Development of a Veteran-Centered Approach to ICD Decision-making in the VA

Background: Aligned with the VA Strategic Plan and Blueprint for Excellence1, it is critical to ensure Veteran- centered, values-concordant care (extent to which Veterans receive therapies that reflect their goals and treatment preferences) through informed, shared decision-making. This is especially important with regards to

ICDs (implantable cardioverter-defibrillators) - permanent, surgically implanted cardiac devices with intent to monitor and treat life-threatening heart rhythms with an electrical shock. ICDs present a complicated balance of patient benefit (ie. detection and treatment of dangerous heart rhythms), procedural risk, long-term

maintenance (ie. battery and lead monitoring) and impact on psychological health (ie. heightened levels of PTSD, anxiety and depression from ICD shocks).2,3 Significance / Impact: Given high rates of heart failure among Veterans4,5, ICD implantation rates across the VA have risen sharply over the past decade with over 25,000 ICDs implanted at an average per-procedure

cost of $64,5006. However, this rise may not be indicative of well-informed, values-concordant care. Numerous prior studies show patients poorly comprehend risks, benefits, psychological effects and complications associated with ICD implantation - often left with false impressions such as ICD is a “cure” for

heart failure, requires no maintenance, and does not lead to inappropriate shocks. Prior data also demonstrate that providers overemphasize the benefit of ICDs and patients markedly overestimate benefit.7 In February 2018, CMS mandated use and documentation of shared decision prior to ICD implantation. Likely an

underestimation, currently there are approximately 135,000 ICD-eligible Veterans in the VA system. Innovation: Nationally and within the VHA, this discord has led to a call for decision-support tools to aid patients in making informed, personalized decisions, particularly for invasive therapies with complex risk-

benefit tradeoffs such as ICDs.8 Innovative aspects include: (1) a significantly improved, comprehensive tool to support ICD communications, (2) designed for routine implementation within VA clinical care, (3) study of transition of tools from a non-VA to VA setting, (4) addressing a high-stakes decision (national mandate by

CMS for SDM tools) and (5) integration into existing VA quality-improvement infrastructure (CART-EP). Specific Aims: The central hypothesis of this proposal is that current ICD decision-making processes are heterogeneous and lack sufficient Veteran perspective. We will address this through: Aim 1: Determine Veteran and VA-provider specific factors surrounding ICD decision-making.

Aim 2: Develop an VA-provider led tool that meets Veteran needs for routine use within the VA. Aim 3: Feasibility testing of the newly developed tools designed to support ICD communications. Methodology: This project will target Veterans that are (1) ICD-eligible, (2) have ICDs in situ or (3) have refused ICD therapy and VA-providers who care for such Veterans. In Aim 1, semi-structured face-to-face

interviews will be conducted with qualitative data analyzed in an inductive-deductive format. Output will directly inform Aim 2 – development of tools to personalize, enhance and support Veteran-provider ICD communications within the VA. Aim 3 will test the tool using the RE-AIM framework among 4 diverse VA sites.

Implementation and Next Steps: At the completion of this CDA, the tools will be ready for immediate testing through an IIR project (IIR #2) seeking to evaluate this tool, in comparison to standard of care, at multiple VA- sites. Dr. Sandhu is leading the development of CART-EP, a VA-funded project extending use of CART

(quality system for invasive cardiovascular procedures) to ICDs. We will incorporate use of this ICD SDM tool as a quality measure into CART-EP prior to ICD implantation within the VA. CART-EP will serve as a method to study large-scale dissemination and implementation of this tool nationally (ie. step-wedge effectiveness-

implementation trial among a broad representation of VA clinical practices).