Project Summary

This implementation project is complete.

PCORI implementation projects promote the use of findings from PCORI-funded studies in real-world healthcare and other settings. These projects build toward broad use of evidence to inform healthcare decisions.

This PCORI-funded implementation project made a left ventricular assist device, or LVAD, decision aid—shown to increase patient knowledge of LVADs and satisfaction with LVAD implants—part of standard practice at eight hospitals.

For some patients with advanced heart failure, one treatment option is an LVAD. An LVAD is a device doctors place in the heart to help pump blood throughout the body. LVADs can help patients live longer and improve symptoms. But LVADs come with serious risks, such as strokes, bleeding, and infection. In addition, people with LVADs need help from a caregiver and must make lifestyle changes.

What was the goal of this implementation project?

Patients with advanced heart failure who are considering an LVAD may need to weigh important trade-offs when deciding whether an LVAD is right for them. A PCORI-funded study tested a decision aid designed to help patients with advanced heart failure work with their doctors to make this decision. The study found that patients who used the decision aid knew more about LVADs than patients who didn’t use it, including what life would be like with an LVAD and what care is needed for a person with an LVAD. Also, patients who used the decision aid and chose an LVAD were more satisfied with their lives and said that life with the LVAD was closer to what they expected.

This project made the decision aid part of regular care at eight hospitals with LVAD clinics in seven states to help patients make decisions about LVADs.

What did this project do?

The project team worked with staff at the LVAD clinics to put the decision aid in place for patients who were eligible for an LVAD and their caregivers. The team adapted the decision aid to include new information and translated it into Spanish. Then at each clinic, LVAD coordinators educated patients about LVADs, answered questions, and encouraged patients to bring the decision aid to visits with their heart doctors.

To make the decision aid part of regular care, the project team:

  • Worked with doctor champions at each clinic who promoted the use of the decision aid, such as LVAD program directors, surgeons, and heart doctors
  • Trained staff, including LVAD coordinators and heart doctors, on how to use the decision aid with patients and their caregivers
  • Conducted visits at each clinic to support the use of the decision aid
  • Gave feedback to LVAD coordinators about the clinic’s use of the decision aid
  • Created plans to help LVAD clinics continue using the decision aid, such as finding ways to print the decision aid at a lower cost or viewing it on a tablet at the clinic

The project team also developed a toolkit for LVAD clinics that want to make the decision aid part of routine care. The toolkit has information about how to start the process and overcome common problems. It also includes a checklist and a list of frequently asked questions.

What was the impact of this project?

During the project, more than 2,000 patients and caregivers received the decision aid. The project team’s evaluation showed that after the program was put in place:

  • More than 90% of eligible patients and caregivers received the decision aid.
  • More than 67% of eligible patients and caregivers used the decision aid.
  • Most clinicians interviewed thought the decision aid helped clinicians and patients make shared decisions about LVADs.

More about this implementation project:

Stakeholders Involved in This Project

  • LVAD coordinators, physician champions, and patient partners at each hospital.
  • Partner hospitals included Houston Methodist, Baylor St. Luke’s, Aurora St. Luke’s, Brigham and Women’s, Cleveland Clinic, Montefiore, University of Chicago, and INTEGRIS Baptist

Publicly Accessible Project Materials

For more information about these materials, please contact the Project Team at [email protected].

The project team developed these materials, which are available for free on the website listed above. Please note that the materials do not necessarily represent the views of PCORI and that PCORI cannot guarantee their accuracy or reliability.

Project Achievements

  • Translated decision aid into Spanish
  • Demonstrated the feasibility of expanding use of the decision aid into clinical practice at eight hospitals
  • Developed a COVID-19 supplement to the decision aid to provide tailored risk-prevention messages to users; used behavioral economics-based approach to encourage uptake
  • Created a publicly available implementation toolkit, which includes resources on beginning implementation, solutions to common barriers, and checklists for full implementation
  • Identified clinic-level factors influencing successful uptake of the decision aid in practice and concrete strategies for enhancing uptake

Implementation Strategies

  • Promoted shared decision making

  • Adapted the shared decision making approach, including plans for decision aid integration, to work for sites’ existing resources and workflows
  • Adapted the decision aid to include updated information about a new LVAD approved by the U.S. Food and Drug Administration, to address patients’ questions and concerns related to COVID-19, and to translate the decision aid into Spanish
  • Provided sites with tools to support implementation, including manuals and toolkits
  • Provided educational materials to patients as part of decision aid
  • Conducted educational meetings for clinicians, including grand rounds and lunch and learns
  • Trained LVAD coordinators and clinicians on shared decision making and on how to introduce and use the decision aid with patients and caregivers, through webinars
  • Identified and prepared physician champions at sites to promote delivery and use of the decision aid by LVAD coordinators and clinicians
  • Conducted site visits
  • Provided technical assistance to sites, including ongoing consultation and performance feedback
  • Developed an implementation guide to support further use of the shared decision making approach at other sites

Evaluation Outcomes

To document implementation:

  • Reach, the percentage of eligible patients or caregivers of patients who received the decision aid
  • Fidelity, the percentage of times staff indicated they:
    • Administered the decision aid
    • Provided assistance in use of the decision aid
    • Explained shared decision making
    • Discussed the patient’s most important values
    • Discussed other options
    • Provided time for open-ended questions from patients
    • Offered to facilitate meetings with an LVAD patient
    • Encouraged the patient to bring the decision aid to physician appointments
    • Referred the patient to a social worker or financial advisor
    • Invited the patient to receive a knowledge quiz

To assess healthcare and health outcomes:

  • Qualitative interviews with physicians and staff about decision aid use.

COVID-19-Related Project Activities

  • PCORI supplemental funding supported project activities to address needs evolving or emerging in the context of the COVID-19 public health crisis.

    At the onset of the pandemic, patients with advanced heart failure who were thinking about getting an LVAD had questions and concerns about COVID-19. With supplemental funding, the project team developed a resource about COVID-19. The resource focused on:

  • Changes to the LVAD treatment process due to COVID-19
  • Ways to reduce the risk of getting COVID-19 before and after surgery

During visits with LVAD clinic staff, more than 260 patients viewed this resource as they used the decision aid.

Project Information

Jennifer Blumenthal-Barby, PhD, MA
Baylor College of Medicine
$803,511
Dissemination and Implementation of a Patient-Centered Decision Aid for Ventricular Assist Device Placement

Key Dates

July 2021
2018
2022

Study Registration Information

Initial PCORI-Funded Research Study

This implementation project focuses on putting findings into practice from this completed PCORI-funded research study: Does a Decision Aid Help Patients Learn about Their Treatment Options for Advanced Heart Failure?

Tags

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Health Conditions Health Conditions These are the broad terms we use to categorize our funded research studies; specific diseases or conditions are included within the appropriate larger category. Note: not all of our funded projects focus on a single disease or condition; some touch on multiple diseases or conditions, research methods, or broader health system interventions. Such projects won’t be listed by a primary disease/condition and so won’t appear if you use this filter tool to find them. View Glossary
State State The state where the project originates, or where the primary institution or organization is located. View Glossary
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Last updated: December 5, 2022