Advancing Rehabilitation Paradigms for Older Adults in Skilled Nursing Facilities
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 4,383
- Locations
- 2
- Primary Endpoint
- Change in Gait Speed
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
Investigators will not be blinded to the arms due to facility/clinician training required for this study design. Study sites [i.e., skilled nursing facilities (SNFs)] will be the unit of randomization. SNF study sites will be made broadly aware of the study initiative during the site recruitment process; however, the site will not be provided with detailed information about the intervention unless randomized to the Intervention arm. As such, clinicians, or rehabilitation care providers, at usual care sites will remain blinded to the intervention for the duration of the study. Clinicians will collect patient-level functional outcomes as part of their standard of care and all patients who are subjects of the intervention will not be aware of the group allocation in the study.
Eligibility Criteria
- Ages
- 50 Years to 120 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion 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
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
Arms & Interventions
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.
Intervention: i-STRONGER (Other)
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.
Intervention: Usual Care (Other)
Outcomes
Primary Outcomes
Change in Gait Speed
Time Frame: 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 Outcomes
- 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)
- Post-discharge Rehospitalization Rate(From date of discharge from the SNF, assessed up to 30 days)