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Awakening-Breathing Coordination, Delirium Monitoring/Management & Early Mobility (ABCDE) Protocol (ABCDE)

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ClinicalTrials.gov Identifier: NCT01413009
Recruitment Status : Unknown
Verified January 2013 by Michele Balas, University of Nebraska.
Recruitment status was:  Active, not recruiting
First Posted : August 9, 2011
Last Update Posted : January 7, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The main goal of the proposed Robert Wood Johnson Foundation's Interdisciplinary Nursing Quality Research Initiative (RWJF INQRI) project is to implement, analyze, and disseminate an evidence-based, nurse-led, inter-professional, multi-component program focused on improving the care and outcomes of critically ill adults.

Condition or disease
ICU Delirium Immobility

Detailed Description:
We face a profound and emerging public health problem in the form of acute and chronic brain dysfunction among young and elderly intensive care unit (ICU) survivors that is altering the landscape of society. Fully two-thirds of ICU patients develop delirium, which is associated with longer stays, billions of dollars in costs globally, and 3-fold excess mortality at 6 months. Over one-half of ICU survivors suffer a functionally debilitating dementia-like illness, which appears related to delirium duration. The impact on a person's life is often devastating. The main goal of the proposed INQRI project is to implement, analyze, and disseminate an evidence-based, nurse-led, inter-professional, multi-component program focused on improving the care and outcomes of critically ill adults. The study will focus on applying Awakening-Breathing Coordination, Delirium Monitoring/Management & Early Mobility (ABCDE), a program of delirium screening, prevention, and treatment developed at Vanderbilt University. The ABCDE approach analyzes and merges the best available evidence related to delirium, analgesia, and sedation (DAS) management in the ICU and tailors the pharmacologic and nonpharmacologic interventions used in prior DAS clinical trials into a program that can be adopted into practice in less "research focused" ICUs. Specifically, the study aims are to (1) implement the ABCDE program in a medical center that does not currently perform routine ICU delirium screenings and identify facilitators and barriers to program adoption; (2) test the impact of the ABCDE program on patient outcomes, nursing quality outcomes, and system outcomes; and (3) assess the extent to which ABCDE implementation is effective, sustainable, and conducive to dissemination into other settings.

Study Design

Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Awakening-Breathing Coordination, Delirium Monitoring/Management & Early Mobility (ABCDE) Protocol
Study Start Date : November 2010
Primary Completion Date : April 2012
Estimated Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
ICU patients


Outcome Measures

Primary Outcome Measures :
  1. Ventilator free days (VFDs) [ Time Frame: Change in ventlator free days at baseline to 9 months ]
    The primary outcome will be a comparison between the 3 month baseline period of ventilator free days and the 9 month period following the intervention. Two interim analyses will be conducted.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Critical care services
Criteria

Inclusion Criteria:

  • Greater than or equal to 19 years of age
  • Patients at the University of Nebraska Medical Center and the Nebraska Medical Center
  • Admitted to either the academic medical or trauma critical care service

Exclusion Criteria:

  • Legally authorized representative not available to provide consent to participate within 48 hours of ICU admission
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01413009


Locations
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Sponsors and Collaborators
University of Nebraska
Robert Wood Johnson Foundation
More Information

Publications:
Happ MB, Tate J, Garret K. Nursing counts. Focus on: nonspeaking older adults in the ICU: communication will require special strategies. American Journal of Nursing 106(5):29, 2006.

Responsible Party: Michele Balas, Assistant Professor, University of Nebraska
ClinicalTrials.gov Identifier: NCT01413009     History of Changes
Other Study ID Numbers: 590-10
First Posted: August 9, 2011    Key Record Dates
Last Update Posted: January 7, 2013
Last Verified: January 2013

Keywords provided by Michele Balas, University of Nebraska:
delirium
ICU
spontaneous awakening trials
spontaneous breathing trials
early mobility

Additional relevant MeSH terms:
Respiratory Aspiration
Delirium
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders