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Prediction of Functional Outcomes From Chronic Critical Illness

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03159208
Recruitment Status : Active, not recruiting
First Posted : May 18, 2017
Last Update Posted : May 18, 2021
Sponsor:
Collaborators:
National Institute of Nursing Research (NINR)
Duke University
University of Pittsburgh
University of Washington
University of Colorado, Denver
Montefiore Medical Center
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

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.

Condition or disease
Chronic Critical Illness Prolonged Mechanical Ventilation

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.

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Study Type : Observational
Actual Enrollment : 589 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prediction of Functional Outcomes From Chronic Critical Illness
Actual Study Start Date : April 17, 2017
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021



Primary Outcome Measures :
  1. Proportion of Patients who Survive with Severe Physical Disability [ Time Frame: 12 months ]
    Severe Physical Disability defined by requiring assistance with 4 of 6 or more Activities of Daily Living (ADLs).

  2. Proportion of Patients who Survive with Severe Cognitive Disability [ Time Frame: 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).

  3. Proportion of Patients who Survive with Severe Physical and Cognitive Disability [ Time Frame: 12 months ]
    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).

  4. Proportion of Patients who Survive with No Severe Functional Disability [ Time Frame: 12 months ]
    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).

  5. Proportion of patients who die within one year [ Time Frame: 12 months ]
    Confirmed dead at 1-year follow up.


Secondary Outcome Measures :
  1. Proportion of Patients who Survive with Severe Physical Disability [ Time Frame: 6 months ]
    Severe Physical Disability defined by requiring assistance with 4 of 6 or more Activities of Daily Living (ADLs).

  2. Proportion of Patients who Survive with Severe Cognitive Disability [ Time Frame: 6 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).

  3. Proportion of Patients who Survive with Severe Physical and Cognitive Disability [ Time Frame: 6 months ]
    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).

  4. Proportion of Patients who Survive with No Severe Functional Disability [ Time Frame: 6 months ]
    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).

  5. Proportion of patients who die within 6 months. [ Time Frame: 6 months ]
    Confirmed dead at 6 month follow up.

  6. Patient Quality of Life Score: NeuroQOL [ Time Frame: 6 and 12 months. ]
    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.

  7. Patient Quality of Life Score: EQ-5D [ Time Frame: 6 and 12 months. ]
    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.

  8. Caregiver Quality of Life Score: EQ-5D [ Time Frame: 6 and 12 months ]
    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.

  9. Caregiver Burden Score: BSFC [ Time Frame: 6 and 12 months ]
    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.

  10. Caregiver Anxiety and Depression Score: HADS [ Time Frame: 12 months ]
    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.

  11. Caregiver PTSD Score: IES-R [ Time Frame: 12 months ]
    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.


Biospecimen Retention:   Samples With DNA
Whole Blood, Plasma, Urine


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients at risk for chronic critical illness after prolonged mechanical ventilation for acute illness or injury.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03159208


Locations
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United States, Colorado
Denver Health and Hospital Authority
Denver, Colorado, United States, 80204
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
United States, North Carolina
University of North Carolina-Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Duke University
Durham, North Carolina, United States, 27710
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15261
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institute of Nursing Research (NINR)
Duke University
University of Pittsburgh
University of Washington
University of Colorado, Denver
Montefiore Medical Center
Investigators
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Principal Investigator: Shannon Carson, MD University of North Carolina, Chapel Hill
Publications:
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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT03159208    
Other Study ID Numbers: 16-0998
R01NR016459 ( U.S. NIH Grant/Contract )
First Posted: May 18, 2017    Key Record Dates
Last Update Posted: May 18, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: A deidentified dataset will be available to investigators 9-36 months following publication of the study.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Beginning 9 to 36 months following publication
Access Criteria: 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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of North Carolina, Chapel Hill:
Prognosis
Critical Illness
Ventilation, Mechanical
Disease Attributes
Socioeconomic Factors
Activities of Daily LIving
Cognition
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes