Improving the process of informed consent in the critically ill

Context Invasive procedures are often performed emergently in the intensive care unit (ICU), and patients or their proxies may not be available to provide informed consent. Little is known about the effectiveness of intensivists in obtaining informed consent. Objectives To describe the nature of informed consent in the ICU and to determine if simple interventions could enhance the process. Design, Setting, and Patients Prospective study of 2 cohorts of consecutively admitted patients (N=270) in a 16-bed ICU at a university hospital. All patients admitted to the ICU during the baseline period from November 1, 2001, to December 31, 2001, and during the intervention period from March 1, 2002, to April 30, 2002, were included. Intervention A hospital-approved universal consent form for 8 commonly performed procedures (arterial catheter, central venous catheter, pulmonary artery catheter, or peripherally inserted central catheter placement; lumbar puncture; thoracentesis; paracentesis; and intubation/mechanical ventilation) was administered to patients or proxies. Handouts describing each procedure were available in the ICU waiting area. Physicians and nurses were introduced to the universal consent form during orientation to the ICU. Main Outcome Measures Incidence of informed consent for invasive procedures at baseline and after intervention; whether the patient or proxy provided informed consent; and understanding by the consenter of the procedure as determined by the responses on a questionnaire. Results Fifty-three percent of procedures (155/292) were performed after consent had been obtained during the baseline period compared with 90% (308/340) during the intervention period (absolute difference, 37.4%; P<.001). During baseline, the majority (71.6%; 111/155) of consents were provided by proxies. This was also the case during the intervention period in which 65.6% (202/308) of consents were provided by proxies (absolute difference, 6.0%; P=.23). Comprehension by consenters of indications for and risks of the procedures was high and not different between the 2 periods (P=.75). Conclusions Invasive procedures are frequent in the ICU and consent for them is often obtained by proxy. Providing a universal consent form to patients, proxies, and health care clinicians significantly increased the frequency with which consent was obtained without compromising comprehension of the process by the consenter.