Advancing Rehabilitation Paradigms for Older Adults in Skilled Nursing Facilities

Not Applicable

Recruiting

• Conditions: Functional Recovery; Skilled Nursing Facility; Aging; Medically Complex; Deconditioning
• Interventions: Other: Usual Care; Other: i-STRONGER

• Registration Number: NCT05492240
• Lead Sponsor: University of Colorado, Denver

Brief 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.

Study Timeline

• Study First Submitted: 2022-07-19
• Study Start: 2022-07-24
• Study First Submitted QC: 2022-08-04
• Study First Posted: 2022-08-08
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-20
• Last Update Posted: 2024-05-21
• Primary Completion: 2025-09-30
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2880

Inclusion Criteria

• Aegis Therapies-contracted skilled nursing facility (SNF)
• Admits approximately 15 patients per month for short term rehabilitation

Patient Inclusion Criteria:

• At least 50 years of age
• Admitted to a SNF from the hospital
• Ambulatory upon SNF admission

Patient

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Exclusion Criteria

• Contraindications to high-intensity resistance training, per American College of Sports Medicine Exercise Testing and Prescription
• Lower extremity weight-bearing precautions
• Neurological diagnosis (e.g., Cerebral vascular accident, Multiple Sclerosis, Parkinson's disease)
• Subsequent SNF admission

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care	Usual Care	The Usual Care SNFs will continue clinical practice as normal, and sites will not have any overlap of personnel or training with i-STRONGER SNFs.
i-STRONGER	i-STRONGER	The high-intensity rehabilitation intervention, termed i-STRONGER, relies on principles of physiologic overload using an 8-repetition max (8RM) to promote muscle strengthening and emphasizes functional carryover for independence.

Primary Outcome Measures

Name	Time	Method
Change in Gait Speed	From date of admission into the SNF to date of discharge from the SNF, which would be an approximate average of 21 days	Gait speed will be measured in meters/second using the time it takes to walk a 4-meter path at usual speed using a stopwatch.

Secondary Outcome Measures

Name	Time	Method
Change in Short Physical Performance Battery (SPPB)	From date of admission into the SNF to date of discharge from the SNF, which would be an approximate average of 21 days	The SPPB is comprised of 3 tasks: a hierarchical standing balance test (side-by-side, semi-tandem, and tandem), a 4-meter usual gait speed, and a 5-time sit-to-stand from a standardized chair. Each subtask is scored (based on time) from 0-4 points and then summarized into a total score of 0-12 points, where 12 points represents the highest performance.
Post-discharge Rehospitalization Rate	From date of discharge from the SNF, assessed up to 30 days	The proportion of patients eligible for high-intensity rehabilitation who return to the hospital within 30 days of discharge from the SNF.

Trial Locations

Locations (2)

University of Colorado Denver, Anschutz Medical Campus; 🇺🇸 Aurora, Colorado, United States

Aegis Therapies; 🇺🇸 Frisco, Texas, United States