In 1999, an Institute of Medicine report, To Err Is Human, placed the concern of healthcare providers to ?first do no harm? squarely in the spotlight. The report spurred evidence-based patient safety practices and the instigation of patient safety guidelines by agencies like the Joint Commission. As a result, healthcare organizations and hospital risk managers have been shifting from protecting the institution to reducing or eliminating harm to patients.

The National Center for Patient Safety describes this shift from one of investigating individuals and mistakes, to one of analyzing events that combine in an unfortunate sequence to cause an incident. By adopting a systems approach to risk management, healthcare professionals are directing their attention to processes that occur before the delivery of care, and have come to view informed consent as integral in this proactive approach to risk management.

Informed consent between physician and patient provides documentation of all issues discussed and can be used as verification about treatment decisions made. Attention to and documentation of this process are key to reducing risk and improving safety, and it has been estimated that 45% of wrong-site surgical procedures could be eliminated simply by having a properly completed consent form.

The Department of Veteran?s Affairs (VA) is one organization that has implemented electronic informed consent successfully on a large scale at its medical facilities. Beginning in 2003, the VA?s National Center for Ethics in Healthcare established the Electronic Support for Patient Decisions (ESPD) initiative to eliminate paper from the process and create a standardized approach to informed consent. The ESPD initiative ultimately resulted in the installation of Dialog Medical?s iMedConsent application in all 154 VA medical centers beginning in the summer of 2004. As part of this nationwide campaign, the Palo Alto VA Health Care System (VAPAHCS) implemented the application in June 2005.

Despite facing initial technical and workflow challenges, implementation proved to be successful?both physicians and patients were quick to recognize its benefits. A separate study of VA patients exposed to both the traditional paper-based and the electronic consent process found that 96.1% of patients preferred the electronic approach.

After using the electronic process, VAPAHCS was able to identify some significant benefits:

Automation. The informed consent discussion is automatically documented in the patient?s electronic medical record (EMR). In the past, patients signed the consent form and VA staff scanned the signed paper document into the EMR, often with a lag time during which the form might be misplaced, misfiled or even lost. With electronic entry, the consent is immediately saved and can be accessed instantly.

Compliance. The forms and templates available in the application are standardized to reflect the consensus priorities of the entire VA Health System. In addition, the application links physicians directly to the VA national policy so the rationale for particular practices is at their fingertips.

Standardization. Standard fields ensure that each provider can quickly prepare consent forms with the appropriate information for a given treatment or procedure, and patients receive comprehensive information to make certain that their consent is truly informed.

Safety. Electronic consent makes critical information readily accessible in the operating room. When consent was obtained on a paper document and scanned into the EMR, this information was hard to access and sometimes illegible. VAPAHCS staff revised the preoperative ?time out? process in which the surgical team verifies the correct patient, procedure and surgical site, to incorporate the auto-generated electronic consent.

Education. Nurses and others charged with educating patients about their condition, treatments and pre- and post-procedure responsibilities have a full library of information that is accessible with the touch of a button. Providers are able to explain complicated procedures more readily, and print easy-to-understand handouts, diagrams and instructions for the patient and the patient?s family to take with them.

------------------

Mary Lou Faustina, RN, MS, and Mary Montufar, RN, MS are clinical applications coordinators for the Palo Alto VA Medical Center.