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Active, Not Recruiting

NCT Number: NCT05066984

MONITOR-IC Post ICU Care Study

* 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Post ICU Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Canisius Wilhelmina Ziekenhuis, Nijmegen, Gelderland, Netherlands

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About this study

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ICU patients at high risk of critical illness-associated morbidity post-ICU
  • 18 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

Treatment and study plan

structured, multidisciplinary and personalized post-ICU care

Other

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

Primary outcomes

  1. Individual's perception of their position in life assessed by the EuroQol-5 dimension (EQ5D) .

    Time frame: 1 year post-ICU

    Quality of life (QoL) assessed by the EQ5D at 1-year post-ICU.

  2. Mental impairments assessed by the Hospital Anxiety and Depression Scale (HADS)

    Time frame: 1 year post-ICU

    Anxiety and depression (assessed by the HADS) at 1-year post-ICU.

Secondary outcomes

  1. Physical functioning measured by fatigue assessed by the Checklist Individual Strength (CIS).

    Time frame: 1- and 2-year post-ICU

    Fatigue (CIS) Patients' level of frailty and vulnerability will be assed using the Clinical Frailty Score (CFS).

  2. Physical functioning measured by frailty assessed by the Clinical Frailty Scale (CFS).

    Time frame: 1- and 2-year post-ICU

    Frailty (CFS) Patients' level of frailty and vulnerability will be assed using the Clinical Frailty Score (CFS).

  3. Physical functioning measured by new physical complaints assessed by the number of new physical complaints.

    Time frame: 1- and 2-year post-ICU

    New physical complaints Patients' level of frailty and vulnerability will be assed using the Clinical Frailty Score (CFS).

  4. Post traumatic stress disorder 1- and 2-year post-ICU assessed by the Impact of Event Scale-Revised (IES-R).

    Time frame: 1- and 2-year post-ICU

    Post traumatic stress disorder (IES-R)

  5. Cognitive functioning 1- and 2-year post-ICU assessed by the 14-item Cognitive Failure Questionnaire (CFQ14).

    Time frame: 1- and 2-year post-ICU

    Cognitive functioning (CFQ14)

  6. Social economic consequences measured by the novel question set designed by Griffiths et al.

    Time frame: 1- and 2-year post-ICU

    Social consequences and return to work will be measured using the novel question set designed by Griffiths et al to determine changes in family circumstances, socioeconomic stability and care requirements.

    (Griffiths J, Hatch RA, Bishop J, et al. An exploration of social and economic outcome and associated health-related quality of life after critical illness in general intensive care unit survivors: a 12-month follow-up study. Critical care. 2013;17(3):R100.)

  7. Cost effectiveness measured by cost per Quality-Adjusted Life Years (QALY)

    Time frame: 1- and 2-year post-ICU

    A cost-effectiveness analysis will be carried out to evaluate whether the costs of structured, multidisciplinary and personalized post-ICU care weigh up to the benefits compared to usual care.

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • Dutch National Health Care Institute
  • ZonMw: The Netherlands Organisation for Health Research and Development

Registry information

Official study title

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

Acronym: MiCare

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Oct 4, 2021
Registry last updated
Aug 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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