Patient Care

Getting Consent

By Ed Bannon

Through new technology, the VA hopes to improve patient-physician dialogues

Informed consent. It's a simple concept: patients must be made fully aware of the course of treatment. Risks and benefits must be spelled out and patients must give their OK before anything happens.

Simple, in theory. In practice, informed consent has become more of a paperwork exercise. It's not just that doctor compliance is haphazard, but also that the quality of the dialogue between clinician and patient often leaves a lot to be desired.

The Veterans Administration hopes to eliminate some of those problems and improve its informed consent compliance with the help of technology. The traditional approach emphasized training and standards for doctors, says Ellen Fox, M.D., director of the VA's National Center for Ethics in Health Care. "The problem is that relies on the individuals to keep in mind a very complex set of policies," she says.

The VA's technology solution--a program called iMedConsent--provides physicians with a digital library of informed consent forms in a step-by-step format. It is meant to be used with a signature pad--like those found at the supermarket checkout line--requiring a patient signature at each step. Most VA hospitals will integrate the forms into their already robust electronic medical records systems.

A review of charts at pilot sites showed 100 percent compliance with informed consent policies, Fox says. Previously, compliance ranged from 50 percent to 90 percent.

While medical studies have linked informed consent to better patient outcomes, there is limited data showing a solid return on investment in terms of lower costs, acknowledges Tim Kelly of Dialog Medical, Atlanta, the VA's technology vendor. Still, there is ample reason for providers to look for ways to improve their processes.

"People tend to view consent as a piece of paper," says Fay Rozovsky, manager, clinical risk management for Chubb Specialty Insurance's Health Care Group, Simsbury, Conn. "When it is done appropriately though, it is the quintessential patient safety tool." Rozovsky suggests that hospitals borrow a model from the aviation field and require a checklist before performing a procedure. "We expect doctors to remember everything," she says. "A checklist becomes evidence of consent."

And if improving quality isn't enough of an incentive, there's the long arm of the Centers for Medicare & Medicaid Services, which last year revised its rules to require more disclosure to patients. For instance, surgery patients must be told who will be in the operating room, including residents and interns. While the agency is in the process of further clarifying some of these changes, Rozovsky says the field has taken note.

Getting doctors to abide by new informed consent practices isn't easy though, says the VA's Fox. VA doctors raised concerns about relying on standardized forms to protect them from malpractice lawsuits. They would tell Fox, "This program won't be on the witness stand with me." To ease these concerns, the VA's national experts approve each form, and doctors can modify their own forms.

This article 1st appeared in the June 2005 issue of HHN Magazine.

To respond to this article, please click here.