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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03874767
Other study ID # 000000000
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date December 2022
Est. completion date September 2023

Study information

Verified date March 2022
Source Vanderbilt University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date September 2023
Est. primary completion date September 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Behavioral:
Patient Mobility
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).

Locations

Country Name City State
United States Vanderbilt University Medical Center Nashville Tennessee

Sponsors (1)

Lead Sponsor Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
Primary 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 Function Independence Measurement (FIM) score Patient function is assessed using the FIMâ„¢ 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.
At discharge (usually less than 1 week after admission)
Secondary 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.
At discharge (usually less than 1 week after admission)
Secondary 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. Admission to discharge (usually less than 1 week)
Secondary Amount of ambulation Amount of ambulation achieved Admission to discharge (usually less than 1 week)
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