Evaluating Health Outcomes and QOL After ALI Among Participants of the ALTA, OMEGA, EDEN, and SAILS ARDS Network Trials

ALI, a life-threatening condition that involves inflammation of the lungs and fluid
accumulation in the air sacs, typically leads to low blood oxygen levels and respiratory
failure. Common causes of ALI include pneumonia, sepsis, and lung trauma. Symptoms,
including breathing difficulty, low blood pressure, and organ failure, usually develop
within 24 to 48 hours of the original injury or illness. Most patients require immediate
care in an intensive care unit (ICU), and the main form of treatment is mechanical
ventilation, which delivers oxygen and a continuous level of pressure to the damaged lungs.
The ARDS Network (ARDSNet) is a group of hospitals and medical centers that conduct research
to improve treatment options for people with ARDS and ALI. This study will enroll people who
participated in the ARDSNet's ALTA, OMEGA, EDEN, or SAILS study; these studies are
investigating new treatments to improve survival and reduce the amount of time people remain
on mechanical ventilation in the ICU after ALI. It is not known whether the ARDSNet's
treatments have any prolonged benefit for patients after they leave the hospital. The
purpose of this study is to evaluate participants' quality of life and long-term health
outcomes after they receive the ALTA, OMEGA, EDEN, or SAILS study treatments.

This study will enroll participants who were in the ALTA, OMEGA, EDEN, or SAILS study. ARDS
Network trial participants from sites that approved this follow-up study will be contacted
by phone at 6 and 12 months to complete a collection of surveys. These surveys assess
quality of life, mental health, memory and cognition, physical functioning, fatigue,
employment and health insurance status, and health care utilization. At the end of each
follow-up, participants will be asked for feedback regarding their experience during the
follow-up.

For participants from a sub-set of ARDS Network study sites participating in this study,
researchers will review participants' medical records and information collected during the
ARDSNet studies. Six and 12 months after ALI, participants will attend study visits at which
time walking ability, lung function, and muscle strength will be measured. Weight, dietary
changes, and changes in muscle and fat composition will also be assessed. Participants will
take part in interviews to evaluate memory and cognition. If participants cannot attend the
study visits, research staff will either visit participants' homes to complete the
evaluations or conduct some of the evaluations over the phone.

Inclusion Criteria:

- Participated in the ALTA, EDEN, OMEGA, or SAILS study

- Survived until hospital discharge

Exclusion Criteria:

- Does not understand or speak English

- Has no fixed address

- Pre-existing cognitive impairment that prevents completion of the study assessments