Bill Klaproth (Host): Welcome to the ASHRM Podcast, made possible by the American Society for Healthcare Risk Management to support efforts to advance safe and trusted healthcare through enterprise risk management. You can visit ashrm.org, that's A-S-H-R-M.org/membership, to learn more and to become an ASHRM member. I'm Bill Klaproth.

And with us to discuss this is Bruce Keplinger, founding member of Norris Keplinger Hicks and Welder. He is also a mediator for Jay Daugherty Mediation and Arbitration. And Dr. Ankur Patel, co-chair of the North American Neuromodulation Society Residents and Fellows, and the Young Neuromodulator Section. Bruce and Ankur, welcome to the ASHRM Podcast.

Bruce Keplinger: Thank you. It's great to be here.

Dr. Ankur Patel: Hey, Bill. Thanks for having us.

Host: You bet. Well, Bruce and Ankur, thank you again. Ankur, let me start with you. The intent of this podcast is to present the benefits associated with the use of video to support the informed consent process. Before we get into that, can you just share a little bit of your background and expertise in this area?

Dr. Ankur Patel: Yeah, absolutely. And again, thank you for inviting us today to discuss this important topic regarding medical informed consent. I'm Ankur Patel. I'm an interventional pain physician. I completed my residency training in physical medicine and rehabilitation at New York Presbyterian Hospital, Columbia and Cornell, and my pain medicine fellowship at Weill Cornell, Memorial Sloan Kettering Cancer Center and Hospital for Special Surgery. It's great to be here today to discuss this exciting topic, and I look forward to this podcast.

Host: Yeah, absolutely. So, thank you again for your time. So, why was there a need to create new guidelines for informed consent? Can you give us your thoughts on that?

Dr. Ankur Patel: Yeah, excellent question. So, the current informed consent processes and recommendations that are typically published by medical societies and boards tend to provide general guidance and are not specific to the area of practice. Oftentimes, the informed consent forms typically list a wide variety of risks. And this includes like bleeding, infection, organ injury. But oftentimes, we see that these are not specific to the individual procedure or an area of specialty.

So, the goal of the guidelines, which were developed by the American Society of Pain and Neuroscience, was to provide recommendations and a framework for interventional pain physicians and spine surgeons. And the goal here was to determine effective and appropriate education and informed consent practices. The authors had determined about eight best practice categories and provided consensus-based recommendations, and these guidelines were actually presented this past July at the annual American Society of Pain and Neuroscience meeting. And we received positive feedback from providers in terms of how to incorporate this into their daily practice and to improve the overall informed consent process with their patients.

Host: So, it sounds like these guidelines are more specific now.

Dr. Ankur Patel: Exactly. So, they're a little bit more specific and they're tailored to the interventional pain physicians and spine surgeons. Different areas of specialties will have their own variations in terms of their guidance. But one of the big components that we had discussed was the use of multimedia, which is kind of one of the big components we're going to be discussing today on the show.

Host: Yeah, that should help with patient retention. So, let's talk about patient retention. As you know, patients remember very little of the information presented during the informed consent discussion many times. They're anxious, they're nervous, they have a hard time remembering what was told to them. And some studies suggest that patients may only remember 25% of all the risks and complications and alternatives that's explained to them. So, can the use of video then help patients improve their understanding of the procedure?

Dr. Ankur Patel: Yeah, Bill. Great question. And I think going back to your previous statement, it's very interesting that like 25%, that's a very shocking number, right? So, like the amount you're going to tell a patient, they're going to remember about a quarter of that. And a lot of this is very valuable and very important information, especially as they're deciding if they want to undergo this procedure or intervention.

So, studies overall have looked at the incorporation of multimedia in the informed consent process, and have found that videos actually help patients increase the understanding of the procedure and the entailed risk. This often results in higher satisfaction rates, and there's data indicating that there's a direct correlation between higher satisfaction scores and a lower likelihood that the patient will sue their physician.

Another benefit to the physician is that the video informed consent can ensure that all the required information is presented to the patient, removing the risk that some information was incorrect or omitted. So, this actually allows for patients to be really educated regarding the risk, benefits and alternatives prior to them consenting for the procedure.

Host: I could see how the standardization would really help in making sure that no information is accidentally left out. So, how do these videos get made?

Dr. Ankur Patel: Yeah, great question. So, the videos developed are vetted by a malpractice attorney and physician who specialize in the particular field. So, these make these videos very specific and tailored for that individual procedure itself. Overall, I believe that the key component is incorporating the use of videos to help supplement the traditional informed consent discussion,, which can help increase patient comprehension and satisfaction and really further individualize the process as the patient's kind of going through the informed consent discussion.

Host: And then, at what point in the process or where do the patients watch the video?

Dr. Ankur Patel: So currently, patients are able to watch a video in the doctor's office as part of the evaluation. This allows the patient the opportunity to ask questions and have a discussion prior to signing the consent. The next generation of the software will actually allow patients to be able to receive a link to watch the video at a time that is convenient for them. So, many patients may actually elect to watch this with the family member or caregiver and have the option to watch as many times as they wish in order for them to feel comfortable with the procedure. As physicians, we really want our patients to feel very comfortable, especially in understanding the risks, being educated, and have ample opportunity to ask questions with their family members. So, I think this next generation of the software will really allow that. The patient will then electronically, sign the consent video, and a copy is sent to the electronic medical record.

Host: Well, there seems to be so many positives with video that you just mentioned. One, you can watch it over and over if you like, and you can watch it with family members as well. So, that does really seem to be beneficial when it comes to video. So, are malpractice carriers supportive of the use of video to document the consent process?

Dr. Ankur Patel: Great question. I think at this time, it is a little too early to determine this. Some early adopters have mentioned that they may be able to reduce their premium through the video informed consent process. However, this cycle will vary between practice and malpractice carriers.

Bruce Keplinger: And if I could chime in, anecdotally, I'm aware of several carriers because I deal with them who are very intrigued and excited about this process. Supportive is the word you used, Bill, and I can't say supportive, but they're intrigued and enthusiastic and they see it as the wave of the future.

Host: Well, thanks for chiming in on that, Bruce. We appreciate it. So, let's bring you into the conversation. Can you tell us about your expertise and background in this area?

Bruce Keplinger: Certainly. Thanks again for having me. I've been a lawyer for 46 plus years and, for at least four decades, have focused on defending physicians and hospitals. I've tried 150 jury trials to verdict and over a hundred of those have been medical malpractice trials. I've handled thousands of cases. I was elected in the American College of Trial Lawyers in 2009. And I've been in Best Lawyers in America on malpractice defense for a little over 25 years. And I've seen my share of informed consent cases.

Host: Outstanding. So, you definitely are well-versed in this area. So, how often do you work on a case related to informed consent?

Bruce Keplinger: Well, I would say that when a plaintiff files a petition, they can name a number of counts, and I would say informed consent is a part of the complaint at least a third of the time, maybe 40%. And it's the focus of the claim, like the main claim, maybe 20% of the time. There's a statistic that's broader than my experience that shows 27% as the informed consent number, which is probably more reliable than my personal anecdotal experience, but I'm more like 20% that it's focused on informed consent.

Host: And in the cases that went for the patient, just curious, what type of payment are we generally talking about?

Bruce Keplinger: Well, nothing is typical. It depends on the level of injury. I personally handled an oral surgery case where the informed consent was improper as to the difference between conscious sedation and general anesthesia. And the patient consented to the former, but was given the latter and everything went wrong, and that resulted in an eight-figure payment to the plaintiff.

I'm aware of a gynecological case, where I think physician really did give all the proper warnings, but he did not have a complete record that he had. And that was a seven-figure verdict. I'm also aware of a pain management epidural-type injection case followed by a catastrophic infection where the plaintiff claimed that he was not warned of infection, which makes no sense at all, but the jury believed it. And it wasn't really recorded in the record, and that was a seven-figure verdict. And there are defense verdicts too, but that gives you some idea.

Host: For sure. So then, what is your opinion on the use of video to support the informed consent process?

Bruce Keplinger: Oh, I think it's a complete game changer. Some physicians and even lawyers still think that the written consent form is proof of informed consent, but at best, it's only part of the process. You need to prove that the physician gave sufficient information for the patient to understand, and there can be a lot of reasons that the patient didn't understand. They're nervous, they have language issues, they have capacity issues, there's cultural differences, lots of reasons why just putting a paper in front of somebody and having them sign it is not the end of the discussion. Whereas the informed consent video that we're talking about gives all the benefits Dr. Patel has already mentioned. It's complete, it's consistent, it's tailored to the procedure, and it allows the physician if there are further questions to give responses tailored to that unique patient's unique questions rather than time after time, giving a rote answer of the risk, benefits, alternatives, et cetera. And then, there's a video proof that the patient was watching and being told these things so they really can't deny it later. And I think it's an extraordinarily valuable tool that will make a defense lawyer's life easier and I hope make physicians' lives easier.

Host: Yeah. So, it sounds like you're not necessarily a fan of written consents. You obviously have worked with them a lot.

Bruce Keplinger: They're better than nothing, but I think juries basically ignore them and analogize them to the manual in the glove compartment of your car when you buy a car. Nobody studies those and nobody studies those forms before they sign them.

Host: So in the cases you've been involved with, did you feel the patients had a true understanding of all the elements of the proposed procedure, the risks, the complications, the alternatives?

Bruce Keplinger: I would say almost never. Sitting here, I can't recall a case. Of course, a lawsuit has been filed by a plaintiff, so it would be rare for that person to say, "Oh, yes. I understood everything." But as Dr. Patel said, I think it's the truth that they understand 25% or less of what's thrown at them before a procedure. Whereas the point of this, while making suits harder to file and easier to win for the defense, the main thing is giving better information to the patient, giving them ample time to understand, still giving them time to ask questions. So, the best benefit of this isn't the legal benefit, it's what Dr. Patel talked about. It's better for the patients.

Host: So then, when it comes to written consents, are they always held up in court?

Bruce Keplinger: No. Written consents, I think, seldom carry the day for the reasons I said before. Almost every juror has themselves signed a consent that was shoved in front of them, more or less at the last minute. And perhaps with no conversation with the physician herself or himself as to what the procedure is going to be like.

So, I would say written consents are certainly better than nothing. And, as Dr. Patel said, even at the end of this type of video consent, there still needs to be a signature. So in that extent, they're important.

Host: So then in your experience, what other issues may lead to a patient filing a claim related to informed consent?

Bruce Keplinger: Well, it's basically that something happens to the patient that they didn't anticipate. And whether the broad language of, for example, a gynecological procedure, if the printed page says damage to adjacent organs and, during a gynecological procedure, a ureter gets cut and they lose a kidney. They truly say, "I had no idea I could lose my kidney from this." And so, it just needs to be explained better. And in the video that's specific for this procedure, damage to adjacent organs is explained in much more detail, including loss of adjacent organs such as the kidney if the ureter is damaged, so the patient really is better informed.

Host: So, you mentioned earlier people are filmed watching the informed consent process. That seems like it's really important. Can you talk about that?

Bruce Keplinger: Yes. Again, from the legal point, I think the best thing about this informed consent is it's better for the patients. But from a legal point-of-view, there's just no way for a patient to deny that they were told something when there is video evidence that their eyes were focused on the screen as they were hearing and seeing the explanation that did mention the complication that happened. And my understanding of the software is that if the patient looks away or stops paying attention, the video reacts to that. So at the end of the day, you get a signed video consent of somebody who incontrovertibly was told about the complication, which forcloses the informed consent on that issue.

Host: And then, there was a recent article indicating that 10% of physicians are now using some form of video to support the consent discussion. Where do you see the use of video going in the future?

Bruce Keplinger: Oh, I think it's going to rise until it's what most people do. I hesitate to use the term standard of care because this will be listened to at least nationwide. And standard of care means different things in different states. It's physician-based in about half of the states. It's patient-based in about half of the states. And the better model going forward is a mutual shared decision-making standard for informed consent. And that's what this video informed consent does. It gives a complete and consistent explanation of the current science on the risk, benefits and alternatives, and still gives the patient with unique questions. Perhaps they're diabetic and that raises a special issue in a particular case, they can and should speak with their physician one-on-one about that particular unique aspect. So, there will still be face-to-face, there will still be tailoring the case to the specific patient, but I think the use of video will be, I won't say standard of care, but I will say I think it will become standard.

Host: So, thank you for your time, Bruce. We appreciate it. As we wrap up, any final thoughts as we talk about using video for the informed consent process?

Bruce Keplinger: Well, this is probably repetitive, but I think it's so important because it raises the patient's understanding. It gives them ample time to review multiple opportunities to review, and it just makes them a better informed patient, which is better for everybody. And it's better for the legal position of the physician, because there is proof that the patient was informed with a product that has been, as Dr. Patel said, vetted by a physician in the specialty and an attorney. So, the final thought is this is just a win-win for the patient and the physician.

Host: Absolutely. And then, Ankur, we'll bring you back in. Any final thoughts from you as we talk about the informed consent process?

Dr. Ankur Patel: Yeah, absolutely. I agree with Bruce. The informed consent process can have significant legal implication. I think the use of video informed consent is just emerging in the medical field. And as it continues to gain traction, it will really change the overall process. What I want to leave you with is that the goal of informed consent process is not merely a signature, but it's an evolving discussion to effectively educate patients regarding the risk, the benefits and the reasonable expectations of treatment. I think video informed consent will help supplement this process as we go forward.

Host: Absolutely. Well, Ankur, thank you so much for your thoughts. So Bruce and Ankur, thank you for your time today. We really appreciate it.

Bruce Keplinger: Well, it's been our pleasure to talk to you, Bill. And we hope that this discussion is of some benefit to those who listen to it.

Dr. Ankur Patel: Thank you, Bill. I really appreciate the invitation.

Host: And once again, that's Bruce Keplinger and Ankur Patel. And for more information, please visit informedconsent.com. That's informedconsent.com and the ASHRM podcast was made possible by the American Society for Healthcare Risk Management to support efforts to advance, safe and trusted healthcare through enterprise risk management. You can visit ashrm.org, that's A-S-H-R-M.org/membership, to learn more and to become an ASHRM member. And if you found this podcast helpful, please share it on your social channels and check out the full podcast library for topics of interest to you. Thanks for listening.