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CompletedNCT03329924Updated Mar 7, 2023

ICU Liberation: Does Enhanced Patient Mobilization Improve Outcomes?

An observational study in Early Mobilization of Mechanically Ventilated Patients, sponsored by Bassett Healthcare. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-07.

Sponsored by Bassett Healthcare · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
220
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Early Mobilization of Mechanically Ventilated Patients
03

In context

Lead sponsor

Bassett Healthcare is the lead sponsor of 22 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
220 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • post-implementation cohort

    These patients will have been exposed to the fully executed early mobilization program.

    Other: Activity level measurement by accelerometer

Interventions

  • OtherActivity level measurement by accelerometer

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

06

What researchers measure

Primary outcomes

  1. Activity level

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

    Time frame: one week

Secondary outcomes

  1. Length of ICU admission

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

    Time frame: one week

  2. length of total hospitalization

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

    Time frame: one month

07

Study locations

1 site
  • Bassett Medical Center
    Cooperstown, New York 13326, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Dec 2017 to primary completion in Dec 2020, 36 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 31, 2017
First posted
Nov 6, 2017
StartActual
Dec 1, 2017
Primary completionActual
Dec 1, 2020
CompletionActual
Jan 1, 2023
Last update
Mar 7, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 7, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03329924
Lead sponsor
Bassett Healthcare
Responsible party
Erik Riesenfeld (Attending Physician - Critical Care & Pulmonology, Bassett Healthcare) — Principal investigator
First posted
Nov 6, 2017
Start date
Dec 1, 2017
Primary completion
Dec 1, 2020
Completion
Jan 1, 2023
Last update
Mar 7, 2023

Study contacts

Erik riesenfeld, MD
principal investigator · Bassett Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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