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A multicenter trial of a shared decision support intervention for patients and their caregivers offered destination therapy for end-stage heart failure: the DECIDE LVAD trial
Investigator (PI): Allen, Larry
Performing Organization (PO): (Current): University of Colorado Denver, Anschutz Medical Campus, School of Medicine, Department of Medicine, Division of Cardiology / (303) 724-2089
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2014
Final Year: 2019
Record Source/Award ID: PCORI/CDR-1310-06998
Funding: Total Award Amount: $2,052,964
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: Background: With 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 people each year. While patients may live longer with a DT LVAD, there are many risks, too, 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 that 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, we made a paper and video decision aid to help people 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; our decision aid is fair and balanced; and our decision aid 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 (1) explore how often the decision aid is used among eligible patients; (2) test how well the decision aids and training improve the quality of patient and caregiver decisions; and (3) measure how well doctors, nurses, and hospitals adopt, implement, and continue to use the decision aids and training. Methods and patient outcomes: Six hospitals across the United States are participating. During the study, hospitals will be switched from what they do now to our new decision aid and training. We will survey patients and caregivers before and after to see how well 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 health care options" and "encouraging participation in care decisions and in shared decision making."
MeSH Terms:
  • Caregivers
  • Chronic Disease
  • * Decision Making
  • * Decision Support Techniques
  • Heart Failure /*therapy
  • Heart-Assist Devices
  • Humans
  • Motion Pictures
  • * Multicenter Studies as Topic
  • Patient Participation
  • Professional-Patient Relations
  • Risk
  • United States
Country: United States
State: Colorado
Zip Code: 80045
UI: 20152088
CTgovId: NCT02344576
Project Status: Completed
Record History: ('2017: Project extended to 2019',)