ICU Liberation: Does Enhanced Patient Mobilization Improve Outcomes?

March 6, 2023 updated by: Erik Riesenfeld, Bassett Healthcare
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
220

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Cooperstown, New York, United States, 13326
        • Bassett Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Eligible patients will wear an accelerometer to measure activity levels while in the ICU.
post-implementation cohort
These patients will have been exposed to the fully executed early mobilization program.
Other: Activity level measurement by accelerometer
Eligible patients will wear an accelerometer to measure activity levels while in the ICU.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Activity level
Time Frame: one week
activity level during a patient's ICU admission will be measured by accelerometer
one week

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Length of ICU admission
Time Frame: one week
the amount of time spent as as an admitted patient to the ICU will be measured
one week
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
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bassett Healthcare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 31, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 6, 2017

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 7, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2084

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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