Specialized Treatment, Rehabilitation and Outcome in Patients With Prolonged Critical Illness

Study Overview
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Brief Summary
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This prospective observational study aims to describe the outcome for patients with persistent or chronic critical illness treated at Remeo, a clinic specialized for patients in need of prolonged intensive care and intensive care rehabilitation in Sweden. Patients' disease characteristics and the treatment in multidisciplinary patient centered teams for intensive care, weaning from mechanical ventilation and simultaneous rehabilitation will be described. Patients will be followed one year after discharge to document health related quality of life, physical function, frailty, mental illness and used health care resources.

Official Title
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A Prospective Observational Study of Patients Suffering From Prolonged Critical Illness Treated by Patient Centered Multidisciplinary Teams at a Specialized Unit: Patient Characteristics, Treatment and Follow-up Results

Conditions
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Critical Illness

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Admission to unit (Remeo, Stockholm, Sweden) Treated for prolonged critical illness Exclusion Criteria: Treated less than 48 hours at unit (Remeo, Stockholm, Sweden)

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mechanical ventilation status | Time (Days) from admittance to unit until weaned from mechanical ventilation | Assessed at admittance and immediately after discharge from unit | 
| Change in tracheostomy status | Time (Days) from admittance to unit until decannulation | Assessed at admittance and immediately after discharge from unit | 
| In-patient mortality and mortality | Mortality during care at unit | Assessed immediately after discharge from unit | 
| Mortality during 12 months follow-up after discharge | Mortality during 12 months follow-up after discharge | Assessed 12 months after discharge | 
| Health related quality of Life assessed by the Rand 36-Item Health Survey (RAND36) | RAND36 (scale 0-100, higher value better) questionnaire | 3 months after discharge from unit | 
| Health related quality of Life assessed by the Rand 36-Item Health Survey (RAND36) | RAND36 (scale 0-100, higher value better) questionnaire | 6 months after discharge from unit | 
| Health related quality of Life assessed by the Rand 36-Item Health Survey (RAND36) | RAND36 (scale 0-100, higher value better) questionnaire | 12 months after discharge from unit | 
| Health related quality of Life assessed by EuroQoL 5-dimension 5-level (EQ-5D-5L) | EQ-5D-5L questionnaire | 3 months after discharge from unit | 
| Health related quality of Life assessed by EuroQoL 5-dimension 5-level (EQ-5D-5L) | EQ-5D-5L questionnaire | 6 months after discharge from unit | 
| Health related quality of Life assessed by EuroQoL 5-dimension 5-level (EQ-5D-5L) | EQ-5D-5L questionnaire | 12 months after discharge from unit | 
| Independence in activities of daily living assessed by Katz Index of Independence in Activities of Daily Living (Katz ADL) | Katz ADL (scale 0-6, higher value better) | At admission to unit | 
| Independence in activities of daily living assessed by Katz Index of Independence in Activities of Daily Living (Katz ADL) | Katz ADL (scale 0-6, higher value better) | Immediately before decannulation | 
| Independence in activities of daily living assessed by Katz Index of Independence in Activities of Daily Living (Katz ADL) | Katz ADL (scale 0-6, higher value better) | Immediately before discharge from unit | 
| Independence in activities of daily living assessed by Katz Index of Independence in Activities of Daily Living (Katz ADL) | Katz ADL (scale 0-6, higher value better) | 6 months after discharge from unit | 
| Independence in activities of daily living assessed by Katz Index of Independence in Activities of Daily Living (Katz ADL) | Katz ADL (scale 0-6, higher value better) | 12 months after discharge from unit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms of depression as assessed by the Patient Health Questionnaire-9 (PHQ-9) | PHQ-9, a patient related outcome questionnaire, scale 0-27, higher value indicating more severe symptoms | 3 months after discharge from unit | 
| Symptoms of depression as assessed by the Patient Health Questionnaire-9 (PHQ-9) | PHQ-9, a patient related outcome questionnaire, scale 0-27, higher value indicating more severe symptoms | 6 months after discharge from unit | 
| Symptoms of depression as assessed by the Patient Health Questionnaire-9 (PHQ-9) | PHQ-9, a patient related outcome questionnaire, scale 0-27, higher value indicating more severe symptoms | 12 months after discharge from unit | 
| Symptoms of generalized anxiety as assessed by the General anxiety disorder 7 (GAD-7) questionnaire | GAD-7, a patient related outcome questionnaire, scale 0-21, higher value indicating more severe symptoms | 3 months after discharge from unit | 
| Symptoms of generalized anxiety as assessed by the General anxiety disorder 7 (GAD-7) questionnaire | GAD-7, a patient related outcome questionnaire, scale 0-21, higher value indicating more severe symptoms | 6 months after discharge | 
| Symptoms of generalized anxiety as assessed by the General anxiety disorder 7 (GAD-7) questionnaire | GAD-7, a patient related outcome questionnaire, scale 0-21, higher value indicating more severe symptoms | 12 months after discharge from unit | 
| Frailty as assessed by the Clinical frailty scale (CFS) | The Clinical frailty scale has 9 levels from very fit to terminally ill (1-9, lower value indicate better outcome) | At admission to unit | 
| Frailty as assessed by the Clinical frailty scale (CFS) | The Clinical frailty scale has 9 levels from very fit to terminally ill (1-9, lower value indicate better outcome) | Immediately before discharge from unit | 
| Frailty as assessed by the Clinical frailty scale (CFS) | The Clinical frailty scale has 9 levels from very fit to terminally ill (1-9, lower value indicate better outcome) | At 6 months after discharge from unit | 
| Frailty as assessed by the Clinical frailty scale (CFS) | The Clinical frailty scale has 9 levels from very fit to terminally ill (1-9, lower value indicate better outcome) | At 12 months after discharge from unit | 
| Physical status as assessed by the 6 minutes walk test | The 6 min walk test evaluated by a physiotherapist (longer distance (meters) better outcome) | At admission to unit | 
| Physical status as assessed by the 6 minutes walk test | The 6 min walk test evaluated by a physiotherapist (longer distance (meters) better outcome) | Immediately before decannulation | 
| Physical status as assessed by the 6 minutes walk test | The 6 min walk test evaluated by a physiotherapist (longer distance (meters) better outcome) | Immediately before discharge from unit | 
| Physical status as assessed by the 6 minutes walk test | The 6 min walk test evaluated by a physiotherapist (longer distance (meters) better outcome) | 6 months after discharge from unit | 
| Physical status as assessed by the 6 minutes walk test | The 6 min walk test evaluated by a physiotherapist (longer distance (meters) better outcome) | 12 months after discharge from unit | 
| Cognitive status as assessed by the Montreal cognitive assessment (MoCa) test | Performed by an occupational therapist. The MoCa test score scale is 0-30 Points, higher value indicate better outcome | At admission to unit | 
| Cognitive status as assessed by the Montreal cognitive assessment (MoCa) test | Performed by an occupational therapist. The MoCa test score scale is 0-30 Points, higher value indicate better outcome | Immediately before decannulation | 
| Cognitive status as assessed by the Montreal cognitive assessment (MoCa) test | Performed by an occupational therapist. The MoCa test score scale is 0-30 Points, higher value indicate better outcome | Immediately before discharge from unit | 
| Physical status as assessed by the Chelsea Critical Care Physical Assessment tool (CPAx). | CPAx performed by a physiotherapist (scale 0-50 Points, higher value indicate better outcome) | At admission to unit | 
| Physical status as assessed by the Chelsea Critical Care Physical Assessment tool (CPAx). | CPAx performed by a physiotherapist (scale 0-50 Points, higher value indicate better outcome) | Immediately after decannulation | 
| Physical status as assessed by the Chelsea Critical Care Physical Assessment tool (CPAx). | CPAx performed by a physiotherapist (scale 0-50 Points, higher value indicate better outcome) | Immediately before discharge from unit | 
| Physical status as assessed by the Chelsea Critical Care Physical Assessment tool (CPAx). | CPAx performed by a physiotherapist (scale 0-50 Points, higher value indicate better outcome) | 6 months after discharge from unit | 
| Physical status as assessed by the Chelsea Critical Care Physical Assessment tool (CPAx). | CPAx performed by a physiotherapist (scale 0-50 Points, higher value indicate better outcome) | 12 months after discharge from unit | 
| Swallowing function and possibility of oral intake | Using the Functional oral intake scale (FOIS) | At admission to unit | 
| Swallowing function and possibility of oral intake | Using the Functional oral intake scale (FOIS) | Immediately before decannulation | 
| Swallowing function and possibility of oral intake | Using the Functional oral intake scale (FOIS), seven different levels 1-7, higher level indicate better function | Immediately before discharge from unit | 
| Swallowing function and possibility of oral intake | Using the Functional oral intake scale (FOIS), seven different levels 1-7, higher level indicate better function | At at 6 months after discharge from unit | 
| Swallowing function and possibility of oral intake | Using the Functional oral intake scale (FOIS), seven different levels 1-7, higher level indicate better function | At at 12 months after discharge from unit | 
| Inflammatory status relative to outcome | HMGB1 and routine inflammation markers' effect on outcome measures | Through study completion, an average of 14 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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persistent critical illness, chronic critical illness, prolonged intensive care, weaning from mechanical ventilation, decannulation, multidisciplinary team, intensive care rehabilitation