Malpractice, Patient Safety, Physician-Patient Relationship

Informed Consent: An Essential Element of a Good Physician-Patient Relationship

Editor’s note: In this guest opinion article, Dr. Sina Haeri discusses why obtaining informed consent is an essential element for a good physician-patient relationship.

By Sina Haeri, MD, MHSA (Chief Medical Officer, Confirmed Consent)

When speaking to clinicians, odds are that obtaining an informed consent as part of their daily practice is not a top-of-mind item, and in many cases, it’s viewed as a nuisance due to the redundant nature of the task. In fact, that redundancy in itself leads to complacency, where many pass the task to their staff including a nurse or a medical assistant. Furthermore, given that the time spent counseling the patient is baked into the procedure reimbursement, some providers view this redundant task as one that keeps them from generating revenue. Further compounding the issue is that with decreasing reimbursements clinicians are supposed to see more patients in less time, which again acts as a dissatisfier for the process.

From the patient’s perspective, the reactions are highly variable. While many folks are happy with the overall consent process, many 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, process? How much of the information can you relay to your loved ones when you get home? Indeed, studies have shown that up to 60-70% of patients don’t demonstrate adequate memory recall when walking out of the provider’s office.

With that said, what can we do about the consent process to make it more enjoyable for both the provider and the patients? More importantly, what can we do to make the process serve its intended purpose, which is educating the patient to the point that the decision is truly an informed one? In the sections below, I’ll use some of the biggest legal mistakes a clinician can make during the consent process to provide suggestions for a better process. 

Failing to 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 clinician bias and other variables in the clinical setting. A common personal observation with trainees has been to notice the difference in the counseling when it is known that the patient is an attorney. Don’t all patients deserve that level of detail? How about a patient of a lower income level or a specific race- how do we ensure that the internal perceptions and biases of the clinicians don’t impact the level of detail they deliver to the patient. The best practice for this would be to remove the human bias element. 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.

Failing to have a procedure to document that the patient has understood the information provided, and all questions answered

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. Ask yourself how that is being done in your current practice? Is it a matter of writing in the chart “patient verbalized understanding?” If, so, how do you prove this? 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. 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.

Failing to obtain a documented consent

This may seem silly, but it happens in a multitude of ways. The clinician delivers the information, but never gets around to documenting it. Or better yet, 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 obtains the patient’s consent for a myomectomy (removal of a fibroid), but while 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 ever cause torsion of the ovary or other related complications, and decides to remove it. The patient returns to the ER a week later with bleeding from where it was removed. Best intention or not, did the patient truly consent to 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 obtaining informed consent.

Failing to have the informed consent information 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 much flexibility to consider my options. He was a delightful man who basically came up, went over details of general anesthesia, without any alternatives. How is a patient supposed to consider alternatives in this very common scenario? 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 stated” Good luck with that!” Don’t our patients deserve better than this? With the advent of technology, why can’t patients receive the counseling prior to the procedure?

Failing to 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 also less likely to be unhappy with the outcome leading to litigation risk. 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 an invaluable 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, nothing beats adding some visual cues so that the patient can better conceptualize what you plan to do.

Failing to use layman’s terms

It is very common for us to get caught up in our comfort zone, which is rattling off the pathophysiology of the disease, the surgical technique, and not stop and have the patient ask questions. The best practice is to slow down, speak in layman’s terms without coming off as patronizing, and stopping to explain medical jargon that might be confusing for a patient. Another point to mention in this is a scenario where the patient or a family member may be a physician colleague. I’ll use my specialty as an example. As a Maternal-Fetal Medicine specialist, at times I find myself speaking to a 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.

Failing to 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. Now, 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 early impact of cognitive decline? We must also be conscious about documenting the refusal along with the reason provided as that can impact the patient’s care in the future. For example, a patient with severe anemia (hemoglobin of 5) 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 clinical coming from behind have any idea about the patient’s wishes? 

Delegating informed consent duties to an assistant or trainee

During the course of my work with the informed consent process, and customer discovery process, nothing uniformly 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, know the risks first-hand, and are there times when the patient has questions but feels “bad” by asking to see the clinician as they may inconvenience them? Another related scenario is that of trainees (residents, fellows) consenting 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 he had observed (during a routine site visit at prominent institutions) surgical patients recovering from a procedure that the consent on the chart was signed by a resident. We must 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 as the ultimate responsibility to the patient belongs to the attending. 

Failing to inform the patient that they have the right to say no to the procedure

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 to refuse. As clinicians, at times we get so caught up in the disease and the treatment that we forget it is not the only option for the patient.

With those points stated, the question that comes up is “so what can we do?” 

  • The best first step is to recognize that just because this is not a top-of-mind item for many clinicians, it doesn’t mean that the process can’t be improved. 
  • 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.
  • Evaluate the many available resources, best-practice guidelines, and vendors available to optimize your facility’s consent workflow.
  • During routine customer satisfaction surveys, inquire about the experience with consent as this is an often-overlooked item.
  • Incorporate your findings from the above steps to optimize the process so that your patients are truly making an informed decision.

Sina Haeri, MD, MHSAChief Medical Officer, Confirmed Consent

Sina  Haeri is a Maternal-Fetal Medicine specialist with over 15-years of leadership experience in healthcare including developing maternity programs to improve access to care for some of the nation’s largest healthcare entities including HCA, and Access Physicians, and currently serves on the Society for Maternal-Fetal Medicine’s Healthcare Policy and Advocacy committee. He co-founded Confirmed Consent in 2017, where he is now the Chief Medical Officer.

About Confirmed Consent

Confirmed Consent is an interactive peri-operative consent platform that provides standardized and documented patient education, and facilitates obtaining informed consent while confirming the patient’s competency and cognition. 

 

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