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.
Professional Abstract
Objective
To examine the effectiveness of a shared decision support intervention for destination therapy with a left ventricular assist device (DT LVAD) compared with usual education for improving patient and caregiver decision quality
Study Design
| Design Elements | Description |
|---|---|
| Design | Randomized controlled trial |
| Population | 248 patients with end-stage heart failure considering DT LVAD who received care from 6 hospitals across the United States and 182 of their caregivers |
| Interventions/ Comparators |
|
| Outcomes | Patient and caregiver knowledge of DT LVAD, concordance between patients’ and caregivers’ values and intended treatment choice, concordance between patients’ and caregivers’ values and actual treatment received |
| Timeframe | 1-month follow-up for study outcomes |
This stepped-wedge cluster-randomized trial tested the effectiveness of a shared decision support intervention on improving decision quality, measured by knowledge and values-choice concordance, in patients considering DT LVAD and their caregivers. Researchers randomly assigned six hospitals across the United States to begin the intervention at different times. Before each hospital implemented the intervention, patients and caregivers were in the usual education group.
The shared decision support intervention had two components. First, researchers trained clinicians to use two decision aids—a video and a pamphlet—with information to help patients and caregivers understand their values and the benefits and harms of DT LVAD. Second, the clinicians integrated the intervention into existing hospital education and shared decision making processes. Researchers compared patients and caregivers who received the intervention with patients and caregivers who received usual education before implementation of the intervention. Usual education was typically a one- to two-hour teaching session with trained hospital staff.
The study included 248 patients with end-stage heart failure considering DT LVAD and 182 caregivers. Of the patients, 81% were white, 13% were black, and 6% were other races. The average age was 63, and 84% were male. Of the caregivers, 81% were white, 11% were black, and 5% were other races. The average age was 61, 77% were women, and 76% were patients’ spouses.
Before and after receiving the shared decision or usual education intervention, participants completed a survey that assessed their knowledge about DT LVAD. One month after their intervention, participants completed a survey about their values on topics such as maximizing lifespan or avoiding surgery. Researchers determined concordance by comparing patients’ stated values and their stated treatment choice. They used health records to verify whether patients actually received DT LVAD.
A patient who received DT LVAD and the caregiver of a patient who did not receive DT LVAD helped create the intervention and reviewed study results.
Results
DT-LVAD knowledge increased for patients and caregivers in both groups. Compared with patients who received usual education, patients who received the shared decision support intervention had a greater increase in DT LVAD knowledge (p=0.03). Caregivers in the two groups did not differ in this outcome.
One month after receiving standard education or intervention, patients (p=0.013) and caregivers (p=0.026) who received the intervention had higher concordance between their stated values and their stated treatment choice compared with patients and caregivers who received usual education. However, patients and caregivers did not differ between groups in concordance between their stated values and the treatment they eventually received.
Limitations
Most patients and caregivers were white. Most patients were male, and most caregivers were female spouses. Results may differ for participants from other backgrounds.
Conclusions and Relevance
The shared decision support intervention improved decision quality by increasing patient knowledge and increasing patient and caregiver concordance between stated values and stated treatment preference.
Future Research Needs
Future research could explore why the difference between groups in concordance between stated values and treatment preference did not extend to actual treatment received.
Final Research Report
View this project's final research report.
Implementation
Related PCORI Dissemination and Implementation Project
Journal Citations
Article Highlight: Surgically implanting a left ventricular assist device (LVAD) can prolong the lives of people with end-stage heart failure. But the surgery and device carry significant risk for harms, such as infections and stroke, according to researchers in an article in JAMA Internal Medicine. Using a shared decision making tool improved patients’ knowledge about the potential benefits and risks of an LVAD compared with typical educational pamphlets. The aid also helped them make initial decisions better aligned with their values.
Results of This Project
Related Journal Citations
Stories and Videos
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.