NCT03329924

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 6, 2017

Completed
25 days until next milestone

Study Start

First participant enrolled

December 1, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

March 7, 2023

Status Verified

March 1, 2023

Enrollment Period

3 years

First QC Date

October 31, 2017

Last Update Submit

March 6, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Activity level

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

    one week

Secondary Outcomes (2)

  • Length of ICU admission

    one week

  • length of total hospitalization

    one month

Study Arms (2)

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

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

Pre-implementation cohortpost-implementation cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients in a rural mixed surgical and medical ICU requiring mechanical ventilation will be included in this study

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bassett Medical Center

Cooperstown, New York, 13326, United States

Location

Study Officials

  • Erik riesenfeld, MD

    Bassett Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Physician - Critical Care & Pulmonology

Study Record Dates

First Submitted

October 31, 2017

First Posted

November 6, 2017

Study Start

December 1, 2017

Primary Completion

December 1, 2020

Study Completion

January 1, 2023

Last Updated

March 7, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations