Decision Support for Implantable Cardioverter-Defibrillator Replacement: A Pilot Feasibility Randomized Controlled Trial.

BACKGROUND: Decision support can help patients facing implantable cardioverter-defibrillator (ICD) replacement understand their options and reach an informed decision reflective of their preferences. OBJECTIVE: The aim of this study was to evaluate the feasibility of a decision support intervention for patients faced with the decision to replace their ICD. METHODS: A pilot feasibility randomized trial was conducted. Patients approaching ICD battery depletion were randomized to decision support intervention or usual care. Feasibility outcomes included recruitment rates, intervention use, and completeness of data; secondary outcomes were knowledge, values-choice concordance, decisional conflict, involvement in decision making, and choice. RESULTS: A total of 30 patients were randomized to intervention (n = 15) or usual care (n = 15). The intervention was used as intended, with 2% missing data. Patients in the intervention arm had better knowledge (77.4% vs 51.1%; P = .002). By 12 months, 8 of 13 (61.5%) in the intervention arm and 10 of 14 (71.4%) in the usual care arm accepted ICD replacement; 1 per arm declined (7.7% vs 7.1%, respectively). CONCLUSION: It was feasible to deliver the intervention, collect data, despite slow recruitment. The decision support intervention has the potential to improve ICD replacement decision quality.