A Multi-Site Trial to Test Benefits of Adding a Personalized Risk Calculator to an Online Decision Aid for Left Ventricular Assist Device (Texas)

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Providing patients with advanced heart failure a holistic and customized clinical decision support system that guides their understanding of how treatment options align with their expressed values, personalized risk estimates, and communicates these values to their clinical team can improve informed and shared decision making.

Project Details - Ongoing

Summary:

A left ventricular assist device (LVAD) is a surgically implanted electromechanical device to assist cardiac circulation in patients with advanced heart failure. This mechanical pump is now rivaling heart transplant as the standard treatment of advanced heart failure for many patients. However, given the highly variable individual risks and outcomes, uncertainty remains over which patients are most likely to benefit from implantation. There is a growing need for more personalized approaches to risk prediction and shared decision making for patients, caregivers, and providers.

The objective of this research is to improve patients’ informed and values-based decision making capabilities surrounding LVAD implementation by employing a holistic and customized clinical decision support system. This novel system will update and integrate a validated, artificial intelligence-based, online risk-prediction and communication tool, the Cardiac Outcomes Risk Assessment (CORA), with the research team’s own validated LVAD decision aid, Deciding Together. This new tool will offer patients a better understanding of how treatment options align with their values and personalized risks, along with the functionality to communicate these values to their clinical team.

The specific aims of the research are as follows:

  • Identify patients’ and physicians’ views on the practical, ethical, and contextual considerations in using CORA to enhance patient understanding of personalized risk. 
  • Translate patients’ and physicians’ views of practical, ethical, and contextual considerations identified in the first aim into a new and improved clinical decision support platform (VADDA-CORA) that integrates CORA with Deciding Together, the efficacy-tested decision aid for LVAD. 
  • Evaluate the impact of the new, integrated, personalized risk decision support platform on the quality of collaborative decisions for LVAD treatment. 

Over the course of 5 years, this research will work to fully understand the needs and considerations of patients, caregivers, and providers when considering LVAD as a treatment option for advanced heart failure. Through interviews with patients, caregivers, and physicians, the research team will enhance the development and implementation of CORA as a clinical decision support tool. The system will be further validated and integrated with Deciding Together to test its efficacy and ensure ethical, responsible, and feasible use of the new tool. Usability testing will occur among patients, caregivers, LVAD coordinators, and physicians to collect feedback and to optimize the patient-facing side of the application. The last phase of the research will consist of a randomized clinical trial across six partnering LVAD clinics to compare standard decision support with the personalized decision support the new CORA system.

The research team hypothesizes that incorporating a personalized risk communication tool for LVAD candidates will enhance informed decision making. This work will also address the urgent need to better identify and respond to the specific and dynamic nature of patient needs and ensure that patients with advanced heart failure receive tailored treatments that lead to optimal and values-based outcomes.