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Do Mobility Technicians Provide Benefit to Patients Recovering From Hip or Lower Extremity Long Bone Fracture Surgery?

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ClinicalTrials.gov Identifier: NCT03874767
Recruitment Status : Not yet recruiting
First Posted : March 14, 2019
Last Update Posted : March 14, 2019
Sponsor:
Information provided by (Responsible Party):
Heather Skaar, Vanderbilt University Medical Center

Brief Summary:

The change in Medicare payment for Surgical Hip and Femur Fracture Treatment (SHFFT) patients gave hospitals an incentive to provide higher quality care to this cohort of patients. The practice of post-operative early ambulation has been shown to improve outcomes by promoting enhanced recovery after surgery in a variety of patients, include those with SHFFT. To that end, Vanderbilt University Medical Center (VUMC) is establishing a "Culture of Mobility". To do so, additional personnel are being hired to help ambulate patients with traumatic hip and femur fractures, and other fractures of the lower extremity long bones, based upon the best available evidence supporting mobility programs. The added personnel are needed as the currently available resources have insufficient bandwidth to ensure complete early mobility for all patients. The relative effectiveness of adding a dedicated resource is assumed. Although the literature suggests adding person-hours increases the amount of mobility achieved, there is an opportunity to evaluate whether this is really the case.

The goal of this study is to evaluate the impact of adding the mobility technician to the usual care team in order to assist patients who could benefit from early ambulation after surgery. We hypothesize that adding a dedicated mobility technician increases the proportion of prescribed early ambulation provided to all eligible patients post-surgery, improves functional independence at discharge, and decreases length of stay since patients achieve readiness for discharge sooner than without early mobility.


Condition or disease Intervention/treatment Phase
Hip Fractures Lower Extremity Fracture Other: Addition of mobility technician Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 763 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: single center, pragmatic cluster trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Does the Addition of a Dedicated Mobility Technician, Increase Early Ambulation, and Provide Meaningful Benefit and Added Value to Patients Recovering From Surgical Treatment for a Hip or Lower Extremity Long Bone Fracture?
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention Arm

During months where a unit has been assigned the mobility technicians, the mobility technician, along with nursing staff, will deliver additional prescribed mobility as well as standard-of-care prescribed therapy provided by physical therapy staff. The intervention will consist of the following steps:

  1. On evaluation, a PT will assign a JH-HLM scale rating to the patient; this marks the highest level of mobility achieved during the session.
  2. If the score is 4 or higher, the PT will add the patient to the mobility technician patient list
  3. The mobility technician will then see that patient daily, unless the score has dropped below 4 for some reason.
  4. Each PT session will involve a re-assessment by the PT of the JH-HLM scale rating as well as the Function Independence Measurement (FIM) score, and subsequently will update the recommended therapy if appropriate
  5. The mobility technician will work with PT and nursing to determine the best time to deliver mobility
Other: Addition of mobility technician
A team of two mobility technicians will switch between two units on a monthly basis. The unit staffed by the mobility technician will be referred to as the intervention unit, while the other will be referred to as the control unit. One unit will start as the control unit and will switch to being the intervention unit after one month. Similarly, the other unit will start as the intervention unit and will switch to becoming the control unit after one month. All patients present on a unit during the intervention period will be provided mobility technician support according to standardized clinical guidelines that have been developed by the care team and described below. Patients who are present on a unit at the time of cross-over will not be included in the analysis, but will either no longer receive mobility technician support (if crossing from intervention to control) or will start to receive mobility technician support (if switching from control to intervention).

No Intervention: Control Arm
During control periods, where a mobility technician is not available to provide additional support, patients will receive standard of care physical therapy.



Primary Outcome Measures :
  1. Length of Stay [ Time Frame: Admission to discharge (usually less than 1 week) ]
    The primary outcome for this study will be length of stay (LOS), defined as time from admission to the unit to discharge from the unit in days. The LOS will be obtained for this study from the Electronic Medical Record (EMR).


Secondary Outcome Measures :
  1. Function Independence Measurement (FIM) score [ Time Frame: At discharge (usually less than 1 week after admission) ]

    Patient function is assessed using the FIM™ instrument at the start of a rehabilitation episode of care and at the end of a rehabilitation episode of care. Admission assessment is collected within 72 hours of the start of a rehabilitation episode. Discharge assessment is collected within 72 hours prior to the end of a rehabilitation episode.

    The FIM score measures a patient's mobility. The score ranges from 6 to 24, where 6 means most limited mobility and 24 means normal mobility.


  2. Johns Hopkins Highest Level of Mobility (JH-HLM) score [ Time Frame: At discharge (usually less than 1 week after admission) ]

    The JH-HLM scale was developed based on input from multiple disciplines (nursing, rehabilitation therapists, physicians, etc.) to help record the mobility that a patient actually does, standardize the description of patient mobility, and to be used as a performance measure for quality improvement projects.

    The JH-HLM score measures a patient's mobility. The score ranges from 1 to 8, where 1 means most limited mobility and 8 means normal mobility.


  3. Total amount of mobility therapy [ Time Frame: Admission to discharge (usually less than 1 week) ]
    Amount of mobility provided, which will be derived from clinical data extracted from the EMR. This will be measured through number additional mobility sessions.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All traumatic fractures of the hip or a lower extremity long bone
  • Treating team considered the patient eligible for care by a mobility technician

Exclusion Criteria:

  • Non-traumatic joint replacements
  • Patients with ankle fractures

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 ClinicalTrials.gov identifier (NCT number): NCT03874767


Contacts
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Contact: Heather Skaar, PT 615-936-6285 heather.skaar@vumc.org
Contact: Scott McLaurin, OT/L 615-322-6059 scott.mclaurin@vumc.org

Locations
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United States, Tennessee
Vanderbilt University Medical Center Not yet recruiting
Nashville, Tennessee, United States, 37211
Contact: , PT         
Principal Investigator: Heather Skaar, PT         
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
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Principal Investigator: Heather Skaar, PT Vanderbilt University Medical Center

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Responsible Party: Heather Skaar, Administrative Director, Physical Medicine & Rehabilitation Acute Care, Dayani Center, Orthopaedic Therapy, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03874767     History of Changes
Other Study ID Numbers: 000000000
First Posted: March 14, 2019    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We do not plan to share IPD.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Heather Skaar, Vanderbilt University Medical Center:
patient mobility
ambulation

Additional relevant MeSH terms:
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Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries