Prediction of Functional Outcomes From Chronic Critical Illness

Study Overview
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Brief Summary
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The purpose of the study is to establish clinical determinants of poor cognitive and physical functional outcome of CCI patients so that the investigators may develop and validate a multi-dimensional clinical prediction model to more effectively inform decision making earlier in the course of the ICU care. The investigators hypothesize that multiple premorbid and acute factors measured early in the course of CCI will have strong independent associations with functional recovery. The investigators further hypothesize that social and economic factors are associated with long-term functional outcomes independent of the acute clinical problems.

Detailed Description
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A substantial number of critically ill patients experience persistent organ failure leading to chronic critical illness (CCI). The majority of these patients die within a year, and many survivors must cope with long-term physical and cognitive limitations that are often severe. Survival with severe physical and cognitive dysfunction is a significant clinical, emotional, and economic burden in this population, but little is known about which patients are at highest risk for physical and cognitive dysfunction. Moreover, although long-term mortality in CCI can be reliably estimated with a validated mortality prediction model, there is currently no validated method to predict long-term functional disability for purposes of shared decision-making and resource planning. In order to address these gaps in knowledge, the investigators will conduct a multi-center prospective cohort study that measures clinical and premorbid risk factors for long-term physical and cognitive dysfunction in CCI. Using these risk factors, the investigators will construct a multi-outcome prognostic model for survival with severe physical or cognitive dysfunction to facilitate shared decision-making and resource planning. Additionally, the investigators will identify independent social and economic variables that are risk factors for long-term survival and functional disability.

Official Title
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Prediction of Functional Outcomes From Chronic Critical Illness

Conditions
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Chronic Critical Illness, Prolonged Mechanical Ventilation

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Patients in enrolling ICU Expected to require 7 days of mechanical ventilation uninterrupted for 72 hours for acute illness. Adults >/= 18yo of age. Exclusion Criteria Patients with respiratory failure due to neuromuscular disease Patients with respiratory failure due to severe burn Patients requiring chronic mechanical ventilation at home Patients receiving mechanical ventilation at an outside hospital >7 days Expected death prior to day 8 of mechanical ventilation therapies in 24 hrs. Prisoners No family member or surrogate available Patient not proficient in English (or Spanish at select sites) Unwilling or unable to provide written informed consent (patient or when indicated, by surrogate) Co-enrollment in another study not approved

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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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 |
| --- | --- | --- |
| Proportion of Patients who Survive with Severe Physical Disability | Severe Physical Disability defined by requiring assistance with 4 of 6 or more Activities of Daily Living (ADLs). | 12 months | 
| Proportion of Patients who Survive with Severe Cognitive Disability | Severe Cognitive Disability defined by the Informant Questionnaire on Cognitive Delay (IQCODE) average score of greater than 3.44 (range 0-5, 5 being worse) and, when available, the Telephone Montreal Cognitive Assessment (T-MoCA) score of less than 17 (Range 0-22, 0 being worse). Severity of Cognitive Delay will be confirmed with a Functional Activities Questionnaire (FAQ) score of greater than 8 (Range 0-30, 30 being worst). | 12 months | 
| Proportion of Patients who Survive with Severe Physical and Cognitive Disability | Severe Physical Disability defined by requiring assistance with 4 of 6 or more Activities of Daily Living (ADLs). Severe Cognitive Disability defined by the Informant Questionnaire on Cognitive Delay (IQCODE) average score of greater than 3.44 (range 0-5, 5 being worse) and, when available, the Telephone Montreal Cognitive Assessment (T-MoCA) score of less than 17 (Range 0-22, 0 being worse). Severity of Cognitive Delay will be confirmed with a Functional Activities Questionnaire (FAQ) score of greater than 8 (Range 0-30, 30 being worst). | 12 months | 
| Proportion of Patients who Survive with No Severe Functional Disability | No severe physical disability is indicated by requiring assistance with 3 or fewer Activities of Daily Living (ADLs). No Severe Cognitive Disability is defined by the Informant Questionnaire on Cognitive Delay (IQCODE) average score of less than 3.44 (range 0-5) and, when available, the Telephone Montreal Cognitive Assessment (T-MoCA) score of greater than 17 (Range 0-22). | 12 months | 
| Proportion of patients who die within one year | Confirmed dead at 1-year follow up. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Patients who Survive with Severe Physical Disability | Severe Physical Disability defined by requiring assistance with 4 of 6 or more Activities of Daily Living (ADLs). | 6 months | 
| Proportion of Patients who Survive with Severe Cognitive Disability | Severe Cognitive Disability defined by the Informant Questionnaire on Cognitive Delay (IQCODE) average score of greater than 3.44 (range 0-5, 5 being worse) and, when available, the Telephone Montreal Cognitive Assessment (T-MoCA) score of less than 17 (Range 0-22, 0 being worse). Severity of Cognitive Delay will be confirmed with a Functional Activities Questionnaire (FAQ) score of greater than 8 (Range 0-30, 30 being worst). | 6 months | 
| Proportion of Patients who Survive with Severe Physical and Cognitive Disability | Severe Physical Disability defined by requiring assistance with 4 of 6 or more Activities of Daily Living (ADLs). Severe Cognitive Disability defined by the Informant Questionnaire on Cognitive Delay (IQCODE) average score of greater than 3.44 (range 0-5, 5 being worse) and, when available, the Telephone Montreal Cognitive Assessment (T-MoCA) score of less than 17 (Range 0-22, 0 being worse). Severity of Cognitive Delay will be confirmed with a Functional Activities Questionnaire (FAQ) score of greater than 8 (Range 0-30, 30 being worst). | 6 months | 
| Proportion of Patients who Survive with No Severe Functional Disability | No severe physical disability is indicated by requiring assistance with 3 or fewer Activities of Daily Living (ADLs). No Severe Cognitive Disability is defined by the Informant Questionnaire on Cognitive Delay (IQCODE) average score of less than 3.44 (range 0-5) and, when available, the Telephone Montreal Cognitive Assessment (T-MoCA) score of greater than 17 (Range 0-22). | 6 months | 
| Proportion of patients who die within 6 months. | Confirmed dead at 6 month follow up. | 6 months | 
| Patient Quality of Life Score: NeuroQOL | Quality of Life with cognitive ability is measured by Quality of Life in Neurological Disorders (NeuroQOL) with 8-items Scores range from 8-20. The higher score indicates better health state perceived by participant. | 6 and 12 months. | 
| Patient Quality of Life Score: EQ-5D | Quality of Life is measured by EQ-5D Questionnaire via 5 items: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The score ranges from -0.594 to 1.000 in the US. The higher score indicates a better health state perceived by the participant. | 6 and 12 months. | 
| Caregiver Quality of Life Score: EQ-5D | Quality of Life is measured by EQ-5D Questionnaire via 5 items: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The score ranges from -0.594 to 1.000 in the US. The higher score indicates a better health state perceived by the participant. | 6 and 12 months | 
| Caregiver Burden Score: BSFC | Caregiver burden is measured by the Burden Scale for Family Caregivers (BSFCs) with 10-items and are rated on a scale from 0 (strongly disagree) to 3 (strongly agree). The score ranges from 0 to 30 points. The higher scores indicate greater caregiver burden. | 6 and 12 months | 
| Caregiver Anxiety and Depression Score: HADS | Caregiver Depression and Anxiety is measured by the Hospital Anxiety and Depression Scale (HADS) with 14-items. Scores for each subscale (anxiety and depression) range from 0 to 21. Scores for the entire scale range from 0 to 42. The higher scores indicating more distress. | 12 months | 
| Caregiver PTSD Score: IES-R | Caregiver PTSD symptoms is measured by Impact of Events Scale-Revised (IES-R) with 22-items. Scores for each subscale (avoidance, intrusion, hyperarousal) range from 0-12. Scores for the entire scale range from 0-88. The higher scores are associated with clinical symptoms of PTSD. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prognosis, Critical Illness, Ventilation, Mechanical, Disease Attributes, Socioeconomic Factors, Activities of Daily LIving, Cognition