NCT05492240

Advancing Rehabilitation Paradigms for Older Adults in Skilled Nursing Facilities

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 4,383 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 50 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

This cluster randomized clinical trial seeks to provide large-scale, foundational evidence that high-intensity rehabilitation is effective and can be systematically implemented to improve functional outcomes for patients admitted to skilled nursing facilities following hospitalization. Additionally, this study will generate a descriptive overview of factors that predict implementation success while informing effective implementation strategies for future skilled nursing facilities innovation.

Detailed description

In the U.S., 8.37 million adults over 65 will experience a hospital stay over the next year, which often has serious and long-lasting consequences including profound deterioration in physical function. Following a hospital stay, around 1.35 million patients with deconditioning require rehabilitation in a skilled nursing facility (SNF) each year to address the deleterious musculoskeletal and functional deficits from deconditioning. More than 64% of patients discharge from SNFs at functional levels that predispose them to adverse events, including rehospitalization, failing health, disability, institutionalization, or death. Physical function is a known modifiable predictor of these deleterious events, which can be addressed with rehabilitation. Therefore, more progressive and targeted musculoskeletal rehabilitation strategies that optimize physical function more effectively are needed. Therefore, the purpose of this study is to determine the effectiveness of a high-intensity rehabilitation approach (also referred to as i-STRONGER) at multiple skilled nursing facilities (SNFs), while evaluating characteristics of successful implementation through a rigorous, pragmatic cluster randomized controlled trial (16 Intervention SNFs vs 16 Usual Care SNFs). The investigators will promote high-intensity rehabilitation delivery to patients in an effort to address poor physical function outcomes. Specifically, the investigators will train rehabilitation clinicians at Intervention sites using distance-based instruction and collect study outcomes via the electronic medical record. Additionally, the investigators will gather quantitative and qualitative data (mixed methods) to evaluate processes, clinician-specific characteristics, and facility-specific contexts of implementation. The study methods seek to maximize successful reach, effectiveness, adoption, implementation, and maintenance (RE-AIM) across Intervention sites. The implementation strategy is informed by the RE-AIM framework and integrated with educational and behavioral theories to facilitate clinical adoption of high-intensity rehabilitation.

Conditions

• Aging
• Functional Recovery
• Skilled Nursing Facility
• Medically Complex
• Deconditioning

Interventions

Type	Name	Description
OTHER	i-STRONGER	An 8RM is the dose necessary for most effective strength gains in community-dwelling older adults, and is equivalent to 80% of a one repetition max, which is the maximal load needed to voluntarily complete one repetition of a given exercise with proper form. Clinicians will tailor the intervention for each activity, so the patient achieves 8 repetitions with failure on the 9th repetition. Failure is the inability to complete a repetition through the full, available range of motion without significant compensation. Further, high-intensity dosing requires continuous, volitional effort from the patient; therefore, incorporation of motivational interviewing strategies across sessions will maximize patient effort and self-efficacy.
OTHER	Usual Care	Usual Care SNFs will continue with routine collection and documentation of physical performance outcomes (gait speed, SPPB, Modified Barthel ADL Index) as standard practice. Furthermore, a combination of chart reviews and on-site or remote observation will allow for characterization of usual care components for descriptive comparison. Importantly, the Usual Care SNF including the facility, rehabilitation clinicians, and patients will not have access to i-STRONGER materials.

Timeline

• Start date: 2022-07-24
• Primary completion: 2025-09-16
• Completion: 2025-09-16
• First posted: 2022-08-08
• Last updated: 2026-01-07

Locations

2 sites across 1 country: United States