Developing a Digital Aid to Improve ICD Decisions

Advanced heart failure, affecting 7 million Americans, has multiple causes and results in greatly increased risk of disability and death. A major problem is sudden cardiac death, when the damaged heart develops an abnormal pattern of electrical conduction that can result in cessation of heart activity. While placement of an Implantable Cardioverter-Defibrillator (ICD) in a patient's chest can help prevent sudden cardiac death, these devices have several important downsides. This protocol focuses on development of a digital decision aid that helps heart failure patients make informed decisions that balance the benefits and downsides of ICD placement. This protocol covers the use of participant surveys, focus groups, and interviews to obtain the needed background information to guide the development of this digital tool, which will be subsequently tested against usual care in a randomized clinical trial. The study design is best described as a mixed methods evaluation and refinement of a digital app to improve ICD decision-making. In the future, the present protocol will be modified to create a new protocol that covers the needed human subjects requirements for performance of this clinical trial.

Advanced heart failure, affecting 7 million Americans, has multiple causes and results in greatly increased risk of disability and death. A major problem is sudden cardiac death, when the damaged heart develops an abnormal pattern of electrical conduction that can result in cessation of heart activity. While placement of an Implantable Cardioverter-Defibrillator (ICD) in a patient's chest can help prevent sudden cardiac death, these devices have several important downsides. This protocol focuses on development of a digital decision aid that helps heart failure patients make informed decisions that balance the benefits and downsides of ICD placement. This protocol covers the use of participant surveys, focus groups, and interviews to obtain the needed background information to guide the development of this digital tool, which will be subsequently tested against usual care in a randomized clinical trial. In the future, the present protocol will be modified to create a new protocol that covers the needed human subjects requirements for performance of this clinical trial.

Participants with heart failure who agree to participate will be recorded in a REDCap system database. We will document in a recruitment tracking log all potentially eligible participants found to be ineligible or who decline participation. The reason for ineligibility or reason for decline will be captured along with age, gender, and race/ethnicity. At the time of their enrollment, we will collect additional information from each participant about their employment status (full-time or part-time employment, no employment, retired), education (no postsecondary education, some postsecondary education), household size (living alone, living with at least one other person).

Participants with heart failure will be asked if they are willing to be interviewed, participate in focus groups, or complete surveys to determine their views on 1) which elements of patient outcome questionnaires are important to them; 2) which decision aid components or educational tools they like or find valuable. Interactions with participants will include open-ended interviews, focus groups, and surveys. These interviews, focus groups, and surveys will be conducted by study staff to help develop a patient-centric shared decision making software tool. Development will occur iteratively with new testing after any modifications. The same individuals may be asked to re-test the app following alterations.

Collaborating teams from UC San Francisco (Site PI: Daniel Morin, MD, MPH) and East Carolina University (Site PI: Samuel Sears, PhD) will join the study before the third month of operation. The participation of these clinical sites is not needed in the first steps on digital tool development. By successfully initiating the project at Stanford, the process of initiation at the clinical sites will be facilitated and is consistent with the mandated use of a single IRB for the three sites.