MONITOR-IC Post ICU Care Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Post ICU Syndrome

Intervention / Treatment
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* Other: structured, multidisciplinary and personalized post-ICU care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Multicenter stepped-wedge cluster randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: structured, multidisciplinary and personalized post-ICU care<br>structured, multidisciplinary and personalized post-ICU care | Other: structured, multidisciplinary and personalized post-ICU care<br>* Structured, personalized and multidisciplinary post-ICU care tailored to patients' health problems initiated by ICU clinicians and coordinated by GPs.<br>|
| No Intervention: Ususal care<br>Usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Individual's perception of their position in life assessed by the EuroQol-5 dimension (EQ5D) . | Quality of life (QoL) assessed by the EQ5D at 1-year post-ICU. | 1 year post-ICU | 
| Mental impairments assessed by the Hospital Anxiety and Depression Scale (HADS) | Anxiety and depression (assessed by the HADS) at 1-year post-ICU. | 1 year post-ICU | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical functioning measured by fatigue assessed by the Checklist Individual Strength (CIS). | Fatigue (CIS) Patients' level of frailty and vulnerability will be assed using the Clinical Frailty Score (CFS). | 1- and 2-year post-ICU | 
| Physical functioning measured by frailty assessed by the Clinical Frailty Scale (CFS). | Frailty (CFS) Patients' level of frailty and vulnerability will be assed using the Clinical Frailty Score (CFS). | 1- and 2-year post-ICU | 
| Physical functioning measured by new physical complaints assessed by the number of new physical complaints. | New physical complaints Patients' level of frailty and vulnerability will be assed using the Clinical Frailty Score (CFS). | 1- and 2-year post-ICU | 
| Post traumatic stress disorder 1- and 2-year post-ICU assessed by the Impact of Event Scale-Revised (IES-R). | Post traumatic stress disorder (IES-R) | 1- and 2-year post-ICU | 
| Cognitive functioning 1- and 2-year post-ICU assessed by the 14-item Cognitive Failure Questionnaire (CFQ14). | Cognitive functioning (CFQ14) | 1- and 2-year post-ICU | 
| Social economic consequences measured by the novel question set designed by Griffiths et al. | 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.) | 1- and 2-year post-ICU | 
| Cost effectiveness measured by cost per Quality-Adjusted Life Years (QALY) | 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. | 1- and 2-year post-ICU | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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post-ICU care, cost-effectiveness, QoL, PROMs