Prediction of Functional Outcomes From Chronic Critical Illness

NCT ID: NCT03159208

Last Updated: 2021-10-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 589 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-04-17
• Study Completion Date: 2021-09-05

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.

Conditions

Chronic Critical Illness; Prolonged Mechanical Ventilation

Keywords

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: collaborator

Montefiore Medical Center

OTHER

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shannon Carson, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

Denver Health and Hospital Authority

Denver, Colorado, United States

Montefiore Medical Center

The Bronx, New York, United States

University of North Carolina-Chapel Hill

Chapel Hill, North Carolina, United States

Duke University

Durham, North Carolina, United States

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

University of Washington

Seattle, Washington, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 26247337 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25377018 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20448093 (View on PubMed)

Other Identifiers

R01NR016459

Identifier Type: NIH

Identifier Source: secondary_id

View Link

16-0998

Identifier Type: -

Identifier Source: org_study_id