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Can Mobility Technicians Provide Value to Hospitalized Patients?

Primary Purpose

Hip Fractures, Lower Extremity Fracture, Lung Transplant

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patient Mobility
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Fractures focused on measuring patient mobility, ambulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All traumatic fractures of the hip or a lower extremity long bone
  • Post-lung transplant patient
  • Patient readmitted following a lung transplant

Exclusion Criteria:

  • Non-traumatic joint replacements
  • Patients with ankle fractures
  • Pre-lung transplant patients
  • Patients readmitted to the orthopedics unit following a traumatic injury

Sites / Locations

  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

10th floor south

6th floor Round Wing

Arm Description

The unit in this arm will be assigned physical therapists plus mobility technicians in the first month and only physical therapists in the following month. 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: On evaluation, a PT will assign a JH-HLM scale rating to the patient If the score is 4 or higher, the PT will add the patient to the mobility technician patient list The mobility technician will then see that patient daily, unless the score is <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 The mobility technician will work with PT and nursing to determine the best time to deliver mobility

The unit in this arm will be assigned only physical therapists in the first month and physical therapists plus mobility technicians in the following month. 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: On evaluation, a PT will assign a JH-HLM scale rating to the patient If the score is 4 or higher, the PT will add the patient to the mobility technician patient list The mobility technician will then see that patient daily, unless the score is <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 The mobility technician will work with PT and nursing to determine the best time to deliver mobility

Outcomes

Primary Outcome Measures

Length of Stay
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).
AM-PAC 6 Clicks score
The AM-PAC 6 clicks score will be the co-primary outcome for this study within the transplant population and is a measurement that helps describe patient basic mobility. This score will be obtained for this study from the Electronic Medical Record (EMR)

Secondary Outcome Measures

Function Independence Measurement (FIM) score
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.
Johns Hopkins Highest Level of Mobility (JH-HLM) score
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.
Total amount of mobility therapy
Amount of mobility provided, which will be derived from clinical data extracted from the EMR. This will be measured through number additional mobility sessions.
Amount of ambulation
Amount of ambulation achieved

Full Information

First Posted
March 11, 2019
Last Updated
March 22, 2022
Sponsor
Vanderbilt University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03874767
Brief Title
Can Mobility Technicians Provide Value to Hospitalized Patients?
Official Title
Can Mobility Technicians Provide Value to Hospitalized Patients?
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Bandwidth and logistics issues exacerbated by COVID-19 pandemic
Study Start Date
December 2022 (Anticipated)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The specific aim of this study is to determine the impact of the addition of a dedicated mobility technician to the care team on specialty specific outcomes for patients recovering from surgical treatment for a hip or lower extremity long bone fracture or a lung transplant. The practice of post-operative early ambulation has been shown to improve outcomes by promoting enhanced recovery after surgery in a variety of patients. To that end, 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, other fractures of the lower extremity long bones, as well as those post-lung transplant or readmitted post-lung transplant 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 ambulation 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 existing care team. The mobility technician will be assisting patients who could benefit from early ambulation after surgery. We hypothesize that by adding this staffing resource, more patients will get the appropriate level of usual care. Specifically, we expect that adding the resource increases the proportion of those patients who are receiving the prescribed amount of early ambulation post-surgery, with subsequent improvements in functional independence at discharge, and decreases length of stay since patients achieve readiness for discharge sooner.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures, Lower Extremity Fracture, Lung Transplant
Keywords
patient mobility, ambulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
single center, pragmatic cluster trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
10th floor south
Arm Type
Active Comparator
Arm Description
The unit in this arm will be assigned physical therapists plus mobility technicians in the first month and only physical therapists in the following month. 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: On evaluation, a PT will assign a JH-HLM scale rating to the patient If the score is 4 or higher, the PT will add the patient to the mobility technician patient list The mobility technician will then see that patient daily, unless the score is <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 The mobility technician will work with PT and nursing to determine the best time to deliver mobility
Arm Title
6th floor Round Wing
Arm Type
Active Comparator
Arm Description
The unit in this arm will be assigned only physical therapists in the first month and physical therapists plus mobility technicians in the following month. 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: On evaluation, a PT will assign a JH-HLM scale rating to the patient If the score is 4 or higher, the PT will add the patient to the mobility technician patient list The mobility technician will then see that patient daily, unless the score is <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 The mobility technician will work with PT and nursing to determine the best time to deliver mobility
Intervention Type
Behavioral
Intervention Name(s)
Patient Mobility
Intervention Description
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).
Primary Outcome Measure Information:
Title
Length of Stay
Description
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).
Time Frame
Admission to discharge (usually less than 1 week)
Title
AM-PAC 6 Clicks score
Description
The AM-PAC 6 clicks score will be the co-primary outcome for this study within the transplant population and is a measurement that helps describe patient basic mobility. This score will be obtained for this study from the Electronic Medical Record (EMR)
Time Frame
7 days post ICU discharge +/- 1 day for post-lung transplant patients and day 7 +/- 1 days for readmitted post-lung transplant patients. Raw scores range from 6-24, where a lower number suggests higher functional/mobile impairment.
Secondary Outcome Measure Information:
Title
Function Independence Measurement (FIM) score
Description
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.
Time Frame
At discharge (usually less than 1 week after admission)
Title
Johns Hopkins Highest Level of Mobility (JH-HLM) score
Description
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.
Time Frame
At discharge (usually less than 1 week after admission)
Title
Total amount of mobility therapy
Description
Amount of mobility provided, which will be derived from clinical data extracted from the EMR. This will be measured through number additional mobility sessions.
Time Frame
Admission to discharge (usually less than 1 week)
Title
Amount of ambulation
Description
Amount of ambulation achieved
Time Frame
Admission to discharge (usually less than 1 week)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All traumatic fractures of the hip or a lower extremity long bone Post-lung transplant patient Patient readmitted following a lung transplant Exclusion Criteria: Non-traumatic joint replacements Patients with ankle fractures Pre-lung transplant patients Patients readmitted to the orthopedics unit following a traumatic injury
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heather Skaar, PT
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37211
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We do not plan to share IPD.

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Can Mobility Technicians Provide Value to Hospitalized Patients?

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