Brief Summary
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.
Brief Title
Prediction of Functional Outcomes From Chronic Critical Illness
Detailed Description
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.
Completion Date
Completion Date Type
Actual
Conditions
Chronic Critical Illness
Prolonged Mechanical Ventilation
Eligibility Criteria
Inclusion Criteria
1. Patients in enrolling ICU
2. Expected to require 7 days of mechanical ventilation uninterrupted for 72 hours for acute illness.
3. Adults \>/= 18yo of age.
Exclusion Criteria
1. Patients with respiratory failure due to neuromuscular disease
2. Patients with respiratory failure due to severe burn
3. Patients requiring chronic mechanical ventilation at home
4. Patients receiving mechanical ventilation at an outside hospital \>7 days
5. Expected death prior to day 8 of mechanical ventilation therapies in 24 hrs.
6. Prisoners
7. No family member or surrogate available
8. Patient not proficient in English (or Spanish at select sites)
9. Unwilling or unable to provide written informed consent (patient or when indicated, by surrogate)
10. Co-enrollment in another study not approved
1. Patients in enrolling ICU
2. Expected to require 7 days of mechanical ventilation uninterrupted for 72 hours for acute illness.
3. Adults \>/= 18yo of age.
Exclusion Criteria
1. Patients with respiratory failure due to neuromuscular disease
2. Patients with respiratory failure due to severe burn
3. Patients requiring chronic mechanical ventilation at home
4. Patients receiving mechanical ventilation at an outside hospital \>7 days
5. Expected death prior to day 8 of mechanical ventilation therapies in 24 hrs.
6. Prisoners
7. No family member or surrogate available
8. Patient not proficient in English (or Spanish at select sites)
9. Unwilling or unable to provide written informed consent (patient or when indicated, by surrogate)
10. Co-enrollment in another study not approved
Inclusion Criteria
Inclusion Criteria
1. Patients in enrolling ICU
2. Expected to require 7 days of mechanical ventilation uninterrupted for 72 hours for acute illness.
3. Adults \>/= 18yo of age.
1. Patients in enrolling ICU
2. Expected to require 7 days of mechanical ventilation uninterrupted for 72 hours for acute illness.
3. Adults \>/= 18yo of age.
Gender
All
Gender Based
false
Keywords
Prognosis
Critical Illness
Ventilation, Mechanical
Disease Attributes
Socioeconomic Factors
Activities of Daily LIving
Cognition
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT03159208
Org Class
Other
Org Full Name
University of North Carolina, Chapel Hill
Org Study Id
16-0998
Overall Status
Completed
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Prediction of Functional Outcomes From Chronic Critical Illness
Primary Outcomes
Outcome Description
Severe Physical Disability defined by requiring assistance with 4 of 6 or more Activities of Daily Living (ADLs).
Outcome Measure
Proportion of Patients who Survive with Severe Physical Disability
Outcome Time Frame
12 months
Outcome Description
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).
Outcome Measure
Proportion of Patients who Survive with Severe Cognitive Disability
Outcome Time Frame
12 months
Outcome Description
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).
Outcome Measure
Proportion of Patients who Survive with Severe Physical and Cognitive Disability
Outcome Time Frame
12 months
Outcome Description
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).
Outcome Measure
Proportion of Patients who Survive with No Severe Functional Disability
Outcome Time Frame
12 months
Outcome Description
Confirmed dead at 1-year follow up.
Outcome Measure
Proportion of patients who die within one year
Outcome Time Frame
12 months
Secondary Ids
Secondary Id
R01NR016459
Secondary Outcomes
Outcome Description
Severe Physical Disability defined by requiring assistance with 4 of 6 or more Activities of Daily Living (ADLs).
Outcome Time Frame
6 months
Outcome Measure
Proportion of Patients who Survive with Severe Physical Disability
Outcome Description
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).
Outcome Time Frame
6 months
Outcome Measure
Proportion of Patients who Survive with Severe Cognitive Disability
Outcome Description
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).
Outcome Time Frame
6 months
Outcome Measure
Proportion of Patients who Survive with Severe Physical and Cognitive Disability
Outcome Description
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).
Outcome Time Frame
6 months
Outcome Measure
Proportion of Patients who Survive with No Severe Functional Disability
Outcome Description
Confirmed dead at 6 month follow up.
Outcome Time Frame
6 months
Outcome Measure
Proportion of patients who die within 6 months.
Outcome Description
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.
Outcome Time Frame
6 and 12 months.
Outcome Measure
Patient Quality of Life Score: NeuroQOL
Outcome Description
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.
Outcome Time Frame
6 and 12 months.
Outcome Measure
Patient Quality of Life Score: EQ-5D
Outcome Description
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.
Outcome Time Frame
6 and 12 months
Outcome Measure
Caregiver Quality of Life Score: EQ-5D
Outcome Description
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.
Outcome Time Frame
6 and 12 months
Outcome Measure
Caregiver Burden Score: BSFC
Outcome Description
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.
Outcome Time Frame
12 months
Outcome Measure
Caregiver Anxiety and Depression Score: HADS
Outcome Description
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.
Outcome Time Frame
12 months
Outcome Measure
Caregiver PTSD Score: IES-R
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Study Population
Patients at risk for chronic critical illness after prolonged mechanical ventilation for acute illness or injury.
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Aluko Hope
Investigator Email
ahope@montefiore.org
Investigator Phone
718-920-8750