Sepucha K, Elmariah S, Valentine KD, Cavender MA, Chang Y, Devireddy CM, Dickert NW, Gama KD, Knoepke CE, Korngold E, Kumbhani DJ, Matlock DD, Messenger JC, Strong S, Thourani VH, Nathan A, Quader N, and Brescia AA
Background: The American College of Cardiology, American Heart Association, and Centers for Medicare and Medicaid Services recommend shared decision-making (SDM) for patients with severe aortic stenosis choosing between transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR). Although tools such as patient decision aids (DAs) and training in SDM have been shown to improve SDM, implementation of SDM and DAs is limited. The IMproving treatment decisions for Patients with AortiC stenosis Through Shared Decision Making (IMPACT SDM) study aims to (1) determine the effectiveness of the interventions (a DA and clinician SDM training) in achieving SDM (primary outcome) and improving the quality of decisions about aortic valve replacement, (2) determine the reach of the DAs and adoption of training, and (3) explore potential mechanisms of effectiveness and implementation at the patient-, clinician-, and clinic-level., Methods: The study is a hybrid type II effectiveness-implementation study using a cluster randomized batched stepped wedge trial with 8 sites across the USA. Eligible patients will be surveyed before and after visits with the heart valve team; clinicians will be surveyed after visits. Reach of DAs and adoption of training will be tracked. Clinicians will be interviewed regarding barriers and facilitators to implementation., Discussion: The IMPACT SDM Study seeks to provide evidence of the ability of the interventions to improve SDM and decision quality, and also to shed light on barriers and facilitators to SDM implementation to promote future implementation efforts., Trial Registration: ClinicalTrials.gov NCT06171737. Registered on December 15, 2023., Competing Interests: Declarations. Ethics approval and consent to participate {24}: Ethical approval for the study will be provided by each site individually. The majority of sites approved waiver of written consent to participate in this minimal risk trial, and consent is implied by completion of the survey. Consent for publication {32}: At 6 sites, participants will receive an information sheet reviewing options, benefits, and risks of the trial and consent will be implied by return of the pre-visit survey. At one site, research staff will obtain written consent and at one site research staff will obtain and document verbal consent. Competing interests {28}: NL reports being a consultant for Edwards Lifesciences. CK reports a K23 from NHLBI (K23HL153892). CD reports paid consulting fees from Medtronic and Record Medical. EK reports receiving honoraria from Abbott, Boston Scientific, Edwards, and Medtronic. ND receives research support from the American Heart Association, NIH, AHRQ, and Merck and research funding and consulting for Abiomed. KS reports receiving funding for shared decision-making research from PCORI, AHRQ, and NIH, outside submitted work. KS developed the Shared Decision-Making Process scale (copyright Massachusetts General Hospital) that is being used as an outcome measure in the study. KV reports receiving support for shared decision-making research from PCORI and AHRQ outside submitted work and receiving research funding from Google LLC outside the submitted work. SE reports receiving research funding and consulting fees from Edwards Lifesciences and Medtronic. VT reports advising and research with Artivion, AtriCure, Boston Scientific, Abbott Vascular, CroiValve, Edwards Lifesciences, Medtronic, JenaValve, HighLife, Innovalve, and DASI Simulations. JM reports institutional grant support from the University of Colorado School of Medicine: Philips Medical Systems, Medtronic Corporation. SS reports travel sponsored by the ACC, Global Heart Hub, TCT, and Heart Valve Collaboratory and significant financial interests in Heart Valve Voice US. AN has received institutional research funding and speaker fees from Edwards Lifesciences, which is involved in products for the treatment of aortic stenosis. AB reports receiving honoraria for teaching a course at Edwards Lifesciences. DM, MC, YC, KG, NQ, and DK report no conflicts of interest., (© 2024. The Author(s).)