Measuring Outcomes of Activity in Intensive Care

Study Overview
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Brief Summary
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Millions of older adults are hospitalized for a critical illness each year and although they are more likely than ever to survive this illness, they commonly face significant morbidity in the form of disabilities in basic self-care activities and in mobility in the months and years afterwards. A better understanding of the underlying risk factors for disability following critical illness is greatly needed, including the effect that activity during hospitalization may have on these outcomes. Therefore, we designed the Measuring OutcomeS of Activity in Intensive Care (MOSAIC) observational study to evaluate the relationship between activity (measured more rigorously than in prior investigations) and disability, physical function, and cognitive function in survivors of critical illness 3 and 12 months after ICU discharge.

Detailed Description
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The MOSAIC observational study will measure activity in critically ill patients for up to 28 days in the hospital using two different, objective measures, a clinical mobility scale and accelerometry. We will evaluate the independent association between activity and outcomes 3 and 12 months after ICU discharge. Specifically, Aim 1 will determine the relationship between activity and disability in ADLs and mobility. Aim 2a will determine the relationship between activity and physical and cognitive function. Aim 2b will evaluate physical and cognitive function as mediators of long-term disability. Aim 3a will determine the relationship between activity and biomarkers of inflammation and coagulation. Aim 3b will determine the relationship between these biomarkers of inflammation and coagulation and disability, physical and cognitive function.

Official Title
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Long-term Outcomes of Physical Activity in Older Adults With Critical Illness

Conditions
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Critical Illness, Sepsis, Mechanical Ventilation, Physical Activity, Disability Physical, Muscle Weakness, Cognitive Impairment

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult patients (≥18 years old), in a medical or surgical ICU at Vanderbilt University Medical Center or The Ohio State University Medical Center, and are being treated for respiratory failure or shock. Exclusion Criteria: Rapidly resolving organ failure criteria, indicated by planned immediate discontinuation of mechanical ventilation, NIPPV, and/or vasopressors at the time of screening for study enrollment, such that the patient will no longer meet inclusion criteria. Cumulative hospital days (ICU plus non-ICU) of five or greater in the last 30 days prior to meeting all inclusion criteria. Inability to live independently at baseline due to acquired or congenital disabling, physical, cognitive or mental health disorder requiring institutionalization (e.g., nursing home, skilled nursing facility, group home, long-term acute care hospital, rehab facility) or any patient who resides outside an institution with an inability to walk without the assistance of another person (e.g., patients with quadriplegia, paraplegia, double amputees, those with residual paralysis from stroke). Acute or subacute severe neurologic (e.g., stroke anoxic injury, spinal cord injury) that is expected to prevent the patient from living independently after hospital discharge. Body mass index >50 Active substance abuse or psychotic disorder (e.g., schizophrenia or schizo-affective disorder), recent (within the past 6 months) serious suicidal gesture necessitating hospitalization Blindness, deafness, or inability to understand English that will preclude follow-up evaluation. Patients with laryngectomies and those with hearing impairments are eligible for enrollment if their medical condition permits them to communicate with research staff. Expected death within 24 hours of enrollment or lack of commitment to aggressive treatment by family or the medical team (e.g., likely to withdraw life support measures within 24 hours of screening). Prisoners Patients who live further than 200 miles from an enrolling center and who do not regularly visit the area. Patients who are homeless and have no secondary contact person available Current enrollment in a study that does not allow co-enrollment Inability to obtain informed consent from the patient or an authorized representative within 72 hours of meeting all inclusion criteria for the following reasons: Attending physician refusal Patient and/or surrogate refusal 72-hour period of eligibility was exceeded before the patient was screened Patient unable to consent and no surrogate available within 72 hours of meeting all inclusion criteria Confirmed or suspected COVID-19 per local guidelines at the time of screen.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adults (≥18 years old) with critical illness<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Precipitating Events Project Disability Questionnaire | Questionnaire assessment of activities of daily living and mobility | 12 months | 
| Life Space Assessment Questionnaire | Questionnaire assessment of activities of community mobility | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Precipitating Events Project Disability Questionnaire | Questionnaire assessment of activities of daily living and mobility | 3 months | 
| Life Space Assessment Questionnaire | Questionnaire assessment of activities of community mobility | 3 months | 
| Survival | Proportion of patients surviving at 30, 90, and 365 days | 30, 90, and 365 days | 
| Ventilator-free days | Days alive and free of mechanical ventilation | out of 28 days | 
| Delirium and coma-free days | Days alive and without delirium or coma | out of 28 days | 
| ICU Length of Stay | Days spent in the ICU during the index hospitalization | up to 28 days | 
| Hospital Length of Stay | Days spent in the hospital during the index hospitalization | up to 28 days | 
| Short Physical Performance Battery | Performance Measure of Physical Function | 3 months | 
| Short Physical Performance Battery | Performance Measure of Physical Function | 12 months | 
| Handgrip Dynamometry | Performance Measure of Muscle Strength | 3 months | 
| Handgrip Dynamometry | Performance Measure of Muscle Strength | 12 months | 
| Repeatable Battery for the Assessment of Neuropsychological Status | Test of Global Cognition | 3 months | 
| Repeatable Battery for the Assessment of Neuropsychological Status | Test of Global Cognition | 12 months | 
| Trail Making Test Parts A & B | Test of Executive Function | 3 months | 
| Trail Making Test Parts A & B | Test of Executive Function | 12 months |