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EARLY: Early Ambulation to Reduce Hospital Length of Stay

Sponsor
University of Florida (Other)
Overall Status
Recruiting
CT.gov ID
NCT04444453
Collaborator
(none)
150
Enrollment
1
Location
2
Arms
31.3
Anticipated Duration (Months)
4.8
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Device: Wearable Pedometer
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Early Ambulation to Reduce Hospital Length of Stay
Actual Study Start Date :
Oct 21, 2020
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Pedometer

Admitted patients who receive a pedometer to wear during their hospital stay to measure steps ambulated

Device: Wearable Pedometer
Pedometer worn on wrist
Other Names:
  • Pedometer

    		•
    No Intervention: Control

    Patients admitted to hospital who do not receive a pedometer, but receive all other usual standard of care

    Outcome Measures

    Primary Outcome Measures

    1. Hospital Length of Stay [Up to 1 month]

      Time patient is admitted in hospital

    Secondary Outcome Measures

    1. Hospital length-of-stay index [Up to 1 month]

    2. Time to first ambulation [Up to 1 month]

    3. Time to first bowel movement [Up to 1 month]

    4. Rate of venous thromboembolism [Up to 1 month]

    5. Total hospitalization costs [Up to 1 month]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Patients ages > or equal to 18 years

    2. Patient has capacity to undergo informed consent

    3. Admitted to UF Health Jacksonville 8N progressive inpatient unit

    4. Inpatient physician orders for patient ambulation and/or activity as tolerated upon hospital admission

    5. Patient with a Fall Predictive Analytics score category of "low risk"

    6. Patient with a Morse Fall Scale (MFS) of < or equal to 50

    7. No contraindications to wearing a wrist pedometer (no skin breakdown, overlying skin infections, contact dermatitis, or indwelling catheters/need for venipuncture at wrist site)

    Exclusion Criteria:

    1. Patient < 18 years of age

    2. Patient without capacity to undergo informed consent

    3. 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

    4. Patient with a Fall Predictive Analytics score category of "high risk"

    5. Patient with MFS > 50 or labelled by clinical team as fall risk

    6. Non-English speaking

    7. In law enforcement custody or ward of the state

    8. Pregnancy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Florida Jacksonville Florida United States 32209

    Sponsors and Collaborators

    • University of Florida

    Investigators

    • Principal Investigator: Jennifer Fishe, MD, University of Florida

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Florida
    ClinicalTrials.gov Identifier:
    NCT04444453
    Other Study ID Numbers:
    • IRB202001410
    • IRB202001410
    First Posted:
    Jun 23, 2020
    Last Update Posted:
    Mar 24, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of Florida
    length of stay
    hospitalization

    Study Results

    No Results Posted as of Mar 24, 2022