Early use of universal forms boosts informed consent among ICU patients

April 15, 2003

By asking permission at the first opportunity rather than when it becomes necessary and urgent, caregivers can nearly double the consent rate for most of the invasive procedures performed in the ICU setting, report researchers from the University of Chicago in the April 16 issue of the Journal of the American Medical Association.

In one of the first detailed studies of the informed-consent process in an ICU, the researchers found that the rapid, unpredictable pace of critical illness combined with the inability of very sick patients to make decisions took a serious toll on patient autonomy.

When caregivers relied on standard practice, patients or their proxies had the opportunity to consent to or refuse invasive procedures recommended by their doctors only 53 percent of the time. A large fraction of procedures were performed because they were deemed necessary by caregivers--with implied consent. After the authors devised a universal consent form that explained the risks and benefits for the eight most common ICU procedures and presented the options to patients and families as soon as they were admitted to the ICU, they were able to raise the consent rate above 90 percent.

"Precise, widely accepted guidelines for obtaining consent in the ICU environment do not exist," said study author Jesse Hall, MD, professor of medicine and chief of pulmonary and critical care at the University of Chicago. "Physicians can't even agree on which procedures require consent. Our goal was to begin to standardize the process and to find ways to make it more effective."

Physicians are obliged to let patients, or their proxy decision-makers, participate in decisions about their care. But in situations where a delay increases risk, most states allow physicians to proceed without obtaining explicit consent. This study was designed to see how often that happened and to test a method to improve to process.

The study was performed in a 16-bed intensive care unit (ICU) at a university hospital. For two months, from November 1 to December 31, 2001, the researchers charted the consent rate for invasive procedures. They found that only 53.1 percent of the time (155 out of 292 procedures) did patients have the opportunity to consent to or refuse treatment. ICU physicians attributed their inability to get consent to the emergent nature of the procedure and the lack of an available proxy when needed.

In the intervention period, March 1 to April 30, 2002, a universal consent form that explained the risks and benefits of each procedure was presented to patients and families soon after they came to the unit. For this period, the consent rate increased to 90.5 percent, with consent secured in advance for 308 out of 340 procedures.

"This is a far more acceptable level of patient participation," said Hall. "It enabled us to be more responsive to family wishes and also allowed patients themselves to make more decisions." Before the universal consent form was introduced, patients made their own decisions in only 28.4 percent of cases. Proxies made the rest. Using the comprehensive form allowed the patient to make the call in 34.4 percent of cases.

Comprehension by both patients and proxy decision-makers was high and did not differ between the two periods. Understanding was excellent at baseline, note the authors, and "was not compromised by routine distribution of this new instrument for guiding informed consent."

"We have shown that education of clinicians, patients, and proxies regarding the process of informed consent can improve this process in critically ill patients," the authors conclude.

The universal consent form described eight commonly performed procedures: placement of an arterial catheter, a central venous catheter, a pulmonary artery catheter, or a peripherally inserted central catheter, lumbar puncture, thoracentesis (surgical puncture through the chest wall with drainage of fluid from the thoracic cavity), paracentesis (surgical puncture through the abdominal wall with drainage or aspiration of fluid from the abdominal cavity) and intubation/mechanical ventilation.

Additional authors of the paper are Nicole Davis, Anne Pohlman, Brian Gehlbach, John Kress, Jane McAtee and Jean Herlitz from the University of Chicago Hospitals. The National Institutes of Health/National Institute of General Medical Sciences funded this study. (JAMA. 2003; 289:1963-1968.)

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