User-centered Development of a Decision Aid for Patients Facing Implantable Cardioverter-Defibrillator Replacement A Mixed-Methods Study

Background: Because of battery depletion, an implantable cardioverter-defibrillator (ICD) generator requires surgical replacement every 5 to 7 years. Routine replacement is the norm without discussion with patients about whether or not to proceed. Objective: The aim of this study was to develop a patient decision aid (PDA) for patients facing ICD replacement and plan for its implementation. Methods: An embedded mixed-methods study was conducted using questionnaires and semistructured interviews focused on current ICD replacement practices; PDA acceptability, usability, and content; and PDA implementation. Transcripts were analyzed using constant comparative analysis. Results: Eighteen PDA end users in 16 interviews characterized the current ICD replacement approach as automatic without consideration for patient preferences. The PDA was positively received, and the content was iteratively revised 4 times during the interviews. Changes were related to missing and excess information, language, and wording. The PDA was identified as a means to support a shared decision-making (SDM) process, not to be used as a standalone instrument. To shift current practices to an SDM process, participants identified that an invitation to discuss the option of ICD replacement is required-whether initiated by the patient or the clinician. Conclusion: Currently, the option of ICD replacement is rarely offered, and patient preferences are seldom elicited. Participants believed the PDA to be a useful intervention that could help facilitate an SDM process for patients facing ICD replacement. Preparing for implementation during the development phase will allow us to strategize effectively to overcome perceived barriers and capitalize on perceived facilitators during actual implementation.