nurses, paramedics, and patients and relatives in the project team increases the support for implementation of the intervention in clinical practice. Patients and relatives will be informed by the patient associations, hospitals and professional associations. Informing healthcare insurers about this project's results is important for the consideration for inclusion of post-ICU care in Dutch standard health insurance. The study is approved by the Radboud University Medical Centre research ethics committee (2021-13125).

Trial Registration Number: NCT05066984.