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  • Adrienne Allen, MD, MPH


A new safety advisory about how to respond when patients decline recommendations around virtual care was released early in 2022 by the Academic Medical Center Patient Safety Organization (or AMC PSO). Since the beginning of the COVID-19 pandemic and a rapid expansion of care delivery online, concern has arisen about patients’ understanding of risks and benefits of that delivery model for their condition. This becomes especially important when their provider tells them that a virtual visit is inadequate. They need to be seen in person, but they won’t come in.

Because medical malpractice cases often take years to be brought and litigated, current trends in virtual care are not reflected in the data related to negligence claims. To get ahead of any potential risk, CRICO turned to the PSO to generate specific guidance for virtual visit informed refusal. The AMC PSO is a component of Risk Management Foundation of the Harvard Medical Institutions that performs patient safety activities as defined and protected under federal law.

The AMC PSO and the CRICO Primary Care Physician Leaders in the Harvard system convened to consider the issue of patient refusal when a primary care clinician recommends an in-person clinic visit instead of virtual care. The resulting Patient Safety Alert highlights the convening’s recommendations, which offer language to help providers communicate with patients, and guidance on documenting the refusal discussion.

The alert includes a review of the top allegations associated primarily with (in-person) informed refusal medical professional liability cases for a recent 10-year period and the factors that contribute to the allegations in those cases, as identified by clinical coders.

One of the co-authors of the informed refusal advisory—Dr. Adrienne Allen—joins us now. Dr. Allen is Senior Director of Quality Safety and Sustainability at North Shore Physicians Group Mass. General Brigham Salem.

Q.) Adrienne, thank you for joining us.

A.) Thanks for having me.

Q.) Could you help us set the context for the advisory. Why was the PSO interested in this issue and why did it feel like it needed to put out something on informed refusal?

A.) You know, I think with the COVID pandemic, virtual care certainly exploded, and there was little guidance on how to handle some of the tricky situations that developed or presented themselves to the clinic. And so, there was an interest in the PSO to do something on virtual care. I will say that in ambulatory medicine, having had reviewed cases for many years, a recurrent theme that shows up in our adverse event review is inaccurate or insufficient documentation of the informed refusal when patients decline the preferred and advised care. And so, whether it was virtual or not, there has been an issue around informed refusal and with the advent of virtual care, wedding the two together just made sense at this time.

Q.) And then when we start to look closely at this issue, what does the data tell us about contributing factors or typical allegations?

A.) You know, the data’s new on virtual care so when we talk about allegations and we talk about contributing factors, it’s really looking at mainly data prior to the virtual care. And prior to virtual care, the top allegations are failure, delay and wrong diagnosis; delay in treatment procedure; improper management; treatment course and improper medication regimen; and failure to monitor the patient’s physiologic status. Those are the top allegations. When we look at the top associated contributing factors, often, and this is why we wanted do the topic, it’s insufficient or lack of documentation, in particular, their refusal to treat. There are patient factors like non-adherence with treatment. There’s patient assessment factors, which is failure or delay in ordering a diagnostic test. There’s failure to appreciate and reconcile relevant signs, symptoms, and tests. And in the patient assessment realm, there’s a narrow diagnosis focus.

Q.) Informed refusal—so this is a situation, you’re with a patient and you’re recommending something. The patient says, ‘I don’t want to do that or I’m going to do it differently. I’m going to wait’ or, you know, just basically not sort of going along with what the doctor is suggesting or the practitioner is suggesting.

A.) That certainly is not rare in practice and there are many reasons for it. When we look at it through the virtual lens, we have to think back that a lot of this care was being delivered during the COVID crisis. And a lot of the refusal of care was patients refusing to come into the office because they were afraid to catch COVID or leave the house. And a lot of it was a failure or a fear of going to the emergency room for similar reasons and then some concerns about copay.

If we look under the hood a little more though, I think there is some patient understanding factors and often what we were finding is that the team would say, we advise you to come in or we advise you to go to the emergency room without saying the scary words of why. And so, there’s a reluctance sometimes to say, ‘I’m worried you are having a heart attack. I’m worried you could die.’ Or ‘I’m worried this abdominal pain could be something serious like a ruptured appendix. This is why we would like you to come in.’

The care team at times is not used to saying what we’re really thinking because sometimes it’s scary. What we’re encouraging clinicians to do is actually say what you’re worried about to help truly engage in that shared decision making. And then document if the patient declines but at least at that point, there’s a shared understanding of what the concern is and what the potential adverse events could be.

Q.) Well, it sort of sounds like we’re worried about telling the patients what we’re worried about but how do you overcome that?

A.) I think that’s at the crux of it, and I think the literature would support that. I think there was an old study about chronic kidney disease in particular, and patients never knowing they had it even though it was listed as a diagnosis. People are afraid to say those words.

You know, I think part of overcoming it is talking about it openly together. There has been great advancements in shared decision making and patient autonomy over the last many years. And so, part of that is giving the patients the information they need and actually saying the worst. Often the team is afraid of scaring the patient and saying what the worst could be or often it’s not the worst, right? We tell them we’re worried it could be a heart attack and it turns out it’s not and then you lose credibility but, you know, I think if framed correctly and with practice, it gets easier to do, you know. ‘While most likely it’s not a heart attack. This could be, I’m worried it could be, and we want to make sure we get you the best care. So it’s really with scripting, scripting and practice with the team.

A big barrier to this quite honestly is time. You know, in a busy practice, with multiple phone calls and particularly during the height of COVID with multiple calls about COVID and other things, it’s hard to take the time needed to adequately discuss this. And this is where scripting can help, you know, short lines or short sentences that could be readily available to team members to say ‘I’m worried your chest pains could be a heart attack. For this reason, we’re going to the emergency room.’ I think scripting can help when time is short and it can help leverage team members, not just the primary care doctor or the head NP to have this conversation. We want to empower others on the team to be able to engage with patients.

Q.) How did you avoid adversarial feelings in this kind of discussion?

A.) Right, that can come up too, I think sometimes when a patient refuses care, there’s a natural inclination to either get defensive or to write off that patient, right. They refuse, often you see the record, they refuse care and we leave it at that. I think it’s hard in the moment and it’s particularly hard when things are busy, and I think that’s when leveraging the team can help. I think sometimes patients don’t express all of their fears to the physician or to the NP and maybe leveraging the nursing team and the medical assistant team if there are community health workers there to say, ‘what’s really going on here and what are you worried about,’ you know. Really asking the patient why is it that you don’t want to go to the ER and then you start to learn things, right. You start to learn things about copays. You start to learn things about previous bad experiences, which help garner our understanding.

But to be honest, sometimes it’s just hard and sometimes those feelings come up and you have to sit with it and say, oh, this is frustrating so let me go back to my script. And that’s where scripting is helpful because in a busy moment, it is frustrating. You want patients to listen and to do things that will help their health. It’s hard to sit back and see a patient do something or make a decision you fear will adversely impact their health, and watching that time and time again is hard. And that’s where conferences like this or, you know, leaning on your colleagues can help.

Q.) Do most clinicians think about documenting that at that point? It was mentioned as a contributing factor to malpractice cases that is often missing, and what should they document?

A.) Yeah, you know, certainly, I think this is a time factor and the amount of time primary care physicians in particular are spending on non face-to-face. This would be non face-to-face: fielding a phone call, or fielding a message coming in on the record has grown. And so, it’s becoming increasingly challenging to adequately document. I think certainly most important is to have the conversation. Documentation becomes important for other team members to see that, for patients who can see their records, to see the documentation and then to help the care go forward and to protect yourself in the case of an event. And this is why we would encourage people to create some scripting ahead of time from phrases you can insert, some preformed paragraphs that you can quickly insert. Make it easier, because if anything, it’s getting harder to adequately do all of this. It’s certainly first and foremost to have the conversation and then trying to make it easy to insert those phrases in so it’s not overly burdensome.

Q.) So, let me just ask you, is there specific language you suggest?

A.) You know, in our PSO document, we put some sample language in there and one thing we noted, if we’re listening to someone and we’re advising them to go to the emergency room, we would want to understand their resistance. We’d ask them what are their reasons for not going and then we say, ‘I understand where you’re coming from. It could be inconvenient to go to the emergency department but I want to make sure you understand what I am worried about and that you have all the information you need to make the right decision. In this case, I’m concerned with your chest pain and you’re having a heart attack because you have two risk factors. You have a family history of heart disease and diabetes. I’m recommending an emergency room evaluation because this is the best way to figure out what’s going on. If you don’t go to the emergency room, there’s a risk of serious damage to your heart, which could cause severe illness or possibly death.’ So, you know, in this case it’s saying what you’re worried about, giving them the information, have them decide and to say what could happen if you have a heart attack. Not everyone may know. Or what could happen if you had a ruptured appendix. Not everyone would know.

Q.) Great. What else do listeners need to know?

A.). You know, I think one area to touch on is a harm reduction, which gets tricky when we’re trying to triage or just go or find a disposition for patients calling with a symptom. Certainly, if we recommend emergency room and they decline, often the question is what to do. Do you bring them in? Do you offer a virtual visit even knowing that it’s second best? I think we don’t want to have patient abandonment and so, I think this is another nuanced area of the informed decision making. So, certainly giving that opportunity to make the decision, to follow your recommendation. If they refuse, however, it’s important not to abandon care. And some care is better than no care, but this is where you’d want to more heavily lean on your documentation. So, ‘we advised emergency room for these reasons, for these risks. Patient declined but some care is better than none so we’re offering this visit.’ And sometimes at that point, you can help get a better understanding or have the time to have a better conversation.

Thank you. Adrienne Allen is Senior Director of Quality Safety and Sustainability at North Shore Physicians Group Mass General Brigham Salem. I’m Tom Augello for Safety Net.

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