Informed Consent

Clinicians often have competing priorities in the clinical setting which hinder their ability to provide time for thorough dialogue with patients. Often, this dialogue contains information about procedures or processes for which the patient needs a thorough understanding in order to make an informed decision. Due to the lack of time, sometimes this informed consent process is passed from the clinician to the medical assistant or nurse. Furthermore, clinicians are increasingly facing pressure to visit with more and more patients, thereby cutting the time with each one shorter and shorter.  Therefore, typically only the most essential information is discussed with the patient during these short times and often, education doesn’t make the cut. This asymmetrical information makes it difficult for patients to make informed decisions about their care and may create situations with unforeseen consequences. These workflow barriers within the system itself make it extraordinarily difficult for clinicians to effectively explain and discuss informed consent with their patients.

From the patient’s perspective, the reactions are highly variable. While many folks are happy with the overall consent process, quite a few can’t recall exactly what the details of the counseling were. Imagine being told that you have a specific diagnosis, and while trying to process that information, you get hit with a barrage of details about a procedure. How much can you truly retain, digest, and process this information? How much of the information can you relay to your loved ones when you get home? Indeed, studies have shown that many patients don’t demonstrate adequate memory recall when walking out of the provider’s office.

What strategies can be implemented to not only enhance education for patients around a specific procedure, but to optimize the patient-provider relationship and improve patient-centered care as a whole?

The sections below illustrate some of the biggest mistakes and challenges in the consent process and offer solutions for improvement.

Develop a standardized consent process.

The informed consent process, or the delivery of the information for that matter, should be standard for each and every patient irrespective of bias and other variables in the clinical setting. Trainees have often observed a difference in counseling when it is known that the patient is an attorney. Don’t all patients deserve that level of detail? How do we ensure that these internal, subconscious biases don’t impact the level of detail delivered to the patient. A potential solution may be to consider human factors of decision making for foundational improvement efforts moving forward. Perhaps record a video in a neutral setting, and present the information in an objective manner so that the recipient gets the same information no matter what the circumstances are. A standardized process removes the accusation that information delivered was incomplete as it can readily be produced during discovery.

Have a procedure to document the patient’s understanding of all information provided.

The core components of an informed consent are delivery of information including risks, benefits, and alternatives, documentation of the process, along with the confirmation that the patient understood the information. Assess how it is being done in current practice. Is it a matter of writing in the chart “patient verbalized understanding?” As mentioned earlier, up to 60-70% of patients don’t recall the details when they walk out the door. In fact, of the 20-25,000 malpractice claims filed annually, 1/3 are on the basis of alleged poor communication (including consent). The best way to address this is to have a standardized and documented simple mechanism to confirm and record said understanding. Consider the use of repeat back strategies to understand the patient’s retention of the knowledge and to understand where to fill in the gaps. Consider the historical hierarchy that has existed in clinical practice. Much of that tradition still exists, so it is imperative to anticipate patient questions and to allocate proper time for discussion, rather than one-sided direction. Furthermore, from a safety standpoint, a patient that is confirmed to understand the procedure is more likely to catch an error in the process that they “understand” to be different.

Obtain documented consent.

This may seem obvious, but there are often large gaps due to the inherent complexity of medicine and the fragmentation of the healthcare system at present. The clinician delivers the information, but never gets around to documenting it. Or the consent for procedure “X” is obtained and documented, but while in the procedure, another problem is encountered, and it is addressed without the patient’s consent. For example, an OBGYN consents a patient for a myomectomy (removal of a fibroid), but in the case, a small benign tumor (i.e. dermoid) is seen on the ovary. The clinician has the best intention at heart, doesn’t want the tumor to cause a torsion of the ovary or other related complications, and decides to remove it. The patient returns to the emergency room a week later with bleeding from where it was removed. Best intention or not, was she truly consented for the additional procedure? The best practice here is to document the consent that is obtained, and to not perform procedures despite your best intentions without a truly informed consent.

Ensure the informed consent information is delivered in a neutral setting for the patient prior to the procedure.

This point is often overlooked. Let me provide a personal example. 3 years ago, I had my inguinal hernia repaired. I don’t let it be known that I’m a physician as a habit. To this day, I’m amazed at the fact that I did not get to meet the anesthesiologist until I was in the pre-op holding area, with an IV in me to run the pre-procedure bolus, and truthfully, without a great deal of flexibility to consider my options. He was a delightful man but went over details of general anesthesia, without any alternatives. How is a patient supposed to know what alternatives are available? When I brought this up to the managing partner of a large anesthesia group, he sat back smugly and said “I tell the patient this is the type of anesthesia you’re getting. You don’t like it? Then find yourself another anesthesiologist.” He then chuckled, sat back, and said “Good luck with that!” Don’t our patients deserve better than this?

Use audio-visual tools to deliver the information to the patient.

A well-informed patient is often happier with the shared decision-making process and less likely to pursue litigation. Even though the use of audio-visual tools is not a must, and not specifically included in the established guidelines such as those from the Joint Commission or CMS, it is a valuable resource in educating patients about the details of the procedure, as well as the risks, which often can be related to the anatomic relationships to the site of the procedure. No matter how well you can describe a procedure, adding visual cues can help the patient better conceptualize what you plan to do.

Use laymen’s terms.

It is very common for us to get caught up in our comfort zone, which is rattling off the pathophysiology of disease and surgical technique and it’s likely the patient may not speak up to tell you that they don’t understand, especially if they sense you have little time to spend with them. Slow down, speak in laymen’s terms without coming off as patronizing, and stop to explain medical jargon that might be confusing for a patient. Furthermore, it is important to consider that the patient or their loved ones may be a clinician themselves. I’ll use my specialty as an example. As a Maternal-Fetal Medicine specialist, at times I find myself speaking to a physician patient with a non-physician spouse in the room or vice versa. In these scenarios, by default, it is best to speak to the couple or the family in laymen’s terms and to avoid the “inside baseball” talk. In essence, as you’re noticing, the theme here is the improvement of patient understanding whenever possible.

Document refusal of treatment.

Documenting an informed consent to proceed is important, but documenting the discussion and the patient’s decision not to proceed is equally as important. The first thought that many clinicians have is that this is crucial against litigation, and that is absolutely true, but we must not forget that the information documented in the process of refusal can be crucial with respect to the patient’s safety, health, and autonomy. Did the patient have the competency and cognition to refuse the treatment? Was this truly an informed refusal or was it the result of early cognitive decline? We must be conscious about documenting the refusal along with the reason provided, as both can impact the patient’s care in the future. For example, a patient with severe anemia refuses a blood transfusion due to religious beliefs with the statement that “under no circumstances, including death, will I accept a transfusion.” Rather than documenting a detailed note about this, the resident merely puts down “transfusion offered and declined.” What if the patient is brought to the hospital via EMS, unresponsive from marked anemia and resultant end-organ damage? During the course of reviewing the records and determining the treatment course, will the clinician have any idea of the patient’s wishes?

Do not delegate informed consent duties to an assistant or trainee.

During the course of my work with the informed consent process, and customer discovery process, nothing shocks me more than the frequency with which we find clinicians who believe that delegating the consent is acceptable. As you can understand, the patient is agreeing to undergo a procedure by the clinician, and as such, the counseling should come from the clinician. In cases of ancillary staff performing the consent, no matter how detailed a script they may follow, the setting is not ideal. How can the patient interact with someone who doesn’t do the procedure and who doesn’t know the risks first-hand. Additionally, there are often times when the patient has questions but neglects to voice their questions for fear of being a ‘burden’. When trainees, such as residents and fellows, consent patients at a training institution, do they know that the consent is intended to be between the attending physician responsible for the case and the patient? In a recent discussion with a former leader at the Joint Commission, our team was shocked to hear story after story of instances when this individual had observed (during a routine site visit at prominent institutions) surgical patients recovering from a procedure in which the consent on the chart was signed by a resident. We understand that trainees do need to learn how to consent as part of their education, but this should not replace the involvement of the attending physician in the overall consent process.

Make sure the patient knows they can say ‘no’.

Perhaps one of the most overlooked aspects of consenting patients is the responsibility of the clinician to let the patient know that they can say “no” or refuse. As clinicians, we often get so caught up in the disease and the treatment that we forget it is not the only option for the patient.

So what can we do to improve?

  • Recognize the organizational barriers, such as competing priorities, that fragment the clinicians’ workflows and, despite their best intentions, may lead to things falling through the cracks.
  • Objectively evaluate the consent process in your clinical setting and see if there are any gaps or deficiencies in the process that can be improved. Assess current state and ideal future state.
  • Evaluate the many available resources, best-practice guidelines, and vendors available to optimize your facility’s consent workflow.
  • During routine patient satisfaction surveys, inquire about experience with consent.
  • Incorporate your findings from the above steps to optimize the process so that your patients are truly making an informed decision.