Abstract 17354: A Canadian Pilot Randomized Controlled Trial for a Decision Support Intervention in de novo Implantable Cardioverter Defibrillator Candidates - Main findings

Introduction: Patient decision aids (PtDA) support quality decision making and improve patient reported outcomes. This pilot randomized controlled trial aimed to evaluate the use of an ICD specific PtDA on patient’s decisional conflict and ICD knowledge. Methods: In accordance with the International Patient Decision Aid Standards (IPDAS), a PtDA was developed. We conducted a single-centre non-blinded RCT with concealed allocation to evaluate the effect of a PtDA in patients offered an ICD for primary prevention. Exclusions: 1) inability to read English and complete a PtDA, 2) ICD for secondary prevention, 3) biventricular devices. Consented patients were randomized to 1) usual care, 2) PtDA intervention. Prior to specialist consultation the PtDA intervention group received the PtDA. The primary outcome of decisional conflict was measured before consultation and post-ICD implantation. The decisional conflict scale measures patient’s perception of difficultly making a decision, uncertainty regarding the decision and factors contributing to uncertainty. Higher scores are indicative of greater decisional conflict. Knowledge was measured as a secondary outcome using 5 questions related to ICD treatment, benefits and risks. Results: Eighty-two patients were randomized to usual care (n=41) or PtDA intervention (n=41). Mean age (SD) was 66.76 (11.05), 27% female. Baseline characteristics between groups were balanced. Patients receiving the PtDA intervention scored significantly lower on the DCS scale with a total mean score of 27.32 (18.37) when compared to usual care, scoring 49.53 (18.62) (p<0.0001). This difference remained post implantation, 21.16 (11.71) PtDA intervention, 29.89 (13.32) usual care, (p=0.0041)). The PtDA intervention group were more knowledgeable, with 47.50% scoring greater than 3/5 of the knowledge questions correct, compared to 23.09% receiving usual care (p=0.023). Conclusion: The results of this pilot study suggest that use of an ICD-specific PtDA reduced patient’s decisional conflict both pre and post implantation and improved knowledge. In the context of making decisions regarding life prolonging interventions, our findings suggest evidence based decision support results in improved patient decision quality.