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DECIDE-LVAD: Decision-making tool improves decision quality among LVAD candidates
ANAHEIM, Calif. — A decision-support intervention was associated with improved decision quality among candidates for a left ventricular assist device, according to results from the DECIDE-LVAD trial.
Decision quality was defined as patient knowledge plus concordance between a patient’s stated values and preference on whether to receive an LVAD, Larry A. Allen, MD, MHS, medical director of advanced HF and associate professor of medicine, University of Colorado Anschutz Medical Campus, Aurora, said during a presentation at the American Heart Association Scientific Sessions.
“A destination therapy left ventricular assist device involves complex trade-offs,” Allen said. “The benefits are significant for carefully selected patients who are inotrope-dependent with end-stage heart failure. Destination therapy can extend the average survival from 20% at 1 year to 80% at 1 year, and also improve average quality of life. However, these devices still come with significant risks and burdens, including a roughly 10% chance of stroke and 20% chance of serious bleeding in the first year, as well as burdens, including ongoing driveline care, power source management and need for caregiving. Therefore, I would postulate that LVADs are a preference-sensitive decision.”
Allen and colleagues conducted a randomized stepped-wedge trial of 246 patients with end-stage HF under consideration for LVAD implantation from six sites. At the beginning of the trial, all sites administered the usual care. Each site was randomly assigned a time to transition to an intervention consisting of clinician education, a comprehensive pamphlet on the risks and benefits of destination LVAD therapy for the patient and family, and video decision aids for the patient and family.
Patients (16% women; 24% older than 70 years) were followed up at 1 month and 6 months. The primary outcome was decision quality as assessed by knowledge and concordance between values and treatment.
Among the patients, 135 were enrolled during a period of usual care and 113 were enrolled during a period where the intervention was used.
Patient knowledge during the decision-making period increased from 59.5% to 64.9% in the control group and from 59.1% to 70% in the intervention group (adjusted difference of difference, 5.5%; P = .03).
Patients were asked to rate their values on a scale of 1 to 10, with 1 representing a desire to do anything to live longer, and 10 representing a willingness to live with whatever time is left. At 1 month, mean values were 2.37 in the control group and 3.33 in the intervention group.
Patient-reported treatment preference at 1 month favored LVAD more strongly in the control group than the intervention group (P < .001).
At 1 month, correlation between stated values and treatment preference was stronger in the intervention group vs. the control group (difference in Kendall’s tau, 0.28; 95% CI, 0.05-0.45), but the correlation did not differ between the groups at 6 months (difference in Kendall’s tau, 0.01; 95% CI, –0.24 to 0.25), Allen said.
Adjusted rate of LVAD implantation at 6 months was 79.9% in the control group vs. 53.9% in the intervention group (P = .008), according to the researchers.
The groups did not differ in decision conflict, decision regret, preferred control or quality-of-life measures, Allen said.
“Formal integration of a decision support intervention for [destination therapy] LVAD was associated with improved decision quality and reduction in implantation rates,” he said.
In a discussant presentation, Kathleen L. Grady, PhD, MS, RN, from Northwestern University, said the study “addresses a critical aspect of patient care, which can impact patient-centric outcomes including survival and quality of life.”
A challenge, she said, is “how can the decision aid be updated to keep up with new technology and changing device designs, and the frequency and types of adverse events which impact outcomes?”
Allen said an online tool at patientdecisionaid.org has been recently updated. – by Erik Swain
Reference:
Allen LA, et al. LBS.06. Evaluating Quality Improvement and Patient Centered Care Interventions. Presented at: American Heart Association Scientific Sessions; Nov. 11-15, 2017; Anaheim, Calif.
Disclosure: Allen reports he consults or serves on an advisory board for Boston Scientific, Janssen and Novartis. Grady reports no relevant financial disclosures.
Editor’s Note: The headline of this article was changed on Nov. 28, 2017 at the request of the presenter.
Perspective
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We know as clinicians that there are patients with advanced HF who have a great benefit to derive if they undergo LVAD therapy. We know that that benefit is in terms of increased survival, increased quality of life, increased functional capacity — although that has not been demonstrated in the long term. But in total, if you are a good candidate with a high probability of doing well with an LVAD, it could be lifesaving and a good option if you want to survive longer. The problem up to now has been that we don’t have the counterpoint: What about the complication rate? What if things don’t go as planned? What if the patient undergoes an LVAD and does well early, but has a major stroke later?
About 5 to 7 years ago, our field was in a state of trying to optimize survival while trying to improve quality of life and functionality. But now, our field is in a state where we know survival has been achieved at greater benefit. The gap in survival among patients with advanced HF is great between those that undergo LVAD therapy and those that don’t. The target now is that we need to appreciate ways to reduce complications from LVAD therapy, especially for an elderly patient that has lived a live that could be very much fulfilled already. In that patient’s perspective, they will be laid up in a nursing home for 1 or 2 months until they die with a stroke, and an LVAD is not worth it at all, even if they may get an extra 3 to 6 months of good quality of life, which they may have had up to some limit with just palliative inotropic and other therapies.
The DECIDE-LVAD trial hits one of the crucibles in our field. What if you had a patient that was not only informed of the success rate and survival improvements of LVADs, with all the inherent bias of the clinicians who developed these gains, but equally informed of the setbacks and complications? One of the important findings is that for the patients who enrolled and were given an opportunity to incorporate decision tools where they were able to determine what they wanted to derive from an LVAD, their values were often concordant with their ultimate decision. Those patients had a minor increase in knowledge about the technology and what could happen if they chose it, but most importantly, the patients that underwent the decision-tool intervention showed a higher concordance between what they valued going in to this decision and what the therapy brought to them. That’s a big deal. At the end of the day, we’re not just saving lives. We truly believe we’re trying to save lives while paying attention to what we call the personalized space of medicine. Such a tailored approach is not always there. I have seen plenty of patients who had certain expectations but the treatment they received was not in line with those. “That was not what I went into this endeavor for” are words we hear all too often.
The work of Dr. Allen, Dr. Grady and others in this space has helped us better understand the importance of quality of life, and the instruments we need to assess it. This trial vindicates that work to some degree. It shows we have a long way to go in trying to give patients a good tool to exchange information with us and make the right decision. The right decision is if they don’t choose an LVAD and are happy, or if they choose an LVAD and are happy. The happiness is because the experience is commensurate with their wishes based on what their life has been.
The other important outcome is that in the intervention group, fewer patients underwent LVAD therapy. What does that mean? I would not look at this trial as proof that if you were to be completely informed, you would have less willingness to undergo LVAD therapy. I would look at this trial as a thrust for the field of where we need to get, so that when a patient is fully informed of all the things that could happen, the rate of adverse events gets reduced, or the adverse events become less clinically important. I hope patients with advanced HF around the world will have the best opportunity to achieve enhanced survival with an excellent meeting of the expectations that they had going in. This is very important in a population that is aging with advanced HF.