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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05492240
Study type Interventional
Source University of Colorado, Denver
Contact Maggie Givan, MA
Phone 719.251.7533
Email maggie.givan@cuanschutz.edu
Status Recruiting
Phase N/A
Start date July 24, 2022
Completion date March 31, 2026

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