A new look at informed consent: automating the informed consent process helps hospitals contain costs and minimize malpractice exposure—and improves patient care and safety in the process

Healthcare Financial Management, Feb, 2006 by Neil Baum

Virtually every hospital in the country uses an informed consent process--in one form or another--to document patients' agreement to undergo medical procedures.

The bad news is that the majority of these processes do not meet their objectives. As a result, hospitals are left vulnerable to higher operating room costs due to delayed procedures, lost revenue from noncompliance with payer directives, inefficient use of human resources spent managing a paper-based process, and increased malpractice risks and judgments stemming from inadequate consents.

The solution? Many organizations have found that automating the informed consent process addresses each of these concerns as it improves the productivity of their operating rooms and enhances their bottom line.

Cracks in the Current Foundation

A recent study in the Archives of Surgery examined 540 consent forms in 157 hospitals. Only 26 percent addressed the four key elements of informed consent: benefits of treatment, risks, alternatives, and educational information (Bottrell et al., "Hospital Informed Consent for Procedure Forms: Facilitating Quality Patient-Physician Interaction," Archives of Surgery, January 2000).

Further, more than two-thirds of patients in the United States do not receive any written information about their condition from their physicians. Other studies have shown that up to 75 percent of written consent forms are incomplete.

As studies underscore the importance of well-informed patients, agencies such as the Joint Commission on Accreditation of Healthcare Organizations and payers such as the Centers for Medicare and Medicaid Services are imposing and tightening guidelines relating to the informed consent process. In response, hospitals are making an effort to both improve and comply with the limited procedures they have in place. This effort involves searching for alternatives to adhere to informed consent guidelines and considering new technologies that automate this process.

Opportunities for Improvement

There are two informed consent processes typically employed by hospitals throughout the United States--large and small, public and private:

> Preparation of informed consent documents by individual providers. Often, these forms are hastily prepared and loaded with handwritten notes and medical jargon that can easily be used by plaintiff attorneys to demonstrate that the patient was not adequately informed about a procedure or operation.

> A one-size-fits-all approach: giving patients a generic form with "fill in the blank" components specific to the scheduled procedure.

The shortcomings that result from these abbreviated, nonstandardized processes can have a significant impact on a hospital's financial health. These processes put both hospitals and physicians at increased risk for malpractice exposure. In 2004, the Archives of Ophthalmology published a study noting that inadequate informed consent was cited as the secondary cause in 90 percent of medical malpractice cases (Kiss et al., "Informed Consent and Decision Making by Cataract Patients," Archives of Ophthalmology, January 2004). Depending on state law, failure to obtain adequate informed consent may place hospitals at risk for litigation ranging from medical negligence to battery.

These types of informed consent processes also can increase a hospital's operating room costs.

Too often, paper-based consent documents get lost--and if the proper paperwork doesn't accompany the patient into the holding area or the operating room, the procedure cannot take place. Once patients are sedated, they are no longer competent to sign a consent form. The consent should be obtained in an environment in which the patient has the opportunity to reflect on the information and ask appropriate questions.

These problems lead to delayed operations and lost revenue while the OR stands idle. A conservative estimate is that one minute of wasted OR time costs the hospital $20. With an average delay of 10 minutes for a lost or misplaced consent, that's $200 for each case. Based on this estimate, as well as studies about the percentage of lost or misplaced informed consent documents, the annual cost associated with this problem could exceed $3.3 billion. This translates to an average cost per hospital of more than $580,000 each year.

Various groups have acknowledged the limitations of the traditional informed consent process and have taken steps to address these issues. States such as Texas and Louisiana have enacted laws that specify a minimum subset of risks that must be disclosed for select procedures in an attempt to ensure at least some level of standardization. The Leapfrog Group, which promotes improvements in patient safety by giving consumers data to make more informed hospital choices, includes questions about facilities' informed consent processes in its annual quality and safety survey.

Automating the Informed Consent Process

Traditional informed consent processes provide hospitals with a significant performance improvement opportunity--improvements that might best be achieved through a technological approach. Computer-assisted informed consent processes encourage clinicians to treat informed consent as a process that occurs over time, rather than in a particular instance.