Advancing Rehabilitation Paradigms for Older Adults in Skilled Nursing Facilities

Sponsor

University of Colorado, Denver (Other)

Overall Status

Recruiting

CT.gov ID

NCT05492240

Collaborator

Aegis Therapies, Inc. (Other), National Institute on Aging (NIA) (NIH)

2,880

Enrollment

Locations

Arms

31.2

Anticipated Duration (Months)

1440

Patients Per Site

46.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Aging Functional Recovery Skilled Nursing Facility Medically Complex Deconditioning	Other: i-STRONGER Other: Usual Care	N/A

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

Anticipated Enrollment :

2880 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.

Primary Purpose:

Treatment

Official Title:

Advancing Rehabilitation Paradigms for Older Adults in Skilled Nursing Facilities

Actual Study Start Date :

Jul 24, 2022

Anticipated Primary Completion Date :

Feb 28, 2025

Anticipated Study Completion Date :

Feb 28, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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.
Active Comparator: 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.	Other: 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.

Arm

Intervention/Treatment

Experimental: 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.

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.

Active Comparator: 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.

Other: 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.

Outcome Measures

Primary Outcome Measures

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

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.

Other Outcome Measures

Change in Total Score Modified Barthel ADL Index (MBI) [From date of admission into the SNF to date of discharge from the SNF, which would be an approximate average of 21 days]
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.
RE-AIM Component: Reach [Up to 16 months]
Proportion of patients treated with high-intensity rehabilitation out of all eligible patients.
RE-AIM Component: Adoption [Up to 16 months]
Proportion of clinicians using high-intensity rehabilitation with at least 75% of eligible patients out of all trained clinicians at Intervention sites.
RE-AIM Component: Implementation [Up to 16 months]
Proportion of completed high-intensity rehabilitation elements out of all intervention elements assessed by a fidelity checklist.
RE-AIM Component: Maintenance [Assessed from 16 months up to 22 months]
Proportion of facilities that sufficiently completed high-intensity elements out of all intervention elements assessed by a fidelity checklist.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 120 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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