Hip FracturesNCT03874767
Can Mobility Technicians Provide Value to Hospitalized Patients?
A study testing Patient Mobility in people with Hip Fractures and Lower Extremity Fracture, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Fractures, Lower Extremity Fracture, Lung Transplant
- What is being tested?
- Patient Mobility
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2022to Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All traumatic fractures of the hip or a lower extremity long bone
- Post-lung transplant patient
- Patient readmitted following a lung transplant
Who cannot join
- Non-traumatic joint replacements
- Patients with ankle fractures
- Pre-lung transplant patients
- Patients readmitted to the orthopedics unit following a traumatic injury
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37211
About this study
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.
- Conditions
- Hip Fractures, Lower Extremity Fracture, Lung Transplant
- Being tested
- Patient Mobility
- Keywords
- patient mobility, ambulation
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient MobilityBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Behavioral: Patient Mobility |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
Measured: 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
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.
Measured: At discharge (usually less than 1 week after admission)
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.
Measured: At discharge (usually less than 1 week after admission)
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.
Measured: Admission to discharge (usually less than 1 week)
Amount of ambulation
Amount of ambulation achieved
Measured: Admission to discharge (usually less than 1 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2019
- Study startDec 2022 (estimated)
- Primary completionSep 2023 (estimated)
- Study completionSep 2023 (estimated)
Why it stopped: Bandwidth and logistics issues exacerbated by COVID-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- single center, pragmatic cluster trial
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heather Skaar, Vanderbilt University Medical Center
- Investigators
- Heather Skaar, PT, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03874767
- Sponsor's protocol ID
- 000000000
- Status last verified
- Mar 2022
- First submitted
- 11 Mar 2019
- Last updated
- 4 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not plan to share IPD.
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Mobility Technicians Provide Value to Hospitalized Patients?
- ClinicalTrials.gov ID
- NCT03874767
- Acronym / sponsor ID
- 000000000
- Conditions
- Hip Fractures, Lower Extremity Fracture, Lung Transplant
- Keywords
- patient mobility, ambulation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Bandwidth and logistics issues exacerbated by COVID-19 pandemic
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- Dec 2022 (estimated)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 14 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- single center, pragmatic cluster trial
| Arm | Type | Receives |
|---|---|---|
| 10th floor south | Active comparator | Behavioral: Patient MobilityThe 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 |
| 6th floor Round Wing | Active comparator | Behavioral: Patient MobilityThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All traumatic fractures of the hip or a lower extremity long bone
- Post-lung transplant patient
- Patient readmitted following a lung transplant
Key exclusion criteria (4 listed)
- Non-traumatic joint replacements
- Patients with ankle fractures
- Pre-lung transplant patients
- Patients readmitted to the orthopedics unit following a traumatic injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient MobilityA 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). | Behavioural | 10th floor south, 6th floor Round Wing |
Primary outcome
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).
AM-PAC 6 Clicks score
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.
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)
4 secondary outcomes
Function Independence Measurement (FIM) score
Time frame: At discharge (usually less than 1 week after admission)
Johns Hopkins Highest Level of Mobility (JH-HLM) score
Time frame: At discharge (usually less than 1 week after admission)
Total amount of mobility therapy
Time frame: Admission to discharge (usually less than 1 week)
Amount of ambulation
Time frame: Admission to discharge (usually less than 1 week)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
- Individual participant dataSharing planned: No. We do not plan to share IPD.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather Skaar, PT principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Mobility in people with Hip Fractures and Lower Extremity Fracture, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of Stay (time frame: Admission to discharge (usually less than 1 week)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2022.