Clinical trial NCT03329924: ICU Liberation: Does Enhanced Patient Mobilization Improve Outcomes?
Official title: ICU Liberation: Does Enhanced Patient Mobilization Improve Outcomes?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Early Mobilization of Mechanically Ventilated Patients
Lead sponsor: Bassett Healthcare
Sponsor class: OTHER
First posted: 2017-11-06
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Activity level
timeFrame: one week
Secondary outcomes:
measure: Length of ICU admission
timeFrame: one week
measure: length of total hospitalization
timeFrame: one month
Other outcomes:
Locations:
city: Cooperstown
country: United States
facility: Bassett Medical Center
state: New York
Study officials:
affiliation: Bassett Medical Center
name: Erik riesenfeld, MD
role: PRINCIPAL_INVESTIGATOR
References: