Clinical trial NCT05492240: Advancing Rehabilitation Paradigms for Older Adults in Skilled Nursing Facilities
Official title: Advancing Rehabilitation Paradigms for Older Adults in Skilled Nursing Facilities
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aging
Functional Recovery
Skilled Nursing Facility
Medically Complex
Deconditioning
Keywords: Rehabilitation
Older Adults
Physical Therapy
Occupational Therapy
RE-AIM
i-STRONGER
High-intensity Rehabilitation
Implementation Science
Post-Acute Care
Physical Function
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Aegis Therapies, Inc.
name: National Institute on Aging (NIA)
First posted: 2022-08-08
Enrollment: 2880
Sex: ALL
Minimum age (years): 50
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Gait Speed
timeFrame: From date of admission into the SNF to date of discharge from the SNF, which would be an approximate average of 21 days
Secondary outcomes:
measure: Change in Short Physical Performance Battery (SPPB)
timeFrame: From date of admission into the SNF to date of discharge from the SNF, which would be an approximate average of 21 days
measure: Post-discharge Rehospitalization Rate
timeFrame: From date of discharge from the SNF, assessed up to 30 days
Other outcomes:
measure: Change in Total Score Modified Barthel ADL Index (MBI)
timeFrame: From date of admission into the SNF to date of discharge from the SNF, which would be an approximate average of 21 days
measure: RE-AIM Component: Reach
timeFrame: Up to 16 months
measure: RE-AIM Component: Adoption
timeFrame: Up to 16 months
measure: RE-AIM Component: Implementation
timeFrame: Up to 16 months
measure: RE-AIM Component: Maintenance
timeFrame: Assessed from 16 months up to 22 months
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver, Anschutz Medical Campus
state: Colorado
city: Frisco
country: United States
facility: Aegis Therapies
state: Texas
Study officials:
affiliation: University of Colorado, Denver
name: Jennifer Stevens-Lapsley, PhD
role: PRINCIPAL_INVESTIGATOR
References: