Prediction of Functional Outcomes From Chronic Critical Illness

Prolonged Mechanical Ventilation Clinical Trial

Official title:

Prediction of Functional Outcomes From Chronic Critical Illness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03159208
• Other study ID #: 16-0998
• Secondary ID: R01NR016459
• Status: Completed
• Start date: April 17, 2017
• Est. completion date: September 5, 2021

Study information

• Verified date: October 2021
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 589
• Est. completion date: September 5, 2021
• Est. primary completion date: September 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Critical Illness
• Critical Illness
• Prolonged Mechanical Ventilation

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York
United States	University of North Carolina-Chapel Hill	Chapel Hill	North Carolina
United States	Denver Health and Hospital Authority	Denver	Colorado
United States	Duke University	Durham	North Carolina
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	University of Washington	Seattle	Washington

Sponsors (7)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Duke University, Montefiore Medical Center, National Institute of Nursing Research (NINR), University of Colorado, Denver, University of Pittsburgh, University of Washington

Country where clinical trial is conducted

United States, 

References & 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Proportion of patients who die within one year	Confirmed dead at 1-year follow up.	12 months
Secondary	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).	6 months
Secondary	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).	6 months
Secondary	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).	6 months
Secondary	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).	6 months
Secondary	Proportion of patients who die within 6 months.	Confirmed dead at 6 month follow up.	6 months
Secondary	Patient Quality of Life Score: NeuroQOL	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.	6 and 12 months.
Secondary	Patient Quality of Life Score: EQ-5D	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.	6 and 12 months.
Secondary	Caregiver Quality of Life Score: EQ-5D	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.	6 and 12 months
Secondary	Caregiver Burden Score: BSFC	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.	6 and 12 months
Secondary	Caregiver Anxiety and Depression Score: HADS	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.	12 months
Secondary	Caregiver PTSD Score: IES-R	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.	12 months