Clinical trial NCT03115840: Measuring Outcomes of Activity in Intensive Care
Official title: Long-term Outcomes of Physical Activity in Older Adults With Critical Illness
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Critical Illness
Sepsis
Mechanical Ventilation
Physical Activity
Disability Physical
Muscle Weakness
Cognitive Impairment
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2017-04-14
Enrollment: 312
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with medical or surgical critical illness

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. adult patients (≥18 years old),
2. in a medical or surgical ICU at Vanderbilt University Medical Center or The Ohio State University Medical Center, and
3. are being treated for respiratory failure or shock.

Exclusion Criteria:

1. 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.
2. Cumulative hospital days (ICU plus non-ICU) of five or greater in the last 30 days prior to meeting all inclusion criteria.
3. 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).
4. 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.
5. Body mass index \>50
6. Active substance abuse or psychotic disorder (e.g., schizophrenia or schizo-affective disorder), recent (within the past 6 months) serious suicidal gesture necessitating hospitalization
7. 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.
8. 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).
9. Prisoners
10. Patients who live further than 200 miles from an enrolling center and who do not regularly visit the area.
11. Patients who are homeless and have no secondary contact person available
12. Current enrollment in a study that does not allow co-enrollment
13. Inability to obtain informed consent from the patient or an authorized representative within 72 hours of meeting all inclusion criteria for the following reasons:

    1. Attending physician refusal
    2. Patient and/or surrogate refusal
    3. 72-hour period of eligibility was exceeded before the patient was screened
    4. Patient unable to consent and no surrogate available within 72 hours of meeting all inclusion criteria
14. Confirmed or suspected COVID-19 per local guidelines at the time of screen.

Primary outcomes:
measure: Precipitating Events Project Disability Questionnaire
timeFrame: 12 months
measure: Life Space Assessment Questionnaire
timeFrame: 12 months
Secondary outcomes:
measure: Precipitating Events Project Disability Questionnaire
timeFrame: 3 months
measure: Life Space Assessment Questionnaire
timeFrame: 3 months
measure: Survival
timeFrame: 30, 90, and 365 days
measure: Ventilator-free days
timeFrame: out of 28 days
measure: Delirium and coma-free days
timeFrame: out of 28 days
measure: ICU Length of Stay
timeFrame: up to 28 days
measure: Hospital Length of Stay
timeFrame: up to 28 days
measure: Short Physical Performance Battery
timeFrame: 3 months
measure: Short Physical Performance Battery
timeFrame: 12 months
measure: Handgrip Dynamometry
timeFrame: 3 months
measure: Handgrip Dynamometry
timeFrame: 12 months
measure: Repeatable Battery for the Assessment of Neuropsychological Status
timeFrame: 3 months
measure: Repeatable Battery for the Assessment of Neuropsychological Status
timeFrame: 12 months
measure: Trail Making Test Parts A & B
timeFrame: 3 months
measure: Trail Making Test Parts A & B
timeFrame: 12 months
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Medical Center
state: Ohio
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
References:
citation: Brummel NE, Balas MC, Morandi A, Ferrante LE, Gill TM, Ely EW. Understanding and reducing disability in older adults following critical illness. Crit Care Med. 2015 Jun;43(6):1265-75. doi: 10.1097/CCM.0000000000000924.
citation: Pandharipande PP, Girard TD, Jackson JC, Morandi A, Thompson JL, Pun BT, Brummel NE, Hughes CG, Vasilevskis EE, Shintani AK, Moons KG, Geevarghese SK, Canonico A, Hopkins RO, Bernard GR, Dittus RS, Ely EW; BRAIN-ICU Study Investigators. Long-term cognitive impairment after critical illness. N Engl J Med. 2013 Oct 3;369(14):1306-16. doi: 10.1056/NEJMoa1301372.
citation: Herridge MS, Tansey CM, Matte A, Tomlinson G, Diaz-Granados N, Cooper A, Guest CB, Mazer CD, Mehta S, Stewart TE, Kudlow P, Cook D, Slutsky AS, Cheung AM; Canadian Critical Care Trials Group. Functional disability 5 years after acute respiratory distress syndrome. N Engl J Med. 2011 Apr 7;364(14):1293-304. doi: 10.1056/NEJMoa1011802.
citation: Gill TM, Allore HG, Gahbauer EA, Murphy TE. Change in disability after hospitalization or restricted activity in older persons. JAMA. 2010 Nov 3;304(17):1919-28. doi: 10.1001/jama.2010.1568.