This transcript has been edited for clarity.
In the EPIC-HF trial, a patient activation tool comprising a short video and drug checklist, available at PatientDecisionAid.org, led to intensification of guideline-directed medical therapy in patients with heart failure and reduced ejection fraction (HFrEF).
Ileana L. Piña, MD, MPH: Hello. I'm Ileana Piña, professor of medicine at Wayne State University and professor of medicine at Central Michigan University, and this is my blog. We have wrapped up the totally virtual 5-day American Heart Association (AHA) Scientific Sessions. My guest today is Larry Allen, who is the vice chief for clinical affairs in cardiology at the University of Colorado (UC) Health Science Center and one of our heart failure mafia members. In the late-breaking trials, Larry presented his work called EPIC-HF. When we talk about Epic, everybody goes, "Oh my God, that terrible electronic medical record that we all hate." But we do always want patients to get the right information and to do well. Tell me a little bit about EPIC-HF.
Addressing Gaps in Optimal HFrEF Therapy
Larry A. Allen, MD, MHS: This was an implementation trial put together within UC Health. We have three regional centers with about eight hospitals in UC Health, and we take care of a variety of patients from Colorado who have HFrEF. We use the Epic electronic health record and have a single instance of that across UC Health. Over the past 10 years, we field-coded all of our left ventricular ejection fraction (LVEF) data — almost like a lab value — in our electronic record, and that allows us to identify patients. So, with the health system on a single instance of Epic and with our EF data, we tried to do more work around the quality of the medications we are prescribing for heart failure patients. That has taken lots of forms over the past few years; it's been encouraged by things like the hospital readmissions reduction program.
One of the key aspects of gaps in quality we noticed is that, like everywhere in the country, the use of guideline-directed medical therapies for patients with an EF of ≤ 40% is really quite poor. Steve Greene was moderating with you at the late-breaker yesterday, and he and you and others worked on the CHAMP registry that had over 100 different cardiology practices essentially showing that beta-blocker dosing is really low, and that the minority of patients have been switched over to sacubitril/valsartan. One thing I always mention is that the minority of patients are on spironolactone or eplerenone, despite being well-tolerated drugs, very cheap, and showing incredible improvements in outcomes (consistent data showing 30% reduction in death and morbidity, hospitalizations). In the setting of all this, now we have new and better drugs to add on to therapy. We have the SGLT2 inhibitors. DAPA-HF was a home-run study last year. EMPEROR-Reduced came out this year and basically said that we now have a fourth agent that makes a big difference in outcomes. Right now, about 2%-3% of people are on those drugs.
How are we going to do a better job of getting people on these drugs? We found that just telling docs to do it is not working. We also created some provider decision support through best practice alerts in the electronic record, where we kind of flagged people and said, "Do you want to consider using an ARNI in this patient?" Or "Why are you not using spironolactone?" That has not worked very well either.
Piña: Decision-support systems encourage the provider. We have seen these for years. Your patient has a high cholesterol and you get a little flash in the electronic health record that says, "Don't you want to adjust the statin dose?"
Allen: It has not worked. There are a lot of issues. A committee at our institution very carefully monitors best practice alerts because they can quickly multiply and overwhelm providers to the point where they are not helping but hurting the flow of care.
Allen: We pivoted and created a tool for patients to use before they went to their cardiology visit. They click on a link and watch a very positive and light 3-minute video that says, "Chances are you are not on perfect therapy for your HFrEF. There are probably a lot of reasons for this. Your clinician is usually in charge of prescribing, but they are dealing with a lot of other concerns, and they may think that you don't want to go up on your drugs. You should go into your visit wanting to talk about your drugs for heart failure. Try to identify at least one thing you can do, because we've seen in multiple studies that 70%-80% of clinic visits for HFrEF have no change in therapy." This video empowers or activates the patient.
Piña: We saw that in GUIDE-IT.
Allen: Basically, people come in and are asked, "How are you doing?" And they say, "I'm doing great." Then the provider says, "Great. Let's not rock the boat. I'll see you back in 6 months." We told patients to go in and engage their provider, saying, "I want to do something with my medicines. I want to do better." We gave them a one-page checklist where they could really see what guideline-directed medical therapy is and how they compare.
We gave the cardiologist or the advanced practice provider a heads-up that this was a patient-targeted intervention. The idea was to kind of flip the classroom. Rather than where the doctor tells the patient what is going on, we primed the patient by giving them some information before the visit so that when they came in, the point of the visit was to have a discussion. We wanted to see what happened. Patients were randomized; 145 of the patients got the video checklist and another 145 had their regular visit as routinely scheduled. Two thirds of them saw the video and half brought the checklist to their visit.
As you know, there are potential downsides when really pushing a dose of a beta-blocker or switching somebody to sacubitril/valsartan or starting spironolactone. We wanted to make sure that we considered this to be research, so we gave people a heads-up and followed patients forward to see what kinds of monitoring they were getting.
Provider and Patient Response to EPIC-HF Intervention
Piña: Physicians should be doing that with whatever changes they make. One of my favorite new phrases is "stability is an illusion." When you think somebody is stable, they are not. Are you going to go back and ask the patients any further about the intervention or how they liked it?
Allen: We surveyed all 145 patients and asked whether they got the materials, downloaded them, and watched them. We asked them some questions about how they felt about the intervention. Those data were not included in the presentation nor in the simultaneous publication in Circulation, but we are working on that. We had to hustle to get this ready as a late-breaker. It was funded by the AHA and it was important to me to present an AHA-funded study at AHA and then get it published in the AHA journal Circulation. The AHA gets donations from people around the country and really puts those donations to work — not only to fund this kind of science, but also to get the word out. It was nice to put this all together.
We also interviewed 30 pairs of patients and clinicians. We asked not only about the intervention but also about the dynamic in the room. We have a variety of patients. Some are passive and say, "I'll do whatever the doctor recommends." We are trying to get those patients to be more engaged by nudging them to ask questions about prescribing in positive ways that then lead to a discussion where their provider can be more proactive.
Piña: Physicians don't always like when patients come in with a page they took out of something they were reading and ask, "Why am I not on this?" That happened a lot with beta-blockers.
Allen: Although, not only from my own experience but from some of these interviews we are now digging into, I think the providers generally like this process. For example, it's hard to get a very passive patient excited about being proactive about their regimen. We want patients to be engaged. I think a lot of patients do want to have control, but when they feel excluded from the process, they try to get control in other ways.
Piña: Or they don't take their medicines.
Allen: That is right. They are like, "I don't trust what you say because I feel excluded from the process. So I'm questioning this beta-blocker and I want to talk to you about some nutraceutical." When patients come in with the checklist and say, "This is what I want to talk about today," I'm like, "Hallelujah." All of a sudden you have accelerated the process of talking about the kinds of therapies we feel have good data behind and having the kinds of discussions I want to have. Overall, we found that when we were conducting the study and doing interviews and talking to people, this was generally very well received, not only from the patient side but from the clinician side.
Piña: I'm happy to hear that because clinicians often feel like everybody is on top of them telling them to do something different. Now we are telling them about more drugs that they need to start in these patients. I feel like I have gotten a lot of resistance from docs in the past.
Allen: If I come to you as a hospital administrator, I'm looking at quality and I say, "You've got to get more patients on SGLT2 inhibitors and sacubitril/valsartan." Now you go to clinic and feel like you need to twist the patient's arm to do that. Conversely, here the patient is primed and comes in and says, "I'd like to do something to improve my medication regimen today." And you say, "Here are a couple of options for you. Let's talk about them."
Piña: This is all on the smartphone.
Allen: Yes. About 60% of patients just downloaded it and watched the video on their smartphone. Many would download it on their computer so they could print the one-page checklist. The list of the various classes of drugs and the individual drugs for HFrEF is pretty long. It works better on a tablet or a computer. It's great if you can print it out. But with so many people being mobile these days, doing a lot of it on the phone lowers the barrier for them to bring it into clinic.
Piña: Some people don't have internet in their home and don't have a laptop. They may not be able to print it, but at least they have something they can show the provider. Larry, I am so proud of you for doing this and I love the fact of activating patients. That is always fun for me. We give patients education to try to activate them and educate them about their heart. This is just taking it to another step. Where is the checklist available?
Patient Decision-Aid Tools
Allen: Our website, PatientDecisionAid.org, hosts our various tools for implantable cardioverter-defibrillator, cardiac resynchronization therapy, left ventricular assist device, and the checklist and video tested in EPIC-HF. We also developed, with partnership from the American College of Cardiology, a tool to help patients decide whether they should start or switch over to sacubitril/valsartan. That tool is somewhat interesting because the majority of that tool is about the cost. When you compare enalapril and sacubitril/valsartan, the side effects are quite similar and the benefits of sacubitril/valsartan are dramatically better than those of enalapril. So why would you not take sacubitril/valsartan? The only real reason is cost. That decision aid shows patients how to find out-of-pocket costs. They can weigh whether it is something they can afford in their total budget and in their medical budget, as so many patients are on multiple medicines. A nice paper came out in Circulation: Heart Failure a couple of weeks ago that showed that the majority of patients are essentially on 10 medicines. That is very burdensome and the kind of discussion we need to be having in clinic.
Piña: Even worse, I count the medications when they leave the hospital, and patients are on 13 medications. Three of those include the laxative, stool softener, and sleeping pill they got in the hospital.
Allen: The various tools are all free for use. They were largely funded by grant money from the Patient-Centered Outcomes Research Institute as well as the National Institutes of Health. We've done the work with support from taxpayers, and now those are available for people to use. We've also been doing a lot of work trying to get the word out about some work related to this, our LVAD decision aid. We've gone out to all 174 LVAD programs in the country and said, "Hey, do you want to incorporate this into your decision-making education pre-vet process?" About 100 of the 174 programs are actually using it.
Piña: Thank you so much for your time. I'm sure this is going to be viewed quite a bit and hopefully get spread out to other providers that don't often think about this as well. This is Ileana Piña, signing off. I hope you have a wonderful day.
Ileana L. Piña, MD, MPH, is a heart failure and cardiac transplantation expert. She serves as an advisor/consultant to the FDA's Center for Devices and Radiological Health and has been a volunteer for the American Heart Association since 1982. Originally from Havana, Cuba, she is passionate about enrolling more women and minorities in clinical trials. She also enjoys cooking and taking spin classes.
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Cite this: Ileana L. Piña, Larry A. Allen. When the Patient Is the Best Practice Alert: EPIC-HF - Medscape - Jan 11, 2021.