John M. Mandrola, MD: Hi, everyone. This is John Mandrola from theheart.org | Medscape Cardiology, and I am here at the American Heart Association Scientific Sessions with Dr Larry Allen from the University of Colorado. He is a cardiologist and outcomes researcher and is first author on a late-breaking clinical trial called the DECIDE-LVAD trial. Larry, welcome.
Larry A. Allen, MD, MHS: Thanks for having me.
Dr Mandrola: This DECIDE-LVAD trial has to do with decision support—decision aids in patients with heart failure who were being considered for left ventricular assist devices (LVADs). Larry, tell us about the background here.
Destination Therapy for Transplant-Ineligible Patients
Dr Allen: I am an advanced heart failure cardiologist, and one of the big changes that has happened over the last decade or two is the emergence of mechanical circulatory support, specifically LVADs that are durable, can be implanted, and people can live with them.
Another change that has been important is that initially these devices were used mostly to bridge people to transplant, but now we are increasingly using them as destination therapy (DT), meaning that they get the LVAD, and they live with it until they die. That is important because the reasons that make people ineligible for transplantation may also make it harder for them to live with an LVAD. They may be old, frail, and/or have multimorbidity.
We have seen lots of patients go through this; some do very well, but some do not. Whether a person should get an LVAD if they have advanced heart failure and are not eligible for transplantation is really a preference-sensitive decision. For some people, it is a good decision; and for others, it may not align with their values and goals in life. That was what really inspired us to think about how to improve that decision process.
Dr Mandrola: This was a clinical trial looking at an intervention in terms of decision support?
Dr Allen: That is right. A few years ago, we looked to see what materials are out there to help a patient and their family decide whether they should get a DT LVAD. We found 77 materials that address this; and only half of them mentioned the risks, only one of them talked about hospice or palliative care as an alternative to LVAD, and none of them met the international patient decision aid standards for what is a high-quality patient decision aid.
We developed decision tools for patients in this situation, and after literally 28 iterations, with input from various patients, families, and other stakeholders, we came up with an eight-page decision aid that was accompanied by a 26-minute video. For this study, we asked programs to implement those decision aids into their process of DT LVAD evaluation and measured whether it changed the quality of the decisions that patients made and what happened to them down the road.
Dr Mandrola: These were six heart failure programs that have a lot of experience?
Dr Allen: That is right. This is a multicenter trial, and it is actually a stepped-wedge design. The intervention involved some training and then integration of the decision aids into the program. We could not really do a patient-level randomization where one patient got it and another did not within a site because the whole site was exposed to it. This is cluster randomized, and the way that the study was conducted was that all six programs started out doing what they usually did, which was obtaining consent from patients, providing some education, and using the materials that they had, which were mostly industry-based materials, and then randomly over time we stepped the programs up to the interventions.
I went to the sites, and we trained people within the programs. We generally contacted between 30 and 70 people, and then we asked them to integrate those decision aids at that time going forward. Then we collected data on the individual patients in the preintervention period and the postintervention period and looked at what happened over about a 2-year period.
Defining High-Quality Decision-Making
Dr Mandrola: The primary endpoint is a decision quality endpoint, and there are components to decision quality.
Dr Allen: Yes. We define a good decision as when an informed patient reflects on their values and makes a choice about therapy that is concordant with those values.
The two components of that are firstly knowledge—patients understand what is happening to them and the options available—and then secondly when they make a decision, is that decision concordant with what they said their values were?
In this case, with DT LVADs, the options are to get an LVAD or not. You need to understand what an LVAD is and what is involved with it as well as what the alternative is, which is to continue current therapy and often move to a more palliative approach. The other key value here is that an LVAD is a very aggressive therapy. While it offers pretty amazing advantages in terms of survival and quality of life in carefully selected patients, it is also aggressive.
It involves major surgery, which doesn't always go well. There can be a significant burden on caregivers. People are now living with a device that is associated with a fair number of complications. We basically had a value spectrum where we said: Do you want to be aggressive, do a lot of stuff to try to optimize your survival, or would you rather live with what time you had left?
Essentially we look at them and say: If you want to be really aggressive, you should probably get an LVAD; and if you don't, you shouldn't get one. We looked over time to see whether people were more likely to make concordant decisions after the intervention.
Dr Mandrola: With those two endpoints as the outcomes, what did you find in this trial?
Dr Allen: A few key things. The first is that in the intervention period, patients' knowledge improved incrementally [compared with before the intervention]. We adjusted for time trends and patient differences, and it did seem like the integration of these less-biased, more-formal patient decision aids improved patients' knowledge about the decision.
The second thing we looked at is whether they got an LVAD or not; their decision seemed to align better with their stated values.
So we had better knowledge, better values—choice concordance, and thus higher-quality decision-making. What was really surprising in a secondary analysis is that even after adjusting for time trends, we saw that over 6 months in the preintervention period, about 80% of patients went on to get an LVAD. In the postintervention period, that dropped to below 60%.
It suggests that integrating a half-hour video with objective information about LVADs in the decision process leads to fewer people deciding to go forward with a quarter-million-dollar therapy that is very invasive. That is pretty striking.
More Informed, Less Aggressive?
Dr Mandrola: It is provocative that if you improve decision quality and decision concordance, then fewer people decide to have the invasive therapy.
Dr Allen: Again, this is a quasi-experimental design, so I do not want to overstate the findings, but it does suggest that when patients are better informed and when they clarify their values and make a decision that is more aligned with those values, we see a decline in the rate of LVAD implantation across the programs.
Dr Mandrola: What are the implications for this? This sounds like a good thing to me.
Dr Allen: There are various perspectives. One of the concerns some programs may have is whether people really understand what happens if they do not get an LVAD—these are life-and-death decisions in some ways. But a lot of that is tied to how we frame it; it really is about the quality and the way people live the end of their days.
There are huge implications for invasive therapies, making sure that patients are truly informed and engaged around these kinds of decisions, and we probably need to do a better job at it.
Dr Mandrola: Do you think there are other avenues of invasive therapy in heart failure or cardiology in general that would benefit from this?
Dr Allen: Yes. As an electrophysiologist, you are very familiar with this example: When Medicare made their national coverage decision for left atrial appendage closure devices, they mandated that in order to get paid, you have to conduct and document a shared decision-making process around getting an occlusion device compared with alternatives. You have to use a formal patient decision aid and document that in the chart.
What we are doing with LVADs is not lost on other areas of cardiology or by payers like Medicare.
Dr Mandrola: Larry, thank you for being with us. It was excellent.
Dr Allen: It is my pleasure. Thank you for having me.
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Cite this: Informed Patients May Choose Less Aggressive Care - Medscape - Dec 26, 2017.