Abstract
Background: In 2018, CMS required shared decision-making (SDM) with a decision (DA) prior to implantation of a primary prevention cardioverter defibrillator (ICD). Little is known about how DAs should be incorporated, but the implementation strategy may affect the process. Providing DAs prior to the SDM visit may facilitate informed discussion. However, this requires identifying ICD candidates ahead of time which may be logistically challenging. Providing the DA during the office visit requires less administrative effort but may reduce the impact of the DA. Objective: To evaluate the impact of DA timing on SDM outcomes. Methods: Patients referred for ICD implantation were block randomized across 3 clinics to receive the DA 30 minutes prior to, or at the end of the SDM visit. Patients were surveyed on implant day in several SDM domains including knowledge about ICDs, decisional conflict, values-choice concordance and the extent to which patients felt engaged in the decision-making process. Patients who chose not to have an ICD implanted after the SDM visit were surveyed by mail. Implanting physicians were also surveyed to assess perceptions about the impact of the DA. Results: Of 42 randomized patients, 24 completed the survey with 9 who received the DA before and 15 after the SDM visit. Three chose not to have an ICD implanted: 1 received the DA before and 2 after the visit. Though overall knowledge about ICDs was similar between groups (Table), every patient who received the DA before the encounter understood the primary purpose of the ICD, compared with 10/15 who received the DA after the visit. Receiving the DA earlier showed a numerically higher rate of understanding the risk of inappropriate ICD shocks. No significant differences were observed in decisional conflict, values-choice concordance, or reported patient engagement in decision-making. Conclusion: Patients who received a DA prior to the visit had numerically, but not significantly, higher rates of understanding the purpose of the ICD and risk of inappropriate shocks. These pilot data suggest that efforts to provide DAs ahead of time may strengthen SDM interaction and that an implementation strategy is critical to study. Important knowledge gaps remain in both groups, suggesting opportunities to improve SDM for ICDs.
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