Heart Failure GDMT: Could Pharmacists Be the Fifth Pillar?

This transcript has been edited for clarity. 
Ileana L. Piña, MD, MPH: Hello. I’m Ileana Piña, professor of medicine at Thomas Jefferson University, and I am here in beautiful Chicago at the American Heart Association (AHA) meetings. I have with me here a special guest, Dr Alex Sandhu, who is from the Palo Alto Veterans Affairs (VA) Healthcare System. I have a very soft spot in my heart for the veterans.
Tell me a little bit about what you do. You’re a heart failure person like I am.
Alexander T. Sandhu, MD, MS: Yes. I’m a heart failure cardiologist and health services researcher both the Palo Alto VA and at Stanford School of Medicine.
Piña: And you work with my good friend, Paul Heinrich.
Sandhu: He was the senior principal investigator on the project.’
Piña: Tell me the name of your project that was presented at the AHA meeting.
Sandhu: It’s called PHARM-HF Audit and Feedback. It was a randomized quality improvement study around trying to improve the use of pharmacist care. 
Piña: Why do you want pharmacists in a clinic?
Sandhu: As you know, we have over 6 million Americans with heart failure, and that number continues to grow. We’re really fortunate to live in a time where we have incredibly effective medical therapies for reducing the morbidity and mortality of heart failure. 
But unfortunately, our patients aren’t getting those therapies for many reasons. Even when they get them, they’re not titrated up to the target doses that we know work. I think we need multipronged, multiple strategies to solve those gaps universally across our healthcare systems.
Piña: Was that your thinking behind this study?
Sandhu: It’s our thinking behind many of our research projects. One thing that Paul, myself, and the VA are really passionate about is the opportunity of expanding the care team for chronic disease management and for heart failure. 
We have a lot of data on pharmacists managing hypertension and diabetes. We now have randomized data on the fact that when pharmacists manage heart failure, patients are more likely to be on beta-blockers or renin-angiotensin system (RAS) inhibitors, and have them uptitrated. This project was to see if we implement it on a broader scale.
Piña: This isreally a translational study. 
Sandhu: Exactly When we look at VA data, we see that veterans who are cared for by a pharmacist, in terms of their heart failure, have higher rates of guideline-directed medical therapy (GDMT), but we also see that only 10% of veterans with heart failure get heart failure care from a pharmacist. The real premise, is how can we get more pharmacists actively managing heart failure problems? 
Piña: Is it an access issue at the VA that they don’t get sent to a pharmacist, or that the pharmacists aren’t embedded in the care? What do you think that difference is?
Sandhu: Actually, a really lucky feature of the VA is that the pharmacists are closely embedded in primary care practices, working side by side with the primary care clinician, and they have a lot of experience with successfully managing diabetes and high blood pressure. 
Why that hasn’t translated to heart failure yet is what we’re trying to understand. I think a lot of it has to do with there being less pharmacist training around heart failure management in the primary care setting. And there’s also less focus on heart failure compared with hypertension 
Piña: It’s the number-one readmission diagnosis in the United States. So, break down your study for us. 
Sandhu: In our study, we took all pharmacists across the eight different sites in our region, and we took any pharmacist in primary care where the leadership said it would be appropriate for them to manage heart failure. This didn’t mean that they were actively doing any heart failure management or that they necessarily had any training, but their primary care bought into it; the primary care physician agreed with them doing that. Then we randomized them to one of three different arms. In the first arm, we provided education. 
Piña: Was this education to them, or from them to the patients?
Sandhu: It was education from us to the pharmacist community to try to increase their comfort with heart failure. It included monthly 1-hour webinars where we talked about GDMT and challenging cases. 
We built a website that included titration protocols, best practice documents, and collaboration with pharmacy leadership. Then we built a database of all the questions they asked over the period of time that would be a living resource when a question came up. Maybe someone else has asked it, and they could reference that.
Piña: So if a new pharmacist comes in, they would have something to go back to and take a look. That’s a great idea.
Sandhu: That was the education intervention that was delivered to all three arms. We compared that with the other two arms that received an audit and feedback intervention where, in addition to the education, we provided them a monthly email telling them how often they had provided heart failure care in the prior 3 months, and how that compared with their peers.
Piña: Did you just capture that on the electronic record?
Sandhu: Yes. ’We’re really fortunate again with the quality of the data that we have in the VA system, where the pharmacists closely document each encounter and what care they deliver. We were using their own documentation and then analyzing it and providing it back to them as well. 
Piña: It’s like a feedback loop,
Sandhu: Exactly, and that feedback also included what the end goal is, which is to get patients on GDMT. We didn’t provide them their personal GDMT rates, but we provided it at the site level and in comparison with other sites in the region,
Piña: So they could see where they sat. And that was your other group.
Sandhu: That was group 2. Then group 3 got the audit and feedback, the education, and targeted patient reports. The targeted patient reports were for a list of up to seven patients in their primary care panel who had heart failure and had gaps in their medical therapy. The hope with the targeted patient reports is we would help them identify patients that they might not actively be seeing, that they could potentially take a population health management strategy and bring them in. 
Piña: What did you find, and how long was your study period?
Sandhu: We included a 2-month blanking period, assuming there’d be some amount of time necessary for the intervention to have effect. And then we analyzed from 3 to 6 months post-intervention. What we found is that in all three arms, there was an increase in the frequency with which pharmacists were providing heart failure care and doing medication management.
Piña: Were these face to face encounters or were they in telehealth?
Sandhu: A combination, but predominantly virtual, either via telephone or video care. We saw that between the two audit and feedback arms — the audit and feedback with or without patient reports vs education only — there was also a significant increase in the number of encounters. There was no difference with vs without the patient targeted reports.
Piña: Interesting. How do you explain that?
Sandhu: We really need to talk to the pharmacists to understand why. Our efforts now are in doing interviews and surveys of the pharmacist to understand why that didn’t work, what aspects did work, and what didn’t we hypothesize. 
I think part of it is that these pharmacists are busy. They’re providing hypertension care, they’re providing diabetes care, and maybe they don’t have a lot of time to review the reports and pull new patients into their clinic. We’ve also found that there might be better strategies for increasing referrals for heart failure. Maybe those referrals have to come from cardiology or from primary care, rather than relying on the pharmacist to reach out independently.
Piña: Do you think your primary care colleagues have bought into the concept of having the pharmacist work with them, specifically for this disease?
Sandhu: Our primary care colleagues in the VA really love the relationship they have with pharmacy, and so there’s a lot of buy-in in terms of working closely for disease management. There’s some site level variability in the overall buy-in, both on the primary care and the cardiology side. We had some sites where there was a very large impact in the intervention, and other sites where we saw less.
Piña: You need to get in there and find out why those differences occurred.
Sandhu: Those contextual differences are critical and ’are core to implementation.
Piña: Maybe the issue is at the primary care level. Not every primary care setting is same.
Sandhu: That’s what we have to understand, and we have to learn from the sites that took this on and try to see how we can translate those findings to the other sites.
Piña: I’m curious that you were able to do some of this remotely with telehealth. I have a very hard time doing telehealth. I can’t see people’s neck veins and do a good exam by telehealth. 
Was there any drug that stood out as having done better because of the pharmacist?
Sandhu: Yes. We saw uptitration of all four classes in both arms. The only therapy where we saw a difference between the education-only and the audit and feedback arms was mineralocorticoid receptor antagonist (MRA) initiation or uptitration. About 11% of patients that were on suboptimal doses of MRA or not on an MRA were uptitrated in the audit and feedback arms, compared with about 9% in the education-only arm. So that’s the one significant difference.
Piña: Every time we look at these big databases, the MRA is at the bottom of the drug list, because everybody’s afraid of potassium increases. You have the potassium binders at the VA now, for 5 years. 
Sandhu: We do, and you’re entirely right. Not only in this study but from others we, know that MRAs are less prescribed than even the sodium-glucose cotransporter 2 inhibitors. The new drug has already exceeded the MRAs. We’ve done a lot of work looking at medical therapy in the VA historically, and MRA rates have been flat; they’ve been relatively flat for over 10 years now, despite being generic. 
Piña: You look at spironolactone, and when I give this drug, am I going to see any difference in symptoms? When you give an RAS inhibitor, the patients feel better within a few days. When you give spiro, you don’t see a difference unless you use it as a diuretic.
Sandhu: I also think that historical sequencing of therapies has led to some amount of the inertia with MRAs, where patients get started on their beta-blocker and RAS inhibitor and typically the MRAs should be next — but we often just unfortunately don’t get to that next.
Piña: I start the spironolactone right away. You have to have really bad kidneys for me not to start spiro.
Sandhu: I totally agree. There’s a mortality benefit, the hemodynamic tolerability is wonderful, and I think it’s really critical that we solve this, especially now that we have data on nonsteroidal MRAs.
Piña: What are we going to do with that one? 
Sandhu:: We’ve got to figure out how to disseminate this to all our patients. 
Piña: So what’s next?
Sandhu: What you hit on is that we need to figure out what worked and what didn’t work, and so we’re really diving into the qualitative data to figure out how to adapt our intervention. Once we’ve adapted our intervention, we’re planning to test it as part of the AHA’s Rural Health Equity Research Network across three additional media regions. We’re excited to both adapt scale and learn more about how we can scale the right way.
Piña: Hopefully the VA data could be translated to the outpatient clinic or to universities, practices not necessarily within the VA system.
Sandhu: That’s an important point. We have a unique position in the VA, where the pharmacist is already embedded in primary care. In some ways, it does limit the generalizability of these findings. That said, I think we all realize, even outside the VAs, we need these bigger team-based care approaches, and I hope that there’s more incentive and innovation around developing these teams. The VA can be an example. 
Piña: Will you look at how many minutes the pharmacists spend with each patient? I find that the teaching takes a long time, but when the pharmacists are with me, then that time is divided up. I do some of the teaching, and they do some of the teaching. 
Sandhu: That’s a great point, and something that we also need to look into is that although the GDMT rates didn’t go up that much, maybe that’s partly because the pharmacist off-shifted some of the work from primary care and cardiology. With the physician shortages, we have access issues, so that is a really important outcome.
Piña: You have a tremendous amount of good data here, I congratulate you and Paul as well, for good work always done out of Palo Alto VA. 
I want to thank my audience for joining me today. I am hoping that this will open up a new era and area of thinking. What a wonderful addition. to your team to have a pharmacist. I work very hard to get them on my team, and I finally succeeded. Thank you for joining me. Have a great 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.