The Dutch Implantable Cardioverter–Defibrillator Decision Aid in Clinical Practice: A Stepped-Wedge Randomized Controlled Trial

Introduction The role of shared decision making (SDM) has become increasingly pivotal, particularly in nuanced choices such as those involving implantable cardioverter–defibrillator (ICD) therapy. This study evaluates the impact of the Dutch ICD Decision Aid on SDM in patients up for ICD implantation or replacement. Methods A stepped-wedge randomized controlled trial was conducted across 6 Dutch hospitals between February 2018 and September 2019, involving patients eligible for ICD implantation or pulse-generator exchange. SDM experiences of the patients and involved medical professionals were assessed using SDM-Q-9 and SDM-Q-Doc questionnaires, respectively. The Decisional Conflict Scale (DCS) scores measured effective decision making. The intervention group received the decision aid on top of standard care. Results A total of 150 patients and 233 health care providers were included in the study. For health care providers, SDM scores did not differ: the SDM-Q-Doc median score was 36 (28–38) in the control phase and 35 (33–40) in the intervention phase ( P = 0.81). Patients in both the intervention and control groups demonstrated high SDM scores as well. Decisional conflict scores were low: the median DCS score was 12.5 (4.3–23.4) in the intervention phase and 16.4 (6.25–25.0) in the control phase ( P = 0.45). Patients with a higher education provided more correct answers to the theoretical knowledge questions. In addition, patients up for a pulse-generator exchange also had significantly more correct answers. Conclusions Although the Dutch ICD Decision Aid did not result in significant differences in SDM scores or levels of decisional conflict between patient groups, both measures remained consistently favorable overall. The decision aid still holds promise as a valuable resource. Efforts should focus on refining decision-making tools and improving patient knowledge and the quality of patient-centered care. Highlights A digital decision aid did not significantly increase shared decision-making (SDM) scores for patients and health care providers, as SDM levels were already high across all groups. Despite high SDM scores, patient knowledge about implantable cardioverter–defibrillator (ICD) therapy remained low, highlighting a gap in understanding. Patients with higher education or prior experience with ICDs demonstrated better knowledge retention, indicating the need for tailored educational interventions. The study emphasizes the ongoing challenge of ensuring unbiased, well-informed decision making in ICD therapy, especially during pulse-generator replacements.