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

History of Changes

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:

MedlinePlus related topics: Delirium

U.S. FDA Resources

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

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:

Ely EW, Shintani A, Truman B, Speroff T, Gordon SM, Harrell FE Jr, Inouye SK, Bernard GR, Dittus RS. Delirium as a predictor of mortality in mechanically ventilated patients in the intensive care unit. JAMA. 2004 Apr 14;291(14):1753-62.

Ely EW, Inouye SK, Bernard GR, Gordon S, Francis J, May L, Truman B, Speroff T, Gautam S, Margolin R, Hart RP, Dittus R. Delirium in mechanically ventilated patients: validity and reliability of the confusion assessment method for the intensive care unit (CAM-ICU). JAMA. 2001 Dec 5;286(21):2703-10.

Pandharipande P, Cotton BA, Shintani A, Thompson J, Pun BT, Morris JA Jr, Dittus R, Ely EW. Prevalence and risk factors for development of delirium in surgical and trauma intensive care unit patients. J Trauma. 2008 Jul;65(1):34-41.

Lat I, McMillian W, Taylor S, Janzen JM, Papadopoulos S, Korth L, Ehtisham A, Nold J, Agarwal S, Azocar R, Burke P. The impact of delirium on clinical outcomes in mechanically ventilated surgical and trauma patients. Crit Care Med. 2009 Jun;37(6):1898-905.

Milbrandt EB, Deppen S, Harrison PL, Shintani AK, Speroff T, Stiles RA, Truman B, Bernard GR, Dittus RS, Ely EW. Costs associated with delirium in mechanically ventilated patients. Crit Care Med. 2004 Apr;32(4):955-62.

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Thomason JW, Shintani A, Peterson JF, Pun BT, Jackson JC, Ely EW. Intensive care unit delirium is an independent predictor of longer hospital stay: a prospective analysis of 261 non-ventilated patients. Crit Care. 2005 Aug;9(4):R375-81. Epub 2005 Jun 1.

Ely EW, Gautam S, Margolin R, Francis J, May L, Speroff T, Truman B, Dittus R, Bernard R, Inouye SK. The impact of delirium in the intensive care unit on hospital length of stay. Intensive Care Med. 2001 Dec;27(12):1892-900. Epub 2001 Nov 08.

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Jackson JC, Gordon SM, Hart RP, Hopkins RO, Ely EW. The association between delirium and cognitive decline: a review of the empirical literature. Neuropsychol Rev. 2004 Jun;14(2):87-98. Review.

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Happ MB. Communicating with mechanically ventilated patients: state of the science. AACN Clin Issues. 2001 May;12(2):247-58. Review.

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Patel RP, Gambrell M, Speroff T, Scott TA, Pun BT, Okahashi J, Strength C, Pandharipande P, Girard TD, Burgess H, Dittus RS, Bernard GR, Ely EW. Delirium and sedation in the intensive care unit: survey of behaviors and attitudes of 1384 healthcare professionals. Crit Care Med. 2009 Mar;37(3):825-32.

Pun BT, Ely EW. The importance of diagnosing and managing ICU delirium. Chest. 2007 Aug;132(2):624-36. Review.

Girard TD, Pandharipande PP, Ely EW. Delirium in the intensive care unit. Critical Care Forum. 2008;12(Suppl 3):S3, 2008.

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Arias-Rivera S, Sánchez-Sánchez Mdel M, Santos-Díaz R, Gallardo-Murillo J, Sánchez-Izquierdo R, Frutos-Vivar F, Ferguson ND, Esteban A. Effect of a nursing-implemented sedation protocol on weaning outcome. Crit Care Med. 2008 Jul;36(7):2054-60.

Quenot JP, Ladoire S, Devoucoux F, Doise JM, Cailliod R, Cunin N, Aubé H, Blettery B, Charles PE. Effect of a nurse-implemented sedation protocol on the incidence of ventilator-associated pneumonia. Crit Care Med. 2007 Sep;35(9):2031-6.

Kress JP, Pohlman AS, O'Connor MF, Hall JB. Daily interruption of sedative infusions in critically ill patients undergoing mechanical ventilation. N Engl J Med. 2000 May 18;342(20):1471-7.

Schweickert WD, Gehlbach BK, Pohlman AS, Hall JB, Kress JP. Daily interruption of sedative infusions and complications of critical illness in mechanically ventilated patients. Crit Care Med. 2004 Jun;32(6):1272-6.

Girard TD, Kress JP, Fuchs BD, Thomason JW, Schweickert WD, Pun BT, Taichman DB, Dunn JG, Pohlman AS, Kinniry PA, Jackson JC, Canonico AE, Light RW, Shintani AK, Thompson JL, Gordon SM, Hall JB, Dittus RS, Bernard GR, Ely EW. Efficacy and safety of a paired sedation and ventilator weaning protocol for mechanically ventilated patients in intensive care (Awakening and Breathing Controlled trial): a randomised controlled trial. Lancet. 2008 Jan 12;371(9607):126-34.

Kress JP, Gehlbach B, Lacy M, Pliskin N, Pohlman AS, Hall JB. The long-term psychological effects of daily sedative interruption on critically ill patients. Am J Respir Crit Care Med. 2003 Dec 15;168(12):1457-61. Epub 2003 Oct 2.

King MS, Render ML, Ely EW, Watson PL. Liberation and animation: strategies to minimize brain dysfunction in critically ill patients. Semin Respir Crit Care Med. 2010 Feb;31(1):87-96. Epub 2010 Jan 25.

Jacobi J, Fraser GL, Coursin DB, Riker RR, Fontaine D, Wittbrodt ET, Chalfin DB, Masica MF, Bjerke HS, Coplin WM, Crippen DW, Fuchs BD, Kelleher RM, Marik PE, Nasraway SA Jr, Murray MJ, Peruzzi WT, Lumb PD; Task Force of the American College of Critical Care Medicine (ACCM) of the Society of Critical Care Medicine (SCCM), American Society of Health-System Pharmacists (ASHP), American College of Chest Physicians. Clinical practice guidelines for the sustained use of sedatives and analgesics in the critically ill adult. Crit Care Med. 2002 Jan;30(1):119-41. No abstract available. Erratum in: Crit Care Med 2002 Mar;30(3):726.

Kress JP, Pohlman AS, Hall JB. Sedation and analgesia in the intensive care unit. Am J Respir Crit Care Med. 2002 Oct 15;166(8):1024-8. No abstract available.

Sessler CN, Pedram S. Protocolized and target-based sedation and analgesia in the ICU. Crit Care Clin. 2009 Jul;25(3):489-513, viii. Review.

Franck LS, Naughton I, Winter I. Opioid and benzodiazepine withdrawal symptoms in paediatric intensive care patients. Intensive Crit Care Nurs. 2004 Dec;20(6):344-51.

Shintani AK, Girard TD, Ely EW. Immortal time bias in critical care. Crit Care Med. 2010 Apr;38(4):1229. No abstract available.

Robinson BR, Mueller EW, Henson K, Branson RD, Barsoum S, Tsuei BJ. An analgesia-delirium-sedation protocol for critically ill trauma patients reduces ventilator days and hospital length of stay. J Trauma. 2008 Sep;65(3):517-26.

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Ely EW, Truman B, Shintani A, Thomason JW, Wheeler AP, Gordon S, Francis J, Speroff T, Gautam S, Margolin R, Sessler CN, Dittus RS, Bernard GR. Monitoring sedation status over time in ICU patients: reliability and validity of the Richmond Agitation-Sedation Scale (RASS). JAMA. 2003 Jun 11;289(22):2983-91.

Vasilevskis EE, Ely EW, Speroff T, Pun BT, Boehm L, Dittus RS. Reducing iatrogenic risks: ICU-acquired delirium and weakness--crossing the quality chasm. Chest. 2010 Nov;138(5):1224-33. Review.

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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 May 21, 2013

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