Informed consent is a routine part of health care, yet it is one of the most misunderstood concepts even among experienced doctors, reports the Medical Group Management Association (MGMA). What informed consent is not: just having patients sign a form. What informed content is: a combination of ethical, legal, and practical considerations that impact the doctor-patient relationship, malpractice claims, patient engagement and outcomes.
As medicine shifts to more patient-centered care, informed consent practices must shift as well. “Informed consent defines 21st-century medicine, contrasting sharply to the days of paternalistic care,” writes physician Sara Scarlet on KevinMD.com. “Informed consent, when done properly, puts decision making into the hands of our patients.”
Here’s what you need to know about informed consent, and some tools that doctors are using to modernize and improve the process.
Not just a legal issue
The legal doctrine of informed consent is founded on the general principle that a person of the age of majority and sound mind has a legal right to determine what may be done to his or her body, explains this article in the AMA Journal of Ethics. “To avoid legal action … physicians must disclose enough information for the patient to make an ‘informed’ decision” about medical treatments and procedures. This is the tricky part, however, because informed consent requirements vary by state, and do not specify how much information is “enough.”
But focusing only on the legal aspects of informed consent misses the point—and not only because doctors who have obtained it have still been sued. “A signed and witnessed informed consent document doesn’t mean there is no legal risk. Many patients who sue claim that their surgeon didn’t give them enough information about the operation or didn’t give enough time to decide whether the operation was right for them,” states this article on the American Academy of Ophthalmology (AAO) web site.
Instead of thinking of informed consent as a box to be checked, it’s better to look at it as an opportunity to educate patients and make them active partners in their care.
What is informed consent?
In his article for MGMA, attorney Stephen Dickens breaks down informed consent into four categories that doctors should cover with their patients when recommending any treatment or procedure:
Risks: What is the danger of a recommended treatment? While doctors don’t need to list every potential adverse outcome, they should address those outcomes most likely to affect patients, and make sure patients understand them. If you’re using high-quality patient education materials, this doesn’t need to take a lot of time. “In theory, if a patient is properly educated, the execution of a signature on paperwork reflecting this should add very little time on the front end but could save years of wasted time in litigation on the back end,” writes Dickens.
Benefits: What can a patient realistically expect to achieve from adhering to the prescribed treatment? It’s a good idea to discuss both the likelihood of potential benefits as well as factors that would prevent those outcomes for that particular patient.
Alternatives: Are there other treatment choices that should be considered? For example, should a patient consider a nonsurgical approach, such as glasses or contacts in lieu of Lasik surgery? Doctors can offer options and opinions without endorsing them.
Consequences: What are the potential implications of a patient’s decision, whether it is to follow a recommended treatment, pursue an alternative, or do nothing? “Truly informed consent may also require disclosure of potential risks associated with not seeking treatment,” notes the AMA Journal of Ethics. An example would be informing a patient who has refused a certain diagnostic test that he or she could be at risk of developing a disease that may go undetected.
How much info is enough?
Again, the question of how much info is enough misses the point. The real question is whether the information you’re providing to your patients is helping them make educated decisions about their health.
Dr. Michael Cooper of Windham Eye Group in Willimantic, Conn., specializes in dry eye treatment. He has incorporated patient education videos into his practice’s informed consent for certain procedures. “If patients don’t watch the video, they can’t get the [procedure] done,” he says. “This helps with compliance.”
As the article in the AMA Journal of Ethics points out, “Many patients may have a limited understanding of medicine, so it is difficult, if not impossible, for a physician to confirm that a patient has given adequately informed consent. Hence, it is almost self-evident that adherence to the doctrine of informed consent requires a physician to disclose enough about the risks and benefits of proposed treatments that the patient becomes sufficiently informed to participate in shared decision making.”
Dr. Cooper says he’s seen a change in his patients’ understanding and participation since he first incorporated the patient education videos. “Their questions aren’t way out there in left field, which is what happened prior to using [the videos]. … They’re relying on us for the details, but it’s no longer surface level. Their questions are more constructive. They really understand what it means.”
As the AAO notes, “informed consent encompasses every piece of educational material your patient gets from your practice,” including verbal descriptions and instructions, patient handouts, videos, and marketing materials.
To find out how you can improve your patient education materials and streamline the informed consent process, contact us today to get started.