A Pilot Study of Rehabilitation Among Intensive Care Unit (ICU) Survivors: the RETURN Trial

The long-term consequences of critical illness and intensive care unit (ICU) hospitalization
in ICU survivors are profound and include cognitive, physical, and functional impairments.
The purpose of this study is to pilot test a 12-week, home-based rehabilitation program
targeting both cognitive functioning and physical functioning, to determine the feasibility
of such a rehabilitation program, and to determine whether participation in a rehabilitation
program will result in improved outcomes among ICU survivors. The study will rely on a
randomized controlled clinical trial design, with patients assigned to either a "usual care"
control group vs. the treatment group. Individuals in the treatment group will receive a
protocolized cognitive rehabilitation intervention, as well as individualized physical and
functional rehabilitation targeted at abilities such as strength, endurance, balance, and
functionality in basic tasks of daily living. Cognitive, physical, and functional
rehabilitation interventions will be delivered in patient homes and will take place on
alternating weeks over a 12 week period. Televideo technology will be employed in the context
of these interventions, with experts from Vanderbilt University and Duke University medical
centers providing assistance via a video monitor in conjunction with a rehabilitation
specialist who will implement interventions in patient homes. The study has 3 primary
outcomes including: (1). Executive functioning (e.g. ability to plan, organize, multi-task)
over time as measured by the Tower Test, a psychometric tool evaluating executive abilities;
(2) Physical Impairment, as measured by the Timed Up and Go (TUG) test; (3) Physical
Functioning, as measured by the Step Activity Monitor (SAM). These three primary outcomes
have been selected as areas of primary focus due to the fact that available research points
to the presence of significant deficits in these areas among ICU survivors. Secondary
outcomes include activities of daily living (Katz ADL) and instrumental activities of daily
living (Pfeffers FAQ), activity specific balance and confidence(ABC Scale), health related
quality of life (SF-36), 12-month mortality, and both rehospitalization rates and number of
rehospitalization days. We will measure change in the outcome measures of interest at 3 and
12-month follow up to determine short term efficacy, along with evaluating overall
feasibility. The study duration will include 1 year of protocol development for the complex
intervention and 1.5 to 2 years of enrollment.

Inclusion Criteria:

- Enrollment in the BRAIN-ICU study (AG027472-01A1), the presence of cognitive
impairment defined via an abnormal Tower Test score (at the time of hospital
discharge) and/or physical impairment defined per standard cutpoints for the Timed Up
and Go Test (at the time of hospital discharge);

- The ability to walk with or without assistance.

Exclusion Criteria:

- Moderate to severe dementia on ICU admission based on a standardized surrogate
assessment (as this would prohibit patients from functioning independently at home);

- The presence of normal cognition and normal physical function at the time of screening
(i.e. hospital discharge) which would eliminate the need for rehabilitation;

- Lacking telephone service with an analog telephone line (which would preclude the
tele-video component of the RETURN intervention).

- Live greater than 125 miles from Nashville

- Patient is unable to provide informed consent.