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Completed

NCT Number: NCT03159208

Prediction of Functional Outcomes From Chronic Critical Illness

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.

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Key information

Conditions

Chronic Critical Illness Critical Illness Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms Prolonged Mechanical Ventilation Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Denver Health and Hospital Authority, Denver, Colorado, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Duke University
  • Montefiore Medical Center
  • National Institute of Nursing Research (NINR)
  • University of Colorado, Denver
  • University of Pittsburgh
  • University of Washington

Registry information

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
May 18, 2017
Registry last updated
Oct 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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