The impact of government-mandated shared decision-making for implantable defibrillators: A natural experiment.

BACKGROUND: In 2018, the Centers for Medicare and Medicaid Services (CMS) mandated that patients considering implantation of an implantable cardioverter-defibrillator (ICD) for primary prevention of sudden cardiac death undergo shared decision-making (SDM) using a decision-aid.
OBJECTIVE: To observe the impact of the CMS's mandate on core measures of SDM using a natural experiment. RESEARCH DESIGN, SUBJECTS, AND MEASURES: Patients who underwent implantation of a primary prevention ICD within the Emory Healthcare system between 2017-2019 (pre and post SDM mandate) were surveyed. Survey domains included knowledge about the ICD, decisional conflict, values-choice concordance, and engagement in decision-making. Patients who had an ICD implant after the mandate were also asked about their views of the decision aid (DA). Responses of patients who had ICD implanted prior to the mandate were compared to those after the mandate using either Student t test or Chi-Squared tests.
RESULTS: Of 101 patients who completed the survey, 45 had an ICD placed before the mandate and 56 had an ICD placed after. There were no major differences between knowledge, decisional conflict, values choice concordance, or patient engagement. Compared to patients with ICDs placed before the mandate, patients with ICDs after the mandate were more likely to subjectively feel more informed about the benefits of the procedure but were less likely to be able to correctly identify the frequency of complications.
CONCLUSIONS: Policy effects to promote SDM that solely focus on a decision-aid may not substantively impact patient centered care.