This research project is in progress. PCORI will post its findings here within 90 days after our final review is complete. In the meantime, results have been published in peer-reviewed journals, as listed below.
Background: Because of advances in medical technology, older people and those with chronic diseases are increasingly offered major surgeries and devices. One such treatment, the left ventricular assist device (LVAD), is growing rapidly among people dying from end-stage heart failure who are unable to get a heart transplant. These patients elect to live out the remainder of their lives dependent on a partial artificial heart—so-called destination therapy (DT). Among the 6 million Americans who currently have heart failure, it is estimated that DT LVAD could be an option for up to 250,000 of them each year. Although patients may live longer with a DT LVAD, it poses many risks, including stroke, serious infection, and bleeding. Most of these patients have other medical problems that are not fixed by the DT LVAD. Patients must be connected to electricity at all times. A caregiver is required, which often places stress on family and loved ones. Therefore, the decision whether or not to get a DT LVAD is often an extremely difficult one. Unfortunately, our research shows problems with the way this medical decision is currently being made in hospitals across the United States. Hospitals that offer DT LVAD treatment do not follow a standard process. The forms, pamphlets, websites, and videos used to help patients and families are biased and too difficult for most people to understand. Lastly, this is an emotional and even scary decision for most patients and their families, but the process does not help them deal with these feelings.
Objectives: Using feedback from patients, caregivers, doctors, surgeons, and nurses, the study team made a paper and video decision aid to help people who are offered DT LVAD make this most difficult of decisions. Unlike the information that is now available, our decision aid focuses on options, fears, and the needs of caregivers; it is fair and balanced; and it is paired with training for doctors and nurses on how to best talk about DT LVAD. We now want to evaluate how our DT LVAD decision aid works in the real world. We will:
- Explore how often the decision aid is used among eligible patients.
- Test how well the decision aid and training improve the quality of patient and caregiver decisions.
- Measure how well doctors, nurses, and hospitals adopt, implement, and continue to use the decision aid and training.
Methods and Patient Outcomes: Six hospitals across the United States are participating in this trial, titled DECIDE-LVAD. During the study, hospitals will switch from their current practice to our new decision aid and training. We will survey patients and caregivers before and after to see how much the new process improves the quality of their decisions. We will also see how doctors, nurses, and hospitals like using this decision aid and training. Our aims match PCORI’s desire for “increasing patient and caregiver awareness of healthcare options” and “encouraging participation in care decisions and in shared decision making.”