Improving Function in Older Adults With Hospital-Associated Deconditioning: Lessons Learned Comparing a Randomized Controlled Trial to Real World Practice.

Objective: The optimal approach for improving physical function following acute hospitalization is unknown. A recent clinical trial of home health physical therapy compared a high-intensity, progressive, multi-component (PMC) intervention to enhanced usual care (EUC). While both groups improved in physical function, no between-group differences were observed. However, the EUC group received care that differed from real world practice due to standardized treatments and a higher frequency of visits. This study compared a non-randomized true usual care (TUC) group to the EUC and PMC groups.

Methods: Participants in the parent trial were randomly assigned to the EUC group (n = 100) and PMC group (n = 100) following hospital discharge. A subset of eligible patients (n = 55) were concurrently enrolled in the TUC group. Both the PMC and EUC groups received strength, activities of daily living, and gait training that differed in intensity but were matched in frequency and duration. TUC group care was determined by the home health agency. The primary outcome at 60-days was the Short Physical Performance Battery (SPPB).

Results: In comparison to the TUC group, the EUC and PMC groups had significantly greater improvements in SPPB score (EUC: +1.04 points [CI = 0.18-1.90]; PMC: +1.12 points [CI = 0.23-2.00]).

Conclusion: While participants in the EUC and PMC groups experienced greater functional recovery compared to those in the TUC group, it cannot be determined whether these differences are due to the interventions received or confounding factors associated with the addition of a third, non-randomized, study group during the trial period.

Impact: This study illustrates the importance of design and interpretation of control groups for clinical trials. Further, the differences between the TUC group and the enhanced intervention groups warrant future research exploring whether increasing visits and standardizing care improve function in older adults receiving home health physical therapy after hospital associated deconditioning.

Lay summary: Participants in the intervention groups received standardized and more therapy than usual care, and experienced greater functional improvements. However, these differences may be due to factors associated with the addition of a non-randomized group during an ongoing clinical trial.