Early Ambulation to Reduce Hospital Length of Stay
EARLY
1 other identifier
interventional
38
1 country
1
Brief Summary
Early ambulation of inpatients has been shown to be a key driver of decreased LOS and also reduced adverse events such as venous thromboembolism (VTE). We will test if a patient wearable device (pedometer) measuring steps and ambulation sessions decreases hospital LOS (primary outcome), decreases hospital LOS index (LOSI), decreases time to first ambulation, decreases time to first bowel movement (BM), decreases incidence of VTEs, and decreases costs (secondary outcomes). In a pilot randomized control trial, we will randomize 150 total adult patients admitted to UF Health Jacksonville in a 1:1 fashion to usual care and wearable pedometer or usual care. Patients randomized to the study intervention will receive a wearable pedometer upon admission, to be worn for the duration of their inpatient stay. Study outcome measures to be compared between the pedometer and no pedometer group include hospital LOS (primary outcome), hospital LOSI, time to first ambulation, time to first BM, incidence of VTEs, patient experience, and costs (secondary outcomes).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2020
Typical duration for not_applicable
1 active site
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
June 18, 2020
CompletedFirst Posted
Study publicly available on registry
June 23, 2020
CompletedStudy Start
First participant enrolled
October 21, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2022
CompletedJanuary 17, 2023
January 1, 2023
1.8 years
June 18, 2020
January 13, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hospital Length of Stay
Time patient is admitted in hospital
Up to 1 month
Secondary Outcomes (5)
Hospital length-of-stay index
Up to 1 month
Time to first ambulation
Up to 1 month
Time to first bowel movement
Up to 1 month
Rate of venous thromboembolism
Up to 1 month
Total hospitalization costs
Up to 1 month
Study Arms (2)
Pedometer
EXPERIMENTALAdmitted patients who receive a pedometer to wear during their hospital stay to measure steps ambulated
Control
NO INTERVENTIONPatients admitted to hospital who do not receive a pedometer, but receive all other usual standard of care
Interventions
Eligibility Criteria
You may qualify if:
- Patients ages \> or equal to 18 years
- Patient has capacity to undergo informed consent
- Admitted to UF Health Jacksonville 8N progressive inpatient unit
- Inpatient physician orders for patient ambulation and/or activity as tolerated upon hospital admission
- Patient with a Fall Predictive Analytics score category of "low risk"
- Patient with a Morse Fall Scale (MFS) of \< or equal to 50
- No contraindications to wearing a wrist pedometer (no skin breakdown, overlying skin infections, contact dermatitis, or indwelling catheters/need for venipuncture at wrist site)
You may not qualify if:
- Patient \< 18 years of age
- Patient without capacity to undergo informed consent
- Patient with a 'do not ambulate' order or has order for bed rest or other contraindication to ambulation (i.e., fall risk) or dependent on more than minimal assistance to ambulate
- Patient with a Fall Predictive Analytics score category of "high risk"
- Patient with MFS \> 50 or labelled by clinical team as fall risk
- Non-English speaking
- In law enforcement custody or ward of the state
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Florida
Jacksonville, Florida, 32209, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer Fishe, MD
University of Florida
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2020
First Posted
June 23, 2020
Study Start
October 21, 2020
Primary Completion
August 1, 2022
Study Completion
September 1, 2022
Last Updated
January 17, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will not share