Patient-Centered, Interprofessional Approach to Improve Functional Outcomes in a Skilled Nursing Facility

Study Overview
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Brief Summary
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During a hospital stay, older adults often become physically deconditioned and lose their ability to perform activities of daily living. Afterwards, they commonly require rehabilitation in a skilled nursing facility to regain independence. Even at discharge, however, many older adults are still far below their pre-hospitalization level of function making them at risk for adverse events such as falls, rehospitalizations, and loss of independence. Two reasons for inadequate outcomes may include that 1) physical and occupational therapy interventions are delivered at too low an intensity to incur substantial physiological gains, and 2) residents are largely sedentary outside of structured therapy time. These two problems represent critical targets for interventions that optimize care in skilled nursing facilities. Therefore, the investigators designed High-Intensity Rehabilitation + Mobility (HeRo), a patient-centered approach to skilled nursing facility care that incorporates a combination of high-intensity (i.e. high resistance, low repetition) functionally-based resistance training along with a structured mobility program outside of therapy time. HeRo includes: 1) a team approach to patient-centered care; 2) a physical activity intervention that incorporates principals of behavioral economics, which uses incentives, goal setting, and gamification to optimize patient engagement and health outcomes and 3) a challenging, high-intensity rehabilitation intervention that pushes patients to expand their limits. The investigators expect that HeRo will improve physical function and physical activity while reducing sedentary time for older adults in the skilled nursing facility. The study team will assess the feasibility and acceptability of HeRo for multiple stakeholders including patients, physical and occupational therapists, nursing staff, and administration. This research will improve patient care in the skilled nursing facility environment, getting older adults on a fast track to developing independence after a hospital stay.

Official Title
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Patient-Centered, Interprofessional Approach to Improve Functional Outcomes in a Skilled Nursing Facility

Conditions
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Physical Disability

Intervention / Treatment
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* Other: High-Intensity Rehabilitation plus Mobility (HeRo)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults over 50 who are admitted to a skilled nursing facility following hospitalization Qualify to receive at least physical therapy services Ambulatory prior to hospitalization Exclusion Criteria: Patients with neurological disorders such as acute stroke or acute traumatic brain injury Patients on hospice care Patient with conditions where strength training is contraindicated (as indicated by the American College of Sports Medicine Guidelines for Exercise Testing and Prescription): Recent unstable fracture Advanced congestive heart failure Bone metastasis sites Tumors in strengthening target areas Acute Illness Recent myocardial infarction (within 3-6 weeks) Weight bearing restrictions on graft or fracture sites Exposed tendon or muscle Absence of pedal pulses Presence of fistula Platelet levels <50,000/μL Weight-bearing precautions and inability to ambulate prior to hospitalization

Ages Eligible for Study
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Minimum Age: 50 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
Intervention Model: Single Group Assignment
Interventional Model Description: This is a single arm study but will use two historical cohorts as comparison groups to assess outcomes: 1) usual care and 2) high-intensity, functionally based resistance training alone. The historical cohorts were included in a previous study (Clinical Trials Registry identifier: E2193-P). This design will include independent cohorts of patients within a single SNF, using the facility as its own control. This design optimally controls for facility-level variables that vary widely between SNFs and may influence care delivery, such as staffing levels, staff experience, and productivity standards.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High-Intensity Rehabilitation plus Mobility (HeRo)<br>The HeRo group will receive a behavior-change intervention based in the principals of behavioral economics to improve mobility. Physical and occupational therapists have been trained to deliver a high-intensity, functional intervention as the standard of care in this skilled nursing facility. | Other: High-Intensity Rehabilitation plus Mobility (HeRo)<br>* Progressive, high-intensity strengthening and functional intervention coupled with structured mobility based in principals of behavioral economics.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gait Speed | Time it takes to walk 4 meters (meters per second) | Change 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 |
| --- | --- | --- |
| Short Physical Performance Battery (SPPB) | Global measure of lower extremity function, which consists of walking speed, chair stands, and balance tests | Change from date of admission into the SNF to date of discharge from the SNF, which would be an approximate average of 21 days |