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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04300413
Enrollment
21
Registered
2020-03-09
Start date
2020-02-16
Completion date
2022-02-09
Last updated
2022-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Physical Disability

Brief summary

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.

Interventions

OTHERHigh-Intensity Rehabilitation plus Mobility (HeRo)

Progressive, high-intensity strengthening and functional intervention coupled with structured mobility based in principals of behavioral economics.

Sponsors

University of Colorado, Denver
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

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

1. Patients with neurological disorders such as acute stroke or acute traumatic brain injury 2. Patients on hospice care 3. Patient with conditions where strength training is contraindicated (as indicated by the American College of Sports Medicine Guidelines for Exercise Testing and Prescription): 1. Recent unstable fracture 2. Advanced congestive heart failure 3. Bone metastasis sites 4. Tumors in strengthening target areas 5. Acute Illness 6. Recent myocardial infarction (within 3-6 weeks) 7. Weight bearing restrictions on graft or fracture sites 8. Exposed tendon or muscle 9. Absence of pedal pulses 10. Presence of fistula 11. Platelet levels \<50,000/μL 4. Weight-bearing precautions and inability to ambulate prior to hospitalization

Design outcomes

Primary

MeasureTime frameDescription
Gait SpeedChange from date of admission into the SNF to date of discharge from the SNF, which would be an approximate average of 21 daysTime it takes to walk 4 meters (meters per second)

Secondary

MeasureTime frameDescription
Short Physical Performance Battery (SPPB)Change from date of admission into the SNF to date of discharge from the SNF, which would be an approximate average of 21 daysGlobal measure of lower extremity function, which consists of walking speed, chair stands, and balance tests

Other

MeasureTime frameDescription
Patient Satisfaction SurveyAt date of discharge after their stay in the Skilled Nursing Facility, (approximately 21 days after admission).8 question survey on patient satisfaction, scoring each question on a 1-10 scale (1=not at all and 10=extremely)
Physical Activity (upright time)Measured during the last 5 days before discharge date from Skilled Nursing Facility (approximate average length of stay 21 days).Percent waking hours spent upright measured using ActivPAL devices
Physical Activity (sedentary time)Measured during the last 5 days before discharge date from Skilled Nursing Facility (approximate average length of stay 21 days).Time spent in sedentary bouts measured using ActivPAL devices
Treatment fidelityAt least 2 observations per provider per year throughout duration of study (approximately 2 years), 2 additional observations scheduled if compliance is <80% on objective fidelity checklist.Provider intervention compliance with high-intensity rehabilitation (PT and OT) and mobility (nursing staff) using a fidelity checklist

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026