Experts ditch paper for automated digital consent

Improving informed consent, a frequent cause of malpractice litigation, is a major challenge that could be met if more facilities used their digital systems to automate the process, according to a presentation at February's Healthcare Information and Management Systems Society meeting in San Diego.

Dr. Neil H. Baum, an associate professor of urology at Tulane Medical School in New Orleans, and Timothy Kelly, vice president at Dialog Medical Systems, highlighted flaws in the current paper-based informed consent process. They said digital medical record and document management systems can be adapted to provide more understandable and more easily managed documents for informed consent.

A radiology malpractice expert, however, warned that while digitally generated consent forms could be the wave of the future, for many right now they could be premature at best and erroneous at worst. Systems that would generate digital consent forms remain costly and out of the reach of many facilities, said Dr. Leonard Berlin, chair of radiology at Rush North Shore Medical Center in Skokie, Illinois, and a malpractice commentator for the American Journal of Roentgenology.

"Informed consent must involve both a discussion with the physician and written confirmation of the discussion," Berlin said. "A written or digital informed consent is okay, but it has to be in addition to, not in lieu of, verbal communication."

Research has demonstrated that written informed consent information is better understood by patients than verbal communication, according to Baum.

Physicians may do a good job of verbal communication in an informed consent situation, but the documentation is usually inadequate, Baum said. Informed consent is often seen as a burdensome administrative detail that involves getting a signature on a form for the legal protection of physicians and institutions.

According to the American Medical Association, informed consent involves statements covering five essential elements:

- diagnosis;

- purpose of treatment or procedure;

- risks and benefits of the treatment or procedure;

- alternatives, including risks and benefits; and

- risks and benefits of not receiving the treatment or procedure.

Problems with traditional paper form-based informed consent include limited descriptions, illegible handwriting, and use of unacceptable abbreviations. One study of 540 written consent forms from 157 hospitals found the five elements suggested by the AMA were present in only 26% of the documents, Baum said (Bottrell MM et al. Arch Surg 2000;135:26-23).

Today's digital environment offers a better option, according to Baum and Kelly. Electronic medical records or document management systems can be used to extract and print out the appropriate informed consent information for any medical procedure or treatment. Systems also allow technicians or nurses to quiz patients and confirm that they understand the written consent material and to collect signatures via an electronic signature pad. The electronic consent form can be added to the patient's record, and alerts issued when information or signatures are missing. Updates can be included via progress notes.

Berlin noted that informed consent standards set forth by the Joint Commission on Accreditation of Healthcare Organizations call for legible handwriting and use of only approved abbreviations. He also said evidence suggests that the paper approach isn't always that bad.

"From what I've seen, interventional radiologists all over the country are doing an excellent job in obtaining informed consent the old-fashioned way: by talking to the patient, having him or her sign a consent form, and following that up with a handwritten (and hopefully legible) note on the chart," Berlin said.

The VA shifted to an automated informed consent system in September 2005, Baum said. A survey of physicians found the system scored 4.7 (on a scale of 5) for overall satisfaction and 4.9 for ease of learning. A survey of patients gave the system a 4.7 rating.