NCT03874767

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 14, 2019

Completed
3.7 years until next milestone

Study Start

First participant enrolled

December 1, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

April 4, 2022

Status Verified

March 1, 2022

Enrollment Period

9 months

First QC Date

March 11, 2019

Last Update Submit

March 22, 2022

Conditions

Keywords

patient mobilityambulation

Outcome Measures

Primary Outcomes (2)

  • 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).

    Admission to discharge (usually less than 1 week)

  • 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)

    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 Outcomes (4)

  • Function Independence Measurement (FIM) score

    At discharge (usually less than 1 week after admission)

  • Johns Hopkins Highest Level of Mobility (JH-HLM) score

    At discharge (usually less than 1 week after admission)

  • Total amount of mobility therapy

    Admission to discharge (usually less than 1 week)

  • Amount of ambulation

    Admission to discharge (usually less than 1 week)

Study Arms (2)

10th floor south

ACTIVE COMPARATOR

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: 1. On evaluation, a PT will assign a JH-HLM scale rating to the patient 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 is \<4 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

Behavioral: Patient Mobility

6th floor Round Wing

ACTIVE COMPARATOR

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: 1. On evaluation, a PT will assign a JH-HLM scale rating to the patient 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 is \<4 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

Behavioral: Patient Mobility

Interventions

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).

10th floor south6th floor Round Wing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37211, United States

Location

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • Heather Skaar, PT

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: single center, pragmatic cluster trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Administrative Director, Physical Medicine & Rehabilitation Acute Care, Dayani Center, Orthopaedic Therapy

Study Record Dates

First Submitted

March 11, 2019

First Posted

March 14, 2019

Study Start

December 1, 2022

Primary Completion

September 1, 2023

Study Completion

September 1, 2023

Last Updated

April 4, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

We do not plan to share IPD.

Locations