Early Ambulation to Reduce Hospital Length of Stay (EARLY)

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).

Study Overview

• Status: Completed
• Conditions: Ambulation; Wearable Devices
• Intervention / Treatment: Device: Wearable Pedometer

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32209
      • University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Length of Stay	Time patient is admitted in hospital	Up to 1 month

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2020
• Primary Completion (Actual): August 1, 2022
• Study Completion (Actual): September 1, 2022

Study Registration Dates

• First Submitted: June 18, 2020
• First Submitted That Met QC Criteria: June 22, 2020
• First Posted (Actual): June 23, 2020

Study Record Updates

• Last Update Posted (Estimate): January 16, 2023
• Last Update Submitted That Met QC Criteria: January 13, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: hospitalization; length of stay
• Other Study ID Numbers: IRB202001410 (Other Identifier: IRB-01)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No