MONITOR-IC Post ICU Care Study (MiCare)

  • STATUS
    Recruiting
  • End date
    Mar 1, 2026
  • participants needed
    2250
  • sponsor
    Radboud University Medical Center
Updated on 14 May 2022
Accepts healthy volunteers

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.

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.

Details
Condition Post ICU Syndrome
Treatment structured, multidisciplinary and personalized post-ICU care
Clinical Study IdentifierNCT05066984
SponsorRadboud University Medical Center
Last Modified on14 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

ICU patients at high risk of critical illness-associated morbidity post-ICU
years or older
Patient or legal representative understands the Dutch language

Exclusion Criteria

Patients discharged from ICU/hospital direct to a nursing home
Patients discharged from ICU/hospital direct to a medical or geriatric rehabilitation clinic
Patients discharged for palliative care
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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