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 a standard of care using an implementation package that includes a clinician training program. Clinicians at Usual Care sites will continue to provide usual care. Posttraining, changes in physical performance (eg, gait speed, Short Physical Performance Battery scores) from patients' admission to discharge will be collected over a period of 12 months. The 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 changes 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. Furthermore, evaluation of the facilitators of, and 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.