Clinical trial NCT04300413: Patient-Centered, Interprofessional Approach to Improve Functional Outcomes in a Skilled Nursing Facility
Official title: Patient-Centered, Interprofessional Approach to Improve Functional Outcomes in a Skilled Nursing Facility
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Disability
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2020-03-09
Enrollment: 21
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Gait Speed
timeFrame: 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 outcomes:
measure: Short Physical Performance Battery (SPPB)
timeFrame: Change from date of admission into the SNF to date of discharge from the SNF, which would be an approximate average of 21 days
Other outcomes:
measure: Patient Satisfaction Survey
timeFrame: At date of discharge after their stay in the Skilled Nursing Facility, (approximately 21 days after admission).
measure: Physical Activity (upright time)
timeFrame: Measured during the last 5 days before discharge date from Skilled Nursing Facility (approximate average length of stay 21 days).
measure: Physical Activity (sedentary time)
timeFrame: Measured during the last 5 days before discharge date from Skilled Nursing Facility (approximate average length of stay 21 days).
measure: Treatment fidelity
timeFrame: 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.
Locations:
city: Aurora
country: United States
facility: Veterans Community Living Center at Fitzsimmons
state: Colorado
Study officials:
affiliation: University of Colorado School of Medicine
name: Jennifer Stevens-Lapsley, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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. doi: 10.1123/japa.18.2.171.