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Informed consent in the critically ill: A two-step approach incorporating delirium screening*

Fan, Eddy MD; Shahid, Shabana MD; Kondreddi, V Praveen MD, MSc; Bienvenu, O Joseph MD, PhD; Mendez-Tellez, Pedro A. MD; Pronovost, Peter J. MD, PhD; Needham, Dale M. MD, PhD

doi: 10.1097/01.CCM.0000295308.29870.4F
Clinical Investigations
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Objectives: Sedation-agitation and delirium are common in critically ill patients and may be important barriers to informed consent. We describe a two-step process for informed consent and evaluate the natural history of patients' competency by repeated application of this process during their hospitalization.

Design: Observational study.

Setting: Nine intensive care units (ICUs) in three teaching hospitals in Baltimore, MD.

Patients: One hundred fifty patients with acute lung injury.

Interventions: Two-step process involving objective evaluation with Richmond Agitation-Sedation Scale (RASS) and Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) (step 1), followed by traditional assessment for competency (step 2) in those patients passing step 1.

Measurements and Main Results: RASS and CAM-ICU assessments (during ICU stay, at consent and hospital discharge); cumulative proportion of patients providing consent at extubation and at ICU and hospital discharge. Of 150 patients, 86 (57%) survived and 77 (90% of survivors) provided consent. Patients were delirious/deeply sedated in 89% of daily assessments during mechanical ventilation. By extubation, 31 (44%) patients passed step 1 and 8 (11%) passed step 2 and were consented. By ICU and hospital discharge, these numbers were 50 (58%) and 18 (21%), and 81 (94%) and 67 (78%), respectively. The median (interquartile range) time to patient consent after acute lung injury diagnosis was 15 (9–28) days.

Conclusions: More than three fourths of critically ill patients are unable to provide informed consent throughout their ICU stay, even after extubation. Sedation-agitation and delirium are common barriers to consent. A two-step consent process, using validated instruments for sedation-agitation and delirium, provides a means of rapidly screening critically ill patients before a more detailed traditional assessment of competency is conducted.

From the Interdepartmental Division of Critical Care Medicine (EF), University of Toronto, Toronto, Ontario, Canada; and the Divisions of Pulmonary and Critical Care Medicine (SS, VPK, DMN) and Anesthesiology and Critical Care Medicine (PAM-T, PJP), and the Department of Psychiatry and Behavioral Sciences (OJB), Johns Hopkins University, Baltimore, MD.

Supported, in part, by the National Institutes of Health (Acute Lung Injury SCCOR grant P050 HL 73994). Dr. Needham is supported by a Clinician-Scientist Award from the Canadian Institutes of Health Research, and Dr. Bienvenu is supported by a grant from the National Institute of Mental Health (K23 MH064543). The funding bodies had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of the manuscript.

The authors have not disclosed any potential conflicts of interest.

For information regarding this article, E-mail: dale.needham@jhmi.edu

© 2008 by the Society of Critical Care Medicine and Lippincott Williams & Wilkins