Is one of the nation’s largest health systems dedicated to the health of children, Nemours employs some 4,400 professionals, including more than 430 specialty and subspecialty physicians and surgeons. We cared for 238,000 individual patients including an estimated 25,000 at affiliated locations for a total of more than 567,000 outpatient visits, 10,000 hospital admissions and 50,000 surgical procedures in 2007. Nemours owns and operates the Alfred I. duPont Hospital for Children (AIDHC) as well as the Nemours Children’s Clinic, a single group practice with multiple locations in Wilmington, Del. and the Delaware Valley, as well as Jacksonville, Orlando and Pensacola, Fla.

Nationally, we know that the traditional informed consent process for parents of children undergoing common surgical procedures is highly variable and dependent on individual practitioner preferences regarding timing, content, process and the clinician obtaining the consent. Yet, the need for a uniformly high-quality pre-procedure education is clear — the perception of incomplete or improper informed consent is an element in up to 35 percent of medical malpractice actions and is the second most common cause of action asserted. Furthermore, in those cases where informed consent is included as an issue, the average award has been found to be as much as $1 million higher.

Several years ago, as part of our approach to risk management and patient safety, Nemours developed and began implementation of an enterprisewide, integrated risk management model. The model is built on processes and principles that are culture-centered, holistic and mission driven.

The goals of the enterprise model are: to focus our efforts on the sources of threats to patient safety in our organization; to optimize collaborative approaches to mitigating or eliminating those threats; to aggregate information for decision making throughout the organization; and, to leverage technology to provide education, understanding and comfort to families, thus enhancing communication, improving patient safety and managing patient expectations. An important initiative that was identified early in our enterprise approach was to improve the informed consent process.

Informed Consent: Purpose and Process

The intent of informed consent is to allow the effective transfer of knowledge from the practitioner to the patient and family while serving as a platform for communication between the parties. The critical elements of informed consent are: 1) a statement of the proposed procedure; 2) the indications for the procedure; 3) a description of the procedure; 4) the risks associated with the procedure; 5) the benefits; and, 6) alternative treatment options, including the consequences of no treatment.

Typically, informed consent occurs in one of two settings — either in the physician’s office at the time of the visit or just prior to the procedure itself. These scenarios produce inherent variability in the information provided to the family.

Numerous factors contribute to this variability including: consistency and completeness of the content; the individual family’s ability to understand the content; how, where and when the information is provided; the stress of understanding the information and making a decision about having their child undergo a surgical procedure; and, finally, limited time for learning and asking questions combined with inaccurate recollections of the information by the family. Each of these elements can negatively impact a family’s ability to learn and retain new information, thus resulting in an ineffective informed consent process and, perhaps, unreasonable expectations by the family regarding outcomes.

Effective informed consent allows the transfer of knowledge from providers to patients/families and serves as a platform for communication between the provider and the patient/family. From an operational perspective, when done well, informed consent assures providers that families understand the risks, benefits and alternatives of a proposed surgery or procedure, and that their expectations of outcomes are realistic. More importantly, from an organizational perspective, we believe that it is the right thing to do for our patients, families and providers because it supports our core value of creating an environment where all children are treated as if they were our own.

Finding a Solution

With this in mind, key leadership within Nemours met to identify methods to achieve our goal of improving the informed consent process. The group included select physician leaders, hospital representatives, senior leaders of corporate risk, quality and patient safety advocates, legal department representatives and leadership of KidsHealth, a Nemours pediatrician-led editorial group that creates family-oriented online, print and video health content.

As we embarked on this process, we investigated various companies who would be willing and able to partner with us in creating a product that would fulfill our organization’s needs. After reviewing several external products, it was clear that Emmi Solutions LLC, a privately held company founded by a physician/lawyer and entrepreneur, could provide the type of healthcare communications solutions we sought.

The company creates interactive, Web-based programs that use animation and simple language to walk patients through an upcoming procedure or chronic condition. Shortly thereafter, the Nemours group met with Emmi Solutions and began a collaborative relationship to develop and disseminate pediatric-specific programs.

Method

Nemours and KidsHealth collaborated with Emmi Solutions to develop and implement a series of programs focused on pediatric procedures and chronic conditions. These patient-focused, interactive, Web-based tools provide essential health information content. Each program is animated and provides the necessary elements of appropriate informed consent to parents and guardians prior to signing the consent form. Content for the pre-procedure education programs are presented through Flash-based animation with narration and include the definition and description of the procedure, indications, benefits and risks, alternatives and post-care.

Pediatric programs currently include general anesthesia, tonsillectomy and adenoidectomy, bilateral myringotomy, catheter ablation, interventional cardiac catheterizations, inguinal hernia repair, repair of undescended testicles, hypospadius repair, spinal fusion for idiopathic scoliosis, colonoscopy and upper endoscopy.

The programs combine audio, video and text information to target all learning modalities of how adults and children process information. The Web-based system lets parents/guardians view the presentation at a time most convenient for them — in the home, at the library, or at a friend or family member’s house. The viewer has control of the pace and can pause or sign off and return later. During the presentation, parents can return to prior segments or skip previously viewed portions. Viewers can ask questions via e-mail to their physician or take notes throughout the program and print a program summary for review at a later time. Parents without Internet access can view the presentation as they complete the necessary pre-procedure visit on site.

The average program takes approximately 20 minutes to review. School-aged children with a parent/guardian can view a majority of the content. Documentation of completion of the entire program along with the times and dates the program was visited is documented and stored for permanent access by a separate, secure entity. A brief survey is activated at the conclusion to solicit feedback regarding parent satisfaction and understanding.

The process of developing an Emmi program starts with research. Medical writers and medical illustrators review peer-reviewed journals, print and online literature as well as national clinical guidelines. The next step is to gather direct patient feedback to prepare an outline for in-depth review and confirmation by medical advisors.

The next step is to assemble an expert panel of medical advisors for each specialty to review the research and identify best practices for a given procedure. A first draft of the script is created by medical writers and then an “alpha” version of the program is created with essential medical illustration and computer-generated voice over. The alpha version is then reviewed by the medical advisors and patient advocates (patients who have experienced the procedure or chronic condition).

Once satisfied with the basic format, remaining illustrations, animations and narration are added. Additional feedback is provided by medical advisers and patients advocates followed by creation of a “beta” version. The beta version is reviewed, revised if necessary and then approved for initial release. The program then goes through outside functionality testing. After the program is finalized in English, it is then translated and released in Spanish.

Implementation

The process begins with a patient visit where the physician recommends a procedure and routine informed consent discussions take place. At the time the procedure is scheduled, the family is given a unique access code by the scheduler for that specific procedure (plus anesthesia, if appropriate) and an e-mail address is collected.

The family watches the program and the interaction is recorded in a secure database. The database documents and archives the patient’s path throughout the program. The vendor also offers a product called EmmiManager, which is a Web-based secure database that is specific to each clinical division or department, and is managed on-site by the administrator of that division or department.

The database contains a log of families to whom the program was prescribed, and tracks access and completion of the program. The system can send automated e-mail reminders to families that have not watched the program, or have not fully completed it. The data is stored indefinitely on a secure server.

Challenges are inherent in the implementation of any new system or program but our experience has been that remaining flexible, starting in small cycles and enlisting the collaboration of the providers was the key to our success.

Results

To date, over 6,000 access codes have been issued by healthcare professionals of the Nemours Foundation, with an average completion rate of 43 percent. When e-mail reminders are forwarded to the family, the completion rate rises to 77 percent. In addition, the availability of a kiosk for viewing on site, results in completion rates above 80 percent. Of the families that viewed the program, 38 percent took the optional post-Emmi program survey.

The survey results reflected that over 90 percent of patients said it improved their understanding of the procedure, provided new information and increased their comfort level with the procedure. Over 85 percent said it increased their confidence in their doctor, answered questions and saved a call to the doctor, covered risks they didn’t know about previously, and improved their understanding of what to expect before and after the procedure. Finally, more than 50 percent of respondents said it helped explain to their child what to expect and that they planned to share it with family or friends.

Effective consent processes are required to ensure that families understand the risks and benefits of a procedure, and are necessary to minimize potential liability.

Utilizing an interactive, Web-based program as an adjunct to the standard consent process, can provide many advantages for families. It enhances the patient’s understanding of the procedure, increases their awareness of the risks, benefits and alternatives, and provides information in a setting that enhances learning from an Internet-based format.

From an organizational perspective, this approach leverages technology to manage patient expectations regarding outcomes, documents patient/family education, and encourages patient participation in healthcare decisions, thus reducing risk and improving patient safety.

Linda A. Pilla, Esq., MBA, is chief risk officer for the Nemours Foundation. Contact her at [email protected].