Patient-Centered, Interprofessional Approach to Improve Functional Outcomes in a Skilled Nursing Facility
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04300413|
Recruitment Status : Recruiting
First Posted : March 9, 2020
Last Update Posted : March 16, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Physical Disability||Other: High-Intensity Rehabilitation plus Mobility (HeRo)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||53 participants|
|Intervention Model:||Single Group Assignment|
|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.|
|Masking:||None (Open Label)|
|Official Title:||Patient-Centered, Interprofessional Approach to Improve Functional Outcomes in a Skilled Nursing Facility|
|Actual Study Start Date :||February 16, 2020|
|Estimated Primary Completion Date :||February 2022|
|Estimated Study Completion Date :||February 2022|
Experimental: High-Intensity Rehabilitation plus Mobility (HeRo)
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)
Progressive, high-intensity strengthening and functional intervention coupled with structured mobility based in principals of behavioral economics.
- Gait Speed [ Time Frame: Change from date of admission into the SNF to date of discharge from the SNF, which would be an approximate average of 21 days ]Time it takes to walk 4 meters (meters per second)
- Short Physical Performance Battery (SPPB) [ Time Frame: Change from date of admission into the SNF to date of discharge from the SNF, which would be an approximate average of 21 days ]Global measure of lower extremity function, which consists of walking speed, chair stands, and balance tests
- Patient Satisfaction Survey [ Time Frame: At 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) [ Time Frame: 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) [ Time Frame: 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 fidelity [ Time Frame: At 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04300413
|Contact: Julie Stutzbach, DPTfirstname.lastname@example.org|
|United States, Colorado|
|Veterans Community Living Center at Fitzsimmons||Recruiting|
|Aurora, Colorado, United States, 80045|
|Principal Investigator:||Jennifer Stevens-Lapsley, PT, PhD||University of Colorado School of Medicine|