Clinical trial NCT03159208: Prediction of Functional Outcomes From Chronic Critical Illness
Official title: Prediction of Functional Outcomes From Chronic Critical Illness
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Critical Illness
Prolonged Mechanical Ventilation
Keywords: Prognosis
Critical Illness
Ventilation, Mechanical
Disease Attributes
Socioeconomic Factors
Activities of Daily LIving
Cognition
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
name: Duke University
name: University of Pittsburgh
name: University of Washington
name: University of Colorado, Denver
name: Montefiore Medical Center
First posted: 2017-05-18
Enrollment: 589
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients at risk for chronic critical illness after prolonged mechanical ventilation for acute illness or injury.

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.

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.

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

Primary outcomes:
measure: Proportion of Patients who Survive with Severe Physical Disability
timeFrame: 12 months
measure: Proportion of Patients who Survive with Severe Cognitive Disability
timeFrame: 12 months
measure: Proportion of Patients who Survive with Severe Physical and Cognitive Disability
timeFrame: 12 months
measure: Proportion of Patients who Survive with No Severe Functional Disability
timeFrame: 12 months
measure: Proportion of patients who die within one year
timeFrame: 12 months
Secondary outcomes:
measure: Proportion of Patients who Survive with Severe Physical Disability
timeFrame: 6 months
measure: Proportion of Patients who Survive with Severe Cognitive Disability
timeFrame: 6 months
measure: Proportion of Patients who Survive with Severe Physical and Cognitive Disability
timeFrame: 6 months
measure: Proportion of Patients who Survive with No Severe Functional Disability
timeFrame: 6 months
measure: Proportion of patients who die within 6 months.
timeFrame: 6 months
measure: Patient Quality of Life Score: NeuroQOL
timeFrame: 6 and 12 months.
measure: Patient Quality of Life Score: EQ-5D
timeFrame: 6 and 12 months.
measure: Caregiver Quality of Life Score: EQ-5D
timeFrame: 6 and 12 months
measure: Caregiver Burden Score: BSFC
timeFrame: 6 and 12 months
measure: Caregiver Anxiety and Depression Score: HADS
timeFrame: 12 months
measure: Caregiver PTSD Score: IES-R
timeFrame: 12 months
Other outcomes:
Locations:
city: Denver
country: United States
facility: Denver Health and Hospital Authority
state: Colorado
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina-Chapel Hill
state: North Carolina
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Shannon Carson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.