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

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.

Study Overview

• Status: Completed
• Conditions: Physical Disability
• Intervention / Treatment: Other: High-Intensity Rehabilitation plus Mobility (HeRo)

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Veterans Community Living Center at Fitzsimmons

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).
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).
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).
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.

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Jennifer Stevens-Lapsley, PT, PhD, University of Colorado School of Medicine

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 16, 2020
• Primary Completion (ACTUAL): February 9, 2022
• Study Completion (ACTUAL): February 9, 2022

Study Registration Dates

• First Submitted: February 24, 2020
• First Submitted That Met QC Criteria: March 5, 2020
• First Posted (ACTUAL): March 9, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 13, 2022
• Last Update Submitted That Met QC Criteria: July 11, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 19-2490

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No