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

Physical Disability Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04300413
• Other study ID #: 19-2490
• Status: Completed
• Phase: N/A
• Start date: February 16, 2020
• Est. completion date: February 9, 2022

Study information

• Verified date: July 2022
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: February 9, 2022
• Est. primary completion date: February 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Physical Disability

Intervention

Other:
• High-Intensity Rehabilitation plus Mobility (HeRo)
Progressive, high-intensity strengthening and functional intervention coupled with structured mobility based in principals of behavioral economics.

Locations

Country	Name	City	State
United States	Veterans Community Living Center at Fitzsimmons	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

References & Publications (3)

Grant PM, Granat MH, Thow MK, Maclaren WM. Analyzing free-living physical activity of older adults in different environments using body-worn activity monitors. J Aging Phys Act. 2010 Apr;18(2):171-84. — View Citation

Mallinson T, Deutsch A, Bateman J, Tseng HY, Manheim L, Almagor O, Heinemann AW. Comparison of discharge functional status after rehabilitation in skilled nursing, home health, and medical rehabilitation settings for patients after hip fracture repair. Arch Phys Med Rehabil. 2014 Feb;95(2):209-17. doi: 10.1016/j.apmr.2013.05.031. Epub 2013 Jul 10. — View Citation

Simning A, Caprio TV, Seplaki CL, Temkin-Greener H, Szanton SL, Conwell Y. Patient-Reported Outcomes in Functioning Following Nursing Home or Inpatient Rehabilitation. J Am Med Dir Assoc. 2018 Oct;19(10):864-870. doi: 10.1016/j.jamda.2018.06.014. Epub 2018 Jul 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient Satisfaction Survey	8 question survey on patient satisfaction, scoring each question on a 1-10 scale (1=not at all and 10=extremely)	At date of discharge after their stay in the Skilled Nursing Facility, (approximately 21 days after admission).
Other	Physical Activity (upright time)	Percent waking hours spent upright measured using ActivPAL devices	Measured during the last 5 days before discharge date from Skilled Nursing Facility (approximate average length of stay 21 days).
Other	Physical Activity (sedentary time)	Time spent in sedentary bouts measured using ActivPAL devices	Measured during the last 5 days before discharge date from Skilled Nursing Facility (approximate average length of stay 21 days).
Other	Treatment fidelity	Provider intervention compliance with high-intensity rehabilitation (PT and OT) and mobility (nursing staff) using a fidelity checklist	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.
Primary	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	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