Improving Physical Function in Skilled Nursing Facility Residents (SNF)

November 11, 2016 updated by: University of Colorado, Denver
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
153

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Arvada, Colorado, United States, 80004
        • Gardens on Quail

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Change from Admission to Discharge (expected average length of stay 21 days)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Change from Admission to Discharge (expected average length of stay 21 days)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
Discharge (expected average length of stay 21 days)
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
Bi-weekly for 5 months during intervention arm
Discharge Location
Time Frame: Discharge (expected average length of stay 21 days)
Record the discharge location of individuals
Discharge (expected average length of stay 21 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Colorado, Denver

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jennifer Stevens-Lapsley, PT, PhD, University of Colorado, Denver

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 13, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 21, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 15, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 11, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 14-2388

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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