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| ID | Type | Description | Link |
|---|---|---|---|
| R01NR016459 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
| Duke University | OTHER |
| University of Pittsburgh | OTHER |
| University of Washington |
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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.
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.
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| 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 |
| 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 |
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Inclusion Criteria
Exclusion Criteria
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Patients at risk for chronic critical illness after prolonged mechanical ventilation for acute illness or injury.
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| Name | Affiliation | Role |
|---|---|---|
| Shannon Carson, MD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Denver Health and Hospital Authority | Denver | Colorado | 80204 | United States | ||
| Montefiore Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26247337 | Background | Hough CL, Caldwell ES, Cox CE, Douglas IS, Kahn JM, White DB, Seeley EJ, Bangdiwala SI, Rubenfeld GD, Angus DC, Carson SS; ProVent Investigators and the National Heart Lung and Blood Institute's Acute Respiratory Distress Syndrome Network. Development and Validation of a Mortality Prediction Model for Patients Receiving 14 Days of Mechanical Ventilation. Crit Care Med. 2015 Nov;43(11):2339-45. doi: 10.1097/CCM.0000000000001205. | |
| 25377018 | Background |
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A deidentified dataset will be available to investigators 9-36 months following publication of the study.
Beginning 9 to 36 months following publication
Data can be obtained upon application to primary investigators. Investigators who proposes to use the data must have approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB) and execute a data use/sharing agreement with UNC.
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D053120 | Respiratory Aspiration |
| D020969 | Disease Attributes |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| OTHER |
| University of Colorado, Denver | OTHER |
| Montefiore Medical Center | OTHER |
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Whole Blood, Plasma, Urine
Confirmed dead at 1-year follow up. |
| 12 months |
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 |
| The Bronx |
| New York |
| 10467 |
| United States |
| University of North Carolina-Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| Duke University | Durham | North Carolina | 27710 | United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15261 | United States |
| University of Washington | Seattle | Washington | 98195 | United States |
| Kahn JM, Le T, Angus DC, Cox CE, Hough CL, White DB, Yende S, Carson SS; ProVent Study Group Investigators. The epidemiology of chronic critical illness in the United States*. Crit Care Med. 2015 Feb;43(2):282-7. doi: 10.1097/CCM.0000000000000710. |
| 20448093 | Background | Nelson JE, Cox CE, Hope AA, Carson SS. Chronic critical illness. Am J Respir Crit Care Med. 2010 Aug 15;182(4):446-54. doi: 10.1164/rccm.201002-0210CI. Epub 2010 May 6. |