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OpenTrials
Completed

NCT Number: NCT03329924

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bassett Medical Center

Cooperstown, New York, 13326, United States

About this study

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:

  • 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
  • ICU length of stay
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Activity level measurement by accelerometer

Other

Eligible patients will wear an accelerometer to measure activity levels while in the ICU.

Primary outcomes

  1. Activity level

    Time frame: one week

    activity level during a patient's ICU admission will be measured by accelerometer

Secondary outcomes

  1. Length of ICU admission

    Time frame: one week

    the amount of time spent as as an admitted patient to the ICU will be measured

  2. length of total hospitalization

    Time frame: one month

    the total amount of time spent as an inpatient for this episode of care will be measured

Sponsors and collaborators

Lead sponsor

Bassett Healthcare

Other

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2023
First posted
Nov 6, 2017
Registry last updated
Mar 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.