Report from HIMSS: Experts ditch paper for automated digital consent

Improving informed consent is a $4.3 billion challenge that could be met if more facilities used their digital systems to automate the process, a pair of presenters said Tuesday at the Healthcare Information and Management Systems Society meeting in San Diego.

Dr. Neil H. Baum, an associate professor of urology at Tulane Medical School, 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 informed consent documents.

Research has demonstrated that written informed consent information is better understood by patients than verbal communication. More knowledgeable patients are more compliant, less anxious, more satisfied, and thus less likely to sue, Baum said. Unfortunately, well-informed patients are too often the exception.

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 five essential elements:

• statements covering diagnosis

• purpose of treatment or procedure

• risks and benefits of the treatment or procedure

• alternatives, including risks and benefits

• 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).

Paper-based forms can also be costly. A study at two VA medical centers found that consent forms were missing from the patient chart 8% of the time. Using that figure and assuming a 10-minute delay in the operating room for each missing record at a cost of $20/minute - although actual delays can be much longer - Baum calculated that the cost of missing consent forms could easily reach $3.4 billion, nearly $590,000 for each U.S. hospital.

Today's digital environment offers a better option. 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, Kelly said. Updates can be included via progress notes.

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.