Prediction of Functional Outcomes From Chronic Critical Illness

NCT03159208 | Completed

• 2 other identifiers: 16-0998R01NR016459
• Study Type: observational
• Target: 589
• Locations: 1 country
• Sites: 6

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.

Conditions

Chronic Critical Illness; Prolonged Mechanical Ventilation

Keywords

Prognosis; Critical Illness; Ventilation, Mechanical; Disease Attributes; Socioeconomic Factors; Activities of Daily LIving; Cognition

Outcome Measures

Primary Outcomes (5)

• 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

  Confirmed dead at 1-year follow up.

  12 months

Secondary Outcomes (11)

• Proportion of Patients who Survive with Severe Physical Disability

  6 months

• Proportion of Patients who Survive with Severe Cognitive Disability

  6 months

• Proportion of Patients who Survive with Severe Physical and Cognitive Disability

  6 months

• Proportion of Patients who Survive with No Severe Functional Disability

  6 months

• Proportion of patients who die within 6 months.

  6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients at risk for chronic critical illness after prolonged mechanical ventilation for acute illness or injury.

You may qualify if:

• Patients in enrolling ICU
• Expected to require 7 days of mechanical ventilation uninterrupted for 72 hours for acute illness.
• Adults \>/= 18yo of age.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute of Nursing Research (NINR): collaborator
• Duke University: collaborator
• University of Pittsburgh: collaborator
• University of Washington: collaborator
• University of Colorado, Denver: collaborator
• Montefiore Medical Center: collaborator

Study Sites (6)

Denver Health and Hospital Authority

Denver, Colorado, 80204, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

University of North Carolina-Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15261, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (3)

• 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.

  PMID: 26247337 BACKGROUND

• 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.

  PMID: 25377018 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.

  PMID: 20448093 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Whole Blood, Plasma, Urine

MeSH Terms

Conditions

Critical Illness; Respiratory Aspiration; Disease Attributes

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Shannon Carson, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2017
• First Posted: May 18, 2017
• Study Start: April 17, 2017
• Primary Completion: September 5, 2021
• Study Completion: September 5, 2021
• Last Updated: October 28, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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.

Locations

US (6)