Progressing Home Health Rehabilitation for Older Adults
Condition: Older Adults; Physical Deconditioning
Study type: Interventional

Summary: 
      This research study explores the effects of a progressive, multi-component intervention
      following a stay in the hospital or rehabilitation facility. The purpose of this research
      study is to compare a multi-component intervention (higher intensity exercise, nutritional
      supplementation, and greater emphasis on functionally enhanced care transitions) with usual
      care physical therapy.
    

Detailed description: 
      Declines in physical function as a result of acute illness are strongly and independently
      associated with a number of adverse health events for older adults. Home Health (HH) physical
      therapy may be the ideal venue for addressing these declines in physical function because
      around 3 million older adults receive HH services following discharge from acute or
      post-acute facilities. However, as currently structured, HH care does not appear to
      adequately restore function, as evidenced by poor long-term outcomes and high rates of
      hospital readmission. Diminished physical function has been particularly implicated as a risk
      factor for re-hospitalization --older adults with lower levels of ambulatory activity are 6
      times more likely to be re-hospitalized than those with greater ambulatory activity. A more
      intensive approach to HH physical therapy for older adults has great potential to maximize
      physical function and reduce hospital readmissions. Therefore, the investigators have
      developed a high intensity home-based, progressive, interdisciplinary, multi-component (PMC)
      intervention that directly addresses the functional deficits seen after hospitalization. This
      intervention will include intensive rehabilitation, a care transitions program, and daily
      protein supplementation. The investigators will conduct a two-arm, randomized clinical trial
      (RCT) of 200 participants admitted to HH from an acute or post-acute facility. Participants
      will receive either 1) an intensive, PMC intervention using resistance exercise and
      evidenced-based motor control training to improve physical function, along with nutritional
      supplementation and emphasis on functionally enhanced care transitions or 2) usual care (UC)
      physical therapy. The primary goal of this investigation is to determine if PMC intervention,
      initiated upon admission to HH, improves physical function, as measured by performance and
      self-report assessments, more than UC physical therapy. The investigators will also examine
      the effects on fatigue, balance confidence, and activities of daily living. In an exploratory
      analysis, the effects of the PMC intervention on re-hospitalization rates, nursing home
      placement, emergency room visits, and falls after discharge from the acute care hospital will
      also be examined. All outcomes will be examined at baseline, 30, 60 (primary endpoint), 90
      and 180 days. If successful in improving patient function and decreasing re-hospitalization
      rates, PMC intervention holds potential for future health care cost savings.
    

Intervention name(s): Progressive Multi-Component (PMC); Enhanced Usual Care (EUC)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants in the "Progressive Multi-component" intervention group will receive 1) high intensity physical therapy, 2) protein supplement, and 3) emphasis on functionally enhanced transitions of care following discharge from post-acute setting. High intensity physical therapy will include progressive resistance training, multi-planar motor control and gait exercises, and high intensity activities of daily living training. Functionally enhanced transitions of care protocol includes a personal health record with 5 domains that are addressed in an interdisciplinary manner with the patient. Participants will receive 12 intervention visits over 60 days. Participants will also receive a home exercise program.; Participants in the "Enhanced Usual Care" group will receive standardized physical therapy following discharge from acute hospitalization. The activities of therapy will include basic strength training, single-planar motor control and gait exercises, and activities of daily living training. Participants will receive 12 intervention visits over 60 days. Participants will also receive a standardized home exercise program and standard nutritional education.
Name of Participant Arm updated to "Enhanced Usual Care" from "Usual Care" effective 8/16/18 to distinguish from Passive Comparator "True Usual Care" group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Home Health; Rehabilitation; High Intensity; Hospital Associated Deconditioning; Functional Mobility; Physical Function