Results Summary

What was the research about?

In advanced heart failure, the heart doesn’t pump blood like it should. Some patients receive surgery that places a device next to the heart to help pump blood for the rest of the patient’s life. This treatment is called destination therapy with left ventricular assist device, or DT LVAD.

Deciding whether to get a DT LVAD can be hard. DT LVAD can help some patients live longer and feel better. But it may also cause stroke, infections, or other problems. Patients who have DT LVAD often need help from a caregiver.

In this study, the research team created a shared decision making program that included a pamphlet and a video for patients and caregivers, as well as teaching for doctors. Shared decision making is a process in which patients and doctors work together to make healthcare decisions. The team wanted to see if the program increased

  • Patient and caregiver knowledge about DT LVAD
  • The number of patients whose personal values, such as doing everything to try to live longer versus wanting to avoid surgery, matched their decision about DT LVAD and the actual care they received

The research team compared a group of patients and caregivers in the program with a group of patients and caregivers who received standard education about DT LVAD.

What were the results?

Knowledge about DT LVAD. Compared with patients who received standard education, patients in the program had a greater increase in DT LVAD knowledge. Caregivers’ increase in knowledge didn’t differ between groups.

Decisions matched with personal values. Compared with those who received standard education, more patients and caregivers in the program made decisions that matched their values. But the groups didn’t ultimately differ in the number of patients who later received treatments that matched their values.

Who was in the study?

The study included 248 patients considering DT LVAD and 182 caregivers of those patients. Patients received care from six hospitals across the United States. Of the patients, 81 percent were white, 13 percent were black, and 6 percent were other races. The average age was 63, and 84 percent were men. Of the caregivers, 76 percent were the patient’s spouse.

What did the research team do?

In one group, patients and caregivers received a standard one- to two-hour DT LVAD education session at a hospital. In the other group, patients and caregivers took part in the shared decision making program; doctors used a video and a pamphlet to teach patients and caregivers about the benefits and harms of DT LVAD, help them think about their own values, and decide whether to receive the treatment.

Before and after receiving standard education or taking part in the program, patients and caregivers filled out a survey about their knowledge of DT LVAD. They also completed another survey one month later about their values and plans to get DT LVAD.

A patient who received a DT LVAD and a caregiver of a patient who didn’t receive a DT LVAD helped create the program.

What were the limits of the study?

Most patients and caregivers were white. Most patients were men, and most caregivers were female spouses. The results may differ for patients and caregivers of other backgrounds.

Future research could look at why taking part in the shared decision making program didn’t affect the number of patients who received treatments that matched their values.

How can people use the results?

Hospitals can use the results when considering how to support patients and caregivers making decisions about DT LVAD.

Final Research Report

View this project's final research report.

More About This Research

Journal Citations

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Peer-Review Summary

Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.

The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments. 

Peer reviewers commented, and the researchers made changes or provided responses. The comments and responses included the following:

  • Reviewers asked for more information about the type of educational materials provided to the usual care control group across sites, so that readers could more easily compare the control group to their own usual care practices. The researchers added details about this, including a table listing the educational materials used at each site.
  • Reviewers asked if the intervention materials were available so that other centers could use them. The researchers said the materials have been online and freely available for many years. They added information to the report about where to find the materials. The researchers also added a recommendation to the report that, based on the study’s results, other left ventricular assist device (LVAD) programs should consider using their educational intervention.
  • Reviewers asked for clarification about sample size and whether the actual number of people completing the study affected the ability to detect differences. The researchers said the study was adequately powered to detect meaningful differences in the primary outcome, since they enrolled substantially more patients and caregivers than required in the study plans. However, the study was not adequately powered for subanalyses. They also noted that missing data were more common among patients who did not receive an LVAD and their caregivers.  
  • Reviewers asked whether the effectiveness study results were consistent with the widely accepted RE-AIM (Reach Effectiveness Adoption Implementation Maintenance) framework for dissemination research. The researchers clarified in the study overview section that the primary endpoints of the effectiveness study specifically targeted the effectiveness and implementation components of RE-AIM and explained how they evaluated these components.

Conflict of Interest Disclosures

Project Information

Larry A. Allen, MD, MHS
University of Colorado Denver
$2,097,085
10.25302/04.2020.CDR.131006998
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

Key Dates

July 2014
May 2019
2014
2019

Study Registration Information

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Last updated: January 12, 2022