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.
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.
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.
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).
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