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

NCT ID: NCT04300413

Last Updated: 2022-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-16

Study Completion Date

2022-02-09

Brief Summary

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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.

Detailed Description

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Conditions

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Physical Disability

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

High-Intensity Rehabilitation plus Mobility (HeRo)

Intervention Type OTHER

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

Interventions

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High-Intensity Rehabilitation plus Mobility (HeRo)

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jennifer Stevens-Lapsley, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado School of Medicine

Locations

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Veterans Community Living Center at Fitzsimmons

Aurora, Colorado, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 23850612 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30056009 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20440029 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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19-2490

Identifier Type: -

Identifier Source: org_study_id

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