• September 2008 FEATURE ARTICLES •
Informed Consent
Visual Confirmation
A children’s healthcare system utilizes educational video modules to bolster the informed consent process.
By Linda A. Pilla
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 Lpilla@Nemours.org.