Legally required in all 50 states since the 1970s, the process of obtaining informed consent has largely gone unchanged over the last 50 years: Doctor gives patient form, patient reads form (in theory), patient signs form. Next!
Move over paperwork. Times are changing. Video, pre-printed templates, quizzes and other resources are joining the informed consent conversation. From cataract treatment options to medication injections for AMD to blepharoplasty eyelid surgery and beyond, practices are increasingly leveraging such resources to bolster their informed consent efforts.
HELP FROM OPHTHALMIC GROUPS
In conjunction with the AAO, for example, the Ophthalmic Mutual Insurance Company (OMIC) offers some 80 videos (tinyurl.com/45czx7zr ) to “help provide a consistent, thorough informed consent process.” The videos cover cataract and refractive, retina, glaucoma, pediatric ophthalmology and oculoplastics subspecialties. Running about 5 minutes in length and offered in English and Spanish, each video presents the risks and benefits of procedures and technological options. The files can be shown on tablets or computers in the office, placed on websites or sent via patient portal/email.
Other companies, such as AATMA Studio of San Francisco and Ocular Innovations, offer specialty-specific animations to enhance patient education related to informed consent.
STANDARDIZED INFORMATION AT THE PATIENT’S FINGERTIPS
Sidney Gicheru, MD, a spokesperson for the AAO and a laser and cataract surgery specialist with Lasercare Eye Center in Dallas, is among the growing number of providers who see the value of such resources. Dr. Gicheru offers online articles, custom videos and other resources for patients to access on his website, many of which his practice produces. In one self-produced video, he explains the informed consent form in terms the average patient can comprehend.
“After doing this spiel for 15 years, I figured it was just easier to have a customized video that has all the information but presents it in a very easy-to-understand way.
“It assures me that for every single patient we do surgery on, that the informed consent process is standardized. It doesn’t matter whether I’m having a good day or a bad day, it’s the same discussion every single time,” says Dr. Gicheru, who also offers animated videos for patients to watch in his waiting and exam rooms. These animations, he says, are “less threatening” to patients than watching videos of real-life procedures.
Robert J. Weinstock, MD, director of cataract and refractive surgery at The Eye Institute of West Florida and the Weinstock Laser Eye Center in Tampa Bay, takes a similar approach. Like Dr. Gicheru, he hosts several of his own self-produced videos, accessible via his website’s patient portal. The videos describe the technologies his practice offers as well as the pros and cons involved. Patients view them on an iPad in the office.
“Patients can reference those videos and hear it directly from me explaining these different solutions, whether they’re monovision lenses or multifocal vision lenses,” he says. The aim is to “help them understand what their options are when it comes to cataract surgery.”
Additionally, Eyesmart (the Academy’s public website) is a resource ophthalmologists often use with their patients for articles and videos (for example: tinyurl.com/4jetc9b8 ; tinyurl.com/yc26c78t ).
A REINFORCEMENT, NOT A REPLACEMENT
The object of these media, the doctors stress, is not to circumvent the traditional, legally required informed consent process. Face-to-face conversations and patient completion of the requisite paperwork remain essential aspects of informed consent. Instead, the goal is to bolster patient education.
Legally speaking, only about a half-dozen elements must be included in an informed consent form: a description of the proposed procedure and its risks and benefits; alternative treatment options and their risks and benefits; the name of the provider performing the procedure and an estimated time for recuperation. However, the application of informed consent can vary by state.
Some, for example, employ a “community standard” that physicians must follow in providing information about risks and other factors that the average prudent physician would disclose. Most other states go further and mandate disclosure of all information that a reasonable patient would find significant in deciding whether to undergo a procedure.
But, that short list belies the fact that most forms provide extensive, detailed information about the benefits and potential risks of a procedure and can run for many pages of legalese. Many patients sign on the dotted line without thoroughly reading them.
“We request that patients review the entire document before signing, but in some cases, patients may sign without reading the entire document,” says William Trattler, MD, an ophthalmologist at the Center for Excellence in Eye Care, Miami.
Providing additional resources such as the videos help battle that tendency. Among other advantages, they can help improve understanding for patients with limited language comprehension, literacy or visual or hearing impairments, and they help providers save time, especially in high-volume practices.
AVOID LAWSUITS
The resources also help set and manage patient expectations. Many ophthalmologists view this as equally important to protecting physicians against accusations of malpractice — particularly with respect to elective procedures such as LASIK, PRK and ICL, as well as choosing IOLs for cataract surgery.
Dr. Trattler notes that patients may initiate a lawsuit if they simply feel they were not fully informed, particularly in the realm of elective procedures.
“Even though they’ve signed an informed consent form and the procedure was performed properly, if the patient is surprised or upset by their outcome or even their experience during and/or after surgery, they can decide to initiate a malpractice claim,” says Dr. Trattler.
Dr. Weinstock agrees. “If a patient is going to be opting for a multifocal lens, they have to understand there may be glare at night,” he says. “If they’re going to be doing monovision, they need to understand that they may need glasses for driving at night. In today’s modern world of cataract surgery, patients [need to] understand what they’re getting into, and in a way that’s an extension of the informed consent process.”
TIPS FOR A MORE INFORMED CONSENT
The Academy and the OMIC offer these tips to help reduce the risk of malpractice litigation:
- Stay current. Outdated patient education materials and informed consent documents can increase the risk of a medical malpractice suit. AAO patient education materials are peer reviewed annually.
- Customize your forms. Download informed consent form templates from the OMIC website to help ensure you have the most current documents.
- Document, document, document. Note directly in your patient’s chart the educational materials provided and the informed consent obtained. Defense attorneys advise documenting the timing and receipt of educational materials by the patient with their initials.
COUNTER “DR. GOOGLE”
Dr. Gicheru says that relatively little information was available online about procedures such as LASIK, PRK and ICL when he began practicing in 2000. Today, however, many prospective patients arrive at his office armed with information they’ve found online — information that’s not always accurate.
“Sometimes you have patients come in for LASIK and think they’re going to end up with almost literally Superman vision,” he says. “It’s important for them to be educated, and I find that these videos and additional resources really help with that.”
To further help guard against unrealistic expectations, Dr. Trattler has in the past given patients a quiz to take after viewing educational videos. The quiz helps demonstrate their understanding of the risks and extent to which a given procedure like LASIK can improve vision. (For more, see “Ophthalmology community gives FDA side-eye,” page 16.)
“When I first started performing laser vision correction, our patients watched a video and then filled out a short questionnaire to demonstrate their understanding of the procedure,” he says. “While this process was helpful in the early days of LASIK, we have moved to having the physician and staff verbally educate patients on the procedure, and then our patients will sign an informed consent document.”
MORE THAN PAPERWORK
When it comes to informed consent, sitting down for a discussion and giving patients the paperwork to read and sign on the dotted line isn’t going away. But along with the growing number of treatments and ubiquity of information — and misinformation — on the internet, there’s a growing recognition that may not be enough. Leveraging additional tools can help patients and providers see their way together to higher-quality care and greater satisfaction.
“I think we all need to go above and beyond what we’re legally required to do,” says Dr. Gicheru. “Informed consent today is much more of a collaborative process to make sure the patient understands the risks and benefits and also has realistic expectations.” OM