Chronic Critical IllnessNCT03159208
Prediction of Functional Outcomes From Chronic Critical Illness
An observational study of Chronic Critical Illness and Prolonged Mechanical Ventilation, run by University of North Carolina, Chapel Hill at 6 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Critical Illness, Prolonged Mechanical Ventilation
- How many people
- 589 participants
- Where
- 6 sitesUnited States
- Study dates
- 17 Apr 2017to 5 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients at risk for chronic critical illness after prolonged mechanical ventilation for acute illness or injury.
Who may be able to join
- Patients in enrolling ICU
- Expected to require 7 days of mechanical ventilation uninterrupted for 72 hours for acute illness.
- Adults >/= 18yo of age.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of North Carolina-Chapel Hill
Chapel Hill, North Carolina, 27599
Denver Health and Hospital Authority
Denver, Colorado, 80204
Duke University
Durham, North Carolina, 27710
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261
University of Washington
Seattle, Washington, 98195
Montefiore Medical Center
The Bronx, New York, 10467
About this study
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.
Read the 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.
- Keywords
- Prognosis, Critical Illness, Ventilation, Mechanical, Disease Attributes, Socioeconomic Factors, Activities of Daily LIving, Cognition
- Medical subject headings
- Critical Illness, Respiratory Aspiration, Disease Attributes
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 12 months
Proportion of patients who die within one year
Confirmed dead at 1-year follow up.
Measured: 12 months
Secondary outcomes (11)
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).
Measured: 6 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).
Measured: 6 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).
Measured: 6 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).
Measured: 6 months
Proportion of patients who die within 6 months.
Confirmed dead at 6 month follow up.
Measured: 6 months
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.
Measured: 6 and 12 months.
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.
Measured: 6 and 12 months.
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.
Measured: 6 and 12 months
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.
Measured: 6 and 12 months
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.
Measured: 12 months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2017
- Study start17 Apr 2017
- Primary completion5 Sep 2021
- Study completion5 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Critical IllnessStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 589 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), Duke University, University of Pittsburgh, University of Washington, University of Colorado, Denver, Montefiore Medical Center
- Responsible party
- Sponsor
- Investigators
- Shannon Carson, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03159208
- Sponsor's protocol ID
- 16-0998
- Other IDs
- R01NR016459
- Status last verified
- Oct 2021
- First submitted
- 16 May 2017
- Last updated
- 28 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A deidentified dataset will be available to investigators 9-36 months following publication of the study.
Publications
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.
PubMed 26247337Kahn 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.
PubMed 25377018Nelson 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.
PubMed 20448093
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Functional Outcomes From Chronic Critical Illness
- ClinicalTrials.gov ID
- NCT03159208
- Acronym / sponsor ID
- 16-0998
- Keywords
- Prognosis, Critical Illness, Ventilation, Mechanical, Disease Attributes, Socioeconomic Factors, Activities of Daily LIving, Cognition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 589 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), Duke University, University of Pittsburgh, University of Washington, University of Colorado, Denver, Montefiore Medical Center
- Study start
- 17 Apr 2017 (actual)
- Primary completion
- 5 Sep 2021 (actual)
- Study completion
- 5 Sep 2021 (actual)
- First posted
- 18 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients at risk for chronic critical illness after prolonged mechanical ventilation for acute illness or injury.
Key inclusion criteria (3 listed)
- Patients in enrolling ICU
- Expected to require 7 days of mechanical ventilation uninterrupted for 72 hours for acute illness.
- Adults >/= 18yo of age.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
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).
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).
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).
Proportion of patients who die within one year
Time frame: 12 months
Confirmed dead at 1-year follow up.
11 secondary outcomes
Proportion of Patients who Survive with Severe Physical Disability
Time frame: 6 months
Proportion of Patients who Survive with Severe Cognitive Disability
Time frame: 6 months
Proportion of Patients who Survive with Severe Physical and Cognitive Disability
Time frame: 6 months
Proportion of Patients who Survive with No Severe Functional Disability
Time frame: 6 months
Proportion of patients who die within 6 months.
Time frame: 6 months
Patient Quality of Life Score: NeuroQOL
Time frame: 6 and 12 months.
Patient Quality of Life Score: EQ-5D
Time frame: 6 and 12 months.
Caregiver Quality of Life Score: EQ-5D
Time frame: 6 and 12 months
Caregiver Burden Score: BSFC
Time frame: 6 and 12 months
Caregiver Anxiety and Depression Score: HADS
Time frame: 12 months
Caregiver PTSD Score: IES-R
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2021.
- Background: PubMed 26247337Hough 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.
- Background: PubMed 25377018Kahn 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.
- Background: PubMed 20448093Nelson 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.
- Individual participant dataSharing planned: Yes. A deidentified dataset will be available to investigators 9-36 months following publication of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shannon Carson, MD principal investigator
University of North Carolina, Chapel Hill
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Critical Illness and Prolonged Mechanical Ventilation, run by University of North Carolina, Chapel Hill at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients who Survive with Severe Physical Disability (time frame: 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03159208, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2021.