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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Robert Wood Johnson Foundation
Information provided by (Responsible Party):
Michele Balas, University of Nebraska
ClinicalTrials.gov Identifier:
NCT01413009
First received: August 2, 2011
Last updated: January 3, 2013
Last verified: January 2013
  Purpose

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
ICU Delirium
Immobility

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Awakening-Breathing Coordination, Delirium Monitoring/Management & Early Mobility (ABCDE) Protocol

Resource links provided by NLM:


Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • Ventilator free days (VFDs) [ Time Frame: Change in ventlator free days at baseline to 9 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 200
Study Start Date: November 2010
Estimated Study Completion Date: October 2013
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
ICU patients

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
Girard TD, Pandharipande PP, Ely EW. Delirium in the intensive care unit. Critical Care Forum. 2008;12(Suppl 3):S3, 2008.

Responsible Party: Michele Balas, Assistant Professor, University of Nebraska
ClinicalTrials.gov Identifier: NCT01413009     History of Changes
Other Study ID Numbers: 590-10
Study First Received: August 2, 2011
Last Updated: January 3, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by 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
Signs and Symptoms, Respiratory
Signs and Symptoms
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 26, 2014