Early Ambulation to Reduce Hospital Length of Stay

NCT ID: NCT04444453

Last Updated: 2023-01-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-21
• Study Completion Date: 2022-09-01

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).

Conditions

Ambulation; Wearable Devices

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Pedometer

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

Group Type: EXPERIMENTAL

Wearable Pedometer

Intervention Type: DEVICE

Pedometer worn on wrist

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Wearable Pedometer

Pedometer worn on wrist

Intervention Type: DEVICE

Other Intervention Names

Pedometer

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennifer Fishe, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

University of Florida

Jacksonville, Florida, United States

Countries

United States

Other Identifiers

IRB202001410

Identifier Type: OTHER

Identifier Source: secondary_id

IRB202001410

Identifier Type: -

Identifier Source: org_study_id