Patient Care

Revamped Informed Consent Puts the Patient at the Center

By Tracy Granzyk Wetzel

Changes focus on providing more relevant, timely information

With the call for more patient-centered, transparent health care, a number of outdated hospital processes are getting a facelift. Informed consent, in particular, has come under scrutiny, as shared decision-making between provider and patient gains greater importance.

"It is time for a fundamental rethinking around informed consent, but there are few incentives to improve it," contends Harlan Krumholz, M.D., professor of medicine, epidemiology and public health at Yale University and author of "Informed Consent to Promote Patient-Centered Care," which appeared in the March 2010 issue of the Journal of the American Medical Association. "Patients are signing documents on a gurney, or minutes away from sedation, and are hardly in the frame of mind to sign. Often, they're choosing procedures they would not if they truly understood what they were getting into."

Finding the right balance of what kind of information to present and when is the key challenge. As an example, outcomes data is not always made readily available to patients, but should be part of the informed consent process, Krumholz says.

"What are the national benchmarks for performance on this procedure? How does your hospital do?" he says.

David Ballard, M.D., chief quality officer at Baylor Health Care System, which is testing new informed consent procedures at The Heart Hospital Baylor Plano in Texas, understands the need for greater transparency, but cautions that patients need relevant information. "Harlan's commentary lays down a significant challenge to hospital systems," he says. "Based on his example, patients could be informed that the hospital or surgeon does not perform the recommended number of procedures annually." However, low-volume hospitals don't necessarily have poor outcomes, he points out.

Geisinger Health System and Veterans Affairs Department have found that when they involve patients in their own care, everyone wins.

"The culture has been physicians make the decisions and patients follow along," says Darrin Michalak, senior performance innovation consultant at Geisinger. "We are trying to reframe that by getting patients to be active participants in their care."

Geisinger utilizes computer-generated videos covering a variety of procedures that the patient can view at home. "Surgeons were concerned the videos gave too much information and would scare patients off," Michalak says. "We need to consider the patient's point-of-view and provide information important to them versus important to us."

The VA Health System rolled out a new informed consent system in 2004 using a customized computer program that holds thousands of informed consent forms and medical information, and supports an interactive, computer-driven informed consent process, allowing for discussion between physician and patient throughout.

"Giving patients a form to sign as they're being wheeled into surgery makes a mockery of informed consent," says Ellen Fox, M.D., chief ethics in health care officer at the VA. "Our system helps to ensure consent is meaningful—the whole idea is to educate patients so they can make informed choices."

This article 1st appeared in the July 2010 issue of HHN Magazine.

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