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

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

Research output: Contribution to journalArticlepeer-review

54 Scopus citations


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.

Original languageEnglish (US)
Pages (from-to)94-99
Number of pages6
JournalCritical care medicine
Issue number1
StatePublished - Jan 2008


  • Critical care
  • Critical illness
  • Delirium
  • Informed consent
  • Intensive care units
  • Psychomotor agitation
  • Sedation

ASJC Scopus subject areas

  • Critical Care and Intensive Care Medicine


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