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Implementation Project (Implementation of Effective Shared Decision Making Approaches PFA)
Completed

Expanding a Shared Decision Making Program for Patients Considering LVAD Treatment

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 expanded the use of a shared decision making program—shown to help patients with advanced heart failure decide whether to get a left ventricular assist device, or LVAD— to LVAD clinics across the United States.
Heart failure occurs when the heart doesn’t pump blood as well as it should. In advanced heart failure, people may have shortness of breath and other symptoms even at rest. An LVAD is a battery-powered pump that doctors implant in the heart to help people with advanced heart failure live longer. But LVADs have serious risks, such as stroke, bleeding, and infection. Patients with an LVAD may also need frequent hospital care. In addition, people who get LVADs need help from a caregiver and must make changes to their lifestyle. Understanding the potential benefits and harms of LVADs can help patients make the best decisions for themselves.

What was the goal of this implementation project?

In shared decision making, or SDM, patients work with their doctors to select treatments and medical tests based on what’s most important to them. A PCORI-funded research study found that patients who took part in an SDM program knew more about LVADs than patients who received usual LVAD education. They were also more likely to get treatment that matched their goals than patients who received usual LVAD education. The program included an eight-page printed decision aid pamphlet and a 26-minute video to help patients understand and weigh the benefits and harms of LVADs. The program also trained doctors and staff in using the materials with patients and caregivers.

This project worked with LVAD clinics across the United States that were interested in adopting the program.

What did this project do?

In preparation for this project, the project team updated the decision aid:

  • To work for all patients thinking about getting an LVAD, including both patients who were and were not considering a heart transplant.
  • To account for new types of LVADs.

First, the project team put the program in place at 18 LVAD clinics that expressed interest in the program. The team then surveyed the remaining 157 U.S. LVAD clinics. Surveys asked how interested and ready clinics were to make SDM part of the standard education they provide to patients with advanced heart failure.

The project team offered all interested LVAD clinics free patient materials, user manuals, training webinars, and support calls for staff. Clinics could select the materials and supports that worked best for them.

The project team designed the SDM program to fit LVAD clinics’ needs. LVAD care teams could choose to use the program before or during a clinic visit or offer it to patients as a stand-alone resource. The decision aid could also be delivered by different team members, such as LVAD nurse coordinators, advanced practice providers, social workers, and palliative care and cardiology physicians.

Several groups helped connect the project team to clinic staff and communicate about the SDM program. These groups were the American College of Cardiology, the Society for Transplant Social Workers, the American Association of Heart Failure Nurses, and the International Consortium of Circulatory Assist Clinicians.

What was the impact of this project?

In total, 169 LVAD clinics, or 97% of all LVAD clinics in the United States, chose to receive free copies of the decision aid pamphlet and SDM program resources.

In surveys completed by 156 of these LVAD clinics, 123 (79%) reported using the decision aid with their patients. In total, these clinics used the decision aid with 7,132 patients, or 83% of all patients who were eligible to receive an LVAD and had a clinical evaluation for LVAD placement at these sites. An additional 10 clinics (6%) reported that they had used the decision aid but stopped using it; 23 clinics (15%) said they didn’t use it.

Among clinics that reported using the decision aid with patients, a majority (65%) reported using it as part of standard care or using it frequently (19%). Some (55%) used both the pamphlet and the video decision aid; others (41%) used just the pamphlet. A few clinics (3%) used only the video version.

Almost all responding clinics (95%) planned to continue using the decision aid.

The project team asked patients at 16 of the clinics to complete surveys about their LVAD decision making. The clinics were of different types and sizes and were located across the country. Among the 205 respondents:

  • 134 reported receiving the decision aid pamphlet; 75% of these patients spent more than 15 minutes with it.
  • 84 reported receiving the decision aid video; 85% of these patients watched the full video.
  • Most (94%) respondents reported reviewing the decision aid with a family member or friend.

Overall, patients reported high levels of SDM. On the CollaboRATE measure of SDM, patients gave their visit an average score of 8.5 out of 9. On another measure of the SDM process, patients gave a mean score of 2.8 out of 4.

In patient reports describing the LVAD decision aid:

  • 66% said it had the right amount of information
  • 53% said it was easy to understand
  • 77% would recommend it to someone with heart failure
  • 84% said it was helpful in the decision-making process

But only 56% of respondents said the information was completely balanced. Further, only 43% said it didn’t present one option as the best choice but was neutral and balanced. Also, in response to specific questions about the SDM conversation:

  • A majority of patients (63%) reported that their care team didn’t talk about an alternative to LVAD as an option to seriously consider.
  • Most patients (95%) reported that their care team discussed reasons patients might want an LVAD; only half (49%) reported discussing reasons they might not want one.

More about this implementation project:

Stakeholders Involved in This Project

  • American College of Cardiology
  • Heart Failure Society of America
  • MyLVAD.com
  • Society for Transplant Social Workers
  • American Association of Heart Failure Nurses
  • International Consortium of Circulatory Assist Clinicians

Publicly Accessible Project Materials

PatientDecisionAid.org website:

For clinicians:

For caregivers:

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

    • Reached 7,132 patients with advanced heart failure who were considering an LVAD.
    • Created implementation resources that LVAD clinics can use to put the SDM program in place.
    • Created resources for caregivers of patients with an LVAD.
    • Worked with 80 LVAD clinics to make the decision aid part of standard care and with 23 additional clinics that used it frequently.

    Implementation Strategies

    • Assessed for readiness at sites. 
    • Promoted SDM. 
    • Adapted the SDM approach, including plans for decision aid integration, to work for sites’ existing resources and workflows. 
    • Provided educational materials to patients as part of the decision aid.
    • Provided educational materials to caregivers of patients with LVADs as part of the course booklet.
    • Provided sites with tools to support implementation, including an implementation user guide. 
    • Trained LVAD clinic staff to deliver the program through webinars. 
    • Used a phased implementation approach based on site readiness. 
    • Identified and prepared local champions at sites. 
    • Provided technical assistance to sites including consultation. 
    • Offered continuing education and maintenance of certification credits.

    Evaluation Measures 

    To document implementation:

    • Number of LVAD clinics reporting that they use the decision aid in clinical care
    • Site survey-based report on consistency of decision aid use with patients
    • Barriers to and facilitators of LVAD SDM program implementation

    To assess healthcare and health outcomes:

    • Patient LVAD decision quality and acceptability

    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.

    Family caregivers help care for patients with an LVAD at home. During COVID-19, as health systems switched from in-person care to telehealth care, caregivers took on expanded roles. Caregivers took patients’ vital signs, managed patients’ medicines, and checked for signs of worsening disease. At the same time, COVID-19 restricted caregivers’ own supports.

    Through this enhancement, the project team added caregiver support to the LVAD SDM program. The project team developed resources for clinicians, including four online training modules, a user guide, and coaching talking points, as well as a course booklet and discussion board for caregivers. Clinicians could refer caregivers to access support from a trained coach via telehealth or through a web-based support group.

    During the project, 45 clinicians completed the training, including registered nurses, social workers, advanced practice providers, and a palliative care physician. Among the clinicians, 10 reported using the program with a total of 23 caregivers.

    Participants voiced appreciation for what they learned from the training and many expressed interest in using it. However, clinicians reported barriers to using the program, including:

    • Competing demands on their time due to staffing shortages
    • Lack of clarity on how best to use the program in practice

    Journal Citations

    Related Journal Citations

    Journal Citation

    Shared Decision-Making for Left Ventricular Assist Devices: Rationale and Design of a Nationwide Dissemination and Implementation Project

    Project Information

    Daniel D. Matlock, MD, MPH
    University of Colorado Denver
    $2,588,989
    Tailored Implementation of a Decision Support Strategy for Left Ventricular Assist Devices

    Key Dates

    June 2018
    July 2023
    2018
    2023

    Study Registration Information

    HSRP20191566

    Initial PCORI-Funded Research Study

    This implementation project focuses on putting findings into practice from this completed PCORI-funded research study: Supporting Shared Decision Making for Patients with Heart Failure Offered a Left Ventricular Assist Device -- The DECIDE-LVAD Trial

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    Last updated: October 13, 2023