Progressive Multicomponent Intervention for Older Adults in Home Health Settings Following Acute Hospitalization: Randomized Clinical Trial Protocol

Abstract

Background: Hospitalization is a profound contributor to functional loss for older adults. Many modifiable risk factors (ie, weakness) may persist after hospitalization, representing portents of poor health, re-hospitalization, or death. Older adults frequently receive home health (HH) care after hospitalization to manage functional deficits that have worsened during hospital stays. However, how best to manage these deficits in HH settings has yet to be determined.

Objective: The objective is to determine if a higher intensity, progressive, multi-component (PMC) intervention, initiated upon admission to HH after an acute hospitalization, improves objectively measured and self-reported physical function more than usual care (UC) physical therapy.

Design: This will be a 2-arm randomized controlled clinical trial.

Setting: The setting will be participant homes.

Participants: A total of 200 older adults with deconditioning following acute hospitalization and referred for HH physical therapy will participate.

Intervention: Participants will be randomized to either a PMC treatment group or a UC group and receive 12 therapy visits over a 60-day period. PMC participants will perform lower extremity resistance training at 80% of a 1-repetition maximum, task-specific activities of daily living training, along with advanced gait and balance training. PMC groups will also receive nutritional supplementation and nursing support during transition from hospital to home. The UC group will receive standard of care HH interventions.

Measurements: Physical performance, self-reported function, fatigue, and health care utilization outcomes will be measured at baseline, 30 days, 60 days, 90 days, and 180 days. All measures will be assessed by blinded study personnel.

Limitations: The limitation is an inability to blind treating therapists to study allocation.

Conclusions: The authors hope to determine whether higher intensity, multi-component exercise interventions improve outcomes more than UC physical therapy for older adults recovering from acute hospitalization in HH settings.

Trial registration: ClinicalTrials.gov NCT02905370.

Published by Oxford University Press on behalf of the American Physical Therapy Association 2019.

Figures

Figure 1.

The proposed CONSORT diagram of recruitment, consent, and movement through the study for each arm.

Figure 2.

Progression of sit-to-stand activity of daily living intervention within the progressive, multi-component training protocol. Participant is reassessed each visit using this algorithm to determine appropriate exercise dosage for treatment session.

Figure 3.

Responsibilities of the care transition nurse are outlined in the figure. Core responsibilities are listed in bold text within the boxes, and sample behaviors are listed below.