Advancing Rehabilitation Paradigms for Older Adults in Skilled Nursing Facilities

Study Overview
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Brief Summary
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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
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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.

Official Title
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Advancing Rehabilitation Paradigms for Older Adults in Skilled Nursing Facilities

Conditions
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Aging, Functional Recovery, Skilled Nursing Facility, Medically Complex, Deconditioning

Intervention / Treatment
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* Other: i-STRONGER
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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Rehabilitation staff at enrolled sites will participate in research activities, as indicated by group assignment. Site 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 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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: i-STRONGER<br>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. | Other: i-STRONGER<br>* 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.<br>|
| Active Comparator: Usual Care<br>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. | Other: Usual Care<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Gait Speed | 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. | From date of admission into the SNF to date of discharge from the SNF, which would be an approximate average of 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Short Physical Performance Battery (SPPB) | 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. | From date of admission into the SNF to date of discharge from the SNF, which would be an approximate average of 21 days | 
| Post-discharge Rehospitalization Rate | The proportion of patients eligible for high-intensity rehabilitation who return to the hospital within 30 days of discharge from the SNF. | From date of discharge from the SNF, assessed up to 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rehabilitation, Older Adults, Physical Therapy, Occupational Therapy, RE-AIM, i-STRONGER, High-intensity Rehabilitation, Implementation Science, Post-Acute Care, Physical Function