Improving the process of informed consent in the critically ill

Area of Science:

• Critical Care Medicine
• Medical Ethics
• Health Services Research

Background:

• Invasive procedures are frequently performed emergently in intensive care units (ICUs).
• Informed consent for these procedures is often challenging due to patient unresponsiveness or unavailability of proxies.
• The effectiveness of intensivists in obtaining informed consent requires further investigation.

Purpose of the Study:

• To characterize the process of informed consent for invasive procedures within the ICU setting.
• To evaluate the impact of simple interventions on enhancing informed consent acquisition.

Main Methods:

• A prospective study involving 270 patients admitted to a university hospital ICU over two periods (baseline and intervention).
• An intervention using a hospital-approved universal consent form for eight common invasive procedures, supplemented by informational handouts.
• Data collected included the incidence of informed consent, the source of consent (patient vs. proxy), and the consenter's understanding of the procedure.

Main Results:

• The incidence of informed consent for invasive procedures increased from 53% at baseline to 90% during the intervention period (P<.001).
• Proxies provided the majority of consents in both periods (71.6% baseline, 65.6% intervention), with no significant difference between groups (P =.23).
• Comprehension of procedure indications and risks by those giving consent remained high and was not affected by the intervention (P =.75).

Conclusions:

• A universal consent form, when provided to patients, proxies, and healthcare clinicians, substantially improves the rate of obtaining informed consent for ICU procedures.
• This intervention effectively increases consent acquisition without compromising the understanding of the procedure's indications and risks by the consenter.
• The findings support the implementation of standardized consent processes in critical care settings.