Advancing Rehabilitation Paradigms for Older Adults in Skilled Nursing Facilities

Aging Clinical Trial

Official title:

Advancing Rehabilitation Paradigms for Older Adults in Skilled Nursing Facilities

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05492240
• Other study ID #: 20-3068
• Secondary ID: R01AG072693
• Status: Recruiting
• Phase: N/A
• Start date: July 24, 2022
• Est. completion date: March 31, 2026

Study information

• Verified date: May 2024
• Source: University of Colorado, Denver
• Contact: Maggie Givan, MA
• Phone: 719.251.7533
• Email: maggie.givan[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2880
• Est. completion date: March 31, 2026
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Aging
• Deconditioning
• Functional Recovery

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Colorado Denver, Anschutz Medical Campus	Aurora	Colorado
United States	Aegis Therapies	Frisco	Texas

Sponsors (3)

Lead Sponsor	Collaborator
University of Colorado, Denver	Aegis Therapies, Inc., National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Total Score Modified Barthel ADL Index (MBI)	The Modified Barthel ADL Index assesses the ability to perform basic Activities of Daily Living (ADL) tasks. Total score range is 0-100. Total score is commuted by summing dependence across 10 ADL tasks: chair/bed transfers, ambulation, stair climbing, toilet transfers, bowel control, bladder control, bathing, dressing, personal hygiene (grooming), and feeding. Higher scores indicate increased independence.	From date of admission into the SNF to date of discharge from the SNF, which would be an approximate average of 21 days
Other	RE-AIM Component: Reach	Proportion of patients treated with high-intensity rehabilitation out of all eligible patients.	Up to 16 months
Other	RE-AIM Component: Adoption	Proportion of clinicians using high-intensity rehabilitation with at least 75% of eligible patients out of all trained clinicians at Intervention sites.	Up to 16 months
Other	RE-AIM Component: Implementation	Proportion of completed high-intensity rehabilitation elements out of all intervention elements assessed by a fidelity checklist.	Up to 16 months
Other	RE-AIM Component: Maintenance	Proportion of facilities that sufficiently completed high-intensity elements out of all intervention elements assessed by a fidelity checklist.	Assessed from 16 months up to 22 months
Primary	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	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
Secondary	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