Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03329924 |
| Other study ID # |
2084 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 1, 2017 |
| Est. completion date |
January 1, 2023 |
Study information
| Verified date |
March 2023 |
| Source |
Bassett Healthcare |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
