ICU Liberation: Does Enhanced Patient Mobilization Improve Outcomes?

Completed

• Conditions: Early Mobilization of Mechanically Ventilated Patients
• Interventions: Other: Activity level measurement by accelerometer

• Registration Number: NCT03329924
• Lead Sponsor: Bassett Healthcare

Brief Summary

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.

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 Timeline

• Study First Submitted: 2017-10-31
• Study First Submitted QC: 2017-10-31
• Study First Posted: 2017-11-06
• Study Start: 2017-12-01
• Primary Completion: 2020-12-01
• Study Completion: 2023-01-01
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-06
• Last Update Posted: 2023-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pre-implementation cohort	Activity level measurement by accelerometer	These patients are being exposed to the current standard of care, which does include some early mobilization practices, but not a formalized program.
post-implementation cohort	Activity level measurement by accelerometer	These patients will have been exposed to the fully executed early mobilization program.

Primary Outcome Measures

Name	Time	Method
Activity level	one week	activity level during a patient's ICU admission will be measured by accelerometer

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Bassett Medical Center; 🇺🇸 Cooperstown, New York, United States