A Pilot Study of Rehabilitation Among Intensive Care Unit (ICU) Survivors: the RETURN Trial
Condition: Brain Injury; Muscle Weakness
MeSH terms: Muscle Weakness; Brain Injuries
Study type: Interventional

Summary: 
      Intensive care unit (ICU) hospitalization saves lives but often does so at a high personal
      cost to ICU survivors who frequently experience significant cognitive impairment and an array
      of physical and functional disabilities that limit their recovery and quality of life. While
      the problems experienced by these patients are likely amenable to rehabilitation, few ICU
      survivors receive focused rehabilitation following hospital discharge. The purpose of this
      study is to initiate and test the feasibility of a complex intervention incorporating a
      cognitive, physical, and functional rehabilitation program at the time of hospital discharge
      and implement this 12 week program using in-home visits and tele-technology. We hypothesize
      that this interdisciplinary rehabilitation program, initiated at hospital discharge and
      implemented using in-home visits and tele-technology, will result in improved recovery of
      neuropsychological and physical performance and overall functional status.
    

Detailed description: 
      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.
    

Intervention name(s): Cognitive, physical, and functional rehabilitation
Intervention type(s): Behavioral
Intervention description(s): A multicomponent program of cognitive, physical, and functional rehabilitation interventions will be delivered to patients in their home environments over a focused 12 week period with the aid of tele-technology to utilize the expertise of physical therapy, occupational therapy, and neuropsychology.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This was a single-site, feasibility, pilot, randomized trial of 21 general medical/surgical intensive care unit survivors (8 controls and 13 intervention patients) with either cognitive or functional impairment at hospital discharge. After discharge, study controls received usual care (sporadic rehabilitation), whereas intervention patients received a combination of in-home cognitive, physical, and functional rehabilitation over a 3-month period via a social worker or master's level psychology technician utilizing telemedicine to allow specialized multidisciplinary treatment. Interventions over 12 wks included six in-person visits for cognitive rehabilitation and six televisits for physical/functional rehabilitation.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: brain injuries, dementia, myopathies, muscle disorders