Will a Digital Carrot and Stick Improve Outcomes in HFrEF?

Ileana L. Piña, MD, MPH; Adam D. DeVore, MD, MHS


March 01, 2018

Ileana L. Piña, MD, MPH: Hello. I'm Ileana Piña from the Albert Einstein College of Medicine and Montefiore Medical Center in the Bronx, New York. I am here at the American Heart Association (AHA) 2017 Scientific Sessions in Anaheim. This is the first time that we have been here in many years. There has been a remarkable change to this city. We are all so close to Mickey.

As usual, I take these opportunities to interview people who are doing excellent work in the field, particularly people who are good colleagues and friends. Today I want to welcome Adam DeVore, who is assistant professor of medicine and a heart failure (HF) colleague at Duke, and a Blue Devil fan like me.

We are going to talk about the CONNECT-HF trial. This audience has heard me say many times how important it is to do patient education and to get patients engaged in their HF care. If we did, patients would probably do better. You guys have come up with some novel concepts using digital media. Tell us about CONNECT-HF.

CONNECT-HF Patients Involved in Planning

Adam D. DeVore, MD, MHS: Thank you for having me. I'm very excited about CONNECT-HF. The study is a clinical trial of different quality-improvement interventions. We are testing a traditional quality-improvement intervention where we meet with sites and work on quality-improvement goals with mentorship by the team. The other intervention is very different: We are directly engaging patients through mobile applications. We helped design that part of the study specifically with a patient panel. It's a lot of fun.

The app works in a couple of different ways: It helps build rituals and it tries to change behavior by using rewards and punishments.

Dr Piña: What you just said about engaging patients is important. We were at Transcatheter Cardiovascular Therapeutics several weeks ago and we had a whole panel about patient outcomes. Patients came in and talked to the audience. We are seeing that more and more. What did the patients tell you?

Dr DeVore: The patients were volunteered from the steering committee members; they all had some connection with the other members of the study team. We met with them early when we were still in the planning stages of the study, and they had a lot of valuable input. As you mentioned, their comments were on medication adherence, understanding their medicines, and trying to learn as much as they could about HF. Two different companies helped design mobile apps, and a behavioral economics group at Duke, through Dan Ariely's lab, helped us come up with a few different interventions. Using the app, people learn more about HF and receive help with their medications and adherence throughout the course of study. The app works in a couple of different ways: It helps build rituals and it tries to change behavior by using rewards and punishments. There are some powerful tools in behavioral economics.

Dr Piña: Using rewards and punishments is interesting. Sounds like what you do with your kid.

Dr DeVore: I have four kids of my own, so I need to pick up some tips for what I can do at the house.

Dr Piña: What are those rewards and punishments like for patients? I tell patients that if they do not eat the right things or if they skip their medicines, they are going to put on fluid weight. That is a punishment.

Dr DeVore: Yes, that is one that the patient quickly learns about. We also are trying to use other tools. Probably the most controversial idea is app blocking. If a patient is unable to remember to take their medications and it's recorded in the app, they will not be able to use one of their self-identified favorite apps for a couple of hours.

There are rewards, too. There are some social media aspects, where they can work with their friends and family and receive cheers and feedback on how they are doing. We are using a lot of different techniques.

Looking Long-term

Dr Piña: What is the control group?

A lot of quality-improvement programs have no concept of what happens on day 31.

Dr DeVore: There is a usual-care registry, which will be really important to understand the outcomes. We are following patients for a year after they are enrolled; we are collecting a lot of important information on adherence, quality of life, and some economics that happen over the following year.

Dr Piña: Every program does their own usual care if they are in the usual-care group?

Dr DeVore: That is correct.

Dr Piña: Are you going to try to quantify what every site does?

Dr DeVore: Yes. That is really important. I think almost every hospital in America has some type of quality-improvement program with the readmissions policies that have happened over the past few years. Trying to understand exactly what hospitals are doing now and how those will change over the course of the study is important. We are serving in the hospitals at many different time points.

Dr Piña: You are going to have a lot of information once you are done on what is happening around the country. How many sites are you planning on?

Dr DeVore: We are planning on 160 sites, all in the United States. We have 80 activated right now already as of AHA. We just started in April, so it has been a busy couple of months.

Dr Piña: That is a lot of work. How many patients are enrolled?

Dr DeVore: We are targeting 8000. So far, we have about 300 enrolled.

Dr Piña: That is not a bad way to begin. Does this app get downloaded like any other app through the app store?

Dr DeVore: Correct. All of the patients have an onboarding process with the study coordinator before they leave the hospital. All patients are enrolled while they are hospitalized for HF.

For hospitals randomized to the app intervention, the app is loaded on the patient's phone before they leave. One important thing about this study is that we are thinking about the next year. A lot of quality-improvement programs have no concept of what happens on day 31.

We are going to follow patients for a year and will provide feedback to the sites. We are going to learn a lot about what happens after the magical 30 days of trying to prevent readmissions. The apps will continue with the patient for the course of the study.

Dr Piña: What are the inclusion criteria? Who are the patients you want?

Dr DeVore: We want this to be broadly applicable. There are only four inclusion and four exclusion criteria—I'm really proud of that. Hopefully that will help with enrollment. All patients are adults with HF and a reduced ejection fraction, or HFrEF. Patients are not on dialysis, have not had a transplant or left ventricular assist device. There is no cutoff level of creatinine. They basically just need to be in the hospital for acute HF.

Dr Piña: Why did you pick HFrEF and not HFpEF (heart failure with preserved ejection fraction)?

Dr DeVore: It's a good question and one we thought a lot about. We picked HFrEF for two reasons. First, this program is sponsored by Novartis and is being run through Duke. [Novartis] is very interested in improving HF care in general, but also very interested in learning about patients who are receiving sacubitril/valsartan.

The second reason is that we are trying to focus on what is in the guidelines. That is where the evidence really sits. I'd love to see CONNECT-HFpEF—maybe that will be next. But for now, we are focusing on the low ejection fractions.

Dr Piña: The guidelines are not being followed. One of my issues is getting patients on the right drugs at the right time. So often they come back because they are not on the right drugs, or someone introduced something that may make the HF worse. I like the fact that we—I say "we" because my hospital is involved in the study—will be pushing for good clinical care.

Patient Demographics

Dr Piña: What ages are the patients?

Dr DeVore: To be enrolled, the patients only have to be adults—over 18 years. There is no cutoff for age. I'll tell you one thing about the apps: At the beginning, we were thinking that older patients would not be interested in apps.

Dr Piña: Yes, that would be my preconceived notion.

Dr DeVore: That is absolutely not true. With the patient engagement, and as the study started to roll out, we learned that a lot of older patients do not have as many apps on their phone as I do. They are actually able to focus on the one that is part of the study.

Dr Piña: That is so interesting.

Dr DeVore: I think a lot of people thought that as well. Hopefully it will have a benefit in that population too.

Dr Piña: What minorities are you going to target?

Dr DeVore: All of the apps will be available in Spanish; we hope that will help boost enrollment. We were happy to see 40% African Americans in early data.

Dr Piña: How many women?

Dr DeVore: We need a little bit of work there. About a third are women. We can work on that.

Dr Piña: I will make sure that you work on that.

Dr DeVore: Yes, you will.

Dr Piña: You hear a lot about automated systems to keep people out of the hospital. Medicare right now does not really pay for many of those. It will be interesting if something like an app becomes so easy that it impacts patients' quality of life and keeps them out of the hospital. The economics is going to be critical. At our place, we are returning money to Medicare every year for the 30-day readmission.

You will be collecting data so you will know the relationship between mortality and hospitalizations. They do not always go in the same direction. Sometimes you improve hospitalizations, but mortality is actually up. That will also be interesting.

We are excited and ready to go. We want to thank Duke and all of the hard work that you guys are doing on this.

I want to thank our audience for joining us. If you have an HF program near you that may be involved in the CONNECT-HF trial, give them a call. Maybe your patients can also benefit from this program.

Thank you for joining me from the AHA. I bid you a good day.


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