ICU Liberation: Does Enhanced Patient Mobilization Improve Outcomes?

The hypothesis of this study is that an early mobilization program coupled with organizational efforts to implement the ABCDEF bundle will increase the rate of ICU patient mobilization and decrease the ICU length of stay, but will not significantly affect patient mortality. Mobilization efforts will be done to improve patient care and the study will allow for measurement of the effects of implementation of this effort. The early mobilization program is being instituted as standard of care. The study will measure the actual degree of change in patients' activity level and to evaluate the effect of the program on outcome measures such as length of stay.

Study Overview

• Status: Completed
• Conditions: Early Mobilization of Mechanically Ventilated Patients
• Intervention / Treatment: Other: Activity level measurement by accelerometer

Detailed Description

The purpose of this study is to study implementation efficacy of an early mobilization program in a rural mixed surgical and medical ICU.

The aim of the study is to test whether a program of early mobilization training along with ongoing ABCEDF bundle implementation will change the following:

1. early mobilization of ventilated patients in the ICU measured using accelerometer data as a primary measure along with other nurse reported data from the EMR
2. ICU length of stay
3. other clinical variable outlined in the design section

This study will have a pre- and post-implementation design. Baseline activity levels of eligible patients will be collected prospectively for approximately 3 months while staff is being trained and the details of the early mobilization program are being finalized. All eligible patients will wear an accelerometer while in the ICU. Length of ICU stay, total hospitalization, discharge disposition, and the occurrence of certain hospital-acquired complications will also be recorded as part of the baseline/current practice data. There will be a pause in data collection as the early mobilization program is incorporated into standard practice.

Data collection will resume approximately one month after the implementation of the program.

All eligible patients will wear an accelerometer to measure activity level while in the ICU. Length of ICU stay, total hospitalization, discharge disposition, and the occurrence of certain hospital-acquired complications will also be recorded. Other variables to be assessed include: ICU staffing costs, overall hospitalization costs, rate of patient falls, rate of staff injuries, level of exercise tolerance achieved by time of discharge.

• Study Type: Observational
• Enrollment (Actual): 220

Contacts and Locations

Study Locations

• United States
  • New York
    • Cooperstown, New York, United States, 13326
      • Bassett Medical Center

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Patients in a rural mixed surgical and medical ICU requiring mechanical ventilation will be included in this study

Description

Inclusion Criteria:

• - Patients in a rural mixed surgical and medical ICU requiring mechanical ventilation

Exclusion Criteria:

• age less than 18
• Pregnant patients
• Cardiac surgery patients
• "boarding" patients in the ICU
• Patients expected to be extubated in less than 24 total hours (e.g. combative trauma patient intubated in order to complete workup),
• Patients unable to walk prior to admission
• Patients without limbs
• Patients with an unstable spinal injury.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pre-implementation cohort; These patients are being exposed to the current standard of care, which does include some early mobilization practices, but not a formalized program.	Other: Activity level measurement by accelerometer; Eligible patients will wear an accelerometer to measure activity levels while in the ICU.
post-implementation cohort; These patients will have been exposed to the fully executed early mobilization program.	Other: Activity level measurement by accelerometer; Eligible patients will wear an accelerometer to measure activity levels while in the ICU.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Activity level	activity level during a patient's ICU admission will be measured by accelerometer	one week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of ICU admission	the amount of time spent as as an admitted patient to the ICU will be measured	one week
length of total hospitalization	the total amount of time spent as an inpatient for this episode of care will be measured	one month

Collaborators and Investigators

• Sponsor: Bassett Healthcare

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Actual): December 1, 2020
• Study Completion (Actual): January 1, 2023

Study Registration Dates

• First Submitted: October 31, 2017
• First Submitted That Met QC Criteria: October 31, 2017
• First Posted (Actual): November 6, 2017

Study Record Updates

• Last Update Posted (Estimate): March 7, 2023
• Last Update Submitted That Met QC Criteria: March 6, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2084

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