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In today's podcast, we will focus on informed refusal of care. And when it comes to refusal of care, the intersection of risk management, ethics, and law become both obvious and crucial. I am incredibly pleased to introduce my colleagues today. We will be joined by Mallory Earley, who is the director of risk management of ProAssurance, where she has spent the last 10 years in risk management. She manages the CME team as well as the regional model, which provides risk management services nationwide.
She also advises internal and external customers on professional liability issues, writes articles, and develops educational courses, along with speaking regularly at conferences and other risk associations. She's an active member of the Alabama Bar Association, the American Society of Health Care Risk Management, and the Alabama Society for Health Care Risk Management, where she served as president. Welcome, Mallory.
MALLORY EARLEY: Thank you, Joan. I'm excited to be here today.
JOAN PORCARO: Thank you. And also from ProAssurance, we have Kelly Riedl. Kelly is a senior risk management consultant for ProAssurance. She graduated from the University of Florida and is a licensed physician assistant with over 15 years of risk management and healthcare experience. As a clinician, she's worked in various specialties, including gastroenterology, orthopedic spine surgery in the clinic, hospital, and ambulatory surgical settings.
At ProAssurance, she advises clinicians and practice administrators on healthcare risk management and professional liability issues. She is a designated certified professional in healthcare risk management, a member of the American Academy of Physician Assistants, the Florida Academy of Physician Assistants, the Florida Society for Healthcare Risk Management and Patient Safety, and the American Society for Healthcare Risk Management. Welcome, Kelly.
KELLY RIEDL: Thank you. I'm very happy to be here.
JOAN PORCARO: So let's start off the discussion. I'm going to turn to you, Mallory. Tell me a little bit more. How do we define refusal of care?
MALLORY EARLEY: All right, Joan. I really want to take a step back first. You can't really have a refusal of care discussion, or even the actual refusal until you begin with informed consent. So before getting into refusal of care, a quick, informed consent discussion must take place. As we all know, informed consent involves a patient and a physician or provider having a discussion for the purpose of understanding and appreciating the risks, benefits, and alternatives surrounding a treatment option, or medication, or a procedure, or some other type of medical care.
Informed consent really applies when a proposed treatment is invasive or potentially carries a heightened risk. Informed means the patient's given the information and a reasonable person would need to know this in order to make the decision. There are a number of misconceptions about informed consent. And we do have a quick two-minute video at ProAssurance listed in the resources below that goes over how to address and overcome some of these misconceptions.
Often, refusal of care comes on the tail end of informed consent process. The patient always has the right to refuse a treatment so long as they have that decision-making capacity. A refusal is just that, the patient, although being well informed, chooses to not partake in a treatment or an invasive procedure despite understanding and appreciating the risks of not receiving care.
JOAN PORCARO: So when we're thinking about refusal of care, would elopement or leaving against medical advice - are they all a form of refusal?
MALLORY EARLEY: Absolutely. We would consider any time a patient leaves AMA, or against medical advice, or declines even some or all of the care recommended, it would be viewed as a refusal. In risk management at ProAssurance, we advise physicians to emphasize the importance of a treatment or procedure, but more importantly, the consequences of declining or not partaking in treatment. Patients should really be made aware of the ramifications of declining. However, if the patient understands the risks of not receiving treatment and still chooses to refuse, the informed refusal discussion must be respected, regardless of how detrimental the physician or health care team member thinks that decision really is.
JOAN PORCARO: As you had mentioned, informed consent sets the stage for refusal of care. And I want to turn the attention to Kelly now. We often say there's a difference between what should be with informed consent versus what actually is. So when we're thinking about informed refusal though, who can obtain that refusal? And are there differences between the states.
KELLY RIEDL: Yes. So it's important to expand upon. Sometimes I do think there can be gaps in the informed consent process for practices. So like you said and like Mallory said, it's important to remember that informed consent is a process and not just that signed form. And this really piggybacks and expands upon that first question that Mallory answered.
So there's multiple steps in that process. And this process is designed to give patients the information necessary to make a voluntary informed decision about a proposed treatment or procedure, even if that patient's ultimate decision is not what the physician believes to be in the patient's best interest. And as Mallory suggested and as you mentioned earlier, this concept supports one of the basic ethical principles of medicine, which is autonomy. So the informed consent process really lays the groundwork for informed refusal to be possible.
Now, with regards to who can obtain consent or refusal, our ProAssurance risk management guidelines suggest that the clinician ordering or providing the care be responsible for obtaining consent, rather than delegating this to others. My understanding is that advanced practice providers can generally obtain informed consent, but it's important to know your state laws. Scope of practice and supervisory requirements vary by state, so the physician may need to be involved.
It's generally best practice from a risk management standpoint for the person who is doing the procedure or who has delegated the duty to perform the procedure to bear the ultimate responsibility for the consent process. This ensures they are available to answer any specific questions that the patient has. And since informed refusal is basically the opposite of informed consent, then you know that would apply to informed refusal as well.
JOAN PORCARO: Thank you, Kelly. So how should the care team evaluate the patient's capacity for medical decision making? Kelly, do you want to take that as well?
KELLY RIEDL: Sure. So the elements of capacity generally are readily apparent through your clinical interaction. So some examples include understanding, reasoning, communication. This evaluation is usually ongoing and informal. Capacity might be called into question when something illogical comes up. So for example, maybe your patient's mental status appears different than in the past. Maybe the patient seems newly confused or suddenly refuses care that they previously accepted. Or maybe they have some risk factors that can impair decision making, like perhaps a neurological condition.
So when a scenario like that presents, a more formal capacity evaluation may need to happen. And there are tools available for clinicians to use. If it's still unclear or there are continued concerns, a referral for more formal cognitive testing may be in order. And then depending on the results, that's when we can better understand if a surrogate decision maker may need to be established and thus be present for any consent decisions.
JOAN PORCARO: So how does patient-centered care and the concept of shared decision making come into play when a patient refuses care? Throw this one out to Mallory.
MALLORY EARLEY: Sure. I mean, we all know that at the center of a good physician-patient relationship, it starts with trust, which is often built slowly and with respect and mutual understanding. Patient-centered care focuses on the needs and preferences of the individual patient. Patients under this model of healthcare are involved in all steps of this decision-making process. Often, a plan is developed together that meets both the needs of the patients, but also the goals of the desired outcome for the treatment.
Involving the patient and their care means allowing times for questions, even complaints, and sometimes just ancillary comments. When a patient refuses care in a patient-centered model with shared decision making, the physician really needs to take a step back and explore the reasons for the declining and address-- maybe there's some misconceptions there that need to be further examined. Risks of refusing the treatment should be communicated clearly and in an easy-to-understand manner.
Sometimes involving family members or caregivers can be helpful, but you want to be cautious of that as it needs to come with the patient's consent for others to be involved in their health care decision making. Documentation of the refusal is key to show that there was not only a discussion, but that the reasons were communicated for the refusal, the patient was given proper information to make the decision, and there were attempts to address the patient's concerns and questions. But ultimately, it becomes the patient's decision to refuse care.
JOAN PORCARO: Thank you, Mallory. I'm thinking about some scenarios I've experienced in my career, and there are times when treatment that's needed is needed to maintain life and sustain life. And when that is refused, what happens? And the patient has capacity too. What should the care team do?
KELLY RIEDL: So I can take this one. This really depends on the clinical scenario. But assuming capacity is intact, patients do have a right to make their healthcare decisions. And again, this goes back to that ethical principle, respect for autonomy. The clinician's role is really to ensure this is an informed decision, and it's well understood that the decision is expected to lead to death. In these scenarios, documentation of any capacity evaluations are important. And the informed consent and refusal process with the signed form can aid in a defense if a surviving family member later tries to pursue a negligence claim because those can serve as evidence.
JOAN PORCARO: So if we were to take the scenario a little bit down a different path. So when I think about obstetrics, it's the only field of medicine in which decisions are made for one party may immediately impact the outcome of another. So when considering patient refusal in the labor and delivery unit, how does the healthcare team evaluate and determine the priority of fetal risk versus maternal risk? Kelly, do you want to take that one as well?
KELLY RIEDL: Sure. So we have seen cases where these types of scenarios can result in a malpractice claim. One that comes to mind is presented in more detail in our march 2024 Claims Rx publication, which was on the topic of clinical ethics. This case involved a patient who planned for natural childbirth, had a well laid out birth plan clearly specifying no C-section. This is something that was given to her OB, and the plan was placed in her chart early in her pregnancy. But there wasn't a lot of dialogue related to this plan documented.
After laboring for a number of hours, failing to progress, and some fetal heart rate concerns, the OB recommended a C-section, and the patient refused. So the OB spent the next few hours trying to obtain consent and ultimately called for an emergency C-section. Unfortunately, the infant was later diagnosed with cerebral palsy and would require full-time attendant care for the rest of her life. So her parents sued the hospital and all members of the labor and delivery team, alleging the delayed delivery caused the brain injuries. The mother denied being informed that continuing labor could result in her child's brain injury.
So this case really points out the importance of prevention to try to avoid these types of situations. Discussing the birth plan is an excellent opportunity to do this. This allows for dialogue and that shared decision making that Mallory described well before the labor and delivery. So while it may take more than one visit or more than one conversation, appropriate revisions to the birth plan for safe care can usually be negotiated. Patients need to fully understand the potential for complications during the birth process and how C-section may be required to safeguard the well-being of the patient and or the fetus.
Now, I know sometimes OBs are meeting patients for the first time during the labor, so this can be more challenging. But if they run into this type of scenario, it's important to talk through and understand the rationale for the patient's birth plan or C-section avoidance. Maybe bring the spouse into the conversation or even get a neonatologist involved if there's time. Ultimately, you want to ensure the patient understands the potential consequences of delaying a needed delivery and well document all aspects of this conversation.
JOAN PORCARO: Thank you, Kelly. I really like to highlight when you mentioned about bringing other parties in to help work upon that conversation with the patient and their significant other. It may even include community members, such as a religious leader or another individual who plays a supportive role in that family's environment. So I think it's an important measure to also say that sometimes challenging situations take a bit of a village type of solution.
KELLY RIEDL: Yes, absolutely.
JOAN PORCARO: When we're thinking about these situations, I think we're all risk management folks here, so how should refusal of care be documented? Mallory, do you want to take that one?
MALLORY EARLEY: Sure. I mean, you can't have a podcast on risk management topics without covering both communication and ultimately, documentation. So if after receiving information about the risks and benefits a patient refuses a treatment or a procedure, the patient's refusal should be documented in the medical record, and the patient should be asked to sign a refusal of treatment form. ProAssurance has a sample form available on our website that includes what all the elements should be in that type of form. The physician should also document the process related to the informed refusal, the main points of the discussions about risks, benefits, and alternatives, but more importantly, the specific consequences of declining the treatment.
For us in risk management, the presentation of a form that includes a risk of death if applicable for refusing, can be a real moment for the patient. They're truly signing that although, my refusal to follow my doctor's advice and undergo the recommended treatment, test, or procedure could seriously impair my health or even result in death, I as the patient choose to refuse the recommended test, treatment, procedure, and ultimately, accept the risks and consequences of my decision. It's a very powerful statement that we like to see in a medical record in the event a patient does choose to refuse treatment or some type of surgery.
We've seen and heard patients reconsider decisions when faced with the statement that bold. And at that point, it really makes them reconsider and take a step back. And when they do sign and date and are able to have that form completed, it's a good memento in the chart to make sure that that documentation is there, the discussion occurred, and that the patient ultimately did make that decision to refuse the care knowing the circumstances that they could be facing.
JOAN PORCARO: Thank you, Mallory. So coming up on time for ending our discussion, but if each of you could share just one thing with the audience on the topic of informed refusal, what would that item be? What would you want to stress? Mallory?
MALLORY EARLEY: Sure, I'll start. I think it all boils down to a strong communication with the patient. You really want to be sure that you're following their wishes, but that they are truly informed of the risks, benefits, and any potential alternatives. So it starts in the informed consent process but really becomes a shared decision making if informed refusal is the way the patient chooses to go, so long as they understand what they're committing to.
KELLY RIEDL: And for me, I would agree with that. I don't think I can pick just one. I think that shared decision making is so important again, that communication is so important. But I think it's also so important to have a great process for informed form consent in order to have a successful informed refusal process. So if you don't understand and go through all the elements that you should go through for informed consent and have a solid foundation through that, it makes it a lot more difficult to have that informed refusal well documented and really the patient being well informed.
JOAN PORCARO: So in closing, Mallory, I'd like to give you a hearty thank you for joining us today.
MALLORY EARLEY: Well, thank you, Joan. It's been a pleasure to spend some time with you and talk about some informed refusal from a risk management standpoint.
JOAN PORCARO: And to Kelly, I thank you to you as well.
KELLY RIEDL: Thank you so much for having us. We've really enjoyed it.
JOAN PORCARO: So in closing, I want to thank our audience and I hope you will be joining us for future discussions in the coming weeks. If you've enjoyed this episode, don't forget to subscribe wherever you get your podcasts and stay tuned for our next conversation featuring industry experts, bringing you the latest on topics of interest to risk management professionals. And again, thank you to our listeners, to our podcast, WTW Vital Signs.
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