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

NCT01413009 | Completed

• 1 other identifier: 0590-10-FB
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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. This 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. Specifically, the study will 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; test the impact of the ABCDE program on patient outcomes, nursing quality outcomes, and system outcomes; and assess the extent to which ABCDE implementation is effective, sustainable, and conducive to dissemination into other settings.

Conditions

ICU Delirium; Immobility

Keywords

delirium; ICU; spontaneous awakening trials; spontaneous breathing trials; early mobility

Outcome Measures

Primary Outcomes (1)

• Ventilator free days (VFDs)

  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.

  Change in ventlator free days at baseline to 9 months

Study Arms (1)

ICU patients

Adult patients admitted to the University of Nebraska Medical Center or the Nebraska Medical Center trauma critical care service.

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Critical care services

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Nebraska: lead
• Robert Wood Johnson Foundation: collaborator

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Related Publications (70)

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MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Michele Balas, PhD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2011
• First Posted: August 9, 2011
• Study Start: December 29, 2010
• Primary Completion: April 1, 2012
• Study Completion: June 1, 2013
• Last Updated: September 15, 2023

Record last verified: 2023-09

Locations

US (1)