Advancing Rehabilitation Paradigms for Older Adults in Skilled Nursing Facilities: An Effectiveness-Implementation Hybrid Type 1 Clinical Trial Protocol

Abstract

Objective Skilled nursing facility rehabilitation is commonly required to address hospital-associated deconditioning among older adults with medical complexity. In skilled nursing facilities, standard-of-care rehabilitation focuses on low-intensity interventions, which are not designed to sufficiently challenge skeletal muscle and impart functional improvements. In contrast, a high-intensity resistance training approach (IntenSive Therapeutic Rehabilitation for Older NursinG homE Residents; i-STRONGER) in a single-site pilot study resulted in better physical function among patients in skilled nursing facilities. To extend this work, an effectiveness-implementation hybrid type 1 design, cluster-randomized trial will be conducted to compare patient outcomes between 16 skilled nursing facilities utilizing i-STRONGER principles and 16 Usual Care sites. Methods Clinicians at i-STRONGER sites will be trained to deliver i-STRONGER as standard-of-care using an implementation package including a clinician training program. Clinicians at Usual Care sites will continue to provide usual care. Post-training, changes in physical performance (e.g., gait speed, Short Physical Performance Battery scores) from patients’ admission to discharge will be collected over a period of 12 months. The RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework will be used to evaluate i-STRONGER effectiveness and factors underlying successful i-STRONGER implementation. Effectiveness will be evaluated by comparing change in physical function between study arms. Reach (proportion of patients treated with i-STRONGER), adoption (proportion of clinicians utilizing i-STRONGER), implementation (i-STRONGER fidelity), and maintenance (i-STRONGER sustainment) will be concurrently quantified and informed by clinician surveys and focus groups. Impact This effectiveness-implementation hybrid type 1, cluster-randomized trial has the potential to shift rehabilitation care paradigms in a nationwide network of skilled nursing facilities, resulting in improved patient outcomes and functional independence. Further, evaluation of the facilitators of, and the barriers to, implementation of i-STRONGER in real-world, clinical settings will critically inform future work evaluating and implementing best rehabilitation practices in skilled nursing facilities.