Results Summary and Professional Abstract
Related PCORI Dissemination and Implementation Project
Final Research Report
View this project's final research report.
|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
Are Decision Aids Beneficial to Patients Deciding Whether to Receive an LVAD? (Right-top)
Principal Investigator Larry Allen, MD, shares the results of this study, which created a formal patient decision aid and video to assist patients and caregivers decide whether to undergo a left ventricular assist device (LVAD) procedure. An LVAD is a mechanical pump implanted inside a person's chest to help a weakened heart pump blood.
Project Involves Caregivers of Patients Considering LVAD Procedures (Right-bottom)
Principal Investigator Larry Allen, MD, shares how this study benefited from the involvement of caregivers. Their experiences shaped the creation of decision aids, which sought to improve materials used to help patients decide whether an LVAD procedure was right for them.
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.
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Training and Education Interventions