Measuring Outcomes of Activity in Intensive Care

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.

Inclusion Criteria:

1. adult patients (≥18 years old),

2. in a medical or surgical ICUs at Vanderbilt 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 Nashville and who do not regularly visit
the Nashville 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