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Improving Physical Function in Skilled Nursing Facility Residents (SNF)

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. Read our disclaimer for details. Identifier: NCT02421692
Recruitment Status : Terminated
First Posted : April 21, 2015
Last Update Posted : November 15, 2016
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:
Each year Medicare spends approximately $31.3 billion on 2.4 million skilled nursing facility (SNF) episodes of care. SNFs rely on interdisciplinary approaches to patient care to maximize rehabilitation potential for return to prior level of function and reduce the risk of adverse events in older adults. However despite a substantial increase in spending on SNF services and minimal change in complexity of the caseload, 68% of patients are below their pre-hospitalization level of function at discharge, 25% return to the community, and 18% are hospitalized. This may be partially explained by current SNF approaches to patient care which foster inactivity and participation in low intensity rehabilitation interventions (preliminary data). Both inactivity and low-intensity interventions may perpetuate further functional decline or impede maximal recovery. The serious implication of risk with functional decline is exemplified by studies which have shown declines in physical function can increase the risk of being re-hospitalized six-fold and may infer other long term effects such as increased risk for mortality, morbidity, and institutionalization. Muscle weakness, reduced cardiorespiratory reserve, and neuromuscular deficits have been attributed to this acute decline in function. However current rehabilitation strategies in SNFs do not promote adequate dose and mode of interventions to induce beneficial systemic adaptations, perhaps due to the lack of evidence on effective rehabilitation protocols for this medically-complex population. Therefore, the investigators have designed an rehabilitation program, which uniquely integrates principles of physiologic tissue overload with strengthening and functional interventions for greater gains in physical function. Data will be collected on the first cohort of patients who cycle through a SNF during Stage 1, in which usual care occurs (5 months). Then, staff training on progressive rehabilitation interventions will occur over 2 months. Finally, data will be collected on a second cohort of patients who cycle through a SNF during Stage 2, in which progressive rehabilitation is implemented by SNF staff (5 months). Given the high turnover of patients in SNFs (average length of stay ~21 days), 2 different cohorts of patients will be studied and the analysis will consist of independent 2-sample t-tests. During Stage 1 and 2, measures of physical function will be assessed on all eligible patients at admission and discharge from SNF. Therapists will be assessed on adherence to the protocol through documentation audits and use of on-site observational checklist. Acceptability of the intervention by the patients will be assessed by a patient satisfaction survey. Any adverse events will be obtained from the medical record and documented. The discharge location of all patients will be documented.

Condition or disease Intervention/treatment Phase
Physical Deconditioning Other: Progressive Rehabilitation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 153 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Improving Physical Function in Skilled Nursing Facility Residents
Study Start Date : April 2015
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Intervention: Usual Care
SNF rehabilitation therapists provide all patients with usual standard of care.
Experimental: Progressive Rehabilitation
SNF rehabilitation therapists have been trained on principles of progressive rehabilitation strategies and will implement to all eligible patients as new standard of care.
Other: Progressive Rehabilitation
Progressive, high-intensity strengthening and functional interventions to facilitate independence with functional activities.

Primary Outcome Measures :
  1. Short Physical Performance Battery (SPPB) [ Time Frame: Change from Admission to Discharge (expected average length of stay 21 days) ]
    Global measure of lower extremity function, which consists of walking speed, chair stands, and balance tests

Secondary Outcome Measures :
  1. Gait Speed [ Time Frame: Change from Admission to Discharge (expected average length of stay 21 days) ]
    Time it takes to walk a 4 meter path

Other Outcome Measures:
  1. Patient Satisfaction Survey [ Time Frame: Discharge (expected average length of stay 21 days) ]
    8 question survey, scoring each question on a 1-10 scale (1=not at all and 10=extremely)

  2. Therapist Intervention Compliance [ Time Frame: Bi-weekly for 5 months during intervention arm ]
    Audits of therapist documentation and on-site observations with an objective checklist during treatment sessions

  3. Discharge Location [ Time Frame: Discharge (expected average length of stay 21 days) ]
    Record the discharge location of individuals

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Adults older ≥55 years of age who are admitted to a skilled nursing facility following hospitalization
  2. Qualify to receive at least physical therapy services.

Exclusion Criteria:

  1. Patients with primary diagnoses related to neurological disorders will be excluded as patient needs require more of a motor-control approach versus the proposed high-intensity approach. Such patient populations include:

    1. Parkinson's Disease
    2. Traumatic Brain Injury
    3. Recent Cerebral Vascular Accident
    4. Alzheimer's
  2. Patients on hospice care will be excluded as the approach is based on palliative principles. Other patients to be excluded will include those 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 fractures
    2. Advanced congestive heart failure (ejection fracture <30%)
    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 a fistula
    11. Platelet levels <50,000/µL.
  3. Additional exclusions assessed prior to randomization include a score of less than 21 on the Mini-Mental Status Exam.

Information from the National Library of Medicine

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 identifier (NCT number): NCT02421692

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United States, Colorado
Gardens on Quail
Arvada, Colorado, United States, 80004
Sponsors and Collaborators
University of Colorado, Denver
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Principal Investigator: Jennifer Stevens-Lapsley, PT, PhD University of Colorado, Denver

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Responsible Party: University of Colorado, Denver Identifier: NCT02421692     History of Changes
Other Study ID Numbers: 14-2388
First Posted: April 21, 2015    Key Record Dates
Last Update Posted: November 15, 2016
Last Verified: November 2016